Apogee Therapeutics Updates Pipeline and Reports Q2 2024 Financials

Apogee Therapeutics, Inc., a clinical-stage biotechnology company, recently shared updates on its pipeline and financial results for the second quarter of 2024. The company is focused on developing novel biologics aimed at treating inflammatory and immunology (I&I) diseases, such as atopic dermatitis (AD), asthma, and chronic obstructive pulmonary disease (COPD).

Michael Henderson, M.D., CEO of Apogee, highlighted significant progress in the first half of the year. He emphasized the company's strategic efforts to deliver treatments with the potential for best-in-class efficacy and improved dosing schedules. Key to this strategy is the combination of various pipeline programs, including the newly added APG333, which targets thymic stromal lymphopoietin (TSLP). TSLP is a critical cytokine in inflammation and has shown potential in treating a broader respiratory disease population, including COPD.

Apogee's pipeline consists of inhibitors targeting IL-13, IL-4Rα, OX40L, and TSLP. These programs offer multiple combination possibilities in dermatology and respiratory diseases, aiming for deeper and broader therapeutic responses. The company is on track with its expected milestones and has a robust cash position to sustain operations into 2028.

Key pipeline developments include:

1. APG777 Phase 2 Trial: APG777 is a novel subcutaneous (SQ) extended half-life monoclonal antibody (mAb) targeting IL-13, a principal driver of AD. The Phase 2 clinical trial commenced dosing in May, and 16-week proof-of-concept data is expected in the second half of 2025. The trial combines typical Phase 2a and 2b portions into a single protocol.

2. APG990 Phase 1 Trial: APG990 is a novel SQ mAb targeting OX40L, developed initially for AD. This antibody could offer broader impact on the inflammatory cascade by inhibiting Type 1, Type 2, and Type 3 pathways. The Phase 1 clinical trial in healthy volunteers (HVs) is set to start in the third quarter of 2024, with interim data expected in 2025.

3. APG808 Phase 1 Trial: APG808 targets IL-4Rα, a validated target across eight Type 2 allergic diseases. Interim data from the Phase 1 HV clinical trial is expected in the fourth quarter of 2024. Pending these results, a Phase 1b clinical trial in asthma is planned, with data expected in the first half of 2025.

4. APG333: This SQ extended half-life mAb targets TSLP, an epithelial cell-derived cytokine involved in Type 2 and Type 3 inflammation. Apogee plans to nominate a development candidate by the end of 2024 and initiate a Phase 1 clinical trial in HVs in 2025. The company also plans to explore combining APG333 with APG777 for potentially greater efficacy in respiratory indications.

5. Combination Approaches: Apogee is developing a combination of APG777 and APG990, aiming for improved clinical responses over monotherapies. This coformulation targets both IL-13 and OX40L, offering potential best-in-class dosing. The first clinical trial of this combination is planned for 2025.

Financially, Apogee reported a cash position of $789.6 million as of June 30, 2024, sufficient to fund operations into 2028. Second-quarter R&D expenses were $33.2 million, primarily due to advancements in the company's programs and clinical trials. General and Administrative (G&A) expenses rose to $10.9 million, reflecting the growth of the company and costs associated with being a public entity. The net loss for the second quarter was $33.8 million.

Apogee also expanded its board of directors, welcoming Dr. Lisa Bollinger, an expert with over 30 years of drug development experience. Dr. Bollinger's regulatory expertise will be invaluable as the company continues to advance its pipeline.

Looking ahead, Apogee plans to hold a Virtual R&D Day in December 2024 to discuss its progress and future plans in detail. The company aims to reshape the standard of care in I&I by developing treatments with best-in-class efficacy and improved dosing schedules.

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