[20-F] KAZIA THERAPEUTICS LTD Files Annual Report (Foreign Issuer)
Kazia Therapeutics Limited filed its Annual Report on Form 20-F, outlining continued operating losses and funding needs as it advances oncology programs. The company reported net losses of A$20.5 million, A$26.8 million, and A$20.7 million for fiscal years 2023, 2024, and 2025, respectively. Revenue was A$42 thousand in 2025, compared with A$2.3 million in 2024, reflecting the irregular nature of licensing income.
As of June 30, 2025, cash at bank was A$4.3 million, and the company raised A$16 million during the year from ADS sales. Management disclosed substantial doubt about the company’s ability to continue as a going concern, with current resources expected to fund operations until approximately March 2026. The “Baby Shelf Rule” limits capital raises under Form F-3 until non‑affiliate float exceeds $75 million. Ordinary shares outstanding were 809,418,734 as of June 30, 2025.
Kazia completed ADS ratio changes, moving to 1 ADS = 100 ordinary shares on October 28, 2024 and to 1 ADS = 500 ordinary shares on April 17, 2025. Lead programs include paxalisib (PI3K/Akt/mTOR inhibitor) and EVT801 (VEGFR3 inhibitor), with added pipeline work through collaborations with QIMR, including a PD‑L1 degrader program.
- None.
- Substantial doubt about going concern with runway only until approximately March 2026
- Limited liquidity: A$4.3 million cash at June 30, 2025 against ongoing R&D needs
- Financing constraints under the Form F-3 Baby Shelf Rule until non-affiliate float exceeds $75 million
Insights
Going concern and limited cash underscore financing risk.
Kazia Therapeutics reported a FY25 net loss of
Management disclosed “substantial doubt” about continuing as a going concern, noting resources are expected to fund operations until approximately
The pipeline centers on paxalisib and EVT801 and references collaborations with QIMR, including a PD‑L1 degrader program. Execution depends on financing and clinical progress; capital availability and trial outcomes will drive updates in subsequent disclosures.
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| REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 |
| ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
| SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
| Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
American Depositary Shares, each representing five-hundred Ordinary Shares* |
The |
* |
Not for trading, but only in connection with the registration of American Depositary Shares. |
| U.S. GAAP ☐ |
by the International Accounting Standards Board ☒ |
Other | ☐ |
Table of Contents
TABLE OF CONTENTS
| FORWARD-LOOKING STATEMENTS |
1 | |||||
| PART I |
2 | |||||
| Item 1. |
Identity of Directors, Senior Management and Advisors | 2 | ||||
| Item 2. |
Offer Statistics and Expected Timetable | 2 | ||||
| Item 3. |
Key Information | 2 | ||||
| Item 4. |
Information on the Company | 32 | ||||
| Item 4A. |
Unresolved Staff Comments | 47 | ||||
| Item 5. |
Operating and Financial Review and Prospects | 47 | ||||
| Item 6. |
Directors, Senior Management and Employees | 55 | ||||
| Item 7. |
Major Shareholders and Related Party Transactions | 65 | ||||
| Item 8. |
Financial Information | 67 | ||||
| Item 9. |
The Offer and Listing | 68 | ||||
| Item 10. |
Additional Information | 69 | ||||
| Item 11. |
Quantitative and Qualitative Disclosures about Market Risk | 81 | ||||
| Item 12. |
Description of Securities Other than Equity Securities | 81 | ||||
| PART II |
83 | |||||
| Item 13. |
Defaults, Dividend Arrearages and Delinquencies | 83 | ||||
| Item 14. |
Material Modifications to the Rights of Security Holders and the Use of Proceeds | 83 | ||||
| Item 15. |
Controls and Procedures | 83 | ||||
| Item 16. |
[Reserved] | 84 | ||||
| Item 16A. |
Audit Committee Financial Expert | 84 | ||||
| Item 16B. |
Code of Ethics | 84 | ||||
| Item 16C. |
Principal Accounting Fees and Services | 84 | ||||
| Item 16D. |
Exemptions from the Listing Standards for Audit Committees | 85 | ||||
| Item 16E. |
Purchases of Equity Securities by the Issuer and Affiliated Purchasers | 85 | ||||
| Item 16F. |
Changes in Registrant’s Certifying Accountant | 85 | ||||
| Item 16G. |
Corporate Governance | 85 | ||||
| Item 16H. |
Mine Safety Disclosure | 86 | ||||
| Item 16I. |
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 86 | ||||
| Item 16J. |
Insider trading policies | 86 | ||||
| Item 16K. |
Cybersecurity | 87 | ||||
| PART III |
87 | |||||
| Item 17. |
Financial Statements | 87 | ||||
| Item 18. |
Financial Statements | 87 | ||||
| Item 19. |
Exhibits | 88 | ||||
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FORWARD-LOOKING STATEMENTS
This Annual Report on Form 20-F includes forward-looking statements, which involve a number of risks and uncertainties. These forward-looking statements can generally be identified as such because the context of the statement will include words such as “may,” “will,” “intend,” “plan,” “believe,” “anticipate,” “expect,” “estimate,” “predict,” “potential,” “continue,” “likely,” or “opportunity,” the negative of these words or other similar words. Similarly, statements that describe our future plans, strategies, intentions, expectations, objectives, goals or prospects and other statements that are not historical facts are also forward-looking statements. Discussions containing these forward-looking statements may be found, among other places, in “Business Overview” and “Operating and Financial Review and Prospects” in this Annual Report on Form 20-F.
These forward-looking statements include, without limitation, statements about the following:
| • | the cost, timing and results of preclinical studies and clinical trials and other development activities by us and our collaborative partners; |
| • | the likelihood of our clinical programs being executed on timelines provided and reliance on our contract research organizations (CROs) and predictability of timely enrollment of subjects and patients to advance our clinical trials and maintain their own operations; |
| • | our reliance on contract manufacturers to supply materials for research and development and the risk of supply interruption from a contract manufacturer; |
| • | the potential for future data to alter initial and preliminary results of early-stage clinical trials; |
| • | the unpredictability of the duration and results of the regulatory review of applications or clearances that are necessary to initiate and continue to advance and progress our clinical programs, and the ability to successfully submit the necessary applications or to obtain the necessary clearances; |
| • | the ability to secure, maintain and realize the intended benefits of collaborations with partners; |
| • | the possible impairment of, inability to obtain, and costs to obtain intellectual property rights; |
| • | our ability to attract and retain key scientific and/or management personnel; our ability to obtain funding for our operations, including funding necessary to complete further development and commercialization of our product candidates, if approved; |
| • | the accuracy of our estimates of our future revenue, expenses, capital requirements and needs for additional financing; |
| • | our estimates regarding the market opportunities for our current and future programs and any future product candidates; |
| • | the impact on our operations and activities that may be slowed or halted by shortage and/or pressure on supply and logistics on the global market, U.S. government shutdown, and/or the impact of the COVID-19 pandemic; |
| • | general business, financial and accounting risks and risks related to litigation and disputes with third parties; and |
| • | the other risks and uncertainties, including those listed under the caption “Risk Factors.” |
For such statements, we claim the protection of the Private Securities Litigation Reform Act of 1995 and section 27A of the Securities Act and Section 21E of the Exchange Act. Readers of this Annual Report on Form 20-F are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the time this Annual Report on Form 20-F was filed with the Securities and Exchange Commission, or SEC. These forward-looking statements are based largely on our expectations and projections about future events and future trends affecting our business and are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements. These risks and uncertainties include, without limitation, those discussed in “Risk Factors” and in “Operating and Financial Review and Prospects” of this Annual Report on Form 20-F. In addition, past financial or operating performance is not necessarily a reliable indicator of future performance, and you should not use our historical performance to anticipate results or future period trends. We can give no assurances that any of the events anticipated by the forward-looking statements will occur or, if any of them do, what impact they will have on our results of operations and financial condition. Except as required by law, we undertake no obligation to update publicly or revise our forward-looking statements to reflect events or circumstances that arise after the filing of this Annual Report on Form 20-F.
In this Annual Report on Form 20-F, “Kazia,” “Company,” “Consolidated Entity,” “we,” “us” and “our” refer to Kazia Therapeutics Limited and its wholly owned subsidiaries on a consolidated basis, unless the context otherwise provides.
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We effected an ADS ratio change to change the ratio of ADSs to ordinary shares from one ADS to ten (10) ordinary shares to a new ratio of one ADS to one-hundred (100) ordinary shares, or the “October 2024 ADS Ratio Change,” on October 28, 2024, and subsequently effected a second ADS ratio change to change the ratio of ADSs to ordinary shares from one ADS to one-hundred (100) ordinary shares to a new ratio of one ADS to five hundred (500) ordinary shares (the “April 2025 ADS Ratio Change”, and together with the October 2024 ADS Ratio Change, the “ADS Ratio Changes”) on April 17, 2025. Unless otherwise expressly indicated, the amounts and sales prices of the ADSs disclosed in this Form 20-F have been adjusted to reflect the cumulative effect of the ADS Ratio Changes, except for such amounts and sales prices of the ADSs that were sold prior to October 28, 2024, which have not been adjusted to reflect any ADS Ratio Changes effected after any such sale of ADSs, and except for such amounts and sales prices of the ADSs that were sold prior to April 17, 2025 but after October 28, 2024, which have not been adjusted to reflect the April 2025 ADS Ratio Change effected after any such sale of ADSs.
PART I
| Item 1. | Identity of Directors, Senior Management and Advisors |
Item 1 details are not required to be disclosed as part of the Annual Report.
| Item 2. | Offer Statistics and Expected Timetable |
Item 2 details are not required to be disclosed as part of the Annual Report.
| Item 3. | Key Information |
A. Reserved
B. Capitalization and Indebtedness.
Not applicable.
C. Reasons for the Offer and Use of Proceeds.
Not applicable.
D. Risk factors
Investment in our securities involves a high degree of risk. You should consider carefully the risks described below, together with other information in this Annual Report on Form 20-F and our other public filings, before making investment decisions regarding our securities. If any of the following events actually occur, our business, operating results, prospects or financial condition could be materially and adversely affected. This could cause the trading price of our ADSs to decline and you may lose all or part of your investment. Moreover, the risks described below are not the only ones that we face. Additional risks not presently known to us or that we currently deem immaterial may also affect our business, operating results, prospects or financial condition.
Risks Related to Our Financial Condition and Capital Requirement
We have incurred significant net losses since our inception. We expect to incur significant net losses for the foreseeable future and may never achieve or maintain profitability.
We have incurred significant net losses. We anticipate that we will continue to incur significant net losses for the foreseeable future and we may never achieve or maintain profitability. We are a biotechnology company and have not yet generated significant revenue. We have incurred losses of A$20.5, A$26.8 million, and A$20.7 million for the fiscal years ended 2023, 2024, and 2025, respectively. We generated revenues of A$42 thousand during 2025 from the licensing of our development stage drug candidates. We generated revenues of A$2.3 million during 2024 from the licensing of our development stage drug candidates. We did not generate any revenues from sales of any of our product candidates in prior financial years.
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As of 30 June 2025, we had accumulated losses of A$134.8 million. We have devoted most of our financial resources to research and development, including our clinical development activities. To date, we have financed our operations primarily through the issuance of equity securities, research and development grants from the Australian government and payments from our collaboration partners. While we have generated significant revenue in recent fiscal years from license transactions, the nature of such revenue is irregular and unpredictable, and is based upon achievement of milestones over which we have limited or no control. As a consequence, we expect to continue to incur significant operating losses for the foreseeable future due to the cost of research and development including clinical trials and the regulatory approval process for product candidates. The amount of our future net losses is uncertain and will depend, in part, on the rate of our future expenditures. Our ability to continue operations will depend on, among other things, our ability to obtain funding through equity or debt financings, strategic collaborations or grants.
We anticipate that our expenses will increase substantially if and as we:
| • | continue our research and clinical development of our product candidates; |
| • | expand the scope of our current clinical studies for our product candidates or initiate additional clinical or other studies for product candidates; |
| • | seek regulatory and marketing approvals for any of our product candidates that successfully complete clinical trials; |
| • | further develop the manufacturing process for our product candidates; |
| • | change or add additional manufacturers or suppliers; |
| • | seek to identify and validate additional product candidates; |
| • | acquire or in-license other product candidates and technologies; |
| • | maintain, protect and expand our intellectual property portfolio; |
| • | create additional infrastructure to support our operations as a public company in the United States and our product development and future commercialization efforts; and |
| • | experience any delays or encounter issues with any of the above. |
The net losses we incur may fluctuate significantly from year to year, such that a period-to-period comparison of our results of operations may not be a good indication of our future performance.
We have a history of operating losses and we expect to continue to incur losses and may never be profitable.
Our ability to generate significant revenue and achieve profitability depends on our ability, alone or with strategic collaboration partners, to successfully complete the development of and obtain the regulatory approvals for our product candidates, to manufacture sufficient supply of our product candidates, to establish a sales and marketing organization or suitable third-party alternative for the marketing of any approved products and to successfully commercialize any approved products on commercially reasonable terms. All of these activities will require us to raise sufficient funds to finance business activities. In addition, we do not anticipate generating revenue from commercializing product candidates for the foreseeable future, if ever. Our ability to generate future revenues from commercializing product candidates depends heavily on:
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| • | successfully initiating and completing clinical trials of our product candidates; |
| • | the timing of the initiation and completion of pre-clinical studies and clinical trials; |
| • | the timing of patient enrollment and dosing in any future clinical trials; |
| • | the timing of the availability of data from clinical trials; |
| • | expectations about the successful completion of clinical trials; |
| • | obtaining regulatory and marketing approvals for product candidates for which we complete clinical trials; |
| • | the timing of expected regulatory filings; |
| • | expectations about approval by regulatory authorities of our drug candidates; |
| • | the clinical utility and potential attributes and benefits of our product candidates, including the potential duration of treatment effects; |
| • | potential licenses of intellectual property and collaborations; |
| • | the commercialization of our product candidates, if approved; |
| • | expectations regarding expenses, ongoing losses, future revenue and capital needs; |
| • | our financial performance; |
| • | the length of time over which we expect our cash and cash equivalents to be sufficient; |
| • | our intellectual property position and the duration of our patent portfolio; |
| • | maintaining, protecting and expanding our intellectual property portfolio, and avoiding infringing on intellectual property of third parties; |
| • | establishing and maintaining successful licenses, collaborations and alliances with third parties; |
| • | developing a sustainable, scalable, reproducible and transferable manufacturing process for our product candidates; |
| • | establishing and maintaining supply and manufacturing relationships with third parties that can provide products and services adequate, in amount and quality, to support clinical development and commercialization of our product candidates, if approved; |
| • | launching and commercializing any product candidates for which we obtain regulatory and marketing approval, either by collaborating with a partner or, if launched independently, by establishing a sales, marketing and distribution infrastructure; |
| • | obtaining market acceptance of any product candidates that receive regulatory approval as viable treatment options; |
| • | the outcome of corresponding endeavors in respect of competitive or potentially competitive product candidates by other drug development companies; |
| • | obtaining favorable coverage and reimbursement rates for our products from third-party payers; |
| • | addressing any competing technological and market developments; |
| • | identifying and validating new product candidates; and |
| • | negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter. |
Even if one or more of our product candidates is approved for commercial sale, we may incur significant costs associated with commercializing any approved product candidate. As one example, our expenses could increase beyond expectations if we are required by the U.S. Food and Drug Administration (“FDA”) or other regulatory agencies, domestic or foreign, to perform clinical and other studies in addition to those that we currently anticipate. Even if we are able to generate revenues from the sale of any approved products, we may not become profitable and may need to obtain additional funding to continue operations, which could have an adverse effect on our business, financial condition, results of operations and prospects.
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We will need additional funding to operate our business; such funding may not be available or, if it is available, such financing is likely to substantially dilute our existing shareholders
During the year ended 30 June 2025 we raised A$16 million from the sale of ADSs. We will need to secure additional financing in order to continue to meet our longer-term business objectives, including advancement of our research and development programs and we may also require additional funds to pursue regulatory clearances, defend our intellectual property rights, establish commercial scale manufacturing facilities, develop marketing and sales capabilities and fund operating expenses. We intend to seek such additional funding through public or private financings and/or through licensing of our assets or strategic alliances or other arrangements with corporate partners.
Until we can generate a sufficient amount of product revenue to finance our cash requirements, which we may never achieve, we expect to finance our cash needs primarily through public or private equity offerings, debt financings or through strategic alliances. We cannot be certain that additional funding will be available on acceptable terms or at all. If we are not able to secure additional funding when needed, we may have to delay, reduce the scope of, or eliminate one or more of our clinical trials, collaborative research or development programs or future commercialisation initiatives. In addition, any additional funding that we do obtain will dilute the ownership held by our existing security holders. The amount of this dilution may be substantially increased if the trading price of our shares is lower at the time of any financing. Regardless, the economic dilution to shareholders will be significant if our stock price does not increase significantly, or if the effective price of any sale is below the price paid by a particular shareholder. Any debt financing could involve substantial restrictions on activities and creditors could seek a pledge of some or all of our assets. We have not identified potential sources for the additional financing that we will require, and we do not have commitments from any third parties to provide any future financing, other than the equity line program with Alumni Capital L.P., which is subject to certain restrictions. If we fail to obtain additional funding as needed, we may be forced to cease or scale back operations, and our results, financial condition and stock price would be adversely affected.
The Company has two product candidates currently in clinical trials. Failure of one or both of these product candidates to show benefit to patients could materially and adversely affect the continuity of our business and our financial condition.
The Company’s lead programs include Paxalisib (formerly GDC-0084), a small molecule inhibitor of the PI3K/Akt/mTOR pathway, and EVT801, a small molecule selective inhibitor of vascular endothelial growth factor receptor 3 (“VEGFR3”). However, even though progress has been made, such as the clinical validation of the PI3K/Akt/mTOR pathway as a target for oncology therapies, development of our product candidates may prove unsuccessful, after completion of clinical trials, due to any failure to provide adequate beneficial effect to cancer patients. It is possible that either or both product candidates may fail to show sufficient benefit as an intended treatment for the specific cancer indication to become commercially viable products, which could materially and adversely affect the continuity of our business and our financial condition.
The Company has ongoing clinical trials in which experimental therapies are administered to human subjects. If profound and unexpected safety concerns are encountered in clinical trials, it may materially and adversely affect the continuity of our business and our financial condition.
Despite all applicable efforts to characterize the safety profile of our drug development candidates through animal studies and other mechanisms, the possibility of unexpected safety concerns remains. If one or both of our clinical stage candidates were found to be associated with profound and unexpected toxicity or other safety concerns, the Company may be required to cease development of one or both candidates, and may additionally incur other impairments to the business including reputational damage, which may materially and adversely affect the continuity of our business and our financial condition.
There is substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain future financing.
The Company has limited cash resources and will periodically need additional funds to maintain the planned level of R&D activity. We expect to consume cash and incur operating losses for the foreseeable future as the Company continues developing its oncology drug candidates. The impact on cash resources and results from operations will vary with the extent and timing of future clinical trial programs. While it is not possible to make accurate predictions of future operating results, we expect existing cash and cash equivalents, including the capital raised under our ATM facility and equity line of credit facility with Alumni Capital L.P., will be sufficient to enable us to continue our research and development activities until approximately March 2026.
As of 30 June 2025, we had cash on hand at the bank of A$4.3 million. The consolidated financial statements have been prepared on a going concern basis, which contemplates continuity of normal activities and realization of assets and settlement of liabilities in the
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normal course of business. As is often the case with drug development companies, our ability to continue as a going concern is dependent upon our ability to derive sufficient cash from investors, from licensing and partnering and collaboration activities and from other sources of revenue such as grant funding.
Furthermore, we are limited by General Instruction I.B.5 to Form F-3 (the “Baby Shelf Rule”) as of the filing of this Annual Report, until such time as our non-affiliate public float exceeds $75 million. The amount of funds we can raise through primary non-affiliate public offerings of securities in any 12-month period using our registration statement on Form F-3 is limited to one-third of the aggregate market value of the ordinary shares held by non-affiliates of the Company, which limitation may change over time based on our stock price, number of ordinary shares outstanding and the percentage of ordinary shares held by non-affiliates. These factors raise substantial doubt about our ability to continue as a going concern within one year after the date that the consolidated financial statements are issued. The independent auditor’s report for the fiscal year ended 30 June 2025 included an explanatory paragraph in relation to the going concern uncertainty.
If the Company is unable to obtain additional funds on favorable terms or at all, it may be required to cease or reduce its operations. Our future success is dependent upon our ability to obtain additional funding. There can be no assurance, however, that we will be successful in obtaining such funding in sufficient amounts, on terms acceptable to us, or at all. Also, if the Company raises more funds by selling additional securities, the ownership interests of holders of its securities will be diluted.
Global economic uncertainty caused by rising inflation, political instability, and conflicts and other events of geopolitical significance, such as the conflict between Russia and Ukraine, and the recent conflict between Israel and Gaza, the evolving regulatory activities and economic policies under the current U.S. government, events related thereto, such as changes to candidates or political unrest or otherwise, and changing interest rates and the imposition of tariffs, could adversely affect our business and financial performance.
Negative global economic conditions may pose challenges to the Company’s business strategy, which relies on access to capital from financial markets and/or investment by other companies. Failure to obtain sufficient funding on acceptable terms could have a material adverse effect on our business, results of operations and financial condition. Negative conditions in the global economy, including credit markets and the financial services industry, have generally made equity and debt financing more difficult to obtain, and may negatively impact the Company’s ability to complete financing transactions. We are currently operating in a period of economic uncertainty and capital markets disruption, which has been significantly impacted by the geopolitical instability due to the ongoing military conflict between Russia and Ukraine and the conflict between Israel and Gaza. Our business, financial condition, and results of operations may be materially adversely affected by the negative impact on the global economy and capital markets resulting from the conflict in Ukraine or any other geopolitical tensions. U.S. and global markets are experiencing volatility and disruption following the escalation of geopolitical tensions, including the military conflict between Russia and Ukraine and the conflict between Israel and Gaza as well as any additional escalations that may develop in the Middle East region. Although the length and impact of these ongoing military conflicts are highly unpredictable, the conflict in Ukraine and the conflict between Israel and Gaza have led to market disruptions, including significant volatility in commodity prices, credit and capital markets, as well as supply chain disruptions.
Additionally, various of Russia’s actions have led to sanctions and other penalties being levied by the U.S., Australia, the European Union, and other countries, as well as other public and private actors and companies, against Russia and certain other geographic areas, including agreement to remove certain Russian financial institutions from the Society for Worldwide Interbank Financial Telecommunication payment system and restrictions on imports of Russian oil, liquified natural gas and coal. Additional potential sanctions and penalties have also been proposed and/or threatened. Russian military actions and the resulting sanctions could further adversely affect the global economy and financial markets and lead to instability and lack of liquidity in capital markets, potentially making it more difficult for us to obtain additional funds.
The duration and severity of these conditions is uncertain, as is the extent to which they may adversely affect the Company’s business and the business of current and prospective vendors and collaborators. If negative global economic conditions persist or worsen, the Company may be unable to secure additional funding to sustain its operations or to find suitable collaborators to advance its internal programs, even if positive results are achieved from research and development efforts.
Any of the above-mentioned factors could affect our business, prospects, financial condition, and operating results. The extent and duration of the military action, sanctions, and resulting market disruptions are impossible to predict, but could be substantial.
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In addition, there have been, and may continue to be, significant changes to U.S. trade policies, sanctions, legislation, treaties and tariffs, including, but not limited to, trade policies and tariffs affecting products from outside of the U.S. The extent and duration of increased tariffs and the resulting impact on general economic conditions and on our business are uncertain and depend on various factors, such as negotiations between the U.S. and affected countries, the responses of other countries or regions, exemptions or exclusions that may be granted, availability and cost of alternative sources of supply, and demand in affected markets. Supply chain disruptions and delays as a result of any new tariff policies or trade restrictions could also negatively impact our cost of materials and production processes. If we are unable to obtain these chemical or biological intermediates in sufficient quantity and in a timely manner due to disruptions in the global supply chain caused by macroeconomic events and conditions, the development, testing and clinical trials of paxalisib and EVT801 or any other current or future product candidates may be delayed or infeasible, and regulatory approval or commercial launch of any resulting product may be delayed or not obtained, which could significantly harm our business.
If we are unable to raise sufficient funding on acceptable terms due to these or other factors, we may be unable to continue to operate. There is no assurance that we will be successful in obtaining sufficient financing on acceptable terms and conditions to fund continuing operations, if at all. Our failure to obtain sufficient funds on acceptable terms when needed could have a material adverse effect on our business, results of operations and financial condition.
Changes in tax law could adversely affect our business and financial condition.
The rules dealing with U.S. federal, state, local and international income taxation are constantly under review by persons involved in the legislative process and by the Internal Revenue Service and the U.S. Treasury Department. For example, the One Big Beautiful Bill Act, or the OBBBA, was signed into law on July 4, 2025 and made significant changes to the U.S. federal tax law. Changes to tax laws (which changes may have retroactive application) could adversely affect us or holders of our common stock. For example, under Section 174 of the Internal Revenue Code of 1986, as amended, or the IRC, in taxable years beginning after December 31, 2021, expenses that are incurred for research and development performed outside the U.S. will be capitalized and amortized, which may have an adverse effect on our cash flow. The OBBBA provides that for taxable years beginning after December 31, 2024, expenses that are incurred for research and development performed in the U.S. may, at the taxpayer’s election, be immediately deducted or capitalized and amortized. In addition, the OBBBA provides that for taxable years beginning after December 31, 2021 and before January 1, 2025, certain eligible taxpayers generally may elect to retroactively deduct expenses for research and development performed in the U.S. in such taxable years by filing amended tax returns for such taxable years, and all other taxpayers that are not eligible to make such an election and that amortized expenses for research and development performed in the U.S. in such taxable years generally may elect to accelerate and deduct the remaining unamortized amounts of such research and development expenses (i) in the first taxable year beginning after December 31, 2024, or (ii) ratably over the two-taxable year period beginning with the first taxable year beginning after December 31, 2024. In recent years, many changes to tax laws have been made and changes are likely to continue to occur in the future. Future changes in tax laws could have a material adverse effect on our business, cash flow, financial condition or results of operations. We urge investors to consult with their legal and tax advisers regarding the implications of potential changes in tax laws on an investment in our common stock.
Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance by financial institutions or transactional counterparties, could adversely affect our current and projected business operations and our financial condition and results of operations.
Events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions, transactional counterparties or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any events of these kinds or other similar risks, have in the past and may in the future lead to market-wide liquidity problems. Although we do not currently have investments with any financial institution that has experienced such events, if any financial institution with which we have a relationship were to be placed into receivership, we may be unable to access such funds. In addition, if any parties with whom we conduct business are unable to access funds pursuant to instruments or lending arrangements with such a financial institution, such parties’ ability to pay their obligations to us or to enter into new commercial arrangements requiring additional payments to us could be adversely affected.
Inflation and increases in interest rates have led to a decline in the trading value of previously issued government securities with interest rates below current market interest rates. Although the U.S. Department of Treasury, Federal Deposit Insurance Corporation (“FDIC”), and Federal Reserve Board have announced a program to provide up to $25 billion of loans to financial institutions secured by certain government securities held by financial institutions to mitigate the risk of potential losses on the sale of such instruments, widespread demands for customer withdrawals or other liquidity needs of financial institutions for immediate liquidity may exceed the capacity of such program. Additionally, there is no guarantee that the U.S. Department of Treasury, FDIC and Federal Reserve Board will provide access to uninsured funds in the event of the closure of other banks or financial institutions in the future, or that they would do so in a timely fashion.
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Although we assess our banking relationships as we believe necessary or appropriate, our access to funding sources in amounts adequate to finance or capitalize our current and projected future business operations could be significantly impaired by factors that affect us, the financial institutions with which we have financial arrangements directly, or the financial services industry or economy in general. These factors could include, among others, events such as liquidity constraints or failures, the ability to perform obligations under various types of financial, credit or liquidity agreements or arrangements, disruptions or instability in the financial services industry or financial markets, or concerns or negative expectations about the prospects for companies in the financial services industry.
In addition, investor concerns regarding the U.S. or international financial systems could result in less favorable commercial financing terms, including higher interest rates or costs and tighter financial and operating covenants, or systemic limitations on access to credit and liquidity sources, thereby making it more difficult for us to acquire financing on acceptable terms or at all. Any decline in available funding or access to our cash and liquidity resources could, among other risks, adversely impact our ability to meet our operating expenses, financial obligations or fulfill our other obligations, result in breaches of our financial and/or contractual obligations or result in violations of federal or state wage and hour laws. Any of these impacts, or any other impacts resulting from the factors described above or other related or similar factors not described above, could have material adverse impacts on our liquidity and our current and/or projected business operations and financial condition and results of operations.
Risks Related to Our Business Operations and Employee Matters
We may not successfully engage in strategic transactions or enter into new collaborations, which could adversely affect our ability to develop and commercialize product candidates, impact our cash position, increase our expenses and present significant distractions to our management.
From time to time, we may consider additional strategic transactions, such as collaborations, acquisitions, asset purchases or sales and out- or in-licensing of product candidates or technologies. In particular we will evaluate and, if strategically attractive, seek to enter into additional collaborations, including with major biotechnology or pharmaceutical companies. For example, on October 7, 2025, we announced an exclusive collaboration and in-licensing agreement with QIMR Berghofer Medical Research Institute (“QIMR”) for a first-in-class PD-L1 degrader program. The lead optimized compound, NDL2, is an advanced PD-L1 protein degrader currently in development and represents a new and innovative frontier of cancer immunotherapy. On September 12, 2024, we announced that an agreement has been executed with QIMR to obtain an exclusive license to certain intellectual property rights in relation to combination therapies consisting of PI3K inhibitor drugs, and one or more immunotherapy or PARP inhibitor drugs (PI3K combination). The competition for collaborators is significant, and the negotiation process is time-consuming and complex. Any new collaboration may be on terms that are not optimal for us, and we may not be able to maintain any new or existing collaboration if, for example, development or approval of a product candidate is delayed, sales of an approved product candidate do not meet expectations or the collaborator discontinues the collaboration. Any such collaboration, or other strategic transaction, may require us to incur non-recurring or other charges, increase our expenditures, pose significant integration or implementation challenges or disrupt our management or business.
These transactions would entail numerous operational and financial risks, including exposure to unknown liabilities, incurrence of substantial debt or dilutive issuances of equity securities to pay transaction consideration or costs, higher than expected collaboration, acquisition or integration costs, write-downs of assets or goodwill or impairment charges, increased amortization expenses, difficulty and cost in facilitating the collaboration or combining the operations and personnel of any acquired business, impairment of relationships with key suppliers, manufacturers or customers of any acquired business due to changes in management and ownership and the inability to retain key employees of any acquired business.
Accordingly, although there can be no assurance that we will undertake or successfully complete any additional transactions of the nature described above, any transactions that we do complete may be subject to the foregoing or other risks and have a material adverse effect on our business, results of operations, financial condition and prospects. Conversely, any failure to enter any collaboration or other strategic transaction that would be beneficial to us could delay and make more expensive the development and potential commercialization of our product candidates and have a negative impact on the competitiveness of any product candidate that reaches market.
Any inability to attract and retain qualified key management and technical personnel would impair our ability to implement our business plan.
Our success largely depends on the continued service of key management and other specialized personnel. The loss of one or more members of our management team or other key employees or advisors could delay or increase the cost of our research and development programs and materially harm our business, financial condition, results of operations and prospects. The relationships
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that our key managers have cultivated within our industry make us particularly dependent upon their continued employment with us. We are dependent on the continued service of our technical personnel because of the highly technical nature of our product candidates and the specialized nature of the regulatory approval process for our product candidates. Because our management team and key employees are not obligated to provide us with continued service, they could terminate their employment with us at any time without penalty. We do not maintain key person life insurance policies on any of our management team members or key employees. Our future success will depend in large part on our continued ability to attract and retain other highly qualified scientific, technical and management personnel, as well as personnel with expertise in clinical testing, manufacturing, governmental regulation and commercialization. We face competition for personnel from other companies, universities, public and private research institutions, government entities and other organizations.
The Company previously identified material weaknesses in connection with its internal control over financial reporting. Although the Company has remediated these material weaknesses, the Company may identify other material weaknesses in the future, which could have a significant adverse effect on its business and the trading price of the ADSs.
For the year ended 30 June 2025, pursuant to Section 404 of the Sarbanes-Oxley Act, the Company was required to furnish a report by our senior management on our internal control over financial reporting. This report is required to include disclosure of any material weaknesses identified by the Company’s management in its internal control over financial reporting. However, while the Company remains an non-accelerated filer, it will not be required to include an attestation report on internal control over financial reporting issued by the Company’s independent registered public accounting firm. To achieve compliance with Section 404 of the Sarbanes-Oxley Act, the Company has been engaged in a process to document and evaluate its internal control over financial reporting, which is both costly and challenging. In this regard, the Company will need to continue to dedicate internal resources, potentially continue to engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting.
Effective internal controls over financial reporting are necessary for us to provide reliable financial reports and, together with adequate disclosure controls and procedures, are designed to prevent fraud. Any failure to implement required new or improved controls, or difficulties encountered in their implementation, could cause us to fail to meet our reporting obligations. In addition, we may identify deficiencies in our internal controls over financial reporting that are deemed to be material weaknesses or that may require prospective or retroactive changes to our financial statements or identify other areas for further attention or improvement. Inferior internal controls could also cause investors to lose confidence in our reported financial information, which could have a negative effect on the trading price of our ADSs. For example, management previously reported, in the Company’s Annual Report for the year ended 30 June 2023, a material weakness in its internal control over financial reporting related to the incorrect application of accounting standards in relation to the acquisition of the EVT-801 intangible asset and the related contingent consideration. The calculation was found to contain errors as discounting for the time value of money was not considered on initial recognition. This was the result of a lack of personnel with specialist accounting knowledge. The material weakness as reported in the Company’s Annual Report for the year ended 30 June 2023 has been remediated as of 30 June 2024. However, we may identify other material weaknesses in the future, which could have a significant adverse effect on its business and the trading price of the ADSs.
Our collaborations with outside scientists and consultants may be subject to restriction and change.
We work with medical experts, chemists, biologists and other scientists at academic and other institutions, and consultants who assist us in our research, development and regulatory efforts, including the members of our scientific advisory board. In addition, these scientists and consultants have provided, and we expect that they will continue to provide, valuable advice regarding our programs and regulatory approval processes. These scientists and consultants are not our employees and may have other commitments that would limit their future availability to us. If a conflict of interest arises between their work for us and their work for another entity, we may lose their services. In addition, we are limited in our ability to prevent them from establishing competing businesses or developing competing products. For example, if a key scientist acting as a principal investigator in any of our future clinical trials identifies a potential product or compound that is more scientifically interesting to professional interests, their availability to remain involved in any future clinical trials could be restricted or eliminated.
We face potential product liability claims, and, if successful claims are brought against us, we may incur substantial liability and costs. If the use of our product candidates harms patients, or is perceived to harm patients even when such harm is unrelated to our product candidates, our regulatory approvals could be revoked or otherwise negatively impacted and we could be subject to costly and damaging product liability claims.
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The use of our product candidates in clinical trials and the sale of any products for which we may in the future obtain marketing approval exposes us to the risk of product liability claims. Product liability claims might be brought against us by consumers, healthcare providers, pharmaceutical companies or others selling or otherwise coming into contact with our product candidates. There is a risk that our product candidates may induce adverse events. If we cannot successfully defend against product liability claims, we could incur substantial liability and costs. In addition, regardless of merit or eventual outcome, product liability claims may result in:
| • | impairment of our business reputation; |
| • | withdrawal of clinical trial participants; |
| • | costs due to related litigation; |
| • | distraction of management’s attention from our primary business; |
| • | substantial monetary awards to patients or other claimants; |
| • | the inability to commercialize our product candidates; |
| • | decreased demand for our product candidates, if approved for commercial sale; and |
| • | increased cost, or impairment of our ability, to obtain or maintain product liability insurance coverage. |
We may use our limited financial and human resources to pursue a particular research program or product candidate and fail to capitalize on programs or product candidates that may be more profitable or for which there is a greater likelihood of success.
Because we have limited resources, we may forego or delay pursuit of opportunities with certain programs or product candidates or for indications that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future research and development programs for product candidates may not yield any commercially viable products. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through strategic collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate, or we may allocate internal resources to a product candidate in a therapeutic area in which it would have been more advantageous to enter into a collaboration arrangement.
Our internal computer and information technology systems, or those of our collaborators and other development partners, third-party Contract Research Organizations (“CROs”) or other contractors or consultants, may fail or suffer security breaches, which could result in a disruption of our product development programs.
Despite the implementation of security measures, our internal computer and information technology systems and those of our current and any future CROs and other contractors, consultants and collaborators are vulnerable to damage from computer viruses, cyber-attacks, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. Such events could cause interruptions of our operations. While we have not experienced any material system failure, accident or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a disruption of our development programs and our business operations, whether due to a loss of our trade secrets or other similar disruptions. One of our major suppliers did experience a cyber attack in April 2023 but it did not result in any material system failure and had no long term impact on our business. For example, the loss of clinical trial data from ongoing or future clinical trials or data from pre-clinical studies could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Likewise, we rely on third parties to manufacture our product candidates and will rely on third parties to conduct future clinical trials, and similar events relating to their computer systems could also have similar consequences to our business. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development and commercialization of our product candidates could be delayed and become more expensive.
Our ability to utilize our net operating losses and certain other tax attributes may be limited.
We have substantial carried forward tax losses which may not be available to offset any future assessable income. In order for an Australian corporate taxpayer to carry forward and utilize tax losses, the taxpayer must pass either the continuity of ownership test (the “COT”), or, if it fails the COT, the same business test (“SBT”), or similar business test, in respect of relevant tax losses.
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We have not carried out any formal analysis as to whether we have met the COT or, failing the COT, the SBT or similar business test over relevant periods. In addition, future shareholding changes may result in a significant ownership change for us. It is therefore uncertain as to whether any of our tax losses carried forward as of 30 June 2025 will be available to be carried forward and available to offset our assessable income, if any, in future periods.
Inadequate funding for the FDA, the SEC, the National Institutes of Health (“NIH”), and other government agencies, including from government shutdowns, or other disruptions to these agencies’ staffing and operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
Currently, federal agencies in the U.S. are operating under a federal government shutdown due to the expiration of the continuing resolution on September 30, 2025. The duration of the current government shutdown is unknown. In addition, the current U.S. administration is focused on reducing costs of the federal government generally, including significantly reducing the number of government employees. Without appropriation of additional funding to federal agencies, our business operations related to our product development activities for the U.S. market could be impacted. The ability of the FDA to review and approve new products and NIH’s ability to conduct and partner with industry on important research can be affected by a variety of factors, including government budget and funding levels, the ability to hire and retain key personnel and accept the payment of user fees, layoffs, and statutory, regulatory and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, including executive and congressional priorities, which is inherently fluid and unpredictable.
Disruptions at the FDA and other federal agencies, including substantial leadership departures, personnel cuts, and policy changes, may also slow the time necessary for new drugs to be reviewed and/or approved, which would harm our business. Changes and cuts in FDA staffing have been reported by some within the pharmaceutical industry as creating instances of delays in the FDA’s responsiveness or in its ability to review IND submissions or applications, issue regulations or guidance, or implement or enforce regulatory requirements in a timely fashion or at all.
There is also substantial uncertainty as to how regulatory reform measures being implemented by the administration, and other political developments, such as government shutdowns or work stoppages, would impact other U.S. regulatory agencies, such as the FDA, SEC and USPTO, on which our operations rely. For example, over the last several years, the U.S. government has shut down and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical employees and stop critical activities. In addition, the current U.S. administration has proposed substantial reductions in force at various government agencies that, if applied in a material way, could significantly reduce the FDA’s and other agencies’ capacities to perform their functions in a manner consistent with past practices. If the current U.S. federal government shutdown is prolonged or if the FDA, NIH, SEC or the USPTO experiences significant decreases in funding or personnel, it could significantly impact the ability of the FDA to issues licenses needed for conduct of our clinical trials, the NIH to conduct research or provide grants, and the abilities of the FDA and the USPTO to timely review and process our regulatory submissions, which could have a material adverse effect on our business and our timelines. Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.
With the change in the U.S. presidential administration in 2025, there is substantial uncertainty as to whether and how the current administration will seek to modify or revise the requirements and policies of the FDA and other regulatory agencies with jurisdiction over our product candidates and any products for which we obtain approval. This uncertainty could present new challenges and/or opportunities as we navigate development and approval of our product candidates. Additionally, the new administration could issue or promulgate executive orders, regulations, policies or guidance that adversely affect us or create a more challenging or costly environment to pursue the development of new therapeutic candidates.
The U.S. Congress, the current administration, or any new administration may make substantial changes to fiscal, tax, and other federal policies that may adversely affect our business.
Since the start of the Trump administration in 2025, U.S. policy changes have been implemented at a rapid pace and additional changes are likely. Changes to U.S. policy implemented by the U.S. Congress, the current administration or any new administration have impacted and may in the future impact, among other things, the U.S. and global economy, international trade relations, unemployment, immigration, healthcare, taxation, the U.S. regulatory environment, inflation and other areas. Although we cannot predict the impact, if any, of these changes to our business, they could adversely affect our business. Until we know what policy changes are made, whether those policy changes are challenged and subsequently upheld by the court system and how those changes impact our business and the business of our competitors over the long term, we will not know if, overall, we will benefit from them or be negatively affected by them.
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Our employees, independent contractors, consultants, collaborators and CROs may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation.
We are exposed to the risk that our employees, independent contractors, consultants, collaborators and CROs may engage in fraudulent conduct or other illegal activity. Misconduct by those parties could include intentional, reckless and/or negligent conduct or disclosure of unauthorized activities to us that violates:
| • | FDA regulations or similar regulations of comparable non-U.S. regulatory authorities, including those laws requiring the reporting of true, complete and accurate information to such authorities; |
| • | manufacturing standards; |
| • | federal and state healthcare fraud and abuse laws and regulations and similar laws and regulations established and enforced by comparable non-U.S. regulatory authorities; and |
| • | laws that require the reporting of financial information or data accurately. |
Activities subject to these laws also involve the improper marketing, use or misrepresentation of information obtained in the course of clinical trials, creating fraudulent data in our preclinical studies or clinical trials or illegal misappropriation of product materials, which could result in regulatory sanctions and serious harm to our reputation. It is not always possible to identify and deter misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws, standards or regulations. Additionally, we are subject to the risk that a person or government could allege such fraud or other misconduct, even if none occurred. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and results of operations, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, disgorgement, integrity oversight and reporting obligations, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could have a material adverse effect on our ability to operate our business and our results of operations.
Risks Related to the Product Development and Regulatory Approval of Our Product Candidates
We may not be able to obtain orphan drug exclusivity, where relevant, in all markets for our product candidates.
