Here are 1-2 brief analogies for Trevi Therapeutics (TRVI):

• Think of Trevi as a clinical-stage Vertex Pharmaceuticals, focused on developing treatments for debilitating chronic pruritus (itch) and chronic cough.
• An early-stage Neurocrine Biosciences, specializing in treatments for debilitating chronic symptoms like severe itch and cough.

• Haduvio (nalbuphine ER): An investigational oral extended-release formulation of nalbuphine, currently in clinical development for chronic pruritic and neurological conditions.

As a clinical-stage biopharmaceutical company, Trevi Therapeutics (TRVI) does not currently have major commercial customers purchasing its product candidates. The company's lead candidate, Haduvio, is still in clinical development and has not yet received regulatory approval for commercial sale. Consequently, Trevi Therapeutics currently generates no revenue from product sales.

If Haduvio were to be approved and commercialized, Trevi Therapeutics would primarily sell its product to other companies within the pharmaceutical supply chain. These potential future major customers would typically include:

• Pharmaceutical Wholesalers: These companies act as intermediaries, purchasing drugs directly from manufacturers and distributing them to pharmacies, hospitals, and other healthcare providers. Major players in this sector include:
  • AmerisourceBergen (Symbol: ABC)
  • Cardinal Health (Symbol: CAH)
  • McKesson Corporation (Symbol: MCK)
• Hospitals and Integrated Delivery Networks (IDNs): Large healthcare systems and hospital groups that procure medications for use within their extensive networks of facilities and clinics. While often supplied via wholesalers, they are ultimate purchasers within the institutional setting.
• Specialty Pharmacies: These pharmacies focus on dispensing and managing medications for complex, chronic, or rare conditions, often providing specialized support services to patients. Given Trevi's focus on neurological and rare diseases, specialty pharmacies would likely be key distribution partners for Haduvio.

Thermo Fisher Scientific (TMO)

Noramco Inc.

Jennifer Good, Co-Founder, President and CEO

Ms. Good is a co-founder of Trevi Therapeutics, serving as President and Chief Executive Officer since its inception in March 2011. She previously served at Penwest Pharmaceuticals Co. from 1997 to 2010, holding various positions including President and Chief Executive Officer, Chief Operating Officer, and Chief Financial Officer. Ms. Good successfully transitioned Penwest from a development-stage company to one generating over $50 million in annual revenues. She also led the negotiations for the sale of Penwest Pharmaceuticals in the fourth quarter of 2010. Ms. Good co-founded Trevi with angel financing and has grown it into a publicly traded company. She currently serves on the board of Rhythm Pharmaceuticals, a publicly-traded biopharmaceutical company, and previously served on the board of Juniper Pharmaceuticals, Inc. until its acquisition by Catalent, Inc. in August 2018.

Lisa Delfini, CFO

Ms. Delfini was appointed Chief Financial Officer of Trevi Therapeutics on August 9, 2021, and will be stepping down on August 22, 2025. She brings 30 years of experience in the financial sector, including helping public and private companies with finance transformation, capital raising activities, and acquisitions. Prior to Trevi, Ms. Delfini served as a Financial Accounting and Advisory Services Partner at Marcum LLP, where she provided advisory services and acted as interim CFO, CAO, or controller for various companies, including those in the pharmaceutical sector. Her background also includes roles as Global Controller for the GE Corporate Technical Center of Excellence and Global Controller for GE Industrial Solutions at General Electric, and a Client Service Partner at Deloitte & Touche LLP.

Thomas Sciascia, M.D., Co-Founder, Chief Scientific Officer

Dr. Sciascia is a co-founder of Trevi Therapeutics. He previously worked with Jennifer Good at Penwest Pharmaceuticals Co., where he served as Chief Medical Officer.

James Cassella, Ph.D., Chief Development Officer

Dr. Cassella serves as the Chief Development Officer for Trevi Therapeutics. He is also mentioned as a director of the company.

Farrell Simon, Pharm.D., Chief Commercial Officer

Dr. Simon is the Chief Commercial Officer at Trevi Therapeutics.

The key risks to Trevi Therapeutics (TRVI) are primarily associated with its status as a clinical-stage biopharmaceutical company with a single lead product candidate.

1. Clinical Trial and Regulatory Risk: Trevi Therapeutics' primary asset, Haduvio (nalbuphine ER), is an investigational therapy in late-stage clinical development, making the success, cost, and timing of its ongoing and planned clinical trials a significant risk. Positive data from earlier-stage trials may not necessarily predict the results of later-stage or pivotal clinical trials in the same or different indications. There is also inherent uncertainty regarding regulatory authorities' views on the clinical trial data and the potential for delays or additional requirements for marketing approval, contributing to a substantial "binary risk" given the company's dependency on this single asset.

2. Competition and Commercial Potential: Despite promising clinical data, Trevi faces competition, particularly from companies like GSK, which has camlipixant (a P2X3 antagonist) in a Phase 3 program for chronic cough. While Haduvio's efficacy may be strong, concerns exist regarding its long-term effectiveness, side effects, and overall commercial potential. Additionally, nalbuphine's opioid nature, despite evidence of low abuse potential, could lead to regulatory caution and impact prescribing decisions, potentially limiting its market adoption.

