Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio (oral nalbuphine ER) for the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced financial results for the quarter ended March 31, 2024, as well as provided business updates.
"I am pleased with the progress across all our clinical trials, which continue to remain on track with our guidance," said Jennifer Good, President and CEO of Trevi Therapeutics. "During the quarter, we continued site activations and recruitment across our clinical trials and, with the clearance of our IND, we are moving towards initiating our planned respiratory physiology trial. We look forward to reporting data from our ongoing trials beginning in the second half of this year. The chronic cough markets in both IPF and refractory chronic cough are significant and currently have no approved therapies in the U.S. We believe our differentiated central and peripheral mechanism of action has the potential to offer an important therapy for these patients."
Key Business Updates
- Phase 2a RIVER trial for the treatment of RCC, in which we expect to enroll approximately 60 patients, now has all sites activated and enrollment is progressing. In line with our current guidance, we expect topline data in the second half of 2024.
- Phase 2b CORAL trial for the treatment of chronic cough in IPF, in which we expect to enroll approximately 160 patients, continues enrollment, and we expect the sample size re-estimation to occur in the second half of 2024 when 50% of the patients are evaluable for the primary endpoint. Assuming no adjustments are made to the sample size, topline results are expected in the first half of 2025.
- Other supportive studies:
- The second part of the human abuse potential (HAP) study, in which we expect to enroll approximately 56 patients, is 75% enrolled and we continue to expect topline data in the second half of 2024.
- With the clearance of our IND, we expect to initiate our planned Phase 1b respiratory physiology study in the United States in the third quarter of 2024. This trial is designed to assist us in defining the IPF population for a pivotal program.
- The Company ended the first quarter of 2024 with $72.8 million in cash, cash equivalents and marketable securities with expected cash runway into 2026.
First Quarter 2024 Financial Highlights
Research and development (R&D) expenses: R&D expenses for the first quarter of 2024 increased to $8.8 million from $5.0 million in the same period in 2023, primarily due to increased clinical development expenses for our Phase 2b CORAL trial, our Phase 2a RIVER trial and our HAP trial. These increases were partially offset by decreased clinical development expenses for our Phase 2b /3 PRISM.
General and administrative (G&A) expenses: G&A expenses were $3.1 million in the first quarter of 2024 compared to $2.6 million in the same period in 2023, primarily due to increases in information technology and finance staffing and activities as well as professional fees.
Other income, net: Other income, net was $1.0 million in the first quarter of 2024 compared to $1.2 million in the same period in 2023.
Net loss: For the first quarter of 2024, the Company reported a net loss of $10.9 million, compared to a net loss of $6.4 million in the same period in 2023.
Conference Call/Webcast
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:
- May 13-14: The Citizens JMP Life Sciences Conference
- May 17-22: ATS 2024 International Conference
- May 20: Life Science Education Series: Chronic Cough - KOL Panel Discussion
- June 3-6: 2024 BIO International Convention
- June 26-28: Oppenheimer's 2024 Montauk Life Sciences Summit
About Trevi Therapeutics, Inc.
www.TreviTherapeutics.com and follow Trevi on X (formerly Twitter) and LinkedIn.
Forward-Looking Statements
Trevi Therapeutics, Inc. Selected Balance Sheet Data (unaudited) (amounts in thousands) | ||||||||
March 31, | December 31, | |||||||
Cash and cash equivalents | $ | 13,811 | $ | 32,397 | ||||
Marketable securities | 59,009 | 50,574 | ||||||
Working capital | 71,490 | 81,723 | ||||||
Total assets | 78,559 | 89,403 | ||||||
Stockholders' equity | 72,334 | 82,547 | ||||||
Trevi Therapeutics, Inc. Selected Statement of Operations Data (unaudited) (amounts in thousands, except per share amounts) | ||||||||
Three Months Ended | ||||||||
2024 | 2023 | |||||||
Operating expenses: | ||||||||
Research and development | $ | 8,804 | $ | 5,000 | ||||
General and administrative | 3,102 | 2,563 | ||||||
Total operating expenses | 11,906 | 7,563 | ||||||
Loss from operations | (11,906) | (7,563) | ||||||
Other income, net | 996 | 1,155 | ||||||
Loss before income taxes | (10,910) | (6,408) | ||||||
Income tax benefit | 8 | 7 | ||||||
Net loss | $ | (10,902) | $ | (6,401) | ||||
Basic and diluted net loss per common share outstanding | $ | (0.11) | $ | (0.06) | ||||
Weighted average common shares used in net loss per share attributable | 99,517,212 | 98,610,671 | ||||||
Investor Contact
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Media Contact
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SOURCE Trevi Therapeutics, Inc.
