Financial Performance - The Company reported no revenues for the years ended December 31, 2020, and 2019[304]. - The net loss for the year ended December 31, 2020, was $3,264,882, compared to a net loss of $2,440,343 for 2019[313]. - Operating activities utilized cash of $2,131,414 for the year ended December 31, 2020, compared to $1,674,148 for 2019[319]. - The Company had working capital of $5,011,951 at December 31, 2020, an increase of $2,577,816 from the previous year[314]. - General and administrative costs increased by $373,604 or 22.4% in 2020 compared to 2019, totaling $2,042,764[307]. - Research and development costs rose by $402,770 in 2020 compared to 2019, amounting to $1,223,676[310]. Funding and Capital - The Company completed the sale of 1,133,102 shares of common stock at a price of $3.70 per share, generating gross proceeds of $4,192,477 and net proceeds of approximately $3,690,030 after cash costs of about $502,447[265]. - The Company completed a public offering in November 2020, generating net cash proceeds of $4,591,349 to fund research and development activities[314]. - The Company is dependent on its ability to raise additional equity capital to fund its research and development activities and achieve sustainable revenues[315]. - The Company has expressed uncertainties regarding the ability to secure additional financing and the potential need to reduce or discontinue research and development programs[359]. Research and Development - The Company has not commenced any revenue-generating operations and has experienced negative operating cash flows since inception, relying on equity capital to fund operations[263][267]. - The Company is focused on the clinical development of the LB-100 series, which has shown activity against a broad spectrum of human cancers in cell culture and animal models[290][292]. - The LB-200 series contains compounds that may be effective for treating chronic hereditary diseases and cancer, but further development is currently on hold due to funding constraints[293]. - The Company has developed two series of pharmacologically active drugs, LB-100 and LB-200, with potential therapeutic applications in cancer and other diseases[290][291]. - The Company intends to maintain composition of matter patents for LB-200 but will not actively pursue its pre-clinical development at this time[293]. Clinical Trials - The Company received FDA approval for a Phase 1b/2 clinical trial of LB-100 in patients with low and intermediate-1 risk MDS, with a total planned enrollment of 41 patients[322]. - The clinical trial for LB-100 combined with doxorubicin in advanced soft tissue sarcoma aims to enroll approximately 150 patients over two years, with a median progression-free survival of 4.5 months for doxorubicin alone and 7.5 months for the combination[326]. - The Phase 1b clinical trial of LB-100 combined with a standard regimen for extensive stage small cell lung cancer is estimated to cost between $2,500,000 and $2,900,000[335]. - The Company incurred total costs of $130,882 related to the GEIS clinical trial agreement as of December 31, 2020[329]. - The aggregate commitments for clinical trial agreements totaled approximately $5,230,000 as of December 31, 2020, with $4,614,000 related to the GEIS trial[330]. - The estimated cost for new inventory of LB-100 for the GEIS clinical trial is between $600,000 and $700,000, with remaining commitments of approximately $300,000 as of December 31, 2020[332]. - The clinical trial monitoring agreement with Theradex is estimated to cost approximately $954,000, with total costs incurred of $75,788 as of December 31, 2020[338]. Agreements and Obligations - The Company has a Patent Assignment Agreement with INSERM, with potential milestone payments totaling up to $8,250,000 upon achieving development and commercial milestones[341]. - The consulting agreement with Liberi Life Sciences Consultancy BV included a one-time retainer of €15,000 (approximately $18,348) and 2.5% of net payments from sales or licensing activities[343]. - 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 is entered into a Phase 1b/2 clinical trial[344]. - 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[345]. - The Company recorded charges to operations of $25,001 and $80,669 for the years ended December 31, 2020 and 2019, respectively, related to the License Agreement[344]. - The Company incurred charges for salary in the amount of $62,500 for Dr. John Kovach's employment agreement during the year ended December 31, 2020[347]. - The Company recorded charges to operations of $131,650 under the Collaboration Agreement with BioPharmaWorks for the years ended December 31, 2020 and 2019[354]. - The Company agreed to pay FAST 5% of all proceeds received from the exploitation of study results, up to a maximum of $250,000, related to the preclinical studies of LB-100[355]. - The Company incurred charges for salary in the amount of $30,000 for Eric Forman's employment agreement during the year ended December 31, 2020[348]. - The Company has no off-balance sheet arrangements as of December 31, 2020[357]. - The Company recorded consulting and advisory fees of $16,000 and $62,000 for the years ended December 31, 2020 and 2019, respectively, under the agreement with NDA Consulting Corp.[352].
Lixte Biotechnology(LIXT) - 2020 Q4 - Annual Report