Lixte Biotechnology(LIXT)

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LIXTE Biotechnology Announces $1.05 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
Newsfilter· 2025-02-11 13:42
Core Viewpoint - LIXTE Biotechnology Holdings, Inc. has announced 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 to purchase the same number of shares at an exercise price of $2.29 per share, expected to raise approximately $1.05 million in gross proceeds [1][2]. Group 1: Offering Details - The offering consists of 434,784 shares of common stock priced at $2.415 per share, with a concurrent issuance of warrants at an exercise price of $2.29 per share, exercisable for five years [1]. - The expected gross proceeds from the offering are approximately $1.05 million, before deducting fees and expenses [2]. - The closing of the offering is anticipated to occur on or about February 12, 2025, subject to customary closing conditions [1]. Group 2: Regulatory and Legal Information - The shares are being offered under a "shelf" registration statement on Form S-3, which became effective on May 2, 2024 [3]. - The warrants are issued in a private placement and have not been registered under the Securities Act, meaning they cannot be offered or sold in the U.S. without an effective registration statement or applicable exemption [4]. Group 3: Company Overview - LIXTE Biotechnology Holdings, Inc. is a clinical-stage pharmaceutical company focused on developing cancer therapies, particularly its lead clinical compound LB-100, which has shown potential in improving outcomes for patients undergoing chemotherapy or immunotherapy [6]. - LB-100 is part of a new treatment paradigm in cancer biology known as activation lethality, and the company holds a comprehensive patent portfolio for its innovative approach [6].
LIXTE Biotechnology Submits Request for Withdrawal of Form S-1 Registration Statement
Newsfilter· 2025-02-10 22:00
Core Viewpoint - LIXTE Biotechnology Holdings, Inc. has withdrawn its Registration Statement for a public offering, indicating a shift in its funding strategy at this time [1]. Company Overview - LIXTE Biotechnology Holdings, Inc. is a clinical-stage pharmaceutical company focused on developing new cancer therapies [3]. - The company’s lead clinical candidate, LB-100, is a first-in-class PP2A inhibitor that has shown good tolerance in cancer patients and potential to enhance outcomes during chemotherapy or immunotherapy [3]. - LIXTE operates in a unique area of cancer biology known as activation lethality, with no known competitors and a comprehensive patent portfolio [3]. - Ongoing proof-of-concept clinical trials are part of LIXTE's innovative approach to cancer treatment [3].
Lixte Biotechnology(LIXT) - 2024 Q3 - Quarterly Report
2024-11-12 21:50
Financial Performance - For the nine months ended September 30, 2024, the Company recorded a net loss of $2,968,271 and used cash in operations of $2,565,861[236]. - The net loss for the three months ended September 30, 2024 was $986,030, compared to a net loss of $1,018,760 for the same period in 2023[305]. - The company incurred a net loss of $2,968,271 for the nine months ended September 30, 2024, an improvement from a net loss of $4,054,774 for the same period in 2023[318]. - General and administrative costs for the three months ended September 30, 2024 were $621,627, a decrease of $270,067 or 30.3% compared to $891,694 in 2023[293][295]. - For the nine months ended September 30, 2024, general and administrative costs were $2,267,890, a decrease of $1,047,407 or 31.6% compared to $3,315,297 in 2023[307][309]. - Research and development costs for the three months ended September 30, 2024 were $361,630, an increase of $229,143 or 173.0% compared to $132,487 in 2023[296][303]. - Research and development costs for the nine months ended September 30, 2024 were $691,402, a decrease from $749,029 in 2023[310][312]. - The Company had no revenues for the three months ended September 30, 2024 and 2023[292]. Cash and Funding - At September 30, 2024, the Company had cash of $1,637,627 available to fund its operations[236]. - The Company estimates that its existing cash resources will fund the current clinical