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Kazia (NASDAQ: KZIA) licenses SETDB1 platform, plans $6M dual-program push

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Rhea-AI Filing Summary

Kazia Therapeutics Limited has entered a License and Commercialisation Agreement with QIMR Berghofer, gaining an exclusive worldwide license to develop and commercialize cancer therapies based on a proprietary SETDB1-targeted epigenetic platform.

Kazia will pay an upfront license fee of $1,390,000 and share a percentage of future commercialization revenue, with rates linked to the development stage at which any product is out-licensed. The lead candidate, MSETC, is a highly selective bicyclic peptide discovered using an AI-integrated epigenetic drug discovery engine and is designed to restore immune signaling in tumors resistant to immunotherapy.

The company plans to advance the SETDB1 and PD-L1 degrader programs through IND-enabling studies over about 18 months at a combined expected cost of approximately $6 million, leveraging shared CRO resources and Australian R&D tax incentives. Kazia views the SETDB1 platform as complementary to its existing oncology pipeline, which includes paxalisib and EVT801.

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Insights

Kazia adds an early-stage SETDB1 epigenetic platform with modest upfront cost and clear development plan.

Kazia Therapeutics has licensed a first-in-class SETDB1-targeted epigenetic platform from QIMR Berghofer, paying an upfront $1,390,000 and agreeing to share commercialization revenue via a tiered structure. The license covers global rights, including the lead candidate MSETC and an AI-enabled discovery engine.

The company plans to move the SETDB1 and PD-L1 degrader programs through IND-enabling work over about 18 months at a combined expected cost of $6 million, while using shared CRO infrastructure and Australian R&D tax incentives to manage spend. These programs are currently preclinical, so any clinical or commercial impact depends on future results and regulatory progress.

This transaction broadens Kazia’s multi-layered oncology strategy, adding chromatin-level immune resistance targeting alongside paxalisib and a PD-L1 degrader. The filing presents the deal as expanding pipeline depth within a large epigenetic oncology market, but without near-term revenue or earnings effects disclosed here.

Upfront license fee $1,390,000 Paid to QIMR Berghofer within 15 business days of execution
Planned development spend $6 million Expected combined cost to advance SETDB1 and PD-L1 programs to IND readiness over 18 months
Development timeline 18 months Planned period to bring SETDB1 and PD-L1 degrader programs to IND-enabling completion
Epigenetic therapeutics market size $15–20 billion annually Estimated global epigenetic oncology market addressed by SETDB1 platform
License scope Exclusive worldwide rights Rights to research, develop, manufacture and commercialize SETDB1-based products
License and Commercialisation Agreement financial
"the Company entered a License and Commercialisation Agreement (the “Agreement”) with QIMR Berghofer"
epigenetic medical
"first-in-class SETDB1-targeted epigenetic drug development platform from QIMR Berghofer"
Epigenetic describes changes that alter how genes are turned on or off without changing the underlying DNA sequence, similar to flipping light switches or adjusting software settings that control a machine. For investors, epigenetic mechanisms matter because they create new targets for drugs, diagnostics, and therapies that can modify disease processes or patient responses, potentially leading to novel products, market opportunities, and long-term revenue streams.
IND-enabling studies regulatory
"the SETDB1 program is currently in preclinical development with a defined path toward IND-enabling studies"
Ind-enabling studies are early research efforts that test whether a new drug or treatment is safe and effective enough to move forward in development. They are like preliminary tests to ensure a product works as intended before investing more resources into large-scale trials. For investors, these studies are important because successful results can signal potential progress toward bringing a new product to market, impacting its future value.
R&D tax incentive financial
"a substantial portion of eligible expenditure expected to qualify for the Australian R&D tax incentive"
A research and development (R&D) tax incentive is a government program that returns part of a company’s spending on developing new products, processes, or technologies, similar to getting a discount or rebate for innovation costs. For investors this matters because it lowers effective development costs, improves cash flow and margins, and can speed up projects—factors that affect profitability, risk and the valuation of companies pursuing new growth.
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 granted Fast Track Designation (FTD) for glioblastoma by the FDA"
A "fast track designation" is a process that speeds up the review and approval of a product or project, allowing it to reach the market or be completed more quickly than usual. For investors, it can signal that a product may become available sooner, potentially leading to earlier revenue or benefits, and indicating a priority status that might influence company performance and market opportunities.

