TRVI

This article first appeared on GuruFocus. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Trevi Therapeutics Inc (NASDAQ:TRVI) is on track with its clinical development plans, having initiated the OCEAN-1 Phase 3 trial for IPF-related chronic cough and the LAKE Phase 2B trial for refractory chronic cough (RCC) in Q2 2026, with OCEAN-2 expected to start in Q3. The company has a strong cash position of approximately $319 million, providing a runway into 2030 and funding for its IPF program through potential FDA approval, as well as Phase 3 development for non-IPF/ILD chronic cough. Following a competitor's termination of its RCC program, Trevi Therapeutics Inc (NASDAQ:TRVI) is essentially alone in all three of its cough indications, positioning it as a potential first-in-class therapy with significant unmet need. The company's data was well-received at the American Thoracic Society (ATS) meeting, with all six submissions accepted, including new data on breathlessness reduction and robust efficacy across all baseline cough counts, and its CORAL trial was highlighted in a 'Clinical Year in Review' session. Trevi Therapeutics Inc (NASDAQ:TRVI) has launched an unbranded awareness campaign that has already reached over 17,000 unique pulmonologists, showing strong engagement and eagerness for new therapies, and is leveraging synergies between its IPF and non-IPF/ILD programs to expedite development. The company's Phase 3 OCEAN trials are well-powered based on the strong effect size from the CORAL study, and management does not expect any waning of effect over longer treatment durations, supported by prior long-term studies. Trevi Therapeutics Inc (NASDAQ:TRVI) is early in enrollment for its initiated trials and has not yet provided specific enrollment numbers, making it difficult to assess progress against its timelines. The upcoming FDA meeting for the non-IPF/ILD chronic cough program is not yet granted, and the company is awaiting confirmation, creating uncertainty about the timeline for this program. The sample size re-estimation (SSRE) for the LAKE trial in RCC could result in a sample size increase of up to 50%, which could delay the readout timeline and introduce uncertainty about the trial's assumptions. The company's cash runway guidance does not include expenses for the commercial launch of HODUVIO or a Phase 3 trial in RCC, meaning additional capital may be required for these activities. The recent termination of a competitor's RCC program means Trevi Therapeutics Inc (NASDAQ:TRVI) will have to build market awareness for RCC on its own, potentially requiring more investment than if a larger pharma had helped educate the market. Management acknowledged that the translation of efficacy from the 6-week CORAL study to the 12-week and 24-week OCEAN trials remains a key question, and while they are confident, there is no guarantee of sustained effect over longer durations. Warning! GuruFocus has detected 2 Warning Sign with TRVI. Is TRVI fairly valued? Test your thesis with our free DCF calculator. Q: With the recent termination of a competitor's RCC program, has that changed the way you think about the overall market landscape, pricing, or the upcoming SSRE for the LAKE trial?A: Farrell Simon (Chief Commercial Officer) stated that the company remains an IPF/ILD-led company, and the RCC approach is unchanged. They will target the treatment-resistant proportion of RCC, which is about a million patients in the U.S., allowing for specialty dynamics and pricing. Dr. James Casella (Chief Development Officer) added that the LAKE trial is powered based on their own data from the RIVER study and CORAL program, and the GSK outcome has zero impact on their clinical program. Jennifer Goode (President and CEO) noted the SSRE protects the program if there is a placebo effect. Q: Can you walk us through the potential scenarios following the SSRE analysis for the LAKE trial, and how should investors think about the magnitude of adjustment and impact on the readout timeline? Also, what is the role of secondary endpoints in the OCEAN trials for labeling?A: Dr. James Casella (Chief Development Officer) explained that the SSRE is similar to the CORAL program, looking for 80% conditional power. If the sample size needs to increase, it can go up to 50% per protocol, which is a statistical exercise and not a big deal. He emphasized that an increase does not indicate a problem with the drug. For the OCEAN trials, key secondary endpoints include cough severity and breathlessness, which are label-enabling if they hit the hierarchy, as discussed with the FDA. Q: With OCEAN 2 expected to read out in the second half of 2027 and OCEAN 1 in the first half of 2028, will you hold top-line data from OCEAN 2 until OCEAN 1 reads out? How much can we read through from the 12-week to the 24-week trial?A: Jennifer Goode (President and CEO) stated they will not hold top-line data; they will release it as soon as possible, likely on a Monday morning after knowing results. She noted that OCEAN 1 should be largely enrolled by that time, minimizing any impact. Regarding read-through, she referenced the CORAL study's good translation and noted the drug was studied for a year in prurigo nodularis without waning of effect. Dr. Casella added that both studies are well-powered, and there is no reason to believe there will be a loss of effect with continued dosing. Q: Regarding the upcoming FDA meeting on non-IPF ILD chronic cough, what questions do you expect from the agency, and what are the options for the trial protocol relative to the IPF program?A: Dr. James Casella (Chief Development Officer) said the meeting will be an alignment meeting, using the IPF program as a foundation. The protocol will follow the OCEAN program closely, with the main difference being the patient population. They will seek alignment on inclusion/exclusion criteria for the non-IPF population and the pathway to an NDA filing. The goal is to get finality on the approach and execute the plan. Q: Given the heterogeneity of the RCC population, what steps are you taking to ensure you enroll the right patients to see the maximum benefit from HODUVIO?A: Dr. James Casella (Chief Development Officer) explained that they have incorporated a placebo run-in period based on KOL insights. They are rigorous about site selection, ensuring sites have the right experience, and they assess every patient coming into the trial with the internal team and site PI to ensure all inclusion criteria are met. Q: With the exit of GSK, how have strategic conversations changed, both in terms of number and how discussions are framed?A: Jennifer Goode (President and CEO) said the news is "hot off the press," and she cannot provide a big read on it yet. She noted that people are aware of the big opportunity, and while there have been challenges translating from Phase 2 to Phase 3, Trevi has benefits with a larger effect size, and IPF has not been plagued by placebo effects. She declined further comment on the strategic side. Q: For the non-IPF ILD study, if it comes out favorable, do you have an avenue for a broad interstitial lung disease label, or do you need another Phase 3?A: Dr. James Casella (Chief Development Officer) said the approach is to design the most