Paxalisib

SYDNEY, May 23, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA) (Kazia or the company) received a letter on May 22, 2024 from Nasdaq notifying the Company that, while the Company has not regained compliance with the Minimum Bid Price Requirement, Nasdaq has determined that the Company is eligible for an additional 180 calendar day period, or until November 18, 2024 (the "Second Compliance Period"), to regain compliance with the Minimum Bid Price Requirement. As previously disclosed, on November 20, 2023, Kazia Therapeutics Limited (the "Company") received a deficiency notification from the Listing Qualifications Staff of the Nasdaq Stock Market LLC ("Nasdaq"), notifying the Company that it was not in compliance with the minimum bid price requirement as set forth in Nasdaq Listing Rule 5550(a)(2) (the "Minimum Bid Price Requirement"). The Company was provided 180 calendar days, or until May 20, 2024, to regain compliance with the Minimum Bid Price Requirement. If at any time during the Second Compliance Period the closing bid price of the Company's security is at least $1.00 per share for a minimum of 10 consecutive business days, Nasdaq will provide written confirmation of compliance. Nasdaq's determination was based on the Company meeting the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on The Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, and the Company's written notice to Nasdaq of its intention to cure the deficiency during the Second Compliance Period and, if necessary, by effecting a ratio change of the American Depositary Shares (the "ADSs"), each representing ten ordinary shares of the Company, to its ordinary shares. The deficiency notification has no immediate impact on the Company's operations or listing. The Company's securities will continue to trade as normal on The Nasdaq Capital Market under the ticker "KZIA." The Company will continue to actively monitor the closing bid price of its ADSs and intends to consider all available options to resolve the deficiency and regain compliance within the Second Compliance Period provided and may, if necessary, implement a ratio change of the ADSs to its ordinary shares, to regain compliance with the Minimum Bid Price Requirement. There can be no assurance that the Company will regain compliance with the Minimum Bid Price Requirement during the Second Compliance Period. If the Company does not regain compliance within the Second Compliance Period, Nasdaq staff will provide notice that the Company's securities will be subject to delisting. The Company would then be entitled to appeal that determination to a Nasdaq Hearings Panel (the "Panel"). There can be no assurance that, if the Company does appeal any delisting determination by the Panel, such appeal would be successful About Kazia Therapeutics Limited Kazia Therapeutics Limited (NASDAQ: KZIA) is an oncology-focused drug development company, based in Sydney, Australia. Our lead program is paxalisib, an investigational brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat multiple forms of brain cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of ten clinical trials in this disease. A completed Phase 2 study in glioblastoma reported early signals of clinical activity in 2021, and a pivotal study in glioblastoma, GBM AGILE, is ongoing, with final data expected in 1H2024. Other clinical trials are ongoing in brain metastases, diffuse midline gliomas, and primary CNS lymphoma, with several of these having reported encouraging interim data. Paxalisib was granted Orphan Drug Designation for glioblastoma by the FDA in February 2018, and FTD for glioblastoma by the FDA in August 2020. Paxalisib was also granted FTD in July 2023 for the treatment of solid tumour brain metastases harboring PI3K pathway mutations in combination with radiation therapy. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Drug Designation by the FDA for diffuse intrinsic pontine glioma in August 2020, and for atypical teratoid / rhabdoid tumours in June 2022 and July 2022, respectively. Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. Preclinical data has shown EVT801 to be active against a broad range of tumour types and has provided evidence of synergy with immuno-oncology agents. Stage one of the Phase I study has been completed and preliminary data is anticipated in CY2024. For more information, please visit or follow us on Twitter @KaziaTx Forward-Looking Statements This announcement may contain forward-looking statements, which can generally be identified as such by the use of words such as "may," "will," "estimate," "future," "forward," "anticipate," or other similar words. Any statement describing Kazia's future plans, strategies, intentions, expectations, objectives, goals or prospects, and other statements that are not historical facts, are also forward-looking statements, including, but not limited to, statements regarding: the timing for results and data related to Kazia's clinical and preclinical trials, Kazia's strategy and plans with respect to its programs, including paxalisib and EVT801, and Kazia's intentions with respect to regaining compliance with the Minimum Bid Price Requirement, including effecting a ratio change of the ADSs to its ordinary shares, if necessary. Such statements are based on Kazia's current expectations and projections about future events and future trends affecting its business and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements, including risks and uncertainties: associated with clinical and preclinical trials and product development, related to regulatory approvals, related to the possibility that Kazia may not regain compliance with the Minimum Bid Price Requirement, and related to the impact of global economic conditions. These and other risks and uncertainties are described more fully in Kazia's Annual Report, filed on form 20-F with the United States Securities and Exchange Commission (the "SEC"), and in subsequent filings with the SEC. Kazia undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this announcement. SOURCE Kazia Therapeutics Limited