Regulatory authorities in some jurisdictions, including the United States, may designate drugs for relatively small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a product intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals annually in the United States. The FDA may also designate a product as an orphan drug if it is intended to treat a disease or condition of more than 200,000 individuals in the United States and there is no reasonable expectation that the cost of developing and making a drug or biological product available in the United States for this type of disease or condition will be recovered from sales of the product candidate.
Generally, if a product with an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation, the product is entitled to a period of marketing exclusivity, which precludes the FDA from approving another marketing application for the same drug for such indication for that time period. The applicable period is seven years in the United States. Orphan drug exclusivity may be lost if the FDA determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the rare disease or condition.
Paxalisib (formerly GDC-0084) was granted orphan drug designation by the FDA in February 2018 for the treatment of glioblastoma, in August 2020 for the treatment of malignant glioma, which includes diffuse intrinsic pontine glioma (“DIPG”), a rare and highly aggressive childhood brain cancer, and in June 2022 for the treatment of atypical rhabdoid / teratoid tumors (“AT/RT”). However, even if we obtain orphan drug exclusivity for additional products in the United States or other jurisdictions, that exclusivity may not effectively protect the product from competition because different drugs can be approved for the same condition, and the same drug could be approved for a different condition. Moreover, even after an orphan drug is approved, the FDA can subsequently approve the same drug, made by a competitor, for the same condition if the FDA concludes that the competitive product is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care.
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Positive results from pre-clinical studies of our product candidates are not necessarily predictive of the results of our planned clinical trials of our product candidates.
Positive results in pre-clinical proof of concept and animal studies of our product candidates may not result in positive results in clinical trials in humans. Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in clinical trials after achieving positive results in pre-clinical development or early-stage clinical trials, and we cannot be certain that we will not face similar setbacks. These setbacks have been caused by, among other things, pre-clinical findings made while clinical trials were underway or safety or efficacy observations made in clinical trials, including adverse events. Moreover, pre-clinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that believed their product candidates performed satisfactorily in pre-clinical studies and clinical trials nonetheless failed to obtain FDA or other regulatory authority approval. If we fail to produce positive results in our clinical trials of our product candidates, the development timeline and regulatory approval and commercialization prospects for our product candidates, and, correspondingly, our business and financial prospects, would be negatively impacted.
Even if the Company receives regulatory approval to commercialize its drug candidates, the ability to generate revenues from any resulting products will be subject to a variety of risks, many of which are out of the Company’s control.
Regardless of regulatory approval, products arising from the development process may not gain market acceptance among physicians, patients, healthcare payers or the medical community. The Company believes that the degree of market acceptance and its ability to generate revenues from such products will depend on a number of factors, including, but not limited to:
| • | advancements in the treatment of cancer that make our treatments obsolete; |
| • | market exclusivity and competitor products; |
| • | timing of market introduction of the Company’s drugs and competitive drugs; |
| • | actual and perceived efficacy and safety of the Company’s drug candidates; |
| • | prevalence and severity of any side effects; |
| • | potential or perceived advantages or disadvantages over alternative treatments; |
| • | strength of sales, marketing and distribution support; |
| • | price of future products, both in absolute terms and relative to alternative treatments; |
| • | the effect of current and future healthcare laws on the Company’s drug candidates; and |
| • | availability of coverage and reimbursement from government and other third-party payers. |
If any of the Company’s drugs are approved and fail to achieve market acceptance, the Company may not be able to generate significant revenue to achieve or sustain profitability.
Risks Related to Commercialization of Our Product Candidates
The markets for paxalisib for brain cancer and EVT801 for advanced solid tumors, and for any other product candidates we are currently developing or may in the future develop or acquire, may be smaller than we expect.
We have historically focused our research and product development on treatments of brain cancer, advanced breast cancer and advanced solid tumors. We base our market opportunity estimates on a variety of factors, including our estimates of the number of people who have these diseases, the potential scope of our approved product labels, the subset of people with these diseases who have the potential to benefit from treatment with paxalisib, EVT801 or any other current or future product candidates, various pricing scenarios, and our understanding of reimbursement policies for rare diseases in particular countries. These estimates are based on many assumptions and may prove incorrect, and new studies may reduce the estimated incidence or prevalence of these diseases. Estimating market opportunities can be particularly challenging for rare indications, such as the ones we currently address, as
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epidemiological data is often more limited than for more prevalent indications and can require additional assumptions to assess potential patient populations. If we are unable to identify patients and successfully commercialize paxalisib, EVT801 or any other current or future product candidates with attractive market opportunities, our future product revenues may be smaller than anticipated, and our business may suffer.
Patient identification efforts also influence the ability to address a patient population. If efforts in patient identification are unsuccessful or less impactful than anticipated, for instance, because of a lack of diagnostic initiatives, inadequate disease awareness among healthcare professionals, difficulties in identifying and accessing patients outside of larger treatment centers or otherwise, we may not address the entirety of the opportunity we are seeking. As a result, patients may be difficult to identify and access, the addressable patient population in the countries in which we are seeking authorization and elsewhere may turn out to be lower than expected, or patients may not be otherwise amenable to treatment with our products, all of which would adversely affect our business, financial condition, results of operations and prospects.
The Company may not be able to establish the contractual arrangements necessary to develop, market and distribute the product candidates. Our failure to do so may adversely affect our business, results of operations and financial condition.
The Company has been successful in executing contractual agreements with strategic partners. This remains a key part of the Company’s business plan and the Company must continue to partner with third parties to manufacture clinical grade drug product and conduct key pre-clinical and clinical investigations. Strategic agreements around packaging, branding, market access and distribution for its drug products will also eventually be required.
However, potential partners could be discouraged by the Company’s limited operating history. There is no assurance that the Company will be able to negotiate commercially acceptable licensing or other agreements for the future exploitation of its drug product candidates including continued clinical development, manufacture or marketing. If the Company is unable to successfully contract for these services, or if arrangements for these services are terminated, the Company may have to delay the commercialization program which will adversely affect its ability to generate operating revenues.
The Company’s commercial opportunity will be reduced or eliminated if competitors develop and market products, devices or other treatments that are more effective, have fewer side effects or are less expensive than its drug candidates.
The development of drug candidates is highly competitive and is high risk. A number of other companies have products or drug candidates in various stages of pre-clinical or clinical development that are intended for the same therapeutic indications for which the Company’s drug candidates are being developed. Some of these potential competing drugs are further advanced in development than the Company’s drug candidates and may be commercialized sooner. Even if the Company is successful in developing effective drugs, its compounds may not compete successfully with products produced by its competitors.
The Company’s competitors include pharmaceutical companies and biotechnology companies, as well as universities and public and private research institutions. In addition, companies active in different but related fields represent substantial competition. Many of the Company’s competitors developing oncology drugs have significantly greater capital resources, larger R&D staff and facilities and greater experience in drug development, regulation, manufacturing and marketing. These organizations also compete with the Company and its service providers, to recruit qualified personnel, and to attract partners for joint ventures and to license technologies. As a result, the Company’s competitors may be able to develop technologies and products that would render the Company’s technologies or its drug candidates obsolete or non-competitive.
We are currently developing, and in the future may develop, product candidates in combination with other approved or investigational therapies, and that may expose us to additional risks.
We are currently developing, and may develop future product candidates, for use in combination with one or more currently approved or other investigational therapies. For example, Paxalisib is currently being tested in combination with several other therapies. If any of the investigational therapies do not receive approval, or if any of the approved therapies we currently or may, in the future, use in combination with a current or future product candidate is found defective, removed from the market, or otherwise becomes unavailable, our clinical trials may face significant delays, be suspended, or terminated. Any such events would likely have a material impact on our operations and the development of the affected product candidate(s) and may ultimately prevent the approval of such product candidate or render continued development efforts too costly to proceed.
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Even if a current or future product candidate were to receive FDA approval to be commercialized in the U.S. for use in combination with one or more new or existing therapies, we would continue to be subject to the risk that the FDA or similar foreign regulatory authorities could revoke approval of the therapy used in combination with our product candidate or that safety, efficacy, manufacturing or supply issues could arise with any such existing therapies. This could result in our own products being removed from the market or cause material delays in, or the suspension or discontinuation, of our production and/or distribution of the applicable product, as our ability to market any such product will be limited to the extent specified in the FDA’s approval, if granted.
The regulatory approval processes of the FDA and comparable foreign health authorities are lengthy, time consuming, expensive and inherently unpredictable. If we will not be able to obtain regulatory approvals for our products, our business will be substantially harmed.
The time required to obtain approval by the FDA and comparable foreign health authorities is unpredictable, typically takes many years following the commencement of clinical studies and depends upon numerous factors. In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions, which may cause delays in the approval or the decision not to approve a marketing application. The likelihood of such difficulties may be increased by our multi-national development and trials. We have not obtained regulatory approval for any product candidate, and it is possible that none of our existing product candidates or any product candidates we may seek to develop in the future will ever obtain regulatory approval.
| • | Applications for our product candidates could fail to receive regulatory approval for many reasons, including but not limited to the following: |
| • | the FDA or comparable foreign health regulatory authorities may disagree with the design or implementation of our clinical studies; |
| • | we may be unable to demonstrate to the FDA or comparable foreign health regulatory authorities that a product candidate’s safety-benefit ratio for its proposed indication is acceptable; |
| • | the population studied in the clinical development program may not be sufficiently broad or representative to assure safety in the full population for which we seek approval; |
| • | the FDA or comparable foreign health regulatory authorities may disagree with our interpretation of data from preclinical or clinical studies; |
| • | the data collected from clinical studies of our product candidates may not be sufficient to support the submission of a new drug application, or NDA, or a Biologics License Application, or a BLA, or other submission or to obtain regulatory approval in the United States or elsewhere; |
| • | the FDA and/or comparable foreign health regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications, or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and |
| • | the approval policies or regulations of the FDA or comparable foreign health regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval. |
The approval process is lengthy and expensive. In addition, results of clinical studies are unpredictable and we may fail to obtain regulatory approval to market any of our product candidates, which would significantly harm our business, results of operations, and prospects.
Even if our drug candidates receive regulatory approval, we may still face future development and regulatory difficulties in the same or other jurisdictions, and we and our products will our products will remain subject to regulatory scrutiny.
Our product candidates, if approved, will also be subject to ongoing regulatory requirements for labeling, packaging, storage, advertising, promotion, record-keeping and submission of safety and other post market information. In addition, approved products, manufacturers and manufacturers’ facilities are required to comply with extensive FDA and EMA requirements and requirements of other similar agencies, including ensuring that quality control and manufacturing procedures conform to current good manufacturing practices (“cGMPs”). As such, we and our contract manufacturers will be subject to continual review and periodic inspections to assess compliance with cGMPs. Accordingly, we and others with whom we work must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and quality control. We will also be required to report certain
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adverse reactions and production problems, if any, to the FDA and EMA and other similar agencies and to comply with requirements concerning advertising and promotion for our products. Promotional communications with respect to prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s approved label. Accordingly, we may not promote our approved products, if any, for indications or uses for which they are not approved.
If a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or disagrees with the promotion, marketing or labeling of a product, such regulatory agency may impose restrictions on that product or us, including requiring withdrawal of the product from the market. If we fail to comply with applicable regulatory requirements, a regulatory agency or enforcement authority may, among other things:
| • | issue warning letters; |
| • | impose civil or criminal penalties; |
| • | suspend or withdraw regulatory approval; |
| • | suspend any of our ongoing clinical studies; |
| • | refuse to approve pending applications or supplements to approved applications submitted by us; or |
| • | seize or detain products, or require a product recall. |
Any government investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity. Any failure to comply with ongoing regulatory requirements may significantly and adversely affect our ability to commercialize and generate revenue from our product candidates. If regulatory sanctions are applied or if regulatory approval is withdrawn, the value of our company and our operating results will be adversely affected.
If we fail to obtain coverage and reimbursement for paxalisib, EVT801 or any other current or future product candidates in new geographies, it could make it difficult for us to sell paxalisib, EVT801 or any other current or future product candidates profitably.
The success of paxalisib, EVT801 and any of our other current or future product candidates, if approved, depends on the availability of adequate coverage and reimbursement from third-party payors. Because paxalisib, EVT801 and any other current or future product candidates represent new approaches to the treatment of the diseases they target, we cannot be sure that coverage and reimbursement will be available for, or accurately estimate the potential revenue from, paxalisib, EVT801 and any other current or future product candidates or for any product that we may develop. If we are unable to obtain adequate levels of reimbursement, our ability to successfully market and sell any such product candidates will be adversely affected. The manner and level at which reimbursement is provided for services related to any current or future product candidates we may develop (e.g., for the administration of our product candidate to patients) is also important. Inadequate reimbursement for such services may lead to physician and payor resistance and adversely affect our ability to market or sell paxalisib, EVT801 or any other current or future product candidates we may develop. In addition, we may need to develop new reimbursement models, in order to realize adequate value. Payors may not be able or willing to adopt such new models and patients may be unable to afford that portion of the cost that such models may require them to bear. If we determine such new models are necessary, but we are unsuccessful in developing them, or if payors do not adopt such models, our business, financial condition, results of operations and prospects could be adversely affected.
Patients who are provided medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment. Adequate coverage and reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and commercial payors, such as private health insurers and health maintenance organizations, are critical to new product acceptance. Government authorities and other third-party payors decide which drugs and treatments they will cover and the reimbursement amount. Coverage and reimbursement by a third-party payor may depend upon a number of factors.
In the U.S., no uniform policy of coverage and reimbursement for products exists among third-party payors. As a result, obtaining coverage and reimbursement approval of a product from a government or other third-party payor is a time consuming and costly process that could require us to provide to each payor supporting scientific, clinical and cost-effectiveness data for the use of our products on a payor-by-payor basis, with no assurance that coverage and adequate reimbursement from third-party payors will be obtained. There is significant uncertainty related to the insurance coverage and reimbursement of newly approved products, which
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uncertainty may be heightened where the product is subject to post-marketing conditions or requirements to provide additional clinical data. In the U.S., the principal decisions about reimbursement for new medicines are typically made by the Centers for Medicare & Medicaid Services (“CMS”), an agency within the U.S. Department of Health and Human Services, as CMS decides whether and to what extent a new medicine will be covered and reimbursed under Medicare. Private payors tend to follow CMS to a substantial degree. Even if we obtain coverage for a given product, the resulting reimbursement payment rates might not be adequate for us to achieve or sustain profitability or may require co-payments that patients find unacceptably high. Future coverage and reimbursement may be subject to increased restrictions, such as prior authorization requirements, both in the U.S. and in international markets. Orphan drugs are typically placed on the highest cost-sharing tier and a substantial percentage are subject to prior authorization requirements. Reimbursement agencies in the EU may be more conservative than CMS.
Outside the U.S., international operations are generally subject to extensive governmental price controls and other market regulations, and we believe the increasing emphasis on cost-containment initiatives in Canada, the EU and other countries has and will continue to put pressure on the pricing and usage of drug products such as paxalisib, EVT801 and any other current or future product candidates we may develop, if approved. We may also incur additional challenges when seeking reimbursement from public and private payers where paxalisib, EVT801 or any future product candidate has been approved subject to post-marketing conditions. Moreover, we might obtain marketing approval for a product in a particular country, but then be subject to price regulations that delay or might even prevent our commercial launch of the product, possibly for lengthy periods of time. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidate to other available therapies. In general, the prices of products under such systems are substantially lower than in the U.S. Other countries allow companies to fix their own prices for products but monitor and control company profits. Additional foreign price controls or other changes in pricing regulation could restrict the amount that we are able to charge for product candidates. Accordingly, in markets outside the U.S., the reimbursement for paxalisib, EVT801 and any other current or future product candidates we may develop may be reduced compared with the U.S. and may be insufficient to generate commercially reasonable revenues and profits.
Ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations.
Changes in regulations, statutes or the interpretation of existing regulations could impact our business in the future by requiring, for example: (i) changes to our manufacturing arrangements; (ii) additions or modifications to product labeling; (iii) the recall or discontinuation of our products; or (iv) additional record-keeping requirements. If any such changes were to be imposed, they could adversely affect the operation of our business.
On April 15, 2025, the Trump Administration published Executive Order 14273, “Lowering Drug Prices by Once Again Putting Americans First,” which generally directs the federal government to take measures to reduce drug prices, including eliminating the so-called “pill penalty” under the Inflation Reduction Act that creates a distinction between small molecule and large molecule products for purposes of determining when a drug may be eligible for drug price negotiation. On May 12, 2025, the Trump Administration published Executive Order 14297, “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” which generally, among other things, directs the federal government to establish and communicate most-favored-nation price targets to pharmaceutical manufacturers to bring prices for American patients in line with comparably developed nations. Further, the Executive Order directs the federal government to support regulatory paths to allow direct-to-patient sales for companies that meet these targets. It also states that the Administration will take additional aggressive action (for example, examining whether marketing approvals should be modified or rescinded or opening the door for individual drug importation waivers) should manufacturers fail to offer American consumers the most-favored-nation lowest price. It also directs the Secretary of Commerce and the U.S. Trade Representative to “take all necessary and appropriate action to ensure foreign countries are not engaged in any act, policy, or practice that may be unreasonable or discriminatory or that may impair United States national security . . . including by suppressing the price of pharmaceutical products below fair market value in foreign countries.” Notably, a similar “Most Favored Nation” pricing rule enacted under the first Trump Administration was subject to an injunction resulting from judicial challenges to the rule, which was formally rescinded by the former Biden Administration in August 2021.
In addition, at the state level, legislatures have increasingly passed legislation and implemented regulations similar to those under consideration at the federal level, as well as laws designed to control pharmaceutical and biotherapeutic product pricing, including restrictions on pricing or reimbursement at the state government level, limitations on discounts to patients, marketing cost disclosure and transparency measures, restrictions or other limitations on patient assistance, and, in some cases, policies to encourage importation from other countries (subject to federal approval) and bulk purchasing. Certain states are also pursuing cost containment efforts through Prescription Drug Affordability Boards (“PDABs”), and similar entities.
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We cannot predict the initiatives that may be adopted in the future. The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affect:
| • | the demand for paxalisib and EVT801 or any other current or future product candidates; |
| • | our ability to set a price that we believe is fair for our approved products; |
| • | our ability to generate revenue and achieve or maintain profitability; |
| • | the level of taxes that we are required to pay; and |
| • | the availability of capital. |
These laws and future state and federal healthcare reform measures that may be adopted in the future may result in additional reductions in Medicare and other healthcare funding and otherwise affect the prices we may obtain for paxalisib, EVT801 or any other current or future product candidates for which we may obtain regulatory approval or the frequency with which any such product candidate is prescribed or used. For example, the Inflation Reduction Act of 2022 (“IRA”), contains provisions that require companies to pay rebates to Medicare for certain drug prices that increase faster than inflation. In addition, any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, sustain profitability or commercialize our product candidates.
Moreover, increasing efforts by governmental and third-party payors in the U.S. and abroad to cap or reduce healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for our product candidates. There has been increasing legislative and enforcement interest in the U.S. with respect to specialty drug pricing practices. Specifically, there have been several recent U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs. The effect of these reform efforts on our business and the healthcare industry in general is not yet known.
Additional state and federal healthcare reform measures are expected to be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in reduced demand for certain pharmaceutical products or additional pricing pressures.
While some of these and other proposed measures may require additional authorization to become effective, Congress and the Biden Trump administration have each indicated that it will continue to seek new legislative and/or administrative measures to decrease pharmaceutical prices in the United States.
Governments outside the U.S. may impose strict price controls, which may adversely affect our revenues, if any.
In some countries, including Canada and certain Member States of the EU, the pricing of prescription drugs is, in part, subject to governmental control. Additional countries may adopt similar approaches to the pricing of prescription drugs. In such countries, pricing negotiations with governmental authorities can take considerable time after receipt of regulatory approval for a product. In addition, there can be considerable pressure by governments and other stakeholders on prices and reimbursement levels, including as part of cost containment measures. Political, economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations may continue after coverage and reimbursement have been obtained. Reference pricing used by various countries and parallel distribution, or arbitrage between low-priced and high-priced countries, can further reduce prices. In some countries, we may be required to conduct a clinical trial or other trials that compare the cost-effectiveness of paxalisib, EVT801 or any other current or future product candidates to other available therapies in order to obtain or maintain reimbursement or pricing approval, which is time-consuming and costly. We cannot be sure that such prices and reimbursement will be acceptable to us. Publication of discounts by third-party payors or authorities may lead to further pressure on the prices or reimbursement levels within the country of publication and other countries. If pricing is set at unsatisfactory levels or if reimbursement of our products is unavailable or limited in scope or amount, our revenues from sales by us or our strategic partners and the potential profitability of paxalisib, EVT801 or any other current or future product candidates in those countries would be negatively affected.
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Compliance with global privacy and data security requirements could result in additional costs and liabilities to us or inhibit our ability to collect and process data globally, and the failure to comply with such requirements could subject us to significant fines and penalties, which may have a material adverse effect on our business, financial condition or results of operations.
The regulatory framework for the collection, use, safeguarding, sharing, transfer and other information processing worldwide is rapidly evolving and is likely to remain uncertain for the foreseeable future. Globally, virtually every jurisdiction in which we operate has established its own data security and privacy frameworks with which we must comply. For example, the collection, use, disclosure, transfer, or other processing of personal data regarding individuals in the European Economic Area (the “EEA”), including personal health data, is subject to the EU General Data Protection Regulation (the “GDPR”), and similarly, processing of personal data regarding individuals in the UK, including personal health data, is subject to the UK General Data Protection Regulation and the UK Data Protection Act 2018 (collectively, the “UK GDPR,” and together with the EU GDPR, the “GDPR”). The GDPR is wide-ranging in scope and imposes numerous requirements on companies that process personal data, including requirements relating to processing health and other sensitive data, obtaining the consent of the individuals to whom the personal data relates, providing detailed information to individuals regarding data processing activities, implementing safeguards to protect the security and confidentiality of personal data, providing notification of data breaches, and taking certain measures when engaging third-party processors. The GDPR also imposes strict rules on the transfer of personal data to countries outside the EEA/UK that are not considered by the European Commission and the UK government as providing “adequate” protection to personal data, including the U.S., and, as a result, increases the scrutiny that clinical trial sites located in the EEA should apply to transfers of personal data from such sites to countries that are considered to lack an adequate level of data protection, such as the U.S. Such transfers of personal data outside of the EEA and UK are prohibited unless a valid GDPR transfer mechanism (for example, the European Commission approved Standard Contractual Clauses, or SCCs, and the UK International Data Transfer Agreement/Addendum, or UK IDTA) has been put in place. Where relying on the SCCs /UK IDTA for data transfers, we may also be required to carry out transfer impact assessments to assess whether the recipient is subject to local laws which allow public authority access to personal data. The international transfer obligations under the EEA/UK data protection regimes will require significant effort and cost, and may result in us needing to make strategic considerations around where EEA/UK personal data is transferred and which service providers we can utilize for the processing of EEA/UK personal data. Any inability to transfer personal data from the EEA and UK to the United States in compliance with data protection laws may impede our ability to conduct trials and may adversely affect our business and financial position. The GDPR also permits data protection authorities to require the destruction of improperly gathered or used personal information and or impose substantial fines for violations of the GDPR, which can be up to four percent of global revenues or €20 million (£17.5 million under the UK GDPR), whichever is greater and it also confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR. Although the UK is regarded as a third country under the EU GDPR, the European Commission has now issued a decision recognizing the UK as providing adequate protection under the EU GDPR, or Adequacy Decision, and, therefore, transfers of personal data originating in the EEA to the UK remain unrestricted. The UK Government has introduced a Data Protection and Digital Information Bill, or UK Bill, into the UK legislative process to reform the UK’s data protection regime, and if passed, the final version of the UK Bill may have the effect of further altering the similarities between the UK and EEA data protection regimes and threaten the UK Adequacy Decision from the European Commission, which may lead to additional compliance costs for us and could increase our overall risk. It is unclear how UK data protection laws and regulations will develop in the medium to longer term, and how data transfers to and from the UK will be regulated in the long term. Although the EU GDPR and the EU GDPR currently impose substantially similar obligations, it is possible that over the time the UK GDPR could become less aligned with the EU GDPR. In addition, EU member states have adopted national laws to supplement the EU GDPR, which may partially deviate from the EU GDPR, and the competent authorities in the EU Member States may interpret EU GDPR obligations slightly differently from country to country, such that we do not expect to operate in a uniform legal landscape in the EEA with respect to data protection regulations. The potential of the respective provisions and enforcement of the EU GDPR and UK GDPR further diverging in the future creates additional regulatory challenges and uncertainties for us. The lack of clarity on future UK laws and regulations and their interaction with EU laws and regulations could add legal risk, uncertainty, complexity and cost to the handling of European personal data and our privacy and data security compliance programs could require us to implement different compliance measures for the UK and EEA.
Similar legal requirements are either in place or are being proposed in the U.S. There are a broad variety of data protection laws that are applicable to our activities, and a wide range of enforcement agencies at both the state and federal levels that can review companies for privacy and data security concerns based on general consumer protection laws. The Federal Trade Commission and state Attorneys General are all aggressive in reviewing consumers’ privacy and data security protections. New laws also are being considered at both the state and federal levels. For example, the California Consumer Privacy Act—which went into effect on January 1, 2020 and which was recently amended by the California Privacy Rights Act —is creating similar risks and obligations as those created by GDPR. Though the Act does exempt certain information collected as part of a clinical trial subject to the Federal Policy for the Protection of Human Subjects, or the Common Rule, it does apply to other personal information that we may otherwise handle, such as personal information collected in a business to business context and personal information collected from employees,
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applicants and retirees residing in California. Similar broad consumer privacy laws have already been passed in numerous states, and laws in Virginia, Colorado and Connecticut already have entered into force. In addition, bills for broad consumer privacy laws are being considered in numerous other states and at the federal level.
Compliance with the above requirements and any other data privacy and data security laws and regulations is a rigorous and time-intensive process and requires significant resources and an ongoing review of our technologies, systems and practices, as well as those of any third-party collaborators, service providers, contractors or consultants that process or transfer personal data. The GDPR and other changes in laws or regulations associated with the enhanced protection of certain types of sensitive data, such as healthcare data or other personal information from our clinical trials, could require us to change our business practices and put in place additional compliance mechanisms, may interrupt or delay our development, regulatory and commercialization activities and increase our cost of doing business, and could lead to government enforcement actions, private litigation and significant fines and penalties against us and could have a material adverse effect on our business, financial condition or results of operations.
Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information, and personal data.
Issues in the development and use of artificial intelligence, combined with an uncertain regulatory environment, may result in reputational harm, liability, or other adverse consequences to our business operations. As with many technological innovations, artificial intelligence presents risks and challenges that could impact our business. We may adopt and integrate generative artificial intelligence tools into our systems for specific use cases reviewed by legal and information security. Our vendors may incorporate generative artificial intelligence tools into their offerings without disclosing this use to us, and the providers of these generative artificial intelligence tools may not meet existing or rapidly evolving regulatory or industry standards with respect to privacy and data protection and may inhibit our or our vendors’ ability to maintain an adequate level of service and experience. If we, our vendors, or our third-party partners experience an actual or perceived breach or privacy or security incident because of the use of generative artificial intelligence, we may lose valuable intellectual property and confidential information and our reputation and the public perception of the effectiveness of our security measures could be harmed. Further, bad actors around the world use increasingly sophisticated methods, including the use of artificial intelligence, to engage in illegal activities involving the theft and misuse of personal information, confidential information, and intellectual property. Any of these outcomes could damage our reputation, result in the loss of valuable property and information, and adversely impact our business.
Risks Related to Our Intellectual Property
If we are unable to protect intellectual property rights related to our product candidates, we may not be able to obtain exclusivity for our product candidates or prevent others from developing similar competitive products.
We rely upon a combination of patents, know-how, trade secret protection and confidentiality agreements to protect the intellectual property related to our product candidates. The strength of patents in the biotechnology and pharmaceutical field involves complex legal and scientific questions and can be uncertain. The patent applications that we own or in-license may fail to result in issued patents with claims that cover our product candidates in the United States or other jurisdictions. In addition, we cannot guarantee that any patents will issue from any pending or future patent applications owned by or licensed to us. There is no assurance that all of the potentially relevant prior art relating to our patents and patent applications has been found. If such prior art exists, it can invalidate a patent or prevent a patent from issuing from a pending patent application. Even if patents do successfully issue and even if such patents cover our product candidates, third parties may initiate opposition, interference, re-examination, post-grant review, inter parties review, nullification or derivation action in court or before patent offices or similar proceedings challenging the validity, enforceability or scope of such patents, which may result in the patent claims being narrowed or invalidated. Furthermore, even if our patents and patent applications are unchallenged, they may not adequately protect our intellectual property, provide exclusivity for our product candidates or prevent others from designing around our claims. Any of these outcomes could impair our ability to prevent competition from third parties.
If the patent applications we hold or have in-licensed with respect to our programs or product candidates fail to issue, or are revoked, if the breadth or strength of our patent protection is threatened, or if our patent portfolio fails to provide meaningful exclusivity for our product candidates, it could dissuade companies from collaborating with us to develop product candidates and threaten our ability to commercialize future products. Any successful opposition to any patents owned by or licensed to us could deprive us of rights necessary for the successful commercialization of any product candidates that we may develop. Further, if we encounter delays in regulatory approvals, the period of time during which we could market a product candidate under patent protection could be reduced. Even where we have a valid and enforceable patent, we may not be able to exclude others from practicing our invention where the other party can show that they used the invention in commerce before our filing date or the other party benefits from a compulsory
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license. In addition, patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after it is filed. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering our product candidates are obtained, once the patent life has expired for a product, we may be open to competition from competitive medications, including biosimilar or generic medications. This risk is material in light of the length of the development process of our products and lifespan of our current patent portfolio.
Even if they are unchallenged, our patents and pending patent applications, if issued, may not provide us with any meaningful protection or prevent competitors from designing around our patent claims to circumvent our patents by developing similar or alternative technologies or therapeutics in a non-infringing manner. For example, a third party may develop a competitive therapy that provides benefits similar to one or more of our product candidates but that uses a formulation and/or a device that falls outside the scope of our patent protection. If the patent protection provided by the patents and patent applications we hold or pursue with respect to our product candidates is not sufficiently broad to impede such competition, our ability to successfully commercialize our product candidates could be negatively affected, which would harm our business. Similar risks would apply to any patents or patent applications that we may own and those which we may license in the future. In many cases, in-licensed intellectual property is at greater risk, as we may not have access to all information or to prosecution and other aspects of the acquisition, maintenance and enforcement of the in-licensed intellectual property.
Patent positions of life sciences companies can be uncertain and involve complex factual and legal questions. The scope of patent protection in jurisdictions outside of the United States is also uncertain. Changes in either the patent laws or their interpretation in any jurisdiction that we seek patent protection may diminish our ability to protect our inventions, maintain and enforce our intellectual property rights; and, more generally, may affect the value of our intellectual property, including the narrowing of the scope of our patents and any that we may license.
The patent prosecution process is complex, expensive, time-consuming and inconsistent across jurisdictions. We may not be able to file, prosecute, maintain, enforce, or license all necessary or desirable patent rights at a commercially reasonable cost or in a timely manner. In addition, we may not pursue or obtain patent protection in all relevant markets. It is possible that we will fail to identify important patentable aspects of our research and development efforts in time to obtain appropriate or any patent protection. While we enter into non-disclosure and confidentiality agreements with parties who have access to confidential or patentable aspects of our research and development efforts, including for example, our employees, corporate collaborators, external academic scientific collaborators, CROs, contract manufacturers, consultants, advisors and other third parties, any of these parties may breach the agreements and disclose such output before a patent application is filed, thereby endangering our ability to seek patent protection. In addition, publications of discoveries in the scientific and scholarly literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not until issuance as a patent. Consequently, we cannot be certain that we were the first to file for patent protection on the inventions claimed in our patents or pending patent applications.
Courts outside the United States are sometimes less willing to protect trade secrets. If we choose to go to court to stop a third party from using any of our trade secrets, we may incur substantial costs. These lawsuits may consume our time and other resources even if we are successful. For example, significant elements of our products, including confidential aspects of sample preparation, methods of manufacturing, cell culturing conditions, computational-biological algorithms, and related processes and software, are based on unpatented trade secrets. Although we take steps to protect our proprietary information and trade secrets, including through contractual means with our employees and consultants, third parties may independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets or disclose our technology.
We may not be able to meaningfully protect our trade secrets. It is our policy to require our employees, consultants, outside scientific collaborators, sponsored researchers and other advisors to execute confidentiality agreements upon the commencement of employment or consulting relationships with us. These agreements provide that all confidential information concerning our business or financial affairs developed or made known to the individual or entity during the course of the party’s relationship with us is to be kept confidential and not disclosed to third parties except in specific circumstances. In the case of employees, the agreements provide that all inventions conceived by the individual, and which are related to our current or planned business or research and development or made during normal working hours, on our premises or using our equipment or proprietary information, are our exclusive property. In addition, we take other appropriate precautions, such as physical and technological security measures, to guard against misappropriation of our proprietary technology by third parties. We have also adopted policies and conduct training that provides guidance on our expectations, and our advice for best practices, in protecting our trade secrets. Despite these undertakings, we may not be able to effectively protect our trade secrets.
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The issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain. Further, the scope of the invention claimed in a patent application can be significantly reduced before the patent is issued, and this scope can be reinterpreted after issuance. Even where patent applications we currently own, license, or that we may license in the future issue as patents, they may not issue in a form that will provide us with adequate protection to prevent competitors or other third parties from competing with us, or otherwise provide us with a competitive advantage. Any patents that eventually issue may be challenged, narrowed or invalidated by third parties. Consequently, we do not know whether any of our product candidates will be protectable or remain protected by valid and enforceable patent rights.
The issuance or grant of a patent is not irrefutable as to its inventorship, scope, validity or enforceability, and our patents may be challenged in the courts or patent offices in the United States and abroad. There may be prior art of which we are not aware that may affect the validity or enforceability of a patent claim. There also may be prior art of which we are aware, but which we do not believe affects the validity or enforceability of a claim, which may, nonetheless, ultimately be found to affect the validity or enforceability of a claim. We may in the future, become subject to a third-party pre-issuance submission of prior art or opposition, derivation, revocation, re-examination, post-grant and inter partes review, or interference proceeding and other similar proceedings challenging our patent rights or the patent rights of others in the U.S. Patent and Trademark Office, or the USPTO, or other foreign patent office. An unfavorable determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our technology or products and compete directly with us, without payment to us, or extinguish our ability to manufacture or commercialize products without infringing third-party patent rights.
In addition to the protection afforded by patents, we rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable or that we elect not to patent, processes for which patents are difficult to enforce and any other elements of our product candidate discovery and development processes that involve proprietary know-how, information or technology that is not covered by patents. However, trade secrets can be difficult to protect. What constitutes a trade secret and what protections are available for trade secrets varies from state to state in the United States and country by country worldwide. We seek to protect our proprietary technology and processes, in part, by entering into confidentiality agreements with our employees, consultants, scientific advisors and contractors. We also seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems. Security measures may be breached, and we may not have adequate remedies for any breach. In addition, our trade secrets may otherwise become known or be independently discovered by competitors. Although we expect all of our employees and consultants to assign their inventions to us, and all of our employees, consultants, advisors and any third parties who have access to our proprietary know-how, information or technology to enter into confidentiality agreements, we cannot provide any assurances that all such agreements have been duly executed or that our trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques.
Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and applications are required to be paid to the USPTO and various governmental patent agencies outside of the United States in several stages over the lifetime of the patents and applications. The USPTO and various corresponding governmental patent agencies outside of the United States require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process and after a patent has issued. There are situations in which non-compliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.
Our success depends, in part, on our ability to protect our intellectual property and our technologies.
Our commercial success depends, in part, on our ability to obtain and maintain patent and trade secret protection for our technologies, our traits, and their uses, as well as our ability to operate without infringing upon the proprietary rights of others. If we do not adequately protect our intellectual property, competitors may be able to use our technologies and erode or negate any competitive advantage we may have, which could harm our business and ability to achieve profitability.
Filing, prosecuting and defending patents on product candidates in all countries around the world would be prohibitively expensive. In addition, we may at times in-license third-party technologies for which limited international patent protection exists and for which the time period for filing international patent applications has passed. Consequently, we may not be able to prevent third parties from practicing our inventions, or from selling or importing products made using our inventions. Potential competitors may use our
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technologies in jurisdictions where we have not obtained patent protection to develop their own products and further, may export otherwise infringing products to territories where we have patent protection but enforcement is difficult. These products may compete with our product candidates, if approved, and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.
Many companies have encountered significant problems in protecting and defending intellectual property rights around the world. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property protection, particularly those relating to biotechnology products, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.
Third-party claims of intellectual property infringement may prevent or delay our product discovery and development efforts.
Our commercial success depends in part on our avoiding infringement of the patents and proprietary rights of third parties. There is a substantial amount of litigation involving the infringement of patents and other intellectual property rights in the biotechnology and pharmaceutical industries. We may be exposed to, or threatened with, future litigation by third parties having patent or other intellectual property rights and who allege that our product candidates, uses and/or other proprietary technologies infringe their intellectual property rights. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are developing our product candidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk that our product candidates may give rise to claims of infringement of the patent rights of others increases. Moreover, it is not always clear to industry participants, including us, which patents exist which may be found to cover various types of drugs, products or their methods of use or manufacture. Thus, because of the large number of patents issued and patent applications currently pending in our fields, there may be a risk that third parties may allege they have patent rights which are infringed by our product candidates, technologies or methods.
If a third party alleges that we infringe its intellectual property rights, we may face a number of issues, including, but not limited to:
| • | infringement and other intellectual property misappropriation which, regardless of merit, may be expensive and time-consuming to litigate and may divert our management’s attention from our core business; |
| • | substantial damages for infringement or misappropriation, which we may have to pay if a court decides that the product candidate or technology at issue infringes on or violates the third-party’s rights, and, if the court finds we have willfully infringed intellectual property rights, we could be ordered to pay treble damages and the patent owner’s attorneys’ fees; |
| • | an injunction prohibiting us from manufacturing, marketing or selling our product candidates, or from using our proprietary technologies, unless the third party agrees to license its patent rights to us; |
| • | even if a license is available from a third party, we may have to pay substantial royalties, upfront fees and other amounts, and/or grant cross-licenses to intellectual property rights protecting our products; and |
| • | we may be forced to try to redesign our product candidates or processes so they do not infringe third-party intellectual property rights, an undertaking which may not be possible or which may require substantial monetary expenditures and time. |
Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue our operations or could otherwise have a material adverse effect on our business, results of operations, financial condition and prospects.
Third parties may assert that we are employing their proprietary technology without authorization. Generally, conducting preclinical and clinical trials and other development activities in the United States is not considered an act of infringement. If one of our product candidates is approved by the FDA, a third party may then seek to enforce its patent by filing a patent infringement lawsuit against us. While we may believe that patent claims or other intellectual property rights of a third party would not have a materially adverse effect
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on the commercialization of our product candidates, we may be incorrect in this belief, or we may not be able to prove it in litigation. In this regard, patents issued in the United States by law enjoy a presumption of validity that can be rebutted only with evidence that is “clear and convincing,” a heightened standard of proof. There may be issued third-party patents of which we are currently unaware with claims to compositions, formulations, methods of manufacture or methods for treatment related to the use or manufacture of our product candidates. Patent applications can take many years to issue. There may be currently pending patent applications which may later result in issued patents that may be infringed by our product candidates. Moreover, we may fail to identify relevant patents or incorrectly conclude that a patent is invalid, not enforceable, exhausted, or not infringed by our activities. If any third-party patents, held now or obtained in the future by a third party, were found by a court of competent jurisdiction to cover the manufacturing process of our product candidates, constructs or molecules used in or formed during the manufacturing process, or any final product or methods use of the product, the holders of any such patents may be able to block our ability to commercialize the product candidate unless we obtained a license under the applicable patents, or until such patents expire or they are finally determined to be held invalid or unenforceable. Similarly, if any third-party patent were held by a court of competent jurisdiction to cover any aspect of our formulations, any combination therapies or patient selection methods, the holders of any such patent may be able to block our ability to develop and commercialize the product candidate unless we obtained a license or until such patent expires or is finally determined to be held invalid or unenforceable. In either case, such a license may not be available on commercially reasonable terms or at all. If we are unable to obtain a necessary license to a third-party patent on commercially reasonable terms, or at all, our ability to commercialize our product candidates may be impaired or delayed, which could in turn significantly harm our business. Even if we obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.
Parties making claims against us may seek and obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize our product candidates. Defense of these claims, regardless of their merit, could involve substantial litigation expense and would be a substantial diversion of employee resources from our business. In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, pay royalties or redesign our infringing products, which may be impossible or require substantial time and monetary expenditure. We cannot predict whether any such license would be available at all or whether it would be available on commercially reasonable terms. Furthermore, even in the absence of litigation, we may need or may choose to obtain licenses from third parties to advance our research or allow commercialization of our product candidates. We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all. In that event, we would be unable to further develop and commercialize our product candidates, which could harm our business significantly.
We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful.
Competitors may infringe our patents or the patents of our licensors. To counter infringement or unauthorized use, we may be required to take legal action to enforce our patents or our licensors’ patents against such infringing activity. Such enforcement proceedings against infringers can be expensive and time-consuming.
In addition, in an infringement proceeding, a court may decide that one or more of our patents is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the compositions or activities in question. An adverse result in any litigation or defense proceedings could put one or more of our patents at risk of being invalidated, held unenforceable, or interpreted narrowly and could put our patent applications at risk of not issuing. Defense against these assertions, non-infringement, invalidity or unenforceability regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business. In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, pay royalties or redesign our infringing products, which may be impossible or require substantial time and monetary expenditure.
Post-grant proceedings provoked by third parties or brought by the USPTO may be brought to determine the validity or priority of inventions with respect to our patents or patent applications or those of our licensors. An unfavorable outcome could result in a loss of our current patent rights and could require us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms. Litigation or post-grant proceedings may result in a decision adverse to our interests and, even if we are successful, may result in substantial costs and distract our management and other employees. We may not be able to prevent, alone or with our licensors, misappropriation of our trade secrets or confidential information, particularly in countries where the laws may not protect those rights as fully as those within the United States.
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Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common shares.
Changes to patent law in the United States and in foreign jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
As is the case with other drug and biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the drug and biopharmaceutical industry involves both technological and legal complexity, and is therefore costly, time-consuming and inherently uncertain. In addition, the United States has passed wide-ranging patent reform legislation under the AIA. Moreover, recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future. We cannot predict how future decisions by the courts, Congress or the USPTO may impact the value of our patents. Similarly, any adverse changes in the patent laws of other jurisdictions could have a material adverse effect on our business and financial condition. Changes in the laws and regulations governing patents in other jurisdictions could similarly have an adverse effect on our ability to obtain and effectively enforce our patent rights.