3. Financial Risk (Profitability and Dilution): Trevi Therapeutics is currently unprofitable and is not projected to achieve profitability within the next three years. As a pre-revenue, single-asset company, its valuation carries inherent risk. Although the company has a cash runway extending into 2028 or 2029, there remains a risk of future shareholder dilution from additional capital raises, a concern exacerbated by prior offerings.

The following are clear emerging threats to Trevi Therapeutics:

• Competition from Dupixent (dupilumab) in Prurigo Nodularis: Sanofi and Regeneron's Dupixent received FDA approval in September 2023 for the treatment of adult patients with prurigo nodularis. Dupixent is an established biologic with significant market presence and robust commercial infrastructure, directly competing with Trevi Therapeutics' Haduvio (nalfurafine ER), which is in development for the same indication. The ongoing commercialization and market penetration of Dupixent present a substantial challenge to Haduvio's potential market share and commercial success.

• Competition from Nemolizumab in Prurigo Nodularis: Nemolizumab, an anti-IL-31 receptor A antibody developed by Amgen and Maruho, is currently in Phase 3 clinical trials for prurigo nodularis. Positive results have been reported from these trials, indicating its potential to become another direct competitor in the treatment of prurigo nodularis. Its potential approval and subsequent launch would further intensify the competitive landscape for Trevi's Haduvio in its lead indication.

Haduvio (nalbuphine ER)

• For chronic cough in patients with idiopathic pulmonary fibrosis (IPF):
  • The addressable market in the U.S. includes approximately 140,000 to 150,000 patients with IPF, of whom up to 85% experience chronic cough.
  • Analyst estimates for Haduvio's peak sales for chronic cough in IPF are around $650 million. Some analysts believe the market opportunity could potentially exceed $1 billion.
  • The 2022 therapeutic market for cough in IPF across the 7 major markets (U.S., EU5) was approximately $154 million, with anticipated significant growth.
• For refractory chronic cough (RCC):
  • The addressable market in the U.S. affects approximately 2 to 3 million patients.
  • Analyst estimates for Haduvio's peak sales for RCC are around $650 million. If successful, the drug could achieve peak sales exceeding $500 million annually in the U.S. alone for chronic cough indications, which include RCC.
• For chronic pruritus, including prurigo nodularis: null

1. Advancement and Potential Market Approval of Haduvio for Chronic Cough in Idiopathic Pulmonary Fibrosis (IPF): Haduvio has demonstrated positive results in its Phase 2b CORAL trial for chronic cough in IPF, showing statistically significant reductions in cough frequency and improvements in quality of life. Trevi Therapeutics plans to request an End-of-Phase 2 meeting with the FDA in the fourth quarter of 2025 and aims to initiate the Phase 3 program in the first half of 2026. The market for IPF-related chronic cough is estimated to be over $1.5 billion, with no FDA-approved therapies currently available, representing a substantial opportunity for Haduvio's potential market entry and subsequent revenue generation. GlobalData projects that Haduvio could generate $31 million for the company in the US by the end of 2027 if it reaches the market.
2. Advancement and Potential Market Approval of Haduvio for Refractory Chronic Cough (RCC): The company reported positive Phase 2a RIVER trial results in March 2025, with Haduvio showing a statistically significant 57% placebo-adjusted reduction in 24-hour cough frequency in patients with RCC. Trevi intends to discuss the next steps with the FDA for this program. Refractory chronic cough affects approximately 2-3 million adults in the U.S., and there are no approved therapies for this condition, indicating a significant market opportunity for Haduvio.
3. Advancement and Potential Market Approval of Haduvio for Prurigo Nodularis (PN): Trevi Therapeutics has reported positive results from its Phase 2b/3 PRISM trial and its open-label extension study for prurigo nodularis, demonstrating efficacy and a consistent safety profile over 52 weeks. The company is preparing for an end-of-Phase 2 meeting with the FDA to discuss the subsequent development steps for this program. Successful navigation of regulatory pathways for PN could lead to another significant revenue stream for Trevi Therapeutics.

Share Issuance

• In June 2025, Trevi Therapeutics priced an underwritten public offering of 20,010,000 shares of its common stock at $5.75 per share, generating approximately $115.1 million in gross proceeds, which included the full exercise of the underwriters' option to purchase additional shares.
• In December 2024, the company announced the pricing of an underwritten offering of 12,500,000 shares of common stock at $4.00 per share, with the aim of raising $50 million before deducting underwriting costs.

Inbound Investments

• The $50 million underwritten offering in December 2024 saw participation from notable healthcare investment firms, including Adage Capital Partners LP, Frazier Life Sciences, and Vivo Capital.
• As of November 2025, Trevi Therapeutics had 312 institutional owners and shareholders holding a total of 126,485,454 shares, with significant increases in stakes by major firms such as Alliancebernstein L.P., Rubric Capital Management LP, and Orbimed Advisors LLC.

Capital Expenditures

• For the trailing twelve months ended June 2025, Trevi Therapeutics reported capital expenditures of -$7,000.
• As of November 3, 2025, the capital expenditure was reported as $0.00 million.