 

 

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 April 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

 

Entry into Material Definitive Agreement

 

This report on Form 6-K (the “Report”) contains information regarding the entry into a material definitive agreement by Kazia Therapeutics Limited (the “Company”). On April 10, 2026, the Company entered into a License and Commercialisation Agreement (the “Agreement”) with QIMR Berghofer Medical Research Institute (“QIMR Berghofer”), pursuant to which the Company obtained an exclusive, worldwide license to research, develop, manufacture, and commercialize products based on QIMR Berghofer’s proprietary SETDB1-targeted epigenetic platform.

 

Under the terms of the Agreement, the Company will pay QIMR Berghofer an upfront license fee of $1,390,000 within 15 business days of execution. The Agreement also provides for the Company to pay QIMR Berghofer a percentage of commercialization revenue received by the Company or its affiliates, with the specific percentage varying based on the stage of development at which any product is out-licensed to a third party. The Company has agreed to use commercially reasonable efforts to develop and commercialize at least one product under the licensed intellectual property.

 

About the SETDB1 Platform

 

SETDB1 is a histone methyltransferase that plays a key role in gene silencing. In cancer, overexpression of SETDB1 is associated with suppression of immune signaling pathways and resistance to immunotherapy. The licensed platform includes proprietary intellectual property directed to the inhibition of SETDB1 as a therapeutic strategy to restore immune function in tumors and enhance the efficacy of cancer treatments. The Company believes this platform complements its existing oncology pipeline by targeting cancer resistance mechanisms at the chromatin level.

 

Press Release

 

The Company is furnishing with this Report on Form 6-K a press release announcing the transaction, dated April 13, 2026, as Exhibit 99.1.

 

The Company hereby incorporates by reference the information contained herein, including Exhibit 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 April 13, 2026.

 

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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: April 13, 2026    

 

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Exhibit 99.1

 

Kazia Therapeutics Expands Oncology Platform with First-in-Class SETDB1 Inhibitor Drug Development Platform

 

Sydney, Australia – April 13, 2026 – Kazia Therapeutics Limited (Nasdaq: KZIA), a clinical-stage oncology company advancing therapies to reprogram cancer biology and overcome treatment resistance, announces the in-licensing of a first-in-class SETDB1-targeted epigenetic drug development platform from QIMR Berghofer.

 

The platform includes use of an AI-integrated epigenetic drug discovery engine, enabling rapid, precise, and scalable candidate generation. The lead drug candidate, MSETC, was discovered and optimized using this AI-integrated epigenetic drug discovery engine. MSETC is a highly selective bicyclic peptide designed to target a novel, disease-associated nuclear SETDB1 complex. By targeting SETDB1, the program is intended to restore immune signaling in tumors that have become resistant to immunotherapy, including checkpoint inhibitors.

 

“SETDB1 represents a compelling emerging target in oncology,” said Dr. John Friend, CEO of Kazia Therapeutics. “With this acquisition, we are extending our strategy to target how cancer controls its own behavior by addressing immune resistance at the chromatin level, one of the earliest layers of tumor immune regulation, alongside transcriptional reprogramming with paxalisib and targeted protein degradation with our PD-L1 platform. Together, these programs position Kazia’s pipeline to address cancer therapy across multiple layers of tumor biology.”

 

SETDB1 A High-Value Target in Immune Resistance

 

SETDB1 is increasingly recognized as a key epigenetic regulator of tumor immune evasion and has been associated with aggressive disease and poorer clinical outcomes in several tumor types. Preclinical studies suggest that inhibition of SETDB1 can restore interferon signaling, enhance antigen presentation, and increase tumor immune recognition.