We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.
Certain of our key patent families have been filed in the United States; however, we have less robust intellectual property rights outside the United States, and, in particular, we may not be able to pursue patent coverage of our product candidates in certain countries outside of the United States. Filing, prosecuting and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States may be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. The breadth and strength of our patents issued in foreign jurisdictions or regions may not be the same as the corresponding patents issued in the United States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and further, may export otherwise infringing products to certain territories where we have patent protection, but enforcement is not as strong as that in the United States. These products may compete with our products and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing. Most of our patent portfolio is at the very early stage. We will need to decide whether and in which jurisdictions to pursue protection for the various inventions in our portfolio prior to applicable deadlines.
Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property protections, particularly those relating to drug and biopharmaceutical products. This difficulty with enforcing patents could make it difficult for us to stop the infringement of our patents or marketing of competing products otherwise generally in violation of our proprietary rights. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly, put our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.
We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
We generally enter into confidentiality and intellectual property assignment agreements with our employees, consultants, and contractors. These agreements generally provide that inventions conceived by the party in the course of rendering services to us will be our exclusive property. However, those agreements may not be honored and may not effectively assign intellectual property rights to us. Moreover, there may be some circumstances, where we are unable to negotiate for such ownership rights. Disputes regarding ownership or inventorship of intellectual property can also arise in other contexts, such as collaborations and sponsored research. If we are subject to a dispute challenging our rights in or to patents or other intellectual property, such a dispute could be expensive and time-consuming. If we were unsuccessful, we could lose valuable rights in intellectual property that we regard as our own.
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We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
We have received confidential and proprietary information from third parties. In addition, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies. We may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed confidential information of these third parties or our employees’ former employers or our consultants’ or contractors’ current or former clients or customers. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial cost and be a distraction to our management and employees. If we are not successful, we could lose access or exclusive access to valuable intellectual property.
Risks Related to Our Reliance on Third Parties
The Company relies on third parties to conduct its pre-clinical studies and clinical trials. If those parties do not successfully carry out their contractual duties or meet expected deadlines, the Company’s drug candidates may not advance in a timely manner or at all.
In the course of discovery, pre-clinical testing and clinical trials, the Company relies on third parties, including laboratories, investigators, clinical CROs, and manufacturers, to perform critical services. For example, the Company relies on third parties to conduct all of its pre-clinical and clinical studies. These third parties may not be available when the Company needs them or, if they are available, may not comply with all regulatory and contractual requirements or may not otherwise perform their services in a timely or acceptable manner, and the Company may need to enter into new arrangements with alternative third parties and the studies may be extended, delayed or terminated. These independent third parties may also have relationships with other commercial entities, some of which may compete with the Company. As a result of the Company’s dependence on third parties, it may face delays or failures outside of its direct control. These risks also apply to the development activities of collaborators, and the Company does not control their research and development, clinical trial or regulatory activities.
The Company has no direct control over the cost of manufacturing its drug candidates. Increases in the cost of manufacturing the Company’s drug candidates would increase the costs of conducting clinical trials and could adversely affect future profitability.
The Company does not intend to manufacture the drug product candidates in-house, and it will rely on third parties for drug supplies both for clinical trials and for commercial quantities in the future. The Company has taken the strategic decision not to manufacture active pharmaceutical ingredients (“API”) for the drug candidates, as these can be more economically supplied by third parties with particular expertise in this area. The Company outsources the manufacture of its drug products and their testing to FDA requirements. The Company uses contract facilities that are registered with the FDA, have a track record of large-scale API manufacture, and have already invested in capital and equipment. The Company has no direct control over the cost of manufacturing its product candidates. If the cost of manufacturing increases, or if the cost of the materials used increases, these costs may be passed on, making the cost of conducting clinical trials more expensive. Increases in manufacturing costs could adversely affect the Company’s future profitability if it was unable to pass all of the increased costs along to its customers.
The Company relies on third-party contract manufacturing organizations to manufacture its drug product candidates. If one or more of these vendors were unable to meet the Company’s needs, it may materially and adversely impact our business.
Manufacture of pharmaceutical material for human administration is technically complex and highly regulated. If one or more of the Company’s vendors failed to produce drug product to the requisite standard, the continuity of the Company’s operations may be severely disrupted. Even if a vendor was found deficient in respect of another product, it may impair the confidence of regulatory agencies in our product candidates, thereby disrupting our operations.
Global contract manufacturing capacity is limited, and the manufacturing process is not readily portable. As a result, the Company’s ability to manufacture its product candidates in a timely manner is dependent on the availability of suitable capacity at its vendors.
The manufactured drug products, and their intermediaries, are of significant financial value. Loss, damage, or theft of this material, for example while in storage or transit, may result in significant detriment to the Company, which may be incompletely cured by insurance.
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Our reliance on third parties for research and development and manufacturing requires us to share our trade secrets, which increases the possibility that our trade secrets will be misappropriated or disclosed, and confidentiality agreements with employees and third parties may not adequately prevent disclosure of trade secrets and protect other proprietary information.
We consider proprietary trade secrets or confidential know-how and unpatented know-how to be important to our business. We may rely on trade secrets or confidential know-how to protect our technology, especially where patent protection is believed by us to be of limited value. We rely on third parties for research and development work, and expect to rely on third parties for future manufacturing of our proprietary product candidate, paxalisib and EVT801, and any other current or future product candidates. We also expect to collaborate with third parties on the development of paxalisib and EVT801, and any other current or future product candidates. As a result of the aforementioned collaborations, we must, at times, share trade secrets with our collaborators.
Trade secrets or confidential know-how can be difficult to maintain as confidential. To protect this type of information against disclosure or appropriation by competitors, our policy is to require our employees, consultants, contractors and advisors to enter into confidentiality agreements and, if applicable, material transfer agreements, consulting agreements or other similar agreements with us prior to beginning research or disclosing proprietary information. These agreements typically limit the rights of the third parties to use or disclose our confidential information, including our trade secrets. However, current or former employees, consultants, contractors and advisers may unintentionally or willfully disclose our confidential information to competitors, and confidentiality agreements may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. The need to share trade secrets and other confidential information increases the risk that such trade secrets become known by our competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements. Given that our proprietary position is based, in part, on our know-how and trade secrets, a competitor’s discovery of our trade secrets or other unauthorized use or disclosure would impair our competitive position and may have an adverse effect on our business and results of operations. Enforcing a claim that a third party obtained illegally and is using trade secrets or confidential know-how is expensive, time consuming and unpredictable. Moreover, the enforceability of confidentiality agreements may vary from jurisdiction to jurisdiction.
In addition, these agreements typically restrict the ability of our advisors, employees, third-party contractors and consultants to publish data potentially relating to our trade secrets, although our agreements may contain certain limited publication rights. Despite our efforts to protect our trade secrets, our competitors may discover our trade secrets, either through breach of our agreements with third parties, independent development or publication of information by any of our third-party collaborators. A competitor’s discovery of our trade secrets would impair our competitive position and have an adverse impact on our business.
Risks Related to our Securities
Enforceability of civil liabilities under the federal securities laws against the Company or the Company’s officers and directors may be difficult.
The Company is a public company limited by shares and is registered and operates under the Corporations Act 2001 (Cth) (“Corporation Act”). Half of the Company’s directors and officers reside outside of the United States. In addition, a substantial portion of the directly owned assets of the Company are located outside of the United States. As a result, it may be difficult or impossible for investors to effect service of process within the United States against the Company or its directors and officers or to enforce against them any of the judgments, including those obtained in original actions or in actions to enforce judgments of the U.S. courts, predicated upon the civil liability provisions of the federal or state securities laws of the United States. There is doubt as to the enforceability in the Commonwealth of Australia, in original actions or in actions for enforcement of judgments of U.S. courts, of civil liabilities predicated solely upon federal or state securities laws of the U.S., especially in the case of enforcement of judgments of U.S. courts where the defendant has not been properly served in Australia.
The Company’s failure to meet the continued listing requirements of Nasdaq could result in a delisting of the ADSs, which could negatively impact the market price and liquidity of the Company’s securities and its ability to access the capital markets.
The ADSs are listed on the Nasdaq Capital Market. If the Company fails to satisfy the continued listing requirements of Nasdaq, such as the corporate governance requirements or the minimum closing bid price requirement, Nasdaq may take steps to delist the ADSs. Such a delisting would have a negative effect on the price of the Company’s securities, impair the ability to sell or purchase our ADSs when persons wish to do so, and any delisting materially adversely affect the Company’s ability to raise capital or pursue strategic restructuring, refinancing or other transactions on acceptable terms, or at all. Delisting from the Nasdaq Capital Market could also have other negative results, including the potential loss of institutional investor interest and fewer business development opportunities. In the event of a delisting, the Company would attempt to take actions to restore its compliance with Nasdaq’s listing requirements, but the Company can provide no assurance that any such action taken by it would allow the ADSs to become listed again, stabilize the market price or improve the liquidity of the ADSs, prevent the ADSs from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s listing requirements.
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On May 12, 2025, the Company received a notification (the Notification) from the Listing Qualifications Staff of the Nasdaq Stock Market LLC (Nasdaq) notifying the Company that from March 28, 2025 to May 9, 2025, the Company’s Market Value of Listed Securities (MVLS) was below the minimum of $35 million. The Notification has no immediate impact on the Company’s operations or listing and Kazia’s American Depositary Shares (ADSs) will continue to trade on the Nasdaq Capital Market under the ticker “KZIA”. In accordance with Nasdaq Listing Rule 5810(c)(3)(C), the Company has 180 calendar days to regain compliance with the MVLS Requirement. Such notification stated that, to regain compliance with the MVLS Requirement, our MVLS must close at $35 million or more for a minimum of ten consecutive business days during the compliance period ending on November 10, 2025. Additionally, the Notice also stated that as of May 9, 2025, the Company did not meet the alternatives of maintaining minimum stockholders’ equity requirement of $2.5 million or net income from continuing operations of $0.5 million in its most recently completed fiscal year or in two of its three most recently completed fiscal years per Listing Rule 5550(b)(3), and as such, the Company did not comply with the Listing Rule 5550 for continued listing on the Nasdaq Capital Market.
However, if we do not regain compliance with the relevant listing requirement during the applicable compliance period, Nasdaq will notify us in writing of its determination to delist our ADSs, at which point we would have an opportunity to appeal the delisting determination. However, there can be no assurance that, if we receive a delisting notice from the Staff and appeal the delisting determination, such appeal would be successful. We intend to actively monitor our MVLS and will take all reasonable measures available to us to regain compliance with the MVLS requirement. There can be no assurance that we will be able to regain compliance with this listing requirement or otherwise maintain compliance with any other listing requirements.
We cannot assure you that we will regain compliance with the MVLS requirement or remain in compliance with all applicable requirements for continued listing on Nasdaq. If we fail to regain or sustain compliance with all applicable requirements for continued listing on Nasdaq, the ADSs may be subject to delisting by Nasdaq.
This could inhibit the ability of holders of the ADSs to trade their ADSs in the open market, thereby severely limiting the liquidity of such ADSs. Although holders of the ADSs may be able to trade such ADSs on the over-the-counter market, there can be no assurance that this would occur. Further, the over-the-counter market provides significantly less liquidity than Nasdaq and other national securities exchanges, is thinly traded and highly volatile, has fewer market makers and is not followed by analysts. As a result, your ability to trade or obtain quotations for these securities may be more limited than if they were quoted on Nasdaq or other national securities exchanges.
The trading price of the ADSs is highly volatile. Your investment could decline in value and the Company may incur significant costs from class action litigations.
The trading price of the ADSs is highly volatile in response to various factors, many of which are beyond the Company’s control, including:
| • | unacceptable toxicity findings in animals and humans; |
| • | lack of efficacy in human trials at Phase II stage or beyond; |
| • | announcements of technological innovations by the Company and its competitors; |
| • | new products introduced or announced by the Company or its competitors; |
| • | changes in financial estimates by securities analysts; |
| • | actual or anticipated variations in operating results; |
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| • | expiration or termination of licenses, research contracts or other collaboration agreements; |
| • | conditions or trends in the regulatory climate in the biotechnology, pharmaceutical and genomics industries; |
| • | changes in the market values of similar companies; |
| • | changes in the broader macroeconomic environment; |
| • | the liquidity of any market for the Company’s securities; and |
| • | additional sales by the Company of its shares. |
In addition, equity markets in general and the market for biotechnology and life sciences companies in particular, have experienced substantial price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of the companies traded in those markets. Further changes in economic conditions in Australia, the U.S., EU, or globally, could impact the Company’s ability to grow profitably. Adverse economic changes are outside the Company’s control and may result in material adverse effects on the Company’s business or results of operations. These broad market and industry factors may materially affect the market price of the Company’s the ADSs regardless of its development and operating performance. In the past, following periods of volatility in the market price of a company’s securities, securities class action litigation has often been instituted against that company. Such litigation, if instituted against the Company, could cause it to incur substantial costs and divert management’s attention and resources.
If the market price of the ADSs falls and remains below US$5.00 per share, under stock exchange rules, the Company’s stockholders will not be able to use such ADSs as collateral for borrowing in margin accounts. This inability to use ADSs as collateral may depress demand as certain institutional investors are restricted from investing in securities priced below US$5.00 and may lead to sales of such ADSs, creating downward pressure on and increased volatility in the market price of the Company’s ordinary shares and ADSs.
The delisting of the Company’s ordinary shares on the ASX may adversely affect the price, liquidity and value of the ADSs.
On 11 October 2023, the Company announced its intention to delist from the Australian Securities Exchange (the “ASX”), which became effective on 15 November 2023. Upon completion of the delisting, the Company’s ordinary shares were no longer quoted or traded on the ASX and only the ADSs are listed on the Nasdaq Capital Market, and as a result, shareholders were no longer able to trade their ordinary shares on the ASX. Following the completion of the delisting, the Company’s ordinary shares are only capable of being traded on Nasdaq in the form of ADSs, which will require shareholders to transfer their ordinary shares to ADSs to trade on Nasdaq and engage a suitably qualified Australian broker or a U.S. based broker who is able to trade on Nasdaq, or by off-market, private transactions, which will require shareholders to identify and agree terms with potential purchasers of ordinary shares. In addition, the Company is no longer subject to the ASX Listing Rules. Accordingly, as there is only one market on which to trade the Company’s securities, the delisting of the Company from the ASX may have impaired the development or liquidity of an active trading market for the ADSs in the U.S. and in turn the values of the ADSs.
If the Company fails to comply with the rules under the Sarbanes-Oxley Act of 2002 related to accounting controls and procedures in the future, or, if the Company discovers material weaknesses and other deficiencies in our internal control and accounting procedures, the price of the ADSs could decline significantly and raising capital could be more difficult.
If the Company fails to comply with the rules under the Sarbanes-Oxley Act of 2002 related to disclosure controls and procedures in the future, or, if we discover material weaknesses and other deficiencies in our internal control and accounting procedures, our stock price could decline significantly and raising capital could be more difficult. Section 404 of the Sarbanes-Oxley Act requires annual management assessments of the effectiveness of our internal control over financial reporting. As of 30 June 2025, the Company’s management determined that we had no material weaknesses in our internal control over financial reporting. If material weaknesses or significant deficiencies are discovered or if the Company otherwise fails to achieve and maintain the adequacy of its internal controls, the Company may not be able to ensure that it can conclude on an ongoing basis that it has effective internal controls over financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act. Moreover, effective internal controls are necessary for the Company to produce reliable financial reports and are important to helping prevent financial fraud. If the Company cannot provide reliable financial reports or prevent fraud, its business and operating results could be harmed, investors could lose confidence in its reported financial information, and the trading price of the ADSs could drop significantly.
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You are reliant on the depository to exercise your voting rights and to receive distributions on ADSs and, as a result, you may be unable to exercise your voting rights on a timely basis or you may not receive certain distributions.
In certain circumstances, holders of ADSs may have limited rights relative to holders of ordinary shares. The rights of holders of ADSs with respect to the voting of ordinary shares and the right to receive certain distributions may be limited in certain respects by the deposit agreement entered into by us and The Bank of New York Mellon. For example, although ADS holders are entitled under the deposit agreement, subject to any applicable provisions of Australian law and of our Constitution, to instruct the depositary as to the exercise of the voting rights pertaining to the ordinary shares represented by the ADSs, and the depositary has agreed that it will try, as far as practical, to vote the ordinary shares so represented in accordance with such instructions, ADS holders may not receive notices sent by the depositary in time to ensure that the depositary will vote the ordinary shares. This means that, from a practical point of view, the holders of ADSs may not be able to exercise their right to vote. Holders of ADSs in respect of which no timely voting instructions have been received shall be deemed to have instructed the depositary to give a discretionary proxy to a person designated by us to vote the ordinary shares represented by such holders’ ADSs; provided, however, that no such discretionary proxy shall be given with respect to any matter to be voted upon as to which we inform the depositary that (i) we do not wish such proxy to be given, (ii) substantial opposition exists, or (iii) the rights of holders of ordinary shares may be materially and adversely affected. In addition, under the deposit agreement, the depositary has the right to restrict distributions to holders of the ADSs in the event that it is unlawful or impractical to make such distributions. We have no obligation to take any action to permit distributions to holders of our ADSs. As a result, holders of ADSs may not receive distributions.
Holders of the ADSs are not treated as holders of our ordinary shares.
Holders of ADSs are not treated as holders of our ordinary shares, unless they withdraw the ordinary shares underlying their ADSs in accordance with the deposit agreement and applicable laws and regulations. The depositary is the holder of the ordinary shares underlying the ADSs. Holders of ADSs therefore do not have any rights as holders of our ordinary shares, other than the rights that they have pursuant to the Deposit Agreement.
You may be subject to limitations on transfer of the ADSs.
The ADSs are only transferable on the books of the depositary. However, the depositary may close its transfer books at any time or from time to time when it deems expedient in connection with the performance of its duties. In addition, the depositary may refuse to deliver, transfer or register transfers of ADSs generally when our books or the books of the depositary are closed, or at any time if we or the depositary deem it advisable to do so because of any requirement of law or of any government or governmental body, or under any provision of the Deposit Agreement, or for any other reason.
If we are, a passive foreign investment company, or PFIC, there could be adverse U.S. federal income tax consequences to U.S. investors.
Based on the composition of our assets and income, we believe that we were not a PFIC for U.S. federal income tax purposes with respect to our 2024 taxable year or our 2025 taxable year. However, even if we will not be considered a PFIC in the 2024 taxable year or the 2025 taxable year, there can be no assurance that we will not be considered a PFIC in the current taxable year or for any future taxable year. Our treatment as a PFIC could result in a reduction in the after-tax return to the U.S. holders of our ordinary shares or ADSs and would likely cause a reduction in the value of such ordinary shares or ADSs. For U.S. federal income tax purposes, we will be classified as a PFIC for any taxable year in which either (i) 75% or more of our gross income is passive income, or (ii) at least 50% of the average quarterly value of all of our assets for the taxable year produce or are held for the production of passive income. If we are classified as a PFIC for U.S. federal income tax purposes, highly complex rules will apply to U.S. holders owning ordinary shares or ADSs. Accordingly, you are urged to consult your tax advisors regarding the application of such rules. See Item 10-Additional Information-Taxation, United States Federal Income Tax Consequences for a more complete discussion of the U.S. federal income tax risks related to owning and disposing of our ordinary shares or ADSs.
We may lose our foreign private issuer status, which would then require us to comply with the Exchange Act’s domestic reporting regime and cause us to incur significant legal, accounting and other expenses.
We are a foreign private issuer. In order to maintain our current status as a foreign private issuer, at least 50% of our outstanding ordinary shares must continue to be either directly or indirectly owned of record by non-residents of the United States. If more than 50% of our outstanding ordinary shares are instead held by U.S. residents, then in order to continue to maintain our foreign private issuer status, (i) a majority of our executive officers or directors must not be U.S. citizens or residents, (ii) more than 50% of our assets must not be located in the United States, and (iii) our business must be administered principally outside the United States.
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Losing our status as a foreign private issuer would require us to comply with all of the periodic disclosure and current reporting requirements of the Exchange Act applicable to U.S. domestic issuers. We also will be required to make changes in our corporate governance practices in accordance with various SEC and Nasdaq rules. The regulatory and compliance costs to us under U.S. securities laws, if we are required to comply with the reporting requirements applicable to a U.S. domestic issuer, would be significantly higher than the cost we would incur as a foreign private issuer. As a result, we would expect that a loss of foreign private issuer status will increase our legal and financial compliance costs and will make some activities highly time consuming and costly. We also expect that if we will be required to comply with the rules and regulations applicable to U.S. domestic issuers, it will make it more difficult and expensive for us to obtain director and officer liability insurance; we may therefore be required to accept reduced coverage or incur substantially higher costs to obtain coverage. These rules and regulations could also make it more difficult for us to attract and retain qualified members of our board of directors.
Australian takeover laws may discourage takeover offers being made for us or may discourage the acquisition of a significant position in our ordinary shares and ADSs.
We are incorporated in Australia and are subject to the takeover laws of Australia. Among other things, we are subject to the Corporations Act. Subject to a range of exceptions, the Corporations Act prohibits the acquisition of a direct or indirect interest in our issued voting shares if the acquisition of that interest will lead to a person’s voting power in us increasing to more than 20%, or increasing from a starting point that is above 20% and below 90%. Australian takeover laws may discourage takeover offers being made for us or may discourage the acquisition of a significant position in our ordinary shares. This may have the ancillary effect of entrenching our board of directors and may deprive or limit our shareholders’ and ADS holders’ opportunity to sell their ordinary shares and ADSs and may further restrict the ability of our shareholders and ADS holders to obtain a premium from such transactions. See Item 10.B “Additional Information - Our Constitution.”
Unfavorable macroeconomic conditions or market volatility resulting from national or global economic conditions, including those affecting the financial services industry, could adversely affect our business, financial condition or results of operations.
Adverse macroeconomic conditions or market volatility resulting from national or global economic developments, political unrest, high inflation, elevated interest rates, international tariffs, changes in international trade relationships and military conflicts, such as the ongoing conflict between Russia and Ukraine, potential for significant changes in U.S. policies or regulatory environment or other factors, could materially and adversely affect our business operations. Sanctions imposed by the U.S. and other countries in response to such conflicts may also continue to adversely impact the financial markets and the global economy, and any economic countermeasures by the affected countries or others could exacerbate market and economic instability. For example, in early 2025, the U.S. imposed blanket 10% tariffs on virtually all imports to the U.S. and significantly higher tariffs applicable to imports from many countries, which have resulted in other countries imposing additional tariffs on imports from the U.S., and is likely to continue to result in more retaliatory tariffs. In addition, the current U.S. administration has expressed an intent to impose tariffs on pharmaceutical imports, with the stated policy objective of reshoring pharmaceutical manufacturing to the United States. Among other means, such tariffs may be imposed by the United States under Section 232 of the Trade Expansion Act of 1962, as amended, pursuant to which the U.S. Department of Commerce recently initiated an investigation to determine the effects of importing pharmaceuticals and pharmaceutical ingredients on national security. The Trump administration has continued to broadly impose tariffs, which could lead to corresponding punitive actions by the countries with which the U.S. trades. While certain tariffs have been suspended, modified or temporarily reduced, we cannot predict the results of the U.S. government’s trade negotiations or the outcome of ongoing legal challenges to specific tariff policies. There can be no assurance that deterioration in credit and financial markets and confidence in economic conditions will not occur. For instance, actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions, transactional counterparties or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any events of these kinds or other similar risks, have in the past and may in the future lead to market-wide liquidity problems. Investor concerns regarding the U.S. or international financial systems could result in less favorable commercial financing terms, including higher interest rates or costs and tighter financial and operating covenants, or systemic limitations on access to credit and liquidity sources, thereby making it more difficult for us to acquire financing on acceptable terms or at all. In addition, any deterioration in the macro-economy or financial services industry could lead to losses or defaults by our suppliers, which in turn, could have a material adverse effect on our current and/or planned business operations and our current or projected results of operations and financial condition. Also, current inflationary trends in the global economy may impact salaries and wages, costs of goods and transportation expenses, among other things, and recent and potential future disruptions in access to bank deposits or lending commitments due to bank failures may create market and economic instability. A severe or prolonged economic downturn or additional global financial crises could result in a variety of risks to our business, including weakened demand for any product candidates we develop or our ability to raise additional capital when needed on acceptable terms, if at all.
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Further, U.S. government appropriations have been affected by larger U.S. government budgetary issues and related legislation. Government spending levels are difficult to predict beyond the near term due to numerous factors, including the external threat environment, future government priorities and the state of government finances. Significant changes in government spending or changes in U.S. government priorities, policies and requirements could have a material adverse effect on our results of operations, financial condition or liquidity.
Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business.
| Item 4. | Information on the Company |
A. History and development of the Company
Kazia Therapeutics Limited (“Kazia” or the “Company”), a public company limited by shares, was incorporated in March 1994 and registered in New South Wales, Australia. Kazia is registered and operates under the Corporations Act.
Kazia has its registered office at Three International Towers, Level 24, 300 Barangaroo Avenue, Sydney, NSW 2000, Australia. Its telephone number and other contact details are: Phone +61-2-9472 4101; email info@kaziatherapeutics.com; and website, www.kaziatherapeutics.com (the information contained in the website does not form part of the Annual Report). Our agent for service of process in the United States is Vcorp Services, LLC, 25 Robert Pitt Drive, Suite 204, Monsey, New York 10952.
The Company’s ADSs, each representing five-hundred Ordinary Shares, trade on the Nasdaq Capital Market under the symbol ‘KZIA’. The Depositary for the Company’s ADSs is The Bank of New York Mellon, 240 Greenwich Street, New York, NY 10286. All information we file with the SEC is available through the SEC’s Electronic Data Gathering, Analysis and Retrieval system, which may be accessed through the SEC’s website at www.sec.gov.
B. Business overview
The ongoing principal business of the Company has been pharmaceutical drug development. The Company is an emerging oncology-focused biotechnology company that has a portfolio of development candidates, diversified across several distinct technologies, with the potential to yield first-in-class and best-in-class agents in a range of oncology indications.
Paxalisib
Kazia’s lead program is Paxalisib, (formerly known as GDC-0084), an investigational brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, that was specifically designed to treat brain cancer.
Paxalisib was developed by Genentech, Inc (South San Francisco, California) and the company entered into a worldwide exclusive license for the asset in October 2016. Prior to this transaction, Genentech had completed an extensive pre-clinical development program that provided convincing validation for Paxalisib as a potential drug for brain cancer. Genentech also completed a phase I clinical trial in 47 patients with advanced recurrent grade III and grade IV glioma (NCT01547546). The most common adverse events were oral mucositis and hyperglycemia. Per ANO criteria, 40% of patients exhibited a best observable response of stable disease, and 26% demonstrated a metabolic partial response on FDG-PET.
The development candidate was granted the International Non-Proprietary Name (INN) ‘Paxalisib’ by the World Health Organisation in December 2019. This was confirmed as the United States Adopted Name (“USAN”) by the USAN Council in April 2020. Paxalisib is orally administered and is presented in a 15mg capsule formulation. The development candidate is the subject of IND 112,608 with the U.S. Food and Drug Administration (“FDA”).
Paxalisib is a potent and selective inhibitor of all four isoforms of phosphoinositide-3-kinase (PI3K) and a moderate inhibitor of the mammalian target of rapamycin (“mTOR”). The PI3K / Akt / mTOR signaling axis has been shown to be dysregulated in approximately 85-90% of cases of glioblastoma, per Cancer Genome Atlas, and is considered a promising target in this disease. More generally, five PI3K inhibitors have thus far been approved by FDA, for a range of hematological malignancies and solid tumors, making this a well-validated target in cancer. Paxalisib is distinguished from these products by the fact that it is the only PI3K inhibitor in mainstream clinical development which is known to cross the blood-brain barrier, a crucial prerequisite for any novel treatment in brain cancer.
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Paxalisib’s mechanism is therefore entirely distinct from that of temozolomide, the existing FDA-approved standard of care treatment. Temozolomide functions primarily by alkylating guanine residues in DNA, thereby inhibiting cell division in the rapidly-growing tumor. Paxalisib, by contrast, inhibits a biochemical control signal, and is therefore associated with a very different resistance and toxicity profile.
Paxalisib is the subject of granted or pending composition-of-matter patents in all key territories. In general, the expiry of these patents is in December 2031. However, the company expects that it will be able to secure patent term extensions in the most substantial markets, including US, EU, China, Japan, and Korea, and that these extensions will provide effective protection until 2036. In addition, the company has recently received notice of grant for a patent protecting the manufacturing process associated with Paxalisib, and this will provide an additional layer of protection in relevant territories until 2036.
Paxalisib was granted orphan drug designation (“ODD”) by the FDA for glioblastoma in February 2018, and for the broader indication of glioma in August 2020 and ODD for atypical rhabdoid/teratoid tumours (“AT/RT”), a rare highly-aggressive childhood brain cancer, in June 2022. The development candidate also received Fast Track designation (“FTD”) for glioblastoma in August 2020, and Rare Pediatric Disease Designation (“RPDD”) for diffuse midline gliomas in August 2020. On July 6, 2023, Kazia announced that Paxalisib had been awarded FTD by the FDA for the treatment of solid tumor brain metastases harboring PI3K pathway mutations in combination with radiation therapy. Collectively, these designations provide opportunities for enhanced access to FDA, a waiver of Prescription Drug Use Fee Act (“PDUFA”) fees, a period of regulatory exclusivity and, in the specific case of RPDD, the potential to secure a pediatric Priority Review Voucher (pPRV) should this program be legislatively extended after statutory sunset dates, and if paxalisib is the first approved product in this indication.
Brain cancers account for about 15% of pediatric cancers and are the second most common type of cancer in children whereas over 300,000 adults are diagnosed every year with primary brain cancer. We believe Paxalisib, by design, has the potential to be an integral component to precision medicine. As a targeted therapeutic, we have focused many of the ongoing trials to evaluate Paxalisib in patients who have PI3K pathway mutations. Enrolling clinical trials with patients who have the potential to have the greatest response and benefits accelerates clinical trial recruitment and time to commercialization. The overall clinical development strategy for Paxalisib has been crafted into three core pillars. Within the adult brain cancer pillar, we have four ongoing clinical studies across three different patient populations. There are two actively recruiting clinical studies and one recently completed study in the pediatric brain cancer pillar. Within the brain metastases pillar, there are three ongoing studies.
Paxalisib in Adult Brain Cancer
Glioblastoma (“GBM”) is a fast-growing and aggressive brain tumour. Paxalisib is being developed primarily for the ~65% of newly-diagnosed unmethylated GBM patients who generally do not respond to existing chemotherapy with temozolomide. The final data from a phase II study in newly diagnosed GBM patients reported promising signals of clinical activity with Paxalisib and was presented at two global conferences in 2023.
GBM AGILE Pivotal study Phase II / III Clinical Trial in Glioblastoma (NCT03970447)
Paxalisib commenced recruitment to GBM AGILE a phase II / III adaptive clinical trial in glioblastoma, in January 2021. GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) is sponsored by the Global Coalition for Adaptive Research, a US-based 501©(3) non-profit organization dedicated to advancing the development of new therapies via the application of cutting-edge statistical methodologies. The goal is to expedite the approval of new drugs for this disease. The study is a platform study, or master protocol study, in which multiple experimental agents are evaluated in parallel, and are compared against a shared control arm. The Paxalisib arm enrolled two patient populations: newly diagnosed patients with unmethylated MGMT promotor status, and recurrent patients.
On 1 August 2022, the Consolidated Entity announced that it had been informed by GCAR that the Paxalisib arm had not graduated to the second stage of the GBM AGILE study, and that recruitment had therefore completed with approximately 150 patients enrolled to the first stage. Those patients remain ongoing, with initial data obtained in 1H CY2024. The interim ‘graduation’ analysis may have been affected by the rapid and back-loaded recruitment profile of the study and does not preclude a positive outcome in the final data.
On 10 July, 2024, Kazia announced results from the GBM-AGILE study. A total of 313 newly diagnosed unmethylated (“NDU”) patients and recurrent patients being treated at top U.S. cancer hospitals were randomized to either a Paxalisib treatment arm (up to 60 mg/day) or the Standard of Care (“SOC”) concurrent control arm from January 2021 to May 2022. For the primary analysis the median Overall Survival (“OS”) was 14.77 months for Paxalisib-treated NDU patients (n=54) versus 13.84 months for cumulative SOC NDU patients (n=75). For a prespecified secondary analysis in the NDU patients, median OS was 15.54 months in the Paxalisib
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arm (n=54) versus 11.89 months for concurrent SOC (n=46). In addition, a prespecified sensitivity analysis in NDU patients showed similar median OS difference between Paxalisib treated patients (15.54 months) and concurrent SOC patients (11.70 months). An efficacy signal was not detected in the recurrent disease population (median OS of 9.69 months for concurrent SOC (n=113) versus 8.05 months for Paxalisib (n=100). Based on the totality of clinical and preclinical data from all completed studies of Paxalisib in newly diagnosed unmethylated glioblastoma (GBM), Kazia has met with the U.S. Food and Drug Administration (FDA) in December 2024 to review the results. Following this discussion, the FDA indicated that the current data are not sufficient to support a new drug application (NDA) at this time and recommended that Kazia obtain additional clinical evidence to further characterize Paxalisib’s efficacy and safety in this population. The Company is evaluating these recommendations and potential next steps for Paxalisib, including the design of future clinical studies and potential regulatory pathways.
LUMOS2 phase II study
Kazia is supporting the University of Sydney on a molecularly guided phase II clinical study evaluating Paxalisib in adult patients with recurrent/progressive isocitrate dehydrogenase (IDH) mutant grade 2 and 3 gliomas (G2/3 gliomas). The LUMOS2 study is sponsored by the University of Sydney with a goal of investigating targeted therapeutics in these patients who have limited options. The study is expected to enroll up to 76 patients with PI3K pathway mutations and will be a multicenter study at several Australian sites, with the potential to expand internationally. Enrollment in the study is ongoing.
Weill Cornell Medicine Phase II Study in Glioblastoma in Combination with Ketogenesis (NCT05183204)
In June 2021, the company entered into an agreement with Weill Cornell Medicine for an investigator-initiated phase II clinical trial combining Paxalisib with ketogenesis in patients with newly- diagnosed and recurrent glioblastoma. The study is actively enrolling in two cohorts of GBM patients, and we anticipate providing an update to this study in 2025.
Dana Farber Cancer Institute (DFCI) Phase II Study in Primary Central Nervous System Lymphoma (PCNSL) (NCT04906096)
Professor Lakshmi Nayak is the Principal Investigator to a phase II clinical study of Paxalisib in patients with primary CNS lymphoma (PCNSL) (NCT04906096). We believe the unique brain-penetrant qualities of Paxalisib make it suitable for investigation in this patient group. Study enrollment is ongoing and expected to recruit approximately 25 patients.
Paxalisib in Pediatric Brain Cancer
Brain cancer is the most common malignancy of childhood and represents about one third of all childhood cancer deaths. The PI3K/AKT/mTOR pathway is frequently upregulated in pediatric cancers and therefore therapeutics that target those pathways could lead to well long-awaited regulatory approvals. DIPG is the most common of a group of childhood brain cancers known as diffuse midline gliomas (“DMGs”). The disease has no FDA approved drug treatments and average survival from diagnosis is approximately 10 months. Kazia recognizes the critical importance and immense unmet need and is exploring Paxalisib in two common forms of childhood cancer-DIPGs and Advanced Childhood Cancer with PI3K/mTOR mutations.
St Jude Children’s Hospital Phase I Study in Diffuse Intrinsic Pontine Glioma (DIPG) (NCT03696355)
In February 2020, the company’s collaborators at St Jude Children’s Research Hospital in Memphis, TN completed recruitment to a phase I investigator- initiated clinical study of Paxalisib in diffuse intrinsic pontine glioma (DIPG), a rare but highly aggressive childhood brain cancer with no approved pharmacological treatments. The St Jude study (NCT03696355) sought to establish a maximum tolerated dose (“MTD”) in the pediatric population before enrolling an expansion cohort to seek definitive signals of efficacy. In September 2019, the company announced that a pediatric MTD of 27 mg/m2 had been determined, which is approximately comparable to the doses used in adult clinical studies. The investigators reported interim data in an oral presentation at the SNO Annual Meeting in November 2020. The study met its primary objective and determined a maximum tolerated dose for pediatric use of 27 mg/m2. 27 patients were recruited, of whom 24 received at least one dose of Paxalisib. The safety profile and pharmacokinetics were highly consistent with the adult data. Clinical study report is anticipated in 2026.
PNOC022 phase II Study in Diffuse Intrinsic Pontine Glioma (DIPG) (NCT05009992)
In December 2020, the company entered into a letter of intent with the Pacific Pediatric Neuro-Oncology Consortium (PNOC), an international consortium focused on the development of novel combination therapies, to execute an investigator-initiated phase II adaptive platform study of Paxalisib in patients with DIPG and other DMGs, a group which collectively constitutes one of the most aggressive childhood cancers. The study will explore Paxalisib in combination with ONC-201, a small-molecule investigational new
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drug which targets dopamine receptor D2 (DRD2), and which is manufactured by Oncoceutics, Inc, a wholly-owned subsidiary of Chimerix, Inc. Preliminary results were presented at Society of Neuro-Oncology 2023 Annual meeting on November 19, 2023. Sixty-eight patients with DMG were enrolled and the Median OS from time of diagnosis was 16.5 months (lower 95% confidence interval (“CI”) 11.6 months) with a median follow-up time of 9.9 months (95% CI: 8.5, 11.4). Most common grade 3 and above treatment-related adverse events were decreased neutrophil count (n=4); mucositis (n=3); and, colitis, drug reaction with eosinophilia and systemic symptoms, decreased lymphocyte count, hyperglycemia, and hypokalemia (n=2). On 27 June, 2024, Kazia announced that updated clinical data from the study will be presented at 21st International Symposium on Pediatric Neuro-Oncology. Highlights of the presentation included median overall survival of 13.2 months in Cohort 1 (newly diagnosed, enrolled pre-radiation n=33), 15.8 months in Cohort 2 (newly diagnosed, enrolled post-radiation n=69) and 8.8 months in Cohort 3 (relapsed patients, enrolled after progression n=30). Further analyses are ongoing by Pediatric Neuro-Oncology Consortium (“PNOC”) researchers and updates are expected in 2025.
OPTIMISE phase II study
Kazia entered into a collaboration with the Australian and New Zealand Children’s Haematology / Oncology Group in March 2023 for a phase II clinical study examining Paxalisib as a targeted therapeutic in children with advanced solid tumours, including brain tumours. The study, named OPTIMISE, is the first Australian-led clinical trial to combine Paxalisib and chemotherapy for children with PI3K pathway mutations in their tumours. Enrollment for this study is ongoing.
Paxalisib in Brain Metastases
Brain metastases occur when cancer cells spread from their original site to the brain, and treatment options are very limited. Brain metastases are a common complication of many tumours, but are particularly common in breast cancer, lung cancer, and melanoma and account for 67% to 89% of all cancers. Brain metastases are typically highly resistant to treatment and survival rates are generally low. Radiotherapy is a common treatment modality for brain metastases. Despite some efficacy, patients typically become resistant over time, and repeat courses of radiotherapy can be associated with significant neurological toxicity. Additionally, PI3K pathway mutations are common in brain metastasis and are frequently associated with a worse prognosis.
MSKCC phase I clinical study in Brain Metastases in Combination with Radiotherapy (NCT04192981)
Paxalisib is the subject of an ongoing phase I clinical study in patients with brain metastases and leptomeningeal metastases who harbor PI3K pathway mutations in combination with radiotherapy sponsored by Memorial Sloan Kettering Cancer Center in New York, NY. Encouraging safety and clinical activity from this study was presented by the lead investigator, Dr. Jonathan Yang in August 2022 at the ASCO/SNO CNS meeting held in Toronto, Canada. Interim data from the first stage of the study indicated that all 9 evaluable patients experienced complete or partial response, representing an overall response rate (ORR) of 100%, according to RANO-BM criteria. The patients comprised a range of primary tumors, with breast cancer the most common, representing one third of patients. The company announced that the phase I expansion cohort had reached an early conclusion based on positive safety data and positive clinical response findings observed to date. Final analyses is ongoing and clinical study report is anticipated in 2026. .
Alliance for Clinical Trials in Oncology Phase II Genomically-Guided Study in Brain Metastases (NCT03994796)
The Alliance for Clinical Trials in Oncology is sponsoring a phase II multi-drug study of multiple agents in the treatment of brain metastases from any primary tumour (NCT03994796) and substantially funded by the US National Cancer Institute. Three patient cohorts are enrolled in the Paxalisib arm: breast cancer, lung cancer, and other tumors. The enrollment is ongoing for all cohorts including the expansion stage of the study in breast cancer brain metastases patients.
Dana Farber Cancer Institute (DFCI) Phase II Study in HER2+ Breast Cancer Brain Metastases in Combination with Trastuzumab (NCT03765983)
Dr Jose Pablo Leone is the Principal Investigator for a phase II study in patients with HER2-positive breast cancer brain metastases, a population for which there are no approved pharmacological treatments, in which Paxalisib is administered in combination with Herceptin (trastuzumab), sponsored by Dana-Farber Cancer Institute in Boston, MA. Study enrollment is complete and final clinical study report is anticipated in 2026.
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Fast Track Designation
We received FTD by the FDA in July 2023 for Paxalisib for the treatment of solid tumour brain metastases harboring PI3K pathway mutations in combination with radiation therapy, based on the promising clinical data from an interim analysis of the MSKCC phase 1 trial.
To be awarded FTD, drugs must generally be able to show some potential advantage over existing therapies, either in terms of safety or efficacy. The key benefits of FTD comprise enhanced access to FDA, with regular and more frequent opportunities for consultation and discussion. In addition, drugs with FTD may be eligible for Accelerated Approval, in which a new medicine is approved based on a surrogate endpoint, and Priority Review, in which the standard 12-month review process may be reduced to eight months. Drugs with FTD may also receive a ‘rolling review’ of their NDA submission, in which sections are submitted for review as they become available, potentially expediting the approval process.
Paxalisib in Advanced Breast Cancer
Preclinical studies conducted in collaboration with QIMR Berghofer demonstrated that Paxalisib, exerts potent epigenetic and immunomodulatory effects in triple-negative breast cancer (TNBC) models. These studies showed that Paxalisib downregulates tumor-intrinsic resistance pathways and enhances immune recognition when combined with checkpoint blockade. The results provided the mechanistic rationale for advancing Paxalisib into a company-sponsored Phase 1b clinical trial evaluating its combination with pembrolizumab (Keytruda®) and chemotherapy in patients with Stage IV TNBC. The ongoing study is designed to establish the recommended Phase 2 dose, assess preliminary safety and efficacy, and explore biomarkers of response. Patient enrollment commenced in 2025, with full enrollment anticipated in 2026. Findings from this program are expected to inform future development of Paxalisib-based immunotherapy regimens in breast cancer and potentially in other solid tumors.
