Foghorn Therapeutics Provides Financial Update for 2024 and 2025 Strategic Outlook

Rhea-AI Summary

Foghorn Therapeutics (FHTX) provided its financial update and 2024-2025 outlook, highlighting continued progress in its clinical programs. The company's lead candidate, FHD-909, a first-in-class oral selective SMARCA2 inhibitor, began Phase 1 trials for SMARCA4 mutated cancers in October 2024, focusing primarily on non-small cell lung cancer (NSCLC).

The company achieved selective degradation of ARID1B and is advancing its Selective CBP degrader and EP300 degrader programs. Preclinical combination data with pembrolizumab and KRAS inhibitors will be presented at AACR 2025.

Financial highlights show collaboration revenues of $22.6 million for 2024 (down from $34.2M in 2023), R&D expenses of $94.5 million (down from $109.7M), and a net loss of $86.6 million (improved from $98.4M). The company maintains a strong balance sheet with $243.7 million in cash and equivalents, providing runway into 2027.

Positive

• Strong cash position of $243.7M providing runway into 2027
• Reduced net loss to $86.6M from $98.4M year-over-year
• Successfully initiated Phase 1 trial of FHD-909 in October 2024
• Achieved selective degradation of ARID1B, addressing 5% of all solid tumors

Negative

• Collaboration revenues declined 34% to $22.6M from $34.2M
• Merck collaboration agreement terminated in 2023

Insights

Oncology Expert

Foghorn Therapeutics' latest financial and strategic update reveals meaningful progress in its pioneering gene expression modification platform with substantial implications for specific cancer populations.

The advancement of FHD-909, their first-in-class SMARCA2 inhibitor, into clinical trials represents a significant milestone. This compound targets a synthetic lethal vulnerability in SMARCA4-mutated cancers, present in approximately 10% of non-small cell lung cancers. The mechanistic approach is particularly promising because SMARCA4 mutations typically confer worse prognosis in NSCLC, creating a clear unmet medical need with a well-defined patient population.

What's most scientifically impressive is Foghorn's achievement in selective paralog targeting across their pipeline. The company has overcome substantial technical challenges in:

• Selectively inhibiting SMARCA2 while sparing SMARCA4 despite high homology
• Selectively degrading CBP while sparing EP300 (and vice versa)
• Achieving selective degradation of ARID1B, a non-enzymatic target previously considered undruggable

The ARID1B degrader program deserves special attention as it addresses a synthetic lethal vulnerability present in ~5% of all solid tumors with ARID1A mutations, including ovarian, endometrial, colorectal, and bladder cancers.

Financially, Foghorn's $243.7 million cash position provides runway into 2027, sufficient to reach multiple clinical inflection points. The 12% improvement in net loss ($86.6M vs $98.4M) while advancing multiple programs indicates responsible cash management.

The upcoming data presentations at AACR 2025 will be critical in validating the combination potential of FHD-909 with pembrolizumab and KRAS inhibitors, potentially addressing resistance mechanisms. For investors, the multiple shots on goal across different chromatin regulatory targets, strong balance sheet, and Lilly partnership validation create a positive outlook for this emerging precision oncology player.

Financial Analyst

Foghorn's financial results and pipeline update demonstrate the kind of operational execution that distinguishes successful clinical-stage biotechs in challenging market conditions.

The company's $243.7 million cash position, providing runway into 2027, represents approximately 3 years of operating capital at current burn rates. This extended runway is particularly valuable given the company's multiple upcoming catalysts and the typically unpredictable nature of clinical development timelines.

What's most impressive is Foghorn's ability to simultaneously:

• Reduce R&D expenses by 14% to $94.5M
• Cut G&A expenses by 12% to $28.4M
• Advance multiple programs across different stages of development
• Improve bottom line with net loss reduction of 12%

The financial efficiency gains appear to be structural rather than temporary, driven by strategic focus and headcount optimization rather than simply delaying program investments.

The Lilly partnership provides significant validation and financial leverage through the 50/50 co-development structure for the SMARCA2 program. This arrangement allows Foghorn to potentially reach commercialization while maintaining substantial economics in their lead program.

From a portfolio perspective, Foghorn's pipeline features multiple shots on goal addressing distinct but related biological mechanisms, creating a balanced risk profile. The company's focus on synthetic lethality in well-defined genetic contexts (SMARCA4 mutations, ARID1A mutations) targets patient populations with clear unmet needs and potentially streamlined regulatory pathways.

With upcoming data presentations at AACR 2025 and program updates expected throughout the year, Foghorn has positioned itself well financially to reach several value-creating inflection points while maintaining capital efficiency - a rare combination in the biotech sector.

First-in-class oral selective SMARCA2 (BRM) inhibitor FHD-909 (LY4050784) continues enrollment in Phase 1 trial for SMARCA4 (BRG1) mutated cancers, with non-small cell lung cancer (NSCLC) as the primary target population

FHD-909 preclinical combination data with pembrolizumab and KRAS inhibitors to be presented at AACR 2025

Selective degradation of ARID1B achieved with program update expected in 2025; continued progress of Selective CBP degrader and Selective EP300 degrader towards IND

Strong balance sheet with cash, cash equivalents, and marketable securities of
$243.7 million as of December 31, 2024, provides cash runway into 2027

CAMBRIDGE, Mass., March 06, 2025 (GLOBE NEWSWIRE) -- 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 update and corporate outlook in conjunction with the Company’s 10-K filing for the year ending December 31, 2024. 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.