 

Internal translational research has also identified a novel SETDB1-associated nuclear complex observed in resistant and metastatic disease settings, supporting continued development of Kazia’s first-in-class therapeutic approach targeting this biology.

 

The SETDB1 program is supported by extensive peptide screening and optimization, generating a pipeline of candidates with strong selectivity and intracellular targeting capability.

 

Building a Differentiated, Multi-Layered Oncology Platform

 

Cancer cells can evade treatment through genetic mutations, but also by dynamically reprogramming how genes and immune signals are regulated. This adaptive behavior underpins resistance to many current therapies, including immunotherapy.

 

Kazia’s pipeline now spans three complementary layers of cancer control:

 

Chromatin-level regulation (SETDB1) restoring immune visibility by reactivating suppressed signaling pathways

 

Transcriptional reprogramming (paxalisib) altering gene expression programs that drive tumor growth and immune suppression

 

Protein-level control (PD-L1 degrader platform, NDL2) eliminating intracellular PD-L1 and overcoming resistance mechanisms beyond antibody-based therapies

 

This integrated approach is designed to address tumor resistance at its source and create new opportunities for combination therapies across multiple cancer types.

 

Positioned Within a Large and Growing Oncology Opportunity

 

Epigenetic therapies represent a validated and expanding segment of oncology, with multiple approved agents demonstrating clinical impact. Earlier approaches helped establish the importance of epigenetic regulation in cancer but were often limited by broad, non-specific activity and modest clinical impact, particularly in solid tumors.

 

Advances in the understanding of tumor biology and immune resistance now enable more precise, mechanism-driven approaches. These next-generation strategies are designed to target specific drivers of tumor adaptation and immune evasion, with the potential for broader applicability and improved outcomes, particularly in combination with immunotherapy.

 

The global epigenetic therapeutics market is estimated to be in the range of $15–20 billion annually and is expected to grow meaningfully over the next decade, driven by next-generation approaches targeting immune resistance and tumor plasticity.

 

By targeting SETDB1, Kazia is addressing a major unmet need in aggressive, treatment-refractory cancers that account for a significant proportion of cancer-related mortality. The approach is designed to restore immune responsiveness across multiple tumor types, particularly in advanced and metastatic disease settings where treatment options remain limited.

 

  

 

 

Clear Development Path and Partnering Potential

 

The SETDB1 program is currently in preclinical development with a defined path toward IND-enabling studies. Kazia plans to generate translational data to support biomarker-driven development and combination strategies with immunotherapies and targeted agents.

 

Given its broad applicability across tumor types, and its role in immune resistance, the Company believes the program represents a compelling opportunity for early strategic partnerships.

 

Efficient Pipeline Expansion

 

Kazia intends to advance the SETDB1 program in parallel with its PD-L1 degrader platform through IND-enabling studies. By leveraging shared CRO resources, coordinated study design, and established scientific collaborations, the Company expects to achieve meaningful execution efficiencies.

 

The combined cost to advance both programs to IND readiness is expected to be approximately $6 million over 18 months, with a substantial portion of eligible expenditure expected to qualify for the Australian R&D tax incentive. This approach enables Kazia to expand its pipeline while maintaining capital discipline and preserving focus on ongoing clinical programs.

 

Transaction Terms

 

Under the terms of the agreement, Kazia has acquired global rights to the SETDB1 platform, including the lead candidate MSETC. Financial terms include an upfront payment of approximately $1.39 million and a tiered revenue-sharing structure aligned with development progress, with no clinical or regulatory milestone obligations.

 

About Kazia

 

Kazia Therapeutics Limited (NASDAQ: KZIA) is an oncology-focused drug development company, based in Sydney, Australia. Our lead program is paxalisib, 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 ten clinical trials in this disease. 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 by the FDA 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. In addition, 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 nuclear PD-L1 protein degrader program targeting a newly identified mechanism of immunotherapy resistance and metastatic progression, currently in preclinical development. For more information, please visit www.kaziatherapeutics.com or follow us on X @KaziaTx.

