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Foghorn Therapeutics Inc

For the period ended Sep 30, 2024. Filed Nov 4, 2024.

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About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2024 · Filed Nov 4, 2024

FHTX$1.87-1.8%Stored close · as of Nov 6, 2026
See the whole filing, with its images and exhibits

Table of Contents

Page
PART I.FINANCIAL INFORMATION1
Item 1.Financial Statements (Unaudited)1
Condensed Consolidated Balance Sheets1
Condensed Consolidated Statements of Operations and Comprehensive Loss2
Condensed Consolidated Statements of Stockholders’ Equity (Deficit)3
Condensed Consolidated Statements of Cash Flows4
Notes to Unaudited Condensed Consolidated Financial Statements5
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations13
Item 3.Quantitative and Qualitative Disclosures About Market Risk21
Item 4.Controls and Procedures21
PART II.OTHER INFORMATION22
Item 1.Legal Proceedings22
Item 1A.Risk Factors22
Item 5.Other Information22
Item 6.Exhibits23
Signatures24

i

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning:

the initiation, timing, progress, enrollment, results, and timing of results and regulatory filings of our research and development programs and our preclinical and clinical studies, including preclinical programs partnered under our collaboration with Eli Lilly and Company (“Lilly”), the ongoing Phase 1 clinical trial of FHD-286 in combination with decitabine in relapsed and/or refractory AML patients and the ongoing Phase 1 dose escalation study of FHD-909 for SMARCA4 mutated cancers with Lilly;

our ability to advance any product candidates that we may develop and to successfully complete preclinical and clinical studies;

our ability to leverage our initial programs to develop additional product candidates using our Gene Traffic Control® platform;

developments related to our competitors and our industry;

our ability to expand the target populations of our programs and the availability of patients for clinical testing;

our ability to obtain regulatory approval for FHD-286, FHD-909 and any future product candidates from the U.S. Food and Drug Administration (the “FDA”) and other regulatory authorities;

our ability to identify and enter into future license agreements and collaborations;

our ability to continue to rely on our contract development and manufacturing organizations (“CDMOs”) or contract research organizations (“CROs”), including those located outside the United States, such as those located in China, for our manufacturing and research needs;

regulatory developments in the United States and foreign countries;

general economic conditions, including recessionary conditions, interest rates, monetary fluctuations and supply chain constraints;

the impact of inflation and interest rates on our operation and our ability to raise additional capital;

the expected trends in our expenses and capital requirements as they relate to our ongoing activities;

geopolitical instability and armed conflict, including those in Asia, Ukraine, Gaza, and the Red Sea;

our ability to attract and retain key scientific and management personnel; and

the scope of protection we are able to establish, maintain and enforce for intellectual property rights covering FHD-286, FHD-909, our future products and our Gene Traffic Control platform.

The forward-looking statements in this Quarterly Report on Form 10-Q are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to a number of known and unknown risks, uncertainties and assumptions, including those described under the section entitled “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. Moreover, we operate in an evolving environment. New risks and uncertainties may emerge from time to time, and it is not possible for management to predict all risks and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

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The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.