8-K: Apogee Therapeutics Announces Positive Phase 1 Results for APG990 and Reports Full Year 2024 Financial Results

Apogee Therapeutics reports positive interim Phase 1 results for APG990, supporting potential for less frequent dosing of APG279, and announces full year 2024 financial results with a strong cash position.

Summary

• Apogee Therapeutics announced positive interim Phase 1 results for APG990, a novel half-life extended OX40L antibody.
• The APG990 trial demonstrated an approximately 60-day half-life, supporting potential maintenance dosing every three to six months for APG279 (APG777 + APG990).
• The company plans to initiate a Phase 1b head-to-head study of APG279 against DUPIXENT in 2025, with a readout expected in the second half of 2026.
• Apogee reported full year 2024 financial results, with cash, cash equivalents, and marketable securities totaling $731.1 million as of December 31, 2024.
• The company expects its cash runway to extend into Q1 2028.
• Research and development expenses were $167.9 million for the year ended December 31, 2024, while general and administrative expenses were $49.0 million.
• The net loss for the year ended December 31, 2024, was $182.1 million.

Sentiment

Score: 8

Explanation: The document presents positive clinical trial results and a strong financial position, indicating a favorable outlook for the company. The progress in multiple programs and the extended cash runway contribute to a positive sentiment.

Positives

• Positive interim Phase 1 results for APG990 support less frequent dosing and combination potential.
• Strong cash position of $731.1 million provides a runway into Q1 2028.
• APG777 Phase 2 APEX trial is progressing ahead of schedule.
• APG990 was well tolerated across all dose groups with a favorable safety profile.
• Preclinical studies of the combination of APG777 and APG990 showed potential for enhanced pharmacologic responses relative to individual agents, and exhibited no safety findings at any dose level.

Negatives

• The company reported a net loss of $182.1 million for the year ended December 31, 2024, which is higher than the $84.0 million net loss for the year ended December 31, 2023.
• Increased R&D and G&A expenses contributed to the higher net loss.

Risks

• The company's forward-looking statements are subject to various risks and uncertainties, including those related to clinical trial outcomes, regulatory approvals, and macroeconomic conditions.
• The unpredictable relationship between preclinical study results and clinical study results could impact the success of the company's programs.
• Global macroeconomic conditions and related volatility could impact the company's liquidity and capital resources.

Future Outlook

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. The company anticipates several meaningful catalysts in 2025, including data readouts from ongoing clinical trials and the initiation of new trials.

Management Comments

• We achieved significant progress across our pipeline in 2024 and are well-positioned to continue executing rapidly on our mission to bring transformative, potentially best-in-class therapies to patients with I&I diseases, said Michael Henderson, M.D., Chief Executive Officer of Apogee.
• Were pleased to report findings from our third clinical program today, APG990, which demonstrated extended PK and a favorable tolerability profile, supporting its potential as a first-in-class combination with APG777 for the treatment of AD and other inflammatory diseases that could address multiple inflammation pathways, said Michael Henderson, M.D., Chief Executive Officer of Apogee.
• Todays results are highly encouraging, further validating our approach to create fully optimized antibodies with the potential to improve patients lives, said Carl Dambkowski, M.D., Chief Medical Officer of Apogee.

Industry Context

Apogee is focused on developing novel biologics for inflammatory and immunology (I&I) markets, including atopic dermatitis, asthma, and eosinophilic esophagitis. The company is targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and dosing, aiming to overcome limitations of existing therapies like DUPIXENT.

Comparison to Industry Standards

• APG808 has similar binding affinity for IL-4R as DUPIXENT, a first-generation mAb, and has demonstrated similar inhibition to DUPIXENT across three in vitro assays.
• In head-to-head preclinical assays, APG990 has demonstrated similar or improved potency to amlitelimab.
• Apogee believes APG990 can be dosed every threeand sixmonths in maintenance, which, if clinical trials are successful, would represent a significant improvement compared to first generation OX40L antibodies that are expected to be dosed every four to twelve weeks.

Stakeholder Impact

• Positive clinical trial results and a strong financial position are likely to benefit shareholders.
• Advancement of pipeline programs could lead to new treatment options for patients with I&I diseases.
• Continued investment in R&D will support job creation and scientific innovation.

Next Steps

• Initiate a Phase 1b trial of APG279 against DUPIXENT in 2025.
• Submit an Investigational New Drug application or foreign equivalent for APG279.
• Continue development of APG777, APG333, and APG808 programs.
• Initiate a Phase 1b trial in asthma in the first half of 2025.
• Initiate a Phase 2b trial in asthma in the second half of 2025.
• Initiate a Phase 2 trial in EoE in 2026.

Key Dates