Trevi Therapeutics(TRVI)
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Trevi Therapeutics(TRVI) - 2022 Q2 - Quarterly Report
2022-08-11 20:35
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38886 TREVI THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 45-0834299 ( State or other jurisdi ...
Trevi Therapeutics(TRVI) - 2022 Q1 - Earnings Call Transcript
2022-05-14 06:40
Financial Data and Key Metrics Changes - For Q1 2022, the company reported a net loss of $7.3 million, an improvement from a net loss of $8.4 million in Q1 2021 [22] - R&D expenses decreased to $4.6 million in Q1 2022 from $5.6 million in the same period of 2021, primarily due to reduced clinical trial subject recruitment costs [22] - G&A expenses were $2.4 million in Q1 2022, slightly down from $2.5 million in Q1 2021, mainly due to lower legal fees [23] - The company raised $55 million through the sale of common stock and prefunded warrants, increasing cash and investments to over $80 million, providing a cash runway into Q1 2024 [18][19] Business Line Data and Key Metrics Changes - The most advanced program is in severe chronic pruritus in prurigo nodularis (PN), with the PRISM trial reaching important milestones, including the last patient completing their final visit [11] - The other clinical program focuses on chronic cough in idiopathic pulmonary fibrosis (IPF), with a positive interim analysis showing a 77% reduction in daytime cough frequency [12][14] Market Data and Key Metrics Changes - The global chronic cough market is estimated to be approximately $10 billion [15] - The company anticipates conducting a second Phase 3 trial in PN, estimating costs between $20 million to $30 million [35] Company Strategy and Development Direction - The company aims to target debilitating aspects of diseases with potential for disease modification over time [7] - The strategy includes exploring how relief from significant disease symptoms may improve the underlying disease itself [8] - The company is preparing for potential expansion into other indications beyond the current focus on pruritus and cough [54] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about upcoming data readouts and the potential for growth based on Haduvio's mechanism [16] - The company is focused on ensuring successful execution of ongoing trials while preparing for future opportunities [54] Other Important Information - The company has approximately 15 million warrants outstanding, which could provide up to $20 million if exercised [20] Q&A Session Summary Question: Expectations for the PRISM trial readout - Management expects to provide top-line results along with some secondary endpoints and safety overview in June [29] Question: Cost and timeline for a second Phase 3 trial in PN - Estimated cost for the second trial is between $20 million to $30 million, with a timeline of about two years for completion [35] Question: Size and management of the chronic cough trial in IPF - The next study is estimated to involve about 300 patients, with an enrollment period of 18 to 24 months [39] Question: Disease modification assessment for chronic cough - Management plans to measure hospitalization rates and respiratory function changes, alongside cough counts [46] Question: Potential for monetizing ex-U.S. opportunities - The company is in discussions with partners for potential monetization strategies in international markets [47]
Trevi Therapeutics(TRVI) - 2022 Q1 - Quarterly Report
2022-05-12 20:34
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38886 TREVI THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 45-0834299 ( State or other jurisd ...
Trevi Therapeutics (TRVI) Investor Presentation - Slideshow
2022-03-31 18:41
Corporate Presentation March 2022 Forward Looking Statement Disclaimer Statements contained in this presentation and oral statements made regarding the subject of this presentation 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 state ...
