STOCK TITAN

Kazia Therapeutics (KZIA) structures up to $120M around cancer drug trials

(Neutral)
(Neutral)
Form Type
6-K

Rhea-AI Filing Summary

Kazia Therapeutics Limited (KZIA) entered into an underwriting agreement for a tranched underwritten public offering of ADSs, pre-funded warrants and Series A and B warrants at a combined public offering price of $15.50 per ADS and accompanying warrants, for expected gross proceeds of approximately $40 million before expenses.

The Series A Warrants cover up to 2,243,478 ADSs at $17.825 per ADS and the Series B Warrants cover up to 2,064,000 ADSs at $19.375 per ADS, which, if fully exercised, could provide about $80 million in additional gross proceeds. Pre-funded warrants have a de minimis $0.0001 exercise price and do not expire until fully exercised.

Warrants become non-exercisable 30 days after specified paxalisib Phase 1b and HR+/HER2- breast cancer progression-free survival milestones or five years from issuance, whichever is earlier, and include beneficial ownership limitations. Net proceeds are intended primarily to fund clinical development of paxalisib and for working capital and general corporate purposes. Company executives and directors agreed to a 60-day lock-up on additional equity sales.

Positive

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Negative

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Combined public offering price per ADS and accompanying Warrants $15.50 Pricing of ADS and accompanying warrants in the underwritten public offering
Expected gross proceeds from Offering approximately $40 million Gross proceeds before underwriting discounts, commissions and expenses
Potential additional gross proceeds from Series A Warrants up to approximately $40 million If all Series A Warrants are exercised in cash
Potential additional gross proceeds from Series B Warrants up to approximately $40 million If all Series B Warrants are exercised in cash
Series A Warrant exercise price $17.825 per ADS 115% of the public offering price per ADS and accompanying warrants
Series B Warrant exercise price $19.375 per ADS 125% of the public offering price per ADS and accompanying warrants
Underwriter purchase price per ADS and accompanying Warrants $14.415 Reflects a 7% underwriting discount to the public offering price
Executive and director lock-up period 60 days Restriction on additional equity sales after the underwriting agreement date
American Depositary Shares financial
"an offering of (i) 2,276,800 American Depositary Shares (the “ADSs”)"
American depositary shares (ADSs) are a way for investors in the United States to buy shares of foreign companies without dealing with international markets directly. They represent ownership in a foreign company's stock and are traded on U.S. stock exchanges, making it easier for American investors to buy, sell, and own parts of companies from around the world.
Pre-Funded Warrants financial
"pre-funded warrants to purchase up to 303,200 ADSs (the “Pre-Funded Warrants”)"
Pre-funded warrants are financial instruments that give investors the right to purchase a company's stock at a set price, but with most or all of the purchase price paid upfront. They function like a coupon or gift card for stock, allowing investors to buy shares later at a fixed price, which can be beneficial if they want to avoid future price increases. This makes them important for investors seeking flexibility and certainty in their investment plans.
beneficial ownership limitations financial
"contain beneficial ownership limitations that restrict the holder from exercising"
Beneficial ownership limitations are rules or contractual caps that restrict how much of a company’s stock an individual or entity can be treated as owning or controlling for legal, regulatory or corporate-governance purposes. They matter to investors because such limits affect voting power, reporting obligations, takeover risk and the ability to increase a stake — like an elevator weight limit or a lane divider that prevents any one car from taking over the whole road.
tranched registered public offering financial
"has commenced a tranched registered public offering (the “Offering”) of (i) American"
Orphan Drug Designation medical
"Paxalisib was granted Orphan Drug Designation for glioblastoma by the U.S."
Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.
Rare Pediatric Disease Designation medical
"Paxalisib was granted Rare Pediatric Disease Designation and Orphan Drug"
A rare pediatric disease designation is an official regulatory status given to a drug or therapy that targets a serious or life‑threatening condition primarily affecting children and is uncommon in the population. It matters to investors because the status often brings financial and development perks — such as tax credits, reduced fees, faster review and periods of market protection — which can lower costs, speed approval and improve the commercial outlook; think of it as a VIP pass that makes bringing a scarce, child‑focused treatment to market easier and potentially more profitable.
Offering Type shelf
Price Range $15.50 combined public offering price per ADS and accompanying Warrants; $15.4999 per Pre-Funded Warrant and accompanying Warrants
Use of Proceeds Fund ongoing and planned clinical development of paxalisib in multiple oncology indications, and for working capital and other general corporate purposes

