Trevi Therapeutics Reports Fourth Quarter and Year End 2023 Financial Results and Provides Business Updates
Reaffirms guidance for the Phase 2a RIVER trial of Haduvio in RCC patients with topline data expected in the second half of 2024
Enrollment progressing in the Phase 2b CORAL dose-ranging trial of Haduvio for the treatment of chronic cough in IPF patients
Human Abuse Potential Study more than 50% enrolled
Management to host a conference call and webcast today at 4:30 p.m. ET
"I am proud of the progress Trevi has made in 2023, with the initiation of clinical trials in the fourth quarter for RCC, chronic cough in IPF, and the final part of the Human Abuse Potential (HAP) study," said
Key Business Updates
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Phase 2a RIVER trial
for the treatment of RCC, in which we expect to enroll approximately 60 patients, was initiated in the fourth quarter of 2023. Enrollment continues across multiple sites with the majority of sites being activated in the first quarter of 2024. Topline data is expected in the second half of 2024. The RIVER trial will measure overall results, as well as results from the 1:1 stratification between patients with 10-19 coughs/hour (moderate 24-hour cough frequency) and those with ≥ 20 coughs/hour (high 24-hour cough frequency).
-
Phase 2b CORAL trial
for the treatment of chronic cough in IPF, in which we expect to enroll approximately 160 patients, was initiated in the fourth quarter of 2023. This trial is expected to be conducted at multiple sites in up to 11 countries. The SSRE is expected 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.
- The final part of the HAP study, in which we expect to enroll approximately 56 patients, initiated dosing and we continue to expect topline data in the second half of 2024. This study is over 50% enrolled.
- The Company ended 2023 with
$83.0 million in cash, cash equivalents and marketable securities with expected cash runway into 2026.
Fourth Quarter 2023 Financial Highlights
Research and development (R&D) expenses: R&D expenses for the fourth quarter of 2023 increased to
General and administrative (G&A) expenses: G&A expenses were
Other income, net: Other income, net was
Net loss: For the fourth quarter of 2023, the Company reported a net loss of
Full-Year 2023 Financial Highlights
R&D expenses: R&D expenses for the year ended
G&A expenses: G&A expenses for the year ended
Other income, net: Other income, net for the year ended
Net loss: For the year ended
Conference Call/Webcast
To participate in today's live conference call by phone, please dial (888) 317 6003 (domestic) or (412) 317 6061 (international) and provide access code 4401006. 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 8-11 : 23rd AnnualNeedham Virtual Healthcare Conference -
April 26-28 : 3rd European Pulmonary FibrosisPatient Summit 2024 –Barcelona, Spain
About
The impact of chronic cough is significant and often leads to a decline in patients' social, physical, and psychological quality of life. In IPF, chronic cough may lead to worsening disease and may be associated with a higher risk of progression, death, or need for lung transplant. There are no approved therapies for the treatment of chronic cough in IPF and current treatment options provide minimal relief to patients. RCC affects up to 10% of the adult population, and Haduvio's expansion into RCC has the potential to reach patients suffering from moderate to severe chronic cough. There are also no approved therapies for RCC in the US.
Parenteral nalbuphine is not scheduled by the
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, 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 ongoing and planned 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
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Selected Balance Sheet Data |
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(unaudited) |
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(amounts in thousands) |
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Cash and cash equivalents |
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$ |
32,397 |
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$ |
12,589 |
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Marketable securities |
|
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50,574 |
|
|
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107,921 |
|
Working capital |
|
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81,723 |
|
|
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109,216 |
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Total assets |
|
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89,403 |
|
|
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123,015 |
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Total debt |
|
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— |
|
|
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9,151 |
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Stockholders' equity |
|
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82,547 |
|
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107,459 |
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Selected Statement of Operations Data |
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(unaudited) |
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(amounts in thousands, except per share amounts) |
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Three Months Ended
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Year Ended
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2023 |
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2022 |
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2023 |
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2022 |
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Operating expenses: |
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Research and development |
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$ |
6,519 |
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$ |
4,317 |
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$ |
23,683 |
|
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$ |
19,834 |
|
General and administrative |
|
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2,415 |
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2,339 |
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10,240 |
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|
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10,073 |
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Total operating expenses |
|
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8,934 |
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6,656 |
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33,923 |
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29,907 |
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Loss from operations |
|
|
(8,934) |
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|
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(6,656) |
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|
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(33,923) |
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|
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(29,907) |
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Other income, net |
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1,130 |
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|
|
1,132 |
|
|
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4,826 |
|
|
|
719 |
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Loss before income taxes |
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(7,804) |
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|
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(5,524) |
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|
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(29,097) |
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|
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(29,188) |
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Income tax (provision) benefit |
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(18) |
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20 |
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32 |
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|
|
36 |
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Net loss |
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$ |
(7,822) |
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$ |
(5,504) |
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$ |
(29,065) |
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$ |
(29,152) |
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Basic and diluted net loss per common share |
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$ |
(0.08) |
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$ |
(0.06) |
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$ |
(0.29) |
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$ |
(0.45) |
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Weighted average common shares used in net |
|
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99,485,873 |
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98,132,668 |
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99,033,373 |
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64,541,911 |
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Investor Contact
203-304-2499
k.mcmanus@trevitherapeutics.com
Media Contact
914-815-1465
rscampoli@marketcompr.com
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