 

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About QIMR Berghofer:

 

QIMR Berghofer is a world-leading, translational medical research institute based in Brisbane, Australia. Established in 1945, the Institute is home to almost 1,000 scientists, clinician-scientists, support staff, and students working across four key research programs of Cancer Research, Infection and Inflammation, Population Health, and Brain and Mental Health. Its state-of-the-art facilities include Q-Gen Cell Therapeutics, which manufactures cell therapies. QIMR Berghofer seeks to deliver better health and wellbeing through impactful medical research that responds to the foremost health challenges of our time.

 

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," 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 potential of the SETDB1 program and epigenetic approaches to cancer treatment; Kazia's plans to advance the SETDB1 program through IND-enabling studies; the expected timeline of approximately 18 months to advance the SETDB1 and PD-L1 degrader programs to IND readiness; the anticipated cost of approximately $6 million to advance both programs; expectations regarding qualification for the Australian R&D tax incentive; the potential for execution efficiencies through shared CRO infrastructure and coordinated study design; expectations regarding commercialization revenue sharing under the QIMR Berghofer license agreement; and Kazia's broader pipeline strategy and the anticipated benefits of its three-platform approach. 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, including the SETDB1 program, the risk that preclinical results may not be predictive of clinical results, risks related to the timing, cost, and outcome of IND-enabling studies, risks related to regulatory approvals, risks related to Kazia's reliance on third-party collaborators, including QIMR Berghofer, risks related to intellectual property protection, risks that anticipated cost savings and efficiencies may not be realized, risks related to the availability and timing of R&D tax incentive refunds, 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.

 

 

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FAQ

What agreement did Kazia Therapeutics (KZIA) enter with QIMR Berghofer?

Kazia Therapeutics entered a License and Commercialisation Agreement with QIMR Berghofer, obtaining an exclusive worldwide license to develop and commercialize therapies from a proprietary SETDB1-targeted epigenetic platform. The deal includes global rights to the platform and its lead candidate, MSETC, plus revenue-sharing terms.

How much is Kazia Therapeutics (KZIA) paying upfront for the SETDB1 platform?

Kazia will pay QIMR Berghofer an upfront license fee of about $1,390,000 within 15 business days of signing. This payment secures exclusive worldwide rights to the SETDB1-targeted epigenetic platform, including the AI-enabled discovery engine and the lead drug candidate, MSETC.

What development plans and costs did Kazia Therapeutics (KZIA) outline for SETDB1 and PD-L1 programs?

Kazia plans to advance the SETDB1 program and its PD-L1 degrader platform through IND-enabling studies over approximately 18 months. The combined cost to reach IND readiness for both programs is expected to be about $6 million, with a substantial portion eligible for the Australian R&D tax incentive.

How does the SETDB1 platform fit into Kazia Therapeutics’ (KZIA) oncology strategy?

The SETDB1 platform targets epigenetic mechanisms of immune resistance at the chromatin level, aiming to restore immune signaling in resistant tumors. Kazia believes it complements paxalisib and its PD-L1 degrader, creating a multi-layered oncology pipeline that addresses tumor biology across several resistance pathways.

What is the size of the epigenetic therapeutics market relevant to Kazia Therapeutics (KZIA)?

The filing states the global epigenetic therapeutics market is estimated at roughly $15–20 billion annually and is expected to grow. Growth is driven by next-generation, mechanism-based approaches targeting immune resistance and tumor plasticity, the same space Kazia’s new SETDB1 program aims to address.

What revenue-sharing terms are included in Kazia Therapeutics’ (KZIA) SETDB1 agreement?

Under the agreement, Kazia will pay QIMR Berghofer a percentage of commercialization revenue it or its affiliates receive. The specific percentage varies depending on the development stage at which any product based on the SETDB1 platform is out-licensed to a third party.

Filing Exhibits & Attachments

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