Trevi Therapeutics, Inc.

Current report

We face competition, which may result in others developing or commercializing products before or more successfully than we do.

Current report

The development and commercialization of new products is highly competitive. We expect that we will face competition from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide with respect to Haduvio or any future product candidate that we may seek to develop or commercialize. Our competitors may succeed in developing, acquiring or licensing technologies and products that are more effective, have fewer or more tolerable side effects or are more convenient or less costly than Haduvio or any future product candidate we may develop, which could render any product candidates obsolete and noncompetitive. Our competitors also may obtain FDA or other marketing approval for their products before we are able to obtain approval for ours, which could result in competitors establishing a strong market position before we are able to enter the applicable market.

Current report

If Haduvio is approved for the treatment of chronic cough in patients with IPF and non-IPF ILD, we expect that it may compete with product candidates that may be developed for the treatment of chronic cough in patients with IPF or ILD. Development of BI 1839100, a TRPA1 antagonist by Boehringer Ingelheim for the treatment of IPF-related chronic cough and progressive pulmonary fibrosis, was terminated in September 2025. It is possible that product candidates currently in development for the treatment of fibrosis in patients with IPF and ILD could, if approved, reduce the need for therapies to treat chronic cough in patients with IPF and non-IPF ILD. We expect that Haduvio might also compete with other product candidates currently in development, for the treatment of patients with RCC that might be used off-label to treat IPF-related chronic cough.

Current report

If Haduvio is approved for the treatment of patients with RCC, we expect that it may compete with product candidates in clinical development for the treatment of patients with RCC. Gefapixant, a P2X3 antagonist, which was developed by Merck & Co., Inc., or Merck, is approved for refractory or unexplained chronic cough in Japan, the United Kingdom, Switzerland, and the E.U. The application filed with the FDA was withdrawn and Merck indicated it does not plan to refile. Camlipixant, a P2x3 antagonist, which was being developed by GSK plc., will not progress further with development in RCC as of July 2026. Other product candidates that are currently in development for the treatment of patients with RCC include taplucainium (formerly NTX-1175), a charged sodium channel blocker, which is being developed by Nocion Therapeutics Inc.

Current report

We also expect that Haduvio would compete with a number of therapeutics that are not specifically approved to treat chronic cough including benzonatate, opioids, corticosteroids, proton-pump inhibitors, and neuromodulators.

Current report

Many of our competitors and potential competitors, either alone or with their strategic partners, have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining marketing approvals and commercializing approved products than we do. Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These companies also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials.

Current report

We are currently eligible to use the scaled disclosure accommodations available to “smaller reporting companies”, and our use of such scaled disclosure accommodations may make our common stock less attractive to investors.

Current report

We are currently eligible to use the scaled disclosure accommodations available to “smaller reporting companies.” These scaled disclosure accommodations include simplified executive compensation disclosure and certain other decreased disclosure obligations in SEC filings, including, among other things, only being required to provide two years of audited financial statements in annual reports. As of June 30, 2026, the last business day of our most recently completed second fiscal quarter, the market value of our common stock held by non-affiliates exceeded $700.0 million. As a result, we will no longer be able to use these scaled disclosure accommodations available to smaller reporting companies beginning with our Quarterly Report on Form 10-Q for the first quarter of fiscal year 2027, however we may, and we expect that we will, continue to take advantage of these scaled disclosure accommodations for the remainder of fiscal year 2026, including in our Annual Report on Form 10-K for the fiscal year ending December 31, 2026. Our use of such scaled disclosure accommodations in our SEC filings may make it harder for investors to analyze our results of operations and financial prospects and may make our common stock less attractive to investors.

Current report — wording carried from elsewhere

During the three months ended June 30, 2026, Michael Heffernan, adirector of the Company, adopted a Rule 10b5-1 trading arrangement for the sale of common stock issuable upon the exercise of certain stock options held by Mr. Heffernan. The trading arrangement is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) of the Exchange Act. The stock options subject to this arrangement are scheduled to expire on February 27, 2027 and December 20, 2027, respectively. This plan was adopted on June 16, 2026 and has an expiration date of December 31, 2027. Pursuant to the plan, the aggregate number of shares for which such options are to be exercised, and the aggregate number of shares of common stock to besold upon exercise of those options, is not to exceed 39,473.