Apogee Therapeutics Provides Pipeline Progress and Reports Third Quarter 2024 Financial Results

Continued execution across all programs, including positive results up to nine months from APG777 Phase 1 trial that continue to support potential best-in-class profile

On track to report Phase 2 Part A data for APG777 in 2H 2025, interim Phase 1 data for APG808 in 4Q 2024 and interim Phase 1 data for APG990 in 1H 2025

APG333 development candidate selected and accelerating initiation of Phase 1 in late 2024 or early 2025; potential to offer best-in-class combination efficacy across multiple respiratory indications

Plans advancing for combination studies, starting with the first clinical trial of the APG777 and APG990 combination for the treatment of AD in 2025

$754 million cash, cash equivalents and marketable securities with runway into 2028

Virtual R&D Day to be held December 2, 2024 at 10am ET

SAN FRANCISCO and WALTHAM, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, including for the treatment of atopic dermatitis (AD), asthma, chronic obstructive pulmonary disease (COPD) and other I&I indications, today reported pipeline highlights and third quarter financial results.

"We continue to execute across our portfolio and advance potentially transformative therapies for patients living with I&I diseases by positioning our pipeline to achieve potential best-in-class efficacy and dosing," said Michael Henderson, M.D., Chief Executive Officer of Apogee. "Over the past year, we demonstrated significant progress advancing three programs -- soon to be four -- into the clinic and our lead program, APG777, into Phase 2 trials. Importantly, we remain in a very strong cash position providing for runway into 2028 and look forward to sharing more details and progress on our pipeline and combination strategy during our R&D Day on December 2(nd) ."

Pipeline Highlights and Upcoming Milestones

   -- Results up to 9 months from the APG777 Phase 1 trial reported at the 
      American College of Allergy, Asthma and Immunology's 2024 Annual 
      Scientific Meeting (ACAAI) continue to support potential best-in-class 
      profile, including a half-life of approximately 75 days: 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. 
 
          -- At ACAAI, Apogee reported updated data from its Phase 1 trial in 
             healthy volunteers, including findings from the 40 enrolled 
             participants across three single-ascending dose cohorts, now with 
             nine months of follow-up, and two multiple-ascending dose cohorts, 
             now with six months of follow-up. Findings demonstrate that 
             APG777, in single and multiple doses up to 1,200 mg, showed a 
             consistent safety, pharmacokinetic $(PK)$ and pharmacodynamic $(PD)$ 
             profile following induction. 
 
          -- PD profile showed near complete inhibition of pSTAT6 and sustained 
             TARC inhibition up to 9 months. 
 
          -- Updated data supports Apogee's ongoing Phase 2 clinical trial of 
             APG777 in AD demonstrating potential for improved clinical 
             responses from greater exposures in induction and maintenance 
             dosing of every 3- or 6-months 
 
          -- The company expects to report 16-week topline data from Part A of 
             the APG777 Phase 2 trial in the second half of 2025. 
 
   -- Phase 1 APG808 trial on track for 4Q 2024 interim data readout: APG808 is 
      a novel SQ extended half-life mAb targeting IL-4R<ALPHA>, a target with 
      clinical validation across eight Type 2 allergic diseases. APG808 has 
      similar binding affinity for IL-4R<ALPHA> as a first generation mAb, 
      DUPIXENT, and has demonstrated similar inhibition to DUPIXENT across 
      three in vitro assays that measure downstream functional inhibition of 
      the IL-13/IL-4 pathway. 
 
          -- The company expects to report interim Phase 1 data for APG808 in 
             the fourth quarter of 2024. 
 
   -- First participants dosed in Phase 1 trial of APG990: APG990 is a novel, 
      SQ half-life extended mAb targeting OX40L, initially being developed for 
      AD. OX40L is located further upstream in the inflammatory pathway than 
      IL-13 or IL-4R<ALPHA> and targeting it could have broader impact on the 
      inflammatory cascade by inhibiting Type 1, Type 2 and Type 3 pathways. 
 
          -- In August 2024, Apogee initiated its Phase 1 APG990 trial, 
             designed as a double-blind, placebo-controlled, first-in-human, 
             single-ascending dose trial in healthy volunteers. The study will 
             evaluate the safety, tolerability and PK of APG990 and is expected 
             to enroll approximately 40 healthy adults across 5 cohorts. 
 
