Financial Position - As of December 31, 2019, the Company had cash and cash equivalents of $2,598,864 available to fund its operations[168]. - As of December 31, 2019, the Company had working capital of $2,434,135, a decrease of $1,689,395 from $4,123,530 in 2018[207]. - The Company has substantial doubt about its ability to continue as a going concern within one year of the date of the financial statements being issued[165]. - The Company expects to need to raise additional capital no later than the fourth quarter of 2020[169]. - The Company expects to begin raising additional capital no later than the fourth quarter of 2020[209]. - The aggregate commitments for clinical trial agreements totaled approximately $5,000,000 as of December 31, 2019, expected to be incurred over the next five years[217]. - At December 31, 2019, the Company had no off-balance sheet arrangements[230]. Revenue and Losses - The Company has not yet commenced any revenue-generating operations and does not expect to do so in the foreseeable future[164]. - The Company reported no revenues for the years ended December 31, 2019, and 2018[198]. - The Company incurred a net loss of $2,440,343 for the year ended December 31, 2019, compared to a net loss of $2,133,128 in 2018[205]. - The Company has experienced recurring operating losses and negative operating cash flows since inception, relying on equity capital to fund operations[164]. Research and Development - The Company incurred costs of $87,471 for a clinical trial agreement, which represented 10.7% of total research and development costs for the year ended December 31, 2019[176]. - Research and development costs increased by $780,203 in 2019, totaling $820,906, primarily due to pre-clinical research activities[204]. - The Company is currently engaged in Phase 2 clinical trials for its lead compound LB-100, with significant therapeutic benefits expected against specific human cancers[191]. - The Company has decided not to actively pursue the pre-clinical development of its LB-200 series of compounds at this time[192]. - The Company has allocated resources to expand its patent portfolio as the potential effectiveness of LB-100 has been documented at the clinical trial level[193]. - The Company plans to complete the validation process for LB-100 for treating depressive or stress disorders within three years, contingent on securing additional capital[220]. Agreements and Collaborations - The Company entered into a Clinical Trial Research Agreement with Moffitt Cancer Center for a Phase 1b/2 clinical trial of its lead anti-cancer compound LB-100[215]. - An Exclusive License Agreement with Moffitt requires a non-refundable license issue fee of $25,000 after the first patient enters a Phase 1b/2 clinical trial, which began in April 2019[222]. - The Company is obligated to pay Moffitt milestone payments totaling $1,897,000, subject to a 40% reduction under certain conditions[222]. - The Company recorded operational charges of $80,669 in 2019 related to the License Agreement, compared to $0 in 2018[222]. - The Company will pay Moffitt earned royalties of 4% on worldwide cumulative net sales of royalty-bearing products, with a minimum payment of $50,000 in the first four years after sales commence[223]. - The Company has a Materials Cooperative Research and Development Agreement (M-CRADA) with the NIH, focusing on anti-cancer activity and neurological research[225]. - The Company agreed to pay $100,000 to the National Cancer Institute for research support, with the second installment of $50,000 canceled in 2018[226]. - Charges to operations under the Collaboration Agreement with BioPharmaWorks were $100,000 in 2019 and $10,000 in 2018, included in research and development costs[229]. Administrative Costs - General and administrative costs decreased by $428,188 or 20.4% in 2019 compared to 2018, totaling $1,669,160[201].
Lixte Biotechnology(LIXT) - 2019 Q4 - Annual Report