KAZIA THERAPEUTICS LTD (KZIA) reports very early but striking Phase 1b data for its lead drug paxalisib in Stage IV triple-negative breast cancer. In six evaluable patients, the company reports a 100% clinical benefit rate, with one complete response, four partial responses and one case of stable disease, for an 83% objective response rate. Median reductions reached 83% in circulating tumor cell clusters by 6–7 weeks and 51% in terminally exhausted CD8+ T cells within about three weeks, while total CD8 counts were maintained. No paxalisib-related serious adverse events were observed in these patients, and the company highlights a durable complete metabolic response in one patient ongoing since November 2025. Kazia positions paxalisib as a dual PI3K/mTOR inhibitor with epigenetic and immunomodulatory activity, with ongoing and planned studies in TNBC, HR+/HER2- breast cancer, pMMR colorectal cancer, glioblastoma and pediatric brain tumors. The investor presentation also notes approximately US$46 million in cash and equivalents as of December 31, 2025, no debt, roughly 14.1 million fully diluted ADS outstanding, and an intention to conduct an equity offering under an effective F-3 shelf.
KAZIA THERAPEUTICS LTD (KZIA) received an amended Schedule 13G/A indicating that investor Jorey Chernett beneficially owns a significant stake in the company’s American Depositary Shares (ADS).
As of the close of business on August 19, 2026, Chernett beneficially owned 2,339,009 ADS, representing 19.6% of the ADS class, based on 11,926,899 ADS outstanding as of the same date. Chernett reports sole voting and sole dispositive power over all 2,339,009 ADS, with no shared voting or dispositive power.
Ikarian Capital, LLC and Neil Shahrestani report beneficial ownership of 575,778 American Depositary Shares (ADSs) of Kazia Therapeutics Limited, representing 4.9% of this ADS class. Each ADS represents five-hundred Ordinary Shares of Kazia.
The reported position includes 179,577 ADSs that may be acquired within 60 days pursuant to warrants, which are subject to a 4.99% beneficial ownership limitation on conversion. The 4.9% figure is calculated using a total of 11,515,568 ADSs, comprising 11,335,991 ADSs outstanding as of December 11, 2025 plus 179,577 ADSs issuable upon warrant exercise, as disclosed in Kazia’s Form F-1. Ikarian Capital manages a master fund and separately managed accounts that are the record owners, and both Ikarian Capital and Mr. Shahrestani disclaim being a “group” or ultimate beneficial owners beyond what may be deemed under Section 13(d) or 13(g).
Kazia Therapeutics Limited is reported to have 264,980,500 Ordinary Shares beneficially owned by Lynwood Opportunities Master Fund, Lynwood Capital Management Inc., and Ben Shapiro, as of June 30, 2026. This represents 4.6% of the 5,713,449,734 Ordinary Shares outstanding as of March 12, 2026.
The shares are held through the issuer’s American Depositary Shares, with each ADS representing 500 Ordinary Shares. Each reporting person has sole voting and dispositive power over the reported shares and confirms ownership of 5 percent or less of the class. The reporting persons disclaim beneficial ownership beyond the shares directly held by each.
Kazia Therapeutics Limited filed a prospectus supplement covering 266,666 American Depositary Shares (ADSs), representing 133,333,000 ordinary shares, and updating its existing Form F-1 prospectus by incorporating a new Form 6-K.
The incorporated Form 6-K includes a press release describing a provisional patent application for a novel perioperative therapeutic strategy using paxalisib to prevent metastatic recurrence in high-risk early-stage triple-negative breast cancer. In a preclinical TNBC model, standard therapy followed by adjuvant paxalisib reduced residual disease and local recurrence by 95% and lung metastatic burden by 40%, while ex vivo studies showed 100% disruption of circulating tumor cell clusters. The company is evaluating expansion of paxalisib development into earlier-stage TNBC. The ADSs trade on Nasdaq under the symbol KZIA, with a last reported price of $12.21 per ADS on July 27, 2026.
