Financial Data and Key Metrics Changes - Cash and cash equivalents and short-term investments totaled $59.2 million as of March 31, 2025 [18] - Research and development expenses increased to $7.2 million for the three months ended March 31, 2025, compared to $1.9 million for the same period in 2024 [19] - General and administrative expenses rose to $4.6 million for the three months ended March 31, 2025, compared to $4.2 million for the same period in 2024 [19] - The net loss for the three months ended March 31, 2025, was $11.1 million, with non-cash share-based compensation expense of $2.2 million [20] Business Line Data and Key Metrics Changes - The company completed enrollment in its Phase IIa CBEYOND trial ahead of schedule and amended the study to extend to 52 weeks [5][6] - Compelling new preclinical data was generated that validates the potential of nirmasumab as a weight loss therapy [6][7] - The Data Safety Monitoring Committee completed three reviews with no safety concerns reported [8] Market Data and Key Metrics Changes - The evolving policy environment presents regulatory uncertainties, particularly regarding drug pricing policy [9] - The company believes its exposure to these regulatory changes is limited in the near term as it prioritizes clinical development milestones [9] Company Strategy and Development Direction - The company aims to address the chronic nature of obesity with sustainable long-term solutions through its differentiated approach to weight loss therapies [10] - The management team emphasizes the importance of clear differentiation from small molecule inhibitors and the potential for nirmasumab to provide durable weight loss with fewer safety concerns [6][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential for nirmasumab to deliver significant weight loss [10] - The company is closely monitoring regulatory developments and has preserved flexibility in its supply chain and capital deployment planning [9][22] Other Important Information - The company anticipates that its current capital will fund operations and key clinical milestones through at least Q1 2027 [19] - The final drug substance is manufactured in Germany, with no expected impact from tariffs on raw materials or excipients [20][21] Q&A Session Summary Question: What can we expect to see at ADA and ECO? - Management deferred to the CSO for details on the presentations at ADA and ECO, highlighting the importance of differentiating their mechanism from small molecules [25][27] Question: How do you view the difference between nirmasumab and monlunabant? - Management believes investors are beginning to grasp the differences, emphasizing the additive effects of nirmasumab in combination with tirzepatide [26][28] Question: What is the incremental benefit of extending the CBION study to 52 weeks? - The extension allows for broader efficacy and safety data collection, which will inform the Phase IIb study [66][68] Question: What are the expectations for separation from placebo in monotherapy? - The primary endpoint is targeting an 8% separation from placebo at 26 weeks [60] Question: How are you managing discontinuations in the combination arm? - The company has minimized gaps in treatment to avoid extended periods off semaglutide, ensuring patients remain on effective doses [100] Question: What are the plans for regulatory interactions? - The company has submitted a protocol amendment to the FDA and expects to resolve minor clarifications without needing a formal meeting [93][94]