Rare Response in Aggressive Breast Cancer Fuels Hope – and Financial Concerns – for Kazia Therapeutics

NEW YORK, NY – November 18, 2025

A remarkable response observed in a patient with metastatic triple-negative breast cancer (TNBC) is injecting cautious optimism into the pipeline of Kazia Therapeutics, an Australian oncology-focused company. While the positive data offers a potential lifeline for patients battling an aggressive form of cancer, it arrives amidst growing financial challenges for the biotech, including a looming threat of delisting from the Nasdaq Stock Market.

A Beacon of Hope in Difficult-to-Treat Cancer

TNBC is known for its aggressive nature and limited treatment options, particularly in the metastatic setting. Traditional chemotherapy often provides only temporary relief, and patients frequently experience disease progression. The recent case, involving a patient who achieved an initial immune-complete response (iCR) after treatment with Kazia’s paxalisib, combined with pembrolizumab (Keytruda) and standard chemotherapy, stands out as a potentially significant development.

The patient, diagnosed with Stage IV TNBC, experienced a substantial 86% reduction in tumor burden within just three weeks of initiating the combination therapy. Subsequent scans revealed complete metabolic resolution of all previously identified lesions, consistent with an iCR – a rare outcome for advanced TNBC. “These results are truly encouraging,” stated one oncologist familiar with the case, requesting anonymity. “To see a complete response in a patient with metastatic TNBC is uncommon, and to achieve it with a novel combination suggests a potentially impactful new approach.”

The observed iCR rate is significantly higher than those typically seen with existing treatments, such as pembrolizumab monotherapy (0.6-4%) or sacituzumab govitecan (2-4%). This suggests the combination therapy might be enhancing the body's immune response to cancer cells in a way that traditional treatments do not. “The combination of paxalisib with an immunotherapy like pembrolizumab appears to be unlocking a more potent anti-tumor effect,” explained a researcher specializing in PI3K/Akt/mTOR inhibitors. “Paxalisib may be modulating the tumor microenvironment, making it more susceptible to immune attack.”

Navigating Financial Turbulence

Despite the promising clinical data, Kazia Therapeutics is facing a critical financial juncture. The company recently received a Nasdaq staff determination letter indicating non-compliance with the minimum $35 million market value of listed securities requirement. This poses a significant threat to its listing on the Nasdaq Stock Market.

Kazia plans to request a hearing before a Nasdaq Hearings Panel to explore its options for regaining compliance. The company is also assessing alternative strategies to strengthen its financial position. “The Nasdaq delisting risk is a serious concern,” noted a financial analyst covering the biotech sector. “It could limit the company's access to capital and hinder its ability to advance its pipeline.”

The company’s financial situation is further complicated by its ongoing investment in multiple clinical trials, including studies evaluating paxalisib in glioblastoma and other cancers. Maintaining these programs requires significant capital, and the potential loss of its Nasdaq listing could jeopardize these efforts. “The company needs to demonstrate a clear path to profitability to reassure investors and maintain its access to funding,” stated another analyst.

Pipeline Progress and Future Outlook

Beyond the TNBC case, Kazia Therapeutics is actively pursuing several other programs. The company is advancing its NDL2 PD-L1 degrader program towards IND-enabling studies, with plans to initiate clinical trials in early 2026. It is also seeking FDA guidance on its glioblastoma program, following a completed Phase 2/3 study (GBM-Agile) and is working toward a registrational study. Additionally, the company is developing EVT801, a small molecule inhibitor of VEGFR3, and exploring its potential in various cancers.

“The diversity of Kazia’s pipeline is a strength,” commented a researcher familiar with the company’s programs. “The company is not solely reliant on a single asset, which mitigates some of the risk.” However, the success of these programs depends on securing sufficient funding and navigating the complex regulatory landscape.

The upcoming presentations at the Brisbane Cancer Conference and the San Antonio Breast Cancer Symposium will provide further insights into Kazia’s research and clinical development programs. Investors and analysts will be closely watching these events for updates on the company’s progress and future outlook. While the company’s financial challenges remain significant, the promising clinical data and ongoing pipeline development offer a glimmer of hope for patients battling aggressive cancers – and for the long-term viability of Kazia Therapeutics.