Leadership Change - Trevi Therapeutics, Inc. appointed David Hastings as Chief Financial Officer, effective January 6, 2026, marking a significant leadership change as the company transitions into a more advanced development stage [2] - Hastings brings 25 years of financial leadership experience in public life sciences companies and has helped raise $2 billion in equity and debt financing, aligning with Trevi's growth strategy [2] Clinical Development - Trevi is preparing to request an End-of-Phase 2 meeting with the FDA in Q4 2025 for its lead program targeting chronic cough associated with idiopathic pulmonary fibrosis (IPF), having completed key Phase 2 work [3] - The company expects to initiate a Phase 3 program in the first half of 2026, reinforcing its transition into this critical phase of development [3] Safety and Efficacy Studies - The ongoing Phase 1 TIDAL study in IPF patients has shown no safety signals, and a completed drug-drug interaction study confirmed that nalbuphine ER can be safely co-administered with standard antifibrotic therapies [4] - Trevi has presented topline Phase 2b CORAL data, enhancing clinical and investor visibility [4] Financial Position - As of the end of Q3 2025, Trevi Therapeutics reported a cash balance of $194.9 million, positioning the company well to capitalize on its clinical momentum [5] - The company is focused on developing Haduvio, an oral extended-release therapy for chronic cough across IPF, Non-IPF ILD, and refractory chronic cough [5]

Market Overview - The article discusses the potential for strong market momentum to continue into 2026, with a focus on identifying the next wave of multibagger stocks [1][2] - Chris Toomey from Morgan Stanley expects a solid year for markets in 2026, driven by secular tailwinds, improving earnings visibility, supportive fiscal and monetary policies, and a revival of market enthusiasm due to deregulation and increased M&A activity [3][4] Investment Strategy - Toomey emphasizes the importance of market leadership broadening, suggesting that previously overlooked sectors may present new investment opportunities, moving beyond the dominance of mega-cap technology stocks [5] - The methodology for selecting the best multibagger stocks includes filtering for stocks with a market capitalization over $500 million, at least 150% returns over the past year, and a minimum of 50% upside potential [7] Company Highlights CytomX Therapeutics, Inc. (NASDAQ:CTMX) - Market Cap: $696.38 million, with a 1-year price return of 263.72% and an upside potential of 58.20% [9] - 90% of analysts are bullish on CTMX, with a median price target of $6.50, indicating a healthy upside potential [10] - H.C. Wainwright has reiterated a "Buy" rating with a $10.00 price target, anticipating critical data for the CX-2051 therapy in colorectal cancer [11] - The firm outlines performance benchmarks for CX-2051, categorizing potential outcomes into "slam dunk," "bull," and "bear" scenarios based on expected response rates and survival metrics [12] - The company is progressing with its CX-2051 program, with enrollment nearing 100 patients ahead of a planned Phase 1 update in Q1 2026 [13][14] Trevi Therapeutics, Inc. (NASDAQ:TRVI) - Market Cap: $1.59 billion, with a 1-year price return of 169.11% and an upside potential of 73.40% [15] - The appointment of David Hastings as CFO is seen as a strategic move to support the company's transition into advanced development stages [16] - Trevi is preparing for a Phase 3 program for Haduvio in chronic cough associated with idiopathic pulmonary fibrosis (IPF), with an End-of-Phase 2 meeting with the FDA expected in Q4 2025 [17] - Ongoing studies have shown no safety signals, and the company has a cash balance of $194.9 million as of Q3 2025, positioning it well for future clinical developments [18][19]

Core Viewpoint - Trevi Therapeutics (TRVI) is being initiated with a "Buy" rating due to its advancement in getting its lead program into phase 3 testing [2]. Company Overview - Trevi Therapeutics is positioned favorably in the biotech sector, with its lead program already progressing to phase 3 testing, indicating a strong potential for future growth and value creation [2]. Analyst Background - The analysis is provided by Terry Chrisomalis, who has extensive experience in the biotech sector and runs the Biotech Analysis Central service, which offers in-depth analysis and a model portfolio of biotech stocks [2].

