DENVER, Nov. 19, 2025 (GLOBE NEWSWIRE) --  Investors are digesting major developments across the energy, tech, oncology, and entertainment sectors. Nuclear Power Roars Back: DOE Backs Constellation’s Crane Clean Energy Center Constellation (NASDAQ: CEG) dominated energy headlines after securing a $1 billion U.S. Department of Energy loan to advance its Crane Clean Energy Center, a project aimed at bringing 835 MW of new baseload nuclear power online. The DOE Loan Programs Office concurrently finalized both ...

Kazia Therapeutics Limited (NASDAQ:KZIA) shares are trending on Wednesday.Check out the current price of KZIA stock here.KZIA surged 51.74% in after-hours trading to $8.74 on Tuesday following the release of clinical data on metastatic triple-negative breast cancer.Patient Achieves Immune-Complete ResponseAccording to the iRECIST criteria, an initial immune-complete response was attained by a patient with stage IV TNBC receiving treatment under a Food and Drug Administration (FDA)-approved single-patient ex ...

Accessibility StatementSkip Navigation SYDNEY, Nov. 18, 2025 /PRNewswire/ -- Kazia Therapeutics Limited (Nasdaq: KZIA), an oncology-focused drug development company, today announced that a patient with stage IV triple-negative breast cancer (TNBC) treated under an FDA-authorized single-patient expanded access protocol combining paxalisib with pembrolizumab (Keytruda®) and standard chemotherapy has achieved an initial immune-complete response (iCR) per iRECIST criteria. This outcome suggests a profound radio ...

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].

Accessibility StatementSkip Navigation SYDNEY, Oct. 27, 2025 /PRNewswire/ -- Kazia Therapeutics Limited ("Kazia" or the "Company") today announced its intention to request and hold a follow-up Type C meeting with the U.S. Food & Drug Administration (FDA) to discuss overall survival (OS) findings in newly diagnosed glioblastoma (GBM) patients treated with paxalisib and to seek agency feedback on a potential regulatory pathway aligned with the FDA Oncology Center of Excellence's Project FrontRunner initiative ...

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]

Accessibility StatementSkip Navigation SYDNEY, Oct. 1, 2025 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), a clinical-stage biotechnology company developing innovative therapies for brain cancers, today announced its participation in a fully funded Australian Medical Research Future Fund (MRFF) project titled "Sequential & Temporal Therapeutic Agility for the Treatment of Diffuse Midline Glioma (DMG)". Under this three-year initiative, a consortium of leading researchers will establish DMG-ADAP ...

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]

Group 1 - Kazia Therapeutics Limited has entered into a securities purchase agreement for a private placement of equity securities, raising approximately $2.0 million [1][2] - The securities in the PIPE are priced at a 5% premium to the closing price of Kazia's ADSs on July 31, 2025, and the transaction is expected to close on August 4, 2025 [1][2] - The net proceeds from the PIPE will be used to support the clinical development of lead programs, including paxalisib and EVT801, as well as for general corporate purposes [2][3] Group 2 - The CEO of Kazia Therapeutics expressed gratitude for investor support and highlighted the importance of the additional capital for advancing clinical-stage assets [3] - The securities sold in this PIPE are not registered under the Securities Act of 1933 and will require a shelf registration statement to be filed with the SEC within 60 days of closing [3][4] - Kazia Therapeutics is focused on developing innovative oncology treatments, with lead programs targeting brain cancer and advanced solid tumors [6]

Core Insights - Kazia Therapeutics has announced preliminary results from its Phase 1b trial involving Paxalisib, pembrolizumab, and standard chemotherapy, showing promising outcomes in a patient with metastatic triple-negative breast cancer [1][5][6] Patient Profile - The trial's first patient is a 61-year-old female diagnosed with metastatic triple-negative breast cancer, specifically localized to the left upper lobe of the lung [3] Clinical Significance of Patient Data - Circulating tumor cell (CTC) clusters are critical in metastasis and are associated with poor prognosis; they can resist apoptosis and evade immune detection [4] - The combination treatment of Paxalisib and immunotherapy resulted in a rapid reduction of both CTC numbers and clusters, which is not typically observed with chemotherapy or immunotherapy alone [5][6] Mechanistic Insights - The early data aligns with preclinical findings that suggest Paxalisib disrupts both single CTCs and multicellular clusters, indicating a mechanistic synergy [2][5] Next Steps - The company plans to explore the relationship between CTC kinetics and radiographic responses, continue patient enrollment, and conduct a comprehensive analysis of the immune microenvironment and CTC kinetics [7] - The investigational regimen includes Paxalisib, pembrolizumab, and chemotherapy, with results showing over 50% reduction in total CTC count and a notable decrease in CTC clusters [7] Company Overview - Kazia Therapeutics is an oncology-focused drug development company based in Sydney, Australia, with its lead program being Paxalisib, which targets the PI3K/Akt/mTOR pathway for various cancers [9]