Trevi Therapeutics, Inc. (TRVI)

Price$16.85Cached quoteAs of 2026-09-04 16:23 UTC

AI: Overvalued

Price checkThe stock price depends on successful drug development, not current earnings or cash assets.

At the observed close, the equity value is about $2.4 billion using 142.4 million June shares. Trevi has reported no revenue and lost $42.8 million in 2025; first-half 2026 operating cash burn was $34.1 million. Cash, cash equivalents, and marketable securities were $318.9 million at June 30, so the equity value was roughly 7.5 times that pool and 7.4 times reported equity. This premium can work only if Phase 3 success, approval, and commercial sales arrive; therefore I judge the shares Overvalued.

Big pictureStrong funding buys time, but the company still has no revenue and depends on clinical milestones.

This is not a cyclical earnings business yet: revenue was zero through 2025 and every year showed an operating loss. Net loss was $42.8 million in 2025, while first-half 2026 operating cash use was $34.1 million, up from $23.6 million. Debt was only $0.6 million against $321.5 million of equity, and management says its $318.9 million of liquid investments can fund planned work into 2030. That is useful protection, but free cash flow—cash left after running and investing—remains negative.

Business strengthPositive trial results and regulatory alignment create a credible path, but approval remains unproven.

The strongest bull case is Haduvio’s Phase 2b CORAL result: in 165 patients with idiopathic pulmonary fibrosis, cough frequency fell significantly across all dose groups, and more than 60% of treated patients cut coughs by at least half at six weeks. Side-effect discontinuation was similar to placebo, 5.6% versus 5.0%. The U.S. Food and Drug Administration agreed on two pivotal Phase 3 trials, including about 300 and 130 patients. These are encouraging facts, but mid-stage results do not guarantee later success or approval.

What could change the storyDilution and trial failure are the main ways today’s optimistic valuation could break.

Capital allocation has funded rapid expansion rather than shareholder returns: April’s offering added 13.34 million shares and raised about $162.3 million after costs. Shares outstanding rose from 128.3 million at 2025 year-end to 142.4 million by June 30, while 17.25 million nearly costless pre-funded warrant shares and 13.63 million option or warrant shares remained potential dilution, meaning existing holders could own a smaller slice. The valuation assumes successful Phase 3 trials, approval, commercial uptake, and limited further fundraising. Delays or failure would leave no sales, roughly $40 million-plus annual cash burn, and financing pressure.

AI: News

Phase Three Trials StartedTrevi began pivotal trials, moving Haduvio closer to approval but increasing spending and execution risk.

On August 6, Trevi reported that it had started the OCEAN-1 Phase 3 trial for cough tied to idiopathic pulmonary fibrosis and the LAKE Phase 2b trial for refractory cough; OCEAN-2 was expected in the third quarter. The update advances the main value driver, but it also raised second-quarter research spending to $15.2 million from $9.4 million. The market impact is not isolated here, but the milestone likely strengthened the approval timeline while increasing execution risk.

New Capital RaisedA large share offering extended the cash runway while materially increasing the number of shares investors must share.

On April 16, the company sold 11.6 million shares and the underwriters exercised an option for another 1.74 million. Net proceeds were about $162.3 million after fees and expenses. This financing reduced near-term funding risk and supports the planned Phase 3 program through potential approval. It also diluted existing holders: reported shares rose from 128.3 million at year-end 2025 to 142.4 million by June 30, before counting pre-funded warrants and other awards.

FDA Pathway ClarifiedRegulatory alignment replaced some development uncertainty with a defined, expensive pair of pivotal trials.

On March 9, Trevi said the U.S. Food and Drug Administration agreed with a two-trial Phase 3 plan for IPF-related chronic cough: roughly 300 patients over 52 weeks and 130 patients over 12 weeks, both using objective cough monitoring. This made the route toward a potential application more concrete and likely supported the valuation. However, the company explicitly warned that positive earlier data may not predict later results, and final protocols still required review.

JAMA Data ValidationPeer-reviewed results reinforced Haduvio’s cough benefit, but the evidence still comes before the decisive approval trials.

On January 22, Trevi announced publication of CORAL results in the Journal of the American Medical Association. Across 165 patients, all dose groups showed statistically significant cough reduction at six weeks, and more than 60% of treated patients achieved at least a 50% reduction from baseline. Treatment discontinuation for side effects was close to placebo, 5.6% versus 5.0%. The publication improves credibility, but it does not remove the risk that larger Phase 3 trials disappoint.

