Core Insights - CFOs are increasingly using terms like "uncertainty" and "unprecedented" to describe the current economic landscape, reflecting a sense of fatigue with ongoing unpredictability [1] - The focus for CFOs is on taking actionable steps to build resilience in the face of uncertainty, rather than succumbing to inaction [1][2] - There is a significant shift in resource allocation towards technology functions within companies, although uncertainty remains regarding AI's full impact on financial performance [3][4] Financial Strategies - Key questions for CFOs include improving liquidity, operational efficiency, and determining essential versus non-essential investments [2] - Despite uncertainty, it is crucial for companies to review long-standing strategies and seize competitive opportunities, particularly in AI investments [2] - The recommended focus for AI efforts is 80% on productivity for growth and 20% on productivity for efficiency, emphasizing better time utilization rather than headcount reduction [5] Future Outlook - McKinsey's research suggests that by 2030, profound changes in work processes will necessitate a reorganization of value creation and activities [4] - Managing uncertainty effectively involves planning for both positive and negative scenarios, highlighting the importance of a cross-functional approach within the C-suite [6] - The global economic outlook indicates that AI-driven investments are supporting better-than-expected growth, despite underlying demand remaining soft [9]

Core Insights - Trevi Therapeutics, Inc. has appointed David Hastings as the new Chief Financial Officer effective January 6, 2026, to lead financial strategy and support the company's growth phase [1][2][3] Company Overview - Trevi Therapeutics is a clinical-stage biopharmaceutical company focused on developing Haduvio™ (oral nalbuphine ER) for treating chronic cough associated with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC) [1][4] - Haduvio is the first investigational therapy to demonstrate a statistically significant reduction in cough frequency in clinical trials for both IPF chronic cough and RCC patients [4] Market Need - There are approximately 150,000 patients with IPF in the U.S., with two-thirds experiencing uncontrolled chronic cough, and around 228,000 patients with non-IPF ILD, with 50-60% also suffering from uncontrolled chronic cough [5] - RCC affects an estimated 2-3 million patients in the U.S. and is characterized by a persistent cough lasting over 8 weeks despite treatment for underlying conditions [6] Leadership Experience - David Hastings brings over 25 years of financial leadership in life sciences and biopharmaceuticals, having raised over $2 billion in equity and debt financing throughout his career [2] - His previous roles include CFO at Arbutus and Incyte, where he managed financial operations during significant transitions and commercialization phases [2][3] Strategic Importance - Hastings' experience is deemed critical as Trevi transitions into Phase 3 development for Haduvio, with a focus on advancing the treatment for chronic cough [3] - The company is positioned with statistically significant data across target indications, limited competition, and a strong cash position, which are expected to enhance long-term value for patients and shareholders [3]

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Trevi Therapeutics (NasdaqGM:TRVI) Q3 2025 Earnings Call November 13, 2025 04:30 PM ET Speaker2Good afternoon and welcome to the Trevi Therapeutics third quarter 2025 earnings conference call. At this time, all participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your phone. To withdraw ...