EVT801
Kazia is also developing EVT801, a small-molecule selective inhibitor of VEGFR3. EVT801 was originally discovered by Sanofi SA and was licensed to Evotec SE as part of a broader transaction. Evotec conducted an extensive program of pre-clinical development, which showed compelling evidence of activity in broad range of animal models. The drug was licensed to Kazia in April 2021.
EVT801 Worldwide Exclusive License and Intellectual Property
The Company entered into an exclusive worldwide license agreement with Evotec SE in April 2021, under which Kazia has the right to develop and commercialize the asset in all indications. Evotec stands to receive up to €301 million in contingent milestone payments, and a royalty on net sales. Evotec has no right to direct the development of EVT801, no right of approval for Kazia to sub-license, and no right of first refusal. However, in the event of sub-licensing, Kazia may under certain circumstances share a portion of receipts from a sub-licensee with Evotec.
EVT801 is protected by granted or pending composition-of-matter patents in all key territories, with exclusivity generally through to the early 2030s.
For several decades, it has been clear that growing tumors require an extensive network of newly formed blood vessels and lymphatic vessels to satisfy their substantial nutrient requirements. Drugs which inhibit the formation of new blood vessels (angiogenesis inhibitors) have proven effective in a wide range of solid tumors, with Avastin (bevacizumab) being the best-known example of the class. However, the use of such drugs is limited by hypoxia- induced resistance mechanisms and, in the case of many small-molecule inhibitors, by toxicity. EVT801 was designed to respond to these challenges by selectively targeting lymphangiogenesis, the formation of new lymphatic vessels. Doing so, and with a high degree of selectivity, is expected to provide many of the same benefits as inhibition of angiogenesis, but without the attendant problems of resistance and toxicity.
In addition, drugs which target VEGF receptors have shown the potential to alter the population of immune cells within the tumour micro-environment, thereby potentially making ‘cold’ tumors more susceptible to immuno-oncology agents such as checkpoint inhibitors. We believe that pre-clinical evidence supports this hypothesis with EVT801 and may provide a second and almost entirely distinct mechanism of action through which the EVT801 may provide benefit to cancer patients.
Phase I Study in Advanced Solid Tumors (NCT05114668)
In November 2021, Kazia commenced recruitment to a phase I, first-in-human, multiple-ascending-dose, clinical trial of EVT801 in patients with advanced solid tumors which seeks to explore both of these mechanisms (inhibition of lymphangiogenesis and
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modulation of tumor immune micro-environment), The trial is being performed at two hospitals in France: Oncopole in Toulouse and Centre Léon Bérard in Lyons and will aim to recruit up to 60 patients with advanced cancer. In addition to the primary endpoints of safety and tolerability, the study is designed to include a rich array of biomarkers that will allow a deeper understanding of the drug’s pharmacology and may inform design of subsequent studies.
On 1 May, 2024, Kazia announced that Stage 1 of the study was complete, and that the primary and secondary endpoints were achieved. A total of 32 patients were enrolled in the study with 26 patients treated across 6 dosing cohorts ranging from 50mg once daily to 500mg twice daily (BID). The MTD was identified as 500mg BID with 400mg BID being the recommended phase 2 dose when given as a monotherapy. Patients with eleven different cancer types (ex. colon, renal cell, pancreatic) were enrolled in the study, with advanced ovarian cancer being the most prevalent indication (11 patients). EVT801 was generally well tolerated across all doses with the majority of toxicities being mild to moderate and transient in nature. In addition, biomarkers have shown strong VEGFR3 expression in multiple indications, and we have observed encouraging clinical activity in High Grade Serous ovarian cancer patients with forty-six percent (46%) having stable disease or for at least three cycles and one patient had a partial response (-39% decrease) after two cycles of EVT801 therapy.
Over the course of FY 2024, interim results from the phase I study including clinical and biomarker EVT801 data have been presented at a number of global conferences, including the American Association for Cancer Research (“AACR”) and the European Society for Medical Oncology (“ESMO”). We anticipate providing additional EVT801 updates and presentations of data at future medical conferences. Plans for phase 2 clinical trial are on hold while exploring regional and strategic partnerships.
Significant changes in the state of affairs
There were no significant changes in the state of affairs of the Consolidated Entity during the financial year.
Anticipated milestones
We anticipate that during fiscal year 2026:
| • | Completion of enrollment in the company-sponsored Phase 1b clinical trial evaluating Paxalisib in combination with pembrolizumab (Keytruda®) and chemotherapy in patients with advanced triple-negative breast cancer (TNBC); |
| • | Preliminary analyses from the expanded-access clinical experience with Paxalisib in TNBC will be published, providing additional insight into clinical activity and biomarkers of response; |
| • | Updated data will be presented from the Phase 2 PNOC022 clinical trial of Paxalisib in combination with ONC201 in pediatric patients with diffuse midline glioma (DMG), including survival outcomes and biomarker correlations; and |
| • | Preliminary analyses from several investigator initiated studies including Cornell Weill (GBM), Dana Farber (PCNSL) and Alliance (brain mets). |
R&D Pipeline
Paxalisib in solid tumours
Kazia’s collaboration with QIMR, one of Australia’s foremost cancer research centers, is currently exploring novel uses of Paxalisib in solid tumours. The collaboration is based on research that identified an entirely separate effect of PI3K inhibition: as a modulator of the immune microenvironment within and around the tumour. Administration of PI3K inhibitors such as Paxalisib, at doses and frequencies different to those conventionally used, may activate the immune system in the tumour, making it more susceptive to immunotherapy. This could therefore open up an important opportunity for Paxalisib in combination with other drugs for the treatment of diseases such as breast cancer and lung cancer. The collaboration is ongoing and will build on initial research that has already led to the filing of a provisional patent in 2022, including the use of Paxalisib as an immune modulator in the treatment of diseases such as breast cancer. On 12 September, 2024, Kazia announced that an agreement had been executed with QIMR Berghofer Medical Research Institute, one of Australia’s foremost cancer research centers, to obtain an exclusive license to certain intellectual property rights in relation to combination therapies consisting of PI3K inhibitor drugs, and one or more immunotherapy or PARP inhibitor drugs (PI3K combination).
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Broad Clinical Program Ongoing
| Sponsor |
Phase | Indication | Registration | |||
| PAXALISIB | ||||||
| Kazia Therapeutics | I | Advanced Breast Cancer | ACTRN12624001340527 | |||
| Global Coalition for Adaptive Research | II / III | Glioblastoma | NCT03970447 | |||
| Weill Cornell Medicine | II | Glioblastoma (with ketogenesis) | NCT05183204 | |||
| Alliance for Clinical Trials in Oncology | II | Brain metastases | NCT03994796 | |||
| Dana-Farber Cancer Institute | II | Breast cancer brain metastases (with Herceptin) | NCT03765983 | |||
| Dana-Farber Cancer Institute | II | Primary CNS lymphoma | NCT04906096 | |||
| University of Sydney | I/II | Grade 2/3 IDH-mutant adult gliomas | ACTRN12623000096651 | |||
| Pacific Pediatric Neuro-Oncology Consortium | II | DIPG (childhood brain cancer) | NCT05009992 | |||
| Aus. & NZ Children’s Oncology Group | II | Advanced solid tumours in children | NCT06208657 | |||
| St Jude Children’s Research Hospital | I | DIPG | NCT03696355 | |||
| Memorial Sloan Kettering Cancer Center | I | Brain metastases (with radiotherapy) | NCT04192981 | |||
| EVT801 | ||||||
| Kazia Therapeutics | I | Advanced solid tumours | NCT05114668 | |||
Patent Protection
The Company has an aggressive global Intellectual Property (“IP”) strategy to protect its key assets and we have partnered with a large Australian law firm to lodge patents that seek to provide protection for our assets. The patent strategy is adapted for each technology platform and the principle mode of protection is through the patenting procedure, seeking to obtain exclusive licenses for all its key inventions and drug pipeline. The overarching strategy in the IP portfolio is to cover the three critical corner stones of pharmaceutical patent: composition of matter (the breadth structures covered in the patent), method of manufacture (the chemical processes used to manufacture the compounds disclosed in the patent) and method of use. Patents are submitted initially as provisional applications and after 12 months’ progress through to a Patent Cooperation Treaty application.
We are continuing to expand our pre-clinical work on Paxalisib and EVT801 through collaborations with research institutions. Where the research programs result in the generation of further patentable subject matter, the Company will pursue an aggressive patent filing strategy based on multiple jurisdictions with a focus on those member countries offering the most significant market opportunities for future development.
Regulatory requirements
Australian Regulatory Requirements
The Therapeutic Goods Act 1989 (“1989 Act”) and its subordinate legislation, sets out the legal requirements for the import, export, manufacture and supply of therapeutic goods, including medicines in Australia. The 1989 Act requires that all therapeutic goods imported into, supplied in, manufactured in or exported from Australia be included in the Australian Register of Therapeutic Goods (“ARTG”), unless specifically exempted or authorized under the 1989 Act.
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Medicines with a higher level of risk (prescription medicines, most over-the-counter medicines) are evaluated by the Therapeutic Goods Administration (“TGA”) for quality, safety and efficacy before registration on the ARTG. Medicines with a lower risk (some over the counter medicines and most complementary medicines, including vitamins) are not individually assessed by the TGA for quality, safety and efficacy prior to listing on the ARTG unless they are “assessed listed medicines” which are subject to pre-market TGA assessment of efficacy (but not quality and safety). Medicines included in the ARTG can be identified by the AUST R number (for registered medicines), AUST L number (for listed medicines) and AUST L(A) number (for assessed listed medicines) which appears on the label of the medicine.
In order to include a product on the ARTG, a sponsoring company must make an application to the TGA. The application usually consists of a form accompanied by data presented in the Common Technical Document (CTD) format to support the quality, safety and efficacy of the product for its intended use and payment of a fee. Application details are available on the TGA website www.tga.gov.au.
The standard application process for prescription medicines consists of eight separate phases which are summarized below:
| 1. | Pre-submission, which involves lodgement of a pre-submission planning form that provides the TGA with necessary information on the scope and scale of an application for the purposes of arranging appropriate resourcing for the processing and evaluation of the application; |
| 2. | Submission, which involves processing activities in preparation for application evaluation, including consideration of the application by the TGA against regulatory requirements; |
| 3. | First round assessment, which involves consideration by the TGA of the data provided in the application, informal requests for information by the TGA and a formal consolidated “section 31” request for information; |
| 4. | Consolidated section 31 request response, which involves the applicant considering the TGA’s consolidated, section 31 request for information or documents, preparation of a response and sending a response to the TGA (in CTD format); |
| 5. | Second round assessment, which involves the TGA evaluators considering the response provided by the applicant to the section 31 request and completing evaluation of the data; |
| 6. | Expert advisory review, which involves the TGA obtaining independent advice (if required) on issues concerning the application from advisory groups such as the Advisory Committee on Medicines (the main advisory group for prescription medicines); |
| 7. | Decision, which involves the TGA determining whether the application is to be approved (possibly modified or varied) or rejected and imposition of any conditions associated with approval for registration on the ARTG. Where any outstanding issues may affect the decision, this may involve further correspondence with the applicant before the decision is finalised |
| 8. | Post-Decision, which involves completion of administrative and regulatory activities such as finalisation of outstanding payments and the ARTG entry. |
During the above process, applicants will be able to comment on evaluation reports to highlight any errors of fact or major omissions and comment on the request for advice from the independent Advisory Committee on Medicines when such advice is sought.
In relation to Phase 2 (“Submission”), above, the TGA must notify the applicant of an acceptance or rejection of the application within 40 working days following receipt of an application, although this usually occurs within 15 or 21 calendar days. Once accepted for evaluation, the TGA has 255 working days to complete its evaluation and make a decision on the registration of the product (excluding any time spent waiting for the applicant to respond to the TGA’s questions).
Aside from the standard application pathway outlined above, the TGA has a priority review pathway and a provisional approval pathway which fast tracks the assessment of eligible prescription medicines (both new medicines and new uses for already approved medicines) onto the Australian market.
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A medicine may be eligible for priority determination if the following criteria are met:
| • | the medicine is a new prescription medicine OR a new indications medicine; |
| • | an indication of the medicine is the treatment, prevention or diagnosis of a life-threatening or seriously debilitating condition; |
| • | there are no therapeutic goods that are intended to treat, prevent or diagnose the condition in the ARTG OR if there is such a therapeutic good included in the ARTG, there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods; and |
| • | there is substantial evidence demonstrating that the medicine provides a major therapeutic advance. |
A medicine may be eligible for provisional determination if the following criteria are met:
| • | the medicine is a new prescription medicine OR a new indications medicine; |
| • | an indication of the medicine is the treatment, prevention or diagnosis of a life threatening or seriously debilitating condition; |
| • | there are no therapeutic goods that are intended to treat, prevent or diagnose the condition on the ARTG OR if there is such a therapeutic good included in the ARTG, there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods; |
| • | there is preliminary clinical data demonstrating that the medicine is likely to provide a major therapeutic advance; and |
| • | there is sufficient evidence of a plan to submit comprehensive clinical data on the safety and efficacy of the medicine within 6 years of the date of provisional registration. |
U.S. Regulatory Requirements
The FDA regulates and imposes substantial requirements upon the research, development, pre-clinical and clinical testing, labelling, manufacture, quality control, storage, approval, advertising, promotion, marketing, distribution, import and export of pharmaceutical products including drugs and biologics, as well as significant reporting and record-keeping obligations. State governments may also impose obligations in some of these areas.
In the United States, pharmaceutical products are primarily regulated by the FDA under the Federal Food, Drug, and Cosmetic Act (“FDCA”) and its implementing regulations, and in the case of biologics, the Public Health Service Act and its implementing regulations. The Company believes that the FDA will regulate its products as drugs. The process required by the FDA before drugs may be marketed in the United States generally involves the following:
| • | pre-clinical laboratory evaluations, including formulation and stability testing, and animal tests performed under the FDA’s Good Laboratory Practices regulations to assess pharmacological activity and toxicity potential; |
| • | submission and review of an IND Application, including results of pre-clinical studies, clinical experience (if any), manufacturing information, and protocols for clinical trials, which must become effective before clinical trials may begin in the United States; |
| • | obtaining approval of Institutional Review Boards (“IRBs”), to administer the products to human subjects in clinical trials; |
| • | adequate and well-controlled human clinical trials to establish the safety and efficacy of the product for the product’s intended use; |
| • | development of manufacturing processes which conform to FDA current Good Manufacturing Practices (“GMPs”), as confirmed by FDA inspection; |
| • | submission of results for pre-clinical and clinical studies, and chemistry, manufacture and control information on the product to the FDA in a New Drug Approval (“NDA”) Application; and |
| • | FDA review and approval of an NDA, prior to any commercial sale, promotion or shipment of a product. |
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The testing and approval process requires substantial time, effort, and financial resources, and the Company cannot be certain that any approval will be granted on a timely basis, if at all.
The results of the pre-clinical studies, clinical experience together with initial specified manufacturing information, the proposed clinical trial protocol, and information about the participating investigators are submitted to the FDA as part of an IND, which must become effective before the Company may begin human clinical trials in the U.S. Additionally, an independent IRB must review and approve each study protocol and oversee conduct of the trial. An IND becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day period, raises concerns or questions about the conduct of the trials as outlined in the IND and imposes a clinical hold. If the FDA imposes a clinical hold, the IND sponsor must resolve the FDA’s concerns before clinical trials can begin. Pre-clinical tests and studies can take several years to complete, and there is no guarantee that an IND submitted, based on such tests and studies, will become effective within any specific time period, if at all.
Human clinical trials are typically conducted in three sequential phases that may overlap, which are:
| • | Phase I: The drug is initially introduced into healthy human subjects or patients and tested for safety and dosage tolerance. For oncology medicines, patients with the target disease are usually enrolled rather than healthy patients. Absorption, metabolism, distribution, and excretion testing, among other tests, are generally performed at this stage. These studies may also provide early evidence of effectiveness. The maximum tolerated dose of the drug may be calculated from phase I studies; |
| • | Phase II: The drug is studied in controlled, exploratory therapeutic trials in a limited number of subjects with the disease or medical condition for which the new drug is intended to be used in order to identify possible adverse effects and safety risks, to determine the preliminary or potential efficacy of the product for specific targeted diseases or medical conditions, and to determine dosage tolerance and the optimal effective dose; and |
| • | Phase III: While phase II studies help demonstrate that a specific dosage range of the drug may be effective and the drug has an acceptable safety profile, controlled, large-scale therapeutic, phase III trials are undertaken at multiple study sites to demonstrate clinical efficacy and to further test for safety in an expanded patient population. These studies are used to evaluate the overall benefit - risk relationship of the drug and provide a basis for physician labelling. |
The Company cannot be certain that it will successfully complete phase I, phase II or phase III testing of its products within any specific time period, if at all. Furthermore, the FDA, the IRB or the Company may suspend or terminate clinical trials at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk.
Results of pre-clinical studies and clinical trials, as well as detailed information about the manufacturing process, quality control methods, and product composition, among other things, are submitted to the FDA as part of an NDA seeking approval to market and commercially distribute the product on the basis of a determination that the product is safe and effective for its intended use. Before approving an NDA, the FDA will inspect the facilities at which the product is manufactured and will not approve the product unless GMP compliance is satisfactory. If applicable regulatory criteria are not satisfied, the FDA may deny the NDA or require additional testing or information. As a condition of approval, the FDA also may require post-marketing testing or surveillance to monitor the product’s safety or efficacy. Even after an NDA is approved, the FDA may impose additional obligations or restrictions (such as labelling changes), or even suspend or withdraw a product approval on the basis of data that arise after the product reaches the market, or if compliance with regulatory standards is not maintained. The Company cannot be certain that the FDA on a timely basis, if at all will approve any NDA it submits. Also, any such approval may limit the indicated uses for which the product may be marketed. Any refusal to approve, delay in approval, suspension or withdrawal of approval, or restrictions on indicated uses could have a material adverse impact on the Company’s business prospects.
A user fee, pursuant to the requirements of the PDUFA, and its amendments, applies to NDAs, unless exempted. The FDA adjusts the PDUFA user fees on an annual basis. PDUFA also imposes an annual product fee for prescription drugs and biologics, and an annual establishment fee on facilities used to manufacture prescription drugs and biologics. A written request can be submitted for a waiver under certain circumstances. Waivers may be possible for the application fee for the first human drug application that is filed by a small business, as defined by the FDCA, but there are no small business waivers for product or establishment fees. Waivers may also be possible for one or more fees, upon written request, when a waiver or reduction is necessary to protect the public health, the user fees would present a significant barrier to innovation, or the fees are anticipated to exceed the present or future costs incurred by FDA. Applications for products designated as orphan drugs are not subject to the application fee unless the application includes an indication for other than a rare disease or condition. The Company is not at the stage of development with its products where it is subject to these fees, but they are significant expenditures that may be incurred in the future and must be paid at the time of application submissions to FDA, as applicable.
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Satisfaction of FDA requirements for product approval typically takes several years. The actual time required varies substantially, based upon the type, complexity, and novelty of the pharmaceutical product, among other things. Government regulation imposes costly and time-consuming requirements and restrictions throughout the product life cycle and may delay product marketing for a considerable period of time, limit product marketing, or prevent marketing altogether. Success in pre-clinical or early stage clinical trials does not ensure success in later stage clinical trials. Data obtained from pre-clinical and clinical activities are not always conclusive and may be susceptible to varying interpretations that could delay, limit, or prevent marketing approval. Even if a product receives marketing approval, the approval is limited to specific clinical indications. Further, even after marketing approval is obtained, the discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the market.
After product approval, there are continuing significant regulatory requirements imposed by the FDA, including record-keeping requirements, obligations to report adverse events in patients using the products, and restrictions on advertising and promotional activities. Quality control and manufacturing procedures must continue to conform to GMPs, and the FDA periodically inspects facilities to assess GMP compliance. Additionally, post-approval changes in ingredient composition, manufacturing processes or facilities, product labelling, or other areas may require submission of an NDA Supplement to the FDA for review and approval. New indications will require additional clinical studies and submission of an NDA Supplement. Failure to comply with FDA regulatory requirements may result in an enforcement action by the FDA, including warning letters, product recalls, suspension or revocation of product approval, seizure of product to prevent distribution, impositions of injunctions prohibiting product manufacture or distribution, and civil and criminal penalties. Maintaining compliance is costly and time-consuming. The Company cannot be certain that it, or its present or future suppliers or third-party manufacturers, will be able to comply with all FDA regulatory requirements, and potential consequences of noncompliance could have a material adverse impact on its business prospects.
The FDA’s policies may change, and additional governmental regulations may be enacted that could delay, limit, or prevent regulatory approval of the Company’s products or affect its ability to manufacture, market, or distribute its products after approval. Moreover, increased attention to the containment of healthcare costs in the U.S. and in foreign markets could result in new government regulations that could have a material adverse effect on the business. The Company’s failure to obtain coverage, an adequate level of reimbursement, or acceptable prices for future products could diminish any revenues the Company may be able to generate. The Company’s ability to commercialize future products will depend in part on the extent to which coverage and reimbursement for the products will be available from government and health administration authorities, private health insurers, and other third-party payers. EU member states and U.S. government and other third-party payers increasingly are attempting to contain healthcare costs by consideration of new laws and regulations limiting both coverage and the level of reimbursement for new drugs. The Company cannot predict the likelihood, nature or extent of adverse governmental regulation that might arise from future legislative or administrative action, either in the U.S. or abroad.
The Company’s activities may also be subject to state laws and regulations that affect its ability to develop and sell products. The Company is also subject to numerous federal, state, and local laws relating to such matters as safe working conditions, clinical, laboratory, and manufacturing practices, environmental protection, fire hazard control, and disposal of hazardous or potentially hazardous substances. The Company may incur significant costs to comply with such laws and regulations now or in the future, and the failure to comply may have a material adverse impact on the Company.
The FDA provides programs intended to facilitate and expedite development and review of new products that are intended to address an unmet medical need in the treatment of a serious or life-threatening disease or condition. These programs are referred to as fast track designation, breakthrough therapy designation and priority review designation. These designations are not mutually exclusive, and a product candidate may qualify for one or more of these programs. While these programs are intended to expedite product development and approval, they do not alter the standards for FDA approval. The FDA may designate a product for fast-track designation if it is intended, whether alone or in combination with one or more other products, for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition. For products with fast-track designation, sponsors may have more frequent interactions with the FDA, the product is potentially eligible for accelerated approval and priority review, if relevant criteria are met. A product may be designated as a breakthrough therapy if it is intended, either alone or in combination with one or more other products, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the product may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. The FDA may take certain actions with respect to breakthrough therapies, including holding meetings with the sponsor throughout the development process; providing timely advice to the product sponsor regarding development and approval; involving more senior staff managers in
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the review process; assigning a cross-disciplinary lead for the review team; and taking other steps to design the clinical trials in an efficient manner. The FDA may designate a product for priority review if it is a product that treats a serious condition and, if approved, would provide a significant improvement in safety or effectiveness when compared with other available therapies. Additionally, drug approval under the accelerated approval pathway may be based on evidence of clinical effect on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical benefit. A post-marketing clinical study will be required to verify clinical benefit, and other restrictions to assure safe use may be imposed.
Under the Drug Price Competition and Patent Term Restoration Act of 1984, a sponsor may obtain marketing exclusivity for a period of time following FDA approval of certain drug applications, regardless of patent status, if the drug is a new chemical entity or if new clinical studies were required to support the marketing application for the drug. This marketing exclusivity prevents a third party from obtaining FDA approval for an identical or nearly identical drug under an Abbreviated New Drug Application. The statute also allows a patent owner to obtain an extension of applicable patent terms for a period equal to one-half the period of time elapsed between the filing of an IND and the filing of the corresponding NDA plus the period of time between the filing of the NDA and FDA approval, with reductions taken for any time an applicant did not act with due diligence. There is a five-year maximum patent extension and a maximum of 14 years protection from product approval. The Company cannot be certain that it will be able to take advantage of either the patent term extension or marketing exclusivity provisions of these laws.
European Union Regulatory Requirements
Outside the United States, the Company’s ability to market its products will also be contingent upon receiving marketing authorizations from the appropriate regulatory authorities and compliance with applicable post-approval regulatory requirements. Although the specific requirements and restrictions vary from country to country, as a general matter, foreign regulatory systems include risks similar to those associated with FDA regulation, described above. In the EU, a marketing authorization application may be submitted either under a centralized or a national procedure. Under the centralized procedure, a single application to the European Medicines Agency (“EMA”) leads to an approval granted by the European Commission that permits the marketing of the product throughout the EU and in the additional member states of the European Economic Area (Norway, Iceland and Liechtenstein). The centralized procedure is mandatory for specific products, including for medicines produced by certain biotechnological processes, products designated as orphan medicinal products, advanced therapy medicinal products (gene therapy, somatic cell therapy and tissue-engineered products) and products with a new active substance indicated for the treatment of certain diseases, including products for the treatment of HIV, AIDS, cancer, diabetes, neurodegenerative diseases, auto-immune and other immune dysfunctions and viral diseases. The centralized procedure is optional for any other products containing new active substances not authorized in the EU or for products which constitute a significant therapeutic, scientific, or technical innovation or for which a centralized authorization is in the interests of patients at EU level. Under the centralized procedure the maximum timeframe for the evaluation of a marketing authorization application by the EMA is 210 days, excluding clock stops, when additional written or oral information is to be provided by the applicant in response to questions asked by the EMA’s Committee for Medicinal Products for Human Use (“CHMP”). Clock stops may extend the timeframe of evaluation of a marketing authorization application considerably beyond 210 days. Where the CHMP gives a positive opinion, it provides the opinion together with supporting documentation to the European Commission, who make the final decision to grant a marketing authorization, which is issued within 67 days of receipt of the EMA’s recommendation. Accelerated assessment might be granted by the CHMP in exceptional cases, when a medicinal product is expected to be of major public health interest, particularly from the point of view of therapeutic innovation. The timeframe for the evaluation of a marketing authorization application under the accelerated assessment procedure is 150 days, excluding clock stops, but it is possible that the CHMP may revert to the standard time limit for the centralized procedure if it determines that the application is no longer appropriate to conduct an accelerated assessment.
As with FDA approval, the Company may not be able to secure regulatory approvals in the EU in a timely manner, if at all. Additionally, as in the U.S., post-approval regulatory requirements, such as those regarding product manufacture, marketing, or distribution, would apply to any product that is approved in the EU, and failure to comply with such obligations could have a material adverse effect on the Company’s ability to successfully commercialize any product.
The conduct of clinical trials in the EU is governed by the Clinical Trials Regulation (EU) No 536/2014 (“CTR”), which replaced the previous Clinical Trials Directive 2001/20/EC on 31 January, 2022. No clinical trial may be commenced in the EU without a clinical trial authorization from the applicable national competent authorities and favourable ethics approval. Under the CTR, a single application can be made through the Clinical Trials Information System for authorization of a clinical trial in up to 30 EU/ European Economic Area countries at the same time and with a single set of documentation.
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The assessment of applications for clinical trials is divided into two parts (Part I contains scientific and medicinal product documentation and Part II contains the national and patient-level documentation). Part I is assessed by a coordinated review by the competent authorities of all EU member states in which an application for authorization of a clinical trial has been submitted (Member States Concerned) of a draft report prepared by a Reference Member State. Part II is assessed separately by each Member State Concerned. The role of the relevant ethics committees in the assessment procedure continues to be governed by the national law of the Member State Concerned, however overall related timelines are defined by the CTR. The new CTR also provides for simplified reporting procedures for clinical trial sponsors.
The European Commission introduced legislative proposals in April 2023 that, if implemented, will replace the current regulatory framework in the EU for all medicines (including those for rare diseases and for children). The European Commission has provided the legislative proposals to the European Parliament and the European Council for their review and approval. In April 2024, the European Parliament adopted its position on the legislative proposals and, in June 2025, the European Council adopted its position. The European Council, European Parliament and European Commission will enter into trilogue negotiations aimed at reaching a consensus on a final version of the legislation.
Environmental, social and governance (ESG) report
Environmental
The Consolidated Entity is not currently subject to any significant or unusual environmental regulation under Australian Commonwealth or State law. We are considering ways in which environmental impacts can be monitored however we do not foresee a material impact.
Sustainability
Kazia’s head office is located in a sustainable carbon neutral commercial precinct. The serviced office is located in a building with a five star NABERS energy rating.
Climate Change
Kazia is mindful of its impact on the environment and strives to reduce its carbon footprint. The Kazia business model is based on outsourcing, and we are working with major partners who are focused on reducing climate change and enhancing climate protection.
Society
Community Contribution
Compassionate Use Program
In rare circumstances, after careful discussion with the treating clinician, Kazia is sometimes able to provide its drug candidates for compassionate use on an individual named patient basis.
Our compassionate use program has treated over 40 patients in 7 countries since its inception in 2018.
Countries we treat compassionate patients in: Australia, USA, Israel, Spain, Switzerland, England and Ireland
Social and Governance
Social and governance matters cover a vast range of potential issues including responsible business policies. Our policies set out our commitment to high social standards.
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The following policies are in place and available on our website:
| • | Anti-Corruption Compliance |
| • | Continuous Disclosure |
| • | Corporate Governance |
| • | Expanded Access |
| • | Shareholder Communications |
| • | Whistleblower |
| • | FDA review and approval of an NDA, prior to any commercial sale, promotion or shipment of a product. |
Employees
The Consolidated Entity aims to ensure that it has a safe operating environment with an inclusive and diverse culture and the best talent and skills for our future success. The following employee policies are in place:
| • | Code of Business Conduct & Ethics |
| • | Recruitment and retention |
| • | Inclusion and diversity |
| • | Parents returning to work |
| • | Education and training |
| • | Employee Share Option Plan |
| • | Health and safety |
| • | Whistleblowing |
| • | Equal Employment Opportunity and Diversity |
| • | Harassment and Discrimination |
| • | Anti-corruption and anti-bribery policies |
| • | Public disclosures |
| • | Securities trading |
| • | Scientific integrity |
Product and Corporate Developments during Fiscal Year 2025
The Company continued to pursue its strategy of focusing resources on clinical programs, being specifically those most likely to provide a return to shareholders.
Paxalisib is involved in ten clinical trials, all being conducted by world renowned research organizations and principally funded by parties other than the Company, giving us multiple opportunities to realise value from this product candidate.
EVT801’s phase I clinical trial was completed and clinical study report is anticipated in 2026.
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At-The-Market (ATM) Facility
Kazia established an ‘at-the-market’ equity program (the “ATM facility”) with Oppenheimer & Co. Inc. (“Oppenheimer”), as sales agent, in April 2022. Under the ATM facility, Kazia may offer and sell through Oppenheimer up to an aggregate amount of US$50 million of its ordinary shares, in the form of ADSs. During the fiscal year ended 30 June 2025, Kazia sold an aggregate amount of US$4,556,252 (2024 US$1,656,016) of ADSs under the ATM facility. The agreement with Oppenheimer was terminated in July 2025.
On July 25, 2025, Kazia entered into a new ATM facility pursuant to an At the Market Offering Agreement with Rodman & Renshaw LLC (“Rodman”), as sales agent, under which the Company may offer and sell, from time to time through Rodman, ADSs, each ADS representing five hundred (500) ordinary shares. The offer and sale of the ADSs, if any, will be made pursuant to the Company’s shelf registration statement previously declared effective by the SEC on September 12, 2024, as supplemented by the prospectus supplement relating to the ADSs which may be issued from time to time pursuant to the agreement with Rodman. Pursuant to the agreement with Rodman and the prospectus supplement filed by the Company on July 25, 2025, the Company may offer and sell up to US$1,906,196 of ADSs.
The ATM facility allows Kazia to raise capital dynamically in the open market, with no discount, no warrant coverage, and modest banking fees, allowing it to fund operations with minimal dilution to existing shareholders.
January 2025 Registered Direct Offering and Concurrent Private Placement
On January 10, 2025, Kazia entered into a securities purchase agreement with Alumni Capital LP, pursuant to which the Company issued and sold (A) in a registered direct offering, 553,440 ADSs and the pre-funded warrants to purchase up to 779,893 ADSs, and (B) in a concurrent private placement, the ordinary warrants to purchase up to 1,333,333 ADSs, which have an exercise price of $1.5 per ADS, are exercisable immediately and will expire on July 14, 2030 (the “Ordinary Warrants”). As part of the compensation to Maxim Group LLC, who acted as the placement agent in connection with such offering in January 2025, Kazia issued to Maxim Partners LLC, the designee of Maxim Group LLC, unregistered placement agent warrants (the “Placement Agent Warrants”), to purchase up to an aggregate of 40,000 ADSs at an exercise price of $1.5 per ADS, pursuant to the Placement Agency Agreement between Kazia and Maxim Group LLC. The Placement Agent Warrants expire on July 14, 2030. The net proceeds to the Company from the Offerings were approximately $1.7 million, after deducting placement agent’s fees and estimated offering expenses.
August 2025 Private Placement
On July 31, 2025, Kazia entered into the Securities Purchase Agreements with certain institutional and accredited purchasers (the “Purchasers”) in connection with a private placement of equity securities, pursuant to which Kazia issued and sold (i) 14,204,500 ordinary shares, at a purchase price of $0.0176 per share, and (ii) pre-funded warrants to purchase up to 204,547 ADSs, each ADS representing five hundred ordinary shares, at a purchase price of $8.7999 per pre-funded warrant. Each pre-funded warrant is exercisable for one ADS at an exercise price of $0.0001 per ADS underlying the Pre-Funded Warrant, is immediately exercisable, and will expire when exercised in full. The net proceeds to the Company from the Private Placement were approximately $2 million, after deducting estimated offering expenses.
Voluntary Delisting from ASX
On 11 October 2023 Kazia announced that it submitted a formal application to the ASX to be removed from the official list of the ASX (the “Official List”) in accordance with ASX Listing Rule 17.11. On 15 November 2023, Kazia was removed from the Official List and its ordinary shares ceased to be traded on the ASX.
Equity Line of Credit
On 19 April 2024, Kazia entered into a purchase agreement (the “Purchase Agreement”) with Alumni Capital LP (“Alumni Capital”). Pursuant to the Purchase Agreement, the Company may sell to Alumni Capital up to an aggregate of $15,000,000, of ADSs from time to time during the term of the Purchase Agreement. During the fiscal year ended 30 June 2025, Kazia sold an aggregate amount of US$2,015,435 (A$5,638,016) of ADSs under the Purchase Agreement.
ADS Ratio Change
On 15 October 2024, Kazia announced that it planned to effect an ADS ratio change to change the ratio of ADSs to ordinary shares from one ADS to ten ordinary shares to the new ratio of one ADS to one-hundred ordinary shares. The ADS ratio change will have the same effect as a one-for-ten reverse ADS split for Kazia’s ADS holders. There will be no change to Kazia’s underlying ordinary shares, and no ordinary shares will be issued or cancelled in connection with the ADS ratio change. The ADS ratio change became effective on 28 October 2024.
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On 1 April 2025, Kazia announced that it planned to affect an ADS ratio change to change the ratio of ADSs to ordinary shares from one ADS to one hundred ordinary shares to the new ratio of one ADS to five hundred ordinary shares. The ADS ratio change will have the same effect as a one-for-five reverse ADS split for Kazia’s ADS holders. There will be no change to Kazia’s underlying ordinary shares, and no ordinary shares will be issued or cancelled in connection with the ADS ratio change. The ADS ratio change became effective on 17 April 2025
C. Organizational structure
Kazia Therapeutics Limited is incorporated in Australia and has the following wholly-owned subsidiaries:
| Name |
Country of incorporation | |
| Kazia Laboratories Pty Ltd | Australia | |
| Kazia Research Pty Ltd | Australia | |
| Kazia Therapeutics Inc. | United States (Delaware) | |
| Glioblast Pty Ltd | Australia |
D. Property, plant and equipment
During fiscal year 2025, the Company continued to work out of a serviced office in Sydney that is subject to a renewable one-year workspace license agreement. In addition, the company extended an office membership agreement with Deerfield Management that is subject to renewable one-year agreement at The Cure, Deerfield’s innovation campus at 345 Park Avenue South, New York, NY.
| Item 4A. | Unresolved Staff Comments |
None.
| Item 5. | Operating and Financial Review and Prospects |
Critical accounting policies
We prepare our consolidated financial statements in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB). As such, we are required to make certain estimates, judgments, and assumptions that management believes are reasonable based upon the information available. These estimates, judgments and assumptions affect the reported amounts of assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the periods presented. The critical accounting policies are summarized in Item 18. “Financial Statements-Note 3 - Critical accounting judgements, estimates and assumptions”.
The following discussion and analysis should be read in conjunction with Item 18. “Financial Statements” included below. Operating results are not necessarily indicative of results that may occur in future periods. This discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. The actual results may differ materially from those anticipated in the forward-looking statements as a result of many factors including, but not limited to, those set forth under “Forward-Looking Statements” and “Risk Factors” in Item 3 “Key Information” included above in this Annual Report on Form 20-F. All forward-looking statements included in this document are based on the information available to the Company on the date of this document and the Company assumes no obligation to update any forward-looking statements contained in this Annual Report on Form 20-F.
A. Operating results
The following discussion relates to our consolidated results of operations, financial condition and capital resources.
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The following tables provide a summary of Revenue, Finance income and Other income for the past three fiscal years:
| For the fiscal year ended 30 June, | ||||||||||||
| 2025 | 2024 | 2023 | ||||||||||
| A$’000 | A$’000 | A$’000 | ||||||||||
| Revenue |
42 | 2,308 | — | |||||||||
| Finance income |
72 | 12 | 22 | |||||||||
| Other income: |
||||||||||||
| Research and development rebate |
209 | 173 | — | |||||||||
| Other sundry income |
1,578 | — | 1 | |||||||||
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| Total Other income |
1,787 | 173 | 1 | |||||||||
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|
|
|||||||
| Total Revenue, Finance and Other income |
$ | 1,901 | 2,493 | 23 | ||||||||
|
|
|
|
|
|
|
|||||||
| Expenses |
||||||||||||
| Research and development expense |
(7,326 | ) | (17,380 | ) | (15,564 | ) | ||||||
| General and administrative expense |
(8,720 | ) | (13,563 | ) | (8,583 | ) | ||||||
| Impairment of intangible assets |
(13,379 | ) | — | — | ||||||||
| (Loss) gain on remeasurement of other financial liabilities |
(2,478 | ) | 1,257 | — | ||||||||
| Gain on remeasurement of promissory note |
— | 25 | — | |||||||||
| Gain on remeasurement of contingent consideration |
7,554 | 119 | 3,388 | |||||||||
|
|
|
|
|
|
|
|||||||
| Loss before income tax benefit |
(22,448 | ) | (27,049 | ) | (20,736 | ) | ||||||
|
|
|
|
|
|
|
|||||||
| Loss before income tax benefit |
1,746 | 271 | 271 | |||||||||
|
|
|
|
|
|
|
|||||||
| Income tax benefit |
(20,702 | ) | (26,778 | ) | (20,465 | ) | ||||||
| Loss after income tax benefit |
||||||||||||
| Other comprehensive loss |
||||||||||||
| Items that may be reclassified subsequently to profit or loss |
||||||||||||
| Net exchange difference on translation of financial statements of foreign controlled entities, net of tax |
(23 | ) | (8 | ) | 110 | |||||||
|
|
|
|
|
|
|
|||||||
| Other comprehensive loss, net of tax |
(23 | ) | (8 | ) | 110 | |||||||
|
|
|
|
|
|
|
|||||||
| Total comprehensive loss |
(20,725 | ) | (26,786 | ) | (20,355 | ) | ||||||
|
|
|
|
|
|
|
|||||||
Fiscal year 2025 compared to fiscal year 2024 and fiscal year 2024 compared to fiscal year 2023
Revenue, finance income and other income
In fiscal year 2025, the Company received a grant of A$42 thousand from the sale of Paxalisib to the Michael J Fox Foundation to explore the therapeutic potential of Paxalisib as a treatment for Parkinson’s disease (PD). In fiscal year 2024, the Company generated revenue of A$2.3 million from contracts with customers that was the result of up-front license fees received from partnering transactions pertaining to the out-license agreements entered into for one of the Company’s assets, Paxalisib. During fiscal year 2023, the Company did not generate any revenue from contracts with customers.
The Company earns interest income derived from interest bearing bank accounts, which is directly linked with the amounts held on deposit. The amount of finance income earned increased as a result of increased cash balances as well as higher interest rates in effect during the year.
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The Company recognized research and development rebate in fiscal year 2025 of A$209 thousand. The Company recognized research and development rebate in fiscal year 2024 of A$173 thousand. The Company did not recognize any research and development rebate in 2023. We anticipate applying for the rebate in future fiscal years as the Company advances Paxalisib development in Australia.
The Company recognized other income in fiscal year 2025 of A$1.6 million from the sale of cantrixil to Vivesto AB. The Company did not recognize other income in fiscal year 2024. The Company recognized other income in fiscal year 2023 of A$1 thousand.
Expenses
Research and development expenses decreased from A$17.4 million in fiscal year 2024 to A$7.3 million in fiscal year 2025 (-58%). The decrease was mainly a result of lower R&D expenses related EVT-801 and Paxalisib in fiscal year 2025. Research and development expenses increased from A$15.6 million in fiscal year 2023 to A$17.4 million in fiscal year 2024 (12%). The increase was mainly a result of transaction fee expenses of A$6.0 million in fiscal year 2023 partially offset by less clinical expenses relating to Paxalisib and lower personnel costs.
General and administrative costs decreased from A$13.6 million in fiscal year 2024 to A$8.7 million in fiscal year 2025 (36%), due to decreased costs related to the lower directors and officers liability and business insurance costs, capital raising costs, and salaries and wages, partially offset by increase share based payment expense. General and administrative costs increased from A$8.6 million (restated) in fiscal year 2023 to A$13.6 million in fiscal year 2024 (58%), due to increased costs related to the issuance of certain warrants to service providers, audit and NASDAQ fees, offset by lower directors and officers liability and business insurance costs.
Net loss after income tax benefit
The Company’s loss after income tax benefit was A$20.7 million in fiscal year 2025 compared to A$26.8 million in fiscal year 2024. The change was mainly a result of a decrease R&D expenditures and gain on remeasurement of contingent consideration, offset by impairment expense of intangible assets.
The Company’s loss after income tax benefit was A$26.8 million in fiscal year 2024 compared to A$20.5 million in fiscal year 2023. The change was mainly a result of the additional R&D expenditures and a dramatic increase in NASDAQ, legal and audit fees, offset by lower personnel expenses, D&O insurance and public relation costs.