trial program through the first quarter of 2025[241]. - The company estimates that its existing cash resources will fund its current clinical trial program through the first quarter of 2025, but additional capital will be needed for further development[322]. - The Company is considering various strategies to obtain additional capital due to uncertainty in market conditions[242]. - The Company is exploring various strategies to raise additional capital to fund its ongoing research and development activities[321]. Clinical Development - The Company is focusing on the clinical development of LB-100, a specific protein phosphatase inhibitor with clinical anti-cancer activity at low toxicity[233]. - LB-100 is currently in clinical trials for Ovarian Clear Cell Carcinoma, Metastatic Micro Satellite Stable Colon Cancer, and Advanced Soft Tissue Sarcoma, showing anti-cancer activity in various animal models[273]. - The Company entered into a Clinical Trial Agreement with the Netherlands Cancer Institute on June 10, 2024, for a Phase 1b/2 clinical trial of LB-100 combined with atezolizumab[299][313]. - The Company announced a Phase 1b/2 clinical trial at MD Anderson Cancer Center to assess LB-100 combined with GSK's dostarlimab-gxly for ovarian clear cell carcinoma, with completion expected by December 31, 2027[350]. - The Phase 1 portion of the trial began in Q2 2023, with a median progression-free survival (PFS) of 4.5 months for doxorubicin alone and 7.5 months for the combination therapy expected[341]. - The interim analysis of the Phase 2 trial will assess the potential superiority of LB-100 plus doxorubicin over doxorubicin alone, which could change the standard therapy for advanced soft tissue sarcoma[346]. Patent and Licensing - The Company received a Notice of Allowance from the USPTO for a patent application related to combining LB-100 with innovative cancer immunotherapies[235]. - The Company has filed patent applications for LB-100 in the U.S. and internationally, with patents issued in multiple countries including the U.S., Mexico, and Japan[277]. - The Company appointed a new President and CEO in September 2023 to analyze its patent portfolio and balance prosecution costs with protection benefits[265]. - The Company plans to discontinue support for certain patent filings starting in 2024, while continuing to develop its patent portfolio related to LB-100[265]. - The Company entered into a Patent License Agreement with NIH effective February 23, 2024, focusing on anti-cancer activity, with an estimated duration of twenty years[369]. - The Company is obligated to pay NIH a non-refundable license issue royalty of $50,000 and a first minimum annual royalty of $25,643, with subsequent annual royalties of $30,000 due each January 1[371]. - The License Agreement includes four benchmarks with a total payment obligation of $1,225,000, the first benchmark payment of $100,000 due by October 1, 2024[373]. Operational Risks - The Company faces risks related to serious adverse events in clinical trials, which could lead to regulatory holds and impact development timelines[281]. - The Company is monitoring potential impacts from geopolitical risks, inflation, and supply chain issues on its operations and financial performance[288]. - Cybersecurity risks are assessed regularly, with no significant challenges reported that have impaired operations or financial condition[289]. - The Company faces uncertainties in research and development, with no assurance of sufficient cash position to develop pharmaceutical compounds for future revenues[391]. Commitments and Agreements - The Company's remaining financial contractual commitments pursuant to clinical trial agreements not yet incurred aggregated approximately $3,918,000, scheduled to be incurred through approximately December 31, 2027[236]. - The aggregate commitment under the agreement with GEIS, as of September 30, 2024, totaled approximately $3,616,000, scheduled to be incurred through December 31, 2027[349]. - The Company's aggregate commitment under the Development Collaboration Agreement with NKI, as of September 30, 2024, totaled approximately $279,000, expected to be incurred through October 8, 2026[388].
