Reinvigoration of immune system + turning cold tumors hot Preliminary ex-vivo data in HER2+ patients demonstrates immune reinvigoration and reductions in CTC and clusters First patient from TNBC trial demonstrated 76% tumor volume shrinkage with corresponding reductions in circulating tumor cells (CTC) and clusters SYDNEY, Dec. 10, 2025 /PRNewswire/ -- Kazia Therapeutics Limited ("Kazia" or the "Company") (NASDAQ: KZIA) today announced new data from two presentations at the 2025 San Antonio Breast Cancer Sy ...

Core Insights - Kazia Therapeutics Limited announced a private placement of approximately $50 million in shares and prefunded warrants, priced at $5 per ADS, with each ADS representing 500 ordinary shares [1] - The net proceeds are expected to be around $46.5 million, which will be utilized for the clinical development of paxalisib, advancing the PD-L1 degrader program, and general corporate purposes [2] - The company anticipates that the net proceeds from the PIPE, along with existing cash, will extend its cash runway into the second half of 2028 [3] Clinical Developments - Kazia Therapeutics reported an initial immune-complete response in a patient with stage IV triple-negative breast cancer treated with paxalisib, pembrolizumab, and standard chemotherapy under an FDA-authorized protocol [3] - After approximately three months of treatment, a PET/CT scan indicated that all previously identified lesions had completely resolved metabolically in the same patient [4] Stock Performance and Predictions - The average 1-year price target for Kazia Therapeutics shares is $20.0, indicating an expected upside of 104.12% [5] - No analysts have bearish recommendations for Kazia Therapeutics, while one analyst has a bullish rating [6] - As of the last check, KZIA stock is up 10.49% at $10.11 [6]

Energy Sector - Constellation secured a $1 billion loan from the U.S. Department of Energy to advance its Crane Clean Energy Center, which aims to bring 835 MW of new baseload nuclear power online [2][3] - The funding is part of the Energy Dominance Financing Program and is expected to lower Constellation's cost of capital, supporting infrastructure for the digital economy and increasing power capacity for AI workloads [3][4] Technology Sector - Adobe announced its acquisition of Semrush for $12.00 per share, valuing the company at approximately $1.9 billion, marking a significant move in digital marketing [10][20] - The acquisition aims to enhance Adobe's customer experience orchestration capabilities in the context of generative AI, addressing challenges in brand visibility and engagement [11][12] Oncology Sector - Kazia Therapeutics reported a patient with stage IV triple-negative breast cancer achieved an initial immune-complete response under an expanded-access protocol, a notable outcome given the low response rates in such cases [6][7] - The company highlighted its plans for upcoming presentations and progress in its drug development pipeline, including a request for a Type C meeting with the FDA [9]

Core Insights - Kazia Therapeutics Limited (NASDAQ: KZIA) shares surged 51.74% in after-hours trading to $8.74 following the release of promising clinical data on metastatic triple-negative breast cancer (TNBC) [1][2] Clinical Data - A patient with stage IV TNBC achieved an immune-complete response under an FDA-approved single-patient expanded access protocol, combining paxalisib with pembrolizumab (Keytruda) and standard chemotherapy [2] - After three months of treatment, a PET/CT scan indicated that all previously identified lesions had completely resolved metabolically, with the patient's tumor burden reduced by 86% after just three weeks of treatment [3] Rare Clinical Outcome - Complete responses in stage IV metastatic TNBC are extremely rare, and the initial complete response observed is considered an encouraging clinical finding by the CEO of Kazia Therapeutics [4] Upcoming Scientific Presentations - Kazia announced acceptance of two presentations at the 2025 San Antonio Breast Cancer Symposium, focusing on a Phase 1b study of paxalisib combined with olaparib or pembrolizumab/chemotherapy, and liquid biopsy tracking of PI3K-mTOR residual disease signatures in metastatic breast cancer [5] Nasdaq Compliance Concerns - Kazia Therapeutics received a staff determination letter from Nasdaq indicating it did not meet the $35 million minimum Market Value of Listed Securities requirement by the Nov. 10 deadline, and plans to request a hearing to address this issue [6] Stock Performance - Year-to-date, Kazia Therapeutics has fallen 34.02%, but has risen 58.24% over the past six months, with a market capitalization of $9.56 million and shares trading between $2.86 and $30.05 over the past year [7] - The stock closed at $5.76, down 5.29% in the regular session, but has a positive price trend across all time frames according to Benzinga Edge Stock Rankings [8]

