Apogee Therapeutics Inc.
03/02/2026 | Press release | Distributed by Public on 03/02/2026 06:15
Apogee Therapeutics Provides Pipeline Progress and Reports Full Year 2025 Financial Results (Form 8-K)
Apogee Therapeutics Provides Pipeline Progress and Reports Full Year 2025 Financial Results
Zumilokibart (APG777) trials continue to advance in atopic dermatitis (AD) with plans for expansion indications underway:
- APEX Phase 2 Part A 52-week data expected this month
- APEX Phase 2 Part B 16-week data expected in Q2 2026
- Phase 3 trial initiation in AD anticipated in 2H 2026
- Successful expansion of zumilokibart beyond AD demonstrated in asthma Phase 1b trial; details on asthma and eosinophilic esophagitis (EoE) trials expected later this year
Phase 1b head-to-head trial of APG279 (zumilokibart + APG990) vs. DUPIXENT underway, with interim AD data anticipated in 2H 2026
Strong total cash position of $902.9 million with runway into 2H 2028 supports advancement toward potential launch of zumilokibart in 2029
San Francisco and Boston, March 2, 2026 - Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing optimized, novel biologics with the potential for best-in-class profiles in the largest inflammatory and immunology (I&I) markets, today provided pipeline progress and reported fourth quarter and full year 2025 financial results.
"In the last 12 months we made meaningful progress across our pipeline, including advancing zumilokibart with positive APEX Phase 2 Part A results, as well as proof-of-concept data from our Phase 1b trial in asthma," said Michael Henderson, M.D., Chief Executive Officer of Apogee Therapeutics. "We are now focused on proving out the potential of zumilokibart in AD with the APEX Phase 2 Part A 52-week maintenance readout expected in March, followed by the APEX Phase 2 Part B dose optimization readout expected in the second quarter and Phase 3 initiation targeted by year end. Later this year, we plan to provide additional details on development for expansion indications including asthma and EoE, further advancing our vision for zumilokibart as a pipeline-in-a-product. In the second half of 2026, our expected head-to-head readout of APG279 compared to DUPIXENT has potential to be the first proof-of-concept for Apogee's combination programs in AD. With cash runway into the second half of 2028, we believe we are well positioned to work toward launching a transformative therapy this decade as we build a leading I&I biotech."
Pipeline Highlights and Upcoming Milestones
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APEX Phase 2 clinical trial of zumilokibart for AD progressing, with 52-week Part A data anticipated this month and 16-week Part B data expected in Q2 2026:
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The company aims to demonstrate the maintenance of EASI-75 and/or IGA 0/1 responses at levels similar or better than DUPIXENT, but with quarterly or better dosing.
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Part B of the APEX trial is designed to find the optimized dose of zumilokibart, looking at low, medium (Part A dose), and high dose regimens vs. placebo. Enrollment is complete.
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Pending results from APEX Part A maintenance, Part B induction and regulatory alignment, the company plans to begin Phase 3 trials of zumilokibart in the second half of 2026.
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Zumilokibart demonstrated positive interim results from Phase 1b trial in mild-to-moderate asthma, reinforcing pipeline-in a-product potential across I&I indications:
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The company plans to provide further details on asthma and EoE trials for zumilokibart this year.
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Additional data from the Phase 1b asthma trial is expected to be shared at upcoming medical conferences.
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Phase 1b head-to-head study of APG279 (zumilokibart + APG990) against DUPIXENT in AD continues to advance with results expected in 2H 2026:
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Interim readout from the head-to-head trial will evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of APG279 vs. DUPIXENT in AD.
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Plans to advance APG273 (zumilokibart + APG333) in respiratory indications will be disclosed in 2026:
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Positive interim results from the APG333 Phase 1 healthy volunteer trial in November 2025 supports advancement of quarterly or less frequently dosed co-administration of APG273 in asthma and COPD.
Full Year 2025 Financial Results
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Cash Position: Cash, cash equivalents and marketable securities were $902.9 million as of December 31, 2025, compared to $731.1 million as of December 31, 2024. Based on current operating plans, Apogee expects its existing cash, cash equivalents and marketable securities will enable the company to fund its operating expenses into the second half of 2028.
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R&D Expenses: Research and development (R&D) expenses were $214.7 million for the year ended December 31, 2025, compared to $167.9 million for the year ended December 31, 2024. R&D expenses increased 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, and increases in external-discovery related costs.
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G&A Expenses: General and administrative (G&A) expenses were $70.9 million for the year ended December 31, 2025, compared to $49.0 million for the year ended December 31, 2024. G&A expenses increased 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.
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Net Loss: Net loss was $255.8 million for the year ended December 31, 2025, compared to $182.1 million for the year ended December 31, 2024. Net loss increased primarily as a result of higher R&D and G&A expenses as described above.
About Apogee
Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of Atopic
Dermatitis (AD), asthma, Eosinophilic Esophagitis (EoE), Chronic Obstructive Pulmonary Disease (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. Zumilokibart (APG777), the company's most advanced program, is being initially developed for the treatment of AD, which is the largest and one of the least penetrated I&I markets, as well as asthma. 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. Based on a broad pipeline and depth of expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today's standard of care. For more information, please visit https://apogeetherapeutics.com.
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