
Financial Performance - Net cash used in operations increased by $8,802,000 to $41,767,000 for 2024, compared to $32,965,000 for 2023[188] - Net cash used in operations increased by $1,909,000 to $32,965,000 in 2023 compared to $31,056,000 in 2022, driven by increased research and development expenses[191] - Net cash provided by financing activities was $31,227,000 in 2024, a decrease from $40,033,000 in 2023, primarily due to changes in transactions[190] - In 2023, the company received $40,033,000 in financing, up from $10,000,000 in 2022, with $30,000,000 from a convertible line of credit and $10,000,000 from stock purchase warrants[192] Research and Development - Research and development expenses for 2024 were $36,571,000, a decrease of 13.8% compared to $32,130,000 in 2023[174] - Clinical program expenses increased to $29,079,000 in 2024 from $23,942,000 in 2023, primarily due to NAVIGATE clinical trial activities[175] - Research and development expenses are charged as incurred, with significant costs related to the NAVIGATE clinical trial and third-party contract research organizations[199] Cash Position and Financing - As of December 31, 2024, the company had $15.1 million in unrestricted cash and cash equivalents, plus $6 million available under a line of credit[187] - The company has raised a net total of $314.5 million from public and private offerings since its inception[187] - The company believes it has sufficient cash to fund operations through August 2025, but will require additional financing thereafter[187] Clinical Trials - The NAVIGATE trial is currently the only active clinical trial, with no plans or funding for additional trials at this time[173] - The company has engaged outside vendors for clinical trial services, which are typically cancellable on 30 days notice[195] Operating Expenses - General and administrative expenses decreased by 1.3% to $5,942,000 in 2024 from $5,862,000 in 2023[178] - Stock-based compensation is measured at grant date fair value and recognized over the service period, with estimates for potential forfeitures included[200] - The company entered into an operating lease for office space in Norcross, GA, with an average rate of approximately $4,250 per month, effective from March 1, 2022[193] Market Risks and Losses - The company has incurred significant operating losses since inception and cannot assure future revenue generation[171] - The company is not exposed to significant market risks as of December 31, 2024, and 2023[201] - The company has not created any off-balance sheet entities that could materially affect liquidity or capital resources[196]