Trevi Therapeutics, Inc. (TRVI): Business Model Canvas [Dec-2025 Updated]

You're sizing up Trevi Therapeutics, Inc. (TRVI) right as they move from promising Phase 2 results to the capital-intensive Phase 3 trial for Haduvio, and frankly, the immediate story is their runway: they held $194.9 million in cash at the end of Q3 2025. As an analyst who has seen companies burn through capital too fast, I see a clear action here-every key activity, from engaging CROs to manufacturing scale-up, must be ruthlessly managed against that cash pile to hit the FDA milestones. This Business Model Canvas strips away the hype to show you the exact structure-the key resources, the zero current product sales revenue, and the dual-mechanism value proposition-that underpins their entire near-term strategy to address a major unmet need in chronic cough. See below how they plan to turn that cash into a market-ready asset.

Trevi Therapeutics, Inc. (TRVI) - Canvas Business Model: Key Partnerships

You're looking at the structure Trevi Therapeutics, Inc. is building to bring Haduvio to market, which is all about who they need to work with to get this investigational therapy across the finish line. Since Haduvio is not yet approved, many of these partnerships are still in the planning or active seeking stage as of late 2025.

Key Opinion Leaders (KOLs) in pulmonology and cough hypersensitivity

Trevi Therapeutics, Inc. relies on expert validation, especially given Haduvio's novel dual mechanism of action (KAMA, or kappa agonist and mu antagonist) targeting both central and peripheral cough pathways. You see KOLs cited when discussing the positive clinical data that supports this approach. For instance, Professor Jacky Smith, Professor of Respiratory Medicine at the University of Manchester, commented on the potential role of nalbuphine ER following the Phase 2a RIVER trial results earlier in 2025. Also, the company's own leadership, like Jennifer Good, co-founder, President and CEO, is a key voice articulating the science behind targeting cough hypersensitivity.

The need for KOL support is clear when you look at the target patient populations:

• Chronic cough in Idiopathic Pulmonary Fibrosis (IPF) affects up to $\mathbf{150,000}$ U.S. patients, with two-thirds having uncontrolled cough.
• Non-IPF Interstitial Lung Disease (non-IPF ILD) impacts $\sim\mathbf{228,000}$ U.S. patients, with $\mathbf{50-60\%}$ experiencing uncontrolled cough.
• Refractory Chronic Cough (RCC) affects $\sim\mathbf{2}$ to $\mathbf{3 \text{ million}}$ U.S. patients.

Potential commercialization partner for U.S. and ex-U.S. markets

As of late 2025, Trevi Therapeutics, Inc. is explicitly stating they are 'actively seeking commercial partners' for both the U.S. and ex-U.S. markets. This suggests they are prioritizing clinical execution and regulatory submission over building out a proprietary sales force right now. They ended the third quarter of 2025 with $\mathbf{\$194.9 \text{ million}}$ in cash, cash equivalents and marketable securities, giving them an expected cash runway into $\mathbf{2028}$, which provides a solid foundation for partnership negotiations leading up to a potential launch.

Clinical Research Organizations (CROs) for Phase 3 trial execution

The focus here is squarely on preparing for the next big step. Trevi Therapeutics, Inc. is preparing to request an End-of-Phase 2 meeting with the FDA in the fourth quarter of 2025. Following that, they plan to initiate a comprehensive Phase 3 program for chronic cough in IPF patients in the first half of $\mathbf{2026}$. While specific CRO names aren't public yet, engaging a capable CRO will be critical for executing a large, multi-site Phase 3 trial, especially one that builds on the $\mathbf{N=160}$ sample size seen in the Phase 2b CORAL trial.

Contract Manufacturing Organizations (CMOs) for Haduvio supply

Since Haduvio (oral nalbuphine ER) is still investigational, the partnership with a CMO for commercial supply is likely in the early stages, focused on securing capacity for late-stage trials and initial launch stock. The company's financial filings show a net loss of $\mathbf{\$11.8 \text{ million}}$ for the third quarter of 2025, indicating resources are still heavily weighted toward R&D and G&A expenses of $\mathbf{\$3.8 \text{ million}}$ for that quarter. Securing a reliable, high-quality CMO for the extended-release formulation will be a major operational milestone post-Phase 3 success.

