Trevi Therapeutics (NASDAQ:TRVI) Issues Quarterly Earnings Results

Key Points

• Quarterly results met expectations: Trevi reported a loss of $0.13 per share, matching analysts’ consensus estimate.
• Clinical programs are advancing: OCEAN-1 and OCEAN-2 trials for idiopathic pulmonary fibrosis are progressing, with results expected in 2028; Trevi also plans to start a Phase II trial for non-IPF interstitial lung disease in Q1 2027.
• Cash runway and LAKE trial outlook: Trevi ended Q3 with about $299 million in cash and expects funding to extend into 2030. An independent review early in Q1 2027 will assess the LAKE trial’s enrollment and potential futility, with full results expected in the second half of 2027.

Trevi Therapeutics (NASDAQ:TRVI - Get Free Report) posted its quarterly earnings data on Monday. The company reported ($0.13) earnings per share for the quarter, hitting analysts' consensus estimates of ($0.13), FiscalAI reports.

Here are the key takeaways from Trevi Therapeutics' conference call:

• IPF trials are underway: Trevi said OCEAN-1 and OCEAN-2 have received regulatory approvals in all participating countries and are progressing through site activation and enrollment. It maintained guidance for OCEAN-2 results in the second half of 2027 and OCEAN-1 results in the first half of 2028.
• FDA alignment advances the non-IPF ILD program: Trevi plans a roughly 120-patient, Phase II dose-ranging trial starting in Q1 2027, with top-line results expected in the first half of 2028. Management said the study is intended to inform dosing and could support a streamlined path to a single Phase III trial.
• LAKE trial results remain uncertain: An independent sample-size review is expected in early Q1 2027 after 50 patients complete the trial; it could recommend keeping the 100-patient enrollment, increasing it to as many as 152, or indicate futility. Trevi expects the full readout in the second half of 2027, including if enrollment is increased.
• Cash is expected to fund key clinical milestones: Trevi ended Q3 with approximately $299 million in cash, equivalents and marketable securities, and said its runway extends into 2030. Management said this covers the ongoing trials and non-IPF ILD Phase II study through data, but excludes RCC or non-IPF ILD Phase III trials and commercial launch costs.
• RCC competition has receded, but commercial questions remain: Management said there are no active competitors in its targeted chronic-cough indications and estimated about one million patients in the most refractory RCC segment. It said market sizing and potential commercial approaches remain under evaluation, and that plans will depend on the LAKE results.

Trevi Therapeutics Trading Up 6.8%

Shares of TRVI traded up $0.98 during trading hours on Monday, reaching $15.31. The company had a trading volume of 1,442,650 shares, compared to its average volume of 1,799,392. Trevi Therapeutics has a 12-month low of $9.82 and a 12-month high of $20.22. The firm has a 50 day simple moving average of $14.24 and a 200-day simple moving average of $14.41. The company has a market capitalization of $2.18 billion, a price-to-earnings ratio of -45.03 and a beta of 1.15.

Insider Buying and Selling

In related news, Director Michael Heffernan sold 39,473 shares of the business's stock in a transaction dated Tuesday, September 15th. The shares were sold at an average price of $15.09, for a total transaction of $595,647.57. Following the sale, the director owned 6,351 shares of the company's stock, valued at approximately $95,836.59. The trade was a 86.14% decrease in their ownership of the stock. The transaction was disclosed in a filing with the Securities & Exchange Commission, which is available at this link. Corporate insiders own 15.39% of the company's stock.

Analyst Upgrades and Downgrades

Several research firms have recently commented on TRVI. B. Riley Financial upped their price target on Trevi Therapeutics from $21.00 to $31.00 and gave the stock a "buy" rating in a research note on Monday, July 20th. Oppenheimer reiterated an "outperform" rating on shares of Trevi Therapeutics in a research report on Friday, September 25th. Cantor Fitzgerald boosted their price objective on shares of Trevi Therapeutics from $25.00 to $30.00 and gave the company an "overweight" rating in a research note on Friday, August 7th. JonesTrading boosted their price objective on shares of Trevi Therapeutics from $24.00 to $28.00 and gave the company a "buy" rating in a research note on Friday, August 14th. Finally, Raymond James Financial restated a "strong-buy" rating and set a $40.00 price objective on shares of Trevi Therapeutics in a research report on Friday, August 7th. One analyst has rated the stock with a Strong Buy rating, eleven have issued a Buy rating and one has issued a Sell rating to the stock. According to MarketBeat, the stock currently has an average rating of "Moderate Buy" and a consensus price target of $27.08.

Trevi Therapeutics Company Profile

Trevi Therapeutics, Inc is a clinical-stage biopharmaceutical company developing treatments for chronic cough and chronic itch. Its lead candidate, Haduvio (oral extended-release nalbuphine), is being studied for conditions including idiopathic pulmonary fibrosis, other interstitial lung diseases and chronic pruritus associated with prurigo nodularis.

Nalbuphine acts on opioid receptors, and Trevi is evaluating its potential to reduce these symptoms. The company's development programs are focused on clinical research; Haduvio is not an approved treatment.

Trevi is headquartered in New Haven, Connecticut, and its operations are centered on developing its drug candidate.

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