Core Insights - Kazia Therapeutics Limited announced a significant clinical milestone with a patient suffering from stage IV triple-negative breast cancer (TNBC) achieving an initial immune-complete response (iCR) after treatment with paxalisib, pembrolizumab (Keytruda®), and standard chemotherapy [1][5]. Clinical Developments - The patient experienced an 86% reduction in tumor burden after three weeks of treatment, with a PET/CT scan showing complete metabolic resolution of all previously identified lesions after approximately three months [2]. - Complete responses in stage IV metastatic TNBC are rare, with pembrolizumab monotherapy showing complete response rates of only 0.6–4% in previous studies [3]. - The initial iCR observed in this case is considered a highly unusual event, suggesting enhanced biological activity of the combination regimen [4]. Future Plans and Presentations - Kazia will present findings related to paxalisib and its NDL2 programs at the upcoming Brisbane Cancer Conference on November 27-28, 2025, and at the San Antonio Breast Cancer Symposium from December 10-14, 2025 [6][7]. - The company is advancing its NDL2 PD-L1 degrader program towards IND-enabling studies anticipated in early 2026, aiming to address resistance mechanisms in immuno-oncology [10]. - Kazia plans to request a Type C meeting with the FDA to discuss overall survival findings from clinical studies involving paxalisib in glioblastoma, aligning with the Project FrontRunner framework [11]. Regulatory and Compliance Updates - Kazia received a notice from Nasdaq regarding non-compliance with the Market Value of Listed Securities requirement, with a deadline to regain compliance by November 10, 2025 [12]. - Following the deadline, Kazia received a staff determination letter indicating non-compliance, but intends to request a hearing to address the situation [13].