Kazia Therapeutics Limited is updating its existing Form F-1 prospectus through a prospectus supplement covering 232,956 American Depositary Shares (ADSs), representing 116,478,000 ordinary shares. The ADSs trade on Nasdaq under “KZIA,” with a last reported price of $12.21 per ADS on July 27, 2026.
Through an attached Form 6-K, the company reports filing a provisional patent application for a novel perioperative strategy using its lead asset, paxalisib, aimed at preventing metastatic recurrence in high-risk early-stage triple-negative breast cancer. Preclinical perioperative studies showed a 95% reduction in residual disease and local recurrence and a 40% reduction in lung metastatic burden when standard therapy was followed by adjuvant paxalisib, while ex vivo studies showed 100% disruption of circulating tumor cell clusters.
Kazia Therapeutics Limited filed a prospectus supplement updating a Form F-1 registration covering 95,110 American Depositary Shares (ADSs), representing 47,555,000 ordinary shares. The supplement incorporates a July 28, 2026 report describing new scientific developments into the offering materials.
The company reports filing a provisional patent for a novel perioperative therapeutic strategy aimed at preventing metastatic recurrence in high-risk early-stage triple-negative breast cancer. In a TNBC preclinical model, standard treatment followed by adjuvant paxalisib reduced residual disease and local recurrence by 95% and lung metastatic burden by 40%. Ex vivo studies on patient tumor samples showed paxalisib fully disrupted (100%) circulating tumor cell clusters. These data, together with observations from an ongoing Phase Ib metastatic TNBC study, are presented as supporting further development of paxalisib across multiple disease stages.
Kazia Therapeutics Limited is updating an existing Form F-1 prospectus covering 10,700,211 American Depositary Shares (ADSs), each representing underlying ordinary shares, by incorporating a new Form 6-K filed on July 28, 2026. The ADSs trade on Nasdaq under the symbol KZIA, and the last reported price on July 27, 2026 was $12.21 per ADS.
The attached report describes a new provisional patent application for a novel therapeutic strategy aimed at preventing metastatic recurrence in high-risk early-stage triple-negative breast cancer using paxalisib. In a perioperative TNBC model, standard therapy followed by paxalisib reduced residual disease and local recurrence by 95% and lung metastatic burden by 40%, and ex vivo patient samples showed 100% disruption of circulating tumor cell clusters. These preclinical and translational findings, together with observations from an ongoing Phase Ib study in metastatic TNBC, are cited as support for broadening paxalisib development across multiple stages of disease.
Kazia Therapeutics Limited filed a provisional patent application for a novel perioperative therapeutic strategy intended to prevent metastatic recurrence in patients with high-risk early-stage triple-negative breast cancer (TNBC).
The strategy is supported by preclinical data in a TNBC model where standard treatment followed by adjuvant paxalisib reduced residual disease and local recurrence by 95% and lung metastatic burden by 40%. Ex vivo studies on tumor samples from high-risk early-stage TNBC patients showed paxalisib disrupted 100% of detected circulating tumor cell clusters. Preliminary findings from an ongoing Phase Ib study of paxalisib with pembrolizumab and chemotherapy in advanced metastatic TNBC, including objective tumor responses and CTC cluster disruption, further support continued development of paxalisib across multiple stages of TNBC. Paxalisib is Kazia’s lead PI3K/Akt/mTOR inhibitor and has been evaluated in multiple clinical trials across several central nervous system and oncology indications, with various FDA designations including Orphan Drug and Fast Track.
Kazia Therapeutics director Steven R. S. Coffey reported a grant of 100,000 employee stock options over ADSs. The options carry an exercise price of $9.10 per ADS, were granted for no consideration, vest on January 8, 2027, and expire on January 8, 2029. Following this award, he holds 100,000 derivative securities directly.