PASADENA, CA, June 06, 2024 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (NASDAQ:LIXT), a clinical stage pharmaceutical company, today announced online publication of new pre-clinical data in the journal EMBO Reports, showing that its lead compound, LB-100, can turn immunologically "cold" tumors "hot," potentially enhancing the benefit of immunotherapy. The current publication is a peer-reviewed version of a preprint that was previously made available in July 2023 to bio ...

LB-100 Generates Neo-Antigens in Cancer Cells that are Presented to the Immune System by Disrupting the Process of RNA Splicing PASADENA, CA, June 06, 2024 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (Nasdaq: LIXT and LIXTW), a clinical stage pharmaceutical company, today announced online publication of new pre-clinical data in the journal EMBO Reports, showing that its lead compound, LB100, can turn immunologically "cold" tumors "hot," potentially enhancing the benefit ...

PASADENA, Calif., June 03, 2024 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (Nasdaq: LIXT and LIXTW), a clinical-stage pharmaceutical company developing a new class of cancer therapy to enhance chemotherapy and immunotherapy, today announced the appointment of Jan Schellens, M.D., Ph.D., as Chief Medical Officer (CMO). Dr. Schellens brings to LIXTE more than 25 years of clinical experience as a medical oncologist, pharmacologist and clinical pharmacologist, including mo ...

Publishing of Findings in Recent Pre-Clinical Study for LIXTE's Proprietary Compound, LB-100, in New Field of Cancer Biology, "Activation Lethality" Presentation at MedInvest Biotech and Pharma Investor Conference Co-Sponsorship/Presentation of Workshop at Harvard University's Dana Farber Cancer Institute PASADENA, CA, May 20, 2024 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (Nasdaq: LIXT and LIXTW), a clinical-stage pharmaceutical company developing a new class of canc ...

Publishing of Findings in Recent Pre-Clinical Study for LIXTE's Proprietary Compound, LB-100, in New Field of Cancer Biology, "Activation Lethality" Presentation at MedInvest Biotech and Pharma Investor Conference Co-Sponsorship/Presentation of Workshop at Harvard University's Dana Farber Cancer Institute PASADENA, CA, May 20, 2024 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (Nasdaq: LIXT and LIXTW), a clinical-stage pharmaceutical company developing a new class of canc ...

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, 2024 ☐ 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) ...

Recent Findings Relate to LIXTE's Lead Clinical Compound, LB-100, to be Presented at Workshop on May 9 and 10 at Harvard's Dana Farber Cancer Institute in Boston PASADENA, CA, May 08, 2024 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (NASDAQ:LIXT), a clinical stage pharmaceutical company, today announced it is co-sponsoring an international scientific workshop on "Therapeutic Over-Activation in Cancer" at Harvard University's Dana Farber Cancer Institute on May 9 and 10, ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______ 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 ...