B. Liquidity and capital resources
We have incurred cumulative losses and negative cash flows from operations since our inception and, as of 30 June 2025, we had accumulated losses of A$134.8 million. We anticipate that we will continue to incur losses for at least the next several years. We expect that our research and development expenditure will continue to increase and, as a result, we will need additional capital to fund our operations, which we may raise through a combination of equity offerings, other third-party funding, and other collaborations, strategic alliances and licensing arrangements.
There was a premium funding facility in place in fiscal year 2025, 2024, and 2023 for the insurance program.
As of 30 June 2025, we had cash and cash equivalents of A$4.3 million held in both Australian dollars and U.S. dollars. Cash in excess of immediate requirements is invested in accordance with our investment policy primarily with a view to liquidity and capital preservation. Currently, our cash and cash equivalents are held in bank accounts with approximately 95.9% of funds being held in U.S. dollars.
Going Concern
We expect to consume cash and incur operating losses for the foreseeable future as the Company continues developing its oncology drug candidates. The impact on cash resources and results from operations will vary with the extent and timing of the future clinical trial programs. The consolidated financial statements have been prepared on a going concern basis, which contemplates continuity of normal activities and realization of assets and settlement of liabilities in the normal course of business. As is often the case with drug development companies, the Company’s ability to continue its development activities as a going concern is dependent upon deriving sufficient cash from investors, from licensing and partnering activities and from other sources of revenue such as grant funding. We may be required to delay, scale-back, or eliminate certain of our activities and other aspects of our operations until such time as we are successful in securing additional funding. We are exploring various dilutive and non-dilutive sources of funding, including equity and debt financings, strategic alliances, business development and other sources. Our future success is dependent upon our ability to obtain additional funding. There can be no assurance, however, that we will be successful in obtaining such funding in sufficient amounts, on
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terms acceptable to us, or at all. Furthermore, under General Instruction I.B.5 to Form F-3 (the “Baby Shelf Rule”) the amount of funds we can raise through primary public offerings of securities in any 12-month period using our registration statement on Form F-3 is limited to one-third of the aggregate market value of the ordinary shares held by non-affiliates of our company, which limitation may change over time based on our stock price, number of ordinary shares outstanding and the percentage of ordinary shares held by non-affiliates. We therefore are limited by the Baby Shelf Rule as of the filing of this Annual Report until such time as our non-affiliate public float exceeds $75 million. There is substantial doubt about our ability to continue as a going concern within one year after the date that the consolidated financial statements for the fiscal year ended 30 June 2025 are issued.
Cash flows
The following table sets forth the sources and uses of cash for the past three fiscal years:
| (in A$ thousands) | 2025 | 2024 | 2023 | |||||||||
| Net cash used in operating activities |
$ | (13,278 | ) | $ | (9,581 | ) | $ | (15,156 | ) | |||
| Net cash provided by financing activities |
$ | 15,982 | $ | 5,985 | $ | 12,972 | ||||||
Operating activities. Net cash used in operating activities for the three fiscal years primarily represents net outflows for the cost of our R&D programs and general and administrative costs of running the business. This amount is heavily impacted by the cost of our clinical programs, as well as cost containment measures adopted to manage the general and administrative costs of the business.
Financing activities. Net cash from the financing activities in fiscal year 2025 arose as a result of the placement of warrants and the sale of ordinary shares in the form of ADSs, using our ATM facility. Net cash from the financing activities in fiscal year 2024 arose as a result of the placement of warrants and the sale of ordinary shares in the form of ADSs, using our ATM facility. Net cash from financing activities in fiscal years 2023 arose as a result of professional placements of the Company’s ordinary shares to institutional investors in certain countries as well as Share Purchase Plans to shareholders in Australia. In addition, net cash from financing activities in fiscal years 2025, 2024, and 2023 was the result of the funds received from our sale of ordinary shares using our ATM facility.
As of 30 June 2025 and 2024, the Company did not hold any derivative financial instruments for managing its foreign currency; however, the Company may from time to time enter into hedging arrangements where circumstances are deemed appropriate.
The Company believes that its future ability to fund its operations will depend on deriving sufficient cash from investors through successful capital raises, from licensing and partnering activities, and government grants.
The Company had no commitments for capital expenditures or material contractual obligations at the end of fiscal year 2025 and 2024. The Company continuously pursues opportunities for non-dilutive funding such as grant applications.
The Company cannot provide assurance that it or its subsidiaries will be able to raise the funds necessary to complete the planned clinical trial programs or find appropriate collaboration or licensing opportunities.
The Company does not have any off-balance sheet arrangements.
Financing activities
Equity issues
The Company has historically financed its operations primarily from issuing equity capital. The amounts of ADSs issued by the Company or issuable by the Company upon exercise of warrants and the corresponding purchase price or exercise price disclosed in this section have not been adjusted to reflect the effect of the ADS Ratio Change.
During fiscal year 2024 the Company issued 104,821,670 ordinary shares. The details of those share issues are as follows:
| • | In July 2023, the Company issued 8,148,140 ordinary shares at a price of A$0.1856 per share under our ATM facility raising A$1,512,522 before transaction costs. |
| • | In July 2023, the Company issued 157,120 ordinary shares at a price of A$0.1647 per share under our ATM facility raising A$25,877 before transaction costs. |
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| • | In August 2023, the Company issued 15,000 ordinary shares at a price of A$0.1679 per share under our ATM facility raising A$2,519 before transaction costs. |
| • | In November 2023, the Company issued 1,066,070 ordinary shares under our ATM facility raising A$107,268 before transaction costs. |
| • | In December 2023, we issued 26,200,000 ordinary shares in the form of ADSs at a price of US$0.45 per ADS and pre-funded warrants to purchase up to 1,824,445 ADSs representing 18,244,450 ordinary shares at a price of US$0.44 per pre-funded warrant with an exercise price of $0.01 per ADS in a registered direct offering for an aggregate consideration of approximately US$2 million. |
| • | In December 2023, we issued unregistered warrants to purchase up to 4,444,445 ADSs representing 44,444,450 ordinary shares at an exercise price of US$0.583 per ADS in a private placement for an aggregate consideration of approximately US$2.6 million. |
| • | December 2023, we issued placement agent warrants to purchase up to 311,111 ADSs representing 3,111,110 ordinary shares at an exercise price of US$0.5625 per ADS pursuant to the Engagement Letter. |
| • | In February 2024, the Company issued 25,910 ordinary shares at a price of A$0.0466 per share under our ATM facility raising A$1,207 before transaction costs. |
| • | In February 2024, the Company issued 319,650 ordinary shares at a price of A$0.0464 per share under our ATM facility raising A$14,834 before transaction costs. |
| • | In February 2024, the Company issued 2,195,980 ordinary shares at a price of A$0.0468 per share under our ATM facility raising A$102,825 before transaction costs. |
| • | In February 2024, the Company issued 205,260 ordinary shares at a price of A$0.0614 per share under our ATM facility raising A$12,597 before transaction costs. |
| • | In February 2024, the Company issued 8,626,580 ordinary shares at a price of A$0.0595 per share under our ATM facility raising A$513,584 before transaction costs. |
| • | In February 2024, the Company issued 18,244,450 ordinary shares in the form of ADSs at an exercise price of US$0.01 per ADS in connection with the exercise of a warrant. |
| • | In February 2024, the Company issued 316,540 ordinary shares at a price of A$0.0461 per share under our ATM facility raising A$14,584 before transaction costs. |
| • | In February 2024, the Company issued 304,860 ordinary shares at a price of A$0.0464 per share under our ATM facility raising A$14,147 before transaction costs. |
| • | In February 2024, the Company issued 250,000 ordinary shares at a price of A$0.0460 per share under our ATM facility raising A$11,502 before transaction costs. |
| • | In May 2024, the Company issued 2,112,560 ordinary shares at a price of A$0.0478 per share under our ATM facility raising A$100,961 before transaction costs. |
| • | In May 2024, the Company issued 375,410 ordinary shares at a price of A$0.0457 per share under our ATM facility raising A$17,147 before transaction costs. |
| • | In May 2024, the Company issued 288,900 ordinary shares at a price of A$0.0469 per share under our ATM facility raising A$13,544 before transaction costs. |
| • | In May 2024, the Company issued 790,100 ordinary shares at a price of A$0.0456 per share under our ATM facility raising A$36,024 before transaction costs. |
| • | In May 2024, the Company issued 20,000 ordinary shares at a price of A$0.0455 per share under our ATM facility raising A$910 before transaction costs. |
| • | In May 2024, the Company issued 242,170 ordinary shares at a price of A$0.0450 per share under our ATM facility raising A$10,891 before transaction costs. |
| • | In June 2024, the Company issued 5,916,970 ordinary shares represented by 591,697 ADSs as repayment of a promissory note. |
| • | In June 2024, the Company issued 29,000,000 ordinary shares under a private ELOC placement raising A$776,031 before transaction costs. |
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During fiscal year 2025 the Company issued 482,484,920 ordinary shares. The details of those share issues are as follows:
| • | In July 2024, the Company issued 14,400,000 ordinary shares at a price of A$0.1534 per share under our ATM facility raising A$2,209,677 before transaction costs. |
| • | In July 2024, the Company issued 25,786,480 ordinary shares represented by 2,578,648 ADSs pursuant to a warrant exercise for US$0.1939 per ADSs. |
| • | In July 2024, the Company issued 11,000,000 ordinary shares represented by 1,100,000 ADSs pursuant to a warrant exercise for US$0.27 per ADSs. |
| • | In July 2024, the Company issued 5,488,230 ordinary shares at a price of A$0.1445 per share under our ATM facility raising A$792,915 before transaction costs. |
| • | In July 2024, the Company issued 4,177,340 ordinary shares at a price of A$0.1075 per share under our ATM facility raising A$449,260 before transaction costs. |
| • | In July 2024, the Company issued 15,000,000 ordinary shares at a price of A$0.0542 per share under a private ELOC placement raising A816,373 before transaction costs. |
| • | In August 2024, the Company issued 2,061,820 ordinary shares at a price of A$0.0624 per share under our ATM facility raising A$128,633 before transaction costs. |
| • | In August 2024, the Company issued 408,270 ordinary shares at a price of A$0.0641 per share under our ATM facility raising A$26,172 before transaction costs. |
| • | In August 2024, the Company issued 2,283,350 ordinary shares at a price of A$0.0617 per share under our ATM facility raising A$140,884 before transaction costs. |
| • | In August 2024, the Company issued 8,660 ordinary shares at a price of A$0.0606 per share under our ATM facility raising A$525 before transaction costs. |
| • | In August 2024, the Company issued 5,250,000 ordinary shares at a price of A$0.0616 per share under our ATM facility raising A$323,403 before transaction costs. |
| • | In August 2024, the Company issued 308,700 ordinary shares at a price of A$0.0591 per share under our ATM facility raising A$18,242 before transaction costs. |
| • | In September 2024, the Company issued 3,000,000 ordinary shares at a price of A$0.0616 per share under our ATM facility raising A$184,682 before transaction costs. |
| • | In September 2024, the Company issued 837,030 ordinary shares at a price of A$0.0638 per share under our ATM facility raising A$53,439 before transaction costs. |
| • | In September 2024, the Company issued 16,049,020 ordinary shares at a price of A$0.0554 per share under our ATM facility raising A$889,682 before transaction costs. |
| • | In September 2024, the Company issued 2,503,820 ordinary shares at a price of A$0.0552 per share under our ATM facility raising A$130,741 before transaction costs. |
| • | In November 2024, the Company issued 442,400 ordinary shares at a price of A$0.0891 per share under our ATM facility raising A$39,420 before transaction costs. |
| • | In November 2024, the Company issued 185,100 ordinary shares at a price of A$0.0881 per share under our ATM facility raising A$16,312 before transaction costs. |
| • | In November 2024, the Company issued 262,200 ordinary shares at a price of A$0.0848 per share under our ATM facility raising A$22,240 before transaction costs. |
| • | In November 2024, we issued 896,700 ordinary shares at a price of A$0.0858 per share under our ATM facility raising A$76,970 before transaction costs. |
| • | In November 2024, we issued 364,700 ordinary shares at a price of A$0.0818 per share under our ATM facility raising A$29,832 before transaction costs. |
| • | In December 2024, we issued 2,926,100 ordinary shares at a price of A$0.0778 per share under our ATM facility raising A$227,709 before transaction costs. |
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| • | In December 2024, we issued 403,300 ordinary shares at a price of A$0.0787 per share under our ATM facility raising A$31,754 before transaction costs. |
| • | In December 2024, we issued 460,800 ordinary shares at a price of A$0.0781 per share under our ATM facility raising A$36,012 before transaction costs. |
| • | In December 2024, we issued 142,200 ordinary shares at a price of A$0.0665 per share under our ATM facility raising A$9,464 before transaction costs. |
| • | In December 2024, we issued 522,100 ordinary shares at a price of A$0.0631 per share under our ATM facility raising A$32,938 before transaction costs. |
| • | In December 2024, the Company issued 15,000,000 ordinary shares at a price of A$0.0537 per share under a private ELOC raising A$874,939 before transaction costs. |
| • | In December 2024, we issued 6,421,800 ordinary shares at a price of A$0.0596 per share under our ATM facility raising A$382,576 before transaction costs. |
| • | In December 2024, the Company issued 20,000,000 ordinary shares at a price of A$0.0437 per share under a private ELOC raising A$804,870 before transaction costs. |
| • | In December 2024, we issued 4,000,000 ordinary shares at a price of A$0.0322 per share under our ATM facility raising A$128,729 before transaction costs. |
| • | In January 2025, we issued 2,939,500 ordinary shares at a price of A$0.0292 per share under our ATM facility raising A$85,921 before transaction costs. |
| • | In January 2025, we issued 10,668,100 ordinary shares at a price of A$0.0286 per share under our ATM facility raising A$305,565before transaction costs. |
| • | In January 2025, we issued 2,453,900 ordinary shares at a price of A$0.0289 per share under our ATM facility raising A$70,828 before transaction costs. |
| • | In January 2025, the Company issued (i) 55,344,000 ordinary shares in the form of ADSs at a price of A$0.0242 per ordinary share and pre-funded warrants to purchase up to 779,893 ADSs representing 77,989,300 ordinary shares at a price of US$1.4999 per pre-funded warrant with an exercise price of $0.0001 per ADS in a registered direct offering for an aggregate consideration of approximately A$1,341,348, (ii) unregistered Ordinary Warrants to purchase up to 1,333,333 ADSs representing 133,333,300 ordinary shares at an exercise price of US$1.50 per ADS in a concurrent private placement, and (iii) unregistered Placement Agent Warrants to purchase up to 40,000 ADSs representing 4,000,000 ordinary shares at an exercise price of US$1.50 per ADS. |
| • | In February 2025, we issued 60,000,000 ordinary shares at a price of A$0.0153 per share under a private ELOC raising A$917,450 before transaction costs. |
| • | In May 2025, the Company issued 15,000,000 ordinary shares at a price of A$0.0094 per share under a private ELOC placement raising A$141,489 before transaction costs. |
| • | In June 2025, the Company issued 32,500,000 ordinary shares at a price of A$0.1550 per share under a private ELOC placement raising A$504,043 before transaction costs. |
| • | In June 2025, the Company issued 35,000,000 ordinary shares at a price of A$0.0280 per share under a private ELOC placement raising A$979,179 before transaction costs. |
| • | In June 2025, the Company issued 30,000,000 ordinary shares at a price of A$0.0200 per share under a private ELOC placement raising A$599,674 before transaction costs. |
In fiscal years 2025 and 2024, the Company held a significant proportion of its cash balances in U.S. dollars and there were no conversion losses. During fiscal year 2023, the Company held the majority of its cash balances in U.S. dollars and there were no conversion losses. See Item 18. “Financial Statements - Note 22 - Financial Instruments” for disclosures about financial risk management including interest rate risk, foreign currency risk and liquidity risk.
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C. Research and development, Patents and Licenses, etc.
Expenditures during the research phase of a project are recognized as an expense when incurred. Development costs are capitalized only when technical feasibility studies identify that the project will deliver future economic benefits and these benefits can be measured reliably.
Research and development expenses consist primarily of costs incurred for the development of our product candidates, which include:
| • | expenses incurred under agreements with academic research centers, clinical research organizations and investigative sites that conduct our clinical trials; and |
| • | the cost of acquiring, developing, and manufacturing clinical trial materials. |
We cannot determine with certainty the duration and completion costs of the current or future product development, pre-clinical studies or clinical trials of our product candidates. The duration, costs, and timing of clinical trials and development of our product candidates will depend on a variety of factors, including:
| • | the scope, rate of progress, and expense of our ongoing as well as any additional clinical trials and other research and development activities; |
| • | the countries in which trials are conducted; |
| • | future clinical trial results; |
| • | uncertainties in clinical trial enrollment rates or drop-out or discontinuation rates of patients; |
| • | potential additional safety monitoring or other studies requested by regulatory agencies; |
| • | significant and changing government regulation; and |
| • | the timing and receipt of any regulatory approvals. |
A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate. For example, if the FDA, or another regulatory authority were to require us to conduct clinical trials beyond those that we anticipate will be required to complete clinical development of a product candidate or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development.
In fiscal years 2025, 2024, 2023 we spent a total of A$7.3 million, A$17.4 million, and A$15.6 million, respectively, on company-sponsored research and development activities.
D. Trend Information
Further to the risk factors discussed in Item 3D, we note that the financial information disclosed in the SEC Form 20-F may not be indicative of future results in the following areas:
| • | While we anticipate that funds will continue to be spent on research and development of our drug candidates, the amounts expended in recent years may not be indicative of the amounts to be expended in future years, because we may have more or fewer drug candidates, they may be at different stages of their lifecycle and the trials deemed suitable for their development may be more or less costly; |
| • | We did not generate material revenue from licensing transactions in fiscal years 2025 and 2023 and we may not generate any revenue in future years. Should the Company generate revenues in future years, the amounts generated in fiscal year 2021 may not be representative of any such revenues in future years. This could be as a result of whether any further licensing transactions are entered into, as well as whether any milestones are met in relation to license agreements already in place; and |
| • | The quantum of general and administrative expenditures in recent years may not be indicative of the expenditures required in future years. |
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E. Critical Accounting Estimates - see Note 2. Material accounting policies
| Item 6. | Directors, Senior Management and Employees |
A. Directors and Senior Management
The names and details of the Company’s Directors and senior management at the date of this report are as follows:
| John Friend | Chief Executive Officer | |
| Bryce Carmine | Chairman, Non-Executive Director | |
| Steven Coffey | Non-Executive Director | |
| Ebru Davidson | Non-Executive Director | |
| Robert Apple | Non-Executive Director | |
| Jeffrey Bonacorda | Vice President, Finance and Controller | |
| Elissa Hansen | Company Secretary |
Directors were in office for the entire period unless otherwise stated.
Names, titles, experience and expertise
| Name: | Bryce Carmine | |
| Title: | Chairman, Non-Executive Director | |
| Qualifications: | B.Sc., Biochemistry, Microbiology & Genetics | |
| Experience and expertise: | Bryce spent 36 years working for Eli Lilly & Co. and retired as Executive Vice President for Eli Lilly & Co, and President, Lilly Bio-Medicines. Prior to this he led the Global Pharmaceutical Sales and Marketing and was a member of the Company’s Executive Committee. Bryce previously held a series of product development portfolio leadership roles culminating when he was named President, Global Pharmaceutical Product Development, with responsibility for the entire late-phase pipeline development across all therapeutic areas for Eli Lilly. During his career with Lilly, Bryce held several country leadership positions including President Eli Lilly Japan, Managing Dir. Australia/NZ & General Manager of a JV for Lilly in Seoul, Korea. Most recently, Bryce was Chairman and CEO of HaemaLogiX Pty Ltd, a Sydney based privately owned biotech until December 2023. Bryce has been a director of HaemaLogiX Pty Ltd since January 2024. | |
| Special responsibilities: | Chair of Remuneration and Nomination Committee, member of Audit, Risk and Governance Committee. | |
| Name: | Steven Coffey | |
| Title: | Non-Executive Director | |
| Qualifications: | B. Comm, CA | |
| Experience and expertise: | Steven is a Chartered Accountant and registered company auditor and has over 35 years experience in the accounting and finance industry. He has been a partner with the chartered accounting firm Watkins Coffey Martin which recently merged with Charternet Chartered Accountants and Steven is a consultant to that group. Steven sits on the board of a number of large private family companies and audits a number of large private companies and not-for-profit entities. Previously, Steven was a director of Ansarada Group Limited (ASX: AND) (formerly The Docyard Limited (ASX:TDY)). | |
| Special responsibilities: | Chair of Audit, Risk and Governance Committee, member of Remuneration and Nomination Committee. | |
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| Name: | Ebru Davidson | |
| Title: | Non-Executive Director | |
| Qualifications: | BSc, JD (Hons), AGIA, GAICD | |
| Experience and expertise: | Ms Davidson is a highly experienced corporate lawyer and is currently the General Counsel for QBiotics Group Limited since 2021, an unlisted public Australian life sciences company. Prior to this, Ms Davidson was a partner at national law firm Thomson Geer Lawyers from 2017 until 2021 and has over 14 years’ experience in equity capital markets, private and public mergers and acquisitions, corporate transactions and corporate governance. Ms Davidson also has extensive experience in advising listed and unlisted entities on compliance and regulatory matters working closely with the Australian Securities and Investment Commission and Australian Securities Exchange. | |
| Special responsibilities: | Chair of Remuneration and Nomination Committee | |
| Name: | Robert Apple | |
| Title: | Non-Executive Director | |
| Qualifications: | B.A. | |
| Experience and expertise: | Mr Robert Apple has more than 25 years of senior leadership experience in the pharmaceutical industry, including 16 years with Antares Pharma, Inc. as Senior Vice President, Chief Financial Officer and Corporate Secretary, before going on to become President and Chief Executive Officer from 2016 until its acquisition by Halozyme Therapeutics in 2022. Mr. Apple also served on the Board of Directors at Antares from 2016 until May 2022. He previously served on the Board of Directors of InKine Pharmaceutical, PaxMedica Inc., and Kerathin Inc. Prior to joining Antares, Mr. Apple served as Chief Operating and Financial Officer at InKine Pharmaceutical. He also held prior roles at Genaera Corporation, Liberty Technologies, and Arthur Andersen & Company. | |
| Special responsibilities: | None | |
| Name: | Dr John Friend | |
| Title: | Chief Executive Officer (appointed 1 May 2023) | |
| Managing Director (appointed 1 August 2023 through December 2024) | ||
| Interim Chairman of the Board (appointed 11 August 2023) | ||
| Chief Medical Officer to 30 April 2023 | ||
| Qualifications: | B.A., M.D | |
| Experience and expertise: | Dr Friend is a highly experienced physician executive who has previously worked with companies ranging from start-up biotechnology companies to multinational pharmaceutical companies. Over the past 15 years, his focus has been in the oncology and hematology therapeutic space. Dr. Friend is a US-trained physician who practiced medicine in North Carolina before transitioning to drug development. Before joining Kazia Therapeutics in November 2021 he was Chief Medical Officer and member of the executive management team at Cellectar Biosciences, Inc, a US publicly traded biopharmaceutical company. | |
| Special responsibilities: | None | |
| Name: | Jeffrey Bonacorda | |
| Title: | Vice President, Finance and Controller | |
| Qualifications: | B.A. | |
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| Experience and expertise: | Mr. Jeffrey Bonacorda is a senior accounting professional with more than thirty years of experience in the pharmaceutical, consumer products and service industries. Prior to joining Kazia, Mr Bonacorda held several senior finance positions supporting global R&D development programs and on market pharmaceuticals. | |
| Name: | Elissa Hansen | |
| Title: | Company Secretary (Appointed 14 June 2024) | |
| Qualifications: | Bc., Grad.Dip. AICD, FGIA, | |
| Experience and expertise: | Ms Elissa Hansen has over 20 years’ experience as a company secretary and governance professional for both listed and unlisted companies. She is a Chartered Secretary who brings best practice governance advice, ensuring compliance with the Corporations Act and other relevant legislation. Since 2015, she has been Principal at CoSec Services, which provides Company Secretarial and Corporate Governance consulting services. | |
B. Compensation
Principles used to determine the nature and amount of remuneration
Remuneration philosophy
Remuneration for Directors and Senior Executives is based on the overall objective of attracting and retaining people of high quality who will make a worthwhile contribution to Kazia in the short, medium and long term, and thereby contribute to long term shareholder value. The Board and its Remuneration and Nomination Committee take a balanced position between the need to pay market rates to attract talent, and the financial resources of Kazia, in determining remuneration.
Non-Executive Directors remuneration
The Constitution of Kazia specifies that the aggregate remuneration of Non-Executive Directors shall be determined from time to time by General Meeting. The last determination for the Consolidated Entity was at the Annual General Meeting held on 16 November 2022 when the shareholders approved the new constitution with an aggregate remuneration of $560,000.
Non-Executive Directors’ fees are reviewed periodically by the Board and are regularly compared with those of companies of comparable market capitalization and stage of development. The Chairman’s fees are determined independently to the fees of other non-executive Directors based on comparative roles in the external market.
The Non-Executive Directors fee structure is a fixed fee model and includes superannuation for Australian based directors.
Executive Directors and other Key Management Personnel (“KMP”)
The Board and the Remuneration and Nomination Committee, in consultation with the Managing Director, have put in place a remuneration structure which provides incentive for employees to drive the activities of the company forward. These arrangements are reviewed annually at the end of the calendar year.
The Board determines an appropriate level of fixed remuneration for the CEO and Group Executives, as well as the proportion of performance-based remuneration.
The executive remuneration and reward framework has three components:
| • | fixed remuneration |
| • | short-term performance incentives - cash bonus |
| • | share-based payments - award of options through the Employee Share Option Plan (“ESOP”) |
Fixed remuneration is reviewed annually by the Remuneration and Nomination Committee based on individual performance, the overall performance of Kazia and comparable market remunerations.
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The short-term incentives program is designed to align the targets of Kazia with the performance hurdles of executives. Short-term incentive payments are granted to executives based on specific annual performance objectives, metrics and performance appraisals. Annual performance reviews are conducted at the end of each calendar year and bonuses are paid shortly after the performance reviews are completed. Annual performance objectives cover matters such as progress in clinical trials, and management of the Company’s financial resources.
The Board or the Remuneration and Nomination Committee may, at its discretion, award bonuses for exceptional performance.
The long-term incentive comprises equity-based payments. The Consolidated Entity aims to attract and retain high calibre executives, and align their interests with those of the shareholders, by granting equity-based payments which are issued at the share price on date of issue and vest in tranches based on tenure. The share-options issued to executives are governed by the ESOP.
Employee share option plan
The Employee Share Option Plan (‘ESOP’) was most recently approved by shareholders on 10 November 2021.
The ESOP provides for the issue of options to eligible individuals, being employees, Officers and Non-executive directors of Kazia.
Each option issued under the ESOP entitles its holder to acquire one fully paid ordinary share and is exercisable at a price based on a formula, which includes the weighted average price of such shares at the close of trading on the Australian Securities Exchange for the five days prior to the date of issue. The number of options offered, the amount payable, the vesting period, the option period, the conditions of exercise or any other factors are at the discretion of the Board of Directors.
Kazia issued 33,467 ADS options under the ESOP during the financial year ended 30 June 2025, of which 6,000 were issued to KMP.
Any change to the ESOP will require approval by shareholders.
Use of remuneration consultants
During fiscal year 2025, the Company did not engage remuneration consultants to assist with the determination of remuneration levels.
Details of remuneration
Amounts of remuneration
Details of the remuneration of key management personnel of Kazia are set out in the following tables, reported in Australian dollars, the functional currency of the Company, unless otherwise noted.
The KMP of Kazia consisted of the following directors of Kazia Therapeutics Limited:
| • | Bryce Carmine - Non-Executive Director, Chairman from 1 February 2024 |
| • | Steven Coffey - Non-Executive Director |
| • | Ebru Davidson - Non-Executive Director - from 5 June 2023 |
| • | Robert Apple - Non-Executive Director - from 15 January 2024 |
And the following persons:
| • | Dr John Friend - Chief Executive Officer |
| • | Jeffrey Bonacorda - Vice President, Finance and Controller |
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| Short-term benefits |
Short-term benefits |
Short-term benefits |
Short-term benefits |
Short-term benefits |
Post- employment benefits |
Share-based payments |
||||||||||||||||||||||||||
| Salary & fees Cash |
Bonus Cash |
Movements in accrued leave Non- monetary |
Movements in long service leave Non- monetary |
Healthcare & Insurance Cash |
Super- annuation |
Options Equity- settled |
Total | |||||||||||||||||||||||||
| 2025 | $ | $ | $ | $ | $ | $ | $ | $ | ||||||||||||||||||||||||
| Non-Executive Directors: |
||||||||||||||||||||||||||||||||
| B Carmine |
110,000 | — | — | — | — | — | 7,833 | 117,833 | ||||||||||||||||||||||||
| S Coffey |
85,000 | — | — | — | — | 9,775 | 7,833 | 102,608 | ||||||||||||||||||||||||
| E Davidson |
85,000 | — | — | — | — | 9,775 | 15,666 | 110,441 | ||||||||||||||||||||||||
| R Apple |
85,000 | — | — | — | — | — | 15,666 | 100,666 | ||||||||||||||||||||||||
| Other Key Management Personnel: |
||||||||||||||||||||||||||||||||
| J Friend * |
850,677 | — | (4,903 | ) | — | 52,587 | 19,140 | 341,352 | 1,258,853 | |||||||||||||||||||||||
| J Bonacorda * |
248,639 | 77,267 | 14,611 | — | 36,734 | 12,432 | 16,863 | 406,546 | ||||||||||||||||||||||||
| E Hansen |
48,000 | — | — | — | — | — | 48,000 | |||||||||||||||||||||||||
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| 1,512,316 | 77,267 | 9,708 | — | 89,321 | 51,122 | 405,213 | 2,144,947 | |||||||||||||||||||||||||
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| * | Salary paid in USD, but disclosed in Australian dollars using conversion rate of 0.6471. |
Service agreements
Under Remuneration and Nomination Committee policy, employment contracts are entered into with each of the executives who is considered to be KMP. Under the terms of the contracts, remuneration is reviewed at least annually. The employment contracts of KMPs include a termination clause whereby a party can terminate the agreement on notice. Notice required is 6 months. Under the terms of each contract, payment in lieu can be made by the Consolidated Entity to substitute the notice period. The Consolidated Entity may terminate the contracts at any time without cause if serious misconduct has occurred. In the event that employment is terminated for cause, no severance pay or other benefits are payable by the Consolidated Entity.
Remuneration and other terms of employment for key management personnel are formalized in service agreements. Details of these agreements are as follows:
| Name: Title: Agreement commenced: Term of agreement: Details: |
Dr John Friend Chief Executive Officer 1 May 2023 Full time employment Base salary for the year ended 30 June 2025 of USD550,000 and healthcare and insurance benefits to be reviewed annually by the Remuneration and Nomination Committee. A bonus of up to 60% of base salary, subject to attainment of key objectives and at the discretion of the board. John’s employment with the Consolidated Entity is at-will, and if terminated, it must pay any outstanding entitlements due to him. |
Key management personnel have no entitlement to termination payments in the event of removal for misconduct.
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Share-based compensation
Issue of options
The options issued on 11 September 2024 were to Ebru Davidson, Robert Apple, Bryce Carmine, and Stephen Coffey for 6,000 ADS options with an exercise price set at the volume weighted average (VWAP) of ADS during the 5 trading days immediately prior to the issue date with a value of A$23,500. Service conditions are that any unvested options are forfeited on cessation of employment. There are no performance conditions, consistent with the Company’s Employee Share Option Plan rules, as re-approved by shareholders on 6 November 2021.
The terms and conditions of each grant of options over ordinary shares granted as remuneration to Directors or other Key Management Personnel in this financial year or future financial years are set out below.
Issue of ADS options
| Tranche | Grant date | Vesting date and exercisable date |
Expiry date | Exercise price | Fair value per option at grant date |
|||||||||
| 20 |
11 September 2024 | 11 September 2024 | 11 September 2029 | A$ | 24.8 | A$ | 23.50 | |||||||
Options granted carry no dividend or voting rights. Each ADS option is convertible to 500 ordinary share upon exercise.
Pension benefits
The Company paid A$51,122 during fiscal year 2025 for employee superannuation benefits and pension benefits related to KMPs.
C. Board Practices
The role of the Board is as follows:
| • | representing and serving the interests of shareholders by overseeing and appraising the strategies, policies and performance of the Company. This includes overviewing the financial and human resources the Company has in place to meet its objectives and the review of management performance; |
| • | protecting and optimizing Company performance and building sustainable value for shareholders in accordance with any duties and obligations imposed on the Board by law and the Company’s Constitution and within a framework of prudent and effective controls that enable risk to be assessed and managed; responsible for the overall Corporate Governance of Kazia Therapeutics Limited and its subsidiaries, including monitoring the strategic direction of the Company and those entities, formulating goals for management and monitoring the achievement of those goals; |
| • | setting, reviewing and ensuring compliance with the Company’s values (including the establishment and observance of high ethical standards); and |
| • | ensuring shareholders are kept informed of the Company’s performance and major developments affecting its state of affairs. |
Responsibilities/functions of the Board include:
| • | selecting, appointing and evaluating from time to time the performance of, determining the remuneration of, and planning for the successor of, the CEO; |
| • | reviewing procedures in place for appointment of senior management and monitoring of its performance, and for succession planning. This includes ratifying the appointment and the removal of the Company Secretary; |
| • | overseeing the Company, including its control and accountability systems; |
| • | input into and final approval of management development of corporate strategy, including setting performance objectives and approving operating budgets; |
| • | reviewing and guiding systems of risk management and internal control and ethical and legal compliance. This includes reviewing procedures in place to identify the main risks associated with the Company’s businesses and the implementation of appropriate systems to manage these risks; |
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| • | overseeing and monitoring compliance with the Code of Conduct and other corporate governance policies; |
| • | monitoring corporate performance and implementation of strategy and policy; |
| • | approving major capital expenditure, acquisitions and divestitures, and monitoring capital management; |
| • | monitoring and reviewing management processes in place aimed at ensuring the integrity of financial and other reporting; |
| • | monitoring and reviewing policies and processes in place relating to occupational health and safety, compliance with laws, and the maintenance of high ethical standards; and |
| • | performing such other functions as are prescribed by law or are assigned to the Board. |
In carrying out its responsibilities and functions, the Board may delegate any of its powers to a Board committee, a director, employee or other person subject to ultimate responsibility of the directors under the Corporations Act.
Matters which are specifically reserved for the Board or its committees include the following:
| • | appointment of a Chair; |
| • | appointment and removal of the managing director; |
| • | appointment of directors to fill a vacancy or as additional directors; |
| • | establishment of Board committees, their membership and delegated authorities; |
| • | approval of dividends; |
| • | development and review of corporate governance principles and policies; |
| • | calling of meetings of shareholders (which may also be requisitioned by shareholders in accordance with the terms of the Corporations Act) |
Structure of the Board
The Company’s Constitution governs the regulation of meetings and proceedings of the Board. The Board determines its size and composition, subject to the terms of the Constitution. The Board does not believe that it should establish a limit on tenure other than stipulated in the Company Constitution (refer to ‘Term of Directors’ below).
While tenure limits can help to ensure that there are fresh ideas and viewpoints available to the Board, they hold the disadvantage of losing the contribution of directors who have been able to develop, over a period of time, increasing insight in the Company and its operation and, therefore, an increasing contribution to the Board as a whole. It is intended that the Board should comprise a majority of independent non-executive directors and comprise directors with a broad range of skills, expertise and experience from a diverse range of backgrounds. The Board regularly reviews the independence of each director in light of the interests disclosed to the Board.
The Board only considers directors to be independent where they are independent of management and free of any business or other relationship that could materially interfere with, or could reasonably be perceived to interfere with, the exercise of their unfettered and independent judgment. The Board has adopted a definition of independence based on that set out in Principle 2.3 of the ASX Corporate Governance Principles and Recommendations (4th edition). The Board will review the independence of each director in light of interests disclosed to the Board from time to time. In accordance with the definition of independence above, and the materiality thresholds set, the Board considers Bryce Carmine, Steven Coffey, Robert Apple, and Ebru Davidson to be independent directors.
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There are procedures in place, agreed by the Board, to enable directors in furtherance of their duties to seek independent professional advice at the Company’s expense. The appointment and expiration dates of each director in office at the date of this report is as follows:
| Name | Position | Year First Appointed | Current term expires | |||
| Bryce Carmine |
Non-executive Director | 2015 | Nov-26 | |||
| Steven Coffey |
Non-executive Director | 2012 | Nov-25 | |||
| Ebru Davidson (appointed 5 June 2023) |
Non-executive Director | 2023 | Nov-26 | |||
| Robert Apple (appointed 15 January 2024) |
Non-executive Director | 2024 | Nov-27 | |||
Further details on each director can be found in “Names, titles, experience and expertise” above.
Term of Directors
Other than the Managing Director, under the Company’s Constitution:
| • | a Director must not hold office without re-election: (a) following the third Annual General Meeting of the Company after that Director’s last appointment or re-election; or (b) for more than 3 years, whichever is longer; and |
| • | if no Director is required to retire at an Annual General Meeting of the Company, then the Director to retire will be the one who has been longest in office since that Director’s last election. |
The Board of Directors has the power to appoint any person to be a director either to fill a casual vacancy or as an additional director (up to a maximum of 10).
Board of Directors
The Board of Kazia is elected by and accountable to shareholders. The Board monitors and directs the business and is responsible for the corporate governance of the Company. As of 30 June 2025, the Board comprised of four directors, all of whom were non-executive directors.
Committees
The Board has established an Audit, Risk and Governance Committee and a Remuneration and Nomination Committee.
Audit, Risk and Governance Committee
The Board has established an Audit, Risk and Governance Committee which operates under a Charter approved by the Board, which is available on the Company’s website. It is the Board’s responsibility to ensure that an effective internal control framework exists within the entity. This includes internal controls to deal with both the effectiveness and efficiency of significant business processes, the safeguarding of assets, the maintenance of proper accounting records, and the reliability of financial information as well as non-financial considerations such as the benchmarking of operational key performance indicators. The Board has delegated responsibility for establishing and maintaining a framework of internal control and ethical standards to the Audit, Risk and Governance Committee.
The Committee also provides the Board with additional assurance regarding the reliability of financial information for inclusion in the financial reports.
Members of the Audit, Risk and Governance Committee are Ebru Davidson (Chairman), Steven Coffey, Robert Apple and Bryce Carmine, each of whom is an independent director.
Remuneration and Nomination Committee
The purpose of the Remuneration and Nomination Committee is to assist and advise the Board to develop, implement and, from time to time, update policies in relation to:
| • | the selection, nomination and appointment processes for directors; and |
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| • | the remuneration of key management personnel and directors. |
This committee is accountable to the Board for its performance and is subject to an annual review by the Board. Members of the Remuneration and Nomination Committee are Bryce Carmine (Chairman), Steven Coffey, Ebru Davidson and Robert Apple each of whom is an independent director.
Performance
The performance of the Board and key executives is reviewed regularly using both measurable and qualitative indicators.
On at least a bi-annual basis, directors will provide written feedback in relation to the performance of the Board and its Committees against a set of agreed criteria:
| • | each Committee of the Board will also be required to provide feedback in terms of a review of its own performance; |
| • | feedback will be collected by the chair of the Board, or an external facilitator, and discussed by the Board, with consideration being given as to whether any steps should be taken to improve performance of the Board or its Committees; |
| • | the Chief Executive Officer will also provide feedback from senior management in connection with any issues that may be relevant in the context of Board performance review; and |
| • | where appropriate to facilitate the review process, assistance may be obtained from third party advisors. |
Remuneration
It is the Company’s objective to provide maximum shareholder benefit from the retention of a high-quality Board and executive team by remunerating directors and key executives fairly and appropriately with reference to relevant employment market conditions. To assist in achieving this objective, the Board, in assuming the responsibilities of assessing remuneration to employees, links the nature and amount of executive directors’ and officers’ remuneration to the Company and Company’s financial and operational performance.
The expected outcomes of the remuneration structure are:
| • | retention and motivation of key executives; |
| • | attraction of high-quality management to the Company; and |
| • | performance incentives that allow executives to share in the success of Kazia Therapeutics Limited. |
For a more comprehensive explanation of the Company’s remuneration framework and the remuneration received by directors and key executives in the current period, please refer to the section “Compensation” above.
There is no plan to provide retirement benefits to executive or non-executive directors, except for the Australian Government Superannuation Guarantee.
The Remuneration and Nomination Committee is responsible for determining and reviewing compensation arrangements for the directors themselves and the Chief Executive Officer and executive team.
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D. Employees
As of the end of each of the last three fiscal years, the Company employed the following number of people-FTEs:
| Category of Activity | 2025 | 2024 | 2023 | |||||||||
| Research and Development |
5.0 | 5.0 | 6.8 | |||||||||
| Finance and Administration |
1.0 | 1.8 | 2.0 | |||||||||
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| Total |
6 | 6.8 | 8.8 | |||||||||
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| Geographic Location | 2025 | 2024 | 2023 | |||||||||
| Australia |
2.0 | 3.0 | 4.8 | |||||||||
| United States |
4.0 | 3.8 | 4.0 | |||||||||
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| Total |
6.0 | 6.8 | 8.8 | |||||||||
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E. Share Ownership
Directors’ and KMP interests in the shares and options of the Company for fiscal year 2025:
Shareholding
The number of shares in the company held during the financial year by each director and other members of Key Management Personnel of the Consolidated Entity, including their personally related parties, is set out below:
| Balance at the start of the year |
Purchased on market |
Share Purchase Plan |
Off market additions/ disposals |
Disposed* (For KMP reporting purposes |
Balance at the end of the year |
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| Ordinary shares |
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| B Carmine |
856,681 | — | — | — | — | 856,681 | ||||||||||||||||||
| S Coffey |
991,993 | — | — | — | — | 991,993 | ||||||||||||||||||
| J Friend |
— | 4,000,000 | — | — | — | 4,000,000 | ||||||||||||||||||
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| 1,848,674 | 4,000,000 | — | — | — | 5,848,674 | |||||||||||||||||||
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Each Director and Key Management Personnel owns less than 1% of shareholding.
Other transactions with key management personnel and their related parties
John Friend was reimbursed for travel and accommodation expenses of $107,932.
