TLDR
- Kazia Therapeutics (KZIA) reported an initial complete response in a stage IV triple-negative breast cancer patient treated with paxalisib, pembrolizumab, and chemotherapy.
- The patient showed 86% tumor reduction after three weeks and complete metabolic resolution after three months of treatment.
- Complete responses in metastatic TNBC are rare, with typical rates of only 0.6-4% in clinical trials with approved therapies.
- The company faces financial challenges with a market cap of $9.62 million and received a Nasdaq non-compliance notice for not meeting the $35 million minimum market value requirement.
- Kazia plans to present data at upcoming conferences and is advancing its NDL2 program toward studies in early 2026.
Kazia Therapeutics announced Tuesday that a stage IV triple-negative breast cancer patient achieved an initial immune-complete response under an FDA-authorized treatment protocol. The patient received paxalisib, the company’s lead drug candidate, combined with Merck’s pembrolizumab and standard chemotherapy.
The company first reported progress for this patient on October 2, noting an 86% reduction in tumor burden after just three weeks of treatment. A follow-up PET/CT scan conducted around three months into therapy showed complete metabolic resolution of all previously detected lesions. This meets the criteria for an initial immune-complete response according to iRECIST standards.
Kazia Therapeutics Limited, KZIA
Triple-negative breast cancer represents one of the most aggressive cancer subtypes. It lacks three key receptors that other breast cancer treatments typically target. Stage IV indicates the cancer has spread to other parts of the body.
Complete responses in metastatic TNBC cases remain uncommon across current treatment options. Pembrolizumab alone shows complete response rates of approximately 0.6-4% in KEYNOTE clinical trials. Sacituzumab govitecan, another approved therapy considered highly active, reports complete response rates of just 2-4% in large studies.
The patient will undergo additional scans to confirm the initial findings. Dr. John Friend, Chief Executive Officer of Kazia Therapeutics, called the initial complete response “extremely encouraging.”
Business Updates and Upcoming Presentations
Kazia announced plans to present data on its paxalisib program at the Brisbane Cancer Conference and San Antonio Breast Cancer Symposium. The company is also advancing its NDL2 program, a PD-L1 degrader, toward studies expected to begin in early 2026.
The company intends to request a Type C meeting with the FDA regarding its glioblastoma program. Paxalisib is designed as a brain-penetrant inhibitor of the PI3K/Akt/mTOR pathway for brain cancer treatment.
Financial Position and Compliance Issues
Kazia operates with a market capitalization of approximately $9.62 million. The company reported minimal revenue of $0.03 million with no growth over the past three years. Its EPS stands at -12.09, reflecting ongoing losses.
The company’s current ratio and quick ratio both sit at 0.35. This indicates potential liquidity constraints. The net margin stands at -49,233.33%.
The Altman Z-Score of -44.51 places Kazia in the distress zone. This suggests elevated bankruptcy risk based on standard financial metrics.
On November 12, Kazia received a staff determination letter from Nasdaq. The notice indicated non-compliance with the exchange’s $35 million minimum market value requirement. The company plans to request a hearing before a Hearings Panel to address the compliance issue.
This hearing request will automatically stay any suspension or delisting action. The company will use this time to evaluate options for regaining compliance with Nasdaq listing standards.
Institutional ownership stands at 8.6%. Insider ownership is minimal at 0.01%. The stock’s beta of 2.24 indicates higher volatility compared to the broader market.
Analysts set a target price of $16.38 with a moderate buy recommendation score of 2. The P/S ratio sits at 288, well above historical medians. The RSI-14 reading of 31.08 suggests the stock is approaching oversold territory.
The stock surged 23.6% in after-hours trading Tuesday following the complete response announcement.
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