Financial Performance - For the nine months ended September 30, 2023, the Company recorded a net loss of $4,054,774 and used cash in operations of $3,391,142[215]. - As of September 30, 2023, the Company had no revenue-generating operations and is dependent on raising equity capital to fund its operating requirements[256]. - The Company reported a net loss of $(1,018,760) for the three months ended September 30, 2023, with a net loss per common share of $(0.49)[257]. - The Company incurred a net loss of $1,018,760 for the three months ended September 30, 2023, compared to a net loss of $1,478,009 for the same period in 2022[269]. - For the nine months ended September 30, 2023, the Company had a net loss of $4,054,774, an improvement from a net loss of $4,681,231 in 2022[282]. - Interest income for the nine months ended September 30, 2023 was $13,538, up from $4,211 in 2022, indicating improved investment returns[280]. Cash and Capital Requirements - As of September 30, 2023, the Company had cash of $5,105,611 available to fund its operations[215]. - The Company estimates that it will need to raise additional capital by mid-2024 to manage its current business plan during the remainder of 2024 and 2025[219]. - The Company has experienced negative operating cash flows since inception and relies on equity capital to fund operations[210]. - The Company estimates it will need to raise additional capital by mid-2024 to continue its operations and clinical trial programs[285]. - The Company had cash of $5,105,611 available to fund operations as of September 30, 2023, reflecting a decrease in working capital from $5,165,227 at December 31, 2022[283]. Clinical Development and Research - The Company is focused on the clinical development of LB-100, a specific protein phosphatase inhibitor with demonstrated anti-cancer activity[209]. - A Phase 1b/2 clinical trial is underway to assess the effectiveness of LB-100 in combination with GSK's dostarlimab for treating ovarian clear cell carcinoma[213]. - The Company completed a Phase 1 clinical trial of LB-100, showing antitumor activity with responses lasting up to 11 months in pancreatic cancer patients[250]. - The LB-100 series of drugs is believed to have a different mechanism of action compared to currently approved cancer agents, showing activity against various cancers in pre-clinical models[244]. - The Company is not planning to further develop the LB-200 series of drugs, focusing instead on the clinical development of LB-100[247]. - Research and development costs for the three months ended September 30, 2023, were $132,487, focused on developing additional novel anti-cancer compounds[262]. - For the three months ended September 30, 2023, research and development costs were $272,388, a decrease of $139,901 or 51.4% compared to the same period in 2022[266]. - For the nine months ended September 30, 2023, research and development costs were $749,029, down from $895,649 in 2022, reflecting a decrease of $146,620 or 16.4%[279]. Costs and Expenses - For the three months ended September 30, 2023, total costs and expenses were $1,024,181, resulting in a loss from operations of $(1,024,181)[257]. - General and administrative costs decreased by $314,419, or 26.1%, from $1,206,113 in 2022 to $891,694 in 2023, primarily due to a reduction in stock option expenses[261]. - General and administrative costs for the nine months ended September 30, 2023 were $3,315,297, a decrease of $467,917 or 12.4% compared to $3,783,214 in 2022[274]. Contractual Commitments - The Company has significant contractual commitments of approximately $6,262,000 related to clinical trial agreements scheduled through December 31, 2027[215]. - Remaining contractual commitments for clinical trial agreements not yet incurred totaled $6,262,000, scheduled to be incurred through approximately December 31, 2027[290]. - The Company entered into Amendment No. 2 to the Development Collaboration Agreement with the Netherlands Cancer Institute, adding €250,000 (approximately $263,000) to the operating budget[265]. - The aggregate commitment under the GEIS agreement, less amounts previously paid, totaled approximately $3,423,000 as of September 30, 2023[305]. - The aggregate commitment under the City of Hope agreement totaled approximately $2,433,000 as of September 30, 2023, expected to be incurred through March 31, 2026[310]. - The aggregate annual cash compensation for all officers increased to $950,000 effective September 26, 2023, and will decrease to $700,000 following the death of Dr. Kovach on October 5, 2023[331]. Strategic Decisions and Future Outlook - The Company has decided not to pursue further studies in myelodysplastic syndrome (MDS) due to other available opportunities[296]. - There is no assurance that the Company's pharmaceutical compounds will achieve regulatory approvals and market acceptance for sustainable revenues[341]. - The Company may need to reduce or discontinue its research and development programs if cash resources are insufficient[341]. - The Company is not currently aware of any trends or events that could materially affect its financial condition in the near term[342].