Clinical Trials and Development - The Phase 2b CORAL trial for Haduvio demonstrated statistically significant reductions in 24-hour cough frequency of 60.2% (p<0.0001), 53.4% (p<0.0001), and 47.9% (p<0.01) for the 108 mg BID, 54 mg BID, and 27 mg BID dose groups, respectively, compared to a placebo reduction of 16.9%[135]. - The Phase 2a RIVER trial showed a 67% reduction in 24-hour cough frequency from baseline and a 57% placebo-adjusted reduction (p<0.0001) for Haduvio in patients with refractory chronic cough[144]. - The Phase 2 CANAL trial showed a statistically significant reduction in daytime cough frequency (p<0.0001) and positive results on patient-reported outcomes for Haduvio[141]. - The TIDAL study aims to assess the safety and tolerability of Haduvio in patients with IPF, with data expected in Q4 2025[140]. - The company is also developing Haduvio for chronic cough in patients with non-IPF interstitial lung disease (ILD) and plans to conduct a clinical trial for this indication[143]. - The company plans to conduct multiple clinical trials for Haduvio, including Phase 3 trials for chronic cough in patients with IPF and non-IPF ILD[183]. - The company plans to request an End-of-Phase 2 meeting with the FDA in Q4 2025 and initiate the Phase 3 program for Haduvio in the first half of 2026[139]. Financial Performance - As of September 30, 2025, the company reported an accumulated deficit of $321.5 million due to research and development and administrative expenses[147]. - The company had cash, cash equivalents, and marketable securities totaling $194.9 million as of September 30, 2025, expected to fund operations for at least 12 months[148]. - Research and development expenses for Q3 2025 decreased to $10.1 million from $11.2 million in Q3 2024, primarily due to reduced clinical development expenses[160]. - General and administrative expenses for Q3 2025 increased to $3.8 million from $2.9 million in Q3 2024, mainly due to higher professional fees and personnel-related costs[161]. - Total operating expenses for Q3 2025 were $13.9 million, a slight decrease from $14.1 million in Q3 2024[159]. - Net loss for Q3 2025 was $11.8 million, compared to a net loss of $13.2 million in Q3 2024, reflecting an improvement of $1.4 million[159]. - Research and development expenses for the nine months ended September 30, 2025, were $27.3 million, down from $30.0 million in the same period of 2024[164]. - General and administrative expenses for the nine months ended September 30, 2025, increased to $11.8 million from $9.2 million in the same period of 2024[165]. - Interest income for Q3 2025 was $2.1 million, up from $0.8 million in Q3 2024, driven by higher cash equivalents and marketable securities[162]. - The company raised approximately $115.1 million from the June 2025 Offering of 17.4 million shares at $5.75 per share[168]. - The company has not generated any revenue since inception and has incurred significant operating losses and negative cash flows[167]. - For the nine months ended September 30, 2025, net cash used in operating activities was $34.5 million, resulting from a net loss of $34.4 million[174]. - Net cash used in investing activities for the nine months ended September 30, 2025, was $63.5 million, primarily due to $116.3 million in purchases of available-for-sale marketable securities[176]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $120.7 million, mainly from cash proceeds of $108.2 million from common stock sales[178]. - The company reported a net increase in cash and cash equivalents of $22.8 million for the nine months ended September 30, 2025, compared to a decrease of $16.3 million in the same period of 2024[173]. - The company’s non-cash charges for the nine months ended September 30, 2025, included stock-based compensation expense of $3.8 million[174]. Future Outlook and Funding Needs - The company anticipates substantial expenditures in the future for the clinical development and commercialization of Haduvio[150]. - The company expects to incur substantial expenditures to advance Haduvio through clinical development and regulatory approval, requiring significant additional funding[181]. - The company believes existing cash, cash equivalents, and marketable securities will fund operations into 2028, but additional capital will be needed for full development and commercialization of Haduvio[186]. - The company has no committed external source of funds and will need to obtain further funding through various means, which may lead to dilution for stockholders[188]. - The company completed a Phase 1 drug-drug interaction study showing no clinically meaningful pharmacokinetic findings when Haduvio was co-administered with pirfenidone or nintedanib[146]. - The safety profile of Haduvio was consistent with previous trials, with discontinuation rates due to adverse events at 5.6% for Haduvio and 5.0% for placebo[142].

Financial Performance - Trevi Therapeutics ended Q3 2025 with $194.9 million in cash, cash equivalents, and marketable securities, providing a cash runway into 2028[5]. - R&D expenses decreased to $10.1 million in Q3 2025 from $11.2 million in Q3 2024, primarily due to reduced clinical development expenses[6]. - G&A expenses increased to $3.8 million in Q3 2025 from $2.9 million in Q3 2024, mainly due to higher professional fees and personnel-related expenses[7]. - Net loss for Q3 2025 was $11.8 million, an improvement from a net loss of $13.2 million in Q3 2024[8]. Clinical Development - The company is preparing to initiate a comprehensive Phase 3 program for chronic cough in patients with idiopathic pulmonary fibrosis in the first half of 2026[1]. - Trevi Therapeutics plans to submit an End-of-Phase 2 meeting request to the FDA in Q4 2025[2]. - The Phase 1 safety study for IPF patients showed no safety signals, allowing for the completion of enrollment[3]. - Topline results from the Phase 2b CORAL trial were presented at the CHEST 2025 Annual Meeting[4]. - The company intends to initiate a Phase 2b study for refractory chronic cough in the first half of 2026 following positive Phase 2a RIVER trial results[10]. Market Opportunity - There are approximately 150,000 U.S. patients with IPF, with two-thirds experiencing uncontrolled chronic cough, highlighting a significant unmet medical need[12].