FAQ

What is Kazia Therapeutics (KZIA) raising in this new offering?

Kazia Therapeutics is conducting an underwritten public offering of ADSs, pre-funded warrants and Series A and B warrants at $15.50 per ADS and accompanying warrants, for expected gross proceeds of approximately $40 million before underwriting discounts, commissions and offering expenses.

How much additional capital could KZIA receive from warrant exercises?

If all Series A and Series B Warrants are exercised in full, Kazia Therapeutics states it could receive additional gross proceeds of approximately $80 million, before deducting warrant exercise fees and other expenses related to those exercises.

What are the exercise prices of KZIA’s Series A and Series B Warrants?

Kazia’s Series A Warrants have an exercise price of $17.825 per ADS, and its Series B Warrants have an exercise price of $19.375 per ADS, each based on 115% and 125%, respectively, of the public offering price per ADS and accompanying warrants.

When do the Series A and Series B Warrants issued by KZIA expire?

The Series A Warrants expire on the earlier of 30 days after a six‑month median progression‑free survival result in 12 Stage IV TNBC patients in the paxalisib trial or five years from issuance; the Series B Warrants follow the same structure tied to HR+/HER2- data.

How will KZIA use the net proceeds from this offering?

Kazia plans to use the net proceeds primarily to fund clinical development of paxalisib, including ongoing and planned studies in triple‑negative breast cancer, HR+/HER2- breast cancer, colorectal cancer and early stage high‑risk TNBC, and for working capital and general corporate purposes.

Are there lock-up restrictions for KZIA insiders in this offering?

Yes. Under the underwriting agreement, Kazia’s executive officers and directors agreed, with certain exceptions, not to offer, sell or dispose of ADSs, ordinary shares or related securities for 60 days after the agreement date without prior written consent from the underwriters’ representatives.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

Form 6-K 

 

 

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16 

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of August 2026

 

Commission File Number 000-29962 

 

 

 

Kazia Therapeutics Limited

(Translation of registrant’s name into English)

 

 

 

Three International Towers Level 24 300 Barangaroo Avenue Sydney NSW 2000

(Address of principal executive office)

 

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. 

 

Form 20-F ☒           Form 40-F ☐ 

 

 

 

 

 

 

INFORMATION CONTAINED IN THIS FORM 6-K REPORT

 

Underwritten Public Offering

 

On August 28, 2026, Kazia Therapeutics Limited (the “Company”) entered into an underwriting agreement (the “Underwriting Agreement”) with Leerink Partners LLC and Guggenheim Securities, LLC, as representatives of the several underwriters named therein (collectively, the “Underwriters”), relating to an underwritten public offering (the “Offering”) of (i) 2,276,800 American Depositary Shares (the “ADSs”), each ADS representing five hundred (500) ordinary shares of the Company, no par value per share (the “Ordinary Shares”), (ii) pre-funded warrants to purchase up to 303,200 ADSs (the “Pre-Funded Warrants”), (iii) Series A Warrants to purchase up to 2,243,478 ADSs (the “Series A Warrants”) and (iv) Series B Warrants to purchase up to 2,064,000 ADSs (the “Series B Warrants” and, together with the Series A Warrants, the “Warrants”; the Pre-Funded Warrants and the Warrants collectively, the “Warrant Securities”), at a combined public offering price of $15.50 per ADS and accompanying Warrants (or $15.4999 per Pre-Funded Warrant and accompanying Warrants, equal to the combined public offering price per ADS and accompanying Warrants less $0.0001). The exercise price of each Series A Warrant is $17.825 per ADS (115% of the public offering price per ADS and accompanying Warrants). The exercise price of each Series B Warrant is $19.375 per ADS (125% of the public offering price per ADS and accompanying Warrants). The exercise price of each Pre-Funded Warrant is $0.0001 per ADS. The purchase price to be paid by the Underwriters to the Company is $14.415 per ADS and accompanying Warrants (or $14.4149 per Pre-Funded Warrant and accompanying Warrants), representing underwriting discounts and commissions of 7% of the gross proceeds of the Offering. BTIG, LLC and Needham & Company, LLC acted as lead managers and Laidlaw & Company (UK) Ltd. acted as co-manager for the Offering. In addition to the foregoing, the underwriters have agreed to assist in soliciting the exercise of the Series A Warrants and Series B Warrants in return for a fee of 7% of the gross proceeds received by the Company upon the cash exercise of such warrants.

