vTv Therapeutics(VTVT) - 2022 Q4 - Annual Report

Research and Development - The company has incurred approximately $612.5 million in research and development expenses since inception, with $12.4 million spent in 2022 alone[296]. - Research and development expenses for TTP399 increased from $917,000 in 2020 to $9.6 million in 2022, reflecting a significant investment in this lead program[296]. - The company anticipates significant ongoing research and development expenses as it advances TTP399 and other drug candidates[296]. - Major components of research and development costs include clinical trials, drug development, and regulatory compliance, which are expensed as incurred[340]. Clinical Trials and Regulatory Strategy - The company plans to conduct two pivotal clinical trials for TTP399, recruiting around 1,000 patients, with the primary endpoint being the difference in hypoglycemia events between treatment and placebo groups[286][287]. - TTP399 received Breakthrough Therapy Designation from the FDA, which may expedite its development and review timelines[289]. - The company has engaged with the FDA on optimal clinical trial designs for TTP399, indicating proactive regulatory strategy[286]. Financial Performance - Revenue for the year ended December 31, 2022, was $2.0 million, a decrease of 49.8% from $4.0 million in 2021[308]. - Research and development expenses decreased by approximately $1.0 million, or 7.3%, from $13.3 million in 2021 to $12.4 million in 2022[309]. - General and administrative expenses slightly decreased by $0.1 million, or 1.2%, from $12.3 million in 2021 to $12.2 million in 2022[310]. - The net loss attributable to vTv Therapeutics Inc. increased to $19.2 million in 2022 from $13.0 million in 2021, representing a decline of 47.7%[307]. - As of December 31, 2022, the company had cash and cash equivalents of $12.1 million and an accumulated deficit of $265.5 million[314]. Funding and Capital Requirements - The company entered into a $25 million investment agreement with G42 Investments, selling shares at $2.41 each, with potential additional shares contingent on FDA approval of TTP399[290]. - A $10 million investment was secured from CinPax, with shares sold at approximately $2.41 each, and additional warrants issued contingent on FDA approval of TTP399[291]. - The company anticipates needing substantial additional funding to continue operations and clinical trials, with ongoing evaluations of financing strategies[327]. - The company expects to finance cash needs through equity offerings, debt financings, and collaborations until substantial revenue from drug sales is generated[330]. - Additional capital raised through equity or convertible debt may dilute existing common stockholders' interests and impose restrictions on company actions[331]. - The company has sold $31.2 million worth of Class A common stock under the ATM Offering, leaving $37.3 million available for future sales[316]. - The company received proceeds of $12.0 million from the G42 promissory note on February 28, 2023, to support liquidity[328]. Future Outlook - The company expects revenue generation to fluctuate based on the timing of license fees, milestone payments, and product sales[294]. - The company expects to continue incurring losses for the foreseeable future as it progresses with clinical trials and seeks regulatory approvals[314]. - Future capital requirements will depend on various factors, including the progress and costs of clinical trials for TTP399, a potential therapy for type 1 diabetes[329]. Tax and Market Risk - The company recognizes deferred tax assets and liabilities based on differences between financial reporting and tax bases, considering future taxable income and tax planning strategies[346]. - Share-based compensation expense is based on the fair value of awards at grant date, estimated using the Black-Scholes option pricing formula[350]. - The company has limited exposure to market risk, with cash and cash equivalents maintained in high credit quality financial institutions[353]. - There is no material foreign currency exposure affecting the company's financial position[354].