Apogee Therapeutics Files 8-K Corporate Update

TL;DR

APGE filed an 8-K on 12/10/24 - check for corporate updates.

AI Summary

On December 10, 2024, Apogee Therapeutics, Inc. filed an 8-K report detailing a corporate update. The company, located at 221 Crescent Street, Waltham, MA, 02453, provided information regarding its ongoing operations and strategic direction. This filing serves as a current report under the Securities Exchange Act of 1934.

Why It Matters

This 8-K filing provides a formal update on Apogee Therapeutics' corporate activities, which could include significant business developments or regulatory disclosures relevant to investors.

Risk Assessment

Risk Level: low — This filing is a routine 8-K for a corporate update and does not appear to contain immediate negative financial news or significant strategic shifts.

Key Players & Entities

• Apogee Therapeutics, Inc. (company) — Registrant
• 221 Crescent Street, Building 17, Suite 102b, Waltham, MA, 02453 (location) — Principal Executive Offices
• December 10, 2024 (date) — Date of earliest event reported

FAQ

Key Financial Figures

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

Filing Documents

• tm2430568d1_8k.htm (8-K) — 31KB
• tm2430568d1_ex99-1.htm (EX-99.1) — 13KB
• tm2430568d1_ex99-1img001.jpg (GRAPHIC) — 5KB
• 0001104659-24-127004.txt ( ) — 233KB
• apge-20241210.xsd (EX-101.SCH) — 3KB
• apge-20241210_lab.xml (EX-101.LAB) — 33KB
• apge-20241210_pre.xml (EX-101.PRE) — 22KB
• tm2430568d1_8k_htm.xml (XML) — 4KB

01

Item 7.01 Regulation FD Disclosure. On December 10, 2024, Apogee Therapeutics, Inc. (the Companyor Apogee) issued a press release announcing that it has initiated dosing of healthy volunteers in its clinical trial of APG333, a novel, subcutaneous half-life extended monoclonal antibody targeting thymic stromal lymphopoietin, which is being evaluated initially as a treatment for people living with asthma, chronic obstructive pulmonary disease (COPD) and broader inflammatory and immunology (I&I) conditions. 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 10, 2024, the Company announced that it has initiated dosing of healthy volunteers in its clinical trial for APG333, a novel, subcutaneous half-life extended monoclonal antibody targeting thymic stromal lymphopoietin, which is being evaluated initially as a treatment for people living with asthma, COPD and broader I&I conditions. The APG333 Phase 1 clinical trial is 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 pharmacokinetics of APG333 and is expected to enroll approximately 32 healthy adults into four cohorts. Apogee expects interim data from the trial in the second half of 2025. 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 product candidates and programs, its plans for current and future clinical trials, including a Phase 1 clinical trial for APG333; Apogee's plans for clinical trial design; the anticipated timing of the initiation of and results from Apogee's clinical trials, including data from Apogee's Phase 1 clinical trial of APG333; and the potential clinical benefit and half-life of APG333 and any other potential programs, including combination therapies. Words such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "develop," "plan" or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Apogee believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on

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 December 10, 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 10, 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