Here's a quick look at the key development and market metrics that frame these partnership needs:

If onboarding takes 14+ days, churn risk rises, and in this stage, a delay in securing a CMO could push back launch timelines, which is a defintely risk to manage.

Trevi Therapeutics, Inc. (TRVI) - Canvas Business Model: Key Activities

You're looking at the core operational focus for Trevi Therapeutics, Inc. as we head into 2026, which is heavily weighted toward advancing Haduvio (oral nalbuphine ER) into late-stage trials and preparing for a potential launch. The company's key activities center on executing clinical programs and securing the necessary regulatory alignment.

Executing the comprehensive Phase 3 program for Haduvio

The primary activity here is the execution plan for the pivotal Phase 3 program targeting chronic cough in patients with idiopathic pulmonary fibrosis (IPF). Trevi Therapeutics is preparing to initiate this comprehensive Phase 3 program in the first half of 2026. This follows the strong data from the Phase 2b CORAL trial, which enrolled N=165 patients. The data supported this move, showing the 108 mg BID dose achieved a 60.2% reduction in 24-hour cough frequency from Baseline, compared to only a 16.9% reduction for placebo at Week 6. The company is also planning for concurrent advancement into other indications.

Here's a quick look at the clinical progress supporting the Phase 3 push:

• Phase 2b CORAL trial met primary endpoint for IPF cough.
• Phase 2a RIVER trial showed a 57% placebo-adjusted reduction in 24-hour cough frequency for refractory chronic cough (RCC).
• Completed a Phase 1 drug-drug interaction study with antifibrotics pirfenidone or nintedanib.

Preparing and submitting the End-of-Phase 2 (EOP2) meeting request to the FDA

A critical near-term activity is securing alignment with the U.S. Food and Drug Administration (FDA) on the Phase 3 design for the IPF chronic cough indication. Trevi Therapeutics is on track to submit its End-of-Phase 2 meeting request to the FDA in the fourth quarter of 2025. This submission is key because the outcome will dictate the final protocol for the Phase 3 study set to begin in 2026. The company is focused on building a robust and comprehensive package for these discussions.

Manufacturing Haduvio (nalbuphine ER) for clinical and future commercial supply

While specific contract manufacturing organization (CDMO) financial details aren't public, the activity involves ensuring supply chain readiness to support the upcoming late-stage trials and eventual commercialization. The company's financial strength is explicitly tied to funding these pivotal trials and subsequent commercial readiness. The completion of the Phase 1 drug-drug interaction study is part of the NDA-enabling work required before a potential New Drug Application (NDA) submission.

The financial backing for these manufacturing and development activities is substantial:

Pre-commercial planning and market access strategy development

With positive data across two indications, Trevi Therapeutics is allocating resources to prepare for a potential market entry, which is supported by their capital position. The expanded cash balance from the June 2025 offering, which raised approximately $115 million, enables these pre-commercial planning activities. The company's strategy focuses on specialty indications like IPF chronic cough, where there are no approved therapies in the U.S. This lack of competition is a defintely key driver for market access planning.

General and administrative (G&A) expenses reflect these operational expansions:

• Q3 2025 G&A expenses were $3.8 million.
• This was an increase from $2.9 million in Q3 2024, driven by professional fees and personnel.
• The CFO noted that the cash runway enables funding for pre-commercial planning activities.

Trevi Therapeutics, Inc. (TRVI) - Canvas Business Model: Key Resources

You're looking at the core assets Trevi Therapeutics, Inc. (TRVI) is relying on to drive its late-stage development, so let's break down the hard numbers and data packages they hold as of late 2025.

Financially, the company's immediate resource strength is clear. As of the end of the third quarter of 2025, Trevi Therapeutics, Inc. reported holding $194.9 million in cash, cash equivalents, and marketable securities. This position gives management confidence in a cash runway extending into 2028, which they project is sufficient to fund the planned initiation of two Phase 3 trials targeting chronic cough in idiopathic pulmonary fibrosis (IPF) patients, a non-IPF interstitial lung disease (ILD) program, and a refractory chronic cough (RCC) Phase 2b trial, along with supportive Phase 1 studies.

