Apogee Therapeutics Provides Business Update, Pipeline Progress and Reports First Quarter 2025 Financial Results

Phase 2 APEX trial of APG777 in atopic dermatitis advancing with interim Part A 16-week data expected in mid-2025 and Part B actively enrolling

First patient dosed in Phase 1b trial of APG777 in mild-to-moderate asthma with readout expected in 1H 2026

APG279 on track to initiate Phase 1b head-to-head trial vs DUPIXENT in 2025 with readout expected in 2H 2026

Positive interim Phase 1b readout of APG808 in patients with mild-to-moderate asthma demonstrated rapid, robust and sustained suppression of FeNO, a biomarker of Type 2 inflammation that is associated with exacerbations in asthma

$681.4 million cash, cash equivalents and marketable securities supports runway into Q1 2028

SAN FRANCISCO and WALTHAM, Mass., May 12, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing novel biologics with the potential for differentiated efficacy and dosing in the largest inflammatory and immunology (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, today provided business updates, pipeline progress and reported first quarter 2025 financial results.

"2025 is poised to be a transformational year for Apogee, and we are pleased with the strong execution in the first quarter as we continue to advance therapies with the goal of reshaping the standard of care for patients living with I&I diseases," said Michael Henderson, M.D., Chief Executive Officer of Apogee. "We have made significant progress in our Phase 2 APEX trial of APG777, which is actively enrolling Part B and on track for the interim 16-week readout from Part A mid-year. Momentum continues across our programs, driven by the initiation of our Phase 1b trial of APG777 in patients with mild-to-moderate asthma, today's announcement of positive interim clinical trial results from our Phase 1b trial of APG808 in patients with mild-to-moderate asthma, as well as the positive Phase 1 interim readout for APG990, which exceeded all trial objectives and unlocked the potential for dosing APG279 (APG777 + APG990) two- to four- times per year with a single 2 mL co-formulated injection. Following these encouraging results from APG990, we are advancing our first-in-class combination strategy with plans to initiate a head-to-head Phase 1b study of APG279 versus DUPIXENT in AD later this year. With a very strong cash position and multiple catalysts across our portfolio in the months ahead, we are looking forward to an exciting and productive 2025 and 2026."

New independent market research reinforces APG777's potential to become a market leader in the rapidly expanding AD biologic space:

Apogee conducted third-party quantitative market research in April 2025 and asked US patients and physicians the likelihood that they would switch to APG777 from their current or previous biologic assuming APG777 had similar efficacy and overall results to DUPIXENT and an every 3-month, or quarterly, injection maintenance schedule.

   -- Responses demonstrated that APG777 was highly preferred over current 
      biologic options by patients and physicians 
 
          -- 96% of patients currently on a biologic, both controlled and 
             inadequately controlled, would likely switch to APG777. 
 
          -- 80% of physicians would likely start their biologic naive patients 
             on APG777, while 83% of physicians would likely switch 
             inadequately controlled biologic patients to APG777. 
 
          -- 67% of physicians are open to switching their controlled patients 
             to a quarterly dose of APG777. 
 
   -- Compared to a hypothetical daily oral with equivalent efficacy and safety, 
      patients and providers prefer APG777's quarterly dosing profile: 
 
          -- Patients prefer the APG777 profile by more than 3 to 1. 
 
          -- Providers prefer the APG777 profile by nearly 4 to 1. 

"Based on the recent market research we commissioned, APG777's potential quarterly dosing is highly preferred by both physicians and patients to other available options. Physicians expressed strong interest in both initiating new-to-biologic patients to APG777 as well as switching patients already on biologics to APG777, assuming comparable efficacy and safety to current biologics," said Jeff Hartness, Chief Commercial Officer of Apogee. "The AD biologic market is expanding rapidly--with year-to-date growth of 23% in total prescriptions and 44% in new-to-brand prescriptions--and new entrants are accelerating the shift from topicals to biologics. We believe APG777 is well positioned to transform the AD treatment landscape and significantly improve the quality of life for patients living with moderate-to-severe AD."