Financial Position - The Company has cash of $2,912,920 available to fund its operations as of June 30, 2023[211]. - The Company raised approximately $3,500,000 in gross proceeds from a registered direct offering and a concurrent private placement on July 20, 2023[209]. - The Company has remaining contractual commitments of $6,389,000 related to clinical trial agreements scheduled to be incurred through approximately December 31, 2025[211]. - The Company estimates that existing cash resources will fund its current clinical trial program through approximately December 31, 2024[215]. - The Company experienced negative operating cash flows since inception and has substantial doubt about its ability to continue as a going concern within one year[213]. - As of June 30, 2023, the company had working capital of $2,692,534, down from $5,165,227 at December 31, 2022, reflecting a decrease of $2,472,693[277]. - The company estimates it will need to raise additional capital to fund operations, including clinical trial commitments, during the latter half of the fiscal year ending December 31, 2024[279]. Revenue and Expenses - The Company has not yet commenced any revenue-generating operations and relies on equity capital to fund its operating requirements[200]. - The Company did not generate any revenues for the three months ended June 30, 2023 and 2022[254]. - General and administrative costs for Q2 2023 were $1,242,541, a decrease of $138,659 or 10.0% compared to Q2 2022[257]. - Research and development costs for Q2 2023 were $427,457, primarily for clinical oversight and pre-clinical research[258]. - The Company reported a net loss of $1,668,355 for Q2 2023, compared to a net loss of $1,546,304 for Q2 2022[253]. - The total costs and expenses for the six months ended June 30, 2023 were $3,040,145, compared to $3,200,362 for the same period in 2022[253]. - General and administrative costs for the six months ended June 30, 2023, were $2,423,603, a decrease of $153,498, or 6.0%, compared to $2,577,101 for the same period in 2022[269]. - The company had interest income of $7,729 for the six months ended June 30, 2023, compared to $300 for the same period in 2022[274]. Clinical Development - The Company is focusing on the clinical development of LB-100, a specific protein phosphatase inhibitor with demonstrated anti-cancer activity[199]. - The Company is focusing on the clinical development of its LB-100 series of drugs, which have shown activity against various cancers[238]. - The Company completed a Phase 1 clinical trial of LB-100, showing antitumor activity in humans with responses lasting up to 11 months[244]. - The Company’s research indicates that LB-100 can turn immunologically "cold" tumors "hot," enhancing the effectiveness of immune checkpoint blockade[204]. - The Company has entered into a collaboration agreement with GEIS for a clinical trial involving LB-100 and doxorubicin, targeting 150 to 170 patients over two years[289]. - The expected median progression-free survival (PFS) is 4.5 months for doxorubicin alone and 7.5 months for the combination with LB-100, aiming for a statistically significant reduction in relative risk of progression or death[290]. - The Company has executed a Clinical Research Support Agreement with City of Hope for a Phase 1b trial of LB-100 in combination with standard treatment for extensive-stage small cell lung cancer, with total costs expected to be approximately $2,433,000[302]. - The clinical trial at City of Hope is expected to enroll between 18 to 30 patients, with a completion date anticipated by December 31, 2024[303]. - The Company finalized a work order agreement with Theradex for a Phase I/II trial of LB-100 plus doxorubicin, with estimated costs of approximately $153,000[305]. - The NCI study aims to determine the extent of LB-100 penetration in recurrent malignant gliomas, with results expected by the end of 2023[309]. Research and Development Costs - Research and development costs for the three months ended June 30, 2023, increased by $262,647, or 159.4%, compared to the same period in 2022, primarily due to an increase in clinical and related oversight costs of $275,898[261]. - For the six months ended June 30, 2023, research and development costs were $616,542, consisting of clinical and related oversight costs of $393,892, regulatory service costs of $7,819, and pre-clinical research costs of $214,831[270]. - The Company incurred costs of $268,829 under the GEIS agreement during the three and six months ended June 30, 2023, compared to $0 in the same periods of 2022[297]. - The Company has incurred total costs of $147,572 under the monitoring agreement with Theradex for the Moffitt clinical trial as of June 30, 2023[311]. - The Company has incurred total costs of $225,924 under the contract with MRI Global as of June 30, 2023[326]. - The Company's aggregate commitment under the contract with MRI Global totaled approximately $100,000 as of June 30, 2023[327]. - The Company has incurred a total of $364,788 under the Development Collaboration Agreement with the Netherlands Cancer Institute as of June 30, 2023[325]. Strategic Focus - The Company is not currently planning to allocate resources to further develop its LB-200 series of drugs, focusing instead on LB-100[241]. - The company has decided not to pursue further studies in myelodysplastic syndrome (MDS) and is now focusing on other common diseases, including advanced soft tissue sarcoma and small cell lung cancer[288]. - The Company is facing uncertainties regarding the ability to secure additional financing and the potential need to reduce or discontinue research and development programs[330]. - There are no current trends or events identified that are likely to materially affect the Company's financial condition in the near term[331]. Legal and Licensing - The Company has filed several patents in 2022 related to LB-100, with stable legal and filing costs expected for the remainder of 2023[231]. - The Company entered into an Exclusive License Agreement with Moffitt, obligating it to pay a non-refundable license issue fee of $25,000 after the first patient entered a Phase 1b/2 clinical trial, which began in July 2019[315]. - The Company is required to pay Moffitt earned royalties of 4% on worldwide cumulative net sales of royalty-bearing products, with a minimum royalty payment of $50,000 in the first four years after sales commence[316]. - The Company incurred charges of $53,178 and $48,886 for the Development Collaboration Agreement with the Netherlands Cancer Institute during the three months ended June 30, 2023 and 2022, respectively[325]. - The Company recorded charges of $30,000 for the Collaboration Agreement with BioPharmaWorks for both the three months ended June 30, 2023 and 2022[324]. Compensation - The total aggregate annual compensation for all officers increased to $800,000 effective November 6, 2022, and has continued through June 30, 2023[320].