Financial Data and Key Metrics Changes - Research and development expenses for Q1 2025 totaled $7.5 million, up from $4.1 million in Q1 2024, primarily due to higher clinical trial and manufacturing costs for socolitinib [4][5] - Net income for Q1 2025 was $15.2 million, including a non-cash loss of $0.5 million related to Angel Pharmaceuticals, compared to a net loss of $5.7 million in Q1 2024 [5] - Total stock compensation expense increased to $1.3 million in Q1 2025 from $0.7 million in Q1 2024 [5] - As of March 31, 2025, cash, cash equivalents, and marketable securities totaled $44.2 million, down from $52 million at the end of 2024 [5][6] Business Line Data and Key Metrics Changes - The socolitinib Phase I trial showed encouraging results, with all treatment cohorts demonstrating a favorable safety and efficacy profile compared to placebo [9][25] - Cohort three patients had a mean baseline EASI score of 27-28, significantly higher than cohorts one and two, which ranged from 17-20, indicating worse disease at baseline for cohort three [14] Market Data and Key Metrics Changes - The Phase I trial included 48 patients, with 16 subjects in each of the first three cohorts, and the study is double-blind [10] - The trial endpoints include safety and efficacy measured by EASI and IGA scores, with cohort three showing earlier and deeper responses compared to cohorts one and two [12][25] Company Strategy and Development Direction - The company plans to amend the Phase I trial protocol to include an extension cohort evaluating an additional 24 patients at a 200 mg twice per day dose for eight weeks [23] - The company is on track to initiate a Phase II trial for socolitinib before the end of the year, which will likely evaluate different doses and durations of therapy [24][27] - The company aims to advance socolitinib on multiple fronts, including key data from the next 24 patients in the atopic dermatitis trial expected in Q4 2025 [28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the results from the trial, highlighting a favorable safety and efficacy profile for socolitinib [25] - The company is not dependent on any partners for development and plans to push forward with its clinical programs independently [84] Other Important Information - The company recorded a non-cash gain of $25.1 million from the change in fair value of warrants during Q1 2025 [5] - The early exercise of warrants resulted in approximately $31.3 million in cash proceeds, enabling the company to fund operations into late 2026 [6][28] Q&A Session Summary Question: Will socolitinib compete with Dupixent and JAK inhibitors? - Management believes socolitinib's data is competitive with other agents approved for atopic dermatitis and sees potential for it to be used as an early line of systemic therapy [32] Question: What is the expected plateau for efficacy? - Management noted that the efficacy curves are still decreasing, suggesting that continued therapy could yield deeper responses [35] Question: What explains the efficacy difference between cohorts two and three? - The higher efficacy in cohort three is attributed to the doubled dose of the drug compared to cohorts one and two [39] Question: What is the design of the extended duration cohort? - The extended duration cohort will study 24 patients at a 200 mg BID dosing regimen [45] Question: Will the company seek partnerships before Phase II? - The company plans to advance its programs independently and is not dependent on partnerships for development [84] Question: What are the thoughts on potential combinations with other therapies? - Management sees opportunities for combinations due to the non-overlapping mechanism of socolitinib with other drugs, but will focus on monotherapy for now [92]