Trevi Therapeutics (NASDAQ: TRVI) raises $162M, funds cough trials
Rhea-AI Filing Summary
Trevi Therapeutics, Inc. reported a first quarter 2026 net loss of $13.2 million, or $0.09 per share, as it increased investment in its chronic cough pipeline. Research and development and general and administrative expenses both rose versus the prior-year period.
The company ended the quarter with $171.8 million in cash, cash equivalents and marketable securities and then completed an underwritten common stock offering in April 2026 that generated approximately $162 million in net proceeds. Trevi now expects its cash runway to extend into 2030, supporting Phase 3 trials in IPF-related chronic cough, Phase 2b trials in non-IPF ILD-related chronic cough and refractory chronic cough, and a potential FDA submission for Haduvio.
Positive
- Substantial financing and extended runway: An April 2026 underwritten common stock offering produced approximately $162 million in net proceeds, and combined with existing cash, cash equivalents and marketable securities of $171.8 million at March 31, 2026, is expected to fund operations into 2030, including late-stage Haduvio trials and a potential FDA submission.
Negative
- None.
Insights
Large equity raise extends Trevi’s cash runway into 2030, funding late-stage cough programs despite ongoing losses.
Trevi Therapeutics remains a clinical-stage company with no product revenue, posting a Q1 2026 net loss of $13.2 million. Operating expenses rose as Phase 3 IPF-related chronic cough and Phase 2b RCC programs ramped, alongside higher G&A tied to intellectual property and personnel.
The key development is an April 2026 underwritten common stock offering generating about $162 million in net proceeds. Combined with quarter-end cash, cash equivalents and marketable securities of $171.8 million, Trevi expects funding into 2030. Management states this should support Haduvio development in IPF-related chronic cough potentially through FDA approval, as well as planned Phase 2b and potential Phase 3 trials in non-IPF ILD-related chronic cough and RCC.
Clinically, Trevi completed an End-of-Phase 2 FDA meeting for IPF-related chronic cough and plans two parallel Phase 3 trials with topline data expected in 2027 and 2028. Additional Phase 2b trials in non-IPF ILD and RCC are planned for 2026. Future company updates around these trial initiations and topline readouts, as described, will shape the development path for Haduvio.
8-K Event Classification
Key Figures
Key Terms
End-of-Phase 2 meeting regulatory
Phase 3 trials medical
adaptive design Phase 2b clinical trial medical
refractory chronic cough (RCC) medical
cash runway financial
underwritten common stock offering financial
Earnings Snapshot
The company expects its current cash, cash equivalents and marketable securities, together with net proceeds from the April 2026 offering, to extend its cash runway into 2030 and to fund Haduvio development in IPF-related chronic cough potentially through FDA approval and key Phase 2b programs.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition
On May 5, 2026, Trevi Therapeutics, Inc., a Delaware corporation (the “Company”), announced its financial results for the quarter ended March 31, 2026. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information provided under Item 2.02 of this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits
Exhibit No. |
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Description |
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99.1 |
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Press release issued by the Company on May 5, 2026* |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
* The exhibit shall be deemed to be furnished, and not filed.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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TREVI THERAPEUTICS, INC. |
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Date: May 5, 2026 |
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By: |
/s/ David C. Hastings |
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Name: David C. Hastings |
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Title: Chief Financial Officer |
Exhibit 99.1
Trevi Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Updates
Completed follow-on common stock offering with net proceeds of ~$162 million, extending expected cash runway into 2030 through potential FDA approval of Haduvio in IPF-related chronic cough and continued pipeline advancement
Clinical development plans remain on track across all chronic cough indications
Management to host a conference call and webcast today at 4:30 p.m. ET
New Haven, Conn., May 5, 2026 – Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC), today announced financial results for the quarter ended March 31, 2026, and provided business updates.
“We are entering an important phase of execution for Trevi, with study initiations anticipated across our chronic cough programs,” said Jennifer Good, President and CEO of Trevi Therapeutics. “Following a very productive End-of-Phase 2 meeting with the FDA on our lead program in IPF-related chronic cough, we are excited to initiate multiple clinical trials this quarter, including our first Phase 3 in IPF-related chronic cough and our Phase 2b in RCC. With an expected cash runway into 2030, we are well-positioned to execute on our development strategy and advance towards a potential FDA submission in IPF-related chronic cough. We believe successful execution of our strategy would establish Trevi as the leader in providing best-in-class therapy in chronic cough indications with significant unmet needs and no FDA-approved therapies.”
Recent Business Highlights
IPF-Related Chronic Cough
Non-IPF ILD-Related Chronic Cough
Refractory Chronic Cough
Corporate
First Quarter 2026 Financial Highlights
Cash, cash equivalents and marketable securities: The Company ended the first quarter of 2026 with $171.8 million. After completion of its underwritten common stock offering in April 2026, the Company expects current cash resources to extend its cash runway into 2030.
The Company expects its current cash, cash equivalents and marketable securities to fund the development of Haduvio for the treatment of patients with IPF-related chronic cough, potentially through FDA approval. The Company also expects these cash resources will enable the Company to fund and report topline data from the planned Phase 2b clinical trial and potentially a subsequent Phase 3 trial for the treatment of patients with non-IPF ILD-related chronic cough, and the planned Phase 2b trial for the treatment of patients with RCC. The planned spending of these resources does not include any commercial expenses related to the commercial launch of Haduvio or any other clinical trials.