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Option holding
The number of options over ordinary shares in the company held during the financial year by each Director and other members of Key Management Personnel of Kazia, including their personally related parties, is set out below:
| Balance at the start of the year |
Granted as renumeration |
Forfeited | Disposed* (For KMP reporting purposes |
Balance at the end of the year |
||||||||||||||||
| Options over ordinary shares |
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| I Ross |
400,000 | — | (400,000 | ) | — | — | ||||||||||||||
| B Carmine |
400,000 | — | (400,000 | ) | — | — | ||||||||||||||
| S Coffey |
400,000 | — | (400,000 | ) | — | — | ||||||||||||||
| J Friend |
4,800,000 | — | — | — | 4,800,000 | |||||||||||||||
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| 6,000,000 | — | (1,200,000 | ) | — | 4,800,000 | |||||||||||||||
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| Balance at the start of the year |
Granted as remuneration |
Forfeited | Disposed (for KMP reporting purposes only) |
Balance at the end of the year |
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| Options over ADS |
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| J Friend |
30,000 | — | — | — | 30,000 | |||||||||||||||
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| 30,000 | — | — | — | 30,000 | ||||||||||||||||
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Share-based compensation
There were no shares issued to Directors or other KMP as part of compensation during fiscal year 2025.
| Item 7. | Major Shareholders and Related Party Transactions |
A. Major shareholders
The following table sets forth information with respect to the beneficial ownership of our ADSs as at September 23, 2025 by:
| • | each of the members of our board and senior management; and |
| • | each person, or group of affiliated persons, known by us to beneficially own more than 5% of our ADSs. |
The percentage of shares beneficially owned is based on a total of 835,288,734 ordinary shares, or 1,670,577 ADSs, outstanding as at September 23, 2025. The numbers and percentages of ADSs beneficially owned are reported on the basis of regulations of the SEC governing the determination of beneficial ownership of securities. Under the applicable SEC rules, a person is deemed to be a “beneficial owner” of a security if that person has or shares voting power, which includes the power to vote or direct the voting of such security, or investment power, which includes the power to dispose of or to direct the disposition of such security, or to receive the economic benefit of ownership of the securities. A person is also deemed to be a beneficial owner of any securities of which that person has a right to acquire beneficial ownership within 60 days of September 23, 2025, and such securities are considered outstanding for the purpose of calculating the percentage ownership of that person but not for the purpose of calculating the percentage ownership of any other person. Under these rules, more than one person may be deemed beneficial owner of the same securities and a person may be deemed to be a beneficial owner of securities as to which such person has no economic interest. Except as otherwise indicated, each of the beneficial owners has, to our knowledge, sole voting and investment power with respect to the indicated ordinary shares, subject to community property laws, where applicable.
Unless otherwise indicated, all information contained in the table below and the footnotes thereto is based upon information provided to us by the shareholders and the public information available to us. Except as otherwise set forth below, the address of the beneficial owner is c/o Kazia Therapeutics Limited, Level 24, Three International Towers, 300 Barangaroo Avenue, Sydney, NSW, 2000, Australia.
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| ADSs Beneficially Owned |
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| Name and Address of Beneficial Owner |
Number | Percentage | ||||||
| Major Shareholders: |
||||||||
| Alumni Capital LP 1 |
182,260 | 2 | 9.99 | % | ||||
| Chernett Jorey 3 |
137,200 | 4 | 8.2 | % | ||||
| Dauntless Investment Group, LLC5 |
115,769 | 6 | 6.9 | % | ||||
| Board Members and Senior Management |
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| John Friend 7 |
8,000 | 0.5 | % | |||||
| Bryce Carmine 8 |
1,713 | 0.1 | % | |||||
| Steven Coffey 9 |
1,983 | 0.1 | % | |||||
| Ebru Davidson |
— | — | % | |||||
| Robert Apple |
— | — | % | |||||
| Jeffrey Bonacorda |
— | — | % | |||||
| Elissa Hansen |
— | — | % | |||||
| All board members and senior management as a group (7 persons) 1 |
11,696 | 0.7 | % | |||||
1. The business address of Alumni Capital LP is 601 Brickell Key Dr. Suite 700, Miami, FL 33131. The general partner of Alumni Capital LP is Alumni Capital GP LLC. Ashkan Mapar is the manager of Alumni Capital GP LLC and as such has voting and disposition control over the Shares. We have been advised that none of Alumni Capital LP, Alumni Capital GP LLC nor Ashkan Mapar is a member of the Financial Industry Regulatory Authority (“FINRA”), or an independent broker-dealer, or an affiliate or associated person of a FINRA member or independent broker-dealer.
2. Consists of (i) 14,204,500 ordinary shares held by Alumni Capital LP based on information provided to us by Alumni Capital LP (ii) 153,851 ADSs issuable upon exercise of the Ordinary Warrants held by Alumni Capital LP and the remaining portion of the Alumni Warrant issued to Alumni Capital LP on April 19, 2024, after giving effect to the exercise limitations of such warrants which prevent its exercise to the extent that such exercise would result in the beneficial ownership by Alumni Capital LP and its affiliates to exceed 9.99% of the ADSs outstanding. The Alumni Warrant allows Alumni Capital LP to purchase a variable number of ordinary shares in the form of ADSs based on the number of ordinary shares outstanding as of the date of exercise. Based on 835,288,734 Ordinary Shares outstanding as of September 23, 2025, if the remaining portion of the Alumni Warrant were to be exercised on September 23, 2025, it was exercisable for up to 69,607 ADSs, representing 34,803,500 ordinary shares.
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3. Information is based on a report on Schedule 13G filed on June 12, 2025 by Chernett Jorey. The business address of Chernett Jorey is 6222 Indianwood Trail, Bloomfield Hills, MI 48301.
4. Information is based on a report on Schedule 13G filed on June 12, 2025 by Chernett Jorey.
5. Information is based on a report on Schedule 13G/A filed on August 5, 2025 by Dauntless Investment Group, LLC. The business address of Dauntless Investment Group, LLC is 8567 Hummingbird, Commerce Township, MI 48382.
6. Information is based on a report on Schedule 13G/A filed on August 5, 2025 by Dauntless Investment Group, LLC.
7. Consists of 8,000 ADSs.
8. Consists of 856,681 ordinary shares, represented by 1,713 ADSs.
9. Consists of 1983 restricted ADSs and 13 ordinary shares.
Significant Changes in the Ownership of Major Shareholders
On April 19, 2024, we entered into a purchase agreement (the “Purchase Agreement”) with Alumni Capital LP, pursuant to which we may sell to Alumni Capital LP up to $15,000,000 (the “Investment Amount”) of ADSs, representing fully paid ordinary shares, from time to time during the term of the Purchase Agreement. In consideration for Alumni Capital LP’s execution and delivery of the Purchase Agreement, we issued a warrant (the “Alumni Warrant”) to Alumni Capital LP, valid for a term of three (3) years, entitling Alumni Capital LP to purchase ADSs (the “Warrant ADSs”) with a value (calculated based on the then-current ADS to ordinary share ratio) equal to five percent (5%) of the Investment Amount. The Alumni Warrant exercise price is variable and is equal to $6,000,000 divided by the number of outstanding ordinary shares as of the time of exercise, multiplied by the then-current ADS to ordinary shares ratio.
On January 10, 2025, we entered into a securities purchase agreement with Alumni Capital LP, pursuant to which we issued and sold (A) in a registered direct offering, 553,440 ADSs and pre-funded warrants to purchase up to 779,893 ADSs, and (B) in a concurrent private placement, the ordinary warrants to purchase up to 1,333,333 ADSs, which have an exercise price of $1.50 per ADS, are exercisable immediately and will expire on July 14, 2030.
On July 31, 2025, we entered into the Securities Purchase Agreements with Alumni Capital LP, Pointillist Global Macro Series of Pointillist Partners, LLC, Daniel Herr and Lauren Rimoin Living Trust and MK Plumeria, LLC in connection with a private placement, pursuant to which we issued and sold (i) 14,204,500 ordinary shares at a purchase price of $0.0176 per share, and (ii) pre-funded Warrants to purchase up to 204,547 ADSs, each ADS representing five hundred ordinary shares, at a purchase price of $8.7999 per pre-funded Warrant. Each pre-funded Warrant is exercisable for one ADS at an exercise price of $0.0001 per ADS underlying the pre-funded Warrant, is immediately exercisable, and will expire when exercised in full.
Major Shareholders Voting Rights
All of our shareholders, including the shareholders listed below, have the same voting rights attached to their ordinary shares.
Record Holders
As of October 10, 2025, there were 2,187 Kazia shareholders holding 917,300,734 fully paid ordinary shares. These numbers are not representative of the number of beneficial holders of our shares nor are they representative of where such beneficial holders reside, since many of these ordinary shares were held of record by brokers or other nominees. The majority of trading by our U.S. investors is done by means of ADS that are held of record by HSBC Custody Nominees (Australia) Ltd., which held 866,587,053 (96.65%) of our ordinary shares as of such date.
B. Related party transactions
During fiscal year 2023, 2024, and 2025, and up to the date of this report, we did not enter into any transactions or loans with any: (i) enterprises that directly or indirectly, through one or more intermediaries, control, are controlled by or are under common control with us; (ii) associates; (iii) individuals owning, directly or indirectly, an interest in our voting power that gives them significant influence over us, and close members of any such individual’s family; (iv) executive officers and close members of such individuals’ families; or (v) enterprises in which a substantial interest in our voting power is owned, directly or indirectly, by any person described in (iii) or (iv) or over which such person is able to exercise significant influence.
Transactions between related parties, when they occur, are on normal commercial terms and the conditions no more favorable than those available to other non-related parties.
C. Interests of Experts and Counsel
Not applicable.
| Item 8. | Financial Information |
A. Consolidated Statements and Other Financial Information
Consolidated financial statements are included in Item 18. “Financial Statements” commencing on page F-1.
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Legal proceedings
From time to time we could be involved in legal proceedings that arise in the ordinary course of business. As at June 30, 2025, we believe no proceedings exists of which the outcome, if determined adversely, would have a material adverse effect on our financial position. During the period covered by the audited and approved financial statements contained herein, we have not been a party to or paid any damages in connection with litigation that has had a material adverse effect on our financial position. Any future litigation may result in substantial costs and be a distraction to management and employees. No assurance can be given that future litigation will not have a material adverse effect on our financial position. Refer to Item 3.D: “Risk factors.”
Dividends
There were no dividends paid, recommended or declared during fiscal years 2025, 2024 or 2023.
B. Significant Changes
On October 15, 2024, Kazia announced that it planned to effect an ADS ratio change to change the ratio of ADSs to ordinary shares from one ADS to ten ordinary shares to the new ratio of one ADS to one hundred ordinary shares. The ADS ratio change will have the same effect as a one-for-ten reverse ADS split for Kazia’s ADS holders. There will be no change to Kazia’s underlying ordinary shares, and no ordinary shares will be issued or cancelled in connection with the ADS ratio change. The ADS ratio change became effective on October 28, 2024.
On 1 April 2025, Kazia announced that it planned to affect an ADS ratio change to change the ratio of ADSs to ordinary shares from one ADS to one hundred ordinary shares to the new ratio of one ADS to five hundred ordinary shares. The ADS ratio change will have the same effect as a one-for-five reverse ADS split for Kazia’s ADS holders. There will be no change to Kazia’s underlying ordinary shares, and no ordinary shares will be issued or cancelled in connection with the ADS ratio change. The ADS ratio change became effective on 17 April 2025.
| Item 9. | The Offer and Listing |
A. Offer and listing details
See Item 9C for more information.
B. Plan of Distribution
Not applicable.
C. Markets
Kazia’s ordinary shares trade in the U.S. in the form of ADSs on the Nasdaq Capital Market. Each ADS represents 500 ordinary shares of Kazia. The trading symbol on the Nasdaq Capital Market is ‘KZIA’. Kazia has entered into a Deposit Agreement with The Bank of New York Mellon under which the Bank of New York, acting as depository, issues the ADSs.
D. Selling Shareholders
Not applicable.
E. Dilution
Not applicable.
F. Expenses of the issue
Not applicable.
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| Item 10. | Additional Information |
A. Share Capital
Not applicable.
B. Our Constitution
Our Constitution is similar in nature to the bylaws of a U.S. corporation. It does not provide for or prescribe any specific objectives or purposes of Kazia. Our Constitution is subject to the terms of the Corporations Act. It may be amended or repealed and replaced by special resolution of shareholders, passed by at least 75% of the votes cast by shareholders entitled to vote on the resolution.
Under Australian law, a company has the legal capacity and powers of an individual both within and outside Australia. The material provisions of our Constitution are summarized below. This summary is not intended to be complete nor to constitute a definitive statement of the rights and liabilities of our shareholders, and is qualified in its entirety by reference to the complete text of our Constitution, a copy of which is incorporated by reference as Exhibit 1.1 to this Annual Report.
Interested Directors
Subject to the Corporations Act, neither a director nor that director’s alternate may vote in respect of any contract or arrangement in which the director has, directly or indirectly, any material interest according to our Constitution. However, that director may execute or otherwise act in respect of that contract or arrangement notwithstanding any material personal interest. Unless a relevant exception applies, the Corporations Act requires our directors to provide disclosure of any material personal interest, and prohibits directors from voting on matters in which they have a material personal interest or being present while such matter is being considered at the board meeting. In addition, the Corporations Act requires shareholder approval of any provision of related party benefits to our directors.
Directors compensation
Our directors are paid remuneration for their services as directors (but excluding any remuneration payable to a director under any executive services contract with us or one of our related bodies corporate) which is determined in a general meeting of shareholders. The aggregate, fixed sum for directors’ remuneration is to be divided among the directors in such proportion as the directors themselves agree and in accordance with our Constitution. The fixed sum remuneration for directors may not be increased except at a general meeting of shareholders and the particulars of the proposed increase are required to have been provided to shareholders in the notice convening the meeting. In addition, executive directors may be paid remuneration as determined by the directors from time to time and including as a salary, commission or participation in profits and/or subject to the Corporations Act by the issue of shares, options to acquire shares or performance rights or other incentives (or a combination of any of these methods of remuneration).
Fees payable to our non-executive directors must be by way of a fixed sum and not by way of a commission on or a percentage of profits. Remuneration paid to our executive directors must also not include a commission or percentage of operating revenue.
Pursuant to our Constitution, if, at our board’s request, any director performs extra services or makes special exertions, Kazia may remunerate that director by paying for those services and exertions.
In addition to other remuneration provided in our Constitution, all of our directors are entitled to be paid by us for all other travelling, accommodation and other expenses incurred by the directors in attending and returning from general meetings, board meetings, committee meetings or otherwise in connection with our business.
Borrowing powers exercisable by Directors
Our board of directors has the power to raise or borrow money or obtain other financial accommodation for Company purposes, and may grant security for the repayment of that sum or sums or the payment, performance or fulfilment of any debts, liabilities, contracts or obligations incurred or undertaken by the Company in any manner and on any terms and conditions as our board thinks fit.
Retirement of Directors
Pursuant to our Constitution, at least one director, other than the Managing Director, must retire from office at every annual general meeting unless there has been an election of directors earlier that year. A director, other than the director who is the Managing Director, must retire from office at the conclusion of three years or following the third annual general meeting after which the director was elected, whichever is longer. If no director is required to retire at an annual general meeting, then the director to retire will be the director who has been longest in office since last being elected. Retired directors are eligible for a re-election to the board of directors unless disqualified from acting as a director under the Corporations Act or our Constitution.
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Rights and restrictions on classes of shares
The rights attaching to our ordinary shares are detailed in our Constitution. Our Constitution provides that our directors may issue shares with any preferential, deferred or special rights, privileges or conditions or with any restriction (whether in relation to dividends, voting, return of share capital or otherwise) as our board of directors may determine. Subject to any approval which is required from our shareholders under the Corporations Act, we may issue further shares on such terms and conditions as our board of directors resolves.
Dividend rights
Subject to our Constitution and the Corporations Act, our board of directors may from time to time determine to pay and declare dividends to shareholders. Except as otherwise provided by law, all dividends unclaimed for one year after having been declared may be invested or otherwise made use of by our board of directors for our benefit until claimed or otherwise disposed of in accordance with our Constitution.
Voting rights
Under our Constitution, the rights and restrictions attaching to a class of shares, each shareholder has one vote on a show of hands at a meeting of the shareholders unless a poll is demanded under the Constitution or the Corporations Act. On a poll vote, each shareholder shall have one vote for each fully paid share and a fractional vote for each share held by that shareholder that is not fully paid, such fraction being equivalent to the proportion of the amount that has been paid to such date on that share. Shareholders may vote in person or by proxy, attorney or representative. Under Australian law, shareholders of a public company are generally not permitted to approve corporate matters by written consent. Our Constitution does not provide for cumulative voting. Note that ADS holders may not directly vote at a meeting of the shareholders but may instruct the depository to vote the number of deposited ordinary shares their ADSs represent in accordance with the underlying deposit agreement.
Right to share in our profits
Pursuant to our Constitution, our shareholders are entitled to participate in our profits by payment of dividends. Our board of directors may from time to time determine to pay dividends to the shareholders; however, no dividend is payable except in accordance with the Corporations Act and our Constitution.
Rights to share in the surplus in the event of winding up
Our Constitution provides for the right of shareholders to participate in a surplus in the event of our winding up, subject to the rights attaching to a class of shares, the Constitution, and the Corporations Act.
No redemption provision for ordinary shares
There are no redemption provisions in our Constitution in relation to ordinary shares. Under our Constitution, any preference shares may be issued on the terms that they are, or may at the option of Kazia or the holder be, liable to be redeemed or converted into ordinary shares.
Variation or cancellation of share rights
Subject to the Corporations Act and the terms of issue of shares of that class, the rights attached to shares in a class of shares may only be varied or cancelled by either:
| • | a special resolution passed at a meeting of members holding shares in that class; or |
| • | the written consent of members with at least 75% of the shares in that class. |
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Directors may make calls
Our Constitution provides that our directors may make calls on a shareholder for all monies unpaid on shares held by that shareholder, other than monies payable at fixed times under the conditions of allotment.
General Meetings of Shareholders
General meetings of shareholders may be called by our board of directors. Except as permitted under the Corporations Act, shareholders may not convene a meeting. The Corporations Act requires the directors to call and arrange to hold a general meeting on the request of shareholders with at least 5% of the votes that may be cast at a general meeting. Notice of the proposed meeting of our shareholders is required at least 21 days prior to such meeting under the Corporations Act.
Foreign Ownership Regulation
Our Constitution does not impose specific limitations on the rights of non-residents to own securities. However, acquisitions and proposed acquisitions of securities in Australian companies may be subject to review and approval by the Australian Federal Treasurer under the Foreign Acquisitions and Takeovers Act 1975 (Cth) (the “Foreign Takeovers Act”), which generally applies to acquisitions or proposed acquisitions:
| • | by a foreign person (as defined in the Foreign Takeovers Act) or associated foreign persons that would result in such persons having an interest in 20% or more of the issued shares of, or control of 20% or more of the voting power in, an Australian company; and |
| • | by non-associated foreign persons that would result in such foreign persons having an aggregate interest in 40% or more of the issued shares of, or control of 40% or more of the voting power in, an Australian company, where the Australian company is valued above the monetary threshold prescribed by Foreign Takeovers Act. |
However, in general terms, any such review or approval under the Foreign Takeovers Act will only be required if the foreign acquirer is a U.S. entity or an entity from certain other countries and the value of the total assets of the Australian company or the value of the total issued securities of the Australian company is more than A$1,464 million, unless that company operates in certain sensitive industries. Exemptions do not generally apply to investments (regardless of the monetary value) by foreign persons if the Australian company is a national security business or investments in any such company by foreign governments and their associated entities.
The Australian Federal Treasurer may prevent a proposed acquisition in the above categories or impose conditions on such acquisition if the Treasurer is satisfied that the acquisition would be contrary to Australia’s national interest or national security. If a foreign person acquires shares, assets or an interest in shares or assets in an Australian company in contravention of the Foreign Takeovers Act, the Australian Federal Treasurer may make a range of orders including an order the divestiture of such person’s shares or interest in shares in that Australian company. Further, breaches of the Foreign Takeovers Act may result in significant fines or court ordered civil and criminal penalties, including imprisonment and substantial monetary penalties.
Ownership Threshold
There are no specific provisions in our Constitution that require a shareholder to disclose ownership above a certain threshold. As we are also a U.S. public company, our shareholders are subject to disclosure requirements under U.S. securities laws.
Issues of Shares and Change in Capital
Subject to our Constitution, the Corporations Act and any other applicable law, we may at any time issue shares and give any person a call or option over any shares on any terms, with preferential, deferred or special rights, privileges or conditions or with any restrictions and for the consideration and other terms that the directors determine.
Subject to the requirements of our Constitution, the Corporations Act and any other applicable law, including relevant shareholder approvals, we may consolidate or divide our share capital into a larger or smaller number by resolution, reduce our share capital in any manner (provided that the reduction is fair and reasonable to our shareholders as a whole, does not materially prejudice our ability to pay creditors and obtains the necessary shareholder approval) or buy back our ordinary shares whether under an equal access buy-back or on a selective basis.
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Change of Control
Takeovers of Australian public companies, such as Kazia, are regulated by the Corporations Act, which prohibits the acquisition of a “relevant interest” in issued voting shares in a listed company if the acquisition will lead to that person’s or someone else’s “voting power” (being the person’s relevant interests plus those of its associates) in Kazia’s issued shares increasing from 20% or below to more than 20% or increasing from a starting point that is above 20% and below 90% (“Takeovers Prohibition”), subject to a range of exceptions.
Generally, a person will have a relevant interest in securities if the person:
| • | is the holder of the securities or the holder of an ADS over the shares; |
| • | has power to exercise, or control the exercise of, a right to vote attached to the securities; or |
| • | has the power to dispose of, or control the exercise of a power to dispose of, the securities, including any indirect or direct power or control. |
If, at a particular time:
| • | a person has a relevant interest in issued securities; and |
| • | the person has: |
| • | entered or enters into an agreement with another person with respect to the securities; |
| • | given or gives another person an enforceable right, or has been or is given an enforceable right by another person, in relation to the securities (whether the right is enforceable presently or in the future and whether or not on the fulfillment of a condition); or |
| • | granted or grants an option to, or has been or is granted an option by, another person with respect to the securities; and |
| • | the other person would have a relevant interest in the securities if the agreement were performed, the right enforced or the option exercised. |
then the other person is taken to already have a relevant interest in the securities.
There are a number of exceptions to the Takeovers Prohibition on acquiring a relevant interest in issued voting shares above 20%. In general terms, some of the more significant exceptions include:
| • | when the acquisition results from the acceptance of an offer under a formal takeover bid; |
| • | when the acquisition has been previously approved by shareholders of Kazia by resolution passed at general meeting; |
| • | an acquisition by a person if, throughout the six months before the acquisition, that person or any other person has had voting power in Kazia of at least 19% and, as a result of the acquisition, none of the relevant persons would have voting power in Kazia more than three percentage points higher than they had six months before the acquisition; |
| • | when the acquisition results from the issue of securities under a pro rata rights issue; |
| • | when the acquisition results from the issue of securities under a dividend reinvestment scheme or bonus share plan; |
| • | when the acquisition results from the issue of securities under certain underwriting arrangements; |
| • | when the acquisition results from the issue of securities through a will or through operation of law; |
| • | an acquisition that arises through the acquisition of a relevant interest in another listed company which is listed on a prescribed financial market or a foreign market approved by the Australian Securities and Investments Commission (“ASIC”); or |
| • | an acquisition arising through a compromise, arrangement, liquidation or buy-back. |
Breaches of the takeovers provisions of the Corporations Act are criminal offenses. ASIC and the Australian Takeover Panel have a wide range of powers relating to breaches of takeover provisions or other circumstances deemed to be unacceptable (whether or not they involve a breach of the takeover provisions), including the ability to make orders canceling contracts, freezing transfers of, and rights attached to, securities, and forcing a party to dispose of securities. There are certain defenses to breaches of the takeover provisions provided in the Corporations Act.
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Access to and Inspection of Documents
Inspection of our records is governed by the Corporations Act. Any member of the public has the right to inspect or obtain copies of our registers on the payment of a prescribed fee. Shareholders are not required to pay a fee for inspection of our registers or minute books of the meetings of shareholders. Other corporate records, including minutes of directors’ meetings, financial records and other documents, are not open for inspection by shareholders or any member of the public. However, where a shareholder is acting in good faith and an inspection is deemed to be made for a proper purpose, a shareholder may apply to the court to make an order for inspection of our books.
C. Material contracts
License Agreement with Genentech Inc.
In October 2016, the Company entered into a worldwide licensing agreement with Genentech, a member of the Roche Group, to develop and commercialize GDC-0084, a small molecule inhibitor of the phosphoinositide-3-kinase (PI3K) pathway. Under the terms of the agreement, the Company paid Genentech an upfront payment of US$5 million. In addition, the terms of the agreement call for performance-related consideration linked to regulatory and commercial outcomes and royalty payments in-line with industry benchmarks.
Acquisition of Glioblast Pty Ltd-Share Sale Agreement with Kilinwata Investments Pty. Ltd., Mi Ok Chong and Paul Hopper
In October 2016, the Company acquired 100% of the issued shares of Glioblast Pty Ltd, a privately-held, neuro-oncology-focused Australian biotechnology company. The transaction included an upfront payment of A$2.1 million, comprising A$600,000 in cash and ordinary fully-paid shares valued at A$1.5 million, with the actual number of shares determined on the basis of the volume-weighted average price of the Company’s shares on the ASX in the seven days prior to this announcement. The shareholders of Glioblast will be eligible for further payments in cash or equity on the achievement of performance related milestones. The first two of these milestones provide for the issue of ordinary fully-paid shares valued at A$1.25 million respectively on commencement and successful completion of a phase II clinical trial of GDC-0084, with the actual number of shares determined on the basis of the volume-weighted average price of the Company’s shares on the ASX in the seven days prior to satisfaction of the relevant milestone being announced. A further two milestones may trigger payments in cash or equity at the Company’s sole discretion. Any issue of equity in the Company will be subject to a minimum six-month escrow period.
At the date of this report, one milestone has lapsed and two have been settled in shares. The remaining milestone relates to the successful completion of a phase II trial in GDC-0084.
Clinical Trial Collaboration and Supply Agreement with the Global Coalition for Adaptive Research
In October 2020, the Company entered into a Clinical Trial Collaboration and Supply Agreement with the Global Coalition for Adaptive Research (GCAR), a US-based 501(C)(3) non-profit organisation. The agreement relates to the inclusion of Kazia’s investigational new drug, Paxalisib (GDC-0084) in a phase II/III adaptive clinical trial known as GBM AGILE (NCT03970447), which is expected to serve as the pivotal study for registration of Paxalisib in glioblastoma by the US Food and Drug Administration (FDA). Under the terms of the agreement, the Company paid GCAR an upfront payment of US$5 million on execution, and will make further payments to GCAR throughout the course of the study, as defined milestones are met, with the total cost of the study capped at a pre-defined amount under the terms of the agreement. GCAR will serve as the sponsor of GBM AGILE and the company will supply investigational product for conduct of the study at its sole expense. It is expected that Paxalisib’s participation in GBM AGILE will be approximately three to four years in duration.
On 1 August 2022, the Consolidated Entity announced that it had been informed by GCAR that the Paxalisib arm had not graduated to the second stage of the GBM AGILE study, and that recruitment had therefore completed with approximately 150 patients enrolled to the first stage. Those patients remain ongoing, with initial data obtained in 1H CY2024. The interim ‘graduation’ analysis may have been affected by the rapid and back-loaded recruitment profile of the study and does not preclude a positive outcome in the final data.
License Agreement with Vivesto AB (formerly Oasmia Pharmaceutical AB)
In March 2021, the Company entered into an exclusive worldwide license agreement with Vivesto AB, (formerly Oasmia Pharmaceutical AB), an innovation-focused specialty pharmaceutical company, for Cantrixil (TRX-E-002-1), a clinical-stage, first-in-class drug candidate under development for the treatment of ovarian cancer. Under the terms of the agreement, Vivesto assumed worldwide exclusive rights to develop and commercialize Cantrixil for all indications, with an initial focus on ovarian cancer. During fiscal 2021, Vivesto made an up-front payment of US$4 million, with contingent milestones of up to US$42 million and double-digit royalties on commercial sales.
In March, 2025 the Company sold all intellectual property and trademarks rights to Cantrixil for USD $1 million, ending the March 2021 license agreement.
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License Agreement with Simcere Pharmaceutical Group Ltd
In March 2021, the Company entered into a licensing agreement with Simcere Pharmaceutical Group Ltd (“Simcere”) to develop and commercialize the Company’s investigational new drug, Paxalisib, in Greater China. Under the terms of the agreement, Simcere assumed responsibility for the development, registration and commercialization of Paxalisib in Greater China (a territory which includes Mainland China, Hong Kong, Macau and Taiwan). The Company received an upfront payment of US$11 million comprising US$7 million in cash and a US$4 million equity investment, priced at a 20% premium to recent trading. The Company will also receive contingent milestone payments of up to US$281 million for glioblastoma, with further milestones payable for indications beyond glioblastoma. Simcere will additionally pay mid-teen percentage royalties on commercial sales.
License Agreement with Evotec SE
In April 2021, the Company entered into a worldwide exclusive licensing agreement with Evotec SE, a leading European drug discovery and development company, for EVT801, a small-molecule, first-in-class oncology drug candidate. Under the terms of the agreement, Evotec has granted Kazia an exclusive license to develop, manufacture, and commercialize EVT801 in all territories and indications. The Company paid an up-front amount of €1 million (approximately A$1.6 million). In addition, the terms of the agreement call for performance-related consideration linked to regulatory and commercial outcomes up to a maximum of €308 million (approximately A$480 million) and tiered single-digit royalty payments.
License Agreement with Sovargen Co. Ltd
On 21 March 2024, the Company announced that it has entered into an exclusive licensing agreement with Sovargen Co., Ltd, a biotechnology company specializing in central nervous system (CNS) diseases, to develop, manufacture and commercialize Paxalisib as a potential treatment of intractable epilepsy in focal cortical dysplasia type 2 (FCD T2) and tuberous sclerosis complex (TSC) disease. Under the agreement, Kazia received an upfront payment of US$1.5 million, potential milestone payments of up to US$19 million upon the achievement of development and regulatory milestones, and a percentage of sub-licensing revenues and royalties on net sales of products incorporating Paxalisib. The licensing agreement includes all countries worldwide, excluding mainland China, Hong Kong, Macao and Taiwan.
License Agreements with QIMR Berghofer Medical Research Institute
On 12 September, 2024, the Company announced that an agreement has been executed with QIMR to obtain an exclusive license to certain intellectual property rights in relation to combination therapies consisting of PI3K inhibitor drugs, and one or more immunotherapy or PARP inhibitor drugs (PI3K combination). Under the license agreement, Kazia receives an exclusive, worldwide, sub-licensable and royalty-bearing licence to certain intellectual property for the development of any drugs or product candidates within the PI3K inhibitor class in combination with immunotherapy or PARP inhibitors. Paxalisib, Kazia’s lead product candidate, is a member of the PI3K inhibitor class. The exclusive license agreement follows a collaboration between Kazia and QIMR Berghofer which began in December 2022 and has already led to the filing of supportive patents which include the use of paxalisib as an immune modulator in the treatment of diseases such as breast cancer. The terms of the license include standard provisions for an upfront license fee and development milestones related to the initiation of Phase 1, Phase 2 trial, first Phase 3 trial, first product approval.
On October 7, 2025, the Company announced an exclusive collaboration and in-licensing agreement with QIMR for a first-in-class PD-L1 degrader program. The lead optimized compound, NDL2, is an advanced PD-L1 protein degrader currently in development and represents a new and innovative frontier of cancer immunotherapy. The program will initially target advanced breast cancer and non-small cell lung cancer (NSCLC), where PD-1/PD-L1 immunotherapies are widely used but resistance remains common. IND-enabling studies are expected to commence within six months, with a goal of initiating first-in-human studies within approximately 15 months. Kazia also intends to explore synergistic opportunities to combine NDL2 with its existing pipeline assets, including paxalisib (a pan-PI3K/mTOR inhibitor) and EVT801 (a selective VEGFR3 inhibitor), given their complementary mechanisms of action in modulating the tumor microenvironment. Under the terms of this agreement, Kazia agreed to make a one-time payment of approximately $1.39 million 15 business days after signing,and is responsible for all development costs. Kazia will receive a percentage of commercialization revenue ranging from mid-to-high double digits depending on the stage of development, which includes any out-licensing payments received from third parties.
D. Exchange controls
Australia has largely abolished exchange controls on investment transactions. The Australian dollar is freely convertible into U.S. dollars. In addition, (other than as specified under “taxation” below and certain restrictions imposed under Australian law in relation to dealings with the assets of and transactions with, designated countries, entities and persons specified by the Australian Government Department of Foreign Affairs and Trade from time to time, including, persons connected with terrorism) there are currently no specific rules or limitations regarding the export from Australia of profits, dividends, capital, or similar funds belonging to foreign investors, except that certain payments to non-residents must be reported to the Australian Transaction Reports and Analysis Centre, which monitors such transactions.
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The circumstances in which review and approval by the Australian Federal Treasurer may be required under the Foreign Takeovers Act are summarized above under section B entitled “Foreign Ownership Regulation” in this Annual Report on Form 20-F.
E. Taxation
U.S. Taxation
This section describes certain material U.S. federal income tax consequences to a U.S. holder (as defined below) of owning ordinary shares or ADSs. It applies only to ordinary shares or ADSs that are held as capital assets for tax purposes. This section does not apply to a holder of ordinary shares or ADSs that is a member of a class of holders subject to special rules, including a financial institution, a dealer or trader in securities, a regulated investment company, a real estate investment trust, a grantor trust, a U.S. expatriate, a tax-exempt organization, an insurance company, a person liable for alternative minimum tax, a person who actually or constructively owns 10% or more of the stock of the Company, a person that holds ordinary shares or ADSs as part of a straddle or a hedging or conversion transaction, a person that purchases or sells ordinary shares or ADSs as part of a wash sale for tax purposes, or a person whose functional currency is not the U.S. dollar. Further, this description does not address state, local, non-U.S, or other tax laws, nor does it address the 3.8% U.S. federal Medicare tax on net investment income, the alternative minimum tax or the U.S. federal gift and estate tax consequences of owning and disposing of ordinary shares or ADSs.
For purposes of this description, a “U.S. holder” is a beneficial owner of ordinary shares or ADSs who holds such ordinary shares or ADSs as capital assets within the meaning of the Internal Revenue Code of 1986, as amended, and is, for U.S. federal income tax purposes: (i) an individual citizen or resident of the United States; (ii) a corporation created or organized in or under the laws of the United States or any state thereof, including the District of Columbia; (iii) an estate the income of which is subject to U.S. federal income taxation regardless of its source; or (iv) a trust that either (a) is subject to the supervision of a court within the United States and has one or more U.S. persons with authority to control all substantial decisions or (b) has a valid election in effect under applicable Treasury Regulations to be treated as a U.S. person.
If a partnership holds the ordinary shares or ADSs, the U.S. federal income tax treatment of a partner generally will depend on the status of the partner and the tax treatment of the partnership. A partner in a partnership holding the ordinary shares or ADSs should consult its tax advisor with regard to the U.S. federal income tax treatment of an investment in the ordinary shares or ADSs.
The discussion is based on the Internal Revenue Code of 1986, as amended, administrative pronouncements, judicial decisions, and final, temporary and proposed Treasury Regulations, all as of the date hereof, changes to any of which may affect the tax consequences described herein - possibly with retroactive effect. There can be no assurances that the Internal Revenue Service (the “IRS”) will not take a contrary or different position concerning the tax consequences of the ownership and disposition of our ordinary shares or ADSs or that such a position would not be sustained by a court. We have not obtained, nor do we intend to obtain, a ruling with respect to the U.S. federal income tax considerations relating to the purchase, ownership or disposition of our ordinary shares or ADSs. Holders should consult their tax advisers concerning the U.S. federal, state, local and non-U.S. tax consequences of owning and disposing of our ordinary shares or ADSs in their particular circumstances.
This section is in part based on the representations of the Depositary and the assumption that each obligation in the deposit agreement and any related agreement will be performed in accordance with its terms. In general, for U.S. federal income tax purposes, a holder of ADSs will be treated as the owner of the ordinary shares represented by those ADSs. Exchanges of ordinary shares for ADSs, and ADSs for ordinary shares generally will not be subject to U.S. federal income tax.
Distributions
Subject to the Passive Foreign Investment Company (“PFIC”) rules discussed below, U.S. holders generally will include as dividend income the U.S. dollar value of the gross amount of any distributions of cash or property (without deduction for any withholding tax), other than certain pro rata distributions of ordinary shares, with respect to ordinary shares or ADSs to the extent the distributions are made from our current or accumulated earnings and profits, as determined for U.S. federal income tax purposes. A U.S. holder will include the dividend income on the day actually or constructively received (i) by the holder, in the case of ordinary shares, or (ii) by the depositary, in the case of ADSs. We do not intend to maintain calculations of earnings and profits, as determined for U.S. federal income tax purposes. Consequently, any distributions generally will be treated as dividend income.
Dividends paid to a non-corporate U.S. holder on shares or ADSs will generally be taxable at the preferential rates applicable to long-term capital gains provided that (a) certain holding period requirements are satisfied, (b) (i) the U.S.-Australia income tax treaty (“the Treaty”) is a qualified treaty and we are eligible for benefits under the Treaty or (ii) our ordinary shares or ADSs are readily tradable on a U.S. securities market, and (c) we were not, in the taxable year prior to the year in which the dividend was paid, and are not, in the taxable year in which the dividend is paid, a PFIC. The Treaty has been approved for the purposes of the qualified dividend rules and the ADSs are listed on Nasdaq. If the Company is a PFIC, any dividends paid to a noncorporate U.S. holder will not qualify for the preferential tax rates ordinarily applicable to “qualified dividends.” In the case of a corporate U.S. holder, dividends on shares and ADSs are taxed as ordinary income and will not be eligible for the dividends received deduction generally allowed to U.S. corporations in respect of dividends received from other U.S. corporations.
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The amount of any cash distribution paid in any foreign currency will be equal to the U.S. dollar value of such currency, calculated by reference to the spot rate in effect on the date such distribution is received by the U.S. holder or, in the case of ADSs, by the Depository, regardless of whether and when the foreign currency is in fact converted into U.S. dollars. If the foreign currency is converted into U.S. dollars on the date received, the U.S. holder generally should not recognize foreign currency gain or loss on such conversion. If the foreign currency is not converted into U.S. dollars on the date received, the U.S. holder will have a basis in the foreign currency equal to its U.S. dollar value on the date received, and generally will recognize foreign currency gain or loss on a subsequent conversion or other disposal of such currency. Such foreign currency gain or loss generally will be treated as U.S. source ordinary income or loss for foreign tax credit limitation purposes.
Dividends will be income from sources outside the United States, and generally will be “passive category” income or, for certain taxpayers, “general category” income, which are treated separately from each other for the purpose of computing the foreign tax credit allowable to a U.S. holder. The availability of the foreign tax credit and the application of the limitations on its availability are fact specific and are subject to complex rules. In general, a taxpayer’s ability to use foreign tax credits may be limited and is dependent on the particular circumstances. U.S. holders should consult their own tax advisors with respect to these matters.
Sale, Exchange or other Disposition of Ordinary Shares or ADSs
Subject to the PFIC rules discussed below, a U.S. holder who sells or otherwise disposes of ordinary shares or ADSs will recognize a capital gain or loss for U.S. federal income tax purposes equal to the difference between the U.S. dollar value of the amount realized and the holder’s tax basis, determined in U.S. dollars, in those ordinary shares or ADSs. The gain or loss will generally be income or loss from sources within the United States for foreign tax credit limitation purposes. The capital gain of a non-corporate U.S. holder is generally taxed at preferential rates where the holder has a holding period greater than 12 months in the shares or ADSs sold. There are limitations on the deductibility of capital losses.
The U.S. dollar value of any foreign currency received upon a sale or other disposition of ordinary shares or ADSs will be calculated by reference to the spot rate in effect on the date of sale or other disposal (or, in the case of a cash basis or electing accrual basis taxpayer, at the spot rate of exchange on the settlement date). A U.S. holder will have a tax basis in the foreign currency received equal to that U.S. dollar amount, and generally will recognize foreign currency gain or loss on a subsequent conversion or other disposal of the foreign currency. This foreign currency gain or loss generally will be treated as U.S. source ordinary income or loss for foreign tax credit limitation purposes. If such foreign currency is converted into U.S. dollars on the date received by the U.S. holder, a cash basis or electing accrual basis U.S. holder should not recognize any gain or loss on such conversion.
Passive Foreign Investment Company
A non-U.S. corporation will be a PFIC for U.S. federal income tax purposes for any taxable year if either:
| • | 75% or more of its gross income for such year is “passive income” which for this purpose generally includes dividends, interest, royalties, rents and gains from commodities and securities transactions and gains from assets that produce passive income; or |
| • | 50% or more of the value of its gross assets (based on an average of the quarterly values of the gross assets) during such year is attributable to assets that produce passive income or are held for the production of passive income. |
Passive income does not include rents and royalties derived from the active conduct of a trade or business. If the stock of a non-U.S. corporation is publicly traded for the taxable year, the asset test is applied using the fair market value of the assets for purposes of measuring such corporation’s assets. If we own at least 25% (by value) of the stock of another corporation, we will be treated, for purposes of the PFIC tests, as owning our proportionate share of the other corporation’s assets and receiving our proportionate share of the other corporation’s income for purposes of the PFIC income and asset tests. If the stock of a non-U.S. corporation is publicly-traded for the taxable year, the asset test is applied using the fair market value of the assets for purposes of measuring such corporation’s assets. If we were a PFIC in any year during a U.S. holder’s holding period for our ordinary shares or ADSs, we would ordinarily continue to be treated as a PFIC for each subsequent year during which the U.S. holder owned the ordinary shares or ADSs, regardless of whether we continue to meet the tests described above unless (a) we ceased to be a PFIC and (b) the U.S. holder has made a deemed sale election under the PFIC rules which may result in recognition of gain (but not loss), taxable under the PFIC rules described below, without the receipt of any corresponding cash. Based on the composition of our assets and income, we believe that we were not a PFIC for U.S. federal income tax purposes with respect to our 2024 taxable year or our 2025 taxable year. However, the determination of PFIC status is a fact-intensive determination that must be made annually at the close of each taxable year applying principles and methodologies that in some circumstances are unclear and subject to varying interpretation. As a result, even if we will not be treated as a PFIC in the 2024 taxable year or the 2025 taxable year there can be no assurance that we will not be treated as a PFIC for the current or any future taxable year. Changes in the nature of our income or assets or a decrease in the trading price of our ordinary shares or ADSs may cause us to be considered a PFIC in the current or any subsequent taxable year.
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If we are a PFIC, and you are a U.S. holder, then unless you make one of the elections described below, a special tax regime will apply to both (a) any “excess distribution” by us to you (generally, your ratable portion of distributions in any year which are greater than 125% of the average annual distribution received by you in the shorter of the three preceding years or your holding period for our ordinary shares) and (b) any gain realized on the sale or other disposition of the ordinary shares. Under this regime, any excess distribution and realized gain will be treated as ordinary income and will be subject to tax as if (a) the excess distribution or gain had been realized ratably over your holding period, (b) the amount deemed realized in each year had been subject to tax in each year of that holding period at the highest marginal rate for such year (other than income allocated to the current period or any taxable period before we became a PFIC, which would be subject to tax at the U.S. holder’s regular ordinary income rate for the current year and would not be subject to the interest charge discussed below), and (c) the interest charge generally applicable to underpayments of tax had been imposed on the taxes deemed to have been payable in those years. In addition, dividend distributions made to you will not qualify for the lower rates of taxation applicable to long-term capital gains discussed above under “Distributions.”