The most critical non-financial resource is the clinical data package supporting Haduvio (oral nalbuphine ER). You saw the positive topline results announced earlier in 2025, which were reinforced by the full data set received in Q3 2025. This data is the foundation for their planned End-of-Phase 2 meeting request with the FDA in Q4 2025, setting up the Phase 3 initiation in the first half of 2026.

Here's a look at the key statistical outcomes from the CORAL trial, which is central to their current valuation narrative:

The clinical data also covers other indications and supportive studies. The RIVER trial for RCC showed positive results earlier in 2025, and a recently completed Phase 1 drug-drug interaction (DDI) study showed no clinically meaningful impact when Haduvio was given with antifibrotic therapies like pirfenidone or nintedanib.

Beyond the drug data, the human capital is a necessary resource for execution. Trevi Therapeutics, Inc. relies on its internal team, which includes specialized R&D and regulatory personnel experienced in late-stage development. The company's Q3 2025 General and Administrative (G&A) expenses rose to $3.8 million, partly due to increased professional fees related to preparing for compliance with Sarbanes-Oxley (SOX) 404(b) regulations, indicating internal focus on financial controls readiness.

The intangible assets supporting the drug's future commercial viability are also key:

• Intellectual Property (IP) for Haduvio, with key patents listed as expiring in 2039 in the initial plan.
• Positive safety reviews from the TIDAL study, which allowed for the completion of enrollment.
• The company reported a net loss of $11.8 million for Q3 2025, down from $13.2 million in Q3 2024, showing operational cost management alongside R&D expenses decreasing to $10.1 million for the quarter.

Finance: draft the 13-week cash view incorporating the projected costs for the Q4 2025 EoP2 meeting preparations by Friday.

Trevi Therapeutics, Inc. (TRVI) - Canvas Business Model: Value Propositions

You're looking at the core value being offered by Trevi Therapeutics, Inc. (TRVI) with Haduvio (oral nalbuphine ER) in late 2025. The proposition centers on delivering efficacy where current standards of care fall short, especially for debilitating chronic cough.

Haduvio is the first investigational therapy to show statistically significant efficacy in IPF chronic cough.

The data from the Phase 2b CORAL trial, presented at CHEST 2025, is the bedrock here. You saw statistically significant reductions in 24-hour cough frequency at Week 6 across all dose groups. The highest dose tested, 108 mg BID, showed a -60.2% change from baseline in objective cough count, translating to a -43.3% placebo-adjusted reduction. What's compelling is the speed; a reduction in cough was observed as early as Week 2. Furthermore, 65% of patients on the 108 mg BID dose achieved at least a 50% reduction from baseline at Week 6 ($p<0.0001$).

This efficacy profile is critical when you consider the patient burden, which is substantial:

• Approximately 85% of the estimated 150,000 U.S. patients with Idiopathic Pulmonary Fibrosis (IPF) are plagued with chronic coughing.
• Patients can cough up to 1,500 times per day.
• The Leicester Cough Questionnaire (LCQ) Total Score, an important quality of life measure, increased by 3.4 points ($p=0.01$) for the 108 mg BID dose group, where an increase of 1.3 points is considered clinically meaningful.

Dual mechanism of action (KAMA) targets both central and peripheral cough pathways.

Haduvio's mechanism is differentiated because it doesn't just address one part of the problem. It acts as a kappa agonist and a mu antagonist (KAMA). This dual action means it targets the cough reflex arc both centrally and peripherally. The theory is that this comprehensive approach addresses cough hypersensitivity, which is thought to be the common link across various chronic cough disorders, regardless of the initial trigger location.

Addresses a significant unmet medical need with no FDA-approved therapies for target indications.

This is a major commercial driver. For chronic cough in IPF and non-IPF Interstitial Lung Disease (ILD), there are currently no FDA-approved therapies in the U.S.. This lack of options creates a clear opening for a first-in-class treatment. Beyond IPF, Trevi Therapeutics is also targeting Refractory Chronic Cough (RCC), which also has no approved therapies in the U.S..

Here's a quick look at the addressable populations based on Trevi Therapeutics' late 2025 view:

Potential for a non-scheduled (non-addictive) opioid-based treatment.

Because Haduvio is based on nalbuphine, it offers a distinct safety profile compared to traditional opioids. Critically, nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency. This is a significant value proposition because it suggests a path to a treatment that can manage severe, chronic neurological symptoms without the high regulatory and patient-perception hurdles associated with controlled substances, which is a major concern in the opioid class.

