Paxalisib

SYDNEY, Dec. 2, 2025 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, today announced that it has entered into a securities purchase agreement with certain established institutional and accredited investors for a private placement of equity securities (PIPE). Pursuant to the securities purchase agreement, the Company agreed to offer and sell to the investors an aggregate of approximately $50.0 million of ordinary shares and prefunded warrants, at a purchase price per share that is the equivalent of $5.00 per ADS, each ADS representing 500 ordinary shares. The PIPE is structured as a straightforward equity investment with no common warrant coverage. The PIPE financing was led by healthcare-dedicated investors including Adar1 Capital Management LLC, Ikarian Capital LLC, Stonepine Capital Management, Velan Capital Investment Management LP, and Revach Capital Management, LLC, alongside existing shareholders, including Jorey Chernett. The transaction is expected to close on Wednesday, December 3, 2025, subject to customary closing conditions. Konik Capital Partners, LLC is acting as the exclusive placement agent for the PIPE. The net proceeds to the Company from the PIPE are expected to be approximately $46.5 million, after deducting placement agent's fees and other estimated offering expenses payable by the Company. The Company currently intends to use the net proceeds from the offering, together with its existing cash, cash equivalents and marketable securities, to support the continued clinical development of its lead program paxalisib, a brain-penetrant dual PI3K/mTOR inhibitor currently in clinical trials for both brain cancer and advanced breast cancer, advancing the PD-L1 degrader program, and for general corporate purposes. The Company expects the net proceeds from the PIPE, combined with the existing cash and cash equivalents, will extend its cash runway into the second half of 2028. The securities sold in this PIPE are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws, and may not be offered or sold in the United States absent an effective registration statement or an applicable exemption from registration requirements. Pursuant to the securities purchase agreement, the Company has agreed to file a shelf registration statement with the U.S. Securities and Exchange Commission (SEC) within 30 days of the closing to register the resale of ADSs representing the ordinary shares and those underlying the pre-funded warrants. This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offering of the securities described above under the resale registration statement will only be by means of a prospectus. About Kazia Therapeutics Limited Kazia Therapeutics Limited (NASDAQ: KZIA) is an innovative oncology-focused drug development company, based in Sydney, Australia. Our lead program is paxalisib, a brain-penetrant pan-PI3K/mTOR inhibitor, which is being developed to treat multiple forms of brain cancer, including glioblastoma and brain metastases. A Phase 1b clinical trial is also underway evaluating paxalisib in combination with checkpoint inhibition and chemotherapy for patients with advanced triple-negative breast cancer. EVT801, a selective VEGFR3 inhibitor, is currently in a Phase 1 clinical trial for advanced solid tumors. Kazia is working to rapidly progress these assets through clinical development and toward commercialization. Forward Looking Statements This announcement may contain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, 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 completion of the PIPE, the satisfaction of customary closing conditions related thereto, the intended use of proceeds from the PIPE, the anticipated extension of the Company's cash runway into the second half of 2028 following completion of the PIPE, and the Company's future expectations, plans and prospects. 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: related to market and other conditions, associated with clinical and preclinical trials and product development, including the risk that preliminary or interim data may not reflect final results, 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 most recent Annual Report, filed on form 20-F with 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. Investors should not place undue reliance on these forward-looking statements, which apply only as of the date of this announcement. For further information contact: Alex Star Managing Director LifeSci Advisors LLC [email protected] Ph: +1 (201) 786-8795 SOURCE Kazia Therapeutics Limited 21% more press release views with Request a Demo

关注公众号，获取三阴抗癌资料包 三阴姐妹互助交流病友群（点击） 2025年11月18日，专注于肿瘤药物研发的Kazia Therapeutics Limited（纳斯达克股票代码：KZIA）宣布，一名IV期三阴性乳腺癌（TNBC）患者，在接受paxalisib联合帕博利珠单抗（Pembrolizumab，K药）和标准化疗后，根据iRECIST标准，已达到初始免疫完全缓解（iCR）。这一结果表明，在高度侵袭性的转移性乳腺癌亚型中，该疗法取得了显著的缓解。 此次进展建立在Kazia于2025年10月2日宣布的结果之上，该结果显示，同一患者在接受治疗仅三周后，肿瘤负荷减少了86%。治疗约三个月后进行的PET/CT扫描显示，所有先前发现的病灶均已完全代谢消退，与初始免疫完全缓解（iCR）相符。患者目前仍在接受治疗，并处于积极的临床监测之下。后续将根据免疫反应评估指南进行扫描，以确认初始扫描结果。 在包括免疫疗法、化疗和抗体药物偶联物在内的多种治疗手段中，IV期转移性三阴性乳腺癌的完全缓解率极其罕见。例如，KEYNOTE研究中，帕博利珠单抗单药治疗转移性三阴性乳腺癌的完全缓解率约为0.6%至4%，即使是目前获批的活性最高的药物——如戈沙妥珠单抗——在大型II期和III期临床试验中也仅报告了约2%至4%的完全缓解率。 在这种情况下，任何与免疫完全缓解（iCR）相符的放射学发现，即使在确诊影像学检查之前，也代表着一种极其罕见的事件，与转移性三阴性乳腺癌的历史标准相比尤为突出。这些数据可能提示联合治疗方案具有增强的生物活性，因此有必要根据iRECIST指南进行持续随访。 “在一例转移性三阴性乳腺癌患者中观察到初步完全缓解，这是一个极其令人鼓舞的临床发现，”Kazia Therapeutics首席执行官John Friend博士表示。“尽管这只是一个扩大用药病例，还需要影像学检查来确认，但缓解的深度与我们的机制假设高度吻合，即 paxalisib 与免疫检查点阻断剂联合使用时，可能显著增强抗肿瘤免疫力。这一结果进一步推动了我们针对晚期乳腺癌的1b期临床试验项目，并与我们更广泛的研发管线取得的显著进展相辅相成。” ◇ 回复关键词"资料"领取 《恶性肿瘤患者膳食指导》文件 温馨提示：加入🌷希望花园·三阴“卡友”陪跑专项群，和姐妹们温暖同行❤️  科普视频合集 👇👇👇 乳癌全知道系列1 |  “最难搞” 的三阴性乳腺癌，确诊后怎么办？怎么治疗？珍藏版科普视频来了！ 乳癌全知道系列2 | 都是乳腺癌，为什么有的人确诊不到一年就走了，而有的人治愈了？ 乳癌全知道系列3 | 做好这件事，早期乳腺癌治愈率接近100% 乳癌全知道系列4 | 如果乳房会说话，它想告诉你这些关于乳腺癌的秘密 乳癌全知道系列5 | 87%患癌vs 100%预防，科学预防遗传性乳腺癌 乳癌全知道系列6 | 从化疗到ADC药物，这些乳腺癌靶向药都进医保了！ 乳癌全知道系列7 | 当乳腺癌遇上内分泌治疗：一场精准的 “断粮” 行动 乳癌全知道系列8 | 治疗结束≠抗癌结束！结疗后这样做，让复发风险降到最低 >>想看更多动画视频请关注公众号 参考文献 https://www.prnewswire.com/news-releases/kazia-therapeutics-achieves-initial-icr-immune-complete-response-in-metastatic-tnbc-and-delivers-q4-business-update-with-breakthroughs-across-breast-cancer-immuno-oncology-and-gbm-regulatory-strategy-302618635.html