Financial Performance - The Company has not commenced any revenue-generating operations and does not have positive cash flows from operations, relying on equity capital to fund its requirements [129]. - As of June 30, 2020, the Company had not generated any revenues and is dependent on raising additional equity capital by early 2021 [134]. - The Company has experienced recurring operating losses and negative operating cash flows since inception, financing its operations primarily through equity securities [132]. - The Company reported no revenues for the three months and six months ended June 30, 2020 and 2019 [160][168]. - The Company incurred a net loss of $373,125 for the three months ended June 30, 2020, an improvement from a net loss of $610,464 in the same period of 2019 [167]. - Working capital decreased by $843,150 to $1,590,985 as of June 30, 2020, compared to $2,434,135 at December 31, 2019 [178]. - The Company utilized cash of $768,682 for operating activities for the six months ended June 30, 2020, compared to $709,056 for the same period in 2019 [183]. - General and administrative costs decreased by $292,320 or 53.4% to $255,443 for the three months ended June 30, 2020, compared to $547,763 in the same period of 2019 [163]. - For the six months ended June 30, 2020, general and administrative costs were $547,928, down from $938,191 in the same period of 2019, a decrease of $390,263 or 41.6% [171]. - Research and development costs increased by $37,823 or 47.2% to $117,946 for the three months ended June 30, 2020, compared to $80,123 in the same period of 2019 [166]. - Research and development costs for the six months ended June 30, 2020, were $212,618, an increase of $84,181 or 65.6% compared to $128,437 in the same period of 2019 [174]. - The Company had cash and cash equivalents of $1,774,332 available to fund operations as of June 30, 2020 [179]. - The Company has substantial doubt about its ability to continue as a going concern within one year of the financial statements being issued [133]. Clinical Development - The Company is focused on developing LB-100, a protein phosphatase 2A inhibitor, which has shown potential anti-cancer activity in initial Phase 1 clinical trials [149]. - The Company is currently engaged in Phase 2 clinical trials and anticipates significant time to develop products capable of generating sustainable revenues [179]. - The Company entered into a Collaboration Agreement with GEIS for a clinical trial involving LB-100 and doxorubicin, aiming to enroll approximately 150 patients over two years [188]. - The clinical trial is now estimated to begin in Q3 2021 and complete by Q3 2024, with an interim analysis expected in June 2023 [190]. - The Company incurred costs of $43,411 related to the GEIS agreement during the three months ended June 30, 2020, with total costs of $130,882 incurred to date [192]. - Aggregate commitments for the clinical trial agreements totaled approximately $4,795,000 as of June 30, 2020, with $4,162,000 related to the GEIS trial [193]. Strategic Partnerships and Agreements - The Company is seeking strategic partnerships or licensing agreements with pharmaceutical companies to support its cancer programs [152]. - The Company has a consulting agreement with Liberi Life Sciences Consultancy BV, which includes a one-time retainer of €15,000 (approximately $18,348) and a 2.5% commission on net payments from sales or licensing activities [198]. - The License Agreement with Moffitt includes a non-refundable license issue fee of $25,000 and milestone payments aggregating $1,897,000 based on clinical and commercial milestones [199]. - The Company is obligated 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 [200]. - As of June 30, 2020, no milestones had been attained under the License Agreement with Moffitt [199]. - The Company entered into employment agreements with key personnel, including Dr. John Kovach with an annual salary of $250,000 and Dr. James Miser with a monthly salary of $12,500 [201][203]. - The Company’s aggregate commitments under the clinical trial monitoring agreement totaled approximately $876,000 as of June 30, 2020, expected to be incurred over the next five years [196]. - The Company entered into a consulting agreement with NDA Consulting Corp. for oncology research and drug development, with quarterly fees of $4,000 since 2014 [204]. - The Collaboration Agreement with BioPharmaWorks commenced on September 14, 2015, with a monthly fee of $10,000, aimed at commercializing products and strengthening the patent portfolio [205]. - Charges recorded under the Collaboration Agreement were $30,000 for Q2 2020 and Q2 2019, and $60,000 for the first half of 2020 compared to $40,000 for the first half of 2019 [206]. - The Collaboration Agreement was suspended from February 1, 2018, to September 13, 2019, and resumed on March 1, 2019 [206]. Market and Operational Risks - The Company anticipates that the COVID-19 pandemic may delay clinical trials by at least three to six months, impacting operational timelines [155]. - As of June 30, 2020, the Company had no off-balance sheet arrangements [207]. - There were no applicable market risks disclosed in the report [208]. - The Board of Directors approved a 1-for-6 reverse stock split of the Company's outstanding shares, pending regulatory approval [131].
Lixte Biotechnology(LIXT) - 2020 Q2 - Quarterly Report