SYDNEY, May 1, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), a biotechnology company specialising in oncology, is pleased to announce that the Safety Review Team (SRT) of the EVT801 Phase 1 clinical trial has concluded that the primary and secondary objectives of stage 1 of the trial have successfully been met. Consisting of the trial's lead investigators, independent medical monitor, and key members from Kazia Therapeutics, the SRT has reviewed all preliminary (non-final) safety and pharmacokinetic (PK) data, and unanimously agreed that the maximal tolerated dose (MTD) has been reached at 500mg twice a day (BID). Under the condition that continuous monotherapy administration will be used in future clinical trials, 400mg BID was identified as the starting recommended phase 2 dose (RP2D). A total of 26 patients received EVT801 across six dosing cohorts ranging from 50mg daily to 500mg BID. In general, EVT801 was tolerated across all doses with the majority of toxicities being mild to moderate and transient in nature. Eleven different cancer types (ex. colon, renal cell, pancreatic) were enrolled in the study, with advanced ovarian cancer being the most prevalent (11 patients). These 11 patients had an average age of 67 years (range: 56-76) and a median time from diagnosis of nine years. Forty-six percent (46%) of the ovarian cancer patients had stable disease or better for at least three cycles of EVT801 therapy. EVT801 is a highly selective small molecule VEGFR3 tyrosine kinase inhibitor targeting tumour angiogenesis. Unlike traditional angiokinase inhibitors, we believe based on preclinical data that EVT801 has favorable immune activity (reduces immunosuppressive cells and no impact on CD3+ T-cells proliferation) and stabilizes tumor blood vessels, minimizing hypoxia and therefore decreases the potential for metastatic spread. The Phase 1 EVT801 monotherapy dose-finding trial targets patients with histologically confirmed advanced or metastatic solid tumours that are unresponsive to standard treatment, or for whom no standard treatment is available or appropriate. Kazia Therapeutics CEO, Dr. John Friend said: "We are extremely pleased that the primary and secondary end points of stage 1 of the Phase 1 clinical trial have been met. The signals of clinical activity, especially in patients with advanced ovarian cancer are highly encouraging as we continue to progress the clinical development program for EVT801 as a potential first-in-class VEGFR3 inhibitor. With a median survival time of less than 4 years, there is a large unmet need for new therapies in patients with high-grade serous ovarian cancer." The Phase 1, open label study is designed to assess the safety, tolerability, and PK of EVT801 in patients with advanced or metastatic solid tumors unresponsive to standard treatment, or for whom no standard treatment is available or appropriate. We look forward to sharing the final stage 1 data and next development steps at an upcoming scientific conference in the second half of 2024. About Kazia Therapeutics Limited Kazia Therapeutics Limited (NASDAQ: KZIA) is an oncology-focused drug development company, based in Sydney, Australia. Our lead program is paxalisib, an investigational brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat multiple forms of brain cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of ten clinical trials in this disease. A completed Phase 2 study in glioblastoma reported early signals of clinical activity in 2021, and a pivotal study in glioblastoma, GBM AGILE, is ongoing, with final data expected in 1H2024. Other clinical trials are ongoing in brain metastases, diffuse midline gliomas, and primary CNS lymphoma, with several of these having reported encouraging interim data. Paxalisib was granted Orphan Drug Designation for glioblastoma by the FDA in February 2018, and FTD for glioblastoma by the FDA in August 2020. Paxalisib was also granted FTD in July 2023 for the treatment of solid tumour brain metastases harboring PI3K pathway mutations in combination with radiation therapy. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Drug Designation by the FDA for diffuse intrinsic pontine glioma in August 2020, and for atypical teratoid / rhabdoid tumours in June 2022 and July 2022, respectively. Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. Preclinical data has shown EVT801 to be active against a broad range of tumour types and has provided evidence of synergy with immuno-oncology agents. Stage one of the Phase I study has been completed and preliminary data is anticipated in CY2024. For more information, please visit or follow us on Twitter @KaziaTx. Forward-Looking Statements This announcement may contain forward-looking statements, which can generally be identified as such by the use of words such as "may," "will," "estimate," "future," "forward," "anticipate," or other similar words. Any statement describing Kazia's future plans, strategies, intentions, expectations, objectives, goals or prospects, and other statements that are not historical facts, are also forward-looking statements, including, but not limited to, statements regarding: the timing for results and data related to Kazia's clinical and preclinical trials, Kazia's strategy and plans with respect to its programs, including paxalisib and EVT801, the potential benefits of EVT801 as a VEGFR3 inhibitor and the potential market opportunity for EVT801. Such statements are based on Kazia's current expectations and projections about future events and future trends affecting its business and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements, including risks and uncertainties: associated with clinical and preclinical trials and product development, related to regulatory approvals, and related to the impact of global economic conditions. These and other risks and uncertainties are described more fully in Kazia's Annual Report, filed on form 20-F with the SEC, and in subsequent filings with the United States Securities and Exchange Commission. Kazia undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this announcement. This announcement was authorized for release by Dr John Friend, CEO. Company Codes: NASDAQ-SMALL:KZIA