Trevi Therapeutics, Inc 8-K, filed Nov 9, 2026
Trevi Therapeutics, Inc. (TRVI)
About this 8-K
Trevi Therapeutics, Inc filed this 8-K on November 9, 2026.
Trevi Therapeutics initiated OCEAN-2 for IPF-related chronic cough in 2026 and aligned with the FDA on a non-IPF ILD Phase 2 trial. The company expects a cash runway into 2030 and reported a $21.5 million net loss for the third quarter. AI summary
Items reported
- Item 2.02: Financial results
- Item 9.01: Financial statements and exhibits
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 November 9, 2026, Trevi Therapeutics, Inc., a Delaware corporation (the “Company”), announced its financial results for the quarter ended September 30, 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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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: November 9, 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 Third Quarter 2026 Financial Results and Provides Business Updates
Initiated Phase 3 OCEAN-2 trial for patients with IPF-related chronic cough in the third quarter; both Phase 3 OCEAN trials actively recruiting
Positive meeting with the FDA on the non-IPF ILD-related chronic cough program held in October 2026; Phase 2 dose-ranging trial expected to initiate in the first quarter of 2027
Notice of Allowance from the USPTO for patent application covering nalbuphine ER dosing in hepatically impaired patients with non-IPF ILD-related chronic cough, with patent expected to expire in 2041
Cash runway into 2030 funding key clinical milestones
Management to host a conference call and webcast today at 4:30 p.m. ET
New Haven, Conn., November 9, 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 September 30, 2026, and provided business updates.
“This is an important time of clinical execution for Trevi as we actively open sites globally and enroll patients across all three active trials,” said Jennifer Good, President and CEO of Trevi Therapeutics. “We also recently aligned with the FDA on our non-IPF ILD-related chronic cough program and expect to initiate a Phase 2 dose-ranging trial in the first quarter of 2027. Chronic cough remains a significant unmet need, and we believe our dual central and peripheral mechanism may be important for the treatment of these patients. The associated respiratory hospitalizations and potential higher risk of lung transplant results in higher cost for IPF and ILD patients, where no FDA-approved therapies exist.”
Recent Business Highlights
IPF-Related Chronic Cough
Non-IPF ILD-Related Chronic Cough
Refractory Chronic Cough
Third Quarter 2026 Financial Highlights
Cash, cash equivalents and marketable securities: The Company ended the third quarter of 2026 with $299.4 million in cash, cash equivalents and marketable securities.
The Company expects its current cash, cash equivalents and marketable securities will provide cash runway into 2030 and fund the development of Haduvio for the treatment of patients with IPF-related chronic cough, through potential FDA approval. The Company also expects these cash resources will enable the Company to fund the clinical development program through Phase 2 for the treatment of patients with non-IPF ILD-related chronic cough, and the ongoing Phase 2b LAKE trial for the treatment of patients with RCC.
Research and development (R&D) expenses: R&D expenses for the third quarter of 2026 increased to $19.1 million from $10.1 million in the same period in 2025, primarily due to increased clinical development expenses associated with the Phase 3 OCEAN-1 trial, the Phase 2b LAKE trial, and the Phase 3 OCEAN-2 trial as well as increases in stock-based compensation and personnel-related expenses. These increases were partially offset by decreased costs for the Phase 1 NDA supportive studies and the Phase 2b CORAL trial.
General and administrative (G&A) expenses: G&A expenses for the third quarter of 2026 increased to $5.4 million from $3.8 million in the same period in 2025, primarily due to an increase in stock-based compensation and personnel-related expenses.
Other Income, net: Other Income, net for the third quarter of 2026 increased to $3.0 million from $2.1 million in the same period in 2025, primarily due to an increase in interest income from higher invested cash equivalents and marketable securities balances.
Net loss: For the third quarter of 2026, the Company reported a net loss of $21.5 million, compared to a net
loss of $11.8 million in the same period in 2025.
Conference Call and Webcast
The Company plans to hold a conference call and webcast to discuss the Company’s financial results and business highlights. 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). In clinical trials, Haduvio showed a statistically-significant reduction in cough frequency, consistent across baseline cough frequencies, and showed improvements in patient-reported outcomes, in both patients with IPF-related chronic cough and in patients with RCC. Haduvio is believed to act on the cough reflex arc both centrally and peripherally as a dual acting kappa opioid receptor agonist and a mu opioid receptor antagonist (“KAMA”), hypothesized to reduce cough hypersensitivity by modulating both central neural pathways and peripheral airway nerves. Nalbuphine has been approved and marketed as an injectable for pain indications for decades in the United States (“U.S.”) and Europe. Parenteral nalbuphine is not currently scheduled by the U.S. Drug Enforcement Administration and in most of Europe.
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.
The FDA has conditionally accepted Haduvio as the trade name for 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, statements regarding FDA guidance and approval, statements 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, including with respect to the timing of the initiation of and generation of data from 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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September 30, |
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December 31, |
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Cash and cash equivalents |
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$ |
27,849 |
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$ |
18,914 |
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Marketable securities |
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271,559 |
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169,346 |
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Working capital |
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297,928 |
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181,907 |
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Total assets |
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310,812 |
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193,439 |
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Stockholders' equity |
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302,756 |
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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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Nine Months Ended |
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2026 |
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2025 |
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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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$ |
19,064 |
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$ |
10,085 |
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$ |
44,157 |
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$ |
27,285 |
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General and administrative |
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5,422 |
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3,831 |
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15,751 |
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11,823 |
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Total operating expenses |
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24,486 |
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13,916 |
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59,908 |
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39,108 |
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Loss from operations |
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(24,486 |
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(13,916 |
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(59,908 |
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(39,108 |
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Other income, net |
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3,015 |
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2,099 |
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7,408 |
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4,617 |
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Loss before income taxes |
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(21,471 |
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(11,817 |
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(52,500 |
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(34,491 |
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Income tax benefit |
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(19 |
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(15 |
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(59 |
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(48 |
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Net loss |
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$ |
(21,452 |
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$ |
(11,802 |
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$ |
(52,441 |
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$ |
(34,443 |
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Basic and diluted net loss per common share outstanding |
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$ |
(0.13 |
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$ |
(0.08 |
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$ |
(0.34 |
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$ |
(0.26 |
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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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159,727,489 |
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145,104,986 |
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154,025,958 |
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131,122,754 |
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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