Kazia Therapeutics (NASDAQ: KZIA) files patent backed by TNBC data

Rhea-AI Filing Summary

Kazia Therapeutics Limited filed a provisional patent application for a novel perioperative therapeutic strategy intended to prevent metastatic recurrence in patients with high-risk early-stage triple-negative breast cancer (TNBC).

The strategy is supported by preclinical data in a TNBC model where standard treatment followed by adjuvant paxalisib reduced residual disease and local recurrence by 95% and lung metastatic burden by 40%. Ex vivo studies on tumor samples from high-risk early-stage TNBC patients showed paxalisib disrupted 100% of detected circulating tumor cell clusters. Preliminary findings from an ongoing Phase Ib study of paxalisib with pembrolizumab and chemotherapy in advanced metastatic TNBC, including objective tumor responses and CTC cluster disruption, further support continued development of paxalisib across multiple stages of TNBC. Paxalisib is Kazia’s lead PI3K/Akt/mTOR inhibitor and has been evaluated in multiple clinical trials across several central nervous system and oncology indications, with various FDA designations including Orphan Drug and Fast Track.

Key Figures

Residual disease and local recurrence reduction: 95% Lung metastatic burden reduction: 40% CTC cluster disruption in patient samples: 100% +1 more

4 metrics

Residual disease and local recurrence reduction 95% Observed in a preclinical high-risk early-stage TNBC model with standard therapy plus adjuvant paxalisib

Lung metastatic burden reduction 40% Observed in the same preclinical TNBC model after adjuvant paxalisib following standard treatment

CTC cluster disruption in patient samples 100% Ex vivo tumor samples from high-risk early-stage TNBC patients treated with paxalisib

Clinical trials involving paxalisib 10 Number of clinical trials in which paxalisib is or has been studied

Key Terms

provisional patent application, triple-negative breast cancer (TNBC), circulating tumor cell (CTC) clusters, Orphan Drug Designation, +2 more

6 terms

provisional patent application regulatory

"announced the filing of a provisional patent application supporting a novel therapeutic strategy"

A provisional patent application is a lightweight, temporary filing that records an inventor’s idea and sets an official filing date without starting the full patent review process. Think of it as placing a hold on an idea while you prepare the complete paperwork; it doesn’t grant a patent but can preserve the right to seek one later. For investors, it signals a company is protecting potential intellectual property, which can affect future competitive advantage and valuation, but it is not a guarantee of patent protection.

triple-negative breast cancer (TNBC) medical

"prevent metastatic recurrence in patients with high-risk early-stage triple-negative breast cancer (TNBC)"

A form of breast cancer that lacks three common proteins (estrogen receptor, progesterone receptor and HER2) that doctors often use as targets for standard treatments, so it is not responsive to those targeted therapies. Investors pay attention because limited treatment options make drug approvals, clinical trial results or new therapies especially valuable — like finding a new key for a locked door — and those breakthroughs can drive company value and regulatory scrutiny.

circulating tumor cell (CTC) clusters medical

"paxalisib completely disrupted (100%) the circulating tumor cell (CTC) clusters that were detected"

Orphan Drug Designation regulatory

"Paxalisib was granted Orphan Drug Designation for glioblastoma by the U.S. Food and Drug Administration"

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.

Fast Track Designation regulatory

"Paxalisib was also granted FTD in July 2023 for the treatment of solid tumor brain metastases"

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

Rare Pediatric Disease Designation regulatory

"paxalisib was granted Rare Pediatric Disease Designation and Orphan Drug Designation by the FDA"

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.

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FAQ

What did Kazia Therapeutics (KZIA) announce regarding triple-negative breast cancer?

Kazia Therapeutics announced filing a provisional patent for a perioperative therapeutic strategy aimed at preventing metastatic recurrence in high-risk early-stage triple-negative breast cancer (TNBC). The approach is supported by preclinical and translational data involving the company’s lead drug candidate, paxalisib.

What preclinical results did Kazia Therapeutics (KZIA) report for paxalisib in TNBC models?

In a high-risk early-stage TNBC model, standard therapy followed by paxalisib reduced residual disease and local recurrence by 95% and lowered lung metastatic burden by 40%. These are preclinical findings and are not yet confirmed in larger clinical trials.