Certain elections may potentially be used to reduce the adverse impact of the PFIC rules on U.S. holders (“qualifying electing fund”, or QEF) , and “mark-to-market” elections), but these elections may accelerate the recognition of taxable income and may result in the recognition of ordinary income.
The rules described above for excess distributions would not apply to a U.S. holder if the U.S. holder makes a timely QEF election for the first taxable year of the U.S. holding period for ordinary shares and we comply with specified reporting requirements. A timely QEF election for a taxable year generally must be made on or before the due date (as may be extended) for filing the taxpayer’s U.S. federal income tax return for the year. A U.S. holder who makes a QEF election generally must report on a current year basis a pro rata share of our ordinary earnings and net capital gain for any taxable year in which we are a PFIC, whether or not those earnings or gains are distributed. A U.S. holder who makes a QEF election must file a Form 8621 with its annual income tax return. If we determine we are a PFIC for any taxable year, we intend to make available an information statement that will contain the necessary information required for a U.S. holder to make a QEF election with respect to our ordinary shares. We may choose to provide such information on our website.
If a U.S. holder does not make a QEF election for the first taxable year of the U.S. holder’s holding period for ordinary shares during which we are a PFIC, the QEF election will not be treated as timely and the adverse tax regime described above would apply to dispositions of or excess distributions on the ordinary shares. In such case, a U.S. holder may make a deemed sale election whereby the U.S. holder would be treated as if the U.S. holder had sold the ordinary shares in a fully taxable sale at fair market value on the first day of such taxable year in which the QEF election takes effect. Such U.S. holder would be required to recognize any gain on the deemed sale as an excess distribution and pay any tax and interest due on the excess distribution when making the deemed sale election. The effect of such further election would be to restart the U.S. holder’s holding period in the ordinary shares, subject to the QEF regime, and to purge the PFIC status of such ordinary shares going forward.
If a U.S. holder makes the mark-to-market election with respect to ordinary shares, the U.S. holder generally will recognize as ordinary income any excess of the fair market value of the ordinary shares at the end of each taxable year over their adjusted tax basis, and will recognize an ordinary loss in respect of any excess of the adjusted tax basis of the ordinary shares over their fair market value at the end of the taxable year (but only to the extent of the net amount of income previously included as a result of the mark-to-market election). If a U.S. holder makes the election, the U.S. holder’s tax basis in the ordinary shares will be adjusted to reflect these income or loss amounts. Any gain recognized on the sale or other disposition of ordinary shares in a year when we are a PFIC will be treated as ordinary income and any loss will be treated as an ordinary loss (but only to the extent of the net amount of income previously included as a result of the mark-to-market election). The mark-to-market election is available only if we are a PFIC and our ordinary shares are “regularly traded” on a “qualified exchange”. Our ordinary shares will be treated as “regularly traded” in any calendar year in which more than a de minimis quantity of the ordinary shares are traded on a qualified exchange on at least 15 days during each calendar quarter (subject to the rule that trades that have as one of their principle purposes the meeting of the trading requirement as disregarded). The Nasdaq is a qualified exchange for this purpose and consequently, if the ordinary shares are regularly traded, the mark-to-market election should be available to a U.S. holder.
U.S. holders should consult their tax advisors to determine whether any of these elections would be available and if so, what the consequences of the alternative treatments would be in their particular circumstances.
If we are a PFIC, the general tax treatment for U.S. holders described in this section would apply to indirect distributions and gains deemed to be realized by U.S. holders in respect of any of our subsidiaries that also may be determined to be PFICs.
If a U.S. holder owns ordinary shares during any year in which we are a PFIC and the U.S. holder recognizes gain on a disposition of our ordinary shares or receives distributions with respect to our ordinary shares, the U.S. Holder generally will be required to file an IRS Form 8621 (Information Return by a Shareholder of a Passive Foreign Investment Company or Qualified Electing Fund) with respect to the company, generally with the U.S. holder’s federal income tax return for that year. If our company were a PFIC for a given taxable year, then you should consult your tax advisor concerning your annual filing requirements.
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The U.S. federal income tax rules relating to PFICs are complex. Prospective U.S. investors are urged to consult their tax advisers with respect to the ownership and disposition of our ordinary shares or ADSs, the consequences to them of an investment in a PFIC, any elections available with respect to our ordinary shares and the IRS information reporting obligations with respect to the ownership and disposition of our ordinary shares or ADSs.
U.S. Information Reporting and Back-up Withholding
Dividend payments with respect to our ordinary shares or ADSs and proceeds from the sale or other disposition of our ordinary shares or ADSs may be subject to information reporting to the IRS and possible U.S. backup withholding. Back-up withholding will not apply, however, to a U.S. holder who furnishes a correct taxpayer identification number and makes any other required certification or who is otherwise exempt from back-up withholding. U.S. holders who are required to establish their exempt status may be required to provide such certification on Internal Revenue Service (“IRS”) Form W-9. U.S. holders should consult their tax advisors regarding the application of the U.S. information reporting and back-up withholding rules.
Back-up withholding is not an additional tax. Amounts withheld as back-up withholding may be credited against a U.S. holder’s U.S. federal income tax liability, and such holder may obtain a refund of any excess amounts withheld under the back-up withholding rules by timely filing the appropriate claim for refund with the IRS and furnishing any required information.
Information With Respect to Foreign Financial Assets
Certain U.S. holders that own “specified foreign financial assets” with an aggregate value in excess of $50,000 are generally required to file an information statement along with their U.S. federal tax returns, currently on IRS Form 8938, with respect to such assets. “Specified foreign financial assets” include any financial accounts held at a non-U.S. financial institution, as well as securities issued by a non-U.S. issuer that are not held in accounts maintained by financial institutions. If a U.S. holder does not include in such holder’s gross income an amount relating to one or more specified foreign financial assets, and the amount such U.S. holder omits is more than $5,000, any tax such U.S. holder owes for the tax year can be assessed at any time within 6 years after the filing of such U.S. holder’s federal tax return. U.S. holders who fail to report the required information could be subject to substantial penalties. U.S. holders are encouraged to consult with their own tax advisors regarding the possible application of the foregoing to our ordinary shares or ADSs in light of their particular circumstances.
Australian Tax Considerations
In this section, we discuss the material Australian income tax, stamp duty and goods and services tax considerations related to the acquisition, ownership and disposal by the absolute beneficial owners of the ordinary shares or ADSs.
It is based upon existing Australian tax law as of the date of this registration statement, which is subject to change, possibly retrospectively. This discussion does not address all aspects of Australian tax law which may be important to particular investors in light of their individual investment circumstances, such as shares held by investors subject to special tax rules (for example, financial institutions, insurance companies, superannuation funds, trusts or tax-exempt organizations). In addition, this summary does not discuss any foreign or state tax considerations, other than stamp duty.
Prospective investors are urged to consult their tax advisors regarding the Australian and foreign income and other tax considerations of the acquisition, ownership and disposition of the shares. Unless otherwise mentioned, this summary is based upon the premise that the holder is not an Australian tax resident holds their shares on capital account for Australian tax purposes, and is not carrying on business in Australia through a permanent establishment (referred to as a “Non-Australian Shareholder” in this summary).
Australian Income Tax
Nature of ADSs for Australian Taxation Purposes
Ordinary shares represented by ADSs held by a U.S. holder will be treated for Australian taxation purposes as held under a “bare trust” for such holder. Consequently, the underlying ordinary shares will be regarded as owned by the ADS holder for Australian income tax and capital gains tax purposes. Dividends paid on the underlying ordinary shares will also be treated as dividends paid to the ADS holder, as the person beneficially entitled to those dividends. Therefore, in the following analysis we discuss the tax consequences to Non-Australian Shareholders which, for Australian taxation purposes, will be the same as to U.S. holders of ADSs.
Taxation of Dividends
Australia operates a dividend imputation system under which dividends may be declared to be “franked” to the extent of tax paid on company profits. Fully franked dividends are not subject to dividend withholding tax. Dividends payable to Non-Australian Shareholders will be subject to dividend withholding tax, to the extent the dividends are not declared to be conduit foreign income, or CFI, and are unfranked. Dividend withholding tax will be imposed at 30%, unless a shareholder is a resident of a country with which
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Australia has a double taxation agreement and qualifies for the benefits of the treaty. In accordance with the provisions of the Double Taxation Convention between Australia and the United States, the maximum rate of Australian withholding tax on any unfranked portion of a dividend to which a tax resident of the United States is beneficially entitled may be reduced to 15%, with a potential further reduction to 5% where the U.S. resident beneficially entitled to the dividends is a company which holds directly 10% or more of the voting power in our company. To rely on the Double Taxation Convention a U.S. tax resident must also be a “qualified person” within the meaning of the Double Taxation Convention. Shareholders seeking to rely on the Double Taxation Convention should obtain specialist taxation advice.
Tax on Sales or other Dispositions of Shares-Capital Gains Tax
Non-Australian Shareholders may disregard the whole of the capital gain or capital loss made on a sale or other disposal of ordinary shares, unless they, together with any associates (as defined in Australian tax law), hold 10% or more of our issued capital at the time of disposal or throughout a 12 months period during the 24 months prior to disposal.
Non-Australian Shareholders who own a 10% or more interest in the company, either alone or together with their associates, should be subject to Australian capital gains tax if more than 50% of the company’s assets held directly or indirectly, determined by reference to market value of the assets at the time of sale, consists of Australian real property (which includes land and leasehold interests) or Australian mining, quarrying or prospecting rights. In the 2024-25 Federal Budget, the Australian government announced its intention to: (a) amend this point-in-time principal asset test to a 365-day testing period (i.e. the testing period being the 365 days before the time of disposal of the shares), (b) clarify and broaden the types of assets Australia can tax foreign residents on to include direct and indirect sales of assets with a close economic connection to Australian land and/or natural resources (e.g. leases or licenses to use Australian land, infrastructure and machinery installed on land situated in Australia) and (c) require foreign residents disposing of shares exceeding A$20 million in value to notify the Australian Tax Office prior to the transaction being executed, effective from 1 July 2025. However in the 2025-26 Federal Budget, it was announced that the start date would be deferred to the later of (a) 1 October 2025; and (b) the first 1 January, 1 April, 1 July or 1 October (i.e. start of the first quarter) after the legislation receives Royal Assent. No legislation has been released to date so these rule should apply from the start of the first quarter after the legislation receives Royal Assent. The Double Taxation Convention between the United States and Australia is unlikely to limit the amount of this taxable gain. Australian capital gains tax applies to net capital gains of foreign shareholders at the Australian tax rates for non-Australian residents, which start at a marginal rate of 30% for individuals & 25%-30% for companies, depending on the size of the company. Net capital gains of foreign shareholders are included in the taxpayer’s assessable income and subject to income tax at the taxpayer’s marginal tax rate. For the year ended 30 June 2025, the marginal tax rates for non-Australian residents, starts at 30% for individuals. The company tax rate is 30% which may be reduced to 25% for the year ended 30 June 2025 onwards for certain small businesses. Net capital gains are calculated by reducing the taxpayer’s capital gains for the income year by its capital losses, which may only be offset against capital gains. Net capital losses may be carried forward to offset against capital gains derived in future income years. Specific loss recoupment rules apply to companies and trusts. These rules may, among other things, limit the ability to offset or obtain capital losses in a current or future income year. Shareholders should obtain specialist tax advice as to how these rules apply.
The 50% capital gains tax discount is not available to Non-Australian Shareholders. Companies are not entitled to a capital gains tax discount.
Broadly, where there is a disposal of certain taxable Australian property, the purchaser will be required to withhold and remit to the Australian Taxation Office (“ATO”) 15% of the proceeds from the sale. A transaction is excluded from the withholding requirements in certain circumstances, including where the transaction is an on-market transaction conducted on an approved stock exchange, the transaction is in a category of certain securities lending arrangements, or the transaction is conducted using an eligible broker operated crossing system. There is also an exception to the requirement to withhold where the entity selling the shares provides the purchaser a declaration covering a certain period specifying either that they are an Australian tax resident or that the shares are not taxable Australian property (specifically, not ‘indirect Australian real property interests’). The Non-Australian Shareholder may be entitled to receive a tax credit for the tax withheld by the purchaser which they may claim in their Australian income tax return. Effective 1 January 2025, amendments to the Australian tax law under the Treasury Laws Amendment (2024 Tax and Other Measures No. 1) Act 2024 increased the withholding rate applicable to disposals of certain taxable Australian property by foreign residents from 12.5% to 15% and removed the previous $750,000 property value threshold. As a result, all acquisitions of relevant CGT assets from foreign residents on or after this date are subject to a 15% withholding obligation, unless the vendor provides a valid clearance certificate or variation notice issued by the Australian Taxation Office. These rules apply equally where the disposal is expected to generate gains on revenue account rather than a capital gain. The Group has considered the impact of these changes on its operations and concluded that no material adjustments are required to the financial statements for the year ended 30 June 2025.
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Tax on Sales or other Dispositions of Shares-Shareholders Holding Shares on Revenue Account
Some Non-Australian Shareholders may hold ordinary shares on revenue rather than on capital account for example, share traders, or those who hold their shares with a view to deriving a short term profit by selling their shares. These shareholders may have the gains made on the sale or other disposal of the ordinary shares and/or warrants included in their assessable income under the ordinary income provisions of the income tax law, if the income is derived directly or indirectly from Australian sources (which is a question of facts and circumstances generally requiring specialist tax advice).
Non-Australian Shareholders assessable under these ordinary income provisions should be subject to income tax in Australia starting at a marginal rate of 30% for individuals. The company tax rate is 30 % which may be reduced to 25% for the year ended 30 June 2025 onwards for certain small businesses. Some relief from Australian income tax may be available to Non-Australian Shareholders under the Double Taxation Convention between the United States and Australia.
To the extent an amount would be included in a Non-Australian Shareholder’s assessable income under both the capital gains tax provisions and the ordinary income provisions, the capital gain amount may be reduced, so that the shareholder may not be subject to double tax on any part of the income gain or capital gain.
Non-Australian Shareholders holding shares on revenue account should obtain advice on the application of the Australian income tax law and the Double Taxation Convention in determining the tax consequences of the disposal of their shares.
Effective 1 January 2025, the Foreign Resident Capital Gains Withholding (FRCGW) rate increased from 12.5% to 15%, and the previous property value threshold of AUD $750,000 was removed. This means all disposals of taxable Australian property by foreign residents are subject to a 15% withholding tax, regardless of value. Purchasers (or lessees in certain cases) must remit this amount to the Australian Taxation Office unless the seller provides a valid ATO clearance certificate confirming Australian tax residency or an approved variation certificate specifying a lower rate. These rules apply equally to transactions generating revenue gains rather than capital gains.
Dual Residency
If a shareholder is a resident of both Australia and the United States under those countries’ domestic taxation laws, that shareholder may be subject to tax as an Australian resident. If, however, the shareholder is determined to be a U.S. resident for the purposes of the Double Taxation Convention between the United States and Australia, the Australian tax may be subject to limitation by the Double Taxation Convention (albeit the tie-breaker rules only apply for individuals). Shareholders should obtain specialist taxation advice in these circumstances.
Stamp Duty
No Australian stamp duty is payable by Australian residents or non-Australian residents on the issue, transfer and/or surrender of the ADSs or the ordinary shares in Kazia, provided that the shares issued, transferred and/or surrendered do not result in the acquisition by any party (either alone, together with associates or with other acquirers as part of one arrangement) of a significant interest in a “landholder”. Broadly, a landholder is an entity with Australian landholdings located in an Australian state or territory over a certain value. A significant interest, with respect to a landholder that is a listed company is normally an interest of 90% or more and with respect to a landholder that is an unlisted company is normally an interest of 50% or more.
Australian Death Duty
Australia does not have estate or death duties. As a general rule, no capital gains tax liability is realized upon the inheritance of a deceased person’s shares. The disposal of inherited shares by beneficiaries may, however, give rise to a capital gains tax liability if the gain falls within the scope of Australia’s jurisdiction to tax.
Goods and Services Tax
The supply of ADSs or ordinary shares in Kazia will not be subject to Australian goods and services tax.
F. Dividends and paying agents
Not applicable.
G. Statement by experts
Not applicable.
H. Documents on Display
The Company is subject to the reporting requirements of the Exchange Act that are applicable to a foreign private issuer. Under the Exchange Act, the Company is required to file periodic reports and other information with the SEC. These materials, including this Annual Report and the exhibits hereto, may be inspected without charge and copied at established rates at the public reference facilities maintained by the SEC at 100 F Street, N.E., Washington, D.C., 20549. Please call the SEC at 1-800-SEC-0330 to obtain information on the operation of the public reference room. Such materials can also be obtained at the SEC’s website at www.sec.gov.
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I. Subsidiary Information
Not applicable.
| Item 11. | Quantitative and Qualitative Disclosures about Market Risk |
Interest rate risk
The Company’s exposure to market interest rates relates primarily to the investments of cash balances. The Company has cash reserves held in both Australian dollars and U.S. dollars, and places funds on deposit with financial institutions for periods generally not exceeding three months.
Credit risk
The Company places its deposits with high credit quality financial institutions, and, by policy, limits the amount of credit exposure to any single counterparty. The Company is averse to principal loss and ensures the safety and preservation of its invested funds by limiting default risk, market risk and reinvestment risk. The Company mitigates default risk by depositing funds with only the safest and highest credit quality financial institutions and by constantly positioning its portfolio to respond appropriately to a significant reduction in a credit rating of any financial institution.
The Company has no interest rate exposure due to rate changes for long-term debt obligations. The Company primarily enters into debt obligations to support general corporate purposes, including capital expenditures and working capital needs. The Company does not consider the effects of interest rate movements to be a material risk to its financial condition.
For additional disclosure regarding interest rate risk see Item 18. “Financial Statements - Note 22 - Financial Instruments”.
Foreign currency risk
The Company operates internationally and is exposed to foreign exchange risk arising from various currency exposures, primarily with respect to the U.S. dollar. Foreign exchange risk arises from future transactions and recognized assets and liabilities denominated in a currency that is not the entity’s functional currency and net investments in foreign operations.
As of 30 June 2025, the Company did not hold derivative financial instruments in managing its foreign currency, however, the Company may from time to time enter into hedging arrangements where circumstances are deemed appropriate. The Company used natural hedging to reduce the foreign currency risk, which involved processing U.S. Dollar (“USD”) payments from cash held in USD. Foreign subsidiaries with a functional currency of Australian Dollar (“AUD”) have exposure to the local currency of these subsidiaries and any other currency these subsidiaries trade in.
For additional disclosure regarding market risk see Item 18. “Financial Statements - Note 22 - Financial Instruments”.
| Item 12. | Description of Securities Other than Equity Securities |
A. Debt Securities
Not applicable.
B. Warrants and Rights
Not applicable.
C. Other Securities
Not applicable.
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D. American Depositary Shares
The depository for the Company’s American Depository Shares (“ADSs”) is the Bank of New York Mellon, located at 240 Greenwich Street, New York, NY 10286. The depository collects its fees for delivery and surrender of American Depository Shares directly from investors depositing shares or surrendering ADSs for the purpose of withdrawal or from intermediaries acting for them. The depository collects fees for making distributions to investors by deducting those fees from the amounts distributed or by selling a portion of distributable property to pay the fees. The depository may collect its annual fee for depository services by deductions from cash distributions or by directly billing investors or by charging the book-entry system accounts of participants acting for them. The depository may generally refuse to provide fee-attracting services until its fees for those services are paid. The depository may collect any of its fees by deduction from any cash distribution payable to you that are obligated to pay those fees.
From time to time, the depository may make payments to us to reimburse or share revenue from the fees collected from you, or waive fees and expenses for services provided, generally relating to costs and expenses arising out of establishment and maintenance of the ADS program. In performing its duties under the deposit agreement, the depository may use brokers, dealers or other service providers that are affiliates of the depository and that may earn or share fees or commissions.
| Persons depositing or withdrawing shares must pay: |
For: | |
| US$5.00 (or less) per 500 ADSs (or portion of 500 ADSs) | • Issuance of ADSs, including issuances resulting from a distribution of shares or rights or other property | |
• Cancellation of ADSs for the purpose of withdrawal, including if the deposit agreement terminates | ||
| US$.05 (or less) per ADS | • Any cash distribution to ADS registered holders | |
| A fee equivalent to the fee that would be payable if securities distributed to you had been shares and the shares had been deposited for issuance of ADSs | • Distribution of securities distributed to holders of deposited securities which are distributed by the depositary to ADS registered holders | |
| US$.05 (or less) per ADSs per calendar year | • Depositary services | |
| Registration or transfer fees | • Transfer and registration of shares on the Company’s share register to or from the name of the depositary or its agent when you deposit or withdraw shares | |
| Expenses of the depositary | • Cable, telex and facsimile transmissions (when expressly provided in the deposit agreement) | |
• Converting foreign currency to U.S. dollars | ||
| Taxes and other governmental charges the depositary or the custodian have to pay on any ADS or share underlying an ADS, for example, stock transfer taxes, stamp duty or withholding taxes | • As necessary | |
| Any charges incurred by the depositary or its agents for servicing the deposited securities | • As necessary | |
The Depositary may collect any of the fees by deduction from any cash distribution payable, or by selling a portion of any securities to be distributed, to holders that are obligated to pay those fees.
See Exhibit 2.2 “Description of Securities” for additional information on the ADSs.
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PART II
| Item 13. | Defaults, Dividend Arrearages and Delinquencies |
This item is not applicable.
| Item 14. | Material Modifications to the Rights of Security Holders and the Use of Proceeds |
This item is not applicable.
| Item 15. | Controls and Procedures |
(a) Disclosure controls and procedures
We maintain “disclosure controls and procedures,” as this term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, that are designed to provide reasonable assurance that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the Securities and Exchange Commission’s (“SEC”) rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Vice President of Finance and Controller, as appropriate, to allow timely decisions regarding required disclosure. Our Chief Executive Officer, Vice President of Finance and Controller and Chief Financial Officer recognize that these controls, no matter how well designed and operated, cannot provide absolute assurance that the objectives of these controls will be met.
Our management, with the participation of our Chief Executive Officer, and Vice President of Finance and Controller , has evaluated the effectiveness of the design and operation of our disclosure controls and procedures as of 30 June 2025. Based upon that evaluation, our Chief Executive Officer, and Vice President of Finance and Controller concluded that the controls and procedures were effective as of 30 June 2025 to ensure that material information was accumulated and communicated to our management as appropriate to allow timely decisions regarding required disclosure.
(b) Management’s annual report on internal control over financial reporting
The management of Kazia Therapeutics Limited is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) under the Exchange Act. Under the supervision and with the participation of our management, including our Chief Executive Officer, and Vice President of Finance and Controller, we conducted an evaluation of the effectiveness of our internal control over financial reporting as of 30 June 2025, based on the criteria set forth in Internal Control Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO 2013). Based on that evaluation, management concluded that our internal control over financial reporting was effective as of 30 June 2025. Kazia Therapeutics Limited’s internal control over financial reporting was designed to provide reasonable assurance to the Company’s management and Board of Directors regarding the preparation and fair presentation of published financial statements. All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.
(c) Attestation Report of the Registered Public Accounting Firm
Not applicable.
(d) Changes in Internal Control over Financial Reporting
No change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the year ended 30 June 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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| Item 16. | [Reserved] |
| Item 16A. | Audit Committee Financial Expert |
| (1) | The board of directors has determined that the Company: |
| (i) | Has one audit committee financial expert serving on its audit committee |
| (2) | Steven Coffey is the audit committee expert and is independent, as that term is defined in the listing standards applicable to the registrant if the registrant is a listed issuer, as defined in 17 CFR 240.10A-3. Steven Coffey meets the independence requirements of the Nasdaq Capital Market and SEC’s rules and regulations as he is a qualified Chartered Accountant and has spent over 30 years in public practice. He is also a registered company auditor. |
| Item 16B. | Code of Ethics |
The Company has adopted a Code of Ethics and Business Conduct (the “Code”). The Code establishes a clear set of values that emphasize a culture encompassing strong corporate governance, sound business practices and good ethical conduct. The Code confirms the Company’s belief in treating all individuals with respect and recognizes that different skills and diversity are essential to enrich the Company’s perspective, improve corporate performance, increase shareholder value and maximize the achievement and goals of the Company. The Code applies to all Company employees, including management and Directors. The Code is available on the Company’s website www.kaziatherapeutics.com.
| Item 16C. | Principal Accounting Fees and Services |
BDO Audit Pty Ltd (“BDO”) has audited the Company’s annual financial statements acting as the independent registered public accounting firm for the fiscal year ended 30 June 2025.
The table below set forth the total fees for services performed by BDO in fiscal years 2025 and 2024 and summarizes these amounts by the category of service.
| 2025 A$ |
2024 A$ |
|||||||
| Audit services - BDO Audit Pty Ltd |
||||||||
| Audit or review of the financial statements |
385,000 | 418,039 | ||||||
| Other services BDO Audit Pty Ltd |
||||||||
| Comfort letters |
107,528 | 28,774 | ||||||
| Consent letter - F-1 |
78,080 | 104,687 | ||||||
| Consent letter - F-3 |
91,408 | 11,199 | ||||||
|
|
|
|
|
|||||
| 662,016 | 562,699 | |||||||
|
|
|
|
|
|||||
Audit fees
The audit fees include the aggregate fees incurred in fiscal years 2025 and 2024 for professional services rendered in connection with the audit of the Company’s annual financial statements and for related services that are reasonably related to the performance of the audit or services that are normally provided by the auditor in connection with regulatory filings of engagements for those financial years (including review of the Company’s Annual Report on Form 20-F, consents and other services related to SEC matters).
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Pre-approval policies and procedures
The Audit Committee Charter sets forth the Company’s policy regarding the appointment of independent auditors. The Audit Committee Charter also requires the Audit Committee to review and approve in advance the appointment of the independent auditors for the performance of 100% of all audit services and, after taking into account the opinion of management, 100% of lawfully permitted non-audit services. The Audit Committee may delegate authority to one or more members of the Audit Committee where appropriate, but no such delegation is permitted if the authority is required by law, regulation or listing standard to be exercised by the Audit Committee as a whole.
| Item 16D. | Exemptions from the Listing Standards for Audit Committees |
This item is not applicable.
| Item 16E. | Purchases of Equity Securities by the Issuer and Affiliated Purchasers |
This item is not applicable.
| Item 16F. | Changes in registrant’s Certifying Accountant |
This item is not applicable.
| Item 16G. | Corporate Governance |
Implications of Being a Foreign Private Issuer
We are also considered a “foreign private issuer.” In our capacity as a foreign private issuer, we are exempt from certain rules under the U.S. Securities Exchange Act of 1934, as amended (the “Exchange Act”), that impose certain disclosure obligations and procedural requirements for proxy solicitations under Section 14 of the Exchange Act. In addition, our officers, directors and principal shareholders are exempt from the reporting and “short-swing” profit recovery provisions of Section 16 of the Exchange Act and the rules under the Exchange Act with respect to their purchases and sales of our ordinary shares. Moreover, we are not required to file periodic reports and financial statements with the SEC as frequently or as promptly as U.S. companies whose securities are registered under the Exchange Act. In addition, we are not required to comply with Regulation FD, which restricts the selective disclosure of material information.
Exemptions from Certain Corporate Governance Rules of the Nasdaq Stock Market, LLC
Exemptions from the corporate governance standards of the Nasdaq Stock Market, LLC (“Nasdaq”) are available to foreign private issuers such as Kazia when those standards are contrary to a law, rule or regulation of any public authority exercising jurisdiction over such issuer or contrary to generally accepted business practices in the issuer’s country of domicile. In connection with Kazia’s National Market Listing Application, Nasdaq granted Kazia exemptions from certain corporate governance standards that were contrary to the laws, rules, regulations or generally accepted business practices of Australia. These exemptions and the practices followed by Kazia are described below:
| • | Kazia is exempt from Nasdaq’s requirement that each Nasdaq issuer shall require shareholder approval of a plan or arrangement in connection with the acquisition of the stock or assets of another company if “any director, officer or substantial shareholder of the issuer has a 5 percent or greater interest (or such persons collectively have a 10 percent or greater interest), directly or indirectly, in the company or assets to be acquired or in the consideration to be paid in the transaction or series of related transactions and the present or potential issuance of common stock, or securities convertible into or exercisable for common stock, could result in an increase in outstanding common shares or voting power of 5 percent or more”. The Corporations Act to which Kazia is also subject generally requires shareholder approval for a transaction with a director or director-controlled entity unless on arm’s length terms. |
| • | Nasdaq requirement under Rule 5620(c) that a quorum consist of holders of 33 1/3% of the outstanding ordinary shares. Our quorum is currently three shareholders. We believe this quorum requirement is generally appropriate and typical of generally accepted business practices in Australia. |
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| • | Nasdaq requirements under Rules 5605(b)(1) and (2) relating to director independence, including the requirements that a majority of the board of directors must be comprised of independent directors and that independent directors must have regularly scheduled meetings at which only independent directors are present. The Corporations Act does not impose any mandatory requirements on director independence or the number of independent directors required for an Australian company. However, in performing their role, directors of Australian companies are subject to a range of duties and obligations under the Corporations Act, the common law and a company’s constitution, which indirectly regulate directors’ independence (including in respect of managing conflicts of interest). We believe that our Board composition is consistent with the requirements of the Corporations Act and that it is appropriate and typical of generally accepted business practices in Australia. |
| • | The requirement that our independent directors meet regularly in executive sessions under Nasdaq Listing Rules. The Corporations Act does not require the independent directors of an Australian company to have such executive sessions. |
| • | The Nasdaq requirements under Rules 5605(d) and 5605(e) that compensation of an issuer’s officers must be determined, or recommended to the Board for determination, either by a majority of the independent directors, or a compensation committee comprised solely of independent directors, and that director nominees must either be selected, or recommended for the Board’s selection, either by a majority of the independent directors, or a nominations committee comprised solely of independent directors. The reasonable remuneration of officers of a public company is an exception under the Corporations Act to the requirement to obtain shareholder approval for related party benefits. Accordingly, the Corporations Act does not generally impose mandatory requirements in respect of the remuneration of officers of Australian companies which are not listed on financial markets operating in Australia. However, the replaceable rules (which do not apply in relation to Kazia) provide that directors are to be paid the remuneration that a company determines by resolution. This is largely reflective of accepted business practices in Australia and largely aligns with our Constitution, which provides that: |
| • | Kazia in general meeting may from time to time determine the maximum aggregate remuneration to be provided to or for the benefit of its non-executive directors for services rendered as non-executive directors (“Remuneration”) and until a different amount is determined, the amount of Remuneration is $560,000 per annum; and |
| • | the directors may divide the Remuneration among themselves in any proportions and in any manner as they may from time to time determine. If the directors do not or are unable to make a determination as to the apportionment of the Remuneration, it must be divided among them equally. |
| • | The requirement prescribed by Nasdaq Listing Rules that issuers obtain shareholder approval prior to the issuance of securities in connection with certain acquisitions, private placements of securities, or the establishment or amendment of certain share option, purchase or other compensation plans. Applicable Australian law differs from Nasdaq requirements, with the Corporations Act not explicitly requiring shareholder approval for these types of matters, unless certain other triggers are met for example where the issuance is made to a related party (and no exceptions apply)). However, under Australian law, the constituent documents of a company may list other circumstances in which shareholder approval is required, and this can extend to circumstances concerning the issuance of securities in connection with certain acquisitions, private placements of securities, or the establishment or amendment of certain share option, purchase or other compensation plans. Our Constitution does not contain such restrictions. |
Item 16H. |
Mine Safety Disclosure |
Item 16I. |
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections |
Item 16J. |
Insider trading policies |
Item 16K. |
Cybersecurity |
Item 17. |
Financial Statements |
Item 18. |
Financial Statements |
Table of Contents
| Item 19. | Exhibits |
(a) Exhibits
| 1.1 | Constitution of Kazia Therapeutics Limited, as amended and restated on November 16, 2022 (incorporated by reference to Exhibit 3.1 to the Company’s Registration Statement on Form F-1 filed with the SEC on January 31, 2024 (File No. 333-276774)). | |
| 2.1 | Amended and Restated Deposit Agreement, dated as of June 13, 2016 among Novogen Limited, The Bank of New York, as Depositary, and owners and holders from time to time of ADSs issued thereunder (incorporated by reference to Exhibit 2.1 to the Company’s Annual Report on Form 20-F filed with the SEC on October 27, 2016 (File No. 000-29962)). | |
| 2.2 | Description of Securities (incorporated by reference to Exhibit 2.2 to the Company’s Annual Report on Form 20-F filed with the SEC on November 15, 2024 (File No. 000-29962)). | |
| 2.3 | Form of Warrant to purchase Ordinary Shares represented by American Depositary Shares (incorporated by reference to Exhibit 4.2 to the Form 6-K filed by the Company with the SEC on December 6, 2023 (File No. 000-29962)). | |
| 2.4 | Form of Placement Agent Warrant to purchase Ordinary Shares represented by American Depositary Shares (incorporated by reference to Exhibit 4.3 to the Form 6-K filed by the Company with the SEC on December 6, 2023 (File No. 000-29962)). | |
| 4.1 | Lease Agreement, dated November 1, 2015 between Coal Services Pty Limited and Novogen (incorporated by reference to Exhibit 4.1 to the Company’s Annual Report on Form 20-F filed with the SEC on October 27, 2016 (File No. 000-29962)). | |
| 4.2 | Convertible Note Deed Poll with Triaxial Pty Ltd Noteholders dated December 6, 2012 (incorporated by reference to Exhibit 4.6 to the Company’s Annual Report on Form 20-F filed with the SEC on October 27, 2016 (File No. 000-29962)). | |
| 4.3 | Amendment to Convertible Note Deed Poll with Triaxial Pty Ltd Noteholders dated December 4, 2014 (incorporated by reference to Exhibit 4.7 to the Company’s Annual Report on Form 20-F filed with the SEC on October 27, 2016 (File No. 000-29962)). | |
| 4.4# | Kazia Therapeutics Officers’ and Employees’ Share Option Plan (incorporated by reference to Exhibit 4.10 to the Company’s Annual Report on Form 20-F filed with the SEC on October 27, 2016 (File No. 000-29962)). | |
| 4.5✓ | Share Sale Agreement dated October 31, 2016 between Kilinwata Investments Pty. Ltd., Mi Ok Chong, Paul Hopper and Novogen Limited (incorporated by reference to Exhibit 4.11 to the Company’s Annual Report on Form 20-F filed with the SEC on October 25, 2017 (File No. 000-29962)). | |
| 4.6✓ | Exclusive License Agreement dated October 25, 2016 between Genentech, Inc. and Novogen Limited (incorporated by reference to Exhibit 4.12 to the Company’s Annual Report on Form 20-F filed with the SEC on October 25, 2017 (File No. 000-29962)). | |
| 4.7 | Sabio Solutions Pty Limited Letter of Appointment – Company Secretary, dated as of September 1, 2016 (incorporated by reference to Exhibit 4.17 to the Company’s Annual Report on Form 20-F filed with the SEC on October 25, 2017 (File No. 000-29962)). | |
| 4.8 | Sabio Solutions Pty Limited Contract Extension Letter, dated as of March 1, 2017 (incorporated by reference to Exhibit 4.18 to the Company’s Annual Report on Form 20-F filed with the SEC on October 25, 2017 (File No. 000-29962)). | |
| 4.9 | Sabio Solutions Pty Limited Contract Extension Letter, dated as of August 23, 2017 (incorporated by reference to Exhibit 4.19 to the Company’s Annual Report on Form 20-F filed with the SEC on October 25, 2017 (File No. 000-29962)). | |
| 4.10 | Investigator Initiated Clinical Trial Agreement between Kazia Therapeutics Limited and Dana-Farber/Partners Cancer Care Inc dated 17 October 2018 (incorporated by reference to Exhibit 4.12 to the Company’s Annual Report on Form 20-F filed with the SEC on October 21, 2019 (File No. 000-29962)). | |
| 4.11 | Research Funding and Supply Agreement between Alliance for Clinical Trials in Oncology Foundation and Kazia Therapeutics Limited, dated 11 June 2019 (incorporated by reference to Exhibit 4.13 to the Company’s Annual Report on Form 20-F filed with the SEC on October 21, 2019 (File No. 000-29962)). | |
| 4.12 | Master Clinical Trial Agreement between St Jude Children’s Hospital Inc. and Kazia Laboratories Pty Limited dated 17 November 2017 and associated work order date 7 June 2019 (incorporated by reference to Exhibit 4.14 to the Company’s Annual Report on Form 20-F filed with the SEC on October 21, 2019 (File No. 000-29962)). | |
| 4.13 | Memorial Sloan Kettering Cancer Center Investigator-Initiated Clinical Trial Agreement with Kazia Therapeutics Limited dated as 22 July 2019 (incorporated by reference to Exhibit 4.15 to the Company’s Annual Report on Form 20-F filed with the SEC on October 22, 2020 (File No. 000-29962)). | |
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| 4.14 | Investigator Initiated Clinical Trial Agreement with Kazia Therapeutics Limited Agreement dated as 18 September 2020 (incorporated by reference to Exhibit 4.16 to the Company’s Annual Report on Form 20-F filed with the SEC on October 22, 2020 (File No. 000-29962)). | |
| 4.15✓ | Global Coalition for Adaptive Research, (“GCAR”) Clinical trial collaboration and supply agreement dated as 15 October 2020 (incorporated by reference to Exhibit 4.17 to the Company’s Annual Report on Form 20-F filed with the SEC on October 22, 2020 (File No. 000-29962)). | |
| 4.16✓ | Development and Commercialisation Licence Agreement between Kazia Therapeutics Limited and Oasmia Pharmaceutical AB, dated March 1, 2021. (incorporated by reference to Exhibit 4.18 to the Company’s Annual Report on Form 20-F filed with the SEC on October 7, 2021 (File No. 000-29962)). | |
| 4.17✓ | License Agreement between Kazia Therapeutics Limited and Simcere Pharmaceutical Co., Ltd., dated March 29, 2021 (incorporated by reference to Exhibit 4.19 to the Company’s Annual Report on Form 20-F filed with the SEC on October 7, 2021 (File No. 000-29962)). | |
| 4.18✓ | License Agreement between Kazia Therapeutics Limited and Evotec (France) SAS, dated April 19, 2021 (incorporated by reference to Exhibit 4.20 to the Company’s Annual Report on Form 20-F filed with the SEC on October 7, 2021 (File No. 000-29962)). | |
| 4.19# | Employment agreement between Kazia Therapeutics Inc. and John Friend dated September 20, 2021 (incorporated by reference to Exhibit 4.21 to the Company’s Annual Report on Form 20-F filed with the SEC on October 17, 2022 (File No. 000-29962)). | |
| 4.20# | Addendum to employment agreement between Kazia Therapeutics Inc. and John Friend dated June 7, 2023 (incorporated by reference to Exhibit 4.23 to the Company’s Annual Report on Form 20-F filed with the SEC on October 26, 2023 (File No. 000-29962)). | |
| 4.21# | Employment agreement between Kazia Therapeutics Inc. and Jeffrey Bonacorda dated April 25, 2024 (incorporated by reference to Exhibit 4.21 to the Company’s Annual Report on Form 20-F filed with the SEC on November 15, 2024 (File No. 000-29962)). | |
| 4.22* | Asset Transfer Agreement between Kazia Therapeutics Limited and Vivesto AB (publ), dated March 30, 2025. | |
| 4.23*✓ | License and Commercialisation Agreement between Kazia Therapeutics Limited and QIMR BERGHOFER, known officially The Counsel of the Queensland Institute of Medical Research, dated October 3, 2025. | |
| 8.1 | Company Subsidiaries (incorporated by reference to Exhibit 8.1 to the Company’s Annual Report on Form 20-F filed with the SEC on October 24, 2018 (File No. 000-29962)). | |
| 11.1 | Securities Trading Policy (incorporated by reference to Exhibit 11.1 to the Company’s Annual Report on Form 20-F filed with the SEC on November 15, 2024 (File No. 000-29962)). | |
| 12.1* | Certification of Principal Executive Officer pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934, as amended. | |
| 12.2* | Certification of Principal Financial Officer pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934, as amended. | |
| 13.1** | Certification of Principal Executive Officer and the Principal Financial Officer pursuant to 18 U.S.C. Section 1350 as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002. | |
| 15.1* | Consent of Independent Registered Public Accounting Firm. | |
| 97.1 | Compensation Recovery Policy (incorporated by reference to Exhibit 97.1 to the Company’s Annual Report on Form 20-F filed with the SEC on November 15, 2024 (File No. 000-29962)). | |
| 101.INS | Interactive Data File - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the inline XBRL document. | |
| 101.SCH | Inline XBRL Taxonomy Extension Schema | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
| * | Filed herewith. |
| ✓ | Certain confidential information in this exhibit was omitted by means of marking such information with brackets (“[***]”) because the identified confidential information is not material and is the type that the registrant treats as private or confidential. |
| ** | Indicates that the exhibit is being furnished and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section. Such exhibit will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except to the extent specifically incorporated by reference into such filing. |
| # | Indicates management contract or compensatory plan or arrangement. |
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SIGNATURES
The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this Annual Report on its behalf.