efficient protocol to get to an NDA as quickly as possible. They will discuss with the FDA whether programs can run in parallel. He emphasized that IPF and non-IPF are all interstitial lung disease, and the lung disease is the common thread mediating the cough, so they will discuss the most efficient pathway to approval. Q: Any thoughts on potential spend to build awareness in RCC upon commercialization, given the lack of a large pharma partner?A: Farrell Simon (Chief Commercial Officer) said they are still an IPF/ILD-led company with 90 ILD care centers in the U.S., making it a focused approach. Pulmonologists are the primary call point, and they will be familiar with the company from the IPF indication. They are taking an efficient digital approach, which has seen great engagement, and will ramp it up closer to launch as part of pre-commercial planning. Q: Have you received any feedback from pulmonologists about a threshold of efficacy they are looking for, or are there key differences in characterizing efficacy across IPF and non-IPF ILD?A: Dr. James Casella (Chief Development Officer) said KOLs view IPF and non-IPF ILD as interchangeable in terms of the reason for the cough. The expectation is for strong efficacy across both populations given the IPF data. There are no differences in endpoints or what to look for; it is just characterizing it in the other part of the ILD world. Q: Have there been any incremental updates on expanding your intellectual property position, and have you had additional FDA interactions since the end of Phase 2 meetings?A: Jennifer Goode (President and CEO) said there has been a lot of activity, with three more patent applications filed in the last few months, though no new issuances yet. Dr. James Casella (Chief Development Officer) confirmed no new FDA interactions regarding trial design; both the LAKE 2B For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Interested in Trevi Therapeutics, Inc.? Here are five stocks we like better. Trevi launched two trials for nalbuphine ER (Haduvio) in chronic cough during Q2: the Phase III OCEAN-1 study in IPF-related cough and the Phase IIb LAKE-2b study in refractory chronic cough. A second Phase III IPF trial, OCEAN-2, is planned for Q3. The company is seeking FDA alignment on a development program for non-IPF interstitial lung disease-related cough and expects a decision on its meeting request in August. Trevi also expects a LAKE trial sample-size re-estimation in Q4, which could increase enrollment by up to 50% if necessary. Trevi ended Q2 with approximately $319 million in cash, cash equivalents and marketable securities, supporting its projected runway into 2030. Upcoming milestones include FDA feedback, progress toward 50% enrollment in LAKE-2b, and OCEAN-2 topline results expected in the second half of 2027. MarketBeat’s Top 5 Rated Small-Cap Stocks Trevi Therapeutics (NASDAQ:TRVI) said it began two clinical trials during the second quarter and plans to launch a third study in the third quarter as it advances nalbuphine ER, also known as Haduvio, for multiple chronic-cough indications. President and Chief Executive Officer Jennifer Good said the company initiated the OCEAN-1 Phase III, 52-week study in patients with idiopathic pulmonary fibrosis, or IPF, related chronic cough, as well as the LAKE-2b trial in refractory chronic cough, or RCC. Trevi expects to initiate OCEAN-2, its second Phase III IPF-related chronic-cough trial, in the third quarter. The OCEAN-2 study is designed to run for 12 weeks. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth The company is bringing up more than 200 global trial sites across the programs, Good said. While enrollment remains at an early stage in the two active trials, management said it is on track with its plans. Trevi plans to disclose when any study reaches approximately 50% enrollment and provide quarterly updates thereafter. Trevi has requested a meeting with the Food and Drug Administration to discuss development of nalbuphine ER for chronic cough associated with non-IPF interstitial lung disease, or ILD. Good said the company expects to learn during August whether the agency has granted the meeting request. → 4 Oil and Gas ETF Plays as Prices Stay Sky-High If the meeting is granted, Trevi plans to submit a full protocol and briefing materials covering the next study and broader development plan for the indication. Chief Development Officer James Cassella said the company expects a prospective non-IPF ILD protocol to closely follow the OCEAN IPF program, including endpoints, while focusing discussions with the FDA on exclusion criteria and the route to a new drug application. Cassella said key opinion leaders have characterized IPF and non-IPF ILD cough as similar in their underlying relationship to lung disease. Trevi intends to discuss what it views as the most efficient regulatory route to approval for non-IPF ILD-related chronic cough, though the final path remains subject to FDA feedback. → Sandisk Just Delivered a Blowout Quarter—Here's Why the Stock Is Falling Trevi expects to report results of a sample-size re-estimation, or SSRE, for the Phase IIb LAKE trial in RCC during the fourth quarter. The analysis will occur after 50% of participants have completed the study and will be conducted by an external, unblinded statistician. The assessment is intended to confirm the study's powering assumptions and adjust enrollment if needed. Cassella said the protocol allows for as much as a 50% increase in sample size and is designed to target 80% conditional power. He said a potential increase in enrollment would be a statistical adjustment rather than an indication of a clinical issue. Management said a recent termination of a competing RCC program has not changed Trevi's clinical approach or the assumptions underlying LAKE. Cassella said the company powered the trial using data from its own RIVER RCC study and the CORAL program in IPF-related chronic cough. Good said the competitive development could offer some protection against uncertainty surrounding placebo response. She also said investigator interest in the RCC trial has been strong, with no competing program currently enrolling patients and a potentially available pool of participants previously involved in other chronic-cough studies. Chief Commercial Officer Farrell Simon said Trevi continues to position itself as an IPF- and ILD-led company, with pulmonologists as its primary commercial audience. The company estimates that its initially targeted treatment-resistant RCC population represents about 1 million patients in the U.S. Simon said the commercial strategy for RCC remains unchanged despite the recent competitor setback. Trevi intends to focus on patients with high unmet needs who have had chronic cough for more than a year and are treated by specialists. In practice, the company expects segmentation to rely more on measures such as cough severity than on cough counts. Management said the eventual dose selected from the RCC Phase II study could affect its commercial options. Simon said a lower dose could potentially enable different market positioning, while a dose similar to that used in IPF and ILD would require attention to preserving specialty pricing and avoiding