Pipeline Highlights and Upcoming Milestones

   -- Apogee continues to execute APG777 monotherapy program in AD and 
      expansion indications: APG777 is a novel, subcutaneous (SQ), extended 
      half-life monoclonal antibody (mAb) targeting IL-13 -- a critical 
      cytokine in inflammation and a primary driver of AD. 
 
          -- The Phase 2 APEX clinical trial of APG777 is progressing, with 
             Part A fully enrolled and Part B actively enrolling patients with 
             moderate-to-severe AD. The company expects to report 16-week 
             topline data from Part A of the trial in mid-2025 and from Part B 
             in the second half of 2026. 
 
          -- Apogee today announced that the first patient has been dosed in a 
             Phase 1b trial of APG777 in patients with mild-to-moderate asthma. 
             The primary endpoint of the trial is safety and tolerability, with 
             secondary endpoints exploring pharmacokinetics $(PK)$, FeNO 
             suppression of APG777, with readout expected in the first half of 
             2026. 
 
          -- The company also plans to initiate a Phase 2 trial in EoE in 2026. 
   -- APG279 (APG777 + APG990) Phase 1b head-to-head study against DUPIXENT on 
      track to initiate in 2025: 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 while Apogee's approach of co-formulating two extended half-life 
      mAbs provides the potential for first-in-class and best-in-class dosing. 
 
          -- In March 2025, Apogee reported positive APG990 Phase 1 interim 
             results in healthy volunteers, unlocking potential maintenance 
             dosing every three and six months for APG279 (APG777 + APG990) 
 
          -- Apogee plans to initiate its first-in-class combination trial, a 
             Phase 1b trial designed to evaluate the safety, PK, 
             pharmacodynamics and efficacy of APG279 against DUPIXENT in 
             patients with moderate-to-severe AD this year, with an interim 
             readout expected in the second half of 2026. 
 
   -- Progress continues in our combination approach of APG777 + APG333: APG333 
      is a novel, SQ, extended half-life mAb targeting thymic stromal 
      lymphopoietin $(TSLP)$, a key driver of Type 2 and Type 3 inflammation in 
      eosinophilic and non-eosinophilic conditions. 
 
          -- A Phase 1 trial of APG333 in healthy volunteers is underway, with 
             data expected in the second half of 2025. 
   -- Positive interim data for APG808 Phase 1b trial in asthma reported: 
      APG808 is a novel, SQ extended half-life mAb targeting IL-4R<ALPHA>, a 
      target with clinical validation across eight Type 2 allergic diseases. In 
      preclinical studies, APG808 has similar binding and femtomolar affinity 
      for IL-4R<ALPHA> as compared to DUPIXENT and has demonstrated similar 
      inhibition to DUPIXENT. 
 
          -- Today, the company reported positive interim results of the Phase 
             1b trial of APG808 in patients with mild-to-moderate asthma. The 
             results demonstrated that APG808 was well-tolerated, with multiple 
             doses of APG808 resulting in rapid suppression of FeNO, a 
             biomarker of Type 2 inflammation that is associated with 
             exacerbations in asthma, with a maximal robust FeNO decrease from 
             baseline of 53% and sustained FeNO decrease from baseline of 50% 
             at 12 weeks. 
 
          -- APG808's optimized PK profile coupled with FeNO suppression out to 
             12-weeks reinforce the potential for 2-months or longer 
             maintenance dosing, offering a significant advantage compared to 
             the current bi-weekly standard of care. 

First Quarter 2025 Financial Results

   -- Cash Position: Cash, cash equivalents and marketable securities were 
      $681.4 million as of March 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 first quarter of 2028. 
 
   -- R&D Expenses: Research and development (R&D) expenses were $46.4 million 
      for the quarter ended March 31, 2025, compared to $28.7 million for the 
      quarter ended March 31, 2024. R&D expenses increased primarily due to the 
      advancement of the pipeline and continued development of the company's 
      programs, and increases in personnel-related expenses and equity-based 
      compensation, associated with the growth in the company's R&D team. 
 
   -- G&A Expenses: General and administrative (G&A) expenses were $16.7 
      million for the quarter ended March 31, 2025, compared to $9.5 million 
      for the quarter ended March 31, 2024. G&A expenses increased primarily 
      due to increases in personnel-related expenses and equity-based 

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