[8-K] Trevi Therapeutics, Inc. Reports Material Event
Rhea-AI Filing Summary
Trevi Therapeutics reported fourth-quarter and full-year 2025 results and outlined plans to advance its chronic cough pipeline. The company is developing Haduvio, an oral nalbuphine extended-release therapy for chronic cough in idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease, and refractory chronic cough.
Trevi ended 2025 with $188.3 million in cash, cash equivalents and marketable securities, which it expects will fund operations into 2028. For 2025, research and development expenses fell to $33.5 million from $39.4 million, while general and administrative costs rose to $15.9 million from $12.1 million. The net loss narrowed to $42.8 million from $47.9 million in 2024.
The company gained overall FDA alignment on its Phase 3 program for IPF-related chronic cough and plans two pivotal Phase 3 trials beginning in 2026. It also plans Phase 2b trials in 2026 for refractory chronic cough and for non-IPF ILD-related chronic cough, and will host an Investor and Analyst Day on May 7, 2026.
Positive
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Negative
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Insights
Trevi narrows losses, secures FDA alignment and funds runway into 2028.
Trevi Therapeutics is positioning Haduvio as a chronic cough therapy across IPF, non-IPF ILD and refractory chronic cough. In 2025 it obtained overall FDA alignment on a Phase 3 program in IPF-related chronic cough, including two pivotal trials plus supporting Phase 1 work for a potential NDA.
Pipeline plans now include two Phase 3 IPF-related chronic cough studies starting in
Financially, Trevi ended 2025 with
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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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 March 17, 2026, Trevi Therapeutics, Inc., a Delaware corporation (the “Company”) announced its financial results for the quarter and year ended December 31, 2025. 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 March 17, 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: March 17, 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 Fourth Quarter and Year End 2025 Financial Results and Provides Business Updates
Following the End-of-Phase 2 meeting with the FDA, the Company gained alignment on its Phase 3 program for the treatment of patients with idiopathic pulmonary fibrosis-related chronic cough
On track to initiate a Phase 2b clinical trial for the treatment of patients with refractory chronic cough in the second quarter of 2026
Company ended 2025 with $188.3 million in cash, cash equivalents and marketable securities, with expected cash runway into 2028
Management to host a conference call and webcast today at 4:30 p.m. ET
New Haven, Conn., March 17, 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 fourth quarter and year ended December 31, 2025, and provided business updates.
“Our progress in 2025 marked a major inflection point for Trevi’s growth trajectory, driven by positive Phase 2 data across our chronic cough programs,” said Jennifer Good, President and CEO of Trevi Therapeutics. “These results provide a strong foundation as we pursue our goal of becoming a leader in treating chronic cough. We’ve carried this momentum into 2026 as we gained overall alignment with the FDA during our End-of-Phase 2 meeting for patients with IPF-related chronic cough. We are now focused on initiating the first of our two pivotal Phase 3 IPF-related chronic cough trials, as well as our Phase 2b RCC trial in the second quarter of this year. Looking ahead, Trevi is well positioned to execute on its clinical programs and help address the high unmet need for patients who are burdened by chronic cough in our target indications, where there are no FDA-approved therapies.”
Recent Business Highlights
IPF-Related Chronic Cough
Refractory Chronic Cough
Non-IPF ILD-Related Chronic Cough
Corporate
Fourth Quarter 2025 Financial Highlights
Cash, cash equivalents and marketable securities: The Company ended 2025 with $188.3 million with expected cash runway into 2028.
Research and development (R&D) expenses: R&D expenses for the fourth quarter of 2025 decreased to $6.2 million from $9.3 million in the same period in 2024, primarily due to decreased clinical development expenses for the Company’s Phase 2a RIVER trial and Phase 2b CORAL trial, which were actively enrolling patients in the prior year period.
General and administrative (G&A) expenses: G&A expenses for the fourth quarter of 2025 increased to $4.0 million from $2.9 million in the same period in 2024, primarily due to an increase in professional fees and personnel-related expenses.
Other Income, net: Other Income, net for the fourth quarter of 2025 increased to $1.9 million from $0.8 million in the same period in 2024, primarily due to an increase in interest income from higher invested cash equivalent and marketable securities balances.
Net loss: For the fourth quarter of 2025, the Company reported a net loss of $8.3 million compared to the net loss of $11.4 million in the same period in 2024.
Full Year 2025 Financial Highlights
R&D expenses: R&D expenses for the year ended December 31, 2025, were $33.5 million compared to $39.4 million in 2024, primarily due to decreased clinical development expenses for the Company’s human abuse potential study, Phase 2a RIVER trial, and Phase 2b CORAL trial, which were actively enrolling patients in 2024, partially offset by increased costs incurred associated with the recently completed Phase 1 drug-drug interaction study and personnel-related expenses.
G&A expenses: G&A expenses for the year ended December 31, 2025, were $15.9 million compared to $12.1 million in 2024, primarily due to an increase in professional fees and personnel-related expenses.
Other income, net: Other income, net was $6.5 million for the year ended December 31, 2025, compared to $3.6 million in 2024, primarily due to an increase in interest income from higher invested cash equivalent and marketable securities balances.
Net loss: For the year ended December 31, 2025, the Company reported a net loss of $42.8 million, compared to a net loss of $47.9 million in 2024.
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.
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 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 ~150,000 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, 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 other statements containing the words “believes,” “anticipates,” “plans,” “expects,” and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: 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; 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, as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended September 30, 2025 filed with the Securities and Exchange Commission and in subsequent filings made by the Company 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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December 31, |
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December 31, |
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Cash and cash equivalents |
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$ |
18,914 |
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$ |
34,097 |
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Marketable securities |
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169,346 |
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73,525 |
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Working capital |
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181,907 |
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98,919 |
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Total assets |
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193,439 |
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110,900 |
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Stockholders' equity |
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183,244 |
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99,644 |
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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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Year Ended |
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2025 |
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2024 |
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2025 |
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2024 |
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Operating expenses: |
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Research and development |
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$ |
6,194 |
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$ |
9,327 |
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$ |
33,478 |
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$ |
39,377 |
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General and administrative |
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4,026 |
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2,916 |
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15,850 |
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12,147 |
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Total operating expenses |
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10,220 |
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12,243 |
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49,328 |
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51,524 |
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Loss from operations |
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(10,220 |
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(12,243 |
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(49,328 |
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(51,524 |
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Other income, net |
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1,888 |
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844 |
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6,505 |
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3,583 |
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Loss before income taxes |
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(8,332 |
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(11,399 |
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(42,823 |
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(47,941 |
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Income tax (benefit) provision |
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(16 |
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17 |
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(64 |
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(30 |
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Net loss |
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$ |
(8,316 |
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$ |
(11,416 |
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$ |
(42,759 |
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$ |
(47,911 |
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Basic and diluted net loss per common share outstanding |
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$ |
(0.06 |
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$ |
(0.11 |
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$ |
(0.32 |
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$ |
(0.47 |
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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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145,502,344 |
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106,009,686 |
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134,747,198 |
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101,971,873 |
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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
Filing Exhibits & Attachments
2 documentsPress Releases
