Apogee Therapeutics Files 8-K

TL;DR

APTG filed an 8-K, standard procedure, no major news yet.

AI Summary

On February 3, 2025, Apogee Therapeutics, Inc. filed an 8-K report. The filing primarily concerns financial statements and exhibits, and other events, indicating ongoing operational and disclosure activities for the company. No specific financial transactions or material events were detailed in the provided excerpt.

Why It Matters

This filing indicates Apogee Therapeutics is meeting its regulatory disclosure requirements, which is standard practice for publicly traded companies. It suggests ongoing business operations and compliance.

Risk Assessment

Risk Level: low — The filing is a routine 8-K report for financial statements and exhibits, not indicating any immediate material adverse events.

Key Players & Entities

• Apogee Therapeutics, Inc. (company) — Registrant
• February 3, 2025 (date) — Date of earliest event reported
• 001-41740 (other) — Commission File Number
• 93-4958665 (other) — I.R.S. Employer Identification No.
• 221 Crescent Street, Building 17, Suite 102b, Waltham, MA, 02453 (address) — Address of Principal Executive Offices

FAQ

Key Financial Figures

• $0.00001 — ch registered Common Stock, par value $0.00001 per share APGE The Nasdaq Global Ma

Filing Documents

• tm255268d1_8k.htm (8-K) — 32KB
• tm255268d1_ex99-1.htm (EX-99.1) — 19KB
• tm255268d1_ex99-1img001.jpg (GRAPHIC) — 18KB
• 0001104659-25-008357.txt ( ) — 257KB
• apge-20250203.xsd (EX-101.SCH) — 3KB
• apge-20250203_lab.xml (EX-101.LAB) — 33KB
• apge-20250203_pre.xml (EX-101.PRE) — 22KB
• tm255268d1_8k_htm.xml (XML) — 4KB

01

Item 7.01 Regulation FD Disclosure. On February 3, 2025, Apogee Therapeutics, Inc. (the "Company"or "Apogee") issued a press release announcing that the first patient has been dosed in the Part B portion of the Phase 2 APEX clinical trial of APG777 in patients with moderate-to-severe atopic dermatitis ("AD"), and that enrollment has been completed in the Part A portion of the trial. A copy of the press release is furnished herewith as Exhibit 99.1. In accordance with General Instruction B.2 of Form 8-K, the information in this Item 7.01, including Exhibit 99.1, shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

01

Item 8.01 Other Events On February 3, 2025, the Company announced that the first patient has been dosed in the Part B portion of the Phase 2 APEX clinical trial of APG777 in patients with moderate-to-severe AD, and that enrollment has been completed in the Part A portion of the trial. APEX is a Phase 2 randomized, placebo-controlled clinical trial evaluating APG777, a novel, subcutaneous extended half-life monoclonal antibody targeting IL-13 – a critical cytokine in inflammation and a primary driver of AD, in patients with moderate-to-severe AD. The trial was designed to combine the typical Phase 2a and 2b portions of a clinical trial into a single protocol. Part A exceeded expected enrollment with 123 patients randomized 2:1 to APG777 versus placebo. Part B is a placebo-controlled dose optimization with approximately 280 patients randomized 1:1:1:1 to high, medium, or low dose APG777 versus placebo. The primary endpoint of each part of the study is mean percentage change in Eczema Area and Severity Index ("EASI") score from baseline at week 16 and secondary endpoints include EASI-75 and Investigator's Global Assessment 0/1 at week 16. Patients benefiting from treatment will continue to APG777 maintenance dosing, which will evaluate 3- or 6-month dosing. Apogee expects Part A 16-week induction data in mid-2025, maintenance data in the first half of 2026 and Part B 16-week data in the second half of 2026. Cautionary Note Regarding Forward-Looking Statements Certain statements in this Current Report on Form 8-K may constitute "forward-looking statements" within the meaning of the federal securities laws, including, but not limited to, statements regarding: Apogee's plans for its current and future clinical trials, including its Phase 2 APEX clinical trial of APG777; Apogee's plans for clinical trial design; the anticipated timing of the results from Apogee's clinical trials, including data from Apogee's Phase 2 APEX clinical trial of APG777; and the potential c

Financial Statements and Exhibits

Financial Statements and Exhibits. (d) Exhibits . The following exhibit is being furnished herewith: EXHIBIT INDEX Exhibit No. Description 99.1 Press Release, dated February 3, 2025 104 Cover Page Interactive Data File (embedded within the Inline XBRL document). SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Apogee Therapeutics, Inc. Date: February 3, 2025 By: /s/ Michael Henderson, M.D. Name: Michael Henderson, M.D. Title: Chief Executive Officer

View Full Filing

View this 8-K filing on SEC EDGAR