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Kazia Therapeutics Limited filings document foreign private issuer disclosures for a clinical-stage oncology company with Nasdaq-traded American depositary shares. Form 6-K reports furnish investor presentations, fact sheets, clinical updates for paxalisib, material-event disclosures, operating and financial results, and updates related to the company's oncology pipeline.
The filing record also covers capital structure and financing activity, including ADS sales agreements, registration-statement references, private placements, ordinary shares, pre-funded warrants, and placement-agent warrants. Governance disclosures include annual general meeting results, director and committee changes, and shareholder voting matters. Material-agreement filings describe licensing arrangements such as the SETDB1-targeted epigenetic platform, while risk and forward-looking disclosures address development-stage biotechnology, regulatory plans, clinical programs, and capital-market compliance.
Kazia Therapeutics Limited files a prospectus supplement covering 95,110 American Depositary Shares (ADSs), which represent 47,555,000 ordinary shares, to update its existing Form F‑1 prospectus with new clinical information from a recent Form 6‑K. The update centers on a Phase 1b study of paxalisib in late‑stage metastatic triple‑negative breast cancer (TNBC) in combination with pembrolizumab and chemotherapy.
In this program, three patients with metastatic TNBC treated with paxalisib‑based regimens have shown meaningful responses: two partial responses in trial participants and one confirmed complete metabolic response in a patient treated under an expanded access program. Paxalisib has been generally well tolerated, with most adverse events considered unlikely or unrelated to the drug and only expected, mainly mild to moderate, paxalisib‑related side effects reported at the 30 mg daily dose.
Kazia plans to activate two additional clinical sites by April 2026 and two more in mid‑2026, targeting enrollment of twelve TNBC patients by the end of 2026 and a topline data readout in early 2027, while continuing broader development of paxalisib and other oncology assets.
Kazia Therapeutics Limited supplements its prospectus covering 232,956 American Depositary Shares, each representing 500 ordinary shares, with a new clinical update on paxalisib in metastatic triple-negative breast cancer (TNBC). The attached Form 6-K details preliminary results from an ongoing Phase 1b study of paxalisib in combination with pembrolizumab and chemotherapy or with olaparib in advanced breast cancer. Three metastatic TNBC patients have shown meaningful responses: two partial responses in trial participants and one confirmed complete metabolic response in an expanded access patient, all remaining on treatment. Paxalisib has been generally well tolerated at a 30 mg daily dose, with mostly mild to moderate expected side effects and two serious adverse events reported as unrelated to paxalisib. Kazia plans to activate additional clinical sites in 2026, target enrollment of twelve TNBC patients by the end of 2026, and expects topline data in early 2027.
Kazia Therapeutics Limited has a prospectus supplement covering 10,700,211 American Depositary Shares, representing 5,350,105,500 ordinary shares, and uses it to incorporate a new clinical update into its existing Form F-1 prospectus. The supplement attaches a Form 6-K that reports preliminary results from an ongoing Phase 1b study of paxalisib in combination with pembrolizumab and chemotherapy in late-stage metastatic triple-negative breast cancer.
The company notes three meaningful clinical responses so far: two partial responses in trial participants and one confirmed complete metabolic response in a patient treated under an expanded access program. Paxalisib has been generally well tolerated with mostly mild to moderate expected side effects, and Kazia plans to activate additional clinical sites in 2026, complete enrollment of twelve TNBC patients by the end of 2026, and target a topline data readout in early 2027.
Kazia Therapeutics reported early clinical signals from an ongoing Phase 1b study of its PI3K/mTOR inhibitor paxalisib in late-stage metastatic triple-negative breast cancer. The drug is being tested with pembrolizumab and chemotherapy, or with olaparib in BRCA-mutated advanced breast cancer. Three metastatic TNBC patients treated with paxalisib-based regimens have shown meaningful responses, including two partial responses in trial participants and one confirmed complete metabolic response in an expanded access patient. Paxalisib has been generally well tolerated, with about 75% of adverse events judged unlikely or unrelated to the drug, mainly mild to moderate expected side effects, one Grade 1 hyperglycemia case, and two serious adverse events deemed unrelated. Kazia plans to activate additional clinical sites in 2026, aims to enroll twelve TNBC patients by the end of 2026, and anticipates a topline data readout in early 2027.
