0001563880false00015638802024-10-212024-10-21

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): October 21, 2024

 

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 (see General Instruction A.2. below):

☐

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. ☒

 

 

Item 8.01 Other Events

On October 21, 2024, Trevi Therapeutics, Inc. (the “Company”) announced that enrollment has been completed in the Company's Phase 2a RIVER trial of Haduvio (oral nalbuphine ER) for the treatment of refractory chronic cough and the Company expects to report topline data in the first quarter 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 expectation of reporting topline data from the Company’s Phase 2a RIVER trial in the first quarter of 2025. Risks that contribute to the uncertain nature of the forward-looking statements include uncertainties regarding the success and timing of the Company's product candidate development activities, including its ongoing clinical trials, uncertainties regarding the Company's ability to execute on its strategy, as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended June 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.

 

 

 

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: October 21, 2024

 

By:

/s/ Lisa Delfini

 

 

 

Name: Lisa Delfini

 

 

 

Title: Chief Financial Officer

 

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Document and Entity Information
Oct. 21, 2024
Cover [Abstract]  
Amendment Flag false
Entity Central Index Key 0001563880
Document Type 8-K
Document Period End Date Oct. 21, 2024
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
Entity Address, State or Province CT
Entity Address, Postal Zip Code 06510
City Area Code (203)
Local Phone Number 304-2499
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Security 12b Title Common stock, $0.001 par value per share
Trading Symbol TRVI
Security Exchange Name NASDAQ
Entity Emerging Growth Company true
Entity Ex Transition Period true
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