EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2025-05-13
Management highlights
Vipin Garg mentioned the upcoming readout of the IMPACT Phase 2b NASH trial expected this quarter, confident in achieving efficacy and safety objectives. The company entered a $100 million credit facility with Hercules Capital. Recent R&D day unveiled plans for Phase 2 trials in alcohol use disorder (AUD) and alcohol liver disease (ALD). Scott Harris discussed the IMPACT Phase 2b trial enrolling 212 participants, dual primary endpoints of MASH resolution or fibrosis improvement at 24 weeks, ongoing biopsy rereading, and progress on AUD and ALD Phase 2 trials. Greg Weaver discussed cash position, $35 million raised via ATM, $100 million credit facility, Q1 financial results with R&D expenses $15.8M, G&A $6M, net loss $19.6M.
Guidance
Expecting readout of IMPACT Phase 2b NASH trial this quarter. Plan to initiate Phase 3 trial in NASH and hold end-of-Phase 2 meeting with FDA in Q4 2025. Progressing towards Phase 2 trial initiations in AUD (Q2) and ALD (Q3) 2025.
Risks
Forward-looking statements subject to risks and uncertainties in filings with SEC. Potential differences between actual results and forward-looking statements.
Q&A highlights
Q: Yasmeen Rahimi asked about biopsy reread distribution, ideal MASH population, and partnering.
A: Scott and Vipin responded.
Q: Liisa Bayko asked about discontinuations, weight loss benchmarking, Phase 3 considerations.
A: Scott responded.
Q: Roger Song asked about trial endpoints, MASH resolution index.
A: Scott responded.
Q: Annabel Samimy asked about Phase 3 timelines, FDA interactions.
A: Scott and Vipin responded.
Q: Jasmine (for Eliana Merle) asked about FDA discussion on F4, cash runway.
A: Scott and Greg responded.
Q: Mayank Mamtani asked about placebo response, secondary endpoints.
A: Scott responded.
Q: Kathryn (for Jon Woolaben) asked about liver fat change speed, biomarkers.
A: Scott responded.
Q: Andy Hsieh asked about clinical site overlap.
A: Scott responded.
Key numbers
Reported versus consensus
Earnings calendar feed
| Metric | Reported | Consensus | Delta | Prior year |
|---|---|---|---|---|
| EPS | — | — | — | — |
| Revenue | — | — | — | — |
Transcript
May 13, 2025Full transcript unavailable for redistribution
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