PASADENA, CALIF, July 01, 2025 (GLOBE NEWSWIRE) -- Lixte Biotechnology Holdings, Inc. (NASDAQ: LIXT) (the “Company”), a clinical stage pharmaceutical company, today announced that, on June 30, 2025 intraday, it entered into a definitive agreement with accredited investors on the purchase and sale of approximately $5.0 million of shares of Common Stock (or Pre-Funded Warrants), Series B Convertible Preferred Stock and Common Warrants. The offering was priced at the market under Nasdaq rules. The offering con ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-39717 LIXTE BIOTECHNOLOGY HOLDINGS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of (I.R.S. Employer incorporation or organization) ...

Pre-Clinical Study in Collaboration with Netherlands Cancer Institute is in addition to LIXTE's Ongoing Clinical Trials for Ovarian and Colorectal Cancers PASADENA, Calif., March 31, 2025 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (Nasdaq: LIXT and LIXTW), a clinical stage pharmaceutical company, today announced it will conduct a new pre-clinical study in collaboration with Netherlands Cancer Institute (NKI) to test whether "initiated" cells that carry mutations found ...

-Started Two New Clinical Trials, Collaborating with MD Anderson and The Netherlands Cancer Institute for Treatment of Ovarian and Colorectal Cancer- -Received Exclusive Patent License Agreement with the NIH on LB-100's Potential in Enhancing Cancer Immunotherapies- -Two Breakthrough Publications in Medical Journals, EMBO and Cancer Discovery,Supporting LIXTE's Clinical Trial Program- PASADENA, Calif, March 27, 2025 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (NASDAQ:LI ...

Clinical Trials and Research - The colorectal study testing LB-100 in combination with atezolizumab has been paused for enrollment due to two Serious Adverse Events (SAEs) observed in the clinical trial launched in August 2024 [44]. - The National Cancer Institute (NCI) initiated a glioblastoma pharmacologic clinical trial in May 2019, with the company providing the LB-100 clinical compound [46]. - LB-100 has shown potential to enhance the effectiveness of standard treatments for glioblastoma, but its ability to penetrate brain tumor tissue remains uncertain [47]. - In a study involving seven patients, LB-100 demonstrated virtually no entry into brain tumor tissue, indicating the need for alternative drug delivery methods [48]. - The company aims to advance LB-100 through Phase 2 clinical trials to evaluate its effectiveness in enhancing existing anti-cancer therapies [75]. - The FDA regulates clinical trials, which are essential for determining the safety and efficacy of new therapies [84]. Intellectual Property - A Patent License Agreement was entered into with the National Institute of Health, focusing on promoting anti-cancer activity in combination with standard anti-cancer drugs [49]. - LB-100 is covered by U.S. patents projected to expire between 2028 and 2034, ensuring protection for its composition and therapeutic uses [63]. - Combination therapies involving LB-100 with other investigational compounds are covered by pending patent applications projected to expire as late as 2043 [66]. - The company relies on a combination of patents, licenses, and trade secrets to protect its intellectual property related to LB-100 and its applications [56]. Financial and Operational Aspects - The company agreed to fund a preclinical study with the Netherlands Cancer Institute at an approximate cost of €391,000 to identify promising drug combinations with LB-100 [53]. - An amendment to the Development Collaboration Agreement extended the research activities and added €500,000 to the operating budget [54]. - The life sciences industry is highly competitive, with major pharmaceutical companies and specialized firms having greater financial and technical resources [77]. - The company relies on outside consultants and advisors for research and development, with only three key personnel as of March 14, 2025 [82]. - The company does not operate or lease any facilities, contracting out research and development activities to commercial laboratories [83]. Regulatory and Legal Environment - Regulatory approvals from the FDA do not guarantee approvals in international markets, complicating commercialization efforts [87]. - The company is not currently subject to any legal claims or proceedings [89]. Cancer Treatment Paradigm - LB-100 series compounds demonstrate anti-cancer activity against a broad spectrum of cancers, including glioblastoma and melanoma, in animal models [73]. - LB-100 is part of a new treatment paradigm in cancer biology, focusing on the hyper-activation of oncogenic signaling to induce cancer cell death [74].

Core Insights - LIXTE Biotechnology Holdings, Inc. announced the publication of new pre-clinical data regarding its lead clinical compound, LB-100, which is converted into the active form endothall, a protein phosphatase (PP2A) inhibitor effective in cancer treatment when combined with immunotherapy [1][4] Group 1: Research Findings - The Netherlands Cancer Institute identified an enzyme that mediates the conversion of LB-100 into endothall, suggesting it could serve as a biomarker to identify patients likely to respond to LB-100 [2] - Research from BioPharmaWorks LLC indicated that LB-100 converts into endothall through hydrolysis, although this process is slow under physiological conditions; the enzymatic conversion identified by the Bernards laboratory accelerates this activation within cells [3] Group 2: Clinical Development - Clinical trials for LB-100 are currently underway targeting ovarian cancer and colorectal cancer, with the new pre-clinical data enhancing understanding of LB-100 and endothall's biological availability in patients, aiding in optimizing patient selection for future trials [4] - LIXTE's LB-100 is positioned as a first-in-class PP2A inhibitor, demonstrating good tolerance in cancer patients at doses linked to anti-cancer activity, with potential to improve outcomes for patients undergoing various therapies [4] Group 3: Company Overview - LIXTE is focused on developing and commercializing cancer therapies, with a comprehensive patent portfolio and no known competitors in its new approach to cancer biology, termed activation lethality [4]

