Apogee Therapeutics Updates on Pipeline and Q1 2024 Financials

Apogee Therapeutics, Inc., a clinical-stage biotechnology company based in San Francisco and Waltham, Massachusetts, has provided an update on its pipeline progress and financial outcomes for the first quarter of 2024. The focus of Apogee is on developing advanced biologics aimed at treating various inflammatory and immunology-related conditions, including atopic dermatitis (AD), chronic obstructive pulmonary disease (COPD), and asthma.

APG777, one of Apogee’s leading programs, is a subcutaneous half-life extended monoclonal antibody targeting IL-13, a crucial cytokine involved in inflammation and a central factor in AD. The company has initiated a Phase 2 clinical trial for APG777 in patients with moderate-to-severe AD, with 16-week proof-of-concept data anticipated in the second half of 2025. This trial merges the typical Phase 2a and 2b stages into one protocol, focusing on the primary endpoint of mean percentage changes in EASI score from baseline to Week 16. APG777 is also set to enter a Phase 2 trial for asthma in 2025.

Another significant program, APG808, is a monoclonal antibody targeting IL-4Rα, a target with clinical validation across multiple Type 2 allergic diseases. The first healthy volunteer has been dosed in a Phase 1 clinical trial for APG808, with initial data expected in the second half of 2024. Following this, a Phase 1b trial for asthma will commence, with data expected in the first half of 2025 and a subsequent COPD trial planned for the same year.

Apogee has also nominated a development candidate for APG990, a monoclonal antibody targeting OX40L, which is positioned upstream in the inflammatory pathway compared to IL-13 and IL-4Rα. This program is initially focused on AD. With its potential to inhibit both Type 1 and Type 2 inflammation, APG990 could represent a broader therapeutic option for patients who do not respond to current treatments. The Phase 1 trial for APG990 in healthy volunteers is expected to start in the second half of 2024.

Financially, Apogee has successfully raised $483 million through an upsized public offering in March 2024, providing significant capital to support its operations into 2028. As of March 31, 2024, the company reported $816.2 million in cash, cash equivalents, and marketable securities. Research and development expenses for the first quarter of 2024 increased to $28.7 million, reflecting the progression of the APG777 and APG808 programs into clinical trials and the expansion of the R&D team. General and administrative expenses also rose to $9.5 million, mainly due to increased personnel costs and the financial requirements of being a public company. The net loss for the quarter was $32.1 million, up from $12.5 million in the same period the previous year.

Apogee Therapeutics continues to advance its pipeline with a focus on delivering innovative treatments for patients with high unmet needs in the inflammatory and immunology space. The company leverages advanced antibody engineering to optimize the properties of its biologic candidates, aiming to overcome the limitations of existing therapies and provide significant clinical benefits.