Research and development (R&D) expenses: R&D expenses for the first quarter of 2026 increased to $9.9 million from $7.8 million in the same period in 2025, primarily due to increased clinical development expenses for the Company's Phase 1 NDA supportive studies, Phase 3 IPF-related chronic cough trials and Phase 2b RCC trial, partially offset by a decrease in clinical development expenses for the Company's Phase 2b CORAL trial and Phase 2a RIVER trial.
General and administrative (G&A) expenses: G&A expenses for the first quarter of 2026 increased to $5.0 million from $3.7 million in the same period in 2025, primarily due to higher legal fees associated with intellectual property filings as well as an increase in non-cash stock option expense and other personnel-related expenses.
Other Income, net: Other Income, net for the first quarter of 2026 increased to $1.7 million from $1.1 million in the same period in 2025, primarily due to an increase in interest income from higher invested cash equivalent and marketable securities balances.
Net loss: For the first quarter of 2026, the Company reported a net loss of $13.2 million, compared to a net loss of $10.3 million in the same period in 2025.
Conference Call and Webcast
To register for the live conference call and webcast, please visit the ‘Investors & News’ section of the Company’s website or access directly at ir.trevitherapeutics.com/news-events/events. Please note for phone participants: Once registered, you will receive an email with unique call-in details. An archived replay of the webcast will also be available for 30 days on the Company's website following the event.
Upcoming Meetings
The Company plans to participate in the following events:
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine extended-release for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC). Haduvio is the first and only investigational therapy to show a statistically-significant reduction in cough frequency in clinical trials across both patients with IPF-related chronic cough and in patients with RCC. Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA), targeting opioid receptors that play a key role in controlling chronic cough. Nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency.
Chronic cough in patients with IPF and non-IPF ILD is a condition with high unmet need and no FDA-approved therapies. There are ~140,000 U.S. patients with IPF, and two-thirds of these patients are faced with uncontrolled chronic cough. Additionally, there are ~228,000 U.S. patients with non-IPF ILD, with 50-60% having uncontrolled chronic cough. The impact of chronic cough is significant, with patients coughing up to 1,500 times per day. This consistent cough, and any associated damage, may lead to a higher risk of morbidity and mortality, including worsening disease, a higher risk of progression, increased respiratory hospitalizations, and a decline in patients' quality of life.
RCC is a condition with high unmet need and no FDA-approved therapies. RCC is defined as a persistent cough lasting >8 weeks despite treatment for an underlying condition (i.e., asthma, gastroesophageal reflux disease, non-asthmatic eosinophilic bronchitis, upper airway cough syndrome, or post-nasal drip) and includes unexplained chronic cough. There are ~2-3 million U.S. patients with RCC, and it is believed to be associated with cough reflex hypersensitivity involving both the central and peripheral nervous systems. RCC is highly debilitating and may impact patients physically, psychologically, and socially.
Trevi intends to propose Haduvio as the trade name for oral nalbuphine ER. Its safety and efficacy have not
been evaluated by any regulatory authority.
For more information, visit www.TreviTherapeutics.com and follow Trevi on X (formerly Twitter) and LinkedIn.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, Trevi’s estimated cash runway, statements regarding Trevi’s business plans and objectives, including future plans or expectations for Haduvio and plans and timing with respect to clinical trials and clinical data, as well as regulatory submissions, statements regarding FDA guidance and approval, and expectations regarding Trevi’s uses and sufficiency of capital, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “may,” and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties inherent in estimating Trevi’s cash runway, future expenses and other financial results, including Trevi’s ability to fund future operations, including clinical trials; uncertainties regarding the success, cost and timing of Trevi’s product candidate development activities and clinical trials; the risk that positive data from a clinical trial may not necessarily be predictive of the results of later clinical trials in the same or a different indication; uncertainties regarding Trevi’s ability to execute on its strategy; uncertainties with respect to regulatory authorities' views as to the data from Trevi’s clinical trials and next steps in the development path for Haduvio in the United States and foreign countries; as well as other risks and uncertainties set forth in the annual report on Form 10-K for the year ended December 31, 2025 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Trevi Therapeutics, Inc.
Selected Balance Sheet Data
(unaudited)
(amounts in thousands)
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March 31, |
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December 31, |
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Cash and cash equivalents |
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$ |
19,412 |
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$ |
18,914 |
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Marketable securities |
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152,371 |
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169,346 |
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Working capital |
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169,006 |
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181,907 |
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Total assets |
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179,606 |
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193,439 |
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Stockholders' equity |
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172,127 |
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183,244 |
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Trevi Therapeutics, Inc.
Selected Statement of Operations Data
(unaudited)
(amounts in thousands, except per share amounts)
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Three Months Ended |
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2026 |
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2025 |
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Operating expenses: |
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Research and development |
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$ |
9,941 |
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$ |
7,811 |
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General and administrative |
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4,971 |
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3,659 |
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Total operating expenses |
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14,912 |
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11,470 |
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Loss from operations |
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(14,912 |
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(11,470 |
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Other income, net |
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1,700 |
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1,119 |
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Loss before income taxes |
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(13,212 |
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(10,351 |
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Income tax benefit |
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(20 |
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(11 |
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Net loss |
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$ |
(13,192 |
) |
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$ |
(10,340 |
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Basic and diluted net loss per common share outstanding |
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$ |
(0.09 |
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$ |
(0.09 |
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Weighted average common shares used in net loss per share attributable to common stockholders, basic and diluted |
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145,592,901 |
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117,610,750 |
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Investor Contact
Jonathan Carlson
Trevi Therapeutics, Inc.
(203) 654 3286
IR@trevitx.com
Media Contact
Rosalia Scampoli
914-815-1465
rscampoli@marketcompr.com