Trevi Therapeutics Reports Fourth Quarter and Year End 2024 Financial Results and Provides Business Updates
Trevi Therapeutics (NASDAQ: TRVI) reported significant progress in its clinical trials for Haduvio, a therapy for chronic cough conditions. The company announced positive topline data from Phase 2a RIVER trial showing a 57% placebo-adjusted reduction in 24-hour cough frequency for refractory chronic cough patients.
Key developments include completed enrollment in the Phase 2b CORAL trial for IPF chronic cough patients, with topline data expected in Q2 2025, and positive sample size re-estimation outcome requiring no changes to the study. The company also reported positive results from its Human Abuse Potential study.
Financial highlights for Q4 2024:
- Cash position: $107.6 million, with runway into H2 2026
- R&D expenses: $9.3 million (up from $6.5M in Q4 2023)
- Net loss: $11.4 million (compared to $7.8M in Q4 2023)
Trevi Therapeutics (NASDAQ: TRVI) ha riportato progressi significativi nei suoi studi clinici per Haduvio, una terapia per le condizioni di tosse cronica. L'azienda ha annunciato dati positivi preliminari dal trial di Fase 2a RIVER, mostrando una riduzione del 57% della frequenza di tosse in 24 ore, corretta per il placebo, per i pazienti con tosse cronica refrattaria.
I principali sviluppi includono il completamento dell'arruolamento nel trial di Fase 2b CORAL per i pazienti con tosse cronica da IPF, con dati preliminari attesi nel secondo trimestre del 2025, e un esito positivo della rivalutazione della dimensione del campione che non richiede modifiche allo studio. L'azienda ha anche riportato risultati positivi dal suo studio sul potenziale di abuso umano.
Risultati finanziari per il quarto trimestre del 2024:
- Posizione di liquidità: 107,6 milioni di dollari, con una disponibilità fino al secondo semestre del 2026
- Spese per R&S: 9,3 milioni di dollari (in aumento rispetto ai 6,5 milioni di dollari nel quarto trimestre del 2023)
- Perdita netta: 11,4 milioni di dollari (rispetto ai 7,8 milioni di dollari nel quarto trimestre del 2023)
Trevi Therapeutics (NASDAQ: TRVI) informó sobre avances significativos en sus ensayos clínicos para Haduvio, una terapia para condiciones de tos crónica. La compañía anunció datos preliminares positivos del ensayo de Fase 2a RIVER que muestran una reducción ajustada al placebo del 57% en la frecuencia de tos de 24 horas para pacientes con tos crónica refractaria.
Los desarrollos clave incluyen la finalización de la inscripción en el ensayo de Fase 2b CORAL para pacientes con tos crónica por IPF, con datos preliminares esperados para el segundo trimestre de 2025, y un resultado positivo de la re-evaluación del tamaño de la muestra que no requiere cambios en el estudio. La compañía también reportó resultados positivos de su estudio sobre el potencial de abuso humano.
Aspectos financieros para el cuarto trimestre de 2024:
- Posición de efectivo: 107,6 millones de dólares, con fondos disponibles hasta el segundo semestre de 2026
- Gastos de I+D: 9,3 millones de dólares (en comparación con 6,5 millones en el cuarto trimestre de 2023)
- Pérdida neta: 11,4 millones de dólares (en comparación con 7,8 millones en el cuarto trimestre de 2023)
Trevi Therapeutics (NASDAQ: TRVI)는 만성 기침 질환 치료제인 Haduvio의 임상 시험에서 중요한 진전을 보고했습니다. 회사는 2상 RIVER 시험의 긍정적인 초기 데이터를 발표하며, 만성 기침 환자에서 24시간 기침 빈도가 위약 조정 기준으로 57% 감소했다고 밝혔습니다.
주요 개발 사항으로는 IPF 만성 기침 환자를 위한 2상 CORAL 시험의 등록 완료가 있으며, 초기 데이터는 2025년 2분기에 예상되고, 연구에 변경이 필요하지 않은 긍정적인 샘플 크기 재추정 결과가 나왔습니다. 회사는 또한 인간 남용 가능성 연구에서 긍정적인 결과를 보고했습니다.
2024년 4분기 재무 하이라이트:
- 현금 보유: 1억 760만 달러, 2026년 하반기까지 자금 확보
- 연구개발 비용: 930만 달러 (2023년 4분기 650만 달러에서 증가)
- 순손실: 1140만 달러 (2023년 4분기 780만 달러와 비교)
Trevi Therapeutics (NASDAQ: TRVI) a signalé des progrès significatifs dans ses essais cliniques pour Haduvio, une thérapie pour les conditions de toux chronique. L'entreprise a annoncé des données préliminaires positives de l'essai de Phase 2a RIVER montrant une réduction ajustée au placebo de 57 % de la fréquence de toux sur 24 heures pour les patients souffrant de toux chronique réfractaire.
Les développements clés incluent l'achèvement de l'inscription dans l'essai de Phase 2b CORAL pour les patients atteints de toux chronique due à l'IPF, avec des données préliminaires attendues au deuxième trimestre 2025, et un résultat positif de la réévaluation de la taille de l'échantillon qui ne nécessite aucun changement dans l'étude. L'entreprise a également rapporté des résultats positifs de son étude sur le potentiel d'abus humain.