 

The gross proceeds from the Offering, before deducting underwriting discounts and commissions and offering expenses payable by the Company, are expected to be approximately $40 million (with potential additional gross proceeds of up to approximately $40 million from the exercise of the Series A Warrants and up to approximately $40 million from the exercise of the Series B Warrants, in each case before deducting the warrant exercise fee payable to the Underwriters). The Company intends to use the net proceeds from the Offering to fund the ongoing and planned clinical development of paxalisib, including its Phase 1b trial in advanced triple-negative breast cancer and planned expansion into HR+/HER2- breast cancer, colorectal cancer, and early stage high risk TNBC, and for working capital and other general corporate purposes. The Offering is expected to close on or about August 31, 2026, subject to the satisfaction of customary closing conditions.

 

The ADSs, the Pre-Funded Warrants and the Warrants were offered by the Company pursuant to an effective registration statement on Form F-3 (File No. 333-294392) filed with the Securities and Exchange Commission (the “SEC”) under the Securities Act of 1933, as amended (the “Securities Act”), and declared effective on March 27, 2026, and a related prospectus supplement dated August 28, 2026 filed with the SEC pursuant to Rule 424(b)(5) under the Securities Act.

 

The Pre-Funded Warrants are immediately exercisable at an exercise price of $0.0001 per ADS and will not expire until exercised in full. The Series A Warrants are immediately exercisable and expire upon the earlier of (i) 30 days after the Company publicly announces that at least 12 patients in its Phase 1b trial in advanced stage IV triple-negative breast cancer have achieved a six-month median progression-free survival or (ii) five years from the date of issuance. The Series B Warrants are immediately exercisable and expire upon the earlier of (i) 30 days after the Company publicly announces that at least 12 patients in its planned clinical evaluation of paxalisib in HR+/HER2- breast cancer have achieved a six-month median progression-free survival or (ii) five years from the date of issuance. Each of the Warrants and the Pre-Funded Warrants contain beneficial ownership limitations that restrict the holder from exercising such warrants to the extent that such exercise would result in the holder, together with its affiliates, beneficially owning in excess of a specified percentage of the Company’s outstanding Ordinary Shares.

 

The Underwriting Agreement contains customary representations, warranties, covenants and agreements by the Company, indemnification obligations of the Company, including for liabilities arising under the Securities Act, other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Underwriting Agreement were made only for the purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement and may be subject to limitations agreed upon by the contracting parties.

 

1 

 

 

Pursuant to the Underwriting Agreement, the Company’s executive officers and directors have agreed, subject to certain exceptions, not to offer, sell or otherwise dispose of any ADSs or Ordinary Shares or any securities convertible into or exchangeable or exercisable for ADSs or Ordinary Shares for a period of 60 days after the date of the Underwriting Agreement without the prior written consent of the representatives.

