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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 15, 2024

 

 

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 x

 

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 15, 2024, Apogee Therapeutics, Inc. (the “Company”) issued a press release announcing that it has initiated dosing in patients with moderate-to-severe atopic dermatitis (“AD”) in its Phase 2 clinical trial for APG777, a novel, subcutaneously-administered half-life extended monoclonal antibody targeting IL-13 – a critical cytokine in inflammation and a primary driver of AD. 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.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits. The following exhibit is being furnished herewith:

 

EXHIBIT INDEX

 

Exhibit
No.
  Description
   
99.1   Press Release, dated May 15, 2024
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: May 15, 2024 By: /s/ Michael Henderson, M.D.
  Name:  Michael Henderson, M.D.
  Title:  Chief Executive Officer