Financial Data and Key Metrics Changes - The company ended Q1 2025 with $150 million in cash, cash equivalents, and short-term investments, an increase from $132 million at the end of 2024 [22] - R&D expenses were $15.8 million for Q1 2025, down from $21.5 million in the same period of 2024 [22] - The net loss for Q1 2025 was $19.6 million, or $0.26 per share, compared to a net loss of $24.4 million, or $0.34 per share, for Q1 2024 [23] Business Line Data and Key Metrics Changes - The company is focused on the development of pemidutide, with significant R&D investments directed towards its clinical trials [8][22] - The IMPACT Phase 2b MATCH trial has enrolled 212 participants, enhancing the study's power compared to the original target [12] Market Data and Key Metrics Changes - The company is expanding into alcohol use disorder (AUD) and alcohol liver disease (ALD), both of which have significant unmet medical needs [8][10] - The market research indicates that a drug like pemidutide, which reduces alcohol consumption and liver inflammation, would be well-received by patients and physicians [17] Company Strategy and Development Direction - The company aims to establish pemidutide as a foundational treatment across multiple fibrotic liver diseases, including NASH, AUD, and ALD [10][18] - The upcoming readout of the IMPACT Phase 2b MATCH trial is expected to be a transformative event for the company, with plans for Phase III trials in NASH following successful results [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the trial's key efficacy and safety objectives for pemidutide, which could become the first therapy to achieve statistical significance on NASH endpoints at 24 weeks [7][13] - The company anticipates 2025 to be a transformative year, with significant milestones expected in clinical development [24] Other Important Information - The company has entered into a credit facility with Hercules Capital for up to $100 million, providing flexibility to support the development of pemidutide [8][20] - The facility includes a $15 million upfront funding and additional tranches available based on milestones [21] Q&A Session Summary Question: Can you provide commentary on the distribution of F2 and F3 in the Phase 2b population? - Management indicated that the demographics of the final qualifying population will be similar to other studies, but precise numbers cannot be disclosed yet [28] Question: What is the ideal population for pemidutide post-IMPACT? - The focus is on treating NASH with obesity, as a significant percentage of NASH patients are obese, which is a key factor in the treatment strategy [30] Question: How are you handling study discontinuations? - Management reported satisfaction with the discontinuation rates and stated that data will be available at the time of the readout [38] Question: How important is weight loss in the study? - Weight loss is crucial, as it impacts the treatment of NASH patients, and the company aims to achieve clinically significant weight loss [41] Question: Will you consider taking a higher dose into Phase III? - The company is strongly considering the 2.4 mg dose for Phase III due to its expected better weight loss outcomes [49] Question: What is the expected range of placebo responses? - The company anticipates a placebo response range of 7% to 13% based on historical data and the trial's design [90] Question: Will you discuss NASH F4 cirrhosis with the FDA? - The company intends to discuss F4 with the FDA and believes it can be successful in this area [80]