Core Insights - LIXTE Biotechnology Holdings, Inc. announced the online publication of pre-clinical data demonstrating the conversion of its lead compound LB-100 into the active form endothall, which is effective in cancer treatment when combined with immunotherapy [1][4] - The discovery of an enzyme that mediates this conversion could serve as a potential biomarker to identify patients likely to respond to LB-100 [2] - Clinical trials for LB-100 are currently underway for ovarian and colorectal cancer, with the new data aiding in optimizing patient selection for future trials [4] Group 1: Scientific Findings - The Netherlands Cancer Institute identified an enzyme that facilitates the conversion of LB-100 into endothall, suggesting its role as a potential biomarker [2] - Research from BioPharmaWorks LLC indicates that LB-100 converts into endothall through hydrolysis, although this process is slow under physiological conditions [3] Group 2: Company Overview - LIXTE is focused on developing new cancer therapies, with LB-100 being a first-in-class PP2A inhibitor that has shown good tolerance in cancer patients [4] - The company claims that LB-100 has the potential to improve outcomes for patients undergoing various chemotherapies or immunotherapies, supported by a comprehensive patent portfolio [4]

Core Viewpoint - LIXTE Biotechnology Holdings, Inc. has initiated a clinical trial combining its compound LB-100 with GSK's immunotherapy Dostarlimab to treat ovarian clear cell cancer, with the first patient dosed at the Lurie Cancer Center [1][2][3]. Group 1: Clinical Trial Details - The clinical trial is led by Dr. Emily M. Hinchcliff at the Lurie Cancer Center, a National Cancer Institute-designated Comprehensive Cancer Center [2]. - Patient recruitment is currently underway, and the trial aims to assess the effectiveness of combining LB-100 with Dostarlimab in treating ovarian clear cell carcinoma, which has a high unmet medical need [3]. - The trial was initially launched in January 2024 at The University of Texas MD Anderson Cancer Center, directed by Dr. Amir Jazaeri [3]. Group 2: Company Overview - LIXTE is a clinical-stage pharmaceutical company focused on developing new cancer therapies, with its lead compound LB-100 being a first-in-class PP2A inhibitor [4]. - LB-100 has shown potential to improve outcomes for patients undergoing various chemotherapies or immunotherapies, supported by extensive preclinical data [4]. - The company operates in a unique field of cancer biology known as activation lethality, with a comprehensive patent portfolio protecting its innovations [4].

Core Viewpoint - LIXTE Biotechnology Holdings, Inc. has initiated a clinical trial combining its compound LB-100 with GSK's immunotherapy Dostarlimab to treat ovarian clear cell cancer, with the first patient dosed at the Lurie Cancer Center [1][2][3]. Group 1: Clinical Trial Details - The clinical trial is led by Dr. Emily M. Hinchcliff at the Lurie Cancer Center, a National Cancer Institute-designated Comprehensive Cancer Center [2]. - Patient recruitment is currently underway, and the trial aims to assess the effectiveness of combining LB-100 with Dostarlimab in treating ovarian clear cell carcinoma, a condition with significant unmet medical needs [3]. - The trial was initially launched in January 2024 at The University of Texas MD Anderson Cancer Center, directed by Dr. Amir Jazaeri [3]. Group 2: Company Overview - LIXTE is a clinical-stage pharmaceutical company focused on developing new cancer therapies, with its lead compound LB-100 being a first-in-class PP2A inhibitor [4]. - LB-100 has shown potential to improve outcomes for patients undergoing various chemotherapies or immunotherapies, supported by extensive preclinical data [4]. - The company operates in a unique field of cancer biology known as activation lethality, and it holds a comprehensive patent portfolio to protect its innovations [4].

Core Viewpoint - LIXTE Biotechnology Holdings, Inc. has successfully closed a registered direct offering of 434,784 shares of common stock at a price of $2.415 per share, along with a concurrent private placement of unregistered warrants [1][2]. Group 1: Offering Details - The total gross proceeds from the offering amount to approximately $1,050,000, before deducting fees and expenses [2]. - The warrants issued in the private placement allow for the purchase of up to 434,784 shares at an exercise price of $2.29 per share, exercisable for five years [1][2]. Group 2: Regulatory and Compliance Information - The shares were offered under a "shelf" registration statement filed with the SEC, which became effective on May 2, 2024 [3]. - The warrants and the underlying shares have not been registered under the Securities Act, limiting their sale in the U.S. without an effective registration statement or applicable exemption [4]. Group 3: Company Overview - LIXTE is a clinical-stage pharmaceutical company focused on developing cancer therapies, particularly its lead clinical compound, LB-100, which is a first-in-class PP2A inhibitor [6]. - LB-100 has shown potential to improve outcomes for patients undergoing various cancer treatments and is part of a new treatment paradigm in cancer biology [6].