Kazia Therapeutics Limited American Depositary Shares - KZIA STOCK NEWS

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.

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.