 

The foregoing description of the Underwriting Agreement is not complete and is qualified in its entirety by reference to the full text of the Underwriting Agreement, a copy of which is filed as Exhibit 1.1 to this Report on Form 6-K and is incorporated herein by reference. A copy of the opinion of Baker & McKenzie LLP relating to the legality of the securities issued and sold in the Offering is filed herewith as Exhibit 5.1.

 

On August 27, 2026, the Company issued a press release announcing the proposed Offering. A copy of the launch press release is attached as Exhibit 99.1 to this Report on Form 6-K and is incorporated herein by reference. On August 28, 2026, the Company issued a press release announcing the pricing of the Offering. A copy of the pricing press release is attached as Exhibit 99.2 to this Report on Form 6-K and is incorporated herein by reference.

 

Incorporation by Reference

 

The Company hereby incorporates by reference the information contained in the body of this Report on Form 6-K and Exhibits 99.1 and 99.2 hereto into the registration statement on Form F-3 of Kazia Therapeutics Limited (File No. 333-294392) (including any prospectuses forming a part of such registration statement) and shall be a part thereof from the date on which this current report is furnished, to the extent not superseded by documents or reports subsequently filed or furnished.

 

Forward-Looking Statements

 

This Report of Foreign Private Issuer on Form 6-K may contain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, which can generally be identified as such by the use of words such as “may,” “will,” “estimate,” “future,” “forward,” “anticipate,” or other similar words. Any statement describing Kazia’s future plans, strategies, intentions, expectations, objectives, goals or prospects, and other statements that are not historical facts, are also forward-looking statements, including, but not limited to, statements regarding: the completion of the Offering, the satisfaction of customary closing conditions related thereto, the intended use of proceeds from the Offering, the exercise of the Warrants and the Pre-Funded Warrants and the receipt of proceeds therefrom, the anticipated extension of the Company’s cash runway into 2029 following completion of the Offering, and the Company’s future expectations, plans and prospects. Such statements are based on Kazia’s current expectations and projections about future events and future trends affecting its business and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements, including risks and uncertainties: related to market and other conditions, associated with clinical and preclinical trials and product development, including the risk that preliminary or interim data may not reflect final results, related to regulatory approvals, and related to the impact of global economic conditions. These and other risks and uncertainties are described more fully in Kazia’s Annual Report, filed on form 20-F with the SEC, and in subsequent filings with the SEC. Kazia undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law. Investors should not place undue reliance on these forward-looking statements, which apply only as of the date of this Report of Foreign Private Issuer on Form 6-K.

 

2 

 

 

EXHIBIT LIST

 

Exhibit   Description
1.1   Underwriting Agreement
5.1   Opinion of Baker McKenzie.
10.1   Form of Pre-Funded Warrant
10.2   Form of Series A Warrant
10.3   Form of Series B Warrant
23.1   Consent of Baker & McKenzie (included in Exhibit 5.1).
99.1   Launch Press Release of Kazia Therapeutics Limited dated August 27, 2026
99.2   Pricing Press Release of Kazia Therapeutics Limited dated August 28, 2026

 

3 

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

Kazia Therapeutics Limited (Registrant)  
     
/s/ John Friend  
Name: John Friend  
Title: Chief Executive Officer  
     
Date: August 31, 2026  

 

4 

 

Exhibit 99.1

 

Kazia Therapeutics Limited Announces Proposed Public Offering

 