How did paxalisib affect circulating tumor cell (CTC) clusters in Kazia Therapeutics (KZIA) studies?

Ex vivo translational studies on tumor samples from high-risk early-stage TNBC patients showed paxalisib completely disrupted (100%) detected circulating tumor cell (CTC) clusters. These results support further investigation of paxalisib’s potential to impact mechanisms linked to metastatic spread.

What ongoing clinical work supports Kazia Therapeutics (KZIA) paxalisib strategy in TNBC?

Kazia is running an ongoing Phase Ib study of paxalisib with pembrolizumab and chemotherapy in advanced metastatic TNBC, which has generated preliminary tumor responses and CTC cluster disruption. The company is evaluating expansion of development into earlier-stage TNBC settings.

What is paxalisib, the lead asset of Kazia Therapeutics (KZIA)?

Paxalisib is an investigational, brain-penetrant PI3K/Akt/mTOR pathway inhibitor being developed for multiple cancers. It has been or is being studied in 10 clinical trials, including glioblastoma, breast cancer, brain metastases, and other CNS tumors, with several FDA designations granted.

Which FDA designations has Kazia Therapeutics (KZIA) received for paxalisib?

Paxalisib has received multiple U.S. FDA designations, including Orphan Drug Designation and Fast Track Designation for glioblastoma and certain brain metastases, plus Rare Pediatric Disease and additional Orphan Drug Designations for specific pediatric brain tumors, supporting its regulatory development pathway.

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 July 2026

Commission File Number: 000-29962

Kazia Therapeutics Limited.

(Exact Name of Registrant as Specified in Its Charter)

Three International Towers Level 24 300 Barangaroo Avenue Sydney NSW 2000

(Address of principal executive offices)

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

Press Release

On July 28, 2026, Kazia Therapeutics Limited (the “Company”) issued a press release titled “Kazia Therapeutics Announces the Filing of Provisional Patent for Novel Strategy, Supported by Preclinical Data, to Prevent Metastatic Recurrence in Triple-Negative Breast Cancer”. A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Incorporation by Reference

The Company hereby incorporates by reference the information contained herein, including 99.1, except for the quotes of Dr. John Friend, Chief Executive Officer of the Company, contained in Exhibit 99.1, into the Company’s registration statements on Form F-3 (File Nos. 333-276091, 333-281937 and 333-294392).

EXHIBIT INDEX

The following exhibits are furnished as part of this Form 6-K:

Exhibit		Description
99.1		Press Release dated July 28, 2026.

1

SIGNATURES

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.
	By:	/s/ John Friend
	Name:	John Friend
	Title:	Chief Executive Officer
Date: July 28, 2026

2

Exhibit 99.1

Kazia Therapeutics Announces the Filing of Provisional Patent for Novel Strategy, Supported by Preclinical Data, to Prevent Metastatic Recurrence in Triple-Negative Breast Cancer

Clinically relevant perioperative studies demonstrate elimination of residual disease and prevention of metastatic spread, supported by complementary translational patient data

SYDNEY, Australia, July 28, 2026 – Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused biotechnology company developing therapies that reprogram cancer biology, restore anti-tumor immunity and overcome treatment resistance, announced the filing of a provisional patent application supporting a novel therapeutic strategy designed to prevent metastatic recurrence in patients with high-risk early-stage triple-negative breast cancer (TNBC).

The patent filing is supported by new preclinical findings from a model designed to replicate high-risk early-stage TNBC. In the model, standard treatment —neoadjuvant chemotherapy, anti-PD-1 immunotherapy and surgical resection — followed by adjuvant paxalisib reduced residual disease and local recurrence by 95% (p<0.0001) and lung metastatic burden by 40% (p<0.027).

Complementary translational studies were conducted on ex vivo tumor samples from patients with high-risk, early-stage TNBC. In these studies, paxalisib completely disrupted (100%) the circulating tumor cell (CTC) clusters that were detected. Together with emerging clinical observations from the Company’s ongoing metastatic TNBC study, these findings strengthen the translational rationale for advancing paxalisib across multiple stages of disease.

