Zumilokibart advancing across multiple indications, with Phase 3 initiation in atopic dermatitis $(AD)$ expected later this year:

- APEX Phase 2 Part A 52-week data demonstrated durable maintenance and improved efficacy over time with every 3- and 6-month dosing in moderate-to-severe AD

- APEX Phase 2 Part B 16-week data in AD expected in Q2 2026

- Following positive Phase 1b asthma results earlier this year, expansion plans are underway with additional trial details for asthma and eosinophilic esophagitis (EoE) expected later this year

Strong cash position of $1.3B following successful public equity offering extending runway into 2029, through planned BLA filing for AD, subject to regulatory alignment

SAN FRANCISCO and BOSTON, May 11, 2026 (GLOBE NEWSWIRE) -- 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 first quarter 2026 financial results.

"We are off to a rapid start in 2026, reflecting the team's relentless focus on execution. Most notably, the APEX Phase 2 Part A 52-week results exceeded our expectations and reinforced the potentially best-in-class profile of zumilokibart as well as the central role of IL-13 as the master cytokine in AD. Zumilokibart demonstrated durable maintenance of response with 3- and 6-month dosing and improved efficacy of responses across all lesional and itch endpoints with meaningfully fewer doses than current therapies, representing a potentially transformational opportunity as a first-line product for AD patients," said Michael Henderson, M.D., Chief Executive Officer of Apogee Therapeutics. "Based on these results, together with the positive Phase 1b asthma data shared in January 2026, we remain confident in the pipeline-in-a-product potential for zumilokibart and plan to outline broader expansion into asthma and EoE trials later this year. Following our recent successful financing, Apogee is well capitalized with cash runway into 2029, supporting advancement towards a BLA filing for AD and continued execution across our development programs, including the APEX Phase 2 Part B readout expected this quarter and initiation of our Phase 3 trials in AD expected later this year."

Pipeline Progress, Corporate Highlights and Upcoming Milestones

   -- APEX Phase 2 Part A 52-week data for zumilokibart demonstrated durable 
      maintenance and improved efficacy with every 3- and 6-month dosing in 
      moderate-to-severe AD; APEX Phase 2 Part B 16-week data expected in Q2 
      2026: 
 
          -- In March 2026, the company reported 52-week maintenance data 
             evaluating 360mg of zumilokibart at 3- and 6-month intervals. At 
             Week 52, durable maintenance of response was observed among Week 
             16 responders, as well as improved efficacy across the full 
             treated population for all lesion and itch endpoints. Zumilokibart 
             was well-tolerated with a safety profile consistent with other 
             agents in the class. 
 
                 -- Of patients that achieved EASI-75 at Week 16, 75% of 
                    patients with every 3-month dosing and 85% of patients with 
                    every 6-month dosing maintained response at Week 52. 
 
                 -- Of patients that achieved IGA 0/1 at Week 16, 86% of 
                    patients with every 3-month dosing and 78% of patients with 
                    every 6-month dosing maintained response at Week 52. 
 
                 -- Across the entire population treated with zumilokibart, 
                    responses improved through Week 52 for both every 3- and 
                    6-month regimens, with IGA 0/1 of 72% and 52% at Week 52 
                    improving up to 35% from Week 16, EASI-90 of 75% and 48% at 
                    Week 52 improving up to 36% from Week 16, and EASI-100 of 
                    41% and 19% at Week 52 improving by up to 33% from Week 16, 
                    for every 3- and 6-month dosing, respectively. 
 
          -- At this year's American Academy of Dermatology (AAD) Annual 
             Meeting, the company presented additional data including a 
             late-breaking oral session, highlighting: 
 
                 -- Of patients who achieved EASI-90 at Week 16, 88% of 
                    patients with every 3-month dosing and 72% of patients with 
                    every 6-month dosing maintained such response at Week 52. 
 
                 -- Zumilokibart demonstrated improvements in lesional skin 
                    transcriptome across Type 1, 2, and 3 inflammatory 
                    pathways. 
 
          -- Part B of the APEX trial is designed to determine the optimized 
             induction dose of zumilokibart, looking at low, medium (Part A 
             dose), and high dose regimens vs. placebo. Results will determine 
             the induction dosing regimen for the planned Phase 3 trials of 
             zumilokibart, expected to initiate in the second half of 2026. 
   -- Completed $403 million upsized public equity offering: 
 
          -- Following the Phase 2 APEX Part A readout in March 2026, Apogee 
             closed on an upsized public equity offering, including the full 
             exercise of the underwriters' option to purchase additional shares, 
             with aggregate gross proceeds of approximately $403 million 
             (before deducting underwriting discounts, commissions, and other 
             offering expenses), which supports cash runway into 2029 through a 
             planned BLA filing for zumilokibart in AD. 
   -- Zumilokibart demonstrated positive interim results from the Phase 1b 
      trial in mild-to-moderate asthma in January 2026, reinforcing 
      pipeline-in-a-product potential across I&I indications: 
 
          -- The company plans to provide further details on asthma and EoE 
             trials for zumilokibart later this year. 
 
          -- Additional data from the Phase 1b asthma trial is expected to be 
             shared at an upcoming medical conference. 
   -- Combination pipeline continues to advance across AD and respiratory 
      indications for APG279 and APG273 with potential for improved efficacy 
      and dosing: 
 
          -- Phase 1b head-to-head study of APG279 (zumilokibart + APG990) 
             versus DUPIXENT in AD is fully enrolled and expanded to 86 
             patients, with interim 24-week data expected in 2H 2026. 
 
          -- Plans to advance APG273 (zumilokibart + APG333) in respiratory 
             indications expected to be disclosed later this year. 
 
                 -- Positive read-through from competitor proof-of-concept data 
                    in respiratory indications supports continued development 
                    of APG273. 

First Quarter 2026 Financial Results

   -- Cash Position: Cash, cash equivalents, marketable securities and 
      long-term marketable securities were $1.3 billion as of March 31, 2026, 
      compared to $902.9 million as of December 31, 2025. Based on current 
      operating plans, Apogee expects its existing cash, cash equivalents, 
      marketable securities and long-term marketable securities will enable the 
      company to fund its operating expenses into 2029. 
 
   -- R&D Expenses: Research and development (R&D) expenses were $60.8 million 
      for the quarter ended March 31, 2026, compared to $46.4 million for the 
      quarter ended March 31, 2025. R&D expenses increased primarily driven by 
      the continued development of our zumilokibart (APG777) and APG990/APG279 
      programs, increased external-discovery related costs, and higher 
      personnel and equity-based compensation expenses associated with the 
      growth in our research and development team, partially offset by 
      decreases in expenses related to the APG333/APG273 program. 
 
   -- G&A Expenses: General and administrative (G&A) expenses were $22.0 
      million for the quarter ended March 31, 2026, compared to $16.7 million 
      for the quarter ended March 31, 2025. 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 of its 
      business. 
 
   -- Net Loss: Net loss was $74.1 million for the quarter ended March 31, 
      2026, compared to a net loss of $55.3 million for the quarter ended March 
      31, 2025. 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 AD, asthma, 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, 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 and EoE. 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.

Forward Looking Statements

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May 11, 2026 07:01 ET (11:01 GMT)