SYDNEY, Australia, August 27, 2026Kazia Therapeutics Limited (NASDAQ: KZIA) (“Kazia” or the “Company”), an oncology-focused biotechnology company developing therapies that selectively reprogram cancer biology, restore anti-tumor immunity and overcome treatment resistance, today announced that it has commenced a tranched registered public offering (the “Offering”) of (i) American Depositary Shares (“ADSs”), each representing five hundred (500) ordinary shares of the Company, no par value per share, or in lieu of ADSs to certain investors, pre-funded warrants to purchase ADSs, (ii) accompanying Series A Warrants to purchase ADSs (or pre-funded warrants in lieu thereof), which are exercisable immediately at an exercise price equal to 115% of the initial public offering price per ADS and accompanying Warrants and expire upon the earlier of 30 days following the Company’s Stage IV triple-negative breast cancer (TNBC) data readout, expected in the second half of 2027, or the five-year anniversary of issuance, and (iii) accompanying Series B Warrants to purchase ADSs (or pre-funded warrants in lieu thereof), which are exercisable immediately at an exercise price equal to 125% of the initial public offering price per ADS and accompanying Warrants and expire upon the earlier of 30 days following the Company’s HR+/HER2- data readout, expected in the first half of 2028, or the five-year anniversary of issuance. All of the securities in the Offering are to be sold by Kazia.

 

Leerink Partners and Guggenheim Securities are acting as joint bookrunning managers for the proposed Offering. BTIG, Needham & Company and Laidlaw & Company are acting as co-managers for the proposed Offering. The proposed Offering is subject to market and other conditions, and there can be no assurance as to whether or when the Offering may be completed or as to the actual size or terms of the Offering.

 

Kazia intends to use the net proceeds from the Offering primarily to fund clinical development of paxalisib, including ongoing and planned studies in triple-negative breast cancer and HR+/HER2- breast cancer and other oncology indications, and for working capital and general corporate purposes.

 

The ADSs and warrants are being offered pursuant to a registration statement on Form F-3 (File No. 333-294392), which was previously filed with and subsequently declared effective by the Securities and Exchange Commission (the “SEC”). The Offering will be made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A copy of the preliminary prospectus supplement relating to and describing the terms of the Offering will be filed with the SEC and will be available for free on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus may also be obtained, when available, from Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@leerink.com, or from Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, telephone: (212) 518-9544, email: GSEquityProspectusDelivery@guggenheimsecurities.com.

 

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in the Offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

 

 

 

 

About Kazia Therapeutics

 

Kazia Therapeutics Limited (NASDAQ: KZIA) is an oncology-focused drug development company, based in Sydney, Australia. The Company’s lead asset, paxalisib, is an investigational brain penetrant inhibitor of the PI3K/Akt/mTOR pathway, which is being developed to treat multiple forms of cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of over 15 clinical trials. A completed Phase 2/3 study in glioblastoma (GBM AGILE) was reported in 2024, and discussions are ongoing for designing and executing a pivotal registrational study in pursuit of a standard approval. Other clinical trials involving paxalisib are ongoing in advanced breast cancer, brain metastases, diffuse midline gliomas, and primary central nervous system lymphoma, with several of these trials having reported encouraging interim data. Paxalisib was granted Orphan Drug Designation for glioblastoma by the U.S. Food and Drug Administration (FDA) in February 2018, and Fast Track Designation (FTD) for glioblastoma in August 2020. Paxalisib was also granted FTD in July 2023 for the treatment of solid tumor brain metastases harboring PI3K pathway mutations in combination with radiation therapy. Additionally, paxalisib was granted Rare Pediatric Disease Designation and Orphan Drug Designation by the FDA for diffuse intrinsic pontine glioma in August 2020 and for atypical teratoid / rhabdoid tumors in June 2022 and July 2022, respectively. Kazia is also developing EVT801, a small molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. In addition to its clinical-stage programs, Kazia is advancing NDL2, a potentially first-in-class intracellular PD-L1 protein degrader program targeting a newly identified mechanism of immunotherapy resistance and metastatic progression, as well as MSETC, a potentially first-in-class SETDB1 inhibitor program intended to restore immune signaling in tumors that have become resistant to immunotherapy, including checkpoint inhibitors. Both programs are currently in preclinical development.

