Kazia Therapeutics Limited develops clinical-stage oncology therapies through an Australian foreign-issuer structure whose American depositary shares trade under KZIA. Company news centers on paxalisib, a brain-penetrant dual PI3K/mTOR inhibitor being developed across brain cancer and advanced breast cancer indications, including triple-negative breast cancer studies that report clinical and translational findings.
Recurring updates also cover Kazia's broader oncology platform, including NDL2, a PD-L1 protein degrader platform, and MSETC, a SETDB1-targeted epigenetic program. Additional company developments include research leadership, licensing activity, financing and capital-structure actions, Nasdaq listing compliance, annual meeting matters, governance changes, and operating or financial results.
Kazia Therapeutics (KZIA) reported that Sovargen has dosed the first patient in a Phase 1b/2a trial of paxalisib for intractable epilepsy associated with focal cortical dysplasia type 2 (FCD T2) and tuberous sclerosis complex (TSC), triggering a $2 million development milestone payment to Kazia.
Sovargen holds an exclusive license from Kazia to develop, manufacture and commercialize paxalisib for mTORopathy‑related epilepsies worldwide, excluding mainland China, Hong Kong, Macao and Taiwan. Under this March 2024 agreement, Kazia is eligible for up to an additional $17 million in development and regulatory milestones, plus a percentage of sub‑licensing revenues and royalties on net sales of any paxalisib products. Paxalisib is described as an oral, brain‑penetrant dual PI3K/mTOR inhibitor, and this study extends its development beyond oncology into rare, treatment‑resistant seizure disorders.
Kazia Therapeutics (KZIA) has dosed the first patient in PNOC035 Arm A, a Phase 2 study of paxalisib plus gemcitabine in AT/RT.
The multicenter, open-label PNOC035 platform trial enrolls patients aged 1 to 39 with recurrent or progressive atypical teratoid/rhabdoid tumor, a highly aggressive pediatric brain cancer with no approved therapies. In Arm A, patients receive once-daily oral paxalisib and intravenous gemcitabine on Days 1, 8 and 15 of each 28‑day cycle. The combination increased median survival from 22 to 82.5 days (p<0.0001) in an orthotopic AT/RT preclinical model, supporting advancement into this clinical study.
Paxalisib holds both Orphan Drug and Rare Pediatric Disease Designations from the FDA for AT/RT, which, if development is successful and marketing approval is obtained, could make Kazia eligible for a pediatric priority review voucher. Paxalisib is an investigational PI3K/Akt/mTOR inhibitor that has been or is being evaluated in more than 15 clinical trials across multiple brain and systemic cancers.
Kazia Therapeutics (NASDAQ: KZIA) reported new preclinical and translational data showing its PI3K/mTOR inhibitor paxalisib reduced tumor burden by 52% (p=0.035) in a microsatellite stable / proficient mismatch repair (MSS/pMMR) colorectal cancer model. In a separate study, adding paxalisib to an existing checkpoint inhibitor immunotherapy cut tumor volume by an additional 50% versus immunotherapy alone (p=0.022). Across both models, treatment was well tolerated with no treatment-related toxicity observed.
Kazia is also running a next-generation biomarker program to define molecular, immune and epigenetic signatures linked to paxalisib response, and has filed a new patent related to colorectal cancer use. The company plans a five-arm Phase 2 trial in pre-treated MSS/pMMR metastatic colorectal cancer, testing paxalisib monotherapy and combinations with pembrolizumab versus standard of care. The primary endpoint will be safety and tolerability, with key efficacy endpoints as secondary measures. Enrollment is expected to start in Q1 2027, with full enrollment of all five arms targeted by year-end 2027.
Kazia Therapeutics (NASDAQ: KZIA) reported new preclinical data showing that its PI3K/mTOR inhibitor paxalisib, in combination with standard-of-care therapy, was well tolerated and produced statistically significant antitumor activity in HR+/HER2- breast cancer models, including resensitizing CDK4/6 inhibitor‑resistant tumors.
Based on these findings, Kazia is expanding its ongoing TNBC clinical trial to include a three‑arm cohort in pre‑treated HR+/HER2- metastatic breast cancer, evaluating paxalisib plus fulvestrant with palbociclib at 15 mg and 30 mg versus fulvestrant alone. The company has filed a provisional patent and identified a high‑risk subset defined by a novel PI3K/mTOR biomarker with tissue‑ and blood‑based tests. Sites for the expansion are expected to activate and enroll the first patient before year‑end 2026, with full enrollment anticipated by end of 2027 and a full data readout in 2028. According to Kazia, recent financing is expected to fund this program through completion.
