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KZIA-News
KZIA-Events
Kazia Therapeutics Reports Paxalisib Significantly Reduces Tumor Burden
Kazia Therapeutics announced new preclinical and translational data showing that its lead asset, paxalisib, reduced tumor burden, the total amount of cancer in the body, by 52% in microsatellite stable / proficient mismatch repair colorectal cancer. In a separate study, adding paxalisib to an existing immunotherapy drug reduced tumor volume by an additional 50%, compared with the immunotherapy alone. Across both studies, treatment was well tolerated, with no evidence of treatment-related toxicity. The Company plans to launch a five-arm Phase 2 clinical trial evaluating paxalisib as a monotherapy in combination with pembrolizumab versus standard of care in pre-treated MSS/pMMR metastatic colorectal cancer. The primary endpoint is safety and tolerability, with progression-free survival, overall response rate and overall survival as secondary endpoints. Enrollment is expected to begin in the first quarter of 2027, with full enrollment of all five arms anticipated by the end of 2027.
Kazia Therapeutics Releases New Data Showing Paxalisib's Anti-Tumor Activity in HR+/HER2- Breast Cancer
Kazia Therapeutics announced new preclinical data demonstrating the safety and anti-tumor activity of paxalisib in HR+/HER2- breast cancer, including evidence that paxalisib resensitized CDK4/6 inhibitor-resistant tumors to standard-of-care therapy. Based on these findings, the Company is moving rapidly to expand its ongoing TNBC clinical trial into hormone receptor-positive, HER2-negative advanced breast cancer to evaluate this effect directly and filed a related provisional patent application. In addition to these findings, paxalisib in combination with fulvestrant, and paxalisib in combination with fulvestrant and palbociclib, showed consistent safety and resulted in statistically significant reductions in tumor volume across preclinical models. Kazia has filed a patent that is supported by the Company's preclinical findings and has identified a high-risk subset of metastatic HR+/HER2- breast cancer defined by a novel PI3K/mTOR biomarker, with tissue- and blood-based tests associated with poor survival.
Kazia Therapeutics Announces $40 Million Public Offering Pricing
Kazia Therapeutics announced the pricing of its previously announced tranched registered public offering of (i) 2,580,000 American Depositary Shares, each representing five hundred ordinary shares of the company, no par value per share, or in lieu of ADSs to certain investors, pre-funded warrants to purchase ADSs, (ii) accompanying Series A Warrants to purchase up to 2,243,478 ADSs, which are exercisable immediately at a purchase price of $17.825 per ADS and will expire upon the earlier of 30 days following the company's Stage IV triple-negative breast cancer (TNBC) data readout, expected in the second half of 2027, or the five-year anniversary of issuance, and (iii) accompanying Series B Warrants to purchase up to 2,064,000 ADSs, which are exercisable immediately at a purchase price of $19.375 per ADS and will expire upon the earlier of 30 days following the company's HR+/HER2- data readout, expected in the first half of 2028, or the five-year anniversary of issuance. All of the securities in the Offering are being sold by Kazia. The combined public offering price for each ADS and accompanying warrants is $15.50, and the combined public offering price for each pre-funded warrant and accompanying warrants is $15.4999, for expected gross proceeds to Kazia of approximately $40M, before deducting underwriting discounts and commissions and offering expenses. If all of the Series A Warrants and Series B Warrants are exercised in full, the company would receive additional gross proceeds of approximately $80M, before deducting applicable expenses. Leerink Partners and Guggenheim Securities are acting as joint bookrunning managers for the Offering. BTIG and Needham & Company are acting as lead managers for the Offering. Laidlaw & Company Ltd. is acting as co-manager for the Offering. The Offering is expected to close on or about August 31.
Kazia Therapeutics Launches Public Offering of ADS and Warrants
Kazia Therapeutics announced that it has commenced a tranched registered public offering of (i) American Depositary Shares, each representing five hundred ordinary shares of the company, no par value per share, or in lieu of ADSs to certain investors, pre-funded warrants to purchase ADSs, (ii) accompanying Series A Warrants to purchase ADSs (or pre-funded warrants in lieu thereof), which are exercisable immediately at an exercise price equal to 115% of the initial public offering price per ADS and accompanying Warrants and expire upon the earlier of 30 days following the Company's Stage IV triple-negative breast cancer data readout, expected in the second half of 2027, or the five-year anniversary of issuance, and (iii) accompanying Series B Warrants to purchase ADSs, which are exercisable immediately at an exercise price equal to 125% of the initial public offering price per ADS and accompanying Warrants and expire upon the earlier of 30 days following the Company's HR+/HER2- data readout, expected in the first half of 2028, or the five-year anniversary of issuance. All of the securities in the Offering are to be sold by Kazia. Leerink Partners and Guggenheim Securities are acting as joint bookrunning managers for the proposed Offering. BTIG, Needham & Company and Laidlaw & Company are acting as co-managers for the proposed Offering.
Kazia Therapeutics Reports 100% Clinical Benefit Rate for Paxalisib in Stage IV TNBC Patients
Kazia Therapeutics announced new data showing its lead asset, paxalisib, achieved a 100% clinical benefit rate in six evaluable patients with Stage IV triple-negative breast cancer, or TNBC. Five of the six patients achieved an objective response - a measurable 30% or greater reduction in tumor burden after treatment - including one complete response and four partial responses, resulting in an objective response rate of 83%. The remaining patient achieved stable disease. Importantly, these results were achieved with the convenience of oral dosing and a favorable safety and tolerability profile, with no paxalisib-related serious adverse events and no grade 3 or higher commonly associated toxicities. Clinical responses were observed across a broad range of metastatic disease sites, including lung, liver, bone, lymph node and central nervous system target lesions, with responses emerging as early as approximately three months post-randomization. Enrollment in the company's ongoing Phase 1b study evaluating paxalisib in combination with pembrolizumab and chemotherapy in advanced metastatic TNBC is expected to be completed by July 2027, with interim clinical updates anticipated throughout 2026 and 2027.
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