Trevi Therapeutics(US:TRVI)2023-03-16 20:14Financial Performance - The company reported an accumulated deficit of $210.1 million as of December 31, 2022, primarily due to research and development and general and administrative expenses [509]. - The company has not generated any revenue from product sales and has incurred net losses each year since its inception [509]. - Net loss for the year ended December 31, 2022, was $29.2 million, compared to a net loss of $33.9 million in 2021, reflecting an improvement of $4.8 million [533]. - Interest income increased by $1.7 million to $1.7 million in 2022, primarily due to higher cash equivalents and marketable securities balances [536]. - Other income, net for 2022 was $0.7 million, compared to other expense, net of $1.5 million in 2021, mainly due to the absence of a $0.4 million expense recorded in 2021 related to shares issued to Lincoln Park [536]. - Total operating expenses for 2022 were $29.9 million, a decrease of $2.6 million from $32.5 million in 2021 [533]. Research and Development - The Phase 2 CANAL trial for Haduvio demonstrated statistically significant results for daytime cough frequency reduction (p<0.0001) with 38 subjects enrolled [503]. - A Phase 2 clinical trial for Haduvio targeting refractory chronic cough is expected to commence in the third quarter of 2023 [505]. - The Phase 2b/3 PRISM trial for prurigo nodularis showed statistically significant results on all primary and secondary endpoints [506]. - The company expects to conduct an additional Phase 3 clinical trial to support NDA submissions for Haduvio for prurigo nodularis [507]. - The company anticipates an increase in research and development expenses as it pursues regulatory approval and prepares for a potential commercial launch of Haduvio [524]. - Research and development expenses decreased by $3.2 million, or 13.7%, to $19.8 million in 2022 from $23.0 million in 2021, primarily due to reduced clinical trial costs [534]. Funding and Cash Flow - As of December 31, 2022, the company had cash, cash equivalents, and marketable securities totaling $120.5 million [516]. - The company may need substantial additional funding to support ongoing operations and growth strategy [518]. - The company expects to incur substantial expenditures for clinical development and regulatory approval of Haduvio, impacting future funding needs [552][553]. - The company has no committed external funding sources and will need to secure additional financing through various means [558]. - The company believes existing cash and marketable securities will fund operations into 2026, excluding costs for additional clinical trials [556]. - Net cash used in operating activities was $28.2 million, a decrease from $28.9 million in 2021 [546][547]. - Net cash used in investing activities for 2022 was $107.4 million, primarily for marketable securities [549]. - Net cash provided by financing activities in 2022 was $111.3 million, significantly up from $20.8 million in 2021 [550][551]. Debt and Obligations - The SVB Term Loan requires interest-only payments until March 2022, with full repayment due by February 1, 2024 [532]. - The SVB Term Loan was originally $14.0 million with an interest rate of either the prime rate plus 1.00% or 4.25% [542]. - The SVB Loan Agreement includes restrictive covenants that may limit the company's operational flexibility [559]. - Failure to raise sufficient capital could lead to delays or abandonment of product development programs [559]. Accounting and Financial Reporting - Financial statements prepared in accordance with U.S. GAAP, requiring estimates and assumptions affecting reported amounts of assets and liabilities [560]. - Research and development expenses are expensed as incurred, with nonrefundable advance payments deferred and capitalized [562]. - Stock-based compensation expense recognized using fair value-based method, influenced by stock price and various complex variables [564]. - Fair value estimates of financial instruments made at a specific point in time, with cash and cash equivalents considered representative of fair value [576]. - No new accounting pronouncements adopted during the year ended December 31, 2022, materially impacting consolidated financial statements [580]. - Company has elected not to avail itself of the JOBS Act exemption, subjecting it to the same new or revised accounting standards as other public companies [579]. - Research and development accruals estimated based on service levels performed and study progress, included in accrued expenses [563]. - Fair value measurements categorized into three levels, with Level 1 being quoted prices in active markets and Level 3 involving unobservable inputs [578]. - Company assesses uncertain tax positions based on sustainability and measures at the largest amount of benefit greater than fifty percent likely to be realized [573]. - Stock options' expected term estimated using the "simplified method," averaging the vesting term and original contractual term [567].