Core Insights - LIXTE Biotechnology Holdings, Inc. is focusing on its lead compound LB-100, a first-in-class small molecule inhibitor of protein phosphatase 2A (PP2A), targeting significant unmet needs in the $200 billion global oncology market [2] - The company is advancing clinical trials for LB-100 in three cancer types: Ovarian Clear Cell Carcinoma, Advanced Soft Tissue Sarcoma, and Metastatic Microsatellite Stable Colon Cancer, with expected trial results in the second half of 2025 [3][4][5] Group 1: Clinical Trials and Market Potential - The Phase 1B/2 trial for Ovarian Clear Cell Carcinoma (OCCC) aims to evaluate LB-100 in combination with the checkpoint inhibitor dostarlimab, addressing a cancer subtype that contributes disproportionately to ovarian cancer mortality [3] - The Phase 1B/2 trial for Advanced Soft Tissue Sarcoma (STS) assesses LB-100 combined with doxorubicin, targeting a group of cancers with poor prognosis [4] - The Phase 1B trial for Metastatic Microsatellite Stable Colon Cancer is investigating LB-100 in combination with atezolizumab, focusing on overcoming immune resistance in this prevalent cancer type [5] Group 2: Upcoming Milestones and Market Impact - Preliminary safety and efficacy data for the OCCC trial is expected in Q4 2025, with the global treatment market projected to exceed $750 million by 2028 due to rising incidence and limited targeted therapies [6] - A safety report for the STS trial is anticipated in Q4 2025, with the global STS drug market estimated to reach $2.1 billion by 2030, driven by combination therapies and unmet medical needs [7] - The colorectal cancer therapeutics market is expected to surpass $18 billion by 2030, with MSS disease representing a significant portion of treatment-resistant cases [8] Group 3: Strategic Positioning and Innovation - LIXTE's strategy of targeting PP2A positions LB-100 as a versatile combination agent with broad applicability across various solid tumors, addressing high unmet needs and limited innovation in oncology [9] - The company has a strong intellectual property position with multiple issued and pending patents covering composition, methods of use, and combinations [14] - Ongoing discussions for co-development opportunities with academic institutions and biopharma partners indicate potential for pipeline expansion into additional tumor types [14]

Core Insights - LIXTE Biotechnology Holdings is focusing on its lead compound LB-100, a first-in-class small molecule inhibitor targeting protein phosphatase 2A (PP2A), which plays a crucial role in cell signaling and DNA damage response [2][13] - The company aims to address high unmet needs in the $200 billion global oncology market, particularly in resistant cancers where traditional treatments have limited efficacy [2] Upcoming Catalysts - The Phase 1B/2 trial for Ovarian Clear Cell Carcinoma (OCCC) is designed to overcome platinum resistance by combining LB-100 with carboplatin and paclitaxel, with preliminary efficacy data expected in Q4 2025 [3][4][7] - The ongoing Phase 1B/2 trial for Advanced Soft Tissue Sarcoma (STS) evaluates LB-100 in combination with doxorubicin, with updates on progression-free survival and objective response rate anticipated in late Q3 2025 [5][8] - A Phase 1B trial for Metastatic Microsatellite Stable (MSS) Colon Cancer is actively recruiting, with initial biomarker and response data expected in Q4 2025 [6][9] Market Potential - The global treatment market for OCCC is projected to exceed $750 million by 2028 due to rising incidence and limited targeted therapies [7] - The global STS drug market is estimated to reach $2.1 billion by 2030, driven by the emergence of combination therapies and unmet medical needs [8] - The global colorectal cancer therapeutics market is expected to surpass $18 billion by 2030, with MSS disease representing a significant portion of treatment-resistant cases [10] Platform Potential - LIXTE's strategy of targeting PP2A positions LB-100 as a versatile combination agent applicable across various solid tumors, addressing oncology subtypes with high unmet needs and limited innovation [11] - The company has a strong intellectual property position with multiple issued and pending patents covering composition, methods of use, and combinations [15] - Ongoing discussions for partnership opportunities with academic institutions and biopharma partners for co-development are in progress [15]

DENVER, Aug. 13, 2025 (GLOBE NEWSWIRE) -- 247marketnews.com, a pioneer in digital media dedicated to the swift distribution of financial market news and corporate information, reports that LIXTE Biotechnology Holdings (Nasdaq: LIXT), a clinical-stage pharmaceutical company developing breakthrough cancer therapeutics, announced today that its Board of Directors approved a bold new treasury policy to diversify its corporate reserves into cryptocurrency, including Bitcoin and potentially other digital assets. ...

PASADENA, Calif., Aug. 13, 2025 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. (“LIXTE” or the “Company”) (Nasdaq: LIXT and LIXTW), a clinical stage pharmaceutical company, today announced that its Board of Directors has approved a strategic capital allocation initiative to acquire cryptocurrency as part of its corporate treasury. The Board approved allocation of up to 25 percent of its treasury to cryptocurrencies, including Bitcoin and potentially other digital assets as it deems appropriate. The ...

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 June 30, 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) ...