Points financiers pour le quatrième trimestre 2024 :
- Position de liquidité : 107,6 millions de dollars, avec des fonds disponibles jusqu'au deuxième semestre 2026
- Dépenses de R&D : 9,3 millions de dollars (en hausse par rapport à 6,5 millions de dollars au quatrième trimestre 2023)
- Perte nette : 11,4 millions de dollars (par rapport à 7,8 millions de dollars au quatrième trimestre 2023)
Trevi Therapeutics (NASDAQ: TRVI) berichtete über bedeutende Fortschritte in seinen klinischen Studien zu Haduvio, einer Therapie für chronische Hustenbedingungen. Das Unternehmen gab positive vorläufige Daten aus der Phase 2a RIVER-Studie bekannt, die eine placebo-adjustierte Reduktion der Hustenfrequenz über 24 Stunden um 57 % bei Patienten mit refraktärem chronischen Husten zeigt.
Wichtige Entwicklungen umfassen den Abschluss der Rekrutierung in der Phase 2b CORAL-Studie für IPF-Patienten mit chronischem Husten, wobei vorläufige Daten im 2. Quartal 2025 erwartet werden, sowie ein positives Ergebnis der Neubewertung der Stichprobengröße, das keine Änderungen an der Studie erfordert. Das Unternehmen berichtete auch von positiven Ergebnissen aus seiner Studie zum Missbrauchspotenzial beim Menschen.
Finanzielle Höhepunkte für das 4. Quartal 2024:
- Liquiditätsposition: 107,6 Millionen Dollar, mit Mitteln bis in die zweite Hälfte von 2026
- F&E-Ausgaben: 9,3 Millionen Dollar (im Vergleich zu 6,5 Millionen Dollar im 4. Quartal 2023)
- Nettoverlust: 11,4 Millionen Dollar (im Vergleich zu 7,8 Millionen Dollar im 4. Quartal 2023)
- Positive Phase 2a RIVER trial results with 57% cough reduction
- Successful completion of $50 million offering strengthening cash position
- Strong cash position of $107.6M with runway into H2 2026
- Positive Human Abuse Potential study results supporting unscheduled status
- Increased net loss to $47.9M in 2024 from $29.1M in 2023
- Higher R&D expenses at $39.4M vs $23.7M previous year
- Declining interest income due to lower cash balances
Insights
Trevi Therapeutics' latest results demonstrate significant clinical progress alongside a solid financial foundation. The company reported multiple positive clinical milestones for Haduvio, their lead candidate for chronic cough conditions. Most notably, the Phase 2a RIVER trial met its primary endpoint with a statistically significant
Financially, Trevi closed 2024 with
The completed enrollment in their Phase 2b CORAL trial for IPF patients with chronic cough positions Trevi for another potential catalyst, with topline data expected in Q2 2025. The positive sample size re-estimation outcome validates their trial design and increases confidence in the upcoming results.
For a clinical-stage biotech, these developments represent important de-risking events. The company is systematically building evidence that Haduvio could address significant unmet needs across multiple chronic cough conditions with no currently approved therapies in the US. The validation across multiple trials suggests their unique central and peripheral mechanism approach may prove commercially viable across several indications.
Trevi's clinical results represent meaningful differentiation in the challenging respiratory therapeutic landscape. The Phase 2a RIVER trial results are particularly noteworthy as Haduvio demonstrated a
The mechanism of action is key to understanding Haduvio's potential advantage. As an oral nalbuphine ER formulation, it works through both central and peripheral pathways relevant to cough suppression. This dual-mechanism approach potentially explains its cross-condition efficacy and could position it as a versatile therapeutic option.
The positive Human Abuse Potential study results further strengthen Haduvio's clinical profile, supporting its unscheduled status – a significant advantage for a chronic use medication targeting conditions requiring ongoing management. The consistency between primary and secondary endpoints in this study suggests the drug maintains its therapeutic benefit without concerning abuse potential.
With the Phase 2b CORAL trial now fully enrolled and results expected in Q2 2025, Trevi has positioned itself at a important inflection point. A positive outcome would establish a consistent pattern of efficacy across multiple cough-related conditions and potentially accelerate Haduvio's path to becoming a first-in-class therapy for chronic cough in IPF, addressing a significant unmet medical need where no approved therapies currently exist in the US market.
