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Apogee Therapeutics Provides Pipeline Progress and Reports Second Quarter 2025 Financial Results
Globenewswireยท 2025-08-11 11:00
Core Insights - Apogee Therapeutics reported positive results from the 16-week Phase 2 Part A APEX trial for APG777, an anti-IL-13 antibody, which met all primary and key secondary endpoints for moderate-to-severe atopic dermatitis [1][2][3] - The company is advancing its pipeline with ongoing trials, including a Phase 1b head-to-head study of APG279 against DUPIXENT, with results expected in the second half of 2026 [1][2][3] - Apogee has a strong cash position of $621.2 million, which is projected to support operations into Q1 2028 [1][6][8] Pipeline Progress - APG777 demonstrated a 71.0% reduction in the Eczema Area and Severity Index (EASI) from baseline compared to 33.8% for placebo (p < 0.001) in the APEX Part A trial [3][4] - The APEX Part A maintenance phase is testing dosing every 3- and 6-months, potentially allowing for 2-4 injections per year versus 26 for standard care [3][7] - The readout for APEX Part B has been accelerated to mid-2026 due to strong enrollment [1][2][3] Financial Performance - Research and development expenses increased to $55.7 million for Q2 2025, up from $33.2 million in Q2 2024, primarily due to the development of APG777 [6][8] - General and administrative expenses rose to $17.5 million in Q2 2025 from $10.9 million in Q2 2024, driven by increased personnel-related costs [6][8] - The net loss for Q2 2025 was $66.1 million, compared to a net loss of $33.8 million in Q2 2024, reflecting higher operating expenses [8][15]
Apogee Therapeutics (APGE) Earnings Call Presentation
2025-07-04 07:41
Pipeline and Clinical Development - Apogee plans to transform the standard-of-care for I&I diseases with novel antibodies and combination approaches [6] - APG777 Phase 2 Part A is fully enrolled, with a readout expected in mid-2025, potentially demonstrating best-in-class efficacy [8, 33] - APG279, a combination of APG777 and APG990, is expected to initiate a Phase 1b trial against DUPIXENT in 2025, with a readout expected in 2H 2026 [6, 19] - APG777+APG333 clinical planning is underway for asthma and COPD [19] - Apogee has 7 clinical trial readouts expected over the next 2 years [105] Financial Position - Apogee has $681 million in total cash, providing an expected runway into Q1 2028 [7, 105] Market Opportunity - The atopic dermatitis (AD) market is projected to be a future $50B+ market [7, 17, 25, 90] - Mature I&I markets have consistently achieved high biologics penetration, approximately 25-60% after 15-20 years [9] - In 2024, the worldwide market size for IBD was $24B, RA was $24B, PsO was $29B [10] APG777 Potential - APG777 has the potential for annual dosing due to its optimized PK profile and 77-day half-life [8, 30, 31] - APG777 Phase 2 induction exposures are designed to exceed EBGLYSS for potentially greater efficacy [35] - APG777 could substantially decrease annual injections for patients, potentially requiring only 2-4 injections compared to EBGLYSS (13-26) and DUPIXENT (26) [45, 46]