cannibalization of those indications. Trevi launched an unbranded digital campaign during the second quarter to raise awareness of chronic cough's disease burden among pulmonologists. Good said the campaign, which includes patient testimonials from IPF and non-IPF ILD populations, has reached more than 17,000 unique pulmonologists. The company plans to expand its outreach through digital efforts, medical meetings and patient-advocacy networks. Chief Financial Officer David Hastings said Trevi ended the second quarter with approximately $319 million in cash, cash equivalents and marketable securities. The company maintained its prior cash-runway guidance, which extends into 2030. The projected runway includes funding for the IPF-related chronic-cough program through potential FDA approval, Phase III development in non-IPF ILD-related chronic cough, the ongoing Phase IIb LAKE trial in RCC, and pre-commercial activities. It does not include the costs of a commercial launch of Haduvio or a Phase III trial in RCC. Trevi also highlighted six presentations or posters accepted at the American Thoracic Society meeting, including Phase II findings involving breathlessness, cough bouts and outcomes across baseline cough-count levels. Good said the company’s Phase IIb CORAL study in IPF-related chronic cough, which was published in JAMA, was highlighted during an ATS clinical year-in-review session. Looking ahead, Trevi expects FDA alignment on its non-IPF ILD program, 50% enrollment in LAKE-2b and the LAKE SSRE result during the second half of 2026. Management said OCEAN-2 is expected to produce topline results in the second half of 2027, followed by OCEAN-1 results in the first half of 2028. Good said Trevi does not intend to hold OCEAN-2 results until OCEAN-1 is complete. Trevi Therapeutics, Inc is a clinical-stage biopharmaceutical company focused on the development of novel non-opioid therapies for the management of chronic and acute pain. The company leverages proprietary drug delivery platforms and targeted molecular approaches to address high unmet needs in cancer-related pain, chemotherapy-induced neuropathy and other severe pain conditions. Its lead product candidate is a proprietary formulation of tetrodotoxin (TTX), a sodium-channel blocking agent being evaluated in early-stage clinical trials for moderate-to-severe pain associated with advanced cancer and peripheral neuropathy. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Trevi Therapeutics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Initiated Phase 3 OCEAN-1 trial for patients with idiopathic pulmonary fibrosis-related chronic cough in the second quarter; Phase 3 OCEAN-2 trial expected to initiate in the third quarter of 2026 Initiated Phase 2b LAKE trial for patients with refractory chronic cough in the second quarter; sample size re-estimation expected in the fourth quarter of 2026 Management to host a conference call and webcast today at 4:30 p.m. ET NEW HAVEN, Conn., Aug. 06, 2026 (GLOBE NEWSWIRE) -- 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 patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC), today announced financial results for the quarter ended June 30, 2026, and provided business updates. “We are on track with our clinical trial plans as we initiated our first Phase 3 trial of Haduvio in patients with IPF-related chronic cough and a Phase 2b trial in patients with RCC during the second quarter. We expect to initiate our second Phase 3 trial in IPF-related chronic cough during the third quarter and meet with the FDA regarding our planned non-IPF ILD-related chronic cough trial,” said Jennifer Good, President and CEO of Trevi Therapeutics. “With an experienced team dedicated to advancing our trials across all three of our chronic cough indications, and a strong balance sheet following our April financing, we are well positioned to execute on our plans. We recognize the significant unmet need these patients have and are working diligently to enroll our trials. Following the recent changes in the competitive landscape, and with no FDA-approved therapies currently available, Haduvio has the potential to become a first-in-class therapy that makes a meaningful difference in patients' lives.” Recent Business HighlightsIPF-Related Chronic Cough The Company initiated the Phase 3 OCEAN-1 trial, the first of two parallel conducted Phase 3 trials in patients with IPF-related chronic cough, in the second quarter of 2026. Topline data from the 52-week fixed dosing OCEAN-1 trial is expected in the first half of 2028. The Company plans to initiate the 12-week fixed dosing OCEAN-2 trial, in the third quarter of 2026, with topline results expected in the second half of 2027. Non-IPF ILD-Related Chronic Cough The Company recently submitted a meeting request to the FDA to discuss the proposed development plan for non-IPF ILD-related chronic cough and to align on the overall regulatory strategy and requirements to support registration. Refractory Chronic Cough The Company initiated the Phase 2b LAKE trial in patients with RCC in the second quarter of 2026. The protocol includes a sample size re-estimation (SSRE) analysis once 50% of the participants complete treatment which is expected to occur in the fourth quarter of 2026. The Company will report the outcome of the SSRE once available and expects to report topline results from the trial in the second half of 2027. Second Quarter 2026 Financial Highlights  Cash, cash equivalents and marketable securities: The Company ended the second quarter of 2026 with $318.9 million. In April 2026, the Company completed an underwritten common stock offering, resulting in net proceeds of approximately $162.3 million, after deducting underwriting discounts, commissions and offering expenses. The Company expects its current cash, cash equivalents and marketable securities to extend its cash runway into 2030 and fund the development of Haduvio for the treatment of patients with IPF-related chronic cough, through potential FDA approval. The Company also expects these cash resources will enable the Company to fund the clinical development program through Phase 3 for the treatment of patients with non-IPF ILD-related chronic cough, and the ongoing Phase 2b LAKE trial for the treatment of patients with RCC. The planned spending of these resources does not include any commercial expenses related to the commercial launch of Haduvio or a Phase 3 clinical trial in RCC. Research and development (R&D) expenses: R&D expenses for the second quarter of 2026 increased to $15.2 million from $9.4 million in the same period in 2025, primarily due to increased clinical development expenses for the Phase 3 OCEAN-1 trial, the Phase 2b LAKE trial, the Phase 3 OCEAN-2 trial and the Phase 1 NDA supportive studies, as well as increases in stock-based compensation and personnel related expenses. These increases were partially offset by decreased costs for the Phase 2b CORAL trial of Haduvio for patients with IPF-related chronic cough.  