vTv Therapeutics(VTVT) - 2025 Q1 - Quarterly Report

Revenue and Financial Performance - Revenue for the three months ended March 31, 2025, was $0, a decrease of $1.0 million compared to $1.0 million in the same period of 2024[112]. - Interest income for the three months ended March 31, 2025, was $0.3 million, an increase from $0.1 million in the same period of 2024[116]. - The total operating expenses for the three months ended March 31, 2025, were $6.5 million, a slight decrease from $6.6 million in 2024[112]. - For the three months ended March 31, 2025, net cash used in operating activities was $5.687 million, a decrease of $1.6 million compared to the same period in 2024[122][123]. - Net cash provided by financing activities for the three months ended March 31, 2024, was $51.0 million, driven by sales of Class A common stock and proceeds from pre-funded warrants[125]. Expenses - Research and development expenses increased by $0.2 million, or 6.8%, to $2.8 million for the three months ended March 31, 2025, primarily due to an increase in indirect expenses[114]. - General and administrative expenses decreased by $0.3 million, or 7.7%, to $3.7 million for the three months ended March 31, 2025, driven by reductions in payroll and legal expenses[115]. - The company anticipates needing substantial additional funding for ongoing operations and commercialization expenses[126][129]. Cash Position and Funding - As of March 31, 2025, the company had cash and cash equivalents of $31.1 million[118]. - The company plans to finance operations through cash and cash equivalents, including future funding activities, and is evaluating financing strategies for clinical trials[127]. - Future capital requirements will depend on various factors, including the progress and costs of clinical trials for cadisegliatin, and the ability to maintain control over costs[128]. - The company sold 179,400 shares of Class A common stock under the TD Cowen ATM Offering for net proceeds of $2.5 million, leaving $47.5 million available to be sold[121]. - The company may face dilution of common stockholders' interests if additional capital is raised through equity or convertible debt securities[130]. Regulatory and Development Updates - The FDA granted Breakthrough Therapy designation for cadisegliatin in 2021, supported by positive results from the Phase 2 SimpliciT-1 Study, which showed a 40% reduction in severe hypoglycemia[98]. - The company plans to initiate two international registrational studies for cadisegliatin in type 1 diabetes, expected to start in 2027[100]. - The company has not generated any revenue from drug product sales to date and does not expect to until regulatory approval is obtained[126]. Financial Risks and Considerations - The company had an accumulated deficit of $304.8 million as of March 31, 2025, and anticipates continued losses and negative cash flow from operations[118]. - As of March 31, 2025, the company did not have any off-balance sheet arrangements[131]. - The company has no material interest rate or foreign currency exposure[136][138].