| KAZIA THERAPEUTICS LIMITED |
| /s/ John Friend |
| Dr John Friend |
| Chief Executive Officer |
| Date: 7 November 2025 |
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Page |
||||
| Consolidated Financial Statements for 30 June 2025, 2024, and 2023 and the years then ended: |
||||
| Report of Independent Registered Public Accounting Firm (BDO Audit Pty Ltd, Sydney, Australia PCAOB ID:# 0 |
F-2 | |||
| Consolidated Statement of Profit or Loss and Other Comprehensive Income |
F-4 | |||
| Consolidated Statement of Financial Position |
F-5 | |||
| Consolidated Statement of Changes in Equity |
F-6 | |||
| Consolidated Statement of Cash Flows |
F-7 | |||
| Notes to Consolidated Financial Statements |
F-8 | |||
• |
Assessing the reasonableness of timing and probabilities of milestone assumptions against: (i) publicly available information, (ii) published clinical trial updates and results, and (iii) review of a sample of contracts; |
• |
Evaluating the consistency and accuracy of management’s historical judgments against actual outcomes; |
• |
Assessing impairment indicators under IAS 36, including trial outcomes, and funding constraints. |
• |
Assessing the reasonableness of assumptions used in the managements’ expert valuation report against industry data, a sample of contracts and other relevant evidence. |
• |
Assessing the appropriateness of the classification by reviewing a sample of contracts against relevant accounting guidance. |
• |
Utilizing professionals with specialized skills and knowledge in valuation to assist in assessing the reasonableness of the valuation methodology applied, including evaluating the reasonableness of the risk-free rate and the volatility assumptions. |
Note |
2025 A$‘000 |
2024 A$‘000 |
2023 A$‘000 |
|||||||||||||
| Revenue from continuing operations |
||||||||||||||||
| Revenue |
4 | |||||||||||||||
| Other income |
6 | |||||||||||||||
| Finance income |
||||||||||||||||
| Expenses |
||||||||||||||||
| Research and development expense |
7 | ( |
) | ( |
) | ( |
) | |||||||||
| General and administrative expense |
7 | ( |
) | ( |
) | ( |
) | |||||||||
| Impairment of intangible assets |
11 | ( |
) | |||||||||||||
| (Loss) gain on remeasurement of other financial liabilities |
17 | ( |
) | |||||||||||||
| Gain on remeasurement of promissory note |
||||||||||||||||
| Gain on remeasurement of contingent consideration |
15 | |||||||||||||||
| |
|
|
|
|
|
|||||||||||
| Loss before income tax benefit |
( |
) | ( |
) | ( |
) | ||||||||||
| Income tax benefit |
8 | |||||||||||||||
| |
|
|
|
|
|
|||||||||||
| Loss after income tax benefit |
( |
) | ( |
) | ( |
) | ||||||||||
| |
|
|
|
|
|
|||||||||||
| Other comprehensive income/(loss) |
||||||||||||||||
| Items that may be reclassified subsequently to profit or loss |
||||||||||||||||
| Net exchange difference on translation of financial statements of foreign controlled entities, net of tax |
( |
) | ( |
) | ||||||||||||
| |
|
|
|
|
|
|||||||||||
| Other comprehensive income (loss), net of tax |
( |
) | ( |
) | ||||||||||||
| |
|
|
|
|
|
|||||||||||
| Total comprehensive income/(loss) |
( |
) |
( |
) |
( |
) | ||||||||||
| |
|
|
|
|
|
|||||||||||
Note |
2025 A$ Cents |
2024 A$ Cents |
2023 A$ Cents |
|||||||||||||
| Earnings per share for loss attributable to the owners of Kazia Therapeutics Limited |
||||||||||||||||
| Basic and diluted earnings per share |
29 | ( |
) | ( |
) | ( |
) | |||||||||
Note |
2025 A$‘000 |
2024 A$‘000 |
||||||||||
| Assets: |
||||||||||||
| Current assets: |
||||||||||||
| Cash and cash equivalents |
||||||||||||
| Trade and other receivables |
9 | |||||||||||
| Other current assets |
10 | |||||||||||
| |
|
|
|
|||||||||
| Total current assets |
||||||||||||
| |
|
|
|
|||||||||
| Non-current assets: |
||||||||||||
| Other receivables |
9 | |||||||||||
| Intangibles |
11 | |||||||||||
| |
|
|
|
|||||||||
| Total non-current assets |
||||||||||||
| |
|
|
|
|||||||||
| Total assets |
||||||||||||
| |
|
|
|
|||||||||
Liabilities: |
||||||||||||
| Current liabilities |
||||||||||||
| Trade and other payables |
12 | |||||||||||
| Other financial liabilities |
17 | |||||||||||
| Borrowings |
13 | |||||||||||
| Employee benefits |
14 | |||||||||||
| Contingent consideration |
15 | |||||||||||
| |
|
|
|
|||||||||
| Total current liabilities |
||||||||||||
| |
|
|
|
|||||||||
| Non-Current liabilities |
||||||||||||
| Deferred tax |
16 | |||||||||||
| Employee benefits |
14 | |||||||||||
| Contingent consideration |
15 | |||||||||||
| |
|
|
|
|||||||||
| Total non-current liabilities |
||||||||||||
| |
|
|
|
|||||||||
| Total liabilities |
||||||||||||
| |
|
|
|
|||||||||
| Shareholders’ equity: |
||||||||||||
| Contributed equity |
18 | |||||||||||
| Other contributed equity |
19 | |||||||||||
| Reserves |
20 | |||||||||||
| Accumulated losses |
( |
) | ( |
) | ||||||||
| |
|
|
|
|||||||||
| Total deficit |
( |
) |
( |
) | ||||||||
| |
|
|
|
|||||||||
| Total liabilities and shareholders’ deficit |
||||||||||||
| |
|
|
|
|||||||||
Contributed equity A$‘000 |
Other Contributed equity A$‘000 |
Reserves A$‘000 |
Accumulated Losses A$‘000 |
Total equity (deficit) A$‘000 |
||||||||||||||||
| Balance at 1 July 2024 |
( |
) | ( |
) | ||||||||||||||||
| Loss after income tax benefit |
( |
) | ( |
) | ||||||||||||||||
| Other comprehensive income, net of tax |
( |
) | ( |
) | ||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|||||||||||
| Total comprehensive income/(loss) for the year |
( |
) | ( |
) | ( |
) | ||||||||||||||
| Transactions with owners in their capacity as owners |
||||||||||||||||||||
| Shares issued (note 18) |
||||||||||||||||||||
| Share issue cost (note 18) |
( |
) | ( |
) | ||||||||||||||||
| Share based payment (note 29) |
||||||||||||||||||||
| Expired options |
( |
) | ||||||||||||||||||
| Unissued equity (note 19) |
( |
) | ||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|||||||||||
| Balance at 30 June 2025 |
( |
) | ( |
) | ||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|||||||||||
Contributed equity A$‘000 |
Other Contributed equity A$‘000 |
Reserves A$‘000 |
Accumulated Losses A$‘000 |
Total equity (deficit) A$‘000 |
||||||||||||||||
| Balance at 1 July 2023 |
( |
) | ||||||||||||||||||
| Loss after income tax benefit |
( |
) | ( |
) | ||||||||||||||||
| Other comprehensive income, net of tax |
( |
) | ( |
) | ||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|||||||||||
| Total comprehensive income/(loss) |
( |
) | ( |
) | ( |
) | ||||||||||||||
| Transactions with owners in their capacity as owners |
||||||||||||||||||||
| Shares issued (note 18) |
||||||||||||||||||||
| Share issue cost (note 18) |
( |
) | ( |
) | ||||||||||||||||
| Share based payment (note 29) |
||||||||||||||||||||
| Expired options |
( |
) | ||||||||||||||||||
| Shares issued upon conversion of convertible note |
||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|||||||||||
| Balance at 30 June 2024 |
( |
) | ( |
) | ||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|||||||||||
Contributed equity A$‘000 |
Other Contributed equity A$‘000 |
Reserves A$‘000 |
Accumulated Losses A$‘000 |
Total equity (deficit) A$‘000 |
||||||||||||||||
| Balance at 1 July 2022 |
( |
) | ||||||||||||||||||
| Loss after income tax benefit |
( |
) | ( |
) | ||||||||||||||||
| Other comprehensive income, net of tax |
||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|||||||||||
| Total comprehensive income/(loss) |
( |
) | ( |
) | ||||||||||||||||
| Transactions with owners in their capacity as owners |
||||||||||||||||||||
| Shares issued (note 18) |
||||||||||||||||||||
| Share issue cost (note 18) |
( |
) | ( |
) | ||||||||||||||||
| Share based payment (note 29) |
||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|||||||||||
| Balance at 30 June 2023 |
( |
) | ||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|||||||||||
Note |
2025 A$‘000 |
2024 A$‘000 |
2023 A$‘000 |
|||||||||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: |
||||||||||||||||
| Loss after income tax expense for the year |
$ | ( |
$ | ( |
) | $ | ( |
) | ||||||||
| Adjustments for: |
||||||||||||||||
| Amortisation |
11 | |||||||||||||||
| Issuance of liability classified warrants for services |
17 | |||||||||||||||
| Share-based payments |
29 | |||||||||||||||
| Foreign currency loss / (gain) |
7 | ( |
) | |||||||||||||
| Loss / (gain) on remeasurement of contingent consideration |
15 | ( |
) | ( |
) | |||||||||||
| Interest on unwinding of contingent consideration |
15 | |||||||||||||||
| Gain on remeasurement of promissory note |
( |
) | ||||||||||||||
| Loss / (gain) on remeasurement of financial liabilities |
17 | ( |
) | |||||||||||||
| Impairment of intangible assets |
11 | |||||||||||||||
| |
|
|
|
|
|
|||||||||||
| ( |
) | ( |
) | ( |
) | |||||||||||
| Change in operating assets and liabilities: |
||||||||||||||||
| Trade and other receivables |
||||||||||||||||
| Other assets |
||||||||||||||||
| Trade and other payables |
( |
) | ||||||||||||||
| Other provisions |
( |
) | ||||||||||||||
| Deferred tax liability |
( |
) | ( |
) | ( |
) | ||||||||||
| Borrowings |
( |
) | ( |
) | ( |
) | ||||||||||
| |
|
|
|
|
|
|||||||||||
| Net cash used in operating activities |
( |
) |
( |
) |
( |
) | ||||||||||
| |
|
|
|
|
|
|||||||||||
| CASH FLOWS FROM FINANCING ACTIVITIES: |
||||||||||||||||
| Proceeds from issuance of shares, net of transaction costs |
18 | |||||||||||||||
| Proceeds from issuance of equity and pre-funded warrants |
17 | |||||||||||||||
| Proceeds from exercise of ordinary warrants |
17 | |||||||||||||||
| Proceeds from promissory note |
||||||||||||||||
| Repayment of promissory note |
( |
) | ||||||||||||||
| |
|
|
|
|
|
|||||||||||
| Net cash provided by financing activities |
||||||||||||||||
| |
|
|
|
|
|
|||||||||||
| Net (decrease)/increase in cash and cash equivalents |
( |
) |
( |
) | ||||||||||||
| Cash and cash equivalents at the beginning of the financial year |
||||||||||||||||
| Effects of exchange rate changes on cash |
( |
) | ||||||||||||||
| |
|
|
|
|
|
|||||||||||
| Cash and cash equivalents at the end of the financial year |
$ | $ | $ | |||||||||||||
| |
|
|
|
|
|
|||||||||||
| NON-CASH INVESTING AND FINANCING ACTIVITIES |
||||||||||||||||
| Conversion of convertible promissory note |
18 | |||||||||||||||
| |
|
|
|
|
|
|||||||||||
| Unissued equity |
19 | |||||||||||||||
| |
|
|
|
|
|
|||||||||||
| Exercise of pre-funded warrants |
17 | |||||||||||||||
| |
|
|
|
|
|
|||||||||||
| • | On 12 May 2025, the Company received a notification (the Notification) from the Listing Qualifications Staff of the Nasdaq Stock Market LLC (Nasdaq) notifying the Company that from 28 March 2025 |
| • | The at-the-market’ |
| • | During the year ended 30 June 2025, US$ |
| • | From July through October 2025, the Consolidated Entity raised total proceeds of US$ |
| • | financial assets at amortized cost |
| • | financial assets at fair value through profit or loss (“FVPL”) |
| • | the entity’s business model for managing the financial asset |
| • | the contractual cash flow characteristics of the financial assets |
| • | they are held within a business model whose objective is to hold the financial assets and collect its contractual cash flows; and |
| • | the contractual terms of the financial assets give rise to cash flows that are solely payments of principal and interest on the principal amount outstanding. |
| • | When the deferred income tax asset or liability arises from the initial recognition of goodwill or an asset or liability in a transaction that is not a business combination and that, at the time of the transaction, affects neither the accounting nor taxable profits; or |
| • | When the taxable temporary difference is associated with interests in subsidiaries, associates or joint ventures, and the timing of the reversal can be controlled and it is probable that the temporary difference will not reverse in the foreseeable future. |
| • | during the options vesting period, the liability at each reporting date is the fair value of the award at that date multiplied by the expired portion of the vesting period. |
| • | from the end of the option vesting period until settlement of the award, the liability is the full fair value of the option at the reporting date. |
| 2025 A$’000 |
2024 A$’000 |
2023 A$’000 |
||||||||||
| Licensing revenue |
||||||||||||
| Sale of Paxalisib |
||||||||||||
| |
|
|
|
|
|
|||||||
| |
|
|
|
|
|
|||||||
| 2025 A$’000 |
2024 A$’000 |
2023 A$’000 |
||||||||||
| Geographical regions |
||||||||||||
| South Korea |
||||||||||||
| Israel |
||||||||||||
| |
|
|
|
|
|
|||||||
| Timing of revenue recognition |
||||||||||||
| Licensing revenue recognised at a point in time |
||||||||||||
| Sale of Paxalisib at a point in time |
||||||||||||
| |
|
|
|
|
|
|||||||
| |
|
|
|
|
|
|||||||
| 2025 A$’000 |
2024 A$’000 |
2023 A$’000 |
||||||||||
| Grant income |
— | |||||||||||
| Other sundry income |
— | |||||||||||
| |
|
|
|
|
|
|||||||
| |
|
|
|
|
|
|||||||
| 2025 A$’000 |
2024 A$’000 |
2023 A$’000 |
||||||||||
| Research and development expense |
||||||||||||
| EVT-801 program costs |
||||||||||||
| Cantrixil program costs |
||||||||||||
| Paxalisib program costs |
||||||||||||
| Scientific Advisory Board costs |
||||||||||||
| Employee benefits expense - salaries & wages and staff benefits |
||||||||||||
| - superannuation |
||||||||||||
| - share based payments |
||||||||||||
| |
|
|
|
|
|
|||||||
| Total research & development expense (excluding amortisation) |
||||||||||||
| Amortisation |
||||||||||||
| Paxalisib licensing agreement |
||||||||||||
| Evotech licensing agreement |
||||||||||||
| |
|
|
|
|
|
|||||||
| Total amortisation |
||||||||||||
| |
|
|
|
|
|
|||||||
| Total research & development expense |
||||||||||||
| Net foreign exchange loss |
||||||||||||
| Net foreign exchange loss/(gain) |
( |
) | ||||||||||
| Lease |
||||||||||||
| Expense relating to short term lease |
||||||||||||
| Superannuation expense |
||||||||||||
| Defined contribution superannuation expense |
||||||||||||
| Employee benefits expense G&A |
||||||||||||
| - salaries & wages and staff benefits |
||||||||||||
| - superannuation |
||||||||||||
| - share based payments |
||||||||||||
| |
|
|
|
|
|
|||||||
| Total employee benefits expense G&A |
||||||||||||
2025 A$’000 |
2024 A$’000 |
2023 A$’000 |
||||||||||
| Numerical reconciliation of income tax benefit and tax at the statutory rate |
||||||||||||
| Loss before income tax benefit |
( |
) | ( |
) | ( |
) | ||||||
| Tax at the statutory tax rate of |
( |
) | ( |
) | ( |
) | ||||||
| Tax effect amounts which are not deductible/(taxable) in calculating taxable income: |
||||||||||||
| Amortisation of intangibles |
||||||||||||
| Share-based payments |
||||||||||||
| Impairment loss on intangible assets |
||||||||||||
| Gain on remeasurement of contingent consideration |
( |
) | ( |
) | ( |
) | ||||||
| |
|
|
|
|
|
|||||||
| ( |
) | ( |
) | ( |
) | |||||||
| Tax losses and timing differences not recognised |
||||||||||||
| |
|
|
|
|
|
|||||||
| Income tax benefit |
( |
) | ( |
) | ( |
) | ||||||
| |
|
|
|
|
|
|||||||
| 2025 A$’000 |
2024 A$’000 |
2023 A$’000 |
||||||||||
| Tax losses not recognised: |
||||||||||||
| Unused tax losses for which no deferred tax asset has been recognised-Australia |
||||||||||||
| Potential tax benefit at |
||||||||||||
| Unused tax losses for which no deferred tax asset has been recognised - US |
||||||||||||
| Potential tax benefit at statutory rate - |
||||||||||||
2025 |
2024 |
|||||||
A$’000 |
A$’000 |
|||||||
| Current assets |
||||||||
| GBM Agile deposit |
||||||||
| GST receivable |
||||||||
| Deposits held |
||||||||
| |
|
|
|
|||||
| |
|
|
|
|||||
| Non-current assets |
||||||||
| Corporate credit card deposit |
||||||||
| |
|
|
|
|||||
| |
|
|
|
|||||
2025 |
2024 |
|||||||
A$’000 |
A$’000 |
|||||||
| Prepayments |
||||||||
| |
|
|
|
|||||
| 2025 A$’000 |
2024 A$’000 |
|||||||
| Licensing agreement - Paxalisib |
||||||||
| Less: Accumulated amortisation |
( |
) | ||||||
| |
|
|
|
|||||
| |
|
|
|
|||||
| Licensing agreement - EVT-801 |
||||||||
| Less: Accumulated amortisation |
( |
) | ||||||
| |
|
|
|
|||||
| |
|
|
|
|||||
| |
|
|
|
|||||
| EVT-801 licensing agreement A$’000 |
Paxalisib licensing agreement A$’000 |
Total A$’000 |
||||||||||
| Balance at 1 July 2023 |
||||||||||||
| Amortisation expense |
( |
) | ( |
) | ( |
) | ||||||
| |
|
|
|
|
|
|||||||
| Balance at 30 June 2024 |
||||||||||||
| Impairment of assets |
( |
) | ( |
) | ( |
) | ||||||
| Amortisation expense |
( |
) | ( |
) | ( |
) | ||||||
| |
|
|
|
|
|
|||||||
| Balance at 30 June 2025 |
||||||||||||
| |
|
|
|
|
|
|||||||
• |
The number of ongoing studies (11 in total), |
• |
The stage of each study within the FDA clinical trial phases (from Preclinical to Commercialisation), |
• |
Probability of success rates for progression through each phase, as published by the FDA. |
2025 |
2024 |
|||||||
A$’000 |
A$’000 |
|||||||
| Trade payables |
||||||||
| Accrued payables |
||||||||
| |
|
|
|
|||||
| |
|
|
|
|||||
2025 |
2024 |
|||||||
A$’000 |
A$’000 |
|||||||
| Insurance premium funding |
||||||||
| |
|
|
|
|||||
| 2025 A$’000 |
2024 A$’000 |
|||||||
| Current Liabilities |
||||||||
| Annual leave |
||||||||
| |
|
|
|
|||||
| |
|
|
|
|||||
| Non-Current Liabilities |
||||||||
| Long service leave |
||||||||
| |
|
|
|
|||||
| |
|
|
|
|||||
2025 A$’000 |
2024 A$’000 |
|||||||
Current Liabilities |
||||||||
Contingent consideration - EVT801 |
||||||||
Non-current Liabilities |
||||||||
Contingent consideration - Paxalisib |
||||||||
Contingent consideration - EVT801 |
||||||||
2025 |
2024 |
|||||||
A$’000 |
A$’000 |
|||||||
Contingent consideration at start of period (current and non-current) |
||||||||
Interest on unwinding of discount |
||||||||
Foreign currency loss / (gain) |
( |
) | ||||||
Gain on remeasurement of contingent consideration |
( |
) | ( |
) | ||||
2025 |
2024 |
|||||||
A$’000 |
A$’000 |
|||||||
Deferred tax liability associated with Licensing Agreement |
||||||||
June 2025 |
June 2024 |
|||||||
A$’000 |
A$’000 |
|||||||
Current liabilities |
||||||||
Prefunded and ordinary warrants |
||||||||
Reconciliation |
||||||||
Opening balance |
— | |||||||
Prefunded and ordinary warrants at initial recognition |
||||||||
Prefunded and ordinary warrants exercised |
( |
) | ( |
) | ||||
Loss / (gain) on remeasurement of other financial liabilities |
( |
) | ||||||
Prefunded and ordinary warrants at period end |
||||||||
2025 |
2024 |
2023 |
2025 |
2024 |
2023 |
|||||||||||||||||||
Shares |
Shares |
Shares |
A$‘000 |
A$‘000 |
A$‘000 |
|||||||||||||||||||
| Ordinary shares - fully paid |
||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Details |
Date |
Shares |
Issue price |
A$ |
||||||||||
| Balance |
1 July 2022 | |||||||||||||
| ATM issue of shares No. 8 |
7 July 2022 | $ | ||||||||||||
| ATM issue of shares No. 9 |
8 August 2022 | $ | ||||||||||||
| ATM issue of shares No. 10 |
9 August 2022 | $ | ||||||||||||
| ATM issue of shares No. 11 |
10 August 2022 | $ | ||||||||||||
| ATM issue of shares No. 12 |
11 August 2022 | $ | ||||||||||||
| ATM issue of shares No. 13 |
12 August 2022 | $ | ||||||||||||
| ATM issue of shares No. 14 |
12 September 2022 | $ | ||||||||||||
| ATM issue of shares No. 15 |
13 September 2022 | $ | ||||||||||||
| Shares issued to Scientific Advisory Board |
14 September 2022 | $ | ||||||||||||
| ATM issue of shares No. 16 |
7 October 2022 | $ | ||||||||||||
| ATM issue of shares No. 17 |
28 October 2022 | $ | ||||||||||||
| ATM issue of shares No. 18 |
11 January 2023 | $ | ||||||||||||
| Professional and sophisticated investors placement - 1st tranche |
16 January 2023 | $ | ||||||||||||
| Professional and sophisticated investors placement - 2nd tranche |
28 February 2023 | $ | ||||||||||||
| Share Placement Plan |
3 March 2023 | $ | ||||||||||||
| Less: share issue transaction costs |
( |
) | ||||||||||||
| |
|
|
|
|||||||||||
| Balance |
30 June 2023 | |||||||||||||
| |
|
|
|
|||||||||||
| Balance |
01 July 2023 | |||||||||||||
| ATM issue of shares No. 19 |
06 July 2023 | $ | ||||||||||||
| ATM issue of shares No. 20 |
07 July 2023 | $ | ||||||||||||
| ATM issue of shares No. 21 |
03 August 2023 | $ | ||||||||||||
| ATM issue of shares No. 22 |
29 November 2023 | $ | ||||||||||||
| Registered Direct Offering |
05 December 2023 | $ | — | — | ||||||||||
| ATM issue of shares No. 23 |
13 February 2024 | $ | ||||||||||||
| ATM issue of shares No. 24 |
14 February 2024 | $ | ||||||||||||
| ATM issue of shares No. 25 |
15 February 2024 | $ | ||||||||||||
| ATM issue of shares No. 26 |
16 February 2024 | $ | ||||||||||||
| Armistice warrants |
21 February 2024 | $ | ||||||||||||
| ATM issue of shares No. 27 |
21 February 2024 | $ | ||||||||||||
| ATM issue of shares No. 28 |
22 February 2024 | $ | ||||||||||||
| ATM issue of shares No. 29 |
23 February 2024 | $ | ||||||||||||
| ATM issue of shares No. 30 |
26 February 2024 | $ | ||||||||||||
| ATM issue of shares No. 31 |
01 May 2024 | $ | ||||||||||||
| ATM issue of shares No. 32 |
02 May 2024 | $ | ||||||||||||
| ATM issue of shares No. 33 |
03 May 2024 | $ | ||||||||||||
| ATM issue of shares No. 34 |
07 May 2024 | $ | ||||||||||||
| ATM issue of shares No. 35 |
10 May 2024 | $ | ||||||||||||
| ATM issue of shares No. 36 |
16 May 2024 | $ | ||||||||||||
| Repayment of promissory note |
19 June 2024 | $ | ||||||||||||
| Equity line of credit |
24 June 2024 | $ | ||||||||||||
| Less: share issue transaction costs |
( |
) | ||||||||||||
| |
|
|
|
|||||||||||
| Balance |
30 June 2024 | |||||||||||||
| |
|
|
|
|||||||||||
| Balance |
30 June 2024 | |||||||||||||
| Conversion of Warrants exercised |
11 July 2024 | — | $ | — | ||||||||||
| Cancellation of convertible note shares |
02 July 2024 | ( |
) | $ | — | ( |
) | |||||||
| ATM issue of shares No. 37 |
12 July 2024 | $ | ||||||||||||
| Alumni warrants shares issued |
11 July 2024 | $ | ||||||||||||
| Armistice warrants shares issued |
11 July 2024 | $ | ||||||||||||
| ATM issue of shares No. 38 |
15 July 2024 | $ | ||||||||||||
| ATM issue of shares No. 39 |
16 July 2024 | $ | ||||||||||||
| Alumni Equity Line of Credit |
18 July 2024 | $ | ||||||||||||
| ATM issue of shares No. 40 |
09 August 2024 | $ | ||||||||||||
| ATM issue of shares No. 41 |
13 August 2024 | $ | ||||||||||||
| ATM issue of shares No. 42 |
14 August 2024 | $ | ||||||||||||
| ATM issue of shares No. 43 |
15 August 2024 | $ | ||||||||||||
| ATM issue of shares No. 44 |
28 August 2024 | $ | ||||||||||||
| ATM issue of shares No. 45 |
29 August 2024 | $ | ||||||||||||
| ATM issue of shares No. 46 |
03 September 2024 | $ | ||||||||||||
| ATM issue of shares No. 47 |
04 September 2024 | $ | ||||||||||||
| ATM issue of shares No. 48 |
13 September 2024 | $ | ||||||||||||
| ATM issue of shares No. 49 |
14 September 2024 | $ | ||||||||||||
| ATM issue of shares No. 50 |
25 November 2024 | $ | ||||||||||||
| ATM issue of shares No. 51 |
26 November 2024 | $ | ||||||||||||
| Alumni Equity Line of Credit |
09 December 2024 | $ | ||||||||||||
| ATM issue of shares No. 52 |
27 November 2024 | $ | ||||||||||||
| ATM issue of shares No. 53 |
29 November 2024 | $ | ||||||||||||
| ATM issue of shares No. 54 |
02 December 2024 | $ | ||||||||||||
| ATM issue of shares No. 55 |
03 December 2024 | $ | ||||||||||||
| ATM issue of shares No. 56 |
04 December 2024 | $ | ||||||||||||
| ATM issue of shares No. 57 |
05 December 2024 | $ | ||||||||||||
| ATM issue of shares No. 58 |
10 December 2024 | $ | ||||||||||||
| ATM issue of shares No. 59 |
11 December 2024 | $ | ||||||||||||
| Alumni Equity Line of Credit |
16 December 2024 | $ | ||||||||||||
| ATM issue of shares No. 60 |
17 December 2024 | $ | ||||||||||||
| ATM issue of shares No. 61 |
02 January 2025 | $ | ||||||||||||
| ATM issue of shares No. 62 |
03 January 2025 | $ | ||||||||||||
| ATM issue of shares No. 63 |
06 January 2025 | $ | ||||||||||||
| ATM issue of shares No. 64 |
07 January 2025 | $ | ||||||||||||
| Maxim Warrants exercised |
30 January 2025 | $ | ||||||||||||
| Alumni Warrants exercised |
30 January 2025 | $ |
Perishing Warrants exercised |
30 January 2025 | $ | ||||||||||||||
Alumni Prefunded Warrants shares issued |
30 January 2025 | — | $ | — | ||||||||||||
Alumni Equity Line of Credit |
11 February 2025 | $ | ||||||||||||||
Alumni Equity Line of Credit |
06 May 2025 | $ | ||||||||||||||
Alumni Equity Line of Credit |
06 June 2025 | $ | ||||||||||||||
Alumni Equity Line of Credit |
12 June 2025 | $ | ||||||||||||||
Alumni Equity Line of Credit |
18 June 2025 | $ | ||||||||||||||
Less: share issue transaction costs |
— | $ | — | ( |
) | |||||||||||
Balance |
June 30, 2025 | |||||||||||||||
2025 |
2024 |
2023 |
||||||||||
A$’000 |
A$’000 |
A$’000 |
||||||||||
Foreign currency reserve |
( |
) | ( |
) | ( |
) | ||||||
Share-based payments reserve |
||||||||||||
Assets |
Liabilities |
|||||||||||||||
| 2025 A$’000 |
2024 A$’000 |
2025 A$’000 |
2024 A$’000 |
|||||||||||||
| US dollars |
||||||||||||||||
| Euros |
— | — | ||||||||||||||
| Pound Sterling |
— | — | ||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
AUD strengthened |
AUD weakened |
|||||||||||||||||||||||
Consolidated - 2025 |
% change |
Effect on profit before tax A$’000 |
Effect on equity A$’000 |
% change |
Effect on profit before tax A$’000 |
Effect on equity A$’000 |
||||||||||||||||||
| US dollars |
% | ( |
) | ( |
) | ( |
)% | |||||||||||||||||
| Euros |
% | ( |
) | ( |
) | ( |
)% | |||||||||||||||||
| Pound Sterling |
% | ( |
) | ( |
) | ( |
)% | |||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||||||||
| ( |
) | ( |
) | |||||||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||||||||
AUD strengthened |
AUD weakened |
|||||||||||||||||||||||
Consolidated - 2024 |
% change |
Effect on profit before tax A$’000 |
Effect on equity A$’000 |
% change |
Effect on profit before tax A$’000 |
Effect on equity A$’000 |
||||||||||||||||||
| US dollars |
% | ( |
) | ( |
) | ( |
)% | |||||||||||||||||
| Euros |
% | ( |
) | ( |
) | ( |
)% | |||||||||||||||||
| Pound Sterling |
% | ( |
) | ( |
) | ( |
)% | |||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||||||||
| ( |
) | ( |
) | |||||||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||||||||
2025 |
2024 |
|||||||||||||||
| Weighted average interest rate % |
Balance A$’000 |
Weighted average interest rate % |
Balance A$’000 |
|||||||||||||
| Cash and cash equivalents |
||||||||||||||||
| |
|
|
|
|||||||||||||
| Net exposure to cash flow interest rate risk |
||||||||||||||||
| |
|
|
|
|||||||||||||
2025 |
1 year or less A$’000 |
Between 1 and 2 years A$’000 |
Between 2 and 5 years A$’000 |
Over 5 years A$’000 |
Remaining contractual maturities A$’000 |
Carrying Amount A$’000 |
||||||||||||||||||
Non-derivatives |
||||||||||||||||||||||||
Trade payables |
— | — | — | |||||||||||||||||||||
Accrued payables |
— | — | — | |||||||||||||||||||||
Total non-derivatives |
— | — | — | |||||||||||||||||||||
Derivatives |
||||||||||||||||||||||||
Other financial liabilities |
— | — | — | |||||||||||||||||||||
Total derivatives |
— | — | — | |||||||||||||||||||||
Total undiscounted financial liabilities |
— | — | ||||||||||||||||||||||
2024 |
1 year or less A$’000 |
Between 1 and 2 years A$’000 |
Between 2 and 5 years A$’000 |
Over 5 years A$’ 000 |
Remaining contractual maturities A$’000 |
Carrying Amount A$’000 |
||||||||||||||||||
Non-derivatives |
||||||||||||||||||||||||
Trade payables |
— | — | — | |||||||||||||||||||||
Accrued payables |
— | — | — | |||||||||||||||||||||
Contingent consideration |
— | — | ||||||||||||||||||||||
Total non-derivatives |
— | — | ||||||||||||||||||||||
Derivatives |
||||||||||||||||||||||||
Other financial liabilities |
— | — | — | |||||||||||||||||||||
Total derivatives |
— | — | — | |||||||||||||||||||||
Total undiscounted financial liabilities |
— | — | ||||||||||||||||||||||
Consolidated - 2025 |
Level 1 A$‘000 |
Level 2 A$‘000 |
Level 3 A$‘000 |
Total A$‘000 |
||||||||||||
Liabilities |
||||||||||||||||
Contingent Consideration |
— | — | ||||||||||||||
Warrants liability |
— | — | ||||||||||||||
Total liabilities |
— | — | ||||||||||||||
Consolidated - 2024 |
||||||||||||||||
Liabilities |
||||||||||||||||
Contingent Consideration |
— | — | ||||||||||||||
Warrants liability |
— | — | ||||||||||||||
Total liabilities |
— | — | ||||||||||||||
Level 3 A$’000 |
Total A$’000 |
|||||||
Consolidated |
||||||||
Balance at 30 June 2023 |
||||||||
Issuance of warrants |
||||||||
Exercise of warrants |
( |
) | ( |
) | ||||
Gain recognised in profit or loss |
( |
) | ( |
) | ||||
Balance at 30 June 2024 |
||||||||
Issuance of warrants |
||||||||
Exercise of warrants |
( |
) | ( |
) | ||||
Gain recognised in profit or loss |
( |
) | ( |
) | ||||
Balance at 30 June 2025 |
||||||||
2025 A$ |
2024 A$ |
2023 A$ |
||||||||||
Short-term employee benefits |
||||||||||||
Post-employment benefits |
||||||||||||
Share-based payments |
||||||||||||
2025 A$’000 |
2024 A$’000 |
|||||||
Statement of profit or loss and other comprehensive income |
||||||||
Loss after income tax |
( |
) | ( |
) | ||||
Total comprehensive loss |
( |
) | ( |
) | ||||
2025 A$’000 |
2024 A$’000 |
|||||||
Statement of financial position |
||||||||
Total current assets |
||||||||
Total assets |
||||||||
Total current liabilities |
||||||||
Total liabilities |
||||||||
Equity |
||||||||
Contributed equity |
||||||||
Other contributed equity |
||||||||
Reserves |
||||||||
Accumulated losses |
( |
) | ( |
) | ||||
Total deficit in equity |
( |
) | ( |
) | ||||
• |
Investments in subsidiaries are accounted for at cost, less any impairment, in the parent entity. |
• |
Dividends received from subsidiaries are recognised as other income by the parent entity and its receipt may be an indicator of an impairment of the investment. |
Ownership interest |
||||||||||
Name |
Principal place of business / Country of incorporation |
2025 % |
2024 % |
|||||||
Kazia Laboratories Pty Ltd |
% | % | ||||||||
Kazia Research Pty Ltd |
% | % | ||||||||
Kazia Therapeutics Inc. |
% | % | ||||||||
Glioblast Pty Ltd |
% | % | ||||||||
2025 A$‘000 |
2024 A$‘000 |
2023 A$‘000 |
||||||||||
Earnings per share for losses from continuing operations |
||||||||||||
Loss after income tax attributable to the owners of Kazia Therapeutics Limited |
( |
) | ( |
) | ( |
) | ||||||
Loss after income tax attributable to the owners of Kazia Therapeutics Limited |
( |
) | ( |
) | ( |
) | ||||||
Number |
Number |
Number |
||||||||||
Weighted average number of ordinary shares used in calculating basic and diluted earnings per share |
||||||||||||
Cents |
Cents |
Cents |
||||||||||
Basic and diluted earnings per share |
( |
) | ( |
) | ( |
) | ||||||
Number of options 2025 - Ordinary shares |
Weighted Average exercise price 2025 |
Number of options 2024 - Ordinary shares |
Weighted Average exercise price 2024 |
|||||||||||||
Outstanding at the beginning of the financial year |
A$ | A$ | ||||||||||||||
Forfeited |
( |
) | A$ | ( |
) | A$ | ||||||||||
Expired |
( |
) | A$ | ( |
) | A$ | ||||||||||
Outstanding at the end of the financial year |
A$ | A$ | ||||||||||||||
Exercisable at the end of the financial year |
A$ | A$ | ||||||||||||||
Number of options 2025 - ADS |
Weighted Average exercise price 2025 |
Number of options 2024 - ADS |
Weighted Average exercise price 2024 |
|||||||||||||
Outstanding at the beginning of the financial year |
A$ | A$ | ||||||||||||||
Granted |
A$ | A$ | ||||||||||||||
Forfeited |
A$ | ( |
) | A$ | ||||||||||||
Expired |
— | A$ | — | — | A$ | — | ||||||||||
Outstanding at the end of the financial year |
A$ | A$ | ||||||||||||||
Exercisable at the end of the financial year |
A$ | A$ | ||||||||||||||
Tranche |
Grant date |
Expiry date |
Exercise price |
Balance at the start of the year - Ordinary shares |
Granted |
Exercised |
Expired / lapsed on termination of employment |
Balance at the end of the year - Ordinary shares |
||||||||||||||||||||||||
4 |
13/01/2025 |
A$ |
— |
— |
( |
) |
||||||||||||||||||||||||||
5 |
09/11/2024 |
A$ |
— |
— |
( |
) |
||||||||||||||||||||||||||
6 |
13/01/2025 |
A$ |
— |
— |
( |
) |
||||||||||||||||||||||||||
7 |
04/01/2025 |
A$ |
— |
— |
( |
) |
||||||||||||||||||||||||||
8 |
26/06/2026 |
A$ |
— |
— |
— |
|||||||||||||||||||||||||||
9 |
16/11/2025 |
A$ |
— |
— |
— |
|||||||||||||||||||||||||||
10 |
16/11/2025 |
A$ |
— |
— |
— |
|||||||||||||||||||||||||||
11 |
16/11/2025 |
A$ |
— |
— |
— |
|||||||||||||||||||||||||||
13 |
01/02/2027 |
A$ |
— |
— |
( |
) |
||||||||||||||||||||||||||
14 |
24/05/2027 |
A$ |
— |
— |
— |
|||||||||||||||||||||||||||
15 |
03/03/2027 |
A$ |
— |
— |
||||||||||||||||||||||||||||
16 |
03/05/2027 |
A$ |
— |
— |
||||||||||||||||||||||||||||
— |
— |
( |
) |
|||||||||||||||||||||||||||||
Weighted average exercise price |
A$ |
A$ |
A$ |
A$ |
A$ |
|||||||||||||||||||||||||||
Tranche |
Grant date |
Expiry date |
Exercise price |
Balance at the start of the year - ADS |
Granted |
Exercised |
Expired / lapsed on termination of employment |
Balance at the end of the year - ADS |
||||||||||||||||||||||||
17 |
22/04/2029 |
$ |
— |
— |
||||||||||||||||||||||||||||
18 |
17/06/2029 |
$ |
— |
|||||||||||||||||||||||||||||
19 |
27/06/2030 |
$ |
— |
— |
||||||||||||||||||||||||||||
20 |
11/09/2024 |
11/09/2029 |
$ |
— |
— |
— |
||||||||||||||||||||||||||
21-22 |
14/01/2025 |
14/07/2030 |
$ |
— |
— |
— |
||||||||||||||||||||||||||
— |
— |
|||||||||||||||||||||||||||||||
Weighted average exercise price |
A$ |
A$ |
A$ |
— |
A$ |
A$ |
||||||||||||||||||||||||||
Tranche |
Grant date |
Expiry date |
Exercise price |
Balance at the start of the year - Ordinary shares |
Granted |
Exercised |
Expired / lapsed on termination of employment |
Balance at the end of the year - Ordinary Shares |
||||||||||||||||||||||||
3 |
04/01/2024 |
A$ |
— |
— |
( |
) |
||||||||||||||||||||||||||
4 |
13/01/2025 |
A$ |
— |
— |
( |
) |
||||||||||||||||||||||||||
5 |
09/11/2024 |
A$ |
— |
— |
— |
|||||||||||||||||||||||||||
6 |
13/01/2025 |
A$ |
— |
— |
— |
|||||||||||||||||||||||||||
7 |
04/01/2025 |
A$ |
— |
— |
( |
) |
||||||||||||||||||||||||||
8 |
26/06/2026 |
A$ |
— |
— |
— |
|||||||||||||||||||||||||||
9 |
16/11/2025 |
A$ |
— |
— |
— |
|||||||||||||||||||||||||||
10 |
16/11/2025 |
A$ |
— |
— |
— |
|||||||||||||||||||||||||||
11 |
16/11/2025 |
A$ |
— |
— |
— |
|||||||||||||||||||||||||||
12 |
01/02/2027 |
A$ |
— |
— |
( |
) |
||||||||||||||||||||||||||
13 |
01/02/2027 |
A$ |
— |
— |
( |
) |
||||||||||||||||||||||||||
14 |
24/05/2027 |
A$ |
— |
— |
— |
|||||||||||||||||||||||||||
15 |
03/03/2027 |
A$ |
— |
( |
) |
|||||||||||||||||||||||||||
16 |
03/05/2027 |
A$ |
— |
( |
) |
|||||||||||||||||||||||||||
— |
— |
( |
) |
|||||||||||||||||||||||||||||
Weighted average exercise price |
A$ |
A$ |
A$ |
A$ |
A$ |
|||||||||||||||||||||||||||
| • | Tranche 20-22 vests yearly over 5 years from the date of the grant |
| • | The options must have vested; |
| • | Option holder must have provided the Company with an Exercise Notice and have paid the Exercise Price for the option; |
| • | The Exercise Notice must be for the exercise of at least the Minimum Number of Options; and |
| • | The Exercise Notice must have been provided to the Company and Exercise Price paid before the expiry of 5 years from the date the Option is issued. |
Tranche |
Grant date |
Expiry date |
Share price at Grant Date |
Exercise price |
Volatility (%) |
Dividend yield (%) |
Risk free Rate (%) |
Fair value per option |
||||||||||||||||||||||||
| 4 |
13/01/2025 |
$ | $ | % | % | $ | ||||||||||||||||||||||||||
| 5 |
09/11/2024 |
$ | $ | % | % | $ | ||||||||||||||||||||||||||
| 6 |
13/01/2025 |
$ | $ | % | % | $ | ||||||||||||||||||||||||||
| 7 |
04/01/2025 |
$ | $ | % | % | $ | ||||||||||||||||||||||||||
| 8 |
26/06/2026 |
$ | $ | % | % | $ | ||||||||||||||||||||||||||
| 9 |
16/11/2025 |
$ | $ | % | % | $ | ||||||||||||||||||||||||||
| 10 |
16/11/2025 |
$ | $ | % | % | $ | ||||||||||||||||||||||||||
| 11 |
16/11/2025 |
$ | $ | % | % | $ | ||||||||||||||||||||||||||
| 13 |
01/02/2027 |
$ | $ | % | % | $ | ||||||||||||||||||||||||||
| 14 |
24/05/2027 |
$ | $ | % | % | $ | ||||||||||||||||||||||||||
| 15 |
03/03/2027 |
$ | $ | % | % | $ | ||||||||||||||||||||||||||
| 16 |
03/05/2027 |
$ | $ | % | % | $ | ||||||||||||||||||||||||||
| 17 |
22/04/2029 |
$ | $ | % | % | $ | ||||||||||||||||||||||||||
| 18 |
17/06/2029 |
$ | $ | % | % | $ | ||||||||||||||||||||||||||
| 19 |
27/06/2030 |
$ | $ | % | % | $ | ||||||||||||||||||||||||||
| 20 |
11/09/2029 |
$ | $ | % | % | $ | ||||||||||||||||||||||||||
| 21-22 |
14/07/2030 |
$ | $ | % | % | $ | ||||||||||||||||||||||||||
FAQ
What were Kazia (KZIA) FY2025 results in the 20-F?
How much cash did Kazia (KZIA) have at year-end FY2025?
Did Kazia (KZIA) raise capital during FY2025?
What going concern disclosure did Kazia (KZIA) make?
What is the current ADS ratio for Kazia (KZIA)?
How many ordinary shares were outstanding for Kazia (KZIA) at FY2025 year-end?
What are Kazia’s (KZIA) lead programs?
