New Research on Kazia Therapeutics Limited (KZIA-NASDAQ)

A new Executive Informational Overview is now available on Kazia Therapeutics Limited (KZIA-NASDAQ), a clinical-stage oncology biotech company advancing two licensed small molecules: paxalisib for glioblastoma and other CNS cancers, and EVT801 for advanced solid tumors, including ovarian cancer. This 60-page report explores Kazia's business model, growth strategy, market opportunity, competitive landscape, and key risks. Download the full report below.

Snapshot

Kazia Therapeutics Limited (“Kazia” or “the Company”) is a Sydney-based clinical-stage oncology company focused on high-need cancers of the central nervous system (CNS) and select hard-to-treat solid tumors. The portfolio includes two small-molecule programs: (1) paxalisib, a brain-penetrant inhibitor of the PI3K/AKT/mTOR pathway, a critical signaling route that helps cancer cells grow and multiply, licensed from Genentech, and (2) EVT801, a selective vascular endothelial growth factor receptor 3 (VEGFR3) inhibitor licensed from Evotec SE. Paxalisib is designed to achieve reliable drug levels in the brain, addressing a central barrier to treatment. It is advancing toward a single pivotal study in newly diagnosed, MGMT-unmethylated glioblastoma (GBM) and is being studied across additional settings, including brain metastases, select gliomas, such as Diffuse Intrinsic Pontine Glioma (DIPG), primary CNS lymphoma, and certain advanced breast cancer subtypes. Paxalisib has secured multiple FDA designations (Orphan Drug, Fast Track, Rare Pediatric Disease), enhancing regulatory engagement speed and providing potential market exclusivity, priority review, and other incentive benefits. EVT801 targets VEGFR3 to limit lymphangiogenesis—the formation of new lymphatic vessels that can enable tumor growth and metastasis—and favorably conditions the tumor microenvironment. Stage 1 of the first-in-human study is complete, with final Phase 1 readout expected in CY2025 and Phase 2 planning underway, initially in high-grade serous ovarian cancer (HGSOC) with potential immunotherapy combinations under evaluation.

Key Points of Kazia Therapeutics Limited

• Kazia runs a lean, partnership-first model. The Company outsources manufacturing and early development, focuses its spending on clinical trials, and pursues non-dilutive capital through regional licenses and research collaborations.
  
  
• Selective deals and collaborations include Simcere (Greater China) and Sovargen (select neurology), with research ties to QIMR Berghofer, Pacific Pediatric Neuro-Oncology Consortium (PNOC), and Memorial Sloan Kettering Cancer Center (MSKCC).
  
  
• Paxalisib’s composition-of-matter patents run to 2031; with process claims and Patent Term Extension (PTE)/Supplementary Protection Certificate (SPC) protection potentially to 2036 in major markets.
  
  
• Kazia’s leadership has been strengthened with CEO Dr. John Friend and Chairman Bryce Carmine, who bring clinical, operational, and market expertise to support the next phase of development.
  
  
• As of December 31, 2024, the Company’s cash position was ~A$3.06 million. Since then, Kazia raised $2 million via a registered direct (January 10, 2025), received $1 million from the Cantrixil IP sale (March 30, 2025), and closed a $2 million premium private placement (August 1, 2025), supporting flexible dilutive and non-dilutive funding as late-stage studies advance.

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