Lixte Biotechnology(US:LIXT)2025-08-07 12:31Financial Performance - The Company recorded a net loss of $1,485,228 and used cash in operations of $1,055,968 for the six months ended June 30, 2025[267]. - The Company has no recurring source of revenues and has experienced negative operating cash flows since inception[269]. - For the first half of 2025, patent and licensing legal and filing fees decreased to $73,386 compared to $146,823 in the same period of 2024, a reduction of 50.0%[298]. - For the three months ended June 30, 2025, the Company reported a net loss of $775,673, compared to a net loss of $1,010,919 for the same period in 2024, indicating a decrease in losses of approximately 23.2%[338]. - The Company had no revenues for the six months ended June 30, 2025, consistent with the same period in 2024[339]. - The Company incurred total costs and expenses of $774,809 for the three months ended June 30, 2025, compared to $1,009,156 for the same period in 2024[325]. - The Company incurred a prorated charge of $207,004 for the cost of patients enrolled in the clinical trial, which is included in accounts payable and accrued expenses as of June 30, 2025[374]. - For the six months ended June 30, 2025, the company incurred a net loss of $1,485,228, an improvement from a net loss of $1,982,241 for the same period in 2024[352]. - The company utilized cash of $1,055,968 in operating activities for the six months ended June 30, 2025, compared to $1,608,266 for the same period in 2024[361]. Cash and Funding - As of June 30, 2025, the Company had cash of $887,212 available to fund its operations[267]. - The Company closed a private placement on July 2, 2025, for gross proceeds of $5,050,000 and a registered direct offering on July 8, 2025, for gross proceeds of $1,500,000[259][260]. - The Company estimates that its existing cash resources, along with recent equity financings, will provide sufficient working capital for at least the next 12 months[270]. - The Company expects existing cash resources, along with net proceeds from recent private placements, to fund operations for at least the next 12 months, but additional capital will be needed for product development[357]. - As of June 30, 2025, the company had working capital of $452,630, down from $827,219 at December 31, 2024, reflecting a net decrease of $374,589[354]. Clinical Development - The Company is focusing on the clinical development of LB-100, a specific protein phosphatase inhibitor, which is believed to have significant therapeutic potential for a broad range of cancers[257]. - The Company is currently investigating LB-100 in combination with checkpoint immunotherapy in two clinical trials, collaborating with GSK and Roche[266]. - The Company is focused on the clinical development of LB-100, a protein phosphatase 2A inhibitor, which is currently being tested in clinical trials for Ovarian Clear Cell Carcinoma, Metastatic Colon Cancer, and Advanced Soft Tissue Sarcoma[307]. - LB-100 has demonstrated anti-cancer activity in animal models and is expected to enhance the effectiveness of existing anti-cancer drugs without significantly increasing toxicity[307]. - The Company aims to secure strategic partnerships or licensing agreements with major pharmaceutical companies as it progresses through the FDA-approval process for LB-100[308]. - The Company has ongoing clinical trials for its lead anti-cancer compound LB-100, with various phases actively recruiting patients[365]. - The Phase 1b clinical trial for LB-100 combined with atezolizumab is evaluating safety, optimal dose, and preliminary efficacy for metastatic microsatellite stable colorectal cancer, with a total of 37 patients expected to be enrolled over 24 months[369]. - The clinical trial opened in August 2024, with two patients enrolled to date, and the study has been paused due to two Serious Adverse Events (SAEs) under investigation[370]. - The collaboration with GEIS aims to enroll approximately 150 to 170 patients in a trial assessing LB-100 plus doxorubicin versus doxorubicin alone, with a planned median progression-free survival of 4.5 months for doxorubicin alone and 7.5 months for the combination[377]. - The MD Anderson Cancer Center clinical trial aims to assess the effectiveness of LB-100 combined with GSK's dostarlimab-gxly in treating ovarian clear cell carcinoma, with completion expected by December 31, 2027[386]. Costs and Expenses - Research and development costs for the three months ended June 30, 2025, were $60,648, a decrease of $150,060 or 71.2% compared to $210,708 in 2024[332]. - General and administrative costs for the three months ended June 30, 2025, were $714,161, down by $84,287 or 10.6% from $798,448 in 2024[335]. - Research and development costs decreased by $177,667, or 53.9%, in 2025 compared to 2024, primarily due to a decrease in clinical oversight costs of $80,507 and preclinical research costs of $138,947[345]. - General and administrative costs decreased by $316,619, or 19.2%, in 2025 compared to 2024, mainly due to reductions in insurance expenses of $125,174 and officer compensation costs of $191,878[349]. - The Company incurred costs of $14,794 and $60,569 for the six months ended June 30, 2025 and 2024, respectively, under the License Agreement[408]. - The Company incurred costs of $34,857 and $9,870 under a contract with MRI Global for stability analysis during the six months ended June 30, 2025 and 2024, respectively[419]. Regulatory and Compliance - The Company received notice from Nasdaq on July 15, 2025, that it was in compliance with the Stockholders' Equity Requirement after recent equity financings[283]. - The Company’s independent registered public accounting firm expressed substantial doubt about its ability to continue as a going concern due to ongoing cash requirements[272]. - The Company has not commenced any revenue-generating operations and is dependent on raising equity capital to fund its operating requirements as of June 30, 2025[323]. - The Company has adopted ASU 2023-07 for segment reporting, which requires additional disclosures effective January 1, 2024[291]. - The Company is evaluating various strategic alternatives, including merger or acquisition opportunities, to obtain capital for operations and maintain its Nasdaq listing[421]. Commitments and Agreements - The Company's remaining financial contractual commitments pursuant to clinical trial agreements not yet incurred aggregate approximately $524,000, scheduled to be incurred through December 31, 2027[268]. - The Company has incurred charges of $685,107 for work done under the GEIS agreement through the fourth milestone as of June 30, 2025[383]. - The aggregate commitment for the Phase 1b portion of the GEIS trial totaled approximately $293,000 as of June 30, 2025, scheduled to be incurred through December 31, 2025[384]. - The Company has a commitment of approximately $1,765,000 under the License Agreement, expected to be incurred over the next twenty years[408]. - The Company's aggregate commitment under the MRI Global contract totaled approximately $90,000 as of June 30, 2025[420].