Financial Performance - The company incurred significant net losses of A$20.5 million, A$26.8 million, and A$20.7 million for the fiscal years ended 2023, 2024, and 2025, respectively[29]. - As of June 30, 2025, the company had accumulated losses of A$134.8 million and cash on hand of A$4.3 million[31][43]. - The company generated revenues of A$42 thousand in 2025 and A$2.3 million in 2024 from licensing development stage drug candidates, with no revenue from product sales in prior years[29]. - The company raised A$16 million from the sale of ADSs during the year ended June 30, 2025, and will need additional financing to meet long-term business objectives[38]. - The company expects to continue incurring operating losses for the foreseeable future due to high research and development costs[31]. - The company anticipates that expenses will increase substantially as it continues its research and clinical development activities[32]. - The company faces substantial doubt about its ability to continue as a going concern, which may hinder future financing efforts[42]. - Global economic uncertainty and geopolitical tensions may adversely affect the company's business and financial performance[47]. Funding and Financial Risks - The company is limited by the "Baby Shelf Rule," which restricts the amount of funds that can be raised through public offerings until its non-affiliate public float exceeds $75 million[45]. - The company may face significant challenges in obtaining sufficient funding on acceptable terms, which could adversely affect its operations and financial condition[52]. - Changes in U.S. tax law, particularly regarding research and development expenses, could have a material adverse effect on the company's cash flow and financial condition[53]. - Inflation and rising interest rates have led to a decline in the trading value of government securities, which could impact the company's liquidity and access to funding[55]. Operational and Strategic Risks - The company has two product candidates in clinical trials, with the potential for failure to show benefit to patients impacting business continuity[40]. - The company is dependent on key management and technical personnel, and the loss of such individuals could delay or increase the cost of research and development programs[61]. - The company may face operational and financial risks associated with strategic transactions, including potential exposure to unknown liabilities and increased costs[59]. - The company may not successfully engage in strategic collaborations, which could hinder the development and commercialization of product candidates[58]. Regulatory and Compliance Risks - The company has remediated previously identified material weaknesses in its internal control over financial reporting, but future weaknesses could still arise, impacting business and stock price[63]. - The current U.S. federal government shutdown, which began on September 30, 2025, may impact the company's product development activities and regulatory approvals[74]. - The FDA's ability to review and approve new products may be hindered by inadequate funding and staffing issues, potentially delaying the company's timelines for product development[75]. - The approval process for the Company's product candidates may be hindered by various factors, including disagreements with regulatory authorities regarding clinical study designs[103]. - The company faces potential revenue impacts due to government and third-party payors' efforts to cap or reduce healthcare costs, which may limit coverage and reimbursement for newly approved products[118]. Product Development and Market Risks - Paxalisib has received orphan drug designation for multiple indications, including glioblastoma and malignant glioma, but exclusivity may not effectively protect it from competition[84]. - The company faces risks related to market acceptance of its products, which may not generate significant revenue even if approved[88]. - The estimated market opportunities for the company's product candidates may be smaller than expected due to various factors, including advancements in cancer treatment and competition[90]. - Patient identification efforts are crucial, and challenges in identifying and accessing patients may adversely affect the company's business and revenue potential[93]. Intellectual Property Risks - The company may face challenges in protecting intellectual property rights related to product candidates, which could hinder exclusivity and commercialization efforts[129]. - The patent protection for the company's product candidates is limited to approximately 20 years from the filing date, which may expose the company to competition from generics and biosimilars post-expiration[131]. - The company may need to conduct costly clinical trials to demonstrate cost-effectiveness in certain countries to obtain or maintain reimbursement approvals[121]. - The company may face significant costs and distractions from litigation related to intellectual property rights, which could adversely affect its business[159]. Market and Trading Risks - The Company received a notification from Nasdaq indicating that its Market Value of Listed Securities (MVLS) was below the minimum requirement of $35 million from March 28, 2025, to May 9, 2025[170]. - If the Company fails to regain compliance, it may face delisting from Nasdaq, which could severely limit the liquidity of its American Depositary Shares (ADSs)[171]. - The trading price of the ADSs is highly volatile, influenced by factors such as toxicity findings, lack of efficacy in trials, and announcements of new products or technologies[175]. - The Company announced its intention to delist from the Australian Securities Exchange (ASX), effective November 15, 2023, which may impair the liquidity and value of its ADSs[179]. Clinical Trials and Collaborations - Kazia's lead program, Paxalisib, is an investigational brain-penetrant inhibitor targeting the PI3K/Akt/mTOR pathway, specifically designed for brain cancer treatment[196]. - Paxalisib has shown promising clinical activity in a phase II study for newly diagnosed glioblastoma patients, with a median overall survival of 14.77 months compared to 13.84 months for standard of care[208]. - The GBM AGILE study enrolled approximately 150 patients in its first stage, with initial data expected in the first half of calendar year 2024[207]. - The company is conducting ongoing clinical trials for Paxalisib across various patient populations, including adult and pediatric brain cancer[204]. - Kazia is collaborating with the University of Sydney on the LUMOS2 phase II study, targeting recurrent/progressive IDH mutant gliomas, with an expected enrollment of up to 76 patients[210].

Core Viewpoint - Kazia Therapeutics Limited plans to hold a follow-up Type C meeting with the U.S. FDA to discuss overall survival findings in newly diagnosed glioblastoma patients treated with paxalisib and to seek feedback on a potential regulatory pathway aligned with the FDA's Project FrontRunner initiative [1][2]. Regulatory Strategy - The company aims to engage the FDA to determine if the overall survival data from newly diagnosed glioblastoma patients treated with paxalisib can support a conditional approval pathway [2]. - Kazia intends to propose the initiation of a post-approval, randomized Phase 3 confirmatory study prior to submitting the New Drug Application (NDA), ensuring alignment with the FDA's emphasis on overall survival as a primary endpoint [2][5]. Project FrontRunner Initiative - Project FrontRunner is an FDA initiative encouraging earlier approval of cancer drugs for advanced or metastatic diseases, rather than only for patients who have exhausted treatment options [3]. - Kazia plans to reference Project FrontRunner principles in its Type C briefing package, including an overall survival-driven confirmatory study plan for newly diagnosed glioblastoma [4]. Clinical Data - In a prespecified secondary analysis, the median overall survival for newly diagnosed unmethylated glioblastoma patients treated with paxalisib was reported as 15.54 months, compared to 11.89 months for the standard of care [4]. - The company emphasizes the importance of overall survival as a meaningful endpoint for patients and clinicians in the context of glioblastoma treatment [2][5]. Company Background - Kazia Therapeutics is an oncology-focused drug development company based in Sydney, Australia, with paxalisib as its lead program, targeting multiple forms of cancer [7]. - Paxalisib has undergone ten clinical trials and has received various designations from the FDA, including Orphan Drug Designation and Fast Track Designation for glioblastoma [7][8].