Trevi Therapeutics(TRVI) - 2021 Q4 - Earnings Call Transcript
2022-03-17 23:31
Financial Data and Key Metrics Changes - In Q4 2021, the company reported a net loss of $8.5 million, an improvement from a net loss of $9.5 million in Q4 2020 [21] - The company raised $14.8 million in financing during the fourth quarter, ending the year with a cash balance of $36.8 million [21] Business Line Data and Key Metrics Changes - The CANAL trial in chronic cough and idiopathic pulmonary fibrosis (IPF) showed a statistically significant reduction in cough, allowing the trial to be stopped early [7] - The PRISM trial for severe chronic pruritus and prurigo nodularis (PN) completed enrollment as of January 31, 2022, with top-line data expected in Q2 2022 [8] Market Data and Key Metrics Changes - The global prevalence of PN is estimated at approximately 730,000 patients, with 300,000 in the U.S. and 430,000 in the rest of the world [9] - The global chronic cough market is estimated to be approximately $10 billion [14] Company Strategy and Development Direction - The company aims to focus on advancing its lead programs in chronic cough and PN, with plans for indication expansion in both areas [16] - The company is considering both refractory chronic cough and other interstitial lung disease cough as it moves forward [27] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of Haduvio in treating chronic cough and PN, highlighting the lack of approved therapies in these indications [8][15] - The company plans to engage with regulatory authorities and initiate discussions with interstitial lung disease centers in the U.S. [30] Other Important Information - The company will host a call on March 30, 2022, to review interim results and provide additional analyses [17] - Management emphasized the importance of mindful cash runway planning for future clinical trials [33] Q&A Session Summary Question: What is the expected development path for the CANAL program? - Management indicated that they believe their mechanism could work broadly in cough and are planning to engage with the FDA for next steps [26][30] Question: How will the company fund future programs given the cash balance? - Management acknowledged the need to raise funds for the next clinical trial and will consider the cost of programs and unmet needs in their planning [32][33] Question: Did the CANAL trial use the same dose and titration protocol as the PRISM study? - The dosing protocol was slightly altered in the CANAL study to gather dose data, but the final dosage remained consistent [41][42] Question: When can the market expect the PRISM trial readout? - The readout for the PRISM trial is anticipated at the end of Q2 2022 [44] Question: What are the implications of Haduvio being used prior to biologics? - Management noted that Haduvio could serve as a step-through therapy, potentially being more cost-effective and easier for patients compared to biologics [49] Question: What is the company's strategy regarding partnerships? - The company is focusing on geographic partnerships, particularly in Asia and Europe, to advance its marketing efforts [50]
Trevi Therapeutics(TRVI) - 2021 Q4 - Annual Report
2022-03-17 20:28
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-38886 TREVI THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) | Delaware | 45-0834299 | | --- | --- | | ( Sta ...
Trevi Therapeutics(TRVI) - 2021 Q4 - Earnings Call Presentation
2022-03-17 14:33
Corporate Presentation March 2022 Forward Looking Statement Disclaimer Statements contained in this presentation and oral statements made regarding the subject of this presentation 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 state ...
Trevi Therapeutics(TRVI) - 2021 Q3 - Earnings Call Transcript
2021-11-11 03:10
Trevi Therapeutics, Inc. (NASDAQ:TRVI) Q3 2021 Earnings Conference Call November 10, 2021 4:30 PM ET Company Participants Jennifer Good - President and CEO Bill Forbes - Chief Development Officer Lisa Delfini - CFO Conference Call Participants Nick Rubino - Stifel Rohit Bhasin - Needham & Company Operator Good afternoon, and welcome to the Trevi Therapeutics Third Quarter 2021 Earnings Conference Call. At this time, all participants will be in listen-only mode. [Operator Instructions] Please note this event ...
Trevi Therapeutics(TRVI) - 2021 Q3 - Quarterly Report
2021-11-10 21:09
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38886 TREVI THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 45-0834299 ( State or other ju ...
Trevi Therapeutics(TRVI) - 2021 Q2 - Earnings Call Transcript
2021-08-13 02:11
Trevi Therapeutics, Inc. (NASDAQ:TRVI) Q2 2021 Earnings Conference Call August 12, 2021 4:30 PM ET Company Participants Jennifer Good - President and Chief Executive Officer Bill Forbes - Chief Development Officer Conference Call Participants Serge Belanger - Needham & Company Operator Good afternoon and welcome to the Trevi Therapeutics Q2 2021 Earnings Conference Call. At this time, all participants will be in listen-only mode. [Operator Instructions] After today's presentation, there will be an opportuni ...