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EX-99.1

2 ex991earningspressrelease0.htm

EX-99.1

Document

Exhibit 99.1

Foghorn Therapeutics Provides First Quarter 2026 Financial and Corporate Update

- FHD-909 (LY4050784) Phase 1 dose-escalation trial on track; preclinical combination data with anti-PD-1 antibody demonstrates potential for robust and durable regression with anti-tumor immune memory

- Selective CBP degrader FHT-171 advancing for the treatment of ER+ breast cancer with IND anticipated in 2027

-Selective EP300 degraders with potential in multiple myeloma and other hematological malignancies with IND anticipated in 2027

- Strong balance sheet with cash, cash equivalents, and marketable securities of approximately

$184 million; cash runway into the first half of 2028

WATERTOWN, Mass. -- (GLOBE NEWSWIRE) – May 7, 2026 -- Foghorn® Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines that treat serious diseases by correcting abnormal gene expression, today provided a financial and corporate update in conjunction with the Company’s 10-Q filing for the quarter ended March 31, 2026. With an initial focus in oncology, Foghorn’s Gene Traffic Control® Platform and resulting broad pipeline have the potential to transform the lives of people suffering from a wide spectrum of diseases.

“Our lead program, FHD-909, continues to advance through dose escalation in collaboration with Lilly. The trial is enriching for NSCLC patients with SMARCA4 mutations, where outcomes remain especially poor and deteriorate with later lines of therapy,” said Adrian Gottschalk, President and Chief Executive Officer of Foghorn Therapeutics. “At this year’s American Association for Cancer Research (AACR) Annual Meeting, we presented compelling preclinical data demonstrating the potential of FHD-909 in combination with an anti-PD-1 antibody to drive complete, durable tumor regression and anti-tumor immune memory.”

Mr. Gottschalk continued, “Across our wholly owned pipeline, we reported new preclinical data highlighting strong anti-tumor activity and tolerability for our Selective CBP degrader FHT-171 in heavily pretreated ER+ breast cancer models, improved safety and efficacy versus clinical benchmark for our Selective EP300 degrader in multiple myeloma, and robust target degradation with potential for oral bioavailability for our cereblon-based selective ARID1B degraders. Together, these programs expand our reach in difficult-to-treat cancers, and we look forward to sharing further progress throughout the year.”

Program Overview and Upcoming Milestones

FHD-909 (LY4050784). FHD-909 is a first-in-class oral SMARCA2 selective inhibitor that has demonstrated in preclinical studies to have high selectivity over its closely related paralog SMARCA4, two proteins that are the catalytic engines across all forms of the BAF complex. Selectively blocking SMARCA2 activity is a promising synthetic lethal strategy intended to induce tumor death while sparing healthy cells. SMARCA4 is mutated in up to 10% of NSCLC patients and implicated in a significant number of solid tumors. Across lines of therapy, significant unmet needs remain for patients with SMARCA4 (BRG1)-mutant cancers with both poor response rates and short progression-free survival.

•Phase 1 trial on track. Enrollment in the first-in-human Phase 1 multi-center trial of FHD-909 is progressing well. The trial in patients with NSCLC as the primary target population is on track, following the dosing of the first patient in October 2024.

•Robust and durable preclinical data for FHD-909 plus anti-PD-1 antibody. New preclinical data presented at AACR demonstrated complete regression in preclinical syngeneic efficacy models of FHD-909 in combination with an anti-PD-1 antibody, with tumors failing to regrow after dosing halted. An immune memory effect was supported by tumor rejection upon rechallenge in animals treated with FHD-909 plus an anti-PD-1 antibody.

•Pending the decision to move into dose expansion portion of trial, Foghorn and Lilly anticipate evaluating FHD-909 in combination studies in the front-line setting of NSCLC.

Ongoing strategic collaboration with Lilly. Foghorn is collaborating with Lilly to develop novel oncology medicines, including a 50/50 U.S. co-development and co-commercialization agreement for its selective SMARCA2 oncology program that includes both a selective inhibitor and a selective degrader, as well as an additional undisclosed oncology target. The collaboration also includes three discovery programs from Foghorn’s proprietary Gene Traffic Control® platform.

Selective CBP degrader program. Foghorn's Selective CBP degrader targets CBP, an acetyltransferase closely related to EP300. CBP lineage dependencies are established in several cancers, including breast cancer. Attempts to selectively drug CBP have been challenging due to the high level of similarity between the two proteins, while dual inhibition of CBP/EP300 has been associated

fhtx-20260311false000182246200018224622026-03-112026-03-11

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): March 11, 2026

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.)

99 Coolidge Avenue, Ste 500 Watertown, MA 02472 (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. ☐

Item 2.02 Results of Operations and Financial Condition. On March 11, 2026, Foghorn Therapeutics Inc. (the “Company”) issued a press release announcing certain of the Company’s financial results for the year ended December 31, 2025. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information in this Item 2.02 (including Exhibit 99.1 attached hereto) is being furnished and shall not be deemed “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 into any filing by the Company under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 7.01    Regulation FD Disclosure

The Company is furnishing as Exhibit 99.2 to this Current Report on Form 8-K a presentation, dated March 2026, which the Company intends to use in meetings with or presentations to investors. The information in this Item 7.01 (including Exhibit 99.2 attached hereto) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing by the Company under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01    Financial Statements and Exhibits. (d) Exhibits

Exhibit No.Description 99.1 Press Release issued on March 11, 2026

99.2 Investor Presentation dated March 2026

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/ Ryan Maynard Ryan Maynard Chief Financial Officer

Date: March 11, 2026