General and administrative (G&A) expenses: G&A expenses for the second quarter of 2026 increased to $5.4 million from $4.3 million in the same period in 2025, primarily due to an increase in stock-based compensation and personnel related expenses, partially offset by decreased outside services and professional fees. Other Income, net: Other Income, net for the second quarter of 2026 increased to $2.7 million from $1.4 million in the same period in 2025, primarily due to an increase in interest income from higher invested cash equivalent and marketable securities balances.  Net loss: For the second quarter of 2026, the Company reported a net loss of $17.8 million, compared to a net loss of $12.3 million in the same period in 2025.  Conference Call and Webcast  The Company plans to hold a conference call and webcast to discuss the Company’s financial results and business highlights. To register for the live conference call and webcast, please visit the ‘Investors & News’ section of the Company’s website or access directly at ir.trevitherapeutics.com/news-events/events. Please note for phone participants: Once registered, you will receive an email with unique call-in details. 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: August 10-12: Stifel’s 2026 Biotech Summer Summit September 9-11: 2026 Cantor Global Healthcare Conference September 14-16: H.C. Wainwright 28th Annual Global Investment Conference September 14-16: Morgan Stanley 24th Annual Global Healthcare Conference About Trevi Therapeutics, Inc.Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine extended-release) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC). In clinical trials, Haduvio showed a statistically-significant reduction in cough frequency, consistent across baseline cough frequencies, and showed improvements in patient-reported outcomes, in both patients with IPF-related chronic cough and in patients with RCC. Haduvio is believed to act on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA), targeting opioid receptors that play a key role in controlling chronic cough. Nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency. Chronic cough in patients with IPF and non-IPF ILD is a condition with high unmet need and no FDA-approved therapies. There are ~140,000 U.S. patients with IPF, and two-thirds of these patients are faced with uncontrolled chronic cough. Additionally, there are ~228,000 U.S. patients with non-IPF ILD, with 50-60% having uncontrolled chronic cough. The impact of chronic cough is significant, with patients coughing up to 1,500 times per day. This consistent cough, and any associated damage, may lead to a higher risk of morbidity and mortality, including worsening disease, a higher risk of progression, increased respiratory hospitalizations, and a decline in patients' quality of life. RCC is a condition with high unmet need and no FDA-approved therapies. RCC is defined as a persistent cough lasting >8 weeks despite treatment for an underlying condition (i.e., asthma, gastroesophageal reflux disease, non-asthmatic eosinophilic bronchitis, upper airway cough syndrome, or post-nasal drip) and includes unexplained chronic cough. There are ~2-3 million U.S. patients with RCC, and it is believed to be associated with cough reflex hypersensitivity involving both the central and peripheral nervous systems. RCC is highly debilitating and may impact patients physically, psychologically, and socially. 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, Trevi’s estimated cash runway, statements regarding Trevi’s business plans and objectives, including future plans or expectations for Haduvio and plans and timing with respect to clinical trials and clinical data, as well as regulatory submissions, statements regarding FDA guidance and approval, and expectations regarding Trevi’s uses and sufficiency of capital, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “may,” and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: 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; uncertainties regarding the success, cost and timing of Trevi’s product candidate development activities and clinical trials, including with respect to the timing of the initiation of and generation of data from 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; as well as other risks and uncertainties set forth in the annual report on Form 10-K for the year ended December 31, 2025 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 update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Contact Jonathan Carlson Trevi Therapeutics, Inc. (203) 654 3286 [email protected] Media Contact Rosalia Scampoli 914-815-1465 [email protected]

Conference call and webcast to be held at 4:30 p.m. ET NEW HAVEN, Conn., July 30, 2026 (GLOBE NEWSWIRE) -- 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 patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC), today announced that senior management will host a conference call and live audio webcast on Thursday, August 6, 2026, at 4:30 p.m. ET, to provide a corporate update and review the Company's financial results for the quarter ended June 30, 2026. Conference Call and WebcastTo register for the live conference call and webcast, please visit the ‘Investors & News’ section of the Company’s website or access directly at ir.trevitherapeutics.com/news-events/events. Please note for phone participants: Once registered, you will receive an email with unique call-in details. An archived replay of the webcast will also be available for 30 days on the Company's website following the event. About Trevi Therapeutics, Inc.       Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine extended-release) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC). In clinical trials, Haduvio showed a statistically-significant reduction in cough frequency, consistent across baseline cough frequencies and showed improvements in patient-reported outcomes, in both patients with IPF-related chronic cough and in patients with RCC. Haduvio is believed to act on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA), targeting opioid receptors that play a key role in controlling chronic cough. Nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency. Chronic cough in patients with IPF and non-IPF ILD is a condition with high unmet need and no FDA-approved therapies. There are ~140,000 U.S. patients with IPF, and two-thirds of these patients are faced with uncontrolled chronic cough. Additionally, there are ~228,000 U.S. patients with non-IPF ILD, with 50-60% having uncontrolled chronic cough. The impact of chronic cough is significant, with patients coughing up to 1,500 times per day. This consistent cough, and any associated damage, may lead to a higher risk of morbidity and mortality, including worsening disease, a higher risk of progression, increased respiratory hospitalizations, and a decline in patients' quality of life.           RCC is a condition with high unmet need and no FDA-approved therapies. RCC is defined as a persistent cough lasting >8 weeks despite treatment for an underlying condition (i.e., asthma, gastroesophageal reflux disease, non-asthmatic eosinophilic bronchitis, upper airway cough syndrome, or post-nasal drip) and includes unexplained chronic cough. There are ~2-3 million U.S. patients with RCC, and it is believed to be associated with cough reflex hypersensitivity involving both the central and peripheral nervous systems. RCC is highly debilitating and may impact patients physically, psychologically, and socially. 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. Investor Contact     Jonathan Carlson     Trevi Therapeutics, Inc.     (203) 654 3286     [email protected]    Media Contact     Rosalia Scampoli     914-815-1465     [email protected]