 

Forward-Looking Statements

 

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, but are not limited to, statements regarding the anticipated Offering and the potential gross proceeds therefrom, including the exercise of the Series A Warrants and Series B Warrants; the Company’s ability to achieve clinical milestones, including the Stage IV TNBC and HR+/HER2- data readouts that may trigger warrant exercise periods; the Company’s intended use of proceeds; and the Company’s plans for clinical development of paxalisib. Forward-looking statements are generally identified by words such as “anticipates,” “believes,” “expects,” “intends,” “plans,” “may,” “will,” “could,” “should,” “estimates,” “projects,” “potential,” and similar expressions. These forward-looking statements are based on management’s current expectations and assumptions as of the date of this press release and are subject to significant risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed or implied. Such risks and uncertainties include, but are not limited to: the Company’s ability to complete the Offering; the Company’s ability to achieve clinical milestones, including the Stage IV TNBC and HR+/HER2- data readouts that trigger warrant exercise periods; risks associated with the conduct of clinical trials and regulatory approvals; volatility in the price of the Company’s ADSs and warrants; general economic and market conditions; and the Company’s ability to maintain compliance with NASDAQ listing requirements.

 

For a more complete discussion of risks and uncertainties, please refer to the Company’s filings with the SEC, including the “Risk Factors” section of the Company’s most recent Annual Report on Form 20-F. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. All forward-looking statements are qualified in their entirety by this cautionary statement.

 

MEDIA CONTACT

 

Michaela Fawcett / Molly Crawford

KCSA Strategic Communications

mfawcett@kcsa.com / mcrawford@kcsa.com

 

 

 

Exhibit 99.2

 

Kazia Therapeutics Limited Announces Pricing of Up to $120 Million Public Offering

 

SYDNEY, Australia, August 28, 2026Kazia Therapeutics Limited (NASDAQ: KZIA) (“Kazia” or the “Company”), an oncology-focused biotechnology company developing therapies that selectively reprogram cancer biology, restore anti-tumor immunity and overcome treatment resistance, today announced the pricing of its previously announced tranched registered public offering (the “Offering”) of (i) 2,580,000 American Depositary Shares (“ADSs”), each representing five hundred (500) ordinary shares of the Company, no par value per share, or in lieu of ADSs to certain investors, pre-funded warrants to purchase ADSs, (ii) accompanying Series A Warrants to purchase up to 2,243,478 ADSs (or pre-funded warrants in lieu thereof), which are exercisable immediately at a purchase price of $17.825 per ADS and will expire upon the earlier of 30 days following the Company’s Stage IV triple-negative breast cancer (TNBC) data readout, expected in the second half of 2027, or the five-year anniversary of issuance, and (iii) accompanying Series B Warrants to purchase up to 2,064,000 ADSs (or pre-funded warrants in lieu thereof), which are exercisable immediately at a purchase price of $19.375 per ADS and will expire upon the earlier of 30 days following the Company’s HR+/HER2- data readout, expected in the first half of 2028, or the five-year anniversary of issuance. All of the securities in the Offering are being sold by Kazia. The combined public offering price for each ADS and accompanying warrants is $15.50, and the combined public offering price for each pre-funded warrant and accompanying warrants is $15.4999 (equal to the combined public offering price per ADS and accompanying warrants less $0.0001), for expected gross proceeds to Kazia of approximately $40 million, before deducting underwriting discounts and commissions and offering expenses. If all of the Series A Warrants and Series B Warrants are exercised in full, the Company would receive additional gross proceeds of approximately $80 million, before deducting applicable expenses.

 

Leerink Partners and Guggenheim Securities are acting as joint bookrunning managers for the Offering. BTIG and Needham & Company are acting as lead managers for the Offering. Laidlaw & Company (UK) Ltd. is acting as co-manager for the Offering.

 

The Offering is expected to close on or about August 31, 2026, subject to satisfaction of customary closing conditions.

 

Kazia intends to use the net proceeds from the Offering primarily to fund clinical development of paxalisib, including ongoing and planned studies in triple-negative breast cancer and HR+/HER2- breast cancer and other oncology indications, and for working capital and general corporate purposes.

