Financial Data and Key Metrics Changes - The company ended 2024 with $75.1 million in cash, restricted cash, cash equivalents, and investments [31] - Research and development expenses were $54.4 million for the year, primarily for clinical trial costs and manufacturing [32] - General and administrative expenses totaled $13.8 million for the year [32] Business Line Data and Key Metrics Changes - Collaboration and license revenue related to the Kirin agreement was $200,000 for the year, with over $20 million received to date [31] - The company is eligible for up to $155 million in additional milestone payments from Kirin, primarily for regulatory and commercial milestones for sarcoidosis [31] Market Data and Key Metrics Changes - The company estimates a total global market opportunity for esofitimod in interstitial lung disease (ILD) at $2 billion to $5 billion, with sarcoidosis representing a significant portion of that range [20] - Recent claims analysis indicates that the number of patients diagnosed with lung involvement is 30% higher than previously estimated, with around 200,000 people affected in the U.S. [16][17] Company Strategy and Development Direction - The company aims to position esofitimod as a potential frontline steroid-reducing agent for patients with moderate to severe sarcoidosis, addressing 50% to 75% of all sarcoidosis patients [20] - The company is also exploring esofitimod for ILD related systemic sclerosis (scleroderma), with a Phase II study currently enrolling patients [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the favorable safety profile of esofitimod, bolstered by four positive Data and Safety Monitoring Board reviews [11] - The company anticipates significant market opportunities with little competition in the sarcoidosis space, supported by new claims data [34] Other Important Information - The company recently appointed Eric Benovich, a seasoned executive in launching high-value pharmaceuticals, to its Board of Directors [21] - A publication in the journal Science Translational Medicine validates the immune regulatory properties of esofitimod, enhancing its scientific rationale [28] Q&A Session Summary Question: Can you shed some light on how measuring the absolute change in steroid reduction impacts the trial? - Management explained that the new method simplifies data analysis and maintains over 90% powering for the trial [39][40] Question: What is the percent of patients in the trial rolling over into the expanded access program? - Management noted that interest in the expanded access program is robust, but specific numbers are difficult to provide due to varying regulatory requirements across countries [42][44] Question: What should investors look for in the baseline demographics from the study? - Management highlighted the importance of average prednisone dose and background immunomodulator use as key metrics to monitor [55] Question: How should we think about the durability of the drug impact? - Management indicated that durability is crucial and will be assessed through time to relapse and clinical worsening as tertiary endpoints [62] Question: What is the current manufacturing readiness for potential commercialization? - Management confirmed that significant investments have been made to ensure commercial readiness and drug supply for patients [86][88]