Financial Performance - The Company has not generated any revenues from operations to date and does not expect to do so in the foreseeable future [114]. - The company reported no revenues for the three months ended September 30, 2019, and 2018 [160]. - The company incurred a net loss of $1,079,072 for the three months ended September 30, 2019, compared to a net loss of $1,033,959 for the same period in 2018 [168]. - The company incurred a net loss of $2,118,272 for the nine months ended September 30, 2019, compared to a net loss of $1,784,539 for the same period in 2018 [177]. - Interest income for the three months ended September 30, 2019, was $13,889, a significant increase from $424 in the same period of 2018 [167]. - The company had interest income of $41,317 for the nine months ended September 30, 2019, compared to $1,547 for the same period in 2018 [176]. Cash and Capital Resources - As of September 30, 2019, the Company had cash and cash equivalents of $2,976,402 available to fund its operations [118]. - As of September 30, 2019, the company had working capital of $2,756,206, a decrease of $1,367,324 from $4,123,530 at December 31, 2018 [179]. - Operating activities utilized cash of $1,296,610 for the nine months ended September 30, 2019, compared to $934,388 for the same period in 2018 [182]. - The company is dependent on raising equity capital to fund its operating requirements, as it has not commenced any revenue-generating operations [156]. - The Company expects to raise additional capital beginning in late 2020 to fund its research and development activities [118]. Research and Development - The Company completed a Phase 1 clinical trial of its lead anti-cancer compound LB-100, showing anti-tumor activity with tumor shrinkage lasting for 11 months in one patient and disease stabilization for 4 months or more in 9 other patients [136]. - The LB-100 series of compounds has potential use in treating not only several types of cancer but also vascular and metabolic diseases [135]. - The LB-200 series of compounds, which are histone deacetylase inhibitors, has demonstrated broad activity against many cancer types and neuroprotective activity but has not yet advanced to the clinical stage [141]. - The Company has established collaborations with leading academic research centers in the U.S., Europe, and Asia to evaluate LB-100 in pre-clinical models of several major cancers [137]. - The company has entered into a Clinical Trial Research Agreement with Moffitt Cancer Center to conduct a Phase 1b/2 clinical trial for LB-100 in patients with low or intermediate-1 risk MDS [150]. - The Phase 1b/2 clinical trial for MDS began in April 2019, with the first patient enrolled in July 2019, and is expected to be completed within two years [150]. - The company is exploring additional clinical trials, including a Phase 1b/2 trial for small cell lung cancer (SCLC) and a trial combining LB-100 with PD-1 inhibitors [152][153]. - Research and development costs increased by $567,148 in 2019 compared to 2018, driven by an increase in the fair value of stock options and contractor costs [166]. - Research and development costs for the nine months ended September 30, 2019, were $699,038, an increase of $628,789 compared to $70,249 for the same period in 2018 [175]. - The company expects to complete the validation process for LB-100 for treating depressive or stress disorders within three years, requiring substantial additional capital [190]. Legal and Administrative Costs - Patent and licensing related legal and filing costs were $372,755 for the three months ended September 30, 2019, compared to $133,985 for the same period in 2018 [128]. - General and administrative costs decreased by $508,569 or 49.3% in 2019 compared to 2018, primarily due to a reduction in the fair value of stock options issued [163]. - Charges recorded under the Collaboration Agreement for the three months ended September 30, 2019, were $30,000, compared to $0 for the same period in 2018 [200]. - For the nine months ended September 30, 2019, charges under the Collaboration Agreement totaled $70,000, up from $10,000 in 2018 [200]. - The company recorded charges of $74,368 for the nine months ended September 30, 2019, in connection with its obligations under the License Agreement with Moffitt [193]. Strategic Partnerships - The company aims to secure strategic partnerships with pharmaceutical companies to support its cancer research and drug development initiatives [154]. - The Company entered into a Materials Cooperative Research and Development Agreement (M-CRADA) with NINDS for four years starting October 18, 2013, focusing on proprietary compounds for anti-cancer activity and neurological conditions [195]. - A Collaboration Agreement with BioPharmaWorks was established on September 14, 2015, with a monthly fee of $10,000, focusing on commercialization and patent portfolio strengthening [199]. - The Company agreed to provide $100,000 funding to the National Cancer Institute for research support, with the first installment of $50,000 paid on July 9, 2017, and the second installment canceled on November 3, 2018 [196]. Going Concern - The Company has experienced recurring operating losses and negative operating cash flows since inception, financing its working capital primarily through the sale of equity securities [114]. - The Company has substantial doubt about its ability to continue as a going concern within one year of the date that the consolidated financial statements are being issued [115]. - As of September 30, 2019, the Company had no off-balance sheet arrangements [201].
Lixte Biotechnology(LIXT) - 2019 Q3 - Quarterly Report