Financial Data and Key Metrics Changes - For Q3 2025, the company reported a net loss of $11.8 million, an improvement from a net loss of $13.2 million in Q3 2024 [9] - R&D expenses decreased to $10.1 million from $11.2 million year-over-year, primarily due to reduced clinical trial work [9] - G&A expenses increased to $3.8 million from $2.9 million, mainly due to higher professional fees and personnel costs [10] - As of September 30, 2025, cash and investments totaled approximately $195 million, providing a cash runway into 2028 [10] Business Line Data and Key Metrics Changes - The company has made significant progress in its chronic cough programs, particularly in the CORAL trial for chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and the RIVER trial for refractory chronic cough (RCC) [3][4] - Recent phase one studies for the IPF cough program showed no clinically meaningful changes in pharmacokinetics when nalbuphine was co-administered with standard anti-fibrotic treatments [5] Market Data and Key Metrics Changes - The company estimates approximately 228,000 patients with non-IPF interstitial lung diseases (ILD) have chronic cough, with 50-60% experiencing uncontrolled cough, significantly expanding the market opportunity [7] Company Strategy and Development Direction - The company is preparing to initiate multiple phase three trials in the first half of next year, focusing on chronic cough in both IPF and non-IPF ILD patients [8] - The strategy includes aligning with regulatory authorities and ensuring efficient clinical and commercial efforts [7][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position, citing strong data in chronic cough conditions and a solid financial foundation to advance therapies closer to patients [11] - The management highlighted the lack of FDA-approved therapies for chronic cough, indicating a significant market opportunity [11] Other Important Information - The company plans to request a meeting with the FDA to discuss the phase three program for chronic cough in patients with IPF and non-IPF ILD [7] - Management indicated that they will apply for orphan drug designation for Haduvio in IPF [46] Q&A Session Summary Question: Inclusion/exclusion criteria for non-IPF ILD study - Management confirmed that the criteria will focus on the amount of cough and lung damage, with no current plans to exclude specific ILDs [13][15] Question: Need for additional drug-drug interaction studies - Management acknowledged the necessity for further DDI studies based on the drug's metabolism mechanisms [20] Question: Completion of the respiratory study before the end of phase two meeting - Management clarified that the study does not need to be completed before the end of phase two meeting, as they will have available data for submission [25] Question: Feedback from the CHEST meeting - Management reported strong interest from pulmonologists and investigators regarding the data presented, indicating a significant burden of chronic cough [26][27] Question: Plans for broader eligibility criteria in future trials - Management stated that they aim to keep the phase three population as broad as possible to reflect real-world patients [67] Question: Long-term data collection in phase three - Management confirmed that long-term safety data collection will be part of the phase three program, anticipating a requirement for 52 weeks of data [74]

Core Insights - Trevi Therapeutics Inc. (NASDAQ:TRVI) is highlighted as a promising multibagger stock, with Morgan Stanley initiating coverage with an Overweight rating and an $18 price target [1][2] Group 1: Haduvio's Market Potential - Haduvio, Trevi's extended-release formulation of nalbuphine, is being developed to treat chronic cough, addressing a significant unmet medical need in a market with limited existing therapies [2][3] - The analyst estimates that Haduvio could represent a multi-billion-dollar opportunity for Trevi, with increasing interest in the pharmaceutical sector further supporting this potential [3] Group 2: Competitive Landscape - Large pharmaceutical companies like GSK and Merck have already engaged in billion-dollar partnerships in the chronic cough treatment space, indicating that Trevi could benefit from increased attention and investment in this area [3]

Financial Data and Key Metrics Changes - For Q2 2025, the company reported a net loss of $12.3 million, slightly improved from a net loss of $12.4 million in Q2 2024 [13] - Research and Development (R&D) expenses decreased to $9.4 million from $10 million in the same quarter of 2024, primarily due to reduced costs in several trials [13] - General and Administrative (G&A) expenses increased to $4.3 million from $3.3 million in Q2 2024, mainly due to higher professional fees and personnel costs [14] - As of June 30, 2025, cash and investments totaled approximately $204 million, providing a cash runway into 2029 [15] Business Line Data and Key Metrics Changes - The CORAL trial for chronic cough in patients with idiopathic pulmonary fibrosis (IPF) showed a statistically significant reduction in cough frequency across all dose groups [5] - The quality of life assessment using the Lester Cough Questionnaire (LCQ) indicated significant improvements, with increases of 3.7 and 3.4 points for the 54 mg and 108 mg BID doses, respectively [6] Market Data and Key Metrics Changes - The company estimates approximately 228,000 patients with non-IPF interstitial lung diseases, with 50% to 60% experiencing uncontrolled cough, effectively doubling the market opportunity for cough treatment [10] Company Strategy and Development Direction - The company plans to initiate Phase III trials for Haduvio in the first half of next year, focusing on chronic cough in both IPF and non-IPF patients [9][11] - There is an emphasis on patient-centric development and commercialization strategies, as indicated by feedback from patient advisory boards [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position to execute its strategy and create value following positive data from recent trials [5] - The end of Phase II meeting with the FDA is anticipated in Q4 2025, where alignment on the Phase III program will be discussed [9][30] Other Important Information - The company is preparing for a study in refractory chronic cough, with plans to initiate a Phase IIb parallel arm study in the first half of next year [11] - The company has received positive feedback from pulmonologists regarding the potential for Haduvio in treating non-IPF interstitial lung diseases [34] Q&A Session Summary Question: Progress on the respiratory depression study - Management confirmed that the respiratory safety study is ongoing with two active sites and expects to have data for the end of Phase II meeting [20][22] Question: Key questions for the upcoming FDA meeting - The focus will be on data from the CORAL trial, adequacy of the program, and specifics of the Phase III protocol [30][31] Question: Parallel design for the non-IPF ILD study - Management indicated that the study will have minimum criteria for enrollment, allowing for a broader patient base while focusing on fibrosis and cough [46][50] Question: Tolerability and adverse events from the CORAL trial - Management expressed satisfaction with the CORAL data and indicated no changes are anticipated going forward [52] Question: Dose selection for the Phase III study - The 54 mg BID dose is expected to be a key dose moving forward based on its performance in the CORAL trial [57] Question: Additional data from the CORAL trial - Management confirmed that the LCQ data complements objective cough data and will be discussed in future meetings [63][64] Question: Commercialization plans and partnering - The company is focused on its Phase III program in the U.S. and may consider partnerships in Europe or Japan [104]

