Trevi Therapeutics, Inc. (TRVI) SEC Filings & Earnings Calls

Pre-revenue clinical-stage company with no approved products; net loss increasing.

“Net loss $17.8M vs $12.3M prior year; no revenue.”

Clinical trial execution risk; topline data not expected until 2027-2028.

“Topline data from the 52-week fixed dosing OCEAN-1 trial is expected in the first half of 2028.” · word for word

No revenue, history of losses

“We have not generated any revenue from product sales and, as a result, we have never been profitable and have incurred net losses in each year since commencement of our operations.” · word for word

Need for substantial additional funding

“We will need substantial additional funding to support our continuing operations and pursue development and commercialization of Haduvio.” · word for word

Clinical trial and regulatory uncertainty

“If the FDA or other regulatory authorities were to require us to conduct clinical trials beyond those that we currently anticipate or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant additional financial resources and time on our development program.” · word for word

No revenue and history of losses

“We have not generated any revenue from product sales and, as a result, we have never been profitable and have incurred net losses in each year since commencement of our operations.” · word for word

Need for substantial additional funding

“We will need substantial additional funding to support our continuing operations and pursue development and commercialization of Haduvio.” · word for word

Clinical development risk

“If the FDA or other regulatory authorities were to require us to conduct clinical trials beyond those that we currently anticipate or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant additional financial resources and time on our development program.” · word for word

Pre-revenue; net loss widening; dependent on clinical trial success.

“Net loss increased to $13.2M from $10.3M; no approved products.”

Clinical trial execution risk; delays could impact cash runway assumptions.

“Phase 3 IPF cough trial initiation expected Q2 2026; topline results not expected until 2027-2028.”

Dilution from share authorization increase

“Proposal 5 seeks to increase authorized common stock from 200,000,000 to 400,000,000 shares.”

Pre-commercial stage; no approved products; reliance on clinical trial success

“As a pre-commercial biotechnology company, we do not use Net Income (Loss) performance in determining our executive compensation” · word for word

Related-party transactions (CEO family members employed)

“Jordyn Saradhi, the daughter of our Chief Executive Officer, has been employed as our Senior Director, R&D Financial Operations since February 1, 2026.” · word for word

Dilution from equity offering; future capital needs remain for commercialization and additional trials.

“The Company will need to raise substantial additional capital to complete the development and commercialization of Haduvio and any future product candidates.”

Clinical-stage biotech with no approved products; reliance on successful trial outcomes and regulatory approvals.

“Company is clinical-stage; Phase 3 trials for IPF cough and Phase 2b for RCC are planned but not yet initiated.”

Single product candidate dependency

“We are dependent on the successful development and commercialization of Haduvio, our sole product candidate.” · word for word

Need for additional funding

“We will need substantial additional funding. If we are unable to raise sufficient capital when needed on acceptable terms or at all, we could be forced to delay, reduce or abandon our product development programs or commercialization efforts.” · word for word

Clinical trial delays

“We have experienced delays and difficulties in the enrollment of patients in our clinical trials in the past.” · word for word

Regulatory uncertainty

“Clinical drug development involves a lengthy and expensive process with an uncertain outcome.” · word for word

Single supplier for drug substance

“We rely, and plan to continue to rely, on a single supplier, Par Health, ... for nalbuphine hydrochloride drug substance.” · word for word

Clinical trial risk; Phase 3 results uncertain.

“Phase 3 trials subject to FDA review and clinical outcomes.”

No material risk signals beyond standard executive transition

Warrant dilution risk

“As of October 31, 2025, pre-funded warrants that we issued and sold in the April 2022 Private Placement to purchase 12,531,332 shares of common stock remained outstanding.” · word for word

NOL limitation risk

“We previously completed a Section 382 analysis, and due to multiple historical ownership changes, all of our net operating loss carryforwards as of December 31, 2022, and research and development tax credits were subject to limitation.” · word for word

Pharmaceutical tariff risk

“On September 25, 2025, via a post on Truth Social, President Trump announced that, beginning October 1, 2025, all branded or patented drugs imported in the U.S. would face a 100% tariff.” · word for word

Nasdaq delisting risk

“We must satisfy Nasdaq’s continued listing requirements, including, among other things, a minimum closing bid price of $1.00 per share, or the Bid Price Requirement, or risk delisting.” · word for word

Clinical trial failure risk; no approved products; regulatory dependency.

“Clinical-stage company with no FDA-approved therapies; Phase 3 program not yet initiated.”