LIXTE Receives U.S. Patent Issue Notification for Immune Oncology
GlobeNewswire News Room· 2024-09-04 12:30
Core Insights - LIXTE Biotechnology Holdings has received a Notice of Allowance for a patent related to combining its LB-100 compound with various cancer immunotherapies, enhancing its intellectual property portfolio [1][2][5] - The company is conducting clinical trials for LB-100 in combination with immunotherapies at notable institutions, including the Netherlands Cancer Institute and MD Anderson Cancer Center [3][4] - LIXTE's LB-100 is positioned as a first-in-class PP2A inhibitor, which is being tested for its potential to improve cancer treatment outcomes [6][7] Patent and Intellectual Property - The newly awarded patent supports LIXTE's commitment to innovative cancer research and treatment solutions [2] - An exclusive patent license agreement with the National Institute of Neurological Disorders and Stroke and the National Cancer Institute allows LIXTE to explore novel combination therapies [5] Clinical Trials and Research - LB-100 is being tested in combination with Roche's atezolizumab for metastatic colon cancer and GSK's dostarlimab-gxly for ovarian clear cell carcinoma [4] - The company is advancing a new treatment paradigm in cancer biology known as activation lethality, with ongoing proof-of-concept trials for various cancer types [7]
LIXTE Biotechnology Provides Update On Recent Activities and Developments
GlobeNewswire News Room· 2024-08-19 12:30
-Collaboration with NKI and Funding Support for New Colorectal Cancer Clinical Trial by Major Pharma Company- -Distinguished Oncologist Jan Schellens Joins LIXTE as Chief Medical Officer- -Preclinical Data Published in Journal EMBO Reports Shows LB-100 as Potentially Enhancing the Benefit of Immunotherapy- -LIXTE to Present at Two Upcoming Investor Conferences- PASADENA, CA, Aug. 19, 2024 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (Nasdaq: LIXT and LIXTW), a clinical-s ...
LIXTE Biotechnology Holdings to Present at Two Investor Conferences
GlobeNewswire News Room· 2024-08-15 12:30
-Company to Present August 20 at Investor Summit Summer 2024 Virtual Conference; and September 9-11 at H.C. Wainwright 26th Annual Global Investment Conference- PASADENA, CALIF., Aug. 15, 2024 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (Nasdaq: LIXT and LIXTW), a clinical stage pharmaceutical company, today announced it will be presenting at two investor conferences: The Investor Summit Summer 2024 Virtual Conference Tuesday, August 20, 2024, at 2 p.m. EDT/11 a.m. PDT. ...
Lixte Biotechnology(LIXT) - 2024 Q2 - Quarterly Report
2024-08-08 20:06
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.0001 per share LIXT The Nasdaq Stock Market LLC Warrants to Purchase Common Stock, par value $0.0001 per share LIXTW The Nasdaq Stock Market LLC 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, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 ...
LIXTE Biotechnology Holdings announces collaboration on a New Colon Cancer Clinical Trial
Newsfilter· 2024-06-14 15:00
Clinical trial to test recent findings that show LIXTE's lead clinical compound, LB-100, increases recognition of colon cancer cells by the immune system "This is an exciting new clinical trial," said Neeltje Steeghs, M.D., Ph.D., medical oncologist from NKI and Antoni van Leeuwenhoek Hospital, who is serving as principal investigator of the trial. "Only about 15% of colon cancers are responsive to immunotherapy, the so-called MSI High cancers. However, approximately 85% of colon cancers are MSI Low where i ...
LIXTE Biotechnology Holdings announces collaboration on a New Colon Cancer Clinical Trial
GlobeNewswire News Room· 2024-06-14 15:00
PASADENA, CA, June 14, 2024 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (Nasdaq: LIXT and LIXTW), a clinical stage pharmaceutical company, today announced a collaboration with Roche and the Netherlands Cancer Institute (NKI) to conduct a new clinical trial in immune therapy unresponsive (MSI Low) metastatic colon cancer. NKI is one of the world's leading comprehensive cancer centers. René Bernards, Ph.D., a leader in the field of molecular carcinogenesis and Senior Staf ...
LIXTE Biotechnology Holdings to Collaborate with Roche and Netherlands Cancer Institute in New Colon Cancer Clinical Trial
Newsfilter· 2024-06-14 13:30
PASADENA, CA, June 14, 2024 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (Nasdaq: LIXT and LIXTW), a clinical stage pharmaceutical company, today announced a collaboration with Roche and the Netherlands Cancer Institute (NKI) to conduct a new clinical trial in immune therapy unresponsive (MSI Low) metastatic colon cancer. "This is an exciting new clinical trial," said Neeltje Steeghs, M.D., Ph.D., medical oncologist from the Netherlands Cancer Institute, who is serving a ...