Kazia Therapeutics (NASDAQ: KZIA) closed an oversubscribed, tranched registered public offering generating approximately $40 million in upfront gross proceeds from the sale of 2,580,000 ADSs (or pre‑funded warrants) at a combined public offering price of $15.50 per ADS with accompanying Series A and Series B warrants. The clinical milestone‑linked warrants are exercisable immediately at premiums to the ADS price: Series A at $17.825 per ADS (15% premium) for up to 2,243,478 ADSs, tied to Stage IV TNBC data expected in 2H 2027, and Series B at $19.375 per ADS (25% premium) for up to 2,064,000 ADSs, tied to HR+/HER2‑ data expected in 1H 2028. If fully exercised, total potential gross proceeds from the Offering would be about $120 million. Kazia plans to use net proceeds primarily to fund clinical development of paxalisib in triple‑negative breast cancer, HR+/HER2‑ breast cancer, and pMMR colorectal cancer, and for working capital and general corporate purposes. The company will host a corporate update call on September 1, 2026 at 8:00am ET.
Kazia Therapeutics (NASDAQ: KZIA) has priced a tranched registered public offering of 2,580,000 American Depositary Shares (ADSs), each representing 500 ordinary shares, or pre-funded warrants in lieu of ADSs, together with Series A and Series B warrants.
The combined public offering price is $15.50 per ADS with accompanying warrants and $15.4999 per pre-funded warrant with accompanying warrants, for expected gross proceeds of approximately $40 million before fees. Series A Warrants cover up to 2,243,478 ADSs at an exercise price of $17.825, expiring 30 days after the Stage IV TNBC data readout (expected 2H 2027) or five years from issuance. Series B Warrants cover up to 2,064,000 ADSs at an exercise price of $19.375, expiring 30 days after the HR+/HER2- data readout (expected 1H 2028) or five years from issuance. If fully exercised, these warrants would provide additional gross proceeds of about $80 million. The offering, sold entirely by Kazia, is expected to close on or about August 31, 2026, and net proceeds are intended mainly to fund clinical development of paxalisib and for general corporate purposes.
Kazia Therapeutics (NASDAQ: KZIA) has commenced a tranched registered public offering of American Depositary Shares (ADSs), each representing 500 ordinary shares, or pre-funded warrants in lieu of ADSs, together with accompanying Series A and Series B warrants to purchase ADSs (or pre-funded warrants).
The Series A warrants are immediately exercisable at 115% of the initial offering price and expire on the earlier of 30 days after the Stage IV triple-negative breast cancer data readout, expected in 2H 2027, or five years from issuance. Series B warrants are exercisable at 125% of the initial offering price and expire on the earlier of 30 days after the HR+/HER2- breast cancer data readout, expected in 1H 2028, or five years from issuance. According to Kazia, all securities are being sold by the company, and net proceeds are intended primarily to fund clinical development of paxalisib and for working capital and general corporate purposes. The size and final terms of the offering remain subject to market and other conditions.
Kazia Therapeutics (NASDAQ: KZIA) reported initial data from six evaluable Stage IV triple-negative breast cancer (TNBC) patients treated with its lead asset, paxalisib, in an ongoing Phase 1b trial combining paxalisib with pembrolizumab and chemotherapy. All six patients achieved clinical benefit, yielding a 100% clinical benefit rate. Five patients achieved an objective response (one complete, four partial), for an 83% objective response rate, and one patient had stable disease. A 44-year-old woman achieved a complete metabolic response with no evidence of disease since November 2025. No paxalisib-related serious adverse events were reported, and no grade 3 or higher hyperglycemia, stomatitis or mucositis were observed.
Translational analyses showed median reductions of 83% in circulating tumor cell clusters within six to seven weeks and 51% in terminally exhausted CD8+ T cells within about three weeks, with preserved total CD8+ T cell counts and blood-based evidence of improved immune function. Enrollment in the Phase 1b study is expected to complete by July 2027, with interim updates anticipated throughout 2026 and 2027.
Kazia Therapeutics (NASDAQ: KZIA) appointed James Levine as Chief Financial Officer, effective June 1, 2026. He brings more than 20 years of investment banking and biotech leadership experience.
Levine has held senior roles at Cardiff Oncology, Cidara Therapeutics, Verenium, Sapphire Energy, and Goldman Sachs, supporting financings and strategic transactions.
Kazia Therapeutics (NASDAQ: KZIA) plans to expand its ongoing Phase 1b trial of paxalisib in advanced triple negative breast cancer, increasing planned enrollment from 12 to 36 patients. The study combines paxalisib with pembrolizumab and chemotherapy.
The larger cohort aims to better characterize safety, tolerability, dose optimization, and preliminary efficacy, including ORR, PFS, and translational biomarkers. Kazia attributes the expansion to encouraging safety, tolerability, and clinical activity data and expects further clinical updates through 2026 and into 2027.