Announced positive topline data from the Phase 2a RIVER trial in patients with refractory chronic cough (RCC), making Haduvio the first therapy in clinical development to show benefit in patients with chronic cough in idiopathic pulmonary fibrosis (IPF) and RCC
Completed enrollment in the Phase 2b CORAL trial in IPF patients with chronic cough in February 2025, with topline data expected in the second quarter of 2025
Announced positive outcome from sample size re-estimation in the Phase 2b CORAL trial, resulting in no change to study sample size
Ended 2024 with
Management to host a conference call and webcast today at 4:30 p.m. ET
"Trevi had three positive and meaningful clinical data read-outs over the past few months validating the strategy of developing Haduvio as a potential best-in-class therapy for chronic cough conditions," said Jennifer Good, President and CEO of Trevi Therapeutics. "With Haduvio, we are looking to address a significant unmet need across chronic cough conditions where there are no therapies approved in the
Fourth Quarter and Recent Business Highlights
- Positive topline data in the Phase 2a RIVER trial for the treatment of patients with RCC (N=66) in March 2025. Haduvio met the primary endpoint with a statistically-significant reduction (p<0.0001) in 24-hour cough frequency with a
57% placebo-adjusted change from baseline and showed similar effects in patients with moderate or severe cough counts. The Company plans to discuss next steps and future study design with the FDA. - Positive sample size re-estimation (SSRE) outcome for the Phase 2b CORAL trial for the treatment of chronic cough in patients with IPF in December 2024. The SSRE reaffirmed the conditional power assumptions and the original sample size (N=160). The trial completed enrollment in February 2025 and topline data is expected in the second quarter of 2025.
- Positive topline results from the Human Abuse Potential study of oral nalbuphine in December 2024. Oral nalbuphine had a statistically significant lower "Drug Liking" for the clinical dose range vs. the active comparator as well as secondary endpoint results that were consistent with the primary endpoint supporting the known profile of nalbuphine and its currently unscheduled status.
- Completed a
underwritten offering in December 2024 to support the continued development of Haduvio.$50 million - Ended 2024 with
in cash, cash equivalents and marketable securities, with expected cash runway into the second half of 2026.$107.6 million
Fourth Quarter 2024 Financial Highlights
Research and development (R&D) expenses: R&D expenses for the fourth quarter of 2024 increased to
General and administrative (G&A) expenses: G&A expenses for the fourth quarter of 2024 increased to
Other income, net: Other income, net was
Net loss: For the fourth quarter of 2024, the Company reported a net loss of
Full Year 2024 Financial Highlights
R&D expenses: R&D expenses for the year ended December 31, 2024, were
G&A expenses: G&A expenses for the year ended December 31, 2024, were
Other income, net: Other income, net was
Net loss: For the year ended December 31, 2024, the Company reported a net loss of
Conference Call/Webcast
To participate in the live conference call by phone, please dial (877) 870 4263 (domestic) or (412) 317 0790 (international) and ask to join the Trevi Therapeutics call. No code is necessary for access. A live audio webcast will be accessible from the 'Investors & News' section on the Company's website at www.TreviTherapeutics.com. 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:
- April 7-10: 24th Annual Needham Virtual Healthcare Conference
- April 8-10: Jones 2025 Healthcare & Technology Summit
- April 16-17: Piper Sandler Spring Biopharma Symposium
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) and refractory chronic cough (RCC). Haduvio is the first and only therapy in clinical development to show a statistically significant reduction in chronic cough across patients with both IPF and RCC. Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA), which are opioid receptors that play a key role in controlling cough hypersensitivity. Nalbuphine is not currently scheduled by the
Chronic cough is a highly prevalent condition in IPF patients, impacting up to
Refractory chronic cough has no approved therapies in the
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, 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, expectations regarding Trevi's uses and sufficiency of capital, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: 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
Trevi Therapeutics, Inc. Selected Balance Sheet Data (unaudited) (amounts in thousands) | ||||||||
December 31, | December 31, | |||||||
Cash and cash equivalents | $ | 34,097 | $ | 32,397 | ||||
Marketable securities | 73,525 | 50,574 | ||||||
Working capital | 98,919 | 81,723 | ||||||
Total assets | 110,900 | 89,403 | ||||||
Stockholders' equity | 99,644 | 82,547 |
Trevi Therapeutics, Inc. Selected Statement of Operations Data (unaudited) (amounts in thousands, except per share amounts) | ||||||||||||||||
Three Months Ended | Year Ended | |||||||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 9,327 | $ | 6,519 | $ | 39,377 | $ | 23,683 | ||||||||
General and administrative | 2,916 | 2,415 | 12,147 | 10,240 | ||||||||||||
Total operating expenses | 12,243 | 8,934 | 51,524 | 33,923 | ||||||||||||
Loss from operations | (12,243) | (8,934) | (51,524) | (33,923) | ||||||||||||
Other income, net | 844 | 1,130 | 3,583 | 4,826 | ||||||||||||
Loss before income taxes | (11,399) | (7,804) | (47,941) | (29,097) | ||||||||||||
Income tax (provision) benefit | (17) | (18) | 30 | 32 | ||||||||||||
Net loss | $ | (11,416) | $ | (7,822) | $ | (47,911) | $ | (29,065) | ||||||||
Basic and diluted net loss per common | $ | (0.11) | $ | (0.08) | $ | (0.47) | $ | (0.29) | ||||||||
Weighted average common shares | 106,009,686 | 99,485,873 | 101,971,873 | 99,033,373 |
Investor Contact
Jonathan Carlson
Trevi Therapeutics, Inc.
(203) 654 3286
carlsonj@trevitherapeutics.com
Media Contact
Rosalia Scampoli
914-815-1465
rscampoli@marketcompr.com
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SOURCE Trevi Therapeutics, Inc.