          -- The company expects to report interim Phase 1 data for APG990 in 
             the first half of 2025. 
 
   -- Potential to expand patient reach with best-in-class efficacy and dosing 
      with planned APG777 and APG990 combination approach, combining IL-13 and 
      OX40L inhibition: Apogee plans to develop APG777 and APG990 together as a 
      potential first-in-class coformulation combining deep and sustained 
      inhibition of Type 2 inflammation via APG777's inhibition of IL-13 with 
      broader inhibition of Types 1-3 inflammation through APG990's inhibition 
      of OX40L. These combined mechanisms offer the potential for improved 
      clinical responses over monotherapies across a variety of I&I diseases 
      while the approach of co-formulating two extended half-life mAbs holds 
      the potential for best-in-class dosing. 
 
          -- The company plans to initiate the first clinical trial of the 
             APG777 and APG990 combination in 2025. 
 
   -- APG333 anti-TSLP antibody development candidate nominated: APG333 is a 
      novel, SQ extended half-life mAb targeting thymic stromal lymphopoietin 
      $(TSLP)$. TSLP is an epithelial cell-derived cytokine that has emerged as 
      an attractive validated target for the treatment of I&I indications. In 
      addition, a TSLP-targeting mAb may be used in combination with other mAbs 
      for potentially greater efficacy in broader populations. TSLP plays 
      important roles in Type 2 and Type 3 inflammation, particularly in both 
      eosinophilic and non-eosinophilic inflammation. TSLP inhibition has been 
      clinically validated, with one approved product on the market for the 
      treatment of severe asthma without biomarker or phenotype restrictions. 
      Based on its mechanism, TSLP inhibition could offer treatment to the 
      approximately 40% of severe asthma patients with low Type 2 inflammation. 
 
          -- The company now plans to initiate a Phase 1 clinical trial in 
             healthy volunteers of APG333 in late 2024 or early 2025. 
 
          -- Pending Phase 1 data, the company has the opportunity to combine 
             APG777 with APG333, combining IL-13 and TSLP inhibition, to drive 
             potential best-in-class efficacy in asthma and other respiratory 
             indications. 

Corporate Highlights

   -- Jeff S. Hartness appointed as Chief Commercial Officer. In September 
      2024, Apogee appointed Mr. Hartness as its Chief Commercial Officer. Mr. 
      Hartness has an extensive track record in commercial and corporate 
      leadership and more than 25 years of experience in the biotech industry 
      focused on product launches, market access strategy, pricing and policy. 
 
   -- Apogee Therapeutics 2024 Virtual R&D Day to be held on December 2, 2024 
      at 10am ET: The company plans to highlight its progress across its 
      pipeline and showcase its path to reshaping the standard of care in I&I 
      by bringing forward monotherapy and combination treatments that offer the 
      potential for best-in-class efficacy and improved dosing. 

Third Quarter 2024 Financial Results

   -- Cash Position: As of September 30, 2024, Apogee had cash, cash 
      equivalents and marketable securities of $753.8 million. Apogee expects 
      that its existing cash will enable it to fund its current operating 
      expenses into the first quarter of 2028. 
 
   -- Research & Development (R&D) Expenses: R&D expenses for the third quarter 
      of 2024 were $45.7 million, compared to $17.1 million for the third 
      quarter of 2023. R&D expenses increased primarily due to further 
      development of the company's APG777, APG808, APG990 and APG333 programs 
      and advancement of its pipeline into clinical trials, as well as 
      increases in personnel costs, including equity-based compensation expense, 
      associated with the growth of its R&D team. 
 
   -- General and Administrative (G&A) Expenses: G&A expenses for the third 
      quarter of 2024 were $13.0 million, compared to $7.2 million for the 
      third quarter of 2023. G&A expenses increased primarily due to increases 
      in personnel costs, including equity-based compensation, associated with 
      the growth of the company's G&A team, as well as increased costs related 
      to being a public company, including for legal, IT and professional 
      services, and to support the growth of the business. 
 
   -- Net Loss: Net loss for the third quarter of 2024 was $49.0 million, 
      compared to the net loss for the third quarter of 2023 which was $20.8 
      million. Net loss increased primarily as a result of higher R&D and G&A 
      expenses as described above, partially offset by higher interest income. 

About Apogee

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November 12, 2024 07:00 ET (12:00 GMT)