Financial Performance - The Company has not generated any revenues from operations to date and does not expect to do so in the foreseeable future [143]. - The Company reported no revenues for the years ended December 31, 2018 and 2017 [199]. - The net loss for the year ended December 31, 2018 was $2,133,128, compared to a net loss of $1,808,414 in 2017 [206]. - General and administrative costs increased by $754,817 or 56.2% in 2018 compared to 2017, totaling $2,097,348 [202]. - Research and development costs decreased by $426,555 or 91.3% in 2018 compared to 2017, amounting to $40,703 [205]. - Operating activities utilized cash of $1,511,034 in 2018, compared to $1,412,181 in 2017 [211]. - The Company has substantial doubt about its ability to continue as a going concern due to recurring operating losses and negative cash flows [207]. - As of December 31, 2018, the Company had working capital of $4,123,530, an increase of $3,128,489 from $995,041 at December 31, 2017 [208]. - Cash available to fund operations at December 31, 2018 was $4,273,012 [209]. Clinical Trials and Research - The Company received FDA approval for its IND Application to conduct a Phase 1b/2 clinical trial for its lead compound LB-100, expected to begin in Q2 2019 [145]. - The clinical trial is anticipated to take approximately three years to complete, with patient accrual expected to last two years [146]. - LB-100 showed anti-tumor activity in a Phase 1 clinical trial, with tumor shrinkage lasting for 11 months in one pancreatic cancer patient and disease stabilization for over 4 months in 9 other patients out of 20 [176]. - Pre-clinical studies indicate that LB-100 enhances the effectiveness of standard cytotoxic drugs and PD-1 blockers without increasing toxicity [179]. - The Company is focusing on demonstrating the therapeutic benefit of LB-100 in Phase 2 clinical trials, particularly for cancers like myelodysplastic syndrome (MDS) and small cell lung cancer (SCLC) [189]. - A Phase 1b/2 clinical trial for LB-100 in patients with del(5q) MDS is expected to begin in Q2 2019, with a two-year patient accrual period [190]. - The Company has established collaborations with leading academic research centers to further investigate LB-100's efficacy in various cancers [177]. - The Company is exploring partnerships for additional financing to support upcoming clinical trials, including those for SCLC and LB-100 combined with PD-1 inhibitors [194]. Drug Development - The Company has two classes of drugs under development for cancer treatment: LB-100 (protein phosphatase inhibitors) and LB-200 (histone deacetylase inhibitors) with potential applications in neurodegenerative diseases [175]. - The LB-200 series has shown broad activity against various cancer types but is currently not being actively pursued due to the focus on LB-100 [182]. - The patent portfolio includes multiple uses of LB-100 and its analogs for various cancers and non-neoplastic diseases, indicating a strong intellectual property position [181]. Funding and Partnerships - The Company is dependent on raising additional equity capital to fund its research and development activities [150]. - The Company entered into a Consulting Agreement with Liberi Life Sciences Consultancy BV, paying a one-time retainer of €15,000 (US $18,348) and 2.5% of net payments from sales or licensing activities generated by the advisor [221]. - The Company has an Exclusive License Agreement with Moffitt Cancer Center, which includes a non-refundable license issue fee of $25,000 and milestone payments totaling $1,897,000, subject to a 40% reduction under certain conditions [222]. - 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 and $100,000 in year five and thereafter [223]. - A Clinical Trial Research Agreement with Moffitt for a Phase 1b/2 clinical trial of the Company's lead compound LB-100 is effective for five years, unless terminated earlier [224]. - The Company entered into a work order agreement with Theradex for monitoring the clinical trial, with estimated costs of approximately $954,000, of which $11,906 has been incurred as of December 31, 2018 [226]. Operational Status - The Company has experienced recurring operating losses and negative operating cash flows since inception [147]. - Management has expressed substantial doubt about the Company's ability to continue as a going concern within one year of the financial statements being issued [148]. - As of December 31, 2018, the Company had not commenced revenue-generating operations and relies on raising equity capital for funding [196]. - As of December 31, 2018, the Company had no off-balance sheet arrangements [227].
Lixte Biotechnology(LIXT) - 2018 Q4 - Annual Report