A New Strategy to Prevent Metastatic Recurrence

Approximately one-third of patients with Stage II/III TNBC continue to have residual disease following standard perioperative therapy and remain at high risk of metastatic recurrence. Current development strategies in this setting are primarily focused on intensifying tumor cell killing through additional cytotoxic therapies and antibody-drug conjugates.

Preventing metastatic recurrence could require more than eliminating residual tumor cells. It may also require targeting the biological programs that allow those surviving cells to evade immune surveillance, disseminate and establish metastatic disease.

Paxalisib represents a differentiated tumor and immune reprogramming strategy designed to potentially intervene before metastatic relapse becomes clinically established.

“For decades, oncology has largely focused on treating metastatic disease once it appears. The next frontier is preventing metastasis before it begins,” said Dr. John Friend II, Chief Executive Officer of Kazia Therapeutics. “Residual disease represents the population of tumor cells most capable of driving future metastatic relapse. Our new preclinical findings, together with encouraging translational observations from patients receiving paxalisib-based therapy, support a differentiated strategy focused on reprogramming tumor biology, restoring anti-tumor immunity and preventing metastatic recurrence. We believe these data significantly expand the potential opportunity for paxalisib beyond advanced disease and establish a strong scientific and intellectual property foundation for future development in high-risk early breast cancer.”

Building on Emerging Clinical Momentum

The Company’s ongoing Phase Ib study evaluating paxalisib in combination with pembrolizumab (Keytruda®) and chemotherapy in advanced metastatic TNBC generated encouraging preliminary clinical and translational findings, including objective tumor responses with disruption of CTC clusters.

Kazia believes the convergence of these patient observations with the newly generated perioperative preclinical data strengthens the rationale for advancing paxalisib across multiple stages of TNBC, from advanced metastatic disease to earlier intervention aimed at reducing residual disease and preventing metastatic recurrence.

Given these findings, the Company is actively evaluating opportunities to broaden the clinical development of paxalisib into earlier-stage TNBC and expects to provide additional details regarding its development strategy in the near term.

About Kazia Therapeutics

Kazia Therapeutics (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 10 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. For more information, please visit www.kaziatherapeutics.com or follow us on X @KaziaTx.

Forward-Looking Statements

This announcement may contain forward-looking statements, which can generally be identified as such by the use of words such as “may,” “will,” “estimate,” “future,” “forward,” “anticipate,” “expect,” “plan,” “believe,” “potential,” 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 filing and prosecution of the provisional patent application and the establishment of intellectual property protection for the perioperative therapeutic strategy; the potential of paxalisib to prevent metastatic recurrence in patients with high-risk early-stage triple-negative breast cancer; expectations regarding the ability of preclinical and translational findings to predict clinical outcomes; the potential therapeutic benefit of paxalisib to reprogram tumor biology, restore anti-tumor immunity and prevent metastatic recurrence; the Company’s plans to evaluate opportunities to broaden clinical development of paxalisib into earlier-stage TNBC; the ongoing Phase Ib clinical trial of paxalisib in advanced TNBC, including preliminary clinical and translational findings; the potential of paxalisib to disrupt circulating tumor cell clusters and reduce residual disease; and the timing and content of future public disclosures regarding the Company’s clinical programs and development strategy. 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 associated with: the development of early-stage therapeutic programs; the conduct of clinical trials, including the ability to enroll patients and achieve anticipated enrollment targets; the preliminary nature of preclinical data, which may not be predictive of clinical results in humans; the preliminary nature of data from small, open-label clinical studies, which may not be predictive of later-stage clinical results; risks related to regulatory approvals; risks related to Kazia’s reliance on third-party collaborators and clinical trial sites; risks related to the Company’s ability to obtain, maintain and protect its intellectual property, including the uncertainty of patent prosecution and the potential for third-party challenges; risks related to the impact of global economic conditions; and risks related to Kazia’s ability to maintain compliance with the applicable NASDAQ continued listing requirements and standards. These and other risks and uncertainties are described more fully in Kazia’s Annual Report on Form 20-F filed with the SEC, and in subsequent filings with the United States Securities and Exchange Commission. 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. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this announcement.

Media Contact

Michaela Fawcett
KCSA Strategic Communications
mfawcett@kcsa.com

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 PRESS RELEASE DATED JULY 28, 2026 15.2 KB