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Revenue

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Financial statements

	2025	2024	2023	2022	2021	2020	2019	2018
Revenue	$0	$0	$0	$0	—	—	—	—
Research & development	$33.5M	$39.4M	$23.7M	$19.8M	$23.0M	$22.3M	$19.3M	$14.1M
Operating expenses	$49.3M	$51.5M	$33.9M	$29.9M	$32.5M	$32.5M	$26.6M	$18.4M
Operating income	−$49.3M	−$51.5M	−$33.9M	−$29.9M	−$32.5M	−$32.5M	−$26.6M	−$18.4M
EBITDA	−$49.2M	−$51.4M	−$33.8M	−$29.9M	−$32.4M	−$32.4M	−$26.6M	−$18.4M
Net income	−$42.8M	−$47.9M	−$29.1M	−$29.2M	−$33.9M	−$32.8M	−$26.1M	−$20.5M
Basic EPSper basic share	-$0.32	-$0.47	-$0.29	-$0.45	-$1.49	-$1.81	-$2.28	-$58.44
Diluted EPSper diluted share	-$0.32	-$0.47	-$0.29	-$0.45	-$1.49	-$1.81	-$2.28	-$58.44

Review official source filings ↗

Owners

Reported shareholders

Reference date Jun 30, 2026

≈9.28%of listed shares

SANDELL SCOTT D13.22M shares · Dec 31, 2025

View holders

Top 20 reported holders of TRVI
Holder	% owned
SANDELL SCOTT D	≈9.28%13.22M shares
NEA Management Company, LLC	9.28%13.22M shares
Walker Paul Edward	≈9.28%13.22M shares
Florence Anthony A. Jr.	≈9.28%13.22M shares
Behbahani Ali	≈9.28%13.22M shares
Makhzoumi Mohamad	≈9.28%13.22M shares
Chang Carmen	≈9.28%13.22M shares
FMR LLC	8.82%12.56M shares
BASKETT FOREST	≈8.62%12.27M shares
NEA Partners 16, L.P. / NEA 16 GP, LLC / New Enterprise Associates 16, L.P.	≈8.62%12.27M shares
BlackRock, Inc.	7.83%11.16M shares
Frazier Life Sciences Management, L.P.	6.98%9.94M shares
WELLINGTON MANAGEMENT GROUP LLP	3.99%5.68M shares
VANGUARD CAPITAL MANAGEMENT LLC	3.88%5.53M shares
Vivo Capital, LLC	3.58%5.09M shares
Woodline Partners LP	2.87%4.08M shares
Vestal Point Capital, LP	2.18%3.1M shares
MPM BIOIMPACT LLC	2.16%3.07M shares
FRONTIER CAPITAL MANAGEMENT CO LLC	2.16%3.07M shares
Assenagon Asset Management S.A.	2.14%3.05M shares

Percentages use 142.42M shares of this listed class outstanding on Jun 30, 2026. ≈ compares the latest reported holding with a share total from a different date; it is not a confirmed current stake.

Reported positions exceed 100% in total, so the circle shows the selected holder only.

Source: SEC Form 5 ↗Updated Sep 29, 2026 · Quarterly data

Insider buys & sells

Jul 1, 2024–Jun 30, 2026

Buys0$0.00 disclosed value

Sells (SEC code S)14$939.0K disclosed value

Transaction	Insider	Type	Shares	Price	Value	Owned after
Mar 25, 2025Form 4	SCIASCIA THOMASChief Scientific Officer	SellCommon Stock	2.6K	$6.60	$17.4K	221.4K
Mar 21, 2025Form 4	GOOD JENNIFER LPresident & CEO	SellCommon Stock	5.3K	$6.58	$34.6K	213.3K
Mar 10, 2025Form 4 · 10b5-1	Simon FarrellChief Commercial Officer	SellCommon Stock	4.3K	$7.15	$31.1K	76.9K
Mar 10, 2025Form 4 · 10b5-1	Simon FarrellChief Commercial Officer	SellCommon Stock	77.0K	$6.73	$518.0K	81.3K
Sep 9, 2024Form 4	GOOD JENNIFER LPresident & CEO	SellCommon Stock	1.8K	$3.04	$5.6K	213.3K