Kazia Therapeutics Limited American Depositary Shares - KZIA STOCK NEWS

Kazia Therapeutics (NASDAQ: KZIA) has secured a Type C meeting with the FDA in December 2024 to discuss potential registration pathways for paxalisib in newly diagnosed glioblastoma multiforme (GBM). The meeting follows promising Phase II/III GBM-AGILE trial results announced in July 2024, where paxalisib showed meaningful improvement in overall survival for newly diagnosed unmethylated GBM patients. The drug has previously received both orphan drug and fast track designations from FDA. The company has updated its corporate presentation with preliminary GBM AGILE trial data and announced participation in upcoming medical conferences, including the Society for Neuro-Oncology Annual Meeting and San Antonio Breast Cancer Symposium.

Kazia Therapeutics (NASDAQ: KZIA) presented promising Phase I data at ASTRO 2024 for paxalisib combined with radiation therapy in patients with solid tumor brain metastases or leptomeningeal metastases harboring PI3K pathway mutations. Key findings include:

- 67% partial response rate with 45mg paxalisib and radiotherapy
- Over two-thirds of patients at maximum tolerated dose achieved intracranial response
- Generally well-tolerated treatment
- Proof-of-principle established for molecularly-selected combination studies in radiation oncology

The study suggests this combination therapy could be a viable approach to address tumor radioresistance in patients with PI3K mutations. Discussions for a potential pivotal registration study are ongoing.

Kazia Therapeutics (NASDAQ: KZIA) presented promising clinical data for EVT801 in high grade serous (HGS) Ovarian Cancer at the 15th Biennial Ovarian Cancer Research Symposium. The Phase 1 first-in-human trial met its primary objectives, identifying the maximal tolerated dose at 500mg twice a day (BID) and the recommended Phase 2 dose at 400mg BID. Key findings include:

• 26 patients treated across 6 dosing cohorts
• 46% of HGS ovarian cancer patients showed stable disease for at least three cycles
• One patient had a partial response (-39% decrease) after 2 cycles
• EVT801 was well-tolerated with mostly mild to moderate, transient toxicities

Dr. John Friend, CEO of Kazia Therapeutics, expressed optimism about EVT801's potential as a first-in-class VEGFR-3 inhibitor for ovarian cancer treatment.

Kazia Therapeutics (NASDAQ: KZIA) has executed an exclusive licensing agreement with QIMR Berghofer Medical Research Institute for intellectual property rights related to PI3K inhibitor combination therapies. The agreement covers the development of PI3K inhibitors combined with immunotherapy or PARP inhibitors, including Kazia's lead candidate, paxalisib. This follows a collaboration that began in December 2022, resulting in supportive patents for paxalisib as an immune modulator in diseases like breast cancer.

The license includes standard provisions for fees and milestones. Kazia's CEO, Dr. John Friend, emphasized the significance of this agreement for paxalisib's development and the company's commercial portfolio. Preclinical studies have shown promising results for paxalisib in combination with immunotherapy in solid tumors, particularly breast cancer. Further data is expected to be presented at scientific meetings in 2025.

Kazia Therapeutics announced results from the GBM-AGILE Phase II/III clinical trial evaluating paxalisib for glioblastoma. The trial showed a 3.8-month improvement in overall survival (OS) for newly diagnosed unmethylated patients, a 33% increase compared to the standard of care (SOC). The median OS for paxalisib-treated patients was 15.54 months versus 11.89 months for SOC. No new safety concerns were identified. Paxalisib did not show efficacy in recurrent disease populations. Based on these results, Kazia plans to discuss accelerated approval with the FDA. Full data will be presented later this year.

Kazia Therapeutics (NASDAQ: KZIA) has announced new data presentations from its lead program, paxalisib, at the 21st International Symposium on Pediatric Neuro-Oncology (ISPNO 2024) in Philadelphia from June 29 to July 2, 2024. The data includes results from the Phase 2 PNOC DMG-ACT study evaluating paxalisib in combination with ONC201, revealing median overall survival rates of 13.2 months (Cohort 1), 15.8 months (Cohort 2), and 8.8 months (Cohort 3). Additional presentations will cover preclinical data on paxalisib combined with an HDAC inhibitor and gemcitabine for treating atypical teratoid/rhabdoid tumors. Concurrently, Kazia's research has been published in the European Journal of Cancer, emphasizing the need for mutation-specific, CNS-penetrant inhibitors for pediatric Diffuse Midline Glioma (DMG). These developments highlight potential advancements in treating pediatric brain cancers.

Kazia Therapeutics (NASDAQ: KZIA) has been granted an additional 180-day extension by Nasdaq, until November 18, 2024, to comply with the Minimum Bid Price Requirement of $1.00 per share. Initially notified of the deficiency on November 20, 2023, Kazia failed to regain compliance by the original deadline of May 20, 2024. Despite this, Nasdaq extended the compliance period based on the company's adherence to other listing criteria and its intent to resolve the issue. Kazia may employ solutions like a ratio change of its American Depositary Shares (ADSs). Failure to comply could lead to delisting, though appeals are possible. The extension does not affect current operations or trading under the ticker 'KZIA' on The Nasdaq Capital Market.

Kazia Therapeutics reported successful completion of stage 1 of the EVT801 Phase 1 clinical trial in advanced cancer patients. The Safety Review Team confirmed meeting primary and secondary objectives, determining a recommended phase 2 dose at 400mg BID. EVT801 showed promising clinical activity, especially in patients with advanced ovarian cancer. The trial included 26 patients across six dosing cohorts, with EVT801 being well-tolerated. CEO Dr. John Friend emphasized the need for new therapies in high-grade serous ovarian cancer patients.