Core Insights - Trevi Therapeutics is advancing its investigational therapy Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), with plans to initiate a comprehensive Phase 3 program in the first half of 2026 [1][5]. Financial Performance - The company reported a net loss of $11.8 million for Q3 2025, an improvement from a net loss of $13.2 million in Q3 2024 [7][13]. - Research and development (R&D) expenses decreased to $10.1 million in Q3 2025 from $11.2 million in Q3 2024, primarily due to reduced clinical development costs [4][13]. - General and administrative (G&A) expenses increased to $3.8 million in Q3 2025 from $2.9 million in Q3 2024, attributed to higher professional fees and personnel-related expenses [6][13]. - The company ended Q3 2025 with $194.9 million in cash, cash equivalents, and marketable securities, providing a cash runway into 2028 [1][4]. Clinical Development - Trevi Therapeutics is preparing to submit an End-of-Phase 2 meeting request to the FDA in Q4 2025 and plans to initiate its Phase 3 program in the first half of 2026 [2][5]. - The safety review committee for the Phase 1 TIDAL study concluded there were no safety signals, allowing for the completion of patient enrollment [5]. - Positive results from the Phase 2a RIVER trial were presented at major medical meetings, and a Phase 2b RCC study is planned for the first half of 2026 [5][9]. Market Opportunity - There are approximately 150,000 patients with IPF in the U.S., with two-thirds experiencing uncontrolled chronic cough, and around 228,000 patients with non-IPF interstitial lung disease, with 50-60% also suffering from uncontrolled chronic cough [9]. - RCC affects an estimated 2-3 million patients in the U.S., representing a significant unmet medical need as there are currently no FDA-approved therapies for these conditions [9].

Core Insights - Trevi Therapeutics, Inc. announced the acceptance of two abstracts for presentation at the CHEST 2025 Annual Meeting, focusing on the efficacy and safety results of nalbuphine ER for chronic cough treatment in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC) [1][5] Group 1: Clinical Trials - The Phase 2b CORAL trial evaluated nalbuphine ER in three doses (27 mg, 54 mg, and 108 mg twice daily) against placebo for chronic cough in IPF patients over a 6-week period, with 165 patients randomized [3] - The primary efficacy endpoint was the relative change in 24-hour cough frequency, measured by an objective cough monitor, comparing nalbuphine ER to placebo at the end of Week 6 [3] - The Phase 2a RIVER trial assessed nalbuphine ER's efficacy, safety, and tolerability in RCC patients through a crossover study design, with each treatment period lasting 21 days [4] Group 2: Patient Population and Unmet Need - There are approximately 150,000 patients with IPF in the U.S., with two-thirds experiencing uncontrolled chronic cough, and around 228,000 patients with non-IPF ILD, with 50-60% also facing uncontrolled chronic cough [6] - Chronic cough can lead to significant morbidity and mortality, including increased respiratory hospitalizations and a decline in quality of life [6] - RCC affects an estimated 2-3 million patients in the U.S., characterized by a persistent cough lasting over 8 weeks despite treatment for underlying conditions, indicating a high unmet medical need [6] Group 3: Product Information - Trevi Therapeutics is developing Haduvio™ (oral nalbuphine ER) as a potential treatment for chronic cough in IPF, non-IPF ILD, and RCC, which has shown statistically significant reductions in cough frequency in clinical trials [5] - Nalbuphine acts on the cough reflex arc as a kappa agonist and mu antagonist, targeting opioid receptors involved in cough control [5]