Core Insights - Kazia Therapeutics Limited reported an 86% reduction in tumor burden in a single patient with triple-negative breast cancer (TNBC) after three weeks of treatment with a combination of immunotherapy, chemotherapy, and the investigational drug paxalisib [1][2][3] Company Overview - Kazia Therapeutics is an oncology-focused drug development company based in Sydney, Australia, primarily developing paxalisib, a pan-PI3K/mTOR inhibitor [5] - The company has conducted multiple clinical trials involving paxalisib, including a completed Phase 2/3 study in glioblastoma and ongoing trials in advanced breast cancer and other cancers [5] Clinical Trial Information - Kazia is conducting a multi-centered Phase 1b study in Australia to evaluate the safety and preliminary anti-tumor activity of paxalisib in combination with Keytruda® and chemotherapy for advanced breast cancer, including TNBC [4] - The ongoing trial aims to assess the effects on circulating tumor cells and cluster dynamics to understand how paxalisib may enhance immunotherapy responsiveness [4] Patient Case Details - The patient treated under the expanded-access protocol was a 40+ year old female diagnosed with TNBC in April 2023, who had no residual cancer after initial treatments but later developed metastatic disease [2] - The treatment regimen included immunotherapy, chemotherapy, and paxalisib, leading to significant tumor regression [2][3]

Core Insights - Kazia Therapeutics Limited is participating in a fully funded Australian Medical Research Future Fund project aimed at improving treatment for diffuse midline glioma (DMG) through an AI-enabled clinical decision-making platform [1][2][3] Project Overview - The initiative, named DMG-ADAPTS, will last three years and focus on optimizing the sequencing and timing of targeted therapies for DMG, which is a severe pediatric cancer with a median survival of less than one year [2][3] - DMG accounts for up to 25% of childhood brain cancer deaths, highlighting the urgent need for effective treatments [3] Kazia's Role - Kazia will provide its investigational drug paxalisib, a dual PI3K/mTOR inhibitor, which is currently being evaluated in multiple clinical studies for various brain cancers [4][5] - Positive signals have been reported in the PNOC 022 study, indicating encouraging activity of paxalisib in pediatric brain cancer [4] Strategic Importance - The project aims to integrate AI with precision therapies to potentially revolutionize the management of aggressive tumors like DMG and DIPG [5][7] - Kazia's involvement underscores its commitment to innovative solutions for pediatric cancers, leveraging global research excellence [5][6] Future Directions - The project will also focus on developing a cloud-based AI platform that integrates multiomics and profiling to guide individualized therapy decisions in real time [7] - Establishing non-invasive biomarkers to anticipate resistance and inform timely therapeutic transitions is a key goal of the initiative [7]

Core Insights - Kazia Therapeutics Limited announced new findings from a collaborative research program indicating that paxalisib, an investigational PI3K–mTOR inhibitor, significantly reduces circulating tumor cells (CTCs) in Stage IV HER2-positive metastatic breast cancer patients [2][3] Company Overview - Kazia Therapeutics is an oncology-focused drug development company based in Sydney, Australia, with a lead program centered on paxalisib, which targets multiple forms of cancer [5] - The company has been developing paxalisib since it was licensed from Genentech in late 2016, and it has been involved in ten clinical trials for various cancers [5] Research Findings - In an ex vivo study, paxalisib monotherapy achieved a complete (100%) disruption of CTC clusters containing three or more cells, which are associated with metastasis and poor prognosis [2][6] - The results extend the understanding of paxalisib's potential beyond triple-negative breast cancer into HER2-positive disease, highlighting its ability to disrupt CTC clusters [3][6] - The findings complement ongoing Phase 1b trials in Stage IV triple-negative breast cancer, where significant reductions in CTCs and clusters have been observed [3] Future Directions - Detailed datasets regarding metastatic signatures and disrupted progenitor populations in Stage IV HER2-positive breast cancer have been submitted for presentation at an upcoming global oncology meeting in 2025 [4]