Financially, the company is positioned to drive this value proposition forward, ending Q3 2025 with $194.9 million in cash and equivalents, projecting a runway into 2028. With a market capitalization of $1.72 billion as of early December 2025, the market is clearly valuing this potential first-in-class status.

Finance: finalize the Q4 2025 cash burn projection based on R&D spend of $10.1 million in Q3.

Trevi Therapeutics, Inc. (TRVI) - Canvas Business Model: Customer Relationships

High-touch engagement with clinical trial investigators and sites is centered around advancing Haduvio (oral nalbuphine ER) through late-stage development.

• The Phase 2b CORAL trial for chronic cough in Idiopathic Pulmonary Fibrosis (IPF) involved N=165 patients.
• The Phase 2a RIVER trial for Refractory Chronic Cough (RCC) involved N=66 patients.
• Trevi Therapeutics, Inc. is preparing to request an End-of-Phase 2 meeting with the FDA in the fourth quarter of 2025.
• The company plans to initiate the Phase 3 program for IPF chronic cough in the first half of 2026.
• A Phase IIb parallel arm dose-ranging study for non-IPF Interstitial Lung Disease (ILD) chronic cough is planned to initiate in the first half of 2026.

Direct communication with patient advocacy groups for IPF and chronic cough is supported by the high unmet need in the target populations.

• Chronic cough in IPF affects two-thirds of approximately ~150,000 U.S. patients.
• Chronic cough in non-IPF ILD affects 50-60% of approximately ~228,000 U.S. patients.
• RCC affects approximately ~2-3 million U.S. patients.
• Patients can cough up to 1,500 times per day.

Investor relations and corporate access events are managed to maintain shareholder confidence, supported by recent financing and financial performance.

Trevi Therapeutics, Inc. management participated in multiple investor conferences in September 2025, including the Wells Fargo Healthcare Conference and the Morgan Stanley 23rd Annual Global Healthcare Conference.

Building relationships with future prescribers (pulmonologists, allergists) involves scientific dissemination to key opinion leaders.

• Data from the CORAL trial was presented via an Oral Presentation at the CHEST 2025 Annual Meeting (October 19 to 22).
• Abstracts from the Phase 2a RIVER Trial data were featured at the European Respiratory Society (ERS) Congress 2025 (September 27 - October 1).

Trevi Therapeutics, Inc. (TRVI) - Canvas Business Model: Channels

You're looking at how Trevi Therapeutics, Inc. plans to get Haduvio (oral nalbuphine ER) to the specialists and patients who need it, which is all about execution once the FDA gives the green light. As of late 2025, the focus is heavily on clinical data dissemination to build the case for late-stage success and future commercial readiness.

Global clinical trial sites for late-stage drug development and patient access

The channel for late-stage access is currently defined by the sites conducting the planned pivotal trials. Trevi Therapeutics is preparing to initiate its Phase 3 program for chronic cough in Idiopathic Pulmonary Fibrosis (IPF) patients in the first half of 2026, following an expected End-of-Phase 2 meeting request with the FDA in the fourth quarter of 2025. Also planned for initiation in the first half of 2026 are a non-IPF Interstitial Lung Disease (non-IPF ILD) study and a Phase 2b study for Refractory Chronic Cough (RCC).

The scale of prior site activity gives you a sense of the network they are building upon. Here's a look at the patient numbers from the recently completed trials that inform the scale of future site needs:

The U.S. patient opportunity is significant, with an estimated ~150,000 U.S. patients with IPF experiencing chronic cough, and approximately ~2-3 million U.S. patients suffering from RCC.

Scientific publications and medical conferences (e.g., CHEST, ERS) to disseminate data

Dissemination of clinical data is a critical channel for building credibility with prescribing physicians and payers. Trevi Therapeutics actively presented its latest findings across major medical forums in 2025.

• Phase 2b CORAL trial key efficacy and safety results were presented via an Oral Presentation at the CHEST 2025 Annual Meeting (October 19-22, Chicago, Illinois).
• Patient-reported outcomes from the Phase 2a RIVER trial were featured as a Poster Presentation at the CHEST 2025 Annual Meeting.
• Results from the Phase 2a RIVER trial were also presented at the ERS Congress 2025 (September 27 - October 1, Amsterdam, Netherlands).
• Management participated in investor/corporate events including the BIO International Convention (June 16 - 19, Boston, Massachusetts) and the 2025 Wells Fargo Healthcare Conference (September 3 - 5).

