SAN FRANCISCO and BOSTON, November 10, 2025 — Leads & Copy — Apogee Therapeutics, Inc. (Nasdaq: APGE) has announced pipeline progress and reported its third quarter 2025 financial results. The clinical-stage biotechnology company is focused on developing optimized, novel biologics with potential for best-in-class profiles in the largest inflammatory and immunology (I&I) markets.
The company anticipates four clinical data readouts in 2026, with APG777 trial readout timelines accelerated. Phase 1b data in asthma and APEX 52-week Part A data in atopic dermatitis (AD) are expected in the first quarter of 2026. APEX 16-week Part B data in AD is anticipated in the second quarter of 2026, and APG279 Phase 1b head-to-head readout against DUPIXENT in AD in the second half of 2026.
Interim Phase 1 results of APG333 in healthy volunteers exceeded trial objectives, demonstrating a half-life of approximately 55 days. It also suppressed key biomarkers for six months following a single dose. This supports potential three- and six-month dosing and the development of a quarterly or less frequently dosed co-formulation of APG273 (APG777+APG333) for respiratory indications.
Apogee completed a $345 million public offering and reported $913 million in cash, cash equivalents, and marketable securities pro forma as of September 30, 2025, which supports operations into the second half of 2028.
According to Michael Henderson, M.D., Chief Executive Officer of Apogee, the company is preparing for a potentially transformative 2026 from a position of strength. He noted the four key readouts expected in 2026 and the recent financing, which provides runway through Phase 3 topline data for APG777 in atopic dermatitis. Henderson believes Apogee is well-positioned to advance its therapies to patients quickly.
In conjunction with the third-quarter results, Apogee shared first-in-human data for APG333, which, together with APG777, could be a best-in-class combination approach for respiratory indications. Dosing could potentially occur every three months or less frequently.
APG777 continues to advance, with Phase 1b data in asthma and AD data from APEX 52-week Part A anticipated in Q1 2026, and APEX 16-week Part B data in Q2 2026. APG777 is a novel, subcutaneous, extended half-life monoclonal antibody targeting IL-13, a critical cytokine in inflammation and a primary driver of AD.
At this year’s European Academy of Dermatology and Venereology (EADV) 2025 Congress, Apogee shared updated data in a late-breaking oral presentation, highlighting that participants treated with APG777 observed statistically significant improvement in itch within 48 hours and remained significant through Week 16. In July, APEX Part A met its primary endpoint, with APG777 demonstrating an EASI reduction from baseline of 71.0% compared to placebo at 33.8% (p < 0.001). APG777 was well-tolerated with a safety profile consistent with other agents in the class.
The Phase 1b trial of APG777 in patients with mild-to-moderate asthma is ongoing, with a readout expected in the first quarter of 2026. The trial evaluates safety and tolerability, PK, and FeNO suppression by APG777.
Apogee expects 52-week data from the maintenance phase of APEX Part A in the first quarter of 2026, aiming to demonstrate the maintenance of EASI-75 and/or IGA 0,1 responses at levels similar to or better than DUPIXENT but with quarterly or better dosing.
Part B of the APEX trial is designed to find the optimized dose of APG777, looking at low, medium (Part A dose), and high dose regimens vs placebo. The trial has enrolled rapidly and has now expanded enrollment to 320 patients, and the study is expected to finish enrolling by the end of 2026, enabling 16-week Part B data in the second quarter of 2026.
Pending results from Part A and Part B, Apogee plans to begin Phase 3 trials of APG777 in the second half of 2026.
The Phase 1b head-to-head study of APG279 (APG777+APG990) against DUPIXENT in AD continues to advance. APG279 is Apogee’s first combination treatment, combining APG990 and APG777. APG990 is a novel, SQ, extended half-life mAb targeting OX40L, and the combination with APG777 offers the potential for improved clinical responses over monotherapy across a variety of I&I diseases. Apogee’s first-in-class approach of co-formulating these two extended half-life mAbs offers the potential for best-in-class efficacy and dosing.
The interim readout from the head-to-head trial evaluating the safety, PK, pharmacodynamics, and efficacy of APG279 vs. DUPIXENT in AD is expected in the second half of 2026.
In October, Apogee completed an underwritten public equity offering, with aggregate gross proceeds of approximately $345.0 million (before deducting underwriting discounts, commissions, and other offering expenses) supports cash runway into the second half 2028 and through APG777 Phase 3 topline data.
Apogee reported positive interim results from the Phase 1 clinical trial evaluating the safety, tolerability, and PK of APG333 in 32 healthy adults across four cohorts. APG333 demonstrated data supporting potential three- and six-month dosing based on a half-life of approximately 55 days across doses tested. Additionally, APG333 was well tolerated across all cohorts, with doses of up to 1,000 mg. Key biomarkers of eosinophils and IL-5 showed depth of suppression in line with TSLP analogs and durability out to six months.
The results support the development of a quarterly or less frequently dosed co-formulation of APG273 (APG777+APG333) for respiratory indications.
Apogee’s cash, cash equivalents, and marketable securities were $588.9 million as of September 30, 2025, compared to $621.2 million as of June 30, 2025. The company completed a $345 million underwritten public equity offering in October, resulting in $913 million in cash, cash equivalents, and marketable securities on a pro forma basis as of September 30, 2025. Apogee expects its existing total cash will enable the company to fund its operating expenses into the second half of 2028.
Research and development (R&D) expenses were $54.2 million for the quarter ended September 30, 2025, compared to $45.7 million for the quarter ended September 30, 2024. The increase was primarily due to the advancement of the pipeline and continued development of the company’s programs, increases in personnel-related expenses, and equity-based compensation associated with the growth in the company’s R&D team.
General and administrative (G&A) expenses were $17.1 million for the quarter ended September 30, 2025, compared to $13.0 million for the quarter ended September 30, 2024. The increase was primarily due to increases in personnel-related expenses and equity-based compensation, primarily driven by increased headcount and an increase in the fair value of equity awards granted. These increases are the result of the company’s expansion of operations to support the growth in its business.
Apogee’s net loss was $65.0 million for the quarter ended September 30, 2025, compared to a net loss of $49.0 million for the quarter ended September 30, 2024. The net loss increased primarily as a result of higher R&D and G&A expenses.
Apogee Therapeutics is advancing optimized, novel biologics with potential for best-in-class profiles in the largest I&I markets, including for the treatment of AD, asthma, EoE, COPD, and other I&I indications. Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.
APG777, the company’s most advanced program, is being initially developed for the treatment of AD. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies.
Apogee believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care, based on a broad pipeline and depth of expertise.
Contact:
Noel Kurdi
VP, Investor Relations
Apogee Therapeutics, Inc.
Noel.Kurdi@apogeetherapeutics.com
Dan Budwick
1AB Media
dan@1abmedia.com
Source: Apogee Therapeutics, Inc.