Lynwood Opportunities Master Fund and its affiliates have disclosed a sizable passive stake in Kazia Therapeutics Limited. The fund, together with its investment manager Lynwood Capital Management Inc. and principal Ben Shapiro, reports beneficial ownership of 307,998,500 Ordinary Shares, representing 5.4% of Kazia’s Ordinary Shares as of the close of business on January 15, 2026. This percentage is based on 5,667,995,734 Ordinary Shares outstanding as of December 11, 2025.
The position is held through Kazia’s American Depositary Shares, each representing 500 Ordinary Shares, under CUSIP 48669G303. The filers certify that the securities were not acquired and are not held for the purpose of changing or influencing control of Kazia, indicating a passive investment stance.
Kazia Therapeutics Limited is registering for resale up to 232,956 American Depositary Shares (ADSs), representing 116,478,000 ordinary shares, held by existing investors. These ADSs consist of ordinary shares and ADSs issuable upon exercise of pre-funded warrants originally sold in a prior private placement, and all sale proceeds will go to the selling shareholders, not the company.
Kazia is an oncology-focused biotech developing paxalisib for glioblastoma and other brain cancers, and EVT801 for solid tumors. In December 2025, the company completed a private placement of 4,530,854,000 ordinary shares and pre-funded warrants to purchase up to 938,490 ADSs, generating approximately $46.5 million in net proceeds, which management expects will fund operations into the second half of 2028. Nasdaq has also confirmed that Kazia’s ADSs remain in compliance with listing standards after a prior deficiency related to market value of listed securities.
Kazia Therapeutics closed a large private placement, selling 4,530,854,000 ordinary shares at $0.01 per share and issuing pre-funded warrants to purchase up to 938,490 ADSs, each ADS representing 500 ordinary shares. It also issued placement agent warrants for up to 700,013 ADSs at $7.50 per ADS.
The transaction closed on December 3, 2025 and generated approximately $46.5 million in net proceeds for the company. Kazia states that, as a result, it now believes its stockholders' equity exceeds the $2.5 million requirement for continued listing on The Nasdaq Capital Market under an alternative standard.
The company plans to inform the Nasdaq Hearings Panel of this status and notes that it anticipates the financing will extend its cash runway into the second half of 2028. However, it cautions that there is no assurance Nasdaq will determine that the company has regained compliance with all continued listing standards.
Kazia Therapeutics Limited is updating a previously registered offering of 95,111 American Depositary Shares, representing 47,555,560 ordinary shares, via a prospectus supplement that incorporates its latest Form 6-K disclosure. The ADSs trade on Nasdaq under the symbol KZIA, and on November 17, 2025, the last reported sale price was $6.08 per ADS.
The attached Form 6-K explains that Kazia has not regained compliance with Nasdaq’s $35 million Market Value of Listed Securities requirement by the November 10, 2025 deadline. Nasdaq staff has issued a determination letter, and Kazia intends to request a hearing before a Nasdaq Hearings Panel, which will temporarily stay any suspension or delisting. The company plans to present a compliance plan at the hearing but cautions there is no assurance the Panel will accept it or that it will ultimately meet all Nasdaq listing standards.
Kazia Therapeutics Limited updates its prospectus covering 1,770,000 American Depositary Shares, representing 885,000,000 ordinary shares, by incorporating a new Form 6-K. The update explains that Nasdaq previously notified the company its Market Value of Listed Securities was below the required $35 million from March 28, 2025 to May 9, 2025, triggering a compliance period that ended on November 10, 2025. On November 12, 2025, Nasdaq staff determined Kazia had not regained compliance and indicated its securities are subject to suspension or delisting unless a hearing is requested. Kazia plans to request a hearing before a Nasdaq Hearings Panel to present a plan to regain and sustain compliance, but there is no assurance the panel will accept the plan or that compliance will be restored.