The company is building a robust package for regulatory discussions based on this data.

Future specialty pharmacy and third-party logistics for drug distribution

While Trevi Therapeutics is currently pre-commercial, its strategy is explicitly focused on specialty indications, which dictates a future channel strategy centered on controlled distribution. The company ended the third quarter of 2025 with $194.9 million in cash, cash equivalents and marketable securities, with an expected cash runway extending into 2028, which supports these pre-commercial planning activities.

The plan involves leveraging this capital for pre-commercial planning activities, which inherently includes establishing the necessary infrastructure for specialty distribution. This will involve contracting with specialty pharmacy networks and third-party logistics (3PL) providers to ensure appropriate handling and access for patients with chronic cough in IPF, non-IPF ILD, and RCC. The company is focused on specialty indications that currently have no approved therapies in the U.S.

Direct sales force to target high-volume prescribing specialists post-approval

The post-approval channel will rely on a targeted commercial infrastructure. Given the focus on chronic cough in IPF, non-IPF ILD, and RCC, the sales force will target pulmonologists, ILD specialists, and potentially cough specialists. The company is preparing for the Phase 3 initiation and is focused on building a comprehensive package for the FDA.

The financial resources are in place to support this build-out; the cash position of $194.9 million as of September 30, 2025, is projected to last into 2028. The G&A expenses for Q3 2025 were $3.8 million, an increase from $2.9 million in Q3 2024, partly due to increased personnel-related expenses, which signals early investment in the team required for commercial readiness. The future sales force will be designed to reach the specific, underserved specialist community treating these chronic cough conditions.

Trevi Therapeutics, Inc. (TRVI) - Canvas Business Model: Customer Segments

You're looking at the core patient populations Trevi Therapeutics, Inc. is targeting with Haduvio (oral nalbuphine ER) as of late 2025. Honestly, the strategy is laser-focused on high-unmet-need chronic cough indications where current off-label treatments offer minimal relief.

The primary customer segments are the patients themselves, defined by their underlying conditions and the persistence of their cough. We can break down the addressable U.S. patient pool with some precision based on the latest company disclosures.

The impact on these patients is significant; for example, some individuals with chronic cough report coughing up to 1,500 times per day, which severely affects their social, physical, and psychological quality of life.

Beyond the patients, Trevi Therapeutics, Inc. must engage with the professional ecosystem that diagnoses and prescribes treatment. These groups are critical for product adoption and market penetration.

• Pulmonologists and cough specialists who treat severe, refractory conditions.
• Allergists/immunologists, as they also treat chronic cough patients.
• Primary care providers, who are often the first point of contact.

The regulatory pathway is a non-negotiable customer segment for any drug developer. You can't sell without their sign-off, so engaging them is a key business activity. Trevi Therapeutics, Inc. is actively working toward this gatekeeper function.

• Regulatory bodies, specifically the FDA, as the gatekeeper for market access.
• Trevi Therapeutics, Inc. is preparing to submit its End-of-Phase 2 meeting request to the FDA in the fourth quarter of 2025.
• The company plans to initiate a comprehensive Phase 3 program for chronic cough in IPF patients by the first half of 2026.

Financially, you should note the company ended the third quarter of 2025 with approximately $194.9 million in cash and marketable securities, which management projects provides a cash runway extending into 2028. This financial footing is what supports the engagement with these customer segments through the next critical clinical steps.

Trevi Therapeutics, Inc. (TRVI) - Canvas Business Model: Cost Structure

You're looking at the cost side of Trevi Therapeutics, Inc. (TRVI) as they pivot hard into late-stage development. This is where the cash burn really gets scrutinized, especially with a major Phase 3 program on the horizon.

The most concrete numbers we have come from the third quarter of 2025 financial release. These figures show the current operational baseline before the anticipated ramp-up for pivotal trials.

The R&D spend is the engine here, but it's set to change. The current $10.1 million in Q3 2025 reflects reduced activity from the recently completed Phase 2a RIVER and Phase 2b CORAL trials. Honestly, that number is about to climb significantly.