Management is pivoting to a multi-indication strategy, leveraging synergies between IPF and non-IPF-ILD programs as both patient populations are treated by the same pulmonologists at identical care centers. The company secured FDA alignment on the IPF-related chronic cough Phase III program, focusing on global site identification for two pivotal studies starting in the first and second halves of 2026. Strategic focus remains on patients with established lung fibrosis and chronic cough, where management believes their central and peripheral mechanism of action provides a competitive advantage over peripheral-only treatments. Intellectual property strategy has shifted toward 'label enablement' patents, targeting specific titration schedules and dosing adjustments to extend protection potentially through 2046. The refractory chronic cough (RCC) program is positioned as a high-value 'third leg of the stool,' targeting the most refractory patients who may not respond to other modalities. Operational scaling since receiving Phase IIb results has included a 10-person headcount increase to manage the simultaneous execution of three major clinical programs without compromising quality. Cash runway is now extended into 2030 following a $162 million offering, intended to fund the IPF program through potential FDA approval and top-line data for ILD and RCC programs. A critical Sample Size Reestimation (SSRE) for the RCC Phase IIb trial is expected in the fourth quarter of 2026 to confirm powering assumptions at the 50% enrollment mark. Management intends to propose an adaptive Phase II/III study design for non-IPF-ILD to the FDA, aiming to streamline the path to approval by rolling dose confirmation directly into a pivotal study. The company expects to initiate a Phase IIb parallel arm dose-ranging trial for refractory chronic cough (RCC) this quarter and plans to initiate a non-IPF-ILD trial in the second half of the year. Guidance for major top-line data readouts is currently set for the second half of 2027, though management notes high investigator interest could influence enrollment timelines. The April 2026 common stock offering added $162 million in net proceeds, removing 'financial overhang' during upcoming high-value clinical readouts. Current cash guidance excludes expenses related to the actual commercial launch of Haduvio or any trials beyond those explicitly mentioned in the development plan. Management identified dyspnea (breathlessness) as a key secondary metric that could enhance payer negotiations and patient adoption, even if not a primary endpoint. A core method of treatment patent for IPF-related chronic cough was recently issued in Europe, matching existing U.S. protection through 2039. Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. The upcoming FDA meeting will focus on using an adaptive design to support an sNDA strategy for approval. The Phase II portion will be used for dose selection and confirmation, while an interim analysis will verify power assumptions for the Phase III component. Management views the RCC market as large enough to support multiple modalities and welcomes peer success to validate the category. Haduvio is expected to show a higher placebo-adjusted change in cough frequency compared to the 15-20% guided by P2X3 competitors. The RCC trial will incorporate a placebo run-in period to stabilize the baseline and mitigate variable responses common in this population. Management is applying 'CNS background' principles to trial conduct to ensure investigators do not set false expectations that inflate placebo effects. Management believes Haduvio can 'lay alongside' new inhaled therapies for IPF/PPF, as it treats cough systemically. Ongoing drug-drug interaction (DDI) studies are being conducted to ensure compatibility with evolving standard-of-care treatments. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here.

Trevi plans near-term trial starts across its chronic cough programs: the first of two IPF-related Phase 3 trials is expected to start this quarter with the second in H2 2026, an adaptive Phase 2/3 for non‑IPF ILD is planned pending FDA alignment (target H2 2026), and a RCC Phase 2b dose‑ranging study is slated to begin this quarter with a sample‑size re‑estimation readout in Q4 2026. The company significantly bolstered its balance sheet with an April equity offering (ended Q1 cash ~$172M plus ~$162M net proceeds), which management says extends Trevi’s cash runway into 2030 and funds planned Phase 2/3 programs and pre‑commercial activities. Trevi strengthened its intellectual property position—its core method‑of‑treatment patent was issued in Europe and the U.S. covering use through 2039, with additional U.S. filings that could extend protection toward 2046 and further patents planned around dosing/titration strategies. Interested in Trevi Therapeutics, Inc.? Here are five stocks we like better. MarketBeat’s Top 5 Rated Small-Cap Stocks Trevi Therapeutics (NASDAQ:TRVI) management used the company’s first-quarter 2026 earnings call to outline upcoming clinical milestones for its chronic cough programs and to highlight an expanded cash runway following an April equity offering. President and CEO Jennifer Good said 2026 is “an important year of execution,” and noted the company is preparing to advance multiple studies across idiopathic pulmonary fibrosis (IPF)-related chronic cough, non-IPF interstitial lung disease (ILD)-related chronic cough, and refractory chronic cough (RCC). → Roblox Stock Slides to New Low as Safety Changes Weigh on Outlook Following what Good described as a positive FDA meeting in the first quarter to align on the company’s IPF-related chronic cough program, Trevi finalized protocols for two Phase 3 trials and has been identifying global trial sites. Good said the company expects to initiate the first of the two Phase 3 studies in the current quarter, with the second slated to begin in the second half of 2026. For non-IPF ILD-related chronic cough, Good said the company plans to request another FDA meeting and submit a protocol to discuss an adaptive Phase 2/3 study design. The company intends to use the Phase 2 portion to confirm dose and assumptions before transitioning into a single pivotal Phase 3 study intended to support approval. If aligned with FDA, Good said Trevi expects to start that trial in the second half of the year. She added that the non-IPF ILD population is expected to resemble the IPF study population, and that the company is planning operationally so it can “act quickly once we have alignment with the FDA on the protocol.” → The Real SpaceX Play: 5 Chip Stocks Powering the IPO Before It Launches On the call, Chief Development Officer James Cassella said the FDA discussion is designed to review Trevi’s intention to use the adaptive Phase 2/3 program in an “sNDA strategy.” Cassella said the company will seek to align on the patient population, dose selection confirmation, and an interim analysis intended to validate power assumptions for