Apogee Therapeutics, Inc.

false 0001974640 0001974640 2026-05-27 2026-05-27 iso4217:USD xbrli:shares iso4217:USD xbrli:shares UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 27, 2026 Apogee Therapeutics, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 001-41740 93-4958665 (State of Incorporation or Organization) (Commission File Number) (I.R.S. Employer Identification No.) 221 Crescent Street , Building 17 , Suite 102b , Waltham , MA , 02453 (Address of Principal Executive Offices, including Zip Code) ( 650 ) 394-5230 (Registrant’s telephone number, including area code) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.00001 per share APGE The Nasdaq Global Market Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ¨ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨ Item 7.01 Regulation FD Disclosure. On May 27, 2026, Apogee Therapeutics, Inc. (the “Company”) issued a press release and made publicly available a data presentation announcing positive 16-week induction dose optimization results from Part B of the Phase 2 APEX clinical trial of zumilokibart (APG777), its potentially best-in-class anti-IL-13 antibody, in patients with moderate-to-severe atopic dermatitis (“AD”). The Company will host a conference call and webcast today, Wednesday, May 27, 2026, at 8:00 a.m., Eastern Time, to discuss the data results. Copies of the press release and the data presentation are furnished as Exhibit 99.1 and Exhibit 99.2, respectively, to this Current Report on Form 8-K (this “Report”) and are incorporated by reference herein. The exhibits furnished under Item 7.01 of this Report shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, regardless of any general incorporation language in such filing. Item 8.01 Other Events. On May 27, 2026, the Company announced positive 16-week induction dose optimization results from Part B of the Phase 2 APEX clinical trial of zumilokibart in patients with moderate-to-severe AD. Zumilokibart Phase 2 Part B Key 16-Week Results The APEX Phase 2 clinical trial is a randomized, placebo-controlled study evaluating zumilokibart in patients with moderate-to-severe AD. In July 2025, the Company announced the APEX Phase 2 Part A 16-week results, and in March 2026, it announced the APEX Phase 2 Part A 52-week maintenance results. In the Part B portion of the trial, 346 adult patients were dosed after being randomized 1:1:1:1 to high-, mid- or low-dose zumilokibart versus placebo. The primary endpoint is the proportion of patients who achieve an Eczema Area and Severity Index (“EASI”) percent score reduction of at least 75 (“EASI-75”) at Week 16. Secondary endpoints include Validated Investigator’s Global Assessment (“IGA”) 0/1, EASI-90, Itch Numeric Rating Scale (“I-NRS ≥4”), EASI-100, and Very Low Disease Activity (vLDA; EASI-90 + I-NRS 0/1) at Week 16. The trial met its primary endpoint. EASI-75 scores at Week 16 were as follows: · High-dose: 61.6% achieved EASI-75 (p<0.001 vs placebo) · Mid-dose: 65.9% achieved EASI-75 (p<0.001 vs placebo) · Low-dose: 50.5% achieved EASI-75 (p<0.001 vs placebo) · Placebo: 23.4% achieved EASI-75 Mid-dose zumilokibart met key secondary endpoints at Week 16 as follows: · IGA 0/1 response in 46.0% of patients, compared to 10.9% in the placebo arm (p<0.001) · EASI-90 response in 47.4% of patients, compared to 9.3% in the placebo arm (p<0.001) · I-NRS ≥4 reduction from baseline in 50.5% of patients, compared to 13.9% in placebo arm (p <0.001) · EASI-100 response in 16.5% of patients, compared to 3.4% in the placebo arm (p<0.01) · vLDA response in 20.6% of patients, compared to 4.5% in the placebo arm (p<0.01) Zumilokibart was well tolerated, with a safety profile generally consistent with other agents in the class. · The most common treatment-emergent adverse events in zumilokibart-treated patients were nasopharyngitis, headache, and noninfective conjunctivitis. · For the planned Phase 3 dose (the mid-dose from Phase 2), the pooled conjunctivitis rate (all conjunctivitis preferred terms) was 10.6%, compared to 15.1% for the low-dose and 20.7% for the high-dose. Based on results from the APEX clinical program, Apogee plans to initiate Phase 3 trials of zumilokibart for moderate-to-severe AD with the mid-dose in the second half of 2026, pending regulatory interactions. Zumilokibart ADventure Phase 3 Trials in AD The ADventure 1 and ADventure 2 trials are randomized, placebo-controlled, replicate Phase 3 monotherapy trials evaluating zumilokibart in patients with moderate-to-severe AD (EASI ≥16, vIGA ≥3, BSA ≥10%). Each study is expected to enroll approximately 400 patients and includes a 16-week induction period followed by maintenance through Week 52. In maintenance, patients will receive dosing every three or six months. The co-primary endpoint is EASI-75 and IGA 0/1 at Week 16, with additional assessment at Week 52. The ADventure TCS Phase 3 trial will evaluate zumilokibart in combination with background topical corticosteroids (“TCS”) in patients with moderate-to-severe AD (EASI ≥16, vIGA ≥3, BSA ≥10%). The randomized, placebo-controlled study is expected to enroll approximately 400 patients and includes a 16-week induction period and maintenance through Week 52. The co-primary endpoint is EASI-75 and IGA 0/1 at Week 16, with longer-term outcomes assessed at Week 52. Zumilokibart ASPIRE Phase 2b trial in Asthma The ASPIRE Phase 2b trial is a randomized, placebo-controlled study evaluating multiple dosing regimens of zumilokibart in patients with moderate-to-severe asthma with elevated Type 2 biomarkers and a history of exacerbations. The study is designed to be potentially registrational and is expected to enroll approximately 500 patients randomized across dosing intervals of every three, six, or twelve months, or placebo. The primary endpoint is annualized exacerbation rate at Week 52, with additional assessments of lung function and symptoms. Zumilokibart ELEVATE Phase 2a trial in Eosinophilic Esophagitis (“EoE”) The ELEVATE Phase 2a trial is an open-label, proof-of-concept study evaluating zumilokibart in patients with EoE. The study is expected to enroll approximately 30 to 50 patients and will assess dosing every three or six months. The primary endpoint is histologic response, including reductions in eosinophil counts, with additional evaluation of endoscopic findings and patient-reported outcomes. Anticipated Program Milestones The Company described expected program readouts and milestones through 2