Clinical trial costs are the next major variable. Trevi Therapeutics is planning to initiate a comprehensive Phase 3 program for chronic cough in idiopathic pulmonary fibrosis (IPF) patients in the first half of 2026. As the company moves into these larger, later-stage studies, you should definitely anticipate a substantial increase in operating expenses (opex) related to site activation, patient recruitment, and monitoring for these pivotal trials.

Costs associated with manufacturing scale-up and regulatory filings are less explicitly quantified for Q3 2025, but the strategic moves point to where the money is going:

• Preparing for the Phase 3 program initiation in 1H 2026 requires scaling up drug substance and drug product manufacturing capabilities for Haduvio.
• The company is preparing to request an End-of-Phase 2 meeting with the FDA in the fourth quarter of 2025, which drives up professional fees within G&A.
• The increase in G&A to $3.8 million in Q3 2025 was partly due to increased professional fees related to preparing for compliance with SOX 404(b) regulations.

To be fair, the current cash position of $194.9 million as of September 30, 2025, is intended to fund these upcoming pivotal trials and secure a runway into 2028. Still, late-stage clinical costs are notoriously high; you'll want to watch the quarterly burn rate closely as they move past the End-of-Phase 2 discussions.

Finance: draft 13-week cash view by Friday.

Trevi Therapeutics, Inc. (TRVI) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Trevi Therapeutics, Inc. (TRVI) as of late 2025, and honestly, it's what you'd expect from a clinical-stage biopharma company focused on a late-stage asset. The primary engine keeping the lights on isn't product sales; it's the capital markets.

Equity financing and capital raises to fund operations (primary source)

The most significant inflow of cash comes from financing activities. You saw a major capital infusion following the positive data from the CORAL trial. Specifically, the company was able to raise approximately $115 million in capital following the data release, bringing the total cash and investments up to approximately $204 million at the end of June 2025. This was a key move to de-risk the path forward. The latest reported cash position, as of September 30, 2025, stood at $194.9 million in cash, cash equivalents, and marketable securities. That level of liquidity supports an expected cash runway extending into 2028, which is definitely a solid footing for the near term.

Interest income from invested cash and marketable securities (Q3 2025: $2.1 million)

Because Trevi Therapeutics, Inc. holds a substantial cash balance from those financing efforts, a secondary, non-operating revenue stream is interest income. For the third quarter of 2025, Other Income, net, which is primarily driven by this interest, increased to $2.1 million. That's up from $0.8 million in the same period in 2024, reflecting both the higher invested balances and prevailing interest rate yields. It's not product revenue, but it helps offset the operating burn.

Here's a quick look at the cash foundation supporting that income stream:

Potential future milestone payments from a commercialization partner

This stream is purely potential right now. Trevi Therapeutics, Inc. is preparing to request an End-of-Phase 2 meeting with the FDA in the fourth quarter of 2025 and is planning to initiate the comprehensive Phase 3 program for chronic cough in IPF patients in the first half of 2026. If a commercialization partnership is established before or after Phase 3 success, milestone payments tied to regulatory achievements or clinical progression would become a revenue source. No specific dollar amounts for potential milestones are public, but this is a standard value-inflection point for non-partnered assets.

Future product sales revenue from Haduvio post-FDA approval (currently zero)

As a clinical-stage company, Trevi Therapeutics, Inc. reports zero in product sales revenue for the third quarter of 2025. Revenue generation from Haduvio is contingent on successful completion of the planned Phase 3 program, subsequent FDA approval, and subsequent market launch across its targeted indications, including chronic cough in IPF and refractory chronic cough (RCC). The company is focused on addressing indications where there are currently no approved therapies in the U.S.

Key financial and operational data points related to the revenue-funding structure include:

• Equity financing raised approximately $115 million in capital as of June 2025.
• Cash and investments totaled $194.9 million at the close of Q3 2025.
• Interest income contributed $2.1 million to Other Income, net in Q3 2025.
• Product sales revenue remains at $0, consistent with clinical-stage status.
• The company is preparing to initiate the Phase 3 program for IPF chronic cough in the first half of 2026.

Finance: finalize the Q4 2025 projected cash burn rate based on the planned H1 2026 Phase 3 initiation by end of January.