TRVI Trevi Therapeutics Inc

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): January 8, 2025

 

Trevi Therapeutics, Inc.

(Exact Name of Registrant as Specified in Charter)

 

 

Delaware		001-38886		45-0834299
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

 

195 Church Street, 16th Floor New Haven, Connecticut		06510
(Address of Principal Executive Offices)		(Zip Code)

 

Registrant’s telephone number, including area code: (203) 304-2499

Not applicable

(Former Name or Former Address, if Changed Since Last Report)

 

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:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class		Trading symbol(s)		Name of each exchange on which registered
Common stock, $0.001 par value per share		TRVI		The Nasdaq Stock Market LLC

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. ☐

 

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Item 2.02. Results of Operations and Financial Condition

On January 8, 2025, Trevi Therapeutics, Inc., a Delaware corporation (the “Company”), issued a press release providing company updates in advance of its participation in the 14th Annual LifeSci Partners Corporate Access Event taking place in San Francisco, California from January 13 to 15, 2025, during the week of the annual J.P. Morgan Healthcare Conference (the “Release”). In the Release, the Company announced that it estimates its cash, cash equivalents, and marketable securities were $107.6 million as of December 31, 2024. The full text of the Release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The Company’s estimate of its cash, cash equivalents, and marketable securities as of December 31, 2024 is a preliminary estimate based on information available as of the date of this Current Report on Form 8-K, and its actual cash, cash equivalents, and marketable securities may be different from this preliminary estimate. In addition, the Company’s independent registered public accounting firm has not audited or reviewed this preliminary estimate.

The information provided under Item 2.02 of this Current Report on 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 8.01. Other Events

The company updates in the Release include:

Phase 2a RIVER Trial

The last patient completed their final visit in the Company’s Phase 2a RIVER trial in refractory chronic cough, which was designed to enroll approximately 60 patients, at the beginning of January 2025. Topline results for the trial continue to be expected in the first quarter of 2025.

Phase 2b CORAL Trial

The positive outcome for the sample size re-estimation analysis for the Company’s Phase 2b CORAL trial in idiopathic pulmonary fibrosis patients with chronic cough was announced in December 2024, reaffirming the original sample size for the trial (N=160). The trial is now approximately 80% enrolled and topline results continue to be expected in the first half of 2025.

Forward-Looking Statements

Statements contained in this Current Report on Form 8-K 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 the Company’s business plans and objectives, including future plans or expectations for Haduvio and plans and timing with respect to clinical trials and clinical data, and statements regarding the Company’s expected cash runway 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 the Company’s product candidate development activities and ongoing and planned 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 the Company’s ability to execute on its strategy; uncertainties with respect to regulatory authorities’ views as to the data from the Company’s clinical trials and next steps in the development path for Haduvio in the United States and foreign countries; uncertainties inherent in estimating the Company’s cash runway, future expenses and other financial results, including the Company’s ability to fund future operations, including clinical trials, as well as other risks and uncertainties set forth in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this Current Report on Form 8-K speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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Item 9.01. Financial Statements and Exhibits

(d) Exhibits

 

Exhibit No.		Description
99.1		Press release issued by the Company on January 8, 2025*
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

* The exhibit shall be deemed to be furnished, and not filed.

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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.

 

		TREVI THERAPEUTICS, INC.
Date: January 8, 2025		By:	/s/ Lisa Delfini
			Name: Lisa Delfini
			Title: Chief Financial Officer

 

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Exhibit 99.1

Trevi Therapeutics Announces Company Updates Ahead of 14th Annual LifeSci Partners Corporate Access Event Held During the J.P. Morgan Healthcare Conference

Last patient completed the Phase 2a RIVER trial in refractory chronic cough (RCC) in early January and topline results continue to be expected in the first quarter of 2025

 

Approximately 80% of enrollment complete in the Phase 2b CORAL trial in idiopathic pulmonary fibrosis (IPF) patients with chronic cough and topline results continue to be expected in the first half of 2025

New Haven, Conn., January 8, 2025 – Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of patients with chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced business updates ahead of its participation in the 14th Annual LifeSci Partners Corporate Access Event taking place in San Francisco, CA, from January 13-15, 2025. This event takes place during the week of the annual J.P. Morgan Healthcare Conference.

 

“We look forward to important readouts on our IPF chronic cough and RCC trials in the first half of the year, which follow our strong execution in 2024,” said Jennifer Good, President and CEO of Trevi Therapeutics. “We ended last year with positive outcomes in both the sample size re-estimation (SSRE) analysis of the Phase 2b CORAL trial in IPF patients with chronic cough and in our Human Abuse Potential study. These trials were key milestones for our IPF clinical trial and overall development program. This clinical development progress brings us closer to potentially providing a differentiated therapy to patients who suffer from chronic cough and have no approved therapies available to them in the U.S.”

Key Company Highlights

 

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The Company’s estimate of its cash, cash equivalents, and marketable securities as of December 31, 2024, included in this press release is a preliminary estimate based on information available as of January 8, 2025, and its actual cash, cash equivalents, and marketable securities may be different from this preliminary estimate. In addition, the Company’s independent registered public accounting firm has not audited or reviewed this preliminary estimate.

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) and refractory chronic cough (RCC). Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA), which are opioid receptors that play a key role in controlling cough hypersensitivity. Nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency.  

Chronic cough is a highly prevalent disease in IPF patients, impacting up to 85% of the IPF population. There are ~140,000 U.S. IPF patients and the impact of chronic cough is significant with patients coughing up to 1,500 times per day. This consistent cough and associated damage may lead to worsening disease, a higher risk of progression, death, or need for lung transplant. Chronic cough also often leads to a decline in patients' social, physical, and psychological quality of life. There are no approved therapies for the treatment of chronic cough in IPF and current off-label treatment options provide minimal benefit to patients. 

Refractory chronic cough affects approximately 2-3 million adults in the U.S. and is caused by cough reflex hypersensitivity in both the central and peripheral nerves. It is highly disruptive and accompanied by a wide range of complications, ranging from urinary incontinence in females to sleep disruption and social embarrassment that causes significant social and economic burdens for patients and those around them. Haduvio is being developed for the treatment of moderate to severe RCC. There are also no approved therapies for RCC in the U.S.  

  

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, and statements regarding Trevi’s expected cash runway 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

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development activities and ongoing and planned 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 Trevi’s quarterly report on Form 10-Q for the quarter ended September 30, 2024 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.

 

Investor Contact

Jonathan Carlson

Trevi Therapeutics, Inc.

(203) 654 3286

carlsonj@trevitherapeutics.com

 

Media Contact

Rosalia Scampoli

914-815-1465

rscampoli@marketcompr.com

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v3.24.4

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Document Type	8-K
Document Period End Date	Jan. 08, 2025
Entity Registrant Name	Trevi Therapeutics, Inc.
Entity Incorporation, State or Country Code	DE
Entity File Number	001-38886
Entity Tax Identification Number	45-0834299
Entity Address, Address Line One	195 Church Street
Entity Address, Address Line Two	16th Floor
Entity Address, City or Town	New Haven
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Security 12b Title	Common stock, $0.001 par value per share
Trading Symbol	TRVI
Security Exchange Name	NASDAQ
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