the Phase 3 component. In RCC, Good said Trevi expects to initiate a Phase 2b parallel-arm dose-ranging study this quarter that will include three dose levels plus placebo. The finalized protocol has been submitted to regulatory authorities, and the company is qualifying sites, she said. → 3 Emerging Markets ETFs to Maximize Exposure to High-Potential Countries Cassella said the RCC Phase 2b includes a sample size re-estimation (SSRE) planned when 50% of patients complete the trial, with an SSRE readout expected in the fourth quarter of 2026. In response to analyst questions, Cassella said the SSRE will evaluate conditional power, targeting 80%. If conditional power is below 80%, the company would increase sample size proportionately, he said, while a futility threshold would be “down in that 30%-40% range.” Asked about mitigating placebo response in RCC, Cassella pointed to Trevi’s prior CORAL study in IPF, which he said showed an “under 20% placebo response,” and added that placebo response can be more variable in RCC. He said Trevi is seeking to control for factors that can contribute to placebo response through trial conduct and includes a placebo run-in period, based on input from experts in the RCC space, to look for stability in cough response. Cassella also addressed patient eligibility in RCC in the context of potential prior exposure to P2X3 antagonists, saying patients who meet eligibility requirements and have been off a P2X3 therapy for an appropriate time period could enroll. Chief Commercial Officer Farrell Simon addressed questions about the competitive landscape in RCC, including anticipated data from camlipixant. Simon said Trevi is “hoping that they are successful,” calling RCC a large unmet-need population that could support multiple modalities. He said Trevi believes it has “strong differentiation with our central and peripheral mechanism of action,” and that the company plans to discuss positioning at its upcoming Investor Day. Simon added that if camlipixant is unsuccessful, the company would reassess competitive positioning while still viewing the market as a “large unmet need.” Cassella said investigators are enthusiastic and that enrollment interest remains strong regardless of outcomes in the broader environment. Good said Trevi’s RCC Phase 2b will likely complete before any competitor’s product could be approved, and suggested competitive dynamics could become more relevant during a potential Phase 3 stage. In another discussion about P2X3 programs, Good said Trevi would be interested in learning about placebo control approaches, but she did not expect competitors’ results to materially change Trevi’s plan. She noted that some P2X3 programs have used more restrictive enrollment approaches and placebo run-ins, while Trevi has “shown data that our drug works broadly in IPF chronic cough and refractory chronic cough across different cough counts.” Separately, Good addressed questions about how increased use of inhaled therapeutics in IPF and progressive pulmonary fibrosis could influence the opportunity for Trevi’s therapy, noting that Trevi is targeting chronic cough that is “more systemic” and that the interaction between hypersensitization and inhaled products “is something that’s gonna have to be learned over time.” She said the company has been conducting drug-drug interaction studies and expects to be able to be used alongside other therapies. Good highlighted that Trevi will be active at the American Thoracic Society (ATS) meeting, where the company had all six submissions accepted for presentations or posters. Cassella previewed several data areas expected at the conference, including new sub-analyses from the CORAL study in an oral presentation by Dr. Philip Molyneaux, analysis of “cough bouts” from CORAL and RIVER, and “breathlessness data” presented by Don Mahler. Simon said the company’s research with physicians and payers indicates dyspnea is among the top three complaints for IPF and ILD patients, alongside cough and fatigue. While he said it does not change the company’s commercial thesis, he believes it could complement uptake and adoption, and could help in payer discussions by supporting “additional value.” In response to a question about forced vital capacity (FVC), Cassella said Trevi will track FVC at baseline and throughout the 52-week Phase 3 period, but emphasized that FVC is highly variable and not central to the company’s trial endpoints. “All I can promise you is that we will see what we see and report it out,” he said. Chief Financial Officer David Hastings said Trevi ended the first quarter of 2026 with approximately $172 million in cash, cash equivalents, and marketable securities, excluding $162 million in net proceeds from an underwritten common stock offering completed in April 2026. Hastings said the offering was “well-received,” and that the financing removed “any financial overhang” heading into key clinical endpoints and extended cash runway into 2030. Hastings said the company’s runway guidance includes funding for the IPF-related chronic cough development program, “potentially through FDA approval.” He said cash resources are expected to also enable Trevi to fund and report top-line data from the planned Phase 2b trial and potentially a subsequent Phase 3 trial in non-IPF ILD-related chronic cough, and to fund the planned Phase 2b trial in RCC. He added that planned spending includes pre-commercial activities, but not expenses related to a commercial launch of Haduvio or any additional clinical trials. On intellectual property, Good said Trevi’s “core method of treatment patent” for IPF-related chronic cough was issued in Europe during the quarter, and that the patent had already been issued in the U.S., providing protection through 2039. She said Trevi filed additional applications in the U.S. this year which, if issued, could extend coverage through 2046. Good also described a strategy to pursue additional patents tied to expected label elements, including titration schedule and dosing adjustments, and noted that ongoing Phase 1 work can be “quite rich for IP.” Looking ahead, Good pointed investors to a May 7 Investor and Analyst Day where the company plans to discuss upcoming trial details, projected timelines, additional analyses of existing clinical data, and commercial learnings from market research, along with input from key opinion leaders. Trevi also plans an investor analyst event at ATS on May 18 featuring Cassella and Dr. Molyneaux to summarize data presented at the conference. Trevi Therapeutics, Inc is a clinical-stage biopharmaceutical company focused on the development of novel non-opioid therapies for the management of chronic and acute pain. The company leverages proprietary drug delivery platforms and targeted molecular approaches to address high unmet needs in cancer-related pain, chemotherapy-induced neuropathy and other severe pain conditions. Its lead product candidate is a proprietary formulation of tetrodotoxin (TTX), a sodium-channel blocking agent being evaluated in early-stage clinical trials for moderate-to-severe pain associated with advanced cancer and peripheral neuropathy. The article "Trevi Therapeutics Q1 Earnings Call Highlights" was originally published by MarketBeat.

