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): August 8, 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:

☐	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 August 8, 2024, Trevi Therapeutics, Inc., a Delaware corporation (the “Company”) announced its financial results for the quarter ended June 30, 2024. 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.		Description
99.1		Press release issued by the Company on August 8, 2024*
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: August 8, 2024		By:	/s/ Lisa Delfini
			Name: Lisa Delfini
			Title: Chief Financial Officer

 

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Exhibit 99.1

 

Trevi Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Updates Reaffirming Clinical Trial Guidance

 

 

Topline results expected in the fourth quarter of 2024 in the Phase 2a RIVER trial in refractory chronic cough (RCC)

Sample size re-estimation milestone is expected in the fourth quarter of 2024 in the Phase 2b CORAL trial in chronic cough in idiopathic pulmonary fibrosis (IPF)

Ended the second quarter of 2024 with $69.5 million in cash, cash equivalents and marketable securities with expected cash runway into 2026

Management to host a conference call and webcast today at 4:30 p.m. ET

 

New Haven, Conn., August 8, 2024 – 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 idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced financial results for the quarter ended June 30, 2024, as well as provided business updates.

"Recruitment in our clinical trials was strong during the quarter," said Jennifer Good, President and CEO of Trevi Therapeutics. "Our Phase 2a RIVER trial in RCC is now approximately 80% enrolled and we look forward to the topline data readout later this year. We also expect to complete the sample size re-estimation in our CORAL trial in the fourth quarter of this year. There is a significant unmet need for new therapies to help IPF and RCC patients. Chronic cough is a condition that is prevalent in 120,000 IPF patients and an estimated 2-3 million RCC patients in the U.S. and for which there are no approved therapies. We believe Haduvio's unique central and peripheral mechanism has the potential to provide a rapid, broad, and deep effect in those suffering from chronic cough.”

Second Quarter and Recent Business Highlights

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Second Quarter 2024 Financial Highlights

 

Research and development (R&D) expenses: R&D expenses for the second quarter of 2024 increased to $10.0 million from $5.8 million in the same period in 2023, primarily due to increased clinical development expenses for our Phase 2b CORAL trial, our Phase 2a RIVER trial, our HAP study and our recently initiated Phase 1b TIDAL study, as well as increases in personnel and related expenses and stock-based compensation expense. These increases were partially offset by decreased clinical development expenses for our Phase 2b/3 PRISM trial.

General and administrative (G&A) expenses: G&A expenses for the second quarter of 2024 increased to $3.3 million from $2.5 million in the same period in 2023, primarily due to increases in personnel and related expenses, stock-based compensation expense, market research costs, as well as information technology services.

Net loss: For the second quarter of 2024, the Company reported a net loss of $12.4 million, compared to a net loss of $7.1 million in the same period in 2023.

Conference Call/Webcast

To participate in the live conference call by phone, please dial (877) 870 4263 (domestic) or (412) 317 0790 (international) and ask to join the Trevi Therapeutics call. No code is necessary for access. A live audio webcast will be accessible from the 'Investors & News' section on the Company's website at www.TreviTherapeutics.com. 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:

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About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). Haduvio is a dual ĸ-opioid receptor agonist and µ-opioid receptor antagonist that works both centrally in the brain as well as peripherally in the lungs and has the potential for a synergistic antitussive effect to treat chronic cough. Parenteral nalbuphine is not scheduled by the U.S. Drug Enforcement Agency.

The impact of chronic cough is significant and often leads to a decline in patients' social, physical, and psychological quality of life. In IPF, chronic cough may lead to worsening disease and may be associated with a higher risk of progression, death, or need for lung transplant. There are no approved therapies for the treatment of chronic cough in IPF and current treatment options provide minimal benefit to patients. Chronic cough affects up to 10% of the adult population, and Haduvio's expansion into RCC has the potential to reach patients suffering from moderate to severe refractory chronic cough. 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, expectations regarding Trevi’s uses and sufficiency of capital, 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 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 the quarterly report on Form 10-Q for the quarter ended March 31, 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

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update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

 

 

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Trevi Therapeutics, Inc.

Selected Balance Sheet Data

(unaudited)

(amounts in thousands)

 

		June 30, 2024				December 31, 2023
Cash and cash equivalents		$	12,963			$	32,397
Marketable securities			56,532				50,574
Working capital			65,377				81,723
Total assets			73,810				89,403
Stockholders' equity			66,174				82,547

 

Trevi Therapeutics, Inc.

Selected Statement of Operations Data

(unaudited)

(amounts in thousands, except per share amounts)

 

		Three Months Ended June 30,								Six Months Ended June 30,
		2024				2023				2024				2023
Operating expenses:
Research and development		$	10,021			$	5,842			$	18,825			$	10,842
General and administrative			3,268				2,540				6,370				5,103
Total operating expenses			13,289				8,382				25,195				15,945
Loss from operations			(13,289	)			(8,382	)			(25,195	)			(15,945	)
Other income, net			929				1,207				1,925				2,362
Loss before income taxes			(12,360	)			(7,175	)			(23,270	)			(13,583	)
Income tax benefit			8				30				16				37
Net loss		$	(12,352	)		$	(7,145	)		$	(23,254	)		$	(13,546	)
Basic and diluted net loss per common share outstanding		$	(0.12	)		$	(0.07	)		$	(0.23	)		$	(0.14	)
Weighted average common shares used in net loss per share attributable to common stockholders, basic and diluted			101,041,573				98,698,579				100,279,393				98,654,868

 

Investor Contact

Katie McManus

Trevi Therapeutics, Inc.

203-304-2499

k.mcmanus@trevitherapeutics.com

 

Media Contact

Rosalia Scampoli

914-815-1465

rscampoli@marketcompr.com

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v3.24.2.u1

Document and Entity Information	Aug. 08, 2024
Cover [Abstract]
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Entity Central Index Key	0001563880
Document Type	8-K
Document Period End Date	Aug. 08, 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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