Trevi Therapeutics, Inc. (“Trevi” or the “Company”) is a clinical-stage biopharmaceutical company focused on the development and commercialization of the investigational therapy Haduvio (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (“IPF”), chronic cough in patients with non-IPF interstitial lung disease (“ILD”), and refractory chronic cough (“RCC”).

Haduvio is an oral extended-release formulation of nalbuphine. Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (“KAMA”). Kappa and mu are opioid receptors that play a key role in controlling cough hypersensitivity. Nalbuphine has been approved and marketed as an injectable for pain indications for more than 30 years in the United States (“U.S.”) and Europe. Nalbuphine’s mechanism of action also potentially mitigates the risk of abuse associated with mu-opioid agonists because it antagonizes or blocks, the mu-opioid receptor. Parenteral nalbuphine is not scheduled as a controlled substance in the U.S. and most of Europe.

The Company’s Consolidated Financial Statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. The Company has financed its operations to date primarily through private placements of its redeemable convertible preferred stock and convertible notes prior to its initial public offering (“IPO”), borrowings under its prior term loan facility, proceeds from its IPO and concurrent private placement completed in May 2019, sales of its common stock pursuant to the at-the-market Sales Agreements (Note 9) with SVB Securities LLC (formerly SVB Leerink LLC) (“SVB Securities”) and Leerink Partners, LLC that the Company entered into in June 2020 and June 2023, respectively, the term loan facility with Silicon Valley Bank (“SVB”) that the Company entered into in August 2020 (Note 8), proceeds from the private placements completed in October 2021 and April 2022 (Note 9), proceeds from the exercise of common stock warrants that were issued in the October 2021 private placements, proceeds from the public offering completed in October 2022 (Note 9) and proceeds from the offering completed in December 2024 (Note 9). The Company has incurred recurring losses since inception, including net losses of $47.9 million and $29.1 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, the Company had cash, cash equivalents and marketable securities of $107.6 million compared to $83.0 million of cash, cash equivalents and marketable securities as of December 31, 2023. The Company had incurred losses and negative cash flows from operations and had an accumulated deficit of $287.0 million as of December 31, 2024. The Company expects to continue to incur losses for the foreseeable future. As of March 18, 2025, the date of issuance of these Consolidated Financial Statements, the Company believes that its cash, cash equivalents and marketable securities as of December 31, 2024, will be sufficient to fund its operating expenses and capital expenditure requirements for 12 months from the date of issuance of these Consolidated Financial Statements.