Kazia Therapeuti (KZIA) Stock News

Kazia Therapeutics (NASDAQ: KZIA) reported remarkable results from a single-patient expanded access case using their investigational drug paxalisib. The patient, diagnosed with triple-negative breast cancer (TNBC), showed an 86% reduction in overall tumor burden after just three weeks of combination therapy including paxalisib, immunotherapy, and chemotherapy.

The patient, a 40+ year old female initially diagnosed in April 2023, had previously undergone neoadjuvant therapy and surgery before developing metastatic disease in the bones and lungs. The treatment approach mirrors Kazia's ongoing Phase 1b TNBC study, which evaluates paxalisib in combination with Keytruda® and chemotherapy.

Kazia Therapeutics (NASDAQ: KZIA) announced its participation in an Australian Medical Research Future Fund (MRFF) project focused on developing an AI-driven platform for treating diffuse midline glioma (DMG) and diffuse intrinsic pontine glioma (DIPG). The three-year initiative will establish DMG-ADAPTS, an AI-enabled clinical decision-making platform to optimize therapy sequencing for these aggressive pediatric brain cancers.

The project aims to integrate multiomics profiling with a therapeutic toolkit of twelve brain-penetrant molecules, including Kazia's investigational drug paxalisib, a dual PI3K/mTOR inhibitor. The initiative addresses DMG/DIPG, which accounts for up to 25% of childhood brain cancer deaths with median survival of less than one year. Kazia will provide paxalisib, which has shown encouraging activity in the PNOC 022 pediatric brain cancer trial.

Kazia Therapeutics (NASDAQ: KZIA) has reported breakthrough results from an ex vivo study of paxalisib, their investigational PI3K-mTOR inhibitor, in Stage IV HER2-positive metastatic breast cancer. The study demonstrated that paxalisib monotherapy achieved 100% disruption of circulating tumor cell (CTC) clusters containing three or more cells.

The research, led by Professor Sudha Rao at QIMR Berghofer, revealed significant potential for paxalisib in treating HER2-positive breast cancer, which represents 15-20% of cases. These findings complement Kazia's ongoing Phase 1b trial in triple-negative breast cancer, where initial data from July 2025 showed promising results in reducing CTCs.

Kazia Therapeutics (NASDAQ: KZIA), an oncology-focused drug development company, has secured a $2 million private placement (PIPE) with institutional investors at a 5% premium to the July 31, 2025 closing price. The transaction, expected to close on August 4, 2025, involves ordinary shares and prefunded warrants without common warrant coverage.

The proceeds will support the clinical development of two key programs: paxalisib, a brain-penetrant dual PI3K/mTOR inhibitor in trials for brain cancer and advanced breast cancer, and EVT801, a selective VEGFR3 inhibitor. The company will file a shelf registration statement within 60 days to register the resale of ADSs representing the ordinary shares and those underlying the pre-funded warrants.

Kazia Therapeutics (NASDAQ: KZIA) has reported promising early results from its Phase 1b trial combining Paxalisib with pembrolizumab and standard chemotherapy. The first patient, a 61-year-old woman with metastatic triple-negative breast cancer, showed a greater than 50% reduction in circulating tumor cells (CTCs) after just 21 days of treatment.

The combination therapy demonstrated significant reduction in both single CTCs and CTC clusters, which are known to be 20-100X more efficient at seeding metastases than single CTCs. Notably, the treatment also reduced the mesenchymal phenotype of remaining CTCs, a characteristic associated with aggressive cancer cells.

These early results align with preclinical findings published in Molecular Cancer Therapeutics, suggesting potential effectiveness against metastatic spread. The trial continues to enroll patients to assess safety, tolerability, and pharmacodynamics.

Kazia Therapeutics (NASDAQ: KZIA) has unveiled groundbreaking preclinical research published in Molecular Cancer Therapeutics demonstrating that its lead drug paxalisib shows promise in treating triple-negative breast cancer (TNBC). The study, conducted at QIMR Berghofer Medical Research Institute, revealed that paxalisib can effectively reprogram the tumor microenvironment and enhance immune response when combined with immunotherapy. Key findings show that paxalisib's dual targeting of PI3K and mTOR inhibits cancer cell growth, increases T cell infiltration, and demonstrates synergistic antitumor activity when combined with KEYTRUDA, leading to tumor regression in preclinical models. The company has already initiated a Phase 1b clinical trial testing paxalisib in combination with checkpoint inhibitors and chemotherapy for advanced breast cancer, with the first patient dosed.

Kazia Therapeutics (NASDAQ: KZIA) has initiated patient dosing in a Phase 1b clinical trial evaluating paxalisib for advanced breast cancer treatment. The study explores combining paxalisib, a dual PI3K/mTOR inhibitor, with olaparib or pembrolizumab. This multi-center, open-label, randomized trial aims to assess safety, tolerability, and preliminary efficacy of these combination treatments. The trial represents a strategic expansion of paxalisib's potential applications beyond brain cancer into broader solid tumor treatments. The study includes comprehensive biomarker profiling to guide future development and will evaluate early clinical activity signals. The research builds on preclinical data demonstrating epigenetic modulation in aggressive breast cancer models, with the combination approach targeting multiple cancer pathways including tumor metabolism, DNA repair, and immune evasion.

Kazia Therapeutics (NASDAQ: KZIA) provided a comprehensive business update highlighting significant progress in Q1 2025. The company received a research grant from The Michael J. Fox Foundation to explore paxalisib as a Parkinson's disease treatment. Key developments include launching a clinical trial for paxalisib combined with immunotherapy in advanced breast cancer patients and reaching FDA alignment on a phase 3 study design for glioblastoma treatment. Kazia raised $3 million in capital, including $1 million in non-dilutive funding. The company completed patient follow-up in EVT801's Phase 1 trial for solid tumors. However, Kazia faces Nasdaq compliance challenges, with its market value falling below the required $35 million threshold. The company implemented a 1:5 reverse ADS split and sold Cantrixil rights for $1 million. CEO Dr. John Friend demonstrated confidence by purchasing 8,000 ADSs at $4.2465 per share.

Kazia Therapeutics (NASDAQ: KZIA) has announced the sale of all intellectual property and trademark rights for its oncology drug candidate Cantrixil to Vivesto for USD $1 million. This transaction follows Vivesto's March 2021 licensing of exclusive global development and commercialization rights for the drug.

Vivesto has opted not to pursue Cantrixil's development in ovarian cancer as initially planned, and is instead exploring its potential in hematological cancers through preclinical studies. Cantrixil contains TRXE-002-01, a third-generation benzopyran SMETI inhibitor, encapsulated in α-cyclodextrin.

The sale provides Kazia with non-dilutive funding to support the advancement of their clinical-stage pipeline.