Financial Position and Funding - As of December 31, 2021, the Company had cash of $4,823,745 available to fund its operations, indicating reliance on equity capital for operational funding [285]. - The Company had no revenues for the years ended December 31, 2021 and 2020, and remains dependent on raising equity capital for operations [327]. - As of December 31, 2021, the Company had working capital of $4,790,338, a decrease of $221,613 from $5,011,951 at the end of 2020 [338]. - The Company raised net cash proceeds of $4,591,349 from a public offering completed on November 30, 2020, and $3,689,761 from a registered direct equity offering on March 2, 2021 [340]. - The Company faces uncertainty regarding its ability to secure additional financing, which may impact its clinical trial schedule and operations [342]. Operating Losses and Costs - The Company reported a net loss of $6,728,396 for the year ended December 31, 2021, compared to a net loss of $3,264,882 for 2020, reflecting an increase in losses of 106.5% [336]. - General and administrative costs increased by $2,940,905, or 144.0%, in 2021 compared to 2020, primarily due to higher stock option expenses and other operational costs [330]. - Research and development costs rose by $513,100, or 41.9%, in 2021, driven by increased contractor costs and clinical oversight expenses [333]. - Stock-based compensation represented 44.2% of total general and administrative costs in 2021, highlighting the Company's reliance on equity awards for employee compensation [294]. Clinical Trials and Research Development - The Company is engaged in Phase 2 clinical trials, which are expected to require significant time and resources before generating sustainable revenues [285]. - The Company completed a Phase 1 clinical trial of LB-100, showing tumor shrinkage lasting for 11 months in one pancreatic cancer patient and stabilization in 9 other solid tumors [319]. - The LB-100 series has demonstrated activity against a broad spectrum of human cancers in pre-clinical models, with a focus on clinical development [314]. - The collaboration with the Netherlands Cancer Institute and Oncode Institute has led to a joint patent application for LB-100 combination therapy, indicating potential for strong synergistic effects in cancer treatment [284]. - The clinical trial initiated with City of Hope is expected to be completed by June 30, 2024, with an aggregate commitment of approximately $2,433,000 as of December 31, 2021 [364]. - The clinical trial for glioblastoma initiated by the National Cancer Institute involves a planned study of eight patients, with the first two enrolled in late 2019 [365]. Regulatory and Market Risks - The company cannot assure that its pharmaceutical compounds will obtain regulatory approvals and market acceptance to achieve sustainable revenues [387]. - There is no assurance that the company will achieve operating profitability or positive operating cash flows [387]. - The company may need to reduce or discontinue research and development programs if cash resources are insufficient [387]. - The company is not currently aware of any trends or events that could materially affect its financial condition in the near term [388]. - New trends or events may develop in the future that could have a material effect on the company's financial condition [388]. - There are no quantitative and qualitative disclosures about market risk applicable to the company [389]. Legal and Patent Costs - Patent and licensing legal and filing fees increased by $175,998 (31.8%) from $553,173 in 2020 to $729,171 in 2021 due to new patent filings and legal services [303]. - The Company expects patent and licensing legal and filing fees to remain stable in 2022 as it focuses on obtaining clinical data for its cancer treatment approach [304]. - The Company has contractual commitments totaling $8,646,000 for clinical trial agreements scheduled through December 31, 2025 [346]. - The aggregate commitment for the collaboration agreement with GEIS is approximately $4,250,000 as of December 31, 2021, expected to be incurred through December 31, 2025 [357]. - The Company has agreed to make milestone payments to INSERM totaling up to $1,750,000 upon achieving development milestones related to LB-100 [372].
Lixte Biotechnology(LIXT) - 2021 Q4 - Annual Report