
Financial Performance - The company has not generated any revenues to date and is dependent on additional outside capital for future operations [186]. - Net cash used in operations increased by $6,748,000 to $31,056,000 in 2022 compared to $24,308,000 in 2021, mainly due to increased research and development activities [187]. - Net cash used in operations increased by $3,707,000 to $24,308,000 for 2021, compared to $20,601,000 for 2020, primarily due to increased research and development activities related to the NAVIGATE clinical trial [190]. - Net cash provided by financing activities was $36,814,000 during 2021, a significant increase from $263,000 in 2020, driven by proceeds from related-party convertible notes and common stock warrants [191]. - The company received $30,000,000 from three related-party convertible notes payable in 2021 [191]. Research and Development - Research and development expenses increased by 33% from $23,818,000 in 2021 to $31,737,000 in 2022, primarily due to costs related to the NAVIGATE clinical trial activities [174]. - Clinical program expenses increased due to costs related to NAVIGATE clinical trial activities and preparations [177]. - The company completed two Phase 1 clinical studies and two Phase 2 clinical studies for its lead product candidate, belapectin [173]. - Research and development expenses are charged as incurred, including costs related to clinical trials and preclinical studies, with significant factors for accruals including patient enrollment and active clinical sites [199]. Cash and Liquidity - As of December 31, 2022, the company had $18.6 million in unrestricted cash and cash equivalents, along with $50 million available under a line of credit [186]. - The company believes it has sufficient cash to fund operations at least through December 31, 2024, but will require more cash thereafter [186]. - The company has not created any off-balance sheet entities for raising capital or incurring debt, ensuring no material impact on liquidity or capital resources [196]. Expenses - General and administrative expenses rose by 4% from $6,361,000 in 2021 to $6,615,000 in 2022, attributed to an increase in non-cash stock-based compensation [178]. - Other income and expense for 2022 included $52,000 of interest income, offset by $1,033,000 in interest expense and amortization of debt discounts [179]. - Stock-based compensation cost is measured at the grant date based on fair value and recognized as an expense over the service period, with estimates of forfeitures included [200]. Operational Activities - The company entered into an operating lease for office space in Norcross, GA, with an average rate of approximately $4,250 per month, starting March 1, 2022 [193]. - The company has engaged outside vendors for clinical trial services, which are typically cancellable on 30 days' notice [195]. - The company monitors patient enrollment levels and related activities through internal reviews and discussions with contract research organizations [199].