PASADENA, Calif., July 16, 2025 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. (“LIXTE” or the “Company”) (Nasdaq: LIXT and LIXTW), a clinical stage pharmaceutical company, today announced it has received a letter from the Nasdaq Hearings Panel stating that the Company has regained compliance with Nasdaq’s Listing Rule 5550(b)(1), the “Equity Rule,” requiring a minimum equity requirement of $2.5 million for continued listing on the Nasdaq Capital Market. The Nasdaq letter follows LIXTE’s closing of ...

Core Insights - Spartan Capital Securities, LLC announced the closing of a $1.5 million registered direct offering for Lixte Biotechnology Holdings, Inc. [1] - The offering involved the sale of 974,026 shares of Common Stock at a public offering price of $1.54 per share [2] - The gross proceeds of approximately $1.5 million will be used for general corporate purposes and working capital [3] Company Overview - Lixte Biotechnology Holdings, Inc. is a clinical-stage pharmaceutical company focused on cancer drug development [2][8] - The company's lead compound, LB-100, is a first-in-class PP2A inhibitor that enhances the effectiveness of chemotherapy and immunotherapy [8] - Clinical trials are currently underway for Ovarian Clear Cell Carcinoma, Metastatic Colon Cancer, and Advanced Soft Tissue Sarcoma [8] Transaction Details - The offering was made under an effective shelf registration statement previously filed with the U.S. Securities and Exchange Commission [5] - Spartan Capital Securities served as the exclusive placement agent for this transaction [1][4] - The transaction reflects a focus on aligning innovative biotech companies with strategic capital for advancing therapies [4]

Core Insights - LIXTE Biotechnology Holdings, Inc. announced that findings published in the journal Nature validate its ongoing clinical trials with the proprietary compound LB100 for Ovarian and Colorectal cancers [1][2] Group 1: Clinical Trials and Research Findings - A study led by Dr. Amir Jazaeri found that Ovarian Clear Cell Carcinoma (OCCC) patients with inactivating mutations in PPP2R1A had significantly better overall survival when treated with immune checkpoint blockade therapy [2][3] - Inactivating mutations in PPP2R1A reduce the enzymatic activity of PP2A, which is the target of LIXTE's LB-100, and these tumors showed increased interferon gamma response pathways associated with improved immune checkpoint responses [3] - LIXTE is conducting two clinical trials to investigate LB-100's activity in combination with checkpoint immunotherapy, one in collaboration with GSK for OCCC and another with Roche for colon cancer patients [4][5] Group 2: Company Overview and Future Directions - LIXTE is focused on developing new cancer therapies and has demonstrated that LB-100 is well-tolerated in cancer patients at doses associated with anti-cancer activity [6][7] - The company is pioneering a new treatment paradigm in cancer biology known as activation lethality, with ongoing proof-of-concept clinical trials for various cancer types [7]

Core Viewpoint - Lixte Biotechnology Holdings, Inc. has successfully closed a registered direct offering, raising approximately $1.5 million through the sale of shares of Common Stock and Pre-Funded Warrants [1][3]. Group 1: Offering Details - The offering included the sale of 974,026 shares of Common Stock or Pre-Funded Warrants, with a public offering price of $1.54 per share [2]. - The Pre-Funded Warrants are immediately exercisable and can be exercised at any time until fully exercised [2]. - The gross proceeds from the transaction amounted to approximately $1.5 million, and the transaction closed on July 8, 2025 [3]. Group 2: Use of Proceeds - The net proceeds from the offering, along with existing cash, are expected to be used for general corporate purposes and working capital [3]. Group 3: Company Overview - Lixte Biotechnology Holdings, Inc. is a clinical-stage pharmaceutical company focused on developing new cancer therapies, particularly its lead clinical compound, LB-100, which has shown potential in enhancing chemotherapies and immunotherapies [6][7]. - LB-100 is part of a new treatment paradigm in cancer biology known as activation lethality, and proof-of-concept clinical trials are currently underway for various cancer types [7].

Group 1: Transaction Overview - Spartan Capital Securities, LLC closed a $5.0 million private placement for Lixte Biotechnology Holdings, Inc. on July 2, 2025, serving as the exclusive placement agent [1][2]. - The offering included the sale of Common Stock (or Pre-Funded Warrants), Series B Convertible Preferred Stock, and Common Warrants to accredited investors [2]. - The company received gross proceeds of approximately $5.0 million, with $4.0 million received at closing and the remaining $1.0 million to be received upon effectiveness of a resale registration statement [3]. Group 2: Use of Proceeds - Proceeds from the offering will be used for general corporate purposes and working capital [3]. Group 3: Company Background - Lixte Biotechnology Holdings, Inc. is a clinical-stage pharmaceutical company focused on developing cancer therapies based on novel biological pathways [8]. - The company's lead compound, LB-100, is a first-in-class PP2A inhibitor that has shown promise in enhancing the effectiveness of chemotherapy and immunotherapy, with clinical trials underway for colon, small cell lung, and sarcoma cancers [8]. Group 4: Representation and Support - Lixte was represented by TroyGould PC, while Spartan Capital Securities was represented by Kaufman & Canoles, P.C. [4].