Kazia gets $2M milestone as Sovargen starts trial

Kazia Therapeutics Limited (KZIA) reports that Sovargen Co. has dosed the first patient in a Phase 1b/2a clinical trial of paxalisib for intractable epilepsy associated with focal cortical dysplasia type 2 and tuberous sclerosis complex.

Rhea-AI Filing Summary

Kazia Therapeutics Limited (KZIA) reports that Sovargen Co. has dosed the first patient in a Phase 1b/2a clinical trial of paxalisib for intractable epilepsy associated with focal cortical dysplasia type 2 and tuberous sclerosis complex. This dosing triggers a $2 million development milestone payment to Kazia under the companies’ exclusive license agreement.

Under this agreement, Sovargen is responsible for developing, manufacturing and commercializing paxalisib for mTORopathy-related epilepsies globally, excluding mainland China, Hong Kong, Macao and Taiwan. Kazia remains focused on oncology development of paxalisib and is eligible to receive up to $17 million in additional development and regulatory milestones, plus a percentage of sub-licensing revenues and royalties on net sales.

Key Figures

Development milestone payment: $2 million Potential additional milestone payments: $17 million Paxalisib clinical trials: Over 15 clinical trials +3 more

6 metrics

Development milestone payment $2 million Payment to Kazia triggered by first patient dosed in Sovargen’s Phase 1b/2a paxalisib trial

Potential additional milestone payments $17 million Maximum further development and regulatory milestones payable to Kazia under Sovargen license

Paxalisib clinical trials Over 15 clinical trials Number of trials paxalisib is or has been the subject of across indications

Orphan Drug Designation Glioblastoma Paxalisib granted Orphan Drug Designation by FDA for glioblastoma in February 2018

Fast Track Designations 2 designations Fast Track Designation for glioblastoma in August 2020 and for certain solid tumor brain metastases in July 2023

Rare Pediatric Disease/Orphan Drug Multiple designations Rare Pediatric Disease and Orphan Drug Designations for diffuse intrinsic pontine glioma and atypical teratoid/rhabdoid tumors

Key Terms

mTORopathy-related epilepsies, Orphan Drug Designation, Fast Track Designation, Rare Pediatric Disease Designation, +2 more

6 terms

mTORopathy-related epilepsies medical

"licensed paxalisib from Kazia for the development and commercialization of paxalisib as a potential treatment for mTORopathy-related epilepsies"

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 Orphan Drug Designation for glioblastoma by the U.S. Food and Drug Administration (FDA) in February 2018, and Fast Track Designation (FTD) for glioblastoma"

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 for diffuse intrinsic pontine glioma"

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.

brain somatic mosaicism medical

"neurological disorders caused by brain somatic mosaicism"

antisense oligonucleotide medical

"SVG105 is an antisense oligonucleotide targeting intractable epilepsies"

An antisense oligonucleotide is a small piece of synthetic genetic material designed to attach to specific molecules in the body’s cells, effectively blocking or modifying how genes are expressed. This technology is important because it can be used to develop targeted treatments for certain diseases, which may influence the value of biotech companies and the broader healthcare sector. Its development reflects advances in personalized medicine and gene-based therapies.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What milestone did Kazia Therapeutics (KZIA) announce in this 6-K?

Kazia Therapeutics announced that Sovargen Co. dosed the first patient in a Phase 1b/2a clinical trial of paxalisib for intractable epilepsy linked to FCD T2 and TSC. This clinical milestone expands paxalisib’s development beyond oncology into rare seizure disorders.

How much is Kazia Therapeutics (KZIA) receiving from Sovargen for this milestone?

Dosing the first patient in Sovargen’s Phase 1b/2a trial triggers a $2 million development milestone payment to Kazia Therapeutics under their exclusive license agreement for paxalisib in mTORopathy-related epilepsies.

What additional payments could Kazia Therapeutics (KZIA) receive under the Sovargen agreement?

Kazia is eligible to receive up to an additional $17 million upon achieving further development and regulatory milestones, plus a percentage of sub-licensing revenues and royalties on net sales of any products incorporating paxalisib.

What is the geographic scope of Sovargen’s license for paxalisib from Kazia Therapeutics (KZIA)?

Sovargen has an exclusive license worldwide to develop, manufacture and commercialize paxalisib for mTORopathy-related epilepsies, excluding mainland China, Hong Kong, Macao and Taiwan, where Kazia retains rights.

What are the key indications targeted in Sovargen’s paxalisib trial licensed from Kazia Therapeutics (KZIA)?

Sovargen’s Phase 1b/2a trial evaluates paxalisib for intractable epilepsy associated with focal cortical dysplasia type 2 (FCD T2), tuberous sclerosis complex (TSC), and more broadly mTORopathy-related epilepsies, which currently have limited treatment options.

