Kazia Therapeuti Stock Price, News & Analysis

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.

Kazia Therapeutics (NASDAQ: KZIA) has received a research grant from The Michael J. Fox Foundation for Parkinson's Research to study paxalisib as a potential treatment for Parkinson's disease (PD). The research will be conducted in collaboration with The Hebrew University of Jerusalem at Professor Ronit Sharon's lab.

The study will focus on evaluating paxalisib, a unique blood-brain barrier-penetrating PI3K inhibitor, through preclinical studies assessing mouse survival, motor and non-motor performances, and various disease biomarkers. The research aims to establish a connection between PD pathophysiology and paxalisib, particularly focusing on its potential to inhibit AKT phosphorylation reaction of α-SynA53T, a protein whose overexpression is associated with Parkinson's disease.

The research builds upon preliminary findings that highlight the role of the PI3K/AKT/mTORC pathway in PD pathogenesis, suggesting paxalisib's potential therapeutic application in addressing underlying disease mechanisms.

Kazia Therapeutics (NASDAQ: KZIA) has announced the launch of ABC-Pax, a groundbreaking clinical trial combining paxalisib with immunotherapy for advanced breast cancer treatment. The phase 1b study will evaluate paxalisib in combination with KEYTRUDA® or LYNPARZA® in women with triple negative breast cancer.

The multi-centre, open-label trial will enroll 24 patients from Queensland, Australia cancer centres, with treatment duration up to 12 months. The study follows promising preclinical research presented at the San Antonio Breast Cancer Symposium in December 2024, showing that the combination triggers epigenetic re-programming of dormant cancer cells, making them visible to the immune system.

The trial will utilize a non-invasive liquid biopsy digital pathology platform to monitor treatment effectiveness in real-time through blood sample analysis. The study is currently open for enrollment at the Royal Brisbane and Women's Hospital, with plans for expansion to other Australian sites.

Kazia Therapeutics (NASDAQ: KZIA) has successfully closed its previously announced registered direct offering, raising $2.0 million through the sale of 1,333,333 American Depositary Shares (ADSs) at $1.50 per ADS to Alumni Capital LP. Each ADS represents 100 ordinary shares.

The offering included concurrent private placement of unregistered warrants to purchase up to 1,333,333 ADSs at an exercise price of $1.50 per ADS. These warrants will be immediately exercisable and expire after five and a half years. Maxim Group served as the exclusive placement agent.

The company plans to use the net proceeds for general corporate purposes, including working capital, research expenses, clinical development and commercial efforts, and general administrative expenses.

Kazia Therapeutics (NASDAQ: KZIA) has announced a $2.0 million registered direct offering of 1,333,333 American Depositary Shares (ADSs) at $1.50 per ADS. Each ADS represents 100 ordinary shares. The company will also issue unregistered warrants to purchase up to 1,333,333 ADSs in a concurrent private placement. The warrants will have an exercise price of $1.50 per ADS, be immediately exercisable, and expire after 5.5 years.

The offering is expected to close around January 13, 2025, with Maxim Group acting as exclusive placement agent. The net proceeds will be used for general corporate purposes, including working capital, research expenses, clinical development, commercial efforts, and administrative expenses.

Kazia Therapeutics (NASDAQ: KZIA) provided an update following its Type C meeting with FDA regarding paxalisib for glioblastoma (GBM) treatment. The July 2024 GBM-AGILE study showed a 3.8-month overall survival improvement in newly diagnosed unmethylated (NDU) patients compared to standard care. FDA indicated that overall survival data would not support accelerated approval but could support traditional approval. The agency and Kazia aligned on key aspects for a proposed pivotal phase 3 study. Paxalisib continues testing in pediatric brain cancer and brain metastases, with Orphan Drug and Rare Pediatric Disease Designations for DIPG and AT/RT. The company expects to outline its path forward by end of January 2025.

Kazia Therapeutics (NASDAQ: KZIA) announced data presentation at the San Antonio Breast Cancer Symposium regarding their lead candidate paxalisib for treating immunotherapy-resistant triple negative breast cancer (TNBC) and HER2 positive metastatic breast cancer with brain metastases.

The preclinical data showed promising therapeutic synergies between paxalisib and pembrolizumab (KEYTRUDA®) in immunotherapy-resistant TNBC models. Additional synergies were observed when combining paxalisib with olaparib (LYNPARZA®). In the TNBC mouse model, paxalisib combined with immunotherapy reduced tumor burden, lung metastases, and liver inflammation.

In a separate phase II trial for HER2 positive breast cancer with brain metastases, while the primary endpoint of overall response rate wasn't met, patients receiving paxalisib with trastuzumab showed a median overall survival of 16.5 months. The combination demonstrated feasible toxicity profiles consistent with PI3K/mTOR inhibitors.