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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): April 24, 2023

________________________________________________________________________________________________

Foghorn Therapeutics Inc.

(Exact name of registrant as specified in its charter)

________________________________________________________________________________________________

Delaware

001-39634

47-5271393

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer Identification No.)

500 Technology Square, Ste 700

Cambridge,

MA

02139

(Address of principal executive offices)

(Zip Code)

(Registrant’s telephone number, including area code): (617) 586-3100

Not Applicable

(Former name or former address, if changed since last report)

________________________

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, $0.0001 par value per share

FHTX

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. ☐

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Item 8.01 Other Events.

On April 24, 2023, Foghorn Therapeutics Inc. (the "Company") issued a press release providing an update on the Company's FHD-609 program in synovial sarcoma and SMARCB1-deleted tumors. The Company announced that enrollment of the dose escalation portion of the study has been completed and a maximum tolerated dose has been identified. The Company also announced that it is pausing enrollment in the study following a grade 4 QTc prolongation event in a synovial sarcoma patient at the second highest dose. After communicating the enrollment pause to U.S. and European regulators, the Food and Drug Administration placed the study on partial clinical hold in the United States, while allowing patients currently enrolled and benefiting from therapy to continue dosing. The Company further announced that it is not at this time planning to pursue a dose expansion study independently.

A copy of the press release is attached to this Current Report as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01    Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.			Description
99.1			Press Release issued on April 24, 2023

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.

 

			FOGHORN THERAPEUTICS INC.
			By:						/s/ Allan Reine
									Allan Reine, M.D.
									Chief Financial Officer

Date: April 24, 2023

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