 

The ADSs and warrants are being offered pursuant to a registration statement on Form F-3 (File No. 333-294392), which was previously filed with and subsequently declared effective by the Securities and Exchange Commission (the “SEC”). The Offering is being made only by means of a prospectus supplement and accompanying prospectus that form a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the Offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Additionally, electronic copies of the preliminary prospectus supplement and the accompanying base prospectus may be obtained from Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@leerink.com, or from Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, telephone: (212) 518-9544, email: GSEquityProspectusDelivery@guggenheimsecurities.com.

 

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in the Offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

 

 

 

 

About Kazia Therapeutics

 

Kazia Therapeutics Limited (NASDAQ: KZIA) is an oncology-focused drug development company, based in Sydney, Australia. The Company’s lead asset, paxalisib, is an investigational brain penetrant inhibitor of the PI3K/Akt /mTOR pathway, which is being developed to treat multiple forms of cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of over 15 clinical trials. A completed Phase 2/3 study in glioblastoma (GBM AGILE) was reported in 2024, and discussions are ongoing for designing and executing a pivotal registrational study in pursuit of a standard approval.

 

Other clinical trials involving paxalisib are ongoing in advanced breast cancer, brain metastases, diffuse midline gliomas, and primary central nervous system lymphoma, with several of these trials having reported encouraging interim data. Paxalisib was granted Orphan Drug Designation for glioblastoma by the U.S. Food and Drug Administration (FDA) in February 2018, and Fast Track Designation (FTD) for glioblastoma in August 2020. Paxalisib was also granted FTD in July 2023 for the treatment of solid tumor brain metastases harboring PI3K pathway mutations in combination with radiation therapy.

 

Additionally, paxalisib was granted Rare Pediatric Disease Designation and Orphan Drug Designation by the FDA for diffuse intrinsic pontine glioma in August 2020 and for atypical teratoid / rhabdoid tumors in June 2022 and July 2022, respectively. Kazia is also developing EVT801, a small molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. In addition to its clinical-stage programs, Kazia is advancing NDL2, a potentially first-in-class intracellular PD-L1 protein degrader program targeting a newly identified mechanism of immunotherapy resistance and metastatic progression, as well as MSETC, a potentially first-in-class SETDB1 inhibitor program intended to restore immune signaling in tumors that have become resistant to immunotherapy, including checkpoint inhibitors. Both programs are currently in preclinical development.

 

Forward-Looking Statements

 

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, but are not limited to, statements regarding the Offering and the potential gross proceeds therefrom, including the exercise of the Series A Warrants and Series B Warrants; the Company’s ability to achieve clinical milestones, including the Stage IV TNBC and HR+/HER2- data readouts that may trigger warrant exercise periods; the Company’s intended use of proceeds; and the Company’s plans for clinical development of paxalisib. Forward-looking statements are generally identified by words such as “anticipates,” “believes,” “expects,” “intends,” “plans,” “may,” “will,” “could,” “should,” “estimates,” “projects,” “potential,” and similar expressions. These forward-looking statements are based on management’s current expectations and assumptions as of the date of this press release and are subject to significant risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed or implied.

 

Such risks and uncertainties include, but are not limited to: the Company’s ability to complete the Offering; the Company’s ability to achieve clinical milestones, including the Stage IV TNBC and HR+/HER2- data readouts that trigger warrant exercise periods; risks associated with the conduct of clinical trials and regulatory approvals; volatility in the price of the Company’s ADSs and warrants; general economic and market conditions; and the Company’s ability to maintain compliance with NASDAQ listing requirements.

 

For a more complete discussion of risks and uncertainties, please refer to the Company’s filings with the SEC, including the “Risk Factors” section of the Company’s most recent Annual Report on Form 20-F. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. All forward-looking statements are qualified in their entirety by this cautionary statement.

 

MEDIA CONTACT

 

Michaela Fawcett / Molly Crawford

KCSA Strategic Communications

mfawcett@kcsa.com / mcrawford@kcsa.com

 

 

 

Filing Exhibits & Attachments

7 documents