KZIA

Paxalisib Monotherapy Significantly Reduced Tumor Burden in Pre-Clinical Model of MSS/pMMR Colorectal Cancer, With the Addition of Pembrolizumab Driving a Further Reduction Paxalisib Was Well Tolerated as Monotherapy and in Combination with Checkpoint Inhibition Kazia is Preparing to Advance Paxalisib Into a Phase 2 Clinical Study to Evaluate Paxalisib in Immunotherapy-Resistant MSS/pMMR Colorectal Cancer SYDNEY, Sept. 1, 2026 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused biotechnology company developing therapies that selectively reprogram cancer biology, restore anti-tumor immunity and overcome treatment resistance, today 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% (p=0.035) in microsatellite stable (MSS) / proficient mismatch repair (pMMR) colorectal cancer.

Preclinical Data Show Paxalisib Combined With Standard-of-Care Therapy Is Well Tolerated and Produces Statistically Significant Antitumor Activity Three-Arm Expansion of the Ongoing TNBC Trial Will Evaluate Paxalisib Plus Fulvestrant, With Palbociclib, Versus Standard-of-Care First Patient Expected By Year-End 2026 and Full Enrollment by End of 2027 SYDNEY, Sept. 1, 2026 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA) ("Kazia" or the "Company"), an oncology-focused biotechnology company developing therapies that selectively reprogram cancer biology, restore anti-tumor immunity and overcome treatment resistance, today 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.

Kazia's first 6 TNBC patients all achieved clinical benefits. These early results make paxalisib a much more promising asset going forward. Responses across visceral, skeletal, and CNS metastases make that early signal more compelling. But it's a relatively small and uncontrolled cohort. KZIA is working towards an expanded Phase 1b trial with 36 patients. That should give us a clearer picture about paxalisib's potential.

SYDNEY, Aug. 28, 2026 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA) ("Kazia" or the "Company"), an oncology-focused biotechnology company developing therapies that selectively reprogram cancer biology, restore anti-tumor immunity and overcome treatment resistance, today announced the pricing of its previously announced tranched registered public offering (the "Offering") of (i) 2,580,000 American Depositary Shares ("ADSs"), each representing five hundred (500) 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 (or pre-funded warrants in lieu thereof), 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 (or pre-funded warrants in lieu thereof), 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.

SYDNEY, Aug. 27, 2026 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA) ("Kazia" or the "Company"), an oncology-focused biotechnology company developing therapies that selectively reprogram cancer biology, restore anti-tumor immunity and overcome treatment resistance, today announced that it has commenced a tranched registered public offering (the "Offering") of (i) American Depositary Shares ("ADSs"), each representing five hundred (500) 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 (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 ADSs (or pre-funded warrants in lieu thereof), 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.

Durable Complete Metabolic Response Ongoing Since November 2025 All Evaluable Patients Demonstrated Reductions in Metastasis-Associated CTC Clusters and Terminally Exhausted T cells, With Median Reductions of 83% and 51% Respectively No Treatment-Related Serious Adverse Events Observed SYDNEY, Aug. 27, 2026 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA) ("Kazia" or the "Company"), an oncology-focused biotechnology company developing therapies that selectively reprogram cancer biology, restore anti-tumor immunity and overcome treatment resistance, today 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 (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 percent.

Kazia Therapeutics is rated Strong Buy, driven by best-in-class potential for paxalisib and a discounted valuation. Paxalisib has shown strong efficacy in triple-negative breast cancer, including a complete response in a heavily pretreated patient. KZIA's pipeline is validated by recent PI3K/AKT/mTOR pathway approvals and acquisitions.

Clinically relevant perioperative studies demonstrate elimination of residual disease and prevention of metastatic spread, supported by complementary translational patient data Clinically relevant perioperative studies demonstrate elimination of residual disease and prevention of metastatic spread, supported by complementary translational patient data

SYDNEY, June 2, 2026 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA) ("Kazia," "Kazia Therapeutics" or the "Company"), a clinical-stage oncology company advancing therapies designed to reprogram cancer biology and overcome treatment resistance, today announced the appointment of James Levine as Chief Financial Officer, effective June 1, 2026. Mr. Levine brings more than two decades of experience across investment banking, executive and financial leadership at publicly traded biotech companies.

Planned Enrollment to Increase from 12 to 36 Patients Following Continued Encouraging Safety and Tolerability Data SYDNEY, May 26, 2026 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA) ("Kazia" or the "Company"), a clinical-stage oncology company advancing therapies designed to reprogram cancer biology and overcome treatment resistance, today announced plans to expand its ongoing Phase 1b clinical trial evaluating lead asset paxalisib in combination with standard-of-care therapies in patients with advanced triple negative breast cancer ("TNBC"). Based on continued encouraging safety, tolerability and clinical activity data observed to date, planned enrollment has increased from 12 to 36 patients.