Kazia Therapeutics

KZIA

Market cap $117M

First patient from TNBC trial demonstrated 76% tumor volume shrinkage with corresponding reductions in circulating tumor cells (CTC) and clusters Reinvigoration of immune system + turning cold tumors hot Preliminary ex-vivo data in HER2+ patients demonstrates immune reinvigoration and reductions in CTC and clusters SYDNEY , Dec. 10, 2025 /PRNewswire/ -- Kazia Therapeutics Limited ("Kazia" or the "Company") (NASDAQ: KZIA) today announced new data from two presentations at the 2025 San Antonio Breast Cancer Symposium (SABCS) providing compelling mechanistic and early clinical evidence supporting the activity of paxalisib, the Company's brain-penetrant dual PI3K/mTOR inhibitor, across both HER2-positive metastatic breast cancer and triple-negative breast cancer (TNBC). The results, originating from advanced liquid biopsy profiling, immune phenotyping, and early clinical readouts, highlight paxalisib's potential to disrupt highly aggressive circulating tumor cell (CTC) clusters, reverse epigenetically-driven resistance pathways, and reinvigorate exhausted T- and B-cell populations, thereby enhancing responsiveness to immunotherapy.

Kazia Therapeutics Limited (NASDAQ: KZIA) announced a private placement of approximately $50 million in shares and prefunded warrants, at a purchase price per share equivalent to $5 per ADS. Each ADS represents 500 ordinary shares.

SYDNEY , Dec. 2, 2025 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, today announced that it has entered into a securities purchase agreement with certain established institutional and accredited investors for a private placement of equity securities (PIPE). Pursuant to the securities purchase agreement, the Company agreed to offer and sell to the investors an aggregate of approximately $50.0 million of ordinary shares and prefunded warrants, at a purchase price per share that is the equivalent of $5.00 per ADS, each ADS representing 500 ordinary shares.

SYDNEY , Nov. 18, 2025 /PRNewswire/ -- Kazia Therapeutics Limited (Nasdaq: KZIA), an oncology-focused drug development company, today announced that a patient with stage IV triple-negative breast cancer (TNBC) treated under an FDA-authorized single-patient expanded access protocol combining paxalisib with pembrolizumab (Keytruda®) and standard chemotherapy has achieved an initial immune-complete response (iCR) per iRECIST criteria. This outcome suggests a profound radiologic response in a highly aggressive metastatic cancer subtype.

SYDNEY , Oct. 27, 2025 /PRNewswire/ -- Kazia Therapeutics Limited ("Kazia" or the "Company") today announced its intention to request and hold a follow-up Type C meeting with the U.S. Food & Drug Administration (FDA) to discuss overall survival (OS) findings in newly diagnosed glioblastoma (GBM) patients treated with paxalisib and to seek agency feedback on a potential regulatory pathway aligned with the FDA Oncology Center of Excellence's Project FrontRunner initiative. "GBM remains one of the most lethal cancers with limited therapeutic options.

SYDNEY , Oct. 7, 2025 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, today announced an exclusive collaboration and in-licensing agreement (the "Agreement") with QIMR Berghofer for a first-in-class PD-L1 degrader program. The lead optimized compound, NDL2, is an advanced PD-L1 protein degrader currently in development and represents a new and innovative frontier of cancer immunotherapy.

SYDNEY , Oct. 2, 2025 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, today reported a substantial reduction in tumor burden from a single-patient expanded access case in triple-negative breast cancer (TNBC) treated with a combination regimen that included the Company's investigational pan-PI3K/mTOR inhibitor, paxalisib. After three weeks of combination immunotherapy/chemotherapy plus paxalisib, imaging performed at the treating institution showed an 86% reduction in overall tumor burden.

SYDNEY , Oct. 1, 2025 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), a clinical-stage biotechnology company developing innovative therapies for brain cancers, today announced its participation in a fully funded Australian Medical Research Future Fund (MRFF) project titled "Sequential & Temporal Therapeutic Agility for the Treatment of Diffuse Midline Glioma (DMG)". Under this three-year initiative, a consortium of leading researchers will establish DMG-ADAPTS, an advanced AI-enabled clinical decision-making platform designed to optimize sequencing and timing of targeted therapies for diffuse midline glioma (DMG), including diffuse intrinsic pontine glioma (DIPG).

SYDNEY , Sept. 11, 2025 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, today announced new findings from a collaborative research program led by Professor Sudha Rao at QIMR Berghofer.

SYDNEY , Aug. 1, 2025 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, today announced that it has entered into a securities purchase agreement with certain established institutional investors for a private placement of equity securities (PIPE). Pursuant to the securities purchase agreement, the Company agreed to offer and sell to an aggregate of approximately $2.0 million of ordinary shares and prefunded warrants.