Core Insights - Trevi Therapeutics, Inc. reported positive topline results from its Phase 2b CORAL trial of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF), achieving the primary endpoint with statistically significant reductions in 24-hour cough frequency across all dose groups at week six [1][2]. Group 1: Trial Results - The 108 mg BID, 54 mg BID, and 27 mg BID dose groups achieved reductions from baseline of 60.2%, 53.4%, and 47.9%, respectively, compared to a placebo reduction of 16.9% [2]. - A rapid reduction in 24-hour cough frequency was observed at week two, with 65% of patients on 108 mg BID, 63% on 54 mg BID, and 60% on 27 mg BID experiencing a 50% reduction at week six, compared to 19% of placebo patients [5]. - Statistically significant improvements were noted in secondary endpoints for the 108 mg BID and 54 mg BID dose groups, including a mean reduction of 3.0 points for 108 mg BID and 3.2 points for 54 mg BID on the cough-severity numerical rating scale, compared to a 1.5-point reduction for placebo [5]. Group 2: Safety and Discontinuation - Discontinuation rates due to adverse events were similar between the Haduvio (5.6%) and placebo groups (5%) [4]. Group 3: Stock Performance - Following the announcement, Trevi Therapeutics' stock declined by 10.45%, trading at $5.83 [4].

Financial Data and Key Metrics Changes - For Q4 2024, the company reported a net loss of $11.4 million, compared to a net loss of $7.8 million in Q4 2023 [25] - R&D expenses increased to $9.3 million in Q4 2024 from $6.5 million in Q4 2023, primarily due to higher clinical trial costs [25][26] - G&A expenses rose to $2.9 million in Q4 2024 from $2.4 million in the same period in 2023, mainly due to increased stock-based compensation [26] - As of December 31, 2024, cash, cash equivalents, and marketable securities totaled $107.6 million, bolstered by a $50 million offering completed in December [26][27] Business Line Data and Key Metrics Changes - The company achieved three positive data readouts in 2024, including studies on Human Abuse Potential, the CORAL study in chronic cough patients with IPF, and the RIVER study in patients with refractory chronic cough [6][20] - The RIVER trial met its primary endpoint with a statistically significant reduction in 24-hour objective cough frequency, achieving a p-value of less than 0.0001% [17] Market Data and Key Metrics Changes - The RIVER study targets a patient population of approximately 2 million to 3 million in the US suffering from refractory chronic cough, which currently has no approved therapies [16] - The company plans to focus on patients who have failed prior therapies, addressing a significant unmet need in the market [18] Company Strategy and Development Direction - The company aims to develop Haduvio as a first-in-class therapy for chronic cough conditions, with a focus on both IPF and RCC [23][24] - Plans include preparing for an End-of-Phase 2 meeting with the FDA by the end of 2025 to discuss pivotal program designs and safety databases [21] - The company intends to release more data from the RIVER trial at upcoming medical conferences, indicating a proactive approach to stakeholder engagement [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the execution of clinical trials and the potential of Haduvio to address significant unmet needs in chronic cough conditions [6][23] - The company remains optimistic about the upcoming data readouts and the potential for Haduvio to be positioned as a best-in-class therapy [23] Other Important Information - The company expects cash burn of approximately $12 million to $14 million per quarter in Q1 and Q2 of 2025, with guidance to be updated as trial designs are finalized [28] - The current fully diluted shares outstanding are approximately 137 million, including about 10 million stock options [29] Q&A Session Summary Question: Could you speak about the patients enrolled in the CORAL study? - Management confirmed that no changes were made to the study protocol or sites after the sample size estimation, maintaining consistency in enrollment statistics [33][34] Question: What are the placebo response expectations for the IPF chronic cough Phase 2 study? - Management clarified that the study includes a two-week titration period, and previous studies indicated a placebo effect ranging from 15% to 23% [42][43] Question: How will the RCC patient population be split between P2X3 and Haduvio? - Management indicated that Haduvio would be positioned as a second or third-line therapy for patients who have failed P2X3 treatments, addressing a significant unmet need [46][48] Question: What exploratory metrics are expected at the time of the IPF chronic cough readout? - Management confirmed that key secondary endpoints will include the EXACT-2 and CS-VAS metrics, but specifics on additional secondary endpoints were not provided [82] Question: Will the next RCC trial have any changes in inclusion criteria? - Management stated that the inclusion criteria will remain similar to the previous study, focusing on patients with a minimum level of cough [60]