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 (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.
Kazia Therapeutics (NASDAQ: KZIA) appointed Dr. Sudha Rao as Chief Scientific Officer on April 15, 2026. Dr. Rao brings 20+ years of translational epigenetics experience, authorship on high‑impact journals, and lead inventorship on 39 international patents to advance Kazia's integrated oncology platform including paxalisib, NDL2, and MSETC.
She will lead R&D, biomarker strategy, external collaborations, and platform expansion with AI‑guided discovery and spatial/liquid epigenetic precision medicine.
Kazia Therapeutics (Nasdaq: KZIA) has in-licensed a first-in-class SETDB1-targeted epigenetic drug development platform from QIMR Berghofer, including the lead candidate MSETC and an AI-integrated discovery engine. The program is in preclinical development with a planned IND-enabling path.
Management expects to advance the SETDB1 and PD-L1 degrader programs to IND readiness for approximately $6 million over 18 months, with an upfront payment of $1.39 million and a tiered revenue-sharing structure.
Kazia Therapeutics (NASDAQ: KZIA) reported preclinical and translational data for NDL2, a bicyclic peptide degrader designed to selectively remove nuclear PD-L1, an intracellular driver of immunotherapy resistance and metastasis. In murine TNBC models NDL2 reduced tumor volume by 49% as monotherapy and 73% with anti-PD-1, plus a 50% reduction in lung metastases in combination. Data show immune reprogramming, favorable preclinical safety/PK, and liquid biopsy biomarker evidence. IND-enabling studies are underway with first-in-human trials targeted for 2027 and a planned dataset presentation in Q2 2026.
Kazia Therapeutics (NASDAQ: KZIA) reported preliminary clinical responses from its ongoing Phase 1b study of paxalisib combined with pembrolizumab and chemotherapy in late-stage metastatic triple-negative breast cancer (TNBC). To date, three patients treated with paxalisib-based regimens showed meaningful responses: two partial responses in trial participants and one confirmed complete metabolic response under expanded access. Median time on treatment is ~6.1 months, all patients remain on therapy, and paxalisib at 30 mg daily showed generally favorable tolerability. The company plans additional site activations and targets 12 TNBC patients by end-2026 with topline data in early 2027.
Kazia Therapeutics (NASDAQ: KZIA) said CEO John Friend will attend J.P. Morgan Healthcare Conference week and meet investors and partners.
The company highlighted it is well capitalized after a recent financing and expects a clinical and translational update before month-end from its Phase 1b paxalisib trial in advanced triple-negative breast cancer (TNBC), including additional clinical responses and expanded circulating tumor cell (CTC) and CTC cluster biomarker analyses. Kazia also plans the first update on its PD-L1 protein degrader program.
Kazia Therapeutics (NASDAQ: KZIA) regained full compliance with all Nasdaq listing standards on Dec 18, 2025 after Nasdaq confirmed the company meets Listing Rule 5550(b)(1) (the $2.5 million minimum stockholders' equity alternative to MVLS).
The restoration follows a $50 million private placement led by healthcare institutional investors that the company says materially strengthened its balance sheet; the previously scheduled Nasdaq hearing was cancelled as moot and Kazia's ADS will continue trading on The Nasdaq Capital Market.