Trevi Therapeutics(TRVI) - 2021 Q3 - Quarterly Report

Financial Position - The company has an accumulated deficit of $172.4 million as of September 30, 2021, primarily due to research and development and general and administrative expenses [132]. - As of September 30, 2021, the company had cash and cash equivalents of $29.3 million, which may not be sufficient to fund operations for the next 12 months [137]. - The company reported a net loss of $25.4 million for the nine months ended September 30, 2021, with non-cash charges of $2.8 million primarily from stock-based compensation [171]. - The company believes existing cash and equivalents will fund operations into Q4 2022, barring any failure to meet Milestone Conditions set by the SVB Loan Agreement [179]. - The company has no committed external source of funds and will need to obtain further funding through public or private equity offerings, debt financings, collaborations, or licensing arrangements to complete the clinical development and commercialization of Haduvio [182]. Clinical Trials - The Phase 2b/3 PRISM trial for Haduvio has increased its enrollment target from 240 to 360 subjects to maintain statistical power, with approximately 90% of subjects already enrolled [128]. - The company expects to report top-line data from the Phase 2b/3 PRISM trial in the first half of 2022, subject to uncertainties related to the COVID-19 pandemic [128]. - The ongoing Phase 2 CANAL trial for chronic cough in patients with IPF aims to enroll approximately 60 subjects, with a goal of having 44 study completers [129]. - The ongoing Phase 2b/3 PRISM trial and Phase 2 CANAL trial for Haduvio are critical to the company's future product development [27]. - The company expects some clinical trial sites may take longer to resume activities due to disruptions caused by the COVID-19 pandemic [141]. Expenses and Financial Performance - Research and development expenses for Q3 2021 decreased to $4.7 million from $4.8 million in Q3 2020, primarily due to decreased purchases of clinical trial supplies [155]. - General and administrative expenses for Q3 2021 decreased to $2.2 million from $2.4 million in Q3 2020, mainly due to lower market research costs and stock-based compensation [156]. - Total operating expenses for the nine months ended September 30, 2021, increased to $24.2 million from $23.3 million in 2020, reflecting a rise in research and development expenses [158]. - Research and development expenses for the nine months ended September 30, 2021, increased to $16.8 million from $15.8 million in 2020, driven by higher personnel-related expenses and consulting fees [159]. - The company anticipates an increase in research and development expenses over the next few years as it pursues regulatory approval and prepares for a possible commercial launch of Haduvio [145]. Funding and Capital Needs - The company anticipates needing substantial additional funding to support operations and growth strategies, relying on equity offerings, debt financings, and collaborations [178]. - The company has raised an aggregate of $102.2 million from preferred stock and convertible notes, and borrowed $15.0 million under the Solar Term Loan prior to its IPO [162]. - The company issued 4,225,053 shares and warrants in private placements in October 2021, generating approximately $14.8 million in gross proceeds [167]. - If the company raises additional funds by issuing equity securities, stockholders may experience dilution, and any debt financing may involve restrictive covenants that could adversely impact business operations [182]. - The company may be required to delay, reduce, or abandon product development programs or commercialization efforts if sufficient capital is not raised [183]. Impact of COVID-19 - The COVID-19 pandemic has significantly impacted clinical trial activities, causing delays and interruptions in subject enrollment and data monitoring [140]. - The impact of the COVID-19 pandemic on clinical trials and product development remains a concern for the company [27]. Accounting and Financial Reporting - The company has not engaged in any off-balance sheet arrangements since inception, indicating a straightforward financial structure [186]. - The adoption of new accounting standards on January 1, 2021, did not materially affect the company's financial statements [187]. - The company’s critical accounting policies include research and development expenses and stock-based compensation, which are essential for understanding financial results [185].