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

Form 6-K: How Foreign Companies Report to the SEC →

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

Available on EDGAR 09/22/2026 - 08:00 AM Accepted by SEC EDGAR 09/22/2026 - 08:00 AM Learn about SEC filing dates

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 September 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 September 22, 2026, Kazia Therapeutics Limited (the “Company”) issued a press release titled “Kazia Therapeutics Announces Sovargen Co. Doses First Patient in Phase 1b/2a Trial of Paxalisib for Rare Seizure Disorders”. 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 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 September 22, 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: September 22, 2026

2

Exhibit 99.1

Kazia Therapeutics Announces Sovargen Co. Doses First Patient in Phase 1b/2a Trial of Paxalisib for Rare Seizure Disorders

Clinical Milestone Expands Development of Paxalisib Beyond Oncology and Triggers $2 Million Payment to Kazia

SYDNEY, Australia, September 22, 2026 – Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused biotechnology company developing therapies that selectively reprogram cancer biology, restore anti-tumor immunity and overcome treatment resistance, today announced that Sovargen Co., Ltd., a biotechnology company specializing in central nervous system (CNS) diseases that has exclusively licensed paxalisib from Kazia for the development and commercialization of paxalisib as a potential treatment for mTORopathy-related epilepsies, has dosed the first patient in a Phase 1b/2a clinical trial evaluating paxalisib for the treatment of intractable epilepsy associated with focal cortical dysplasia type 2 (FCD T2) and tuberous sclerosis complex (TSC). The dosing triggers a $2 million development milestone payment to Kazia under the companies’ exclusive licensing agreement.

Kazia and Sovargen entered into the agreement in March 2024, under which Sovargen is responsible for developing, manufacturing and commercializing paxalisib as a potential treatment for the mTORopathy-related epilepsies in all countries worldwide, excluding mainland China, Hong Kong, Macao and Taiwan. Under the agreement, Kazia is eligible to receive additional milestone payments of up to $17 million upon the achievement of further development and regulatory milestones, plus a percentage of sub-licensing revenues and royalties on net sales of any products incorporating paxalisib.

FCD T2 and TSC are rare, genetically driven neurological disorders in which somatic mutations in the PI3K/Akt/mTOR pathway, or mutations in the TSC1 or TSC2 genes, drive overactivation of the mTOR pathway and contribute to treatment-resistant seizures. There are currently no approved therapies for FCD T2. Paxalisib is an oral, brain-penetrant dual inhibitor of PI3K and mTOR.

“This milestone reflects the steady progress Sovargen is making in advancing paxalisib for patients with FCD T2 and TSC, two rare disorders with significant unmet need,” said Dr. John Friend II, CEO of Kazia Therapeutics. “While our own clinical focus for paxalisib remains in oncology, we’re pleased to see its potential being explored in additional indications where its mechanism of action may address significant unmet medical needs. We look forward to the data generated through this study as the program advances.”

“Families living with FCD T2 and TSC have long faced limited treatment options, making the advancement of new therapies crucial,” said Cheolwon Park, CEO of Sovargen. “Dosing the first patient is a significant step for our program and reflects the dedication of our team and investigators in bringing this study to life. As enrollment continues, we remain focused on executing a rigorous clinical trial and generating the data needed to better understand paxalisib’s potential as a treatment for these rare neurological disorders.”

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 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. For more information, please visit www.kaziatx.com or follow us on X @KaziaTx.

About Sovargen

Sovargen Co., Ltd. is a clinical-stage biotechnology company based in Korea, founded in 2018 as a spin-out from the Korea Advanced Institute of Science and Technology (KAIST). The Company is focused on the discovery and development of medicines for rare and intractable neurological disorders caused by brain somatic mosaicism. The Company’s lead clinical asset, SVG103 (paxalisib), is a brain penetrant dual PI3K/mTOR inhibitor in-licensed from Kazia Therapeutics for the treatment of mTORopathy-related epilepsies, including focal cortical dysplasia type II (FCD T2), tuberous sclerosis complex (TSC), and hemimegalencephaly (HME) — conditions in which mTOR pathway hyperactivation is the underlying cause of drug-resistant seizures. SVG103 is currently being evaluated in a Phase 1b/2a study in adult patients with FCD T2, TSC, and HME. SVG105 is an antisense oligonucleotide targeting intractable epilepsies that has been out-licensed to a European global pharmaceutical company for worldwide development and commercialization. Sovargen’s pipeline is underpinned by its proprietary, integrated platform designed to discover and develop therapeutics for intractable CNS diseases. The platform features SovarIN™ for identifying disease-causing somatic mutations and therapeutic targets. SovarON™ for ASO design, screening, and optimization, and SovarUP™ for target validation and preclinical efficacy evaluation using disease-relevant animal models and human organoid systems. For more information, please visit www.sovargen.com.

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. 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 include, but are not limited to, statements regarding: the $2 million development milestone payment to Kazia; additional milestone payments of up to $17 million upon the achievement of further development and regulatory milestones, plus sub-licensing revenues and royalties; the progress and enrollment of Sovargen’s Phase 1b/2a clinical trial of paxalisib for FCD T2, TSC, and HME; the potential of paxalisib as a treatment for mTORopathy-related epilepsies and other non-oncology indications; and data generation from the clinical study.

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: risks associated with the development of early-stage therapeutic programs; the conduct and enrollment of clinical trials; regulatory review and approval processes; reliance on third-party licensees, collaborators and trial sites; the Company’s ability to obtain, maintain and protect its intellectual property; 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

KCSA Strategic Communications
mfawcett@kcsa.com

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 PRESS RELEASE DATED SEPTEMBER 22, 2026 16.9 KB