Completed follow-on common stock offering with net proceeds of ~$162 million, extending expected cash runway into 2030 through potential FDA approval of Haduvio in IPF-related chronic cough and continued pipeline advancement Clinical development plans remain on track across all chronic cough indications Management to host a conference call and webcast today at 4:30 p.m. ET NEW HAVEN, Conn., May 05, 2026 (GLOBE NEWSWIRE) -- 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 patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC), today announced financial results for the quarter ended March 31, 2026, and provided business updates. “We are entering an important phase of execution for Trevi, with study initiations anticipated across our chronic cough programs,” said Jennifer Good, President and CEO of Trevi Therapeutics. “Following a very productive End-of-Phase 2 meeting with the FDA on our lead program in IPF-related chronic cough, we are excited to initiate multiple clinical trials this quarter, including our first Phase 3 in IPF-related chronic cough and our Phase 2b in RCC. With an expected cash runway into 2030, we are well-positioned to execute on our development strategy and advance towards a potential FDA submission in IPF-related chronic cough. We believe successful execution of our strategy would establish Trevi as the leader in providing best-in-class therapy in chronic cough indications with significant unmet needs and no FDA-approved therapies.” Recent Business Highlights IPF-Related Chronic Cough Completed an End-of-Phase 2 meeting with the FDA and gained overall alignment on the clinical development plan for the treatment of IPF-related chronic cough. Execution plans remain on track to conduct two Phase 3 trials in parallel with the first trial expected to initiate in the second quarter of 2026 and the second trial in the second half of 2026. The Company expects to have topline results from the first Phase 3 trial in the first half of 2028 and from the second Phase 3 trial in the second half of 2027. The Company received a notice to grant a European patent covering nalbuphine ER for the treatment of IPF-related chronic cough, with expected expiration in 2039, further strengthening its global intellectual property portfolio. Non-IPF ILD-Related Chronic Cough The Company plans to initiate an adaptive design Phase 2b clinical trial for the treatment of patients with non-IPF ILD-related chronic cough in the second half of 2026, subject to a meeting with the FDA which includes review of the trial protocol. If the trial is initiated when anticipated, the Company would expect topline results from the Phase 2b trial in the second half of 2027. Refractory Chronic Cough The Company plans to initiate a Phase 2b trial in patients with RCC in the second quarter of 2026, subject to final protocol review by regulatory authorities. The protocol will provide for a sample size re-estimation, or SSRE, analysis, which is expected to occur in the fourth quarter of 2026. The Company expects topline results from the trial in the second half of 2027. Corporate In April 2026, the Company completed an underwritten common stock offering, resulting in net proceeds of approximately $162 million, after deducting underwriting discounts and commissions and estimated offering expenses. The Company plans to host an Investor and Analyst Day on May 7, 2026, from 10:00 a.m. to 12:00 p.m. ET, to discuss its clinical and commercial strategy, with participation from key opinion leaders. To register for the webcast, please visit Trevi's website or register here. The Company plans to host an investor and analyst event in-person on May 18, 2026, from 11:30 a.m. to 1:15 p.m., during the American Thoracic Society (ATS) 2026 International Conference to present data highlights from Trevi’s 2026 ATS presentations. To register for the event, email [email protected]. First Quarter 2026 Financial Highlights Cash, cash equivalents and marketable securities: The Company ended the first quarter of 2026 with $171.8 million. After completion of its underwritten common stock offering in April 2026, the Company expects current cash resources to extend its cash runway into 2030. The Company expects its current cash, cash equivalents and marketable securities to fund the development of Haduvio for the treatment of patients with IPF-related chronic cough, potentially through FDA approval. The Company also expects these cash resources will enable the Company to fund and report topline data from the planned Phase 2b clinical trial and potentially a subsequent Phase 3 trial for the treatment of patients with non-IPF ILD-related chronic cough, and the planned Phase 2b trial for the treatment of patients with RCC. The planned spending of these resources does not include any commercial expenses related to the commercial launch of Haduvio or any other clinical trials. Research and development (R&D) expenses: R&D expenses for the first quarter of 2026 increased to $9.9 million from $7.8 million in the same period in 2025, primarily due to increased clinical development expenses for the Company's Phase 1 NDA supportive studies, Phase 3 IPF-related chronic cough trials and Phase 2b RCC trial, partially offset by a decrease in clinical development expenses for the Company's Phase 2b CORAL trial and Phase 2a RIVER trial. General and administrative (G&A) expenses: G&A expenses for the first quarter of 2026 increased to $5.0 million from $3.7 million in the same period in 2025, primarily due to higher legal fees associated with intellectual property filings as well as an increase in non-cash stock option expense and other personnel-related expenses. Other Income, net: Other Income, net for the first quarter of 2026 increased to $1.7 million from $1.1 million in the same period in 2025, primarily due to an increase in interest income from higher invested cash equivalent and marketable securities balances. Net loss: For the first quarter of 2026, the Company reported a net loss of $13.2 million, compared to a net loss of $10.3 million in the same period in 2025. Conference Call and Webcast To register for the live conference call and webcast, please visit the ‘Investors & News’ section of the Company’s website or access directly at ir.trevitherapeutics.com/news-events/events. Please note for phone participants: Once registered, you will receive an email with unique call-in details. 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: May 7: Trevi Therapeutics Investor and Analyst Day May 12-13: Bank of America Global Healthcare Conference 2026 May 15-20: American Thoracic Society (ATS) 2026 International Conference May 18: Trevi Therapeutics - Data Highlights from Trevi’s ATS 2026 Presentations About Trevi Therapeutics, Inc. Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine extended-release) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC). Haduvio is the first and only investigational therapy to show a statistically-significant reduction in cough frequency in clinical trials across both patients with IPF-related chronic cough and in patients with RCC. Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA), targeting opioid receptors that play a key role in controlling chronic cough. Nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency. Chronic cough in patients with IPF and non-IPF ILD is a condition with high unmet need and no FDA-approved therapies. There are ~140,000 U.S. patients with IPF, and two-thirds of these patients are faced with uncontrolled chronic cough. Additionally, there are ~228,000 U.S. patients with non-IPF ILD, with 50-60% having uncontrolled chronic cough. The impact of chronic cough is significant, with patients coughing up to 1,500 times per day. This consistent cough, and any associated damage, may lead to a higher risk of morbidity and mortality, including worsening disease, a higher risk of progression, increased respiratory hospitalizations, and a decline in patients' quality of life. RCC is a condition with high unmet need and no FDA-approved therapies. RCC is defined as a persistent cough lasting >8 weeks despite treatment for an underlying condition (i.e., asthma, gastroesophageal reflux disease, non-asthmatic eosinophilic bronchitis, upper airway cough syndrome, or post-nasal drip) and includes unexplained chronic cough. There are ~2-3 million U.S. patients with RCC, and it is believed to be associated with cough reflex hypersensitivity involving both the central and peripheral nervous systems. RCC is highly debilitating and may impact patients physically, psychologically, and socially. 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, Trevi’s estimated cash runway, statements regarding Trevi's business plans and objectives, including future plans or expectations for Haduvio and plans and timing with respect to clinical trials and clinical data, as well as regulatory submissions, statements regarding FDA guidance and approval, and expectations regarding Trevi’s uses and sufficiency of capital, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “may,” and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: 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; uncertainties regarding the success, cost and timing of Trevi’s product candidate development activities and 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 as well as other risks and uncertainties set forth in the annual report on Form 10-K for the year ended December 31, 2025 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 update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Contact Jonathan Carlson Trevi Therapeutics, Inc. (203) 654 3286 [email protected] Media Contact Rosalia Scampoli 914-815-1465 [email protected]

