Apogee Therapeutics Provides Business Update, Pipeline Progress and Reports First Quarter 2025 Financial Results

Core Insights - Apogee Therapeutics is advancing its clinical pipeline with significant progress in trials for its lead product APG777, targeting atopic dermatitis and asthma, with key data readouts expected in 2025 and 2026 [1][2][8] Pipeline Progress - The Phase 2 APEX trial of APG777 for atopic dermatitis is actively enrolling, with interim 16-week data from Part A expected in mid-2025 and Part B ongoing [1][2][8] - The first patient has been dosed in a Phase 1b trial of APG777 for mild-to-moderate asthma, with results anticipated in the first half of 2026 [1][8] - APG279, a combination of APG777 and APG990, is set to initiate a Phase 1b head-to-head trial against DUPIXENT in 2025, with readout expected in the second half of 2026 [1][8] Clinical Results - Positive interim results from the Phase 1b trial of APG808 in asthma patients showed rapid and sustained suppression of FeNO, a biomarker for Type 2 inflammation, indicating its potential effectiveness [1][8] - APG990's Phase 1 interim results exceeded trial objectives, suggesting a potential for less frequent dosing of the combination therapy [2][8] Market Research Insights - Recent market research indicates strong interest in APG777, with 96% of patients on biologics likely to switch to it, and 80% of physicians likely to prescribe it to new patients [3][4][5] - The AD biologic market is experiencing rapid growth, with a 23% increase in total prescriptions year-to-date, positioning APG777 favorably to capture market share [4][6] Financial Position - As of March 31, 2025, the company reported cash, cash equivalents, and marketable securities totaling $681.4 million, sufficient to fund operations into Q1 2028 [1][8] - Research and development expenses for Q1 2025 were$46.4 million, up from $28.7 million in Q1 2024, reflecting the advancement of the clinical pipeline [8][12] Upcoming Milestones - The company plans to initiate a Phase 2 trial for eosinophilic esophagitis (EoE) in 2026 and continue its combination approach with APG333 targeting TSLP [8][10] - The first-in-class combination trial of APG279 against DUPIXENT is expected to begin this year, with interim results anticipated in the second half of 2026 [8][10]