Trevi Therapeutics Inc. (NASDAQ:TRVI) announced a cash runway extending into 2030 following a $162 million stock offering in April, positioning the company to fund its chronic cough programs through key clinical milestones without needing additional capital.
"The April offering has not only removed the financial overhang but also extended our cash runway into 2030, allowing us to focus on executing our clinical programs," Jennifer Good, President and Chief Executive Officer of Trevi, said on the company’s first-quarter earnings call.
The company reported a pro forma cash position of approximately $334 million, which includes about $172 million in cash and equivalents at the end of the first quarter plus the net proceeds from the offering. Despite the strengthened balance sheet, the stock saw a slight decline of 1.95% in after-hours trading.
The financing is set to fund a slate of upcoming clinical trials for its lead drug candidate, Haduvio, targeting multiple cough indications, with a pivotal Phase 3 trial in idiopathic pulmonary fibrosis (IPF)-related chronic cough expected to start this quarter.
Clinical Trials Advance
Trevi is advancing a multi-pronged clinical strategy for Haduvio across three distinct chronic cough indications. Following a positive meeting with the U.S. Food and Drug Administration, the company plans to initiate the first of two Phase 3 trials for IPF-related chronic cough this quarter, with the second beginning in the second half of 2026.
For non-IPF interstitial lung disease (ILD)-related chronic cough, Trevi intends to submit a protocol to the FDA for an adaptive Phase 2/3 study. The company hopes to begin that trial in the second half of the year, pending regulatory alignment.
In refractory chronic cough (RCC), a Phase 2b dose-ranging trial is also set to begin this quarter. Chief Development Officer James Cassella said the study includes a sample-size re-estimation planned for the fourth quarter of 2026 to confirm powering assumptions.
Financial Position and Intellectual Property
Chief Financial Officer David Hastings stated the company’s cash runway guidance includes funding for the IPF program potentially through FDA approval, as well as the planned trials in non-IPF ILD and RCC. The runway also covers pre-commercial activities, but not a full commercial launch.
On the intellectual property front, Good confirmed the company’s core method-of-treatment patent for Haduvio in IPF-related chronic cough has been issued in both the U.S. and Europe, providing protection through 2039. She added that new U.S. filings could potentially extend this protection through 2046.
The company faces potential competition from P2X3 antagonists like camlipixant. However, Chief Commercial Officer Farrell Simon said Trevi has “strong differentiation with our central and peripheral mechanism of action” and that the large unmet need in RCC can support multiple treatment options.
The updates position Trevi to reach several clinical inflection points over the next few years. Investors will look toward the company’s Investor and Analyst Day on May 7 and its presentations at the American Thoracic Society meeting later in the month for further details on trial designs and commercial strategy.
This article is for informational purposes only and does not constitute investment advice.