Conference call and webcast to be held at 4:30 p.m. ET NEW HAVEN, Conn., April 28, 2026 (GLOBE NEWSWIRE) -- 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 patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC), today announced that senior management will host a conference call and live audio webcast on Tuesday, May 5, 2026, at 4:30 p.m. ET, to provide a corporate update and review the Company's financial results for the quarter ended March 31, 2026. Conference Call and Webcast To register for the live conference call and webcast, please visit the ‘Investors & News’ section of the Company’s website or access directly at ir.trevitherapeutics.com/news-events/events. Please note for phone participants: Once registered, you will receive an email with unique call-in details. An archived replay of the webcast will also be available for 30 days on the Company's website following the event. About Trevi Therapeutics, Inc. Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine extended-release) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC). Haduvio is the first and only investigational therapy to show a statistically-significant reduction in cough frequency in clinical trials across both patients with IPF chronic cough and in patients with RCC. Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA), targeting opioid receptors that play a key role in controlling chronic cough. Nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency. Chronic cough in patients with IPF and non-IPF ILD is a condition with high unmet need and no FDA-approved therapies. There are ~140,000 U.S. patients with IPF, and two-thirds of these patients are faced with uncontrolled chronic cough. Additionally, there are ~228,000 U.S. patients with non-IPF ILD, with 50-60% having uncontrolled chronic cough. The impact of chronic cough is significant, with patients coughing up to 1,500 times per day. This consistent cough, and any associated damage, may lead to a higher risk of morbidity and mortality, including worsening disease, a higher risk of progression, increased respiratory hospitalizations, and a decline in patients' quality of life. RCC is a condition with high unmet need and no FDA-approved therapies. RCC is defined as a persistent cough lasting >8 weeks despite treatment for an underlying condition (i.e., asthma, gastroesophageal reflux disease, non-asthmatic eosinophilic bronchitis, upper airway cough syndrome, or post-nasal drip) and includes unexplained chronic cough. There are ~2-3 million U.S. patients with RCC, and it is believed to be associated with cough reflex hypersensitivity involving both the central and peripheral nervous systems. RCC is highly debilitating and may impact patients physically, psychologically, and socially. 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. Investor Contact Jonathan Carlson Trevi Therapeutics, Inc. (203) 654 3286 [email protected] Media Contact Rosalia Scampoli 914-815-1465 [email protected]

This article first appeared on GuruFocus. Cash and Cash Equivalents: Approximately $188 million at the end of 2025. Cash Runway: Expected to extend into 2028. Release Date: March 17, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Trevi Therapeutics Inc (NASDAQ:TRVI) reported positive data readouts from the CORAL and RIVER trials, which have driven growth and capital raising. The company had a successful end of Phase II meeting with the FDA for its IPF-related chronic cough program, gaining alignment on the path to NDA. Trevi Therapeutics Inc (NASDAQ:TRVI) plans to initiate two pivotal Phase III clinical trials for IPF-related chronic cough, with clear timelines and trial designs. The company has a strong cash position with $188 million, providing a runway into 2028 to support key clinical milestones. Trevi Therapeutics Inc (NASDAQ:TRVI) is expanding its clinical footprint into the U.S. and has received positive feedback from physicians and patient advocates, indicating strong interest in its trials. The requirement for 52 weeks of controlled safety data in the IPF trial means the 24-week endpoint cannot be read out until the end, potentially delaying data availability. There is uncertainty around the placebo effect in the longer 24-week IPF trial, which could impact trial outcomes. The company faces potential competition from other IPF drugs that may be approved by the time its trials are completed. Trevi Therapeutics Inc (NASDAQ:TRVI) may need to conduct additional drug-drug interaction studies if new IPF drugs are approved during its trial period. The company is still finalizing plans for the non-IPF ILD trial, which could affect timelines and resource allocation. Warning! GuruFocus has detected 1 Warning Sign with TRVI. Is TRVI fairly valued? Test your thesis with our free DCF calculator. Q: Could you elaborate on the remaining Phase I studies discussed with the FDA and their purpose? A: James Cassella, Chief Development Officer: These studies are label-informative, focusing on potential drug-drug interactions and the mechanism of drug metabolism. They are not rate-limiting and can be conducted in parallel with the Phase III trials. Q: Regarding the non-IPF ILD trial design, what are the key features you want to align with the FDA? A: James Cassella, Chief Development Officer: We plan to use learnings from the IPF end of Phase II meeting to inform the non-IPF ILD trial. The focus will be on an adaptive Phase IIb/III design to confirm dose and variability before moving into a pivotal Phase III trial. Q: Was there any discussion about including non-IPF patients in the IPF pivotal program? A: Jennifer Good, CEO: The IPF program is distinct and separate. We plan to apply learnings from the IPF program to the non-IPF ILD population in a separate trial. Q: Can you provide insights on the secondary endpoints for the IPF pivotal trial? A: James Cassella, Chief Development Officer: The primary endpoint is the objective cough monitor. Key secondary endpoints include patient perception of cough frequency and severity, and breathlessness, which is a significant concern for patients. Q: How does the cash runway support your clinical milestones? A: David Hastings, CFO: The cash runway extends into 2028, covering key clinical milestones, including Phase IIb trials in RCC and non-IPF chronic cough, and top-line data from the 12-week pivotal Phase III IPF trial. Q: What are your expectations for enrollment in the Phase III IPF trials? A: James Cassella, Chief Development Officer: We expect enrollment to take about a year, with 80 to 100 sites primarily in the U.S., leveraging the strong interest and awareness from the CORAL study. Q: How do you view the potential impact of new IPF drugs on your trials? A: James Cassella, Chief Development Officer: If new drugs are approved, we may need to conduct drug-drug interaction studies, but this is not seen as a barrier to our trials. Q: What is the strategy for the RCC program following the Phase IIb trial? A: Jennifer Good, CEO: RCC is a significant unmet need, and we plan to move urgently with a single Phase III trial following the Phase IIb, aiming for a fast follow-on sNDA after IPF approval. For the complete transcript of the earnings call, please refer to the full earnings call transcript.