Apogee Therapeutics Files 8-K Report

TL;DR

APOG filed an 8-K. Standard update, no major news yet.

AI Summary

On December 2, 2024, Apogee Therapeutics, Inc. filed an 8-K report. The filing primarily concerns financial statements and exhibits, along with other events and a Regulation FD disclosure. No specific financial figures or new material events were detailed in the provided excerpt.

Why It Matters

This filing indicates a routine update or disclosure from Apogee Therapeutics, Inc. to the SEC, which is important for investors to monitor for any material changes or information.

Risk Assessment

Risk Level: low — The filing is a standard 8-K report with no immediate indication of significant negative events or financial distress.

Key Players & Entities

• Apogee Therapeutics, Inc. (company) — Registrant
• December 2, 2024 (date) — Date of earliest event reported
• 001-41740 (company) — Commission File Number
• 93-4958665 (company) — I.R.S. Employer Identification No.
• Waltham, MA (location) — Principal Executive Offices

FAQ

Key Financial Figures

• $0.00001 — ch registered Common Stock, par value $0.00001 per share APGE The Nasdaq Global Ma
• $50B — other opportunity to disrupt the future $50B+ AD market that is currently served by

Filing Documents

• tm2429855d1_8k.htm (8-K) — 47KB
• tm2429855d1_ex99-1.htm (EX-99.1) — 28KB
• tm2429855d1_ex99-1img001.jpg (GRAPHIC) — 6KB
• 0001104659-24-124279.txt ( ) — 270KB
• apge-20241202.xsd (EX-101.SCH) — 3KB
• apge-20241202_lab.xml (EX-101.LAB) — 33KB
• apge-20241202_pre.xml (EX-101.PRE) — 22KB
• tm2429855d1_8k_htm.xml (XML) — 4KB

01

Item 7.01 Regulation FD Disclosure. On December 2, 2024, Apogee Therapeutics, Inc. (the Company or Apogee) issued a press release titled "Apogee Therapeutics Highlights Progress and Best in Class Potential of Novel Biologic Programs for I&I Diseases at 2024 Inaugural R&D Day." The Company will host its Virtual R&D Day via webcast today, Monday, December 2, 2024, at 10:00 am, Eastern Time. The Company will be posting to its website the presentation to be used in the Company's Virtual R&D Day. The presentation and replays of the webcast will be available on the Company's website at https://apogeetherapeutics.com. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein. The exhibit furnished under Item 7.01 of this Current Report on Form 8-K 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 it 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.

01

Item 8.01 Other Events. On December 2, 2024, the Company will host a Virtual R&D Day and provide an update on its APG808 Phase 1 trial, share additional data up to 12 months from the APG777 Phase 1 trial, share details around the Company's strategy for combinations in atopic dermatitis (AD), asthma and chronic obstructive pulmonary disease (COPD) to deliver better efficacy and dosing regimens, and share the expected significant commercial potential of its programs. The updates to be provided include: APG808 interim Phase 1 healthy volunteer trial results The APG808 Phase 1 trial enrolled 32 healthy adult participants into four single-ascending dose (SAD) cohorts. The Company shared interim data from all four SAD cohorts with at least 3-months follow-up: APG808 demonstrated a potential best-in-class PK profile, including a half-life of approximately 55 days, supporting the potential for every 2- to 3- month maintenance dosing. Single doses of APG808 demonstrated a deep and sustained effect on pharmacodynamic (PD) markers out to ~3 months (longest follow-up available at time of data cut). APG808 was well tolerated across all dose groups. The Company is also now evaluating APG808 in a Phase 1b trial in patients with asthma, with data expected in the first half of 2025. Accelerating a leading franchise in AD The Company is advancing multiple opportunities for best-in-class monotherapy and first-in-class combination approaches for the treatment of AD that could provide transformational dosing and efficacy compared to current approved and investigational biologics. APG777 APG777 is a novel, subcutaneous (SQ) extended half-life monoclonal antibody (mAb) targeting IL-13 with the potential for best-in-class efficacy and dosing compared to currently approved biologics. APG777 is being evaluated in an ongoing Phase 1 trial, which initiated in August 2023, and a global Phase 2 trial in AD, which initiated in May 2024. The Company provided updated data from

Financial Statements and

Financial Statements and Exhibits. (d) Exhibits . The following exhibit is being furnished herewith: EXHIBIT INDEX Exhibit No. Description 99.1 Press Release, dated December 2, 2024 104 Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

SIGNATURES 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: December 2, 2024 By: /s/ Michael Henderson, M.D. Michael Henderson, M.D. Chief Executive Officer

View Full Filing

View this 8-K filing on SEC EDGAR