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].
Lixte Biotechnology(LIXT) - 2023 Q2 - Quarterly Report