Financial Performance - The Company incurred a net loss of $1,656,918 for the three months ended March 31, 2022, compared to a net loss of $1,727,144 for the same period in 2021[204]. - The Company reported no revenues for the three months ended March 31, 2022, and 2021[194]. - Operating activities for the three months ended March 31, 2022, utilized cash of $1,035,097, compared to $1,026,337 for the same period in 2021[211]. - As of March 31, 2022, the Company had working capital of $3,462,186, down from $4,790,338 at December 31, 2021, reflecting a decrease of $1,328,152[206]. - The Company had cash of $3,777,742 available to fund operations as of March 31, 2022[206]. Research and Development - The Company is focused on developing two classes of drugs for cancer treatment, including protein phosphatase inhibitors (LB-100 series) and histone deacetylase inhibitors (LB-200 series), with broad therapeutic potential[150]. - The Company is engaged in Phase 2 clinical trials, which are expected to require significant time and resources before any product can generate sustainable revenues[159]. - The Company completed a Phase 1 clinical trial of LB-100, showing antitumor activity in humans with responses lasting up to 11 months[185]. - The LB-100 series is designed to target various cancers and has shown potential to enhance the effectiveness of existing anti-cancer drugs without increasing toxicity[178]. - The Company has not yet advanced the LB-200 series to clinical stage due to a focus on LB-100 and the need for additional capital[181]. Clinical Trials and Collaborations - The collaboration with the Netherlands Cancer Institute and Oncode Institute has led to a joint patent application for LB-100 combination therapy, indicating progress in research and development efforts[152]. - The Company has entered into a Development Collaboration Agreement with the Netherlands Cancer Institute and Oncode Institute to identify promising drug combinations with LB-100, with an expected duration of approximately two years[249]. - The clinical trial for LB-100 in combination with standard treatment for extensive-stage small cell lung cancer is expected to be completed by June 30, 2024[229]. - The estimated costs for the Phase 1b/2 clinical trial with Theradex are approximately $954,000, with 94% allocated for services and 6% for pass-through costs[236]. - The Company has committed to pay INSERM up to $1,750,000 upon achieving development milestones and up to $6,500,000 upon achieving commercial milestones related to the exploitation of a patent[238]. Costs and Expenses - The Company reported a significant increase in patent and licensing legal and filing fees, totaling $315,237 for the three months ended March 31, 2022, compared to $120,160 in the same period of 2021, representing a 162.3% increase[171]. - General and administrative costs decreased by $85,752, or 6.7%, in 2022 compared to 2021, primarily due to a reduction in stock option compensation[197]. - Research and development costs increased by $14,924, or 3.4%, in 2022 compared to 2021, mainly due to higher contractor costs for LB-100 synthesis[200]. - The Company incurred costs of $292,293 for the preparation of a new batch of clinical LB-100 during the three months ended March 31, 2022[226]. - The Company has recorded charges of $54,230 related to the collaboration agreement with the Netherlands Cancer Institute during the three months ended March 31, 2022[249]. Future Outlook and Risks - The Company has not provided assurances that its forward-looking statements regarding product development and market potential will prove correct, highlighting inherent risks and uncertainties[150]. - The Company faces uncertainties regarding the regulatory approvals and market acceptance of its pharmaceutical compounds, which may impact sustainable revenue generation[252]. - There are no assurances that the Company will achieve operating profitability or positive operating cash flows, even if revenues are generated[252]. - The Company may need to reduce or discontinue its research and development programs if cash resources are insufficient to meet ongoing cash requirements[252]. - Future trends or events may develop that could have a material effect on the Company's financial condition[253]. Equity and Funding - The Company completed the sale of 2,900,000 shares of common stock at a price of $2.00 per share, generating gross proceeds of $5,800,000, with net proceeds of approximately $5,166,160 after costs[158]. - The Company estimates that existing cash resources and proceeds from the equity offering will fund its clinical trial program for approximately 18 months, through September 30, 2023[209]. - As of March 31, 2022, the Company's contractual commitments for clinical trials totaled $8,399,000, scheduled to be incurred through December 31, 2025[214]. - The Company has paid GEIS an aggregate of $67,582 towards the second milestone payment for the clinical trial agreement as of March 31, 2022[223]. - The Company utilized cash of $0 for the GEIS agreement during the three months ended March 31, 2022, compared to $24,171 for the same period in 2021[224].
Lixte Biotechnology(LIXT) - 2022 Q1 - Quarterly Report