“In 2024, we continued our strong execution across our pipeline, which has set us up for an exciting 2025. The Phase 1 trial of FHD-909, a first-in-class oral selective SMARCA2 inhibitor for SMARCA4 mutated cancers with NSCLC as the primary target population, is enrolling well. Preclinical combination data of FHD-909 with pembrolizumab and novel KRAS inhibitors will be presented at AACR,” said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. “We are continuing to progress our Selective CBP degrader and Selective EP300 degrader towards IND and will present additional preclinical data at AACR. Our Selective ARID1B degrader program, which addresses a synthetic lethal target implicated in up to 5% of all solid tumors, continues to make exciting advancements, and we expect to provide a program update later in 2025. Our balance sheet remains strong, and we look forward to sharing progress for programs throughout the year.”

Recent Corporate Updates

Dosed first patient with FHD-909 in October 2024. The first patient was dosed with FHD-909 in the Phase 1 open-label, multicenter trial for SMARCA4 mutated cancers, with non-small cell lung cancer (NSCLC) as the primary target patient population, in October 2024.

Selective degradation of ARID1B achieved. Earlier this year, Foghorn announced that the company has achieved selective degradation of ARID1B and will provide a program update during 2025.

Presented at the 7th Annual Targeted Protein Degradation (TPD) Summit. In October 2024, Foghorn participated in multiple sessions at the 7th Annual TPD Summit, including a CEO Think Tank keynote session entitled "A Strategic Look at Targeted Protein Degradation & Induced Proximity Field" featuring Foghorn’s CEO Adrian Gottschalk, and a presentation by Steve Bellon, Foghorn’s Chief Scientific Officer on the recent developments from Foghorn’s degrader pipeline.

Program Overview and Upcoming Milestones

FHD-909 (LY4050784). FHD-909 is a first-in-class oral selective SMARCA2 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 alone and implicated in a significant number of solid tumors. Patients diagnosed with NSCLC with a SMARCA4 mutation tend to have a worse prognosis.

• Advancing Phase 1 trial. First patient dosed in October 2024 in the Phase 1 trial for FHD-909 in SMARCA4 mutated cancers, with NSCLC as the primary target population.
  • Ongoing first-in-human Phase 1a/b open-label, multicenter trial design for FHD-909 will be presented at the AACR Annual Meeting (April 25-30, 2025).
• Preclinical combination data to be presented. In 2025, preclinical data for FHD-909 in combination with pembrolizumab and KRAS inhibitors will be presented at the AACR Annual Meeting (April 25-30, 2025).
  

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

Selective CBP degrader program. Selectively targets EP300 mutated cancers, including bladder, gastric, and endometrial cancers. CBP and EP300 are highly similar acetyltransferases that create a synthetic lethal relationship when EP300 is mutated. 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 limited by hematopoietic toxicity.

• Identified potent and selective CBP protein degraders. Pharmacodynamic and pharmacokinetic preclinical data demonstrate:
  • Deep and sustained CBP degradation significantly inhibited tumor growth in mouse xenograft solid tumor models.
  • Robust monotherapy preclinical anti-tumor activity that was not associated with significant body weight loss, thrombocytopenia, or anemia.
  • Long-acting injection formulation that resulted in tumor regression from a single dose in a mouse xenograft efficacy study.
• Preclinical combination data to be presented. In 2025, preclinical data for the Selective CBP degrader program, in combination with approved chemotherapeutics and targeted agents, will be presented at the AACR Annual Meeting (April 25-30, 2025).

Selective EP300 degrader program. Selective degradation of EP300 for the treatment of hematopoietic malignancies and prostate cancer. Attempts to selectively drug EP300 have been challenging due to the high level of similarity between EP300 and CBP, while dual inhibition of CBP/EP300 has been limited by hematopoietic toxicity. EP300 lineage dependencies are established in multiple myeloma and diffuse large B cell lymphoma.

• Identified potent and selective EP300 degraders and advancing oral degrader efforts. Pharmacodynamic and pharmacokinetic preclinical data demonstrate candidates:
  • Are well tolerated in vivo with no observed decrease in platelet levels, and no effects on megakaryocyte viability at pharmacologically relevant concentrations in ex vivo studies.
  • Have robust anti-tumor activity in solid tumors and hematological malignancies, including prostate cancer, multiple myeloma, and diffuse large B cell lymphoma.
    
• Preclinical data in hematological malignancies to be presented. In 2025, preclinical data for the Selective EP300 degrader program demonstrating biological activity in hematological malignancies will be presented at the AACR Annual Meeting (April 25-30, 2025).
  

Selective ARID1B degrader program. Selectively targets and degrades ARID1B in ARID1A-mutated cancers. ARID1A is the most mutated subunit in the BAF complex and amongst the most mutated proteins in cancer. These mutations lead to a dependency on ARID1B in several types of cancer, including ovarian, endometrial, colorectal, and bladder. Attempts to selectively drug ARID1B have been challenging because of the high degree of similarity between ARID1A and ARID1B and the fact that ARID1B has no enzymatic activity to target.

• ARID1B is a major synthetic lethal target implicated in up to 5% of all solid tumors.
• Developed highly potent and selective binders. Preclinical data demonstrated potent and selective small molecule binders to ARID1B.
• Selective degradation of ARID1B achieved. Foghorn has successfully selectively degraded ARID1B.
• Selective ARID1B degrader program update expected in 2025.

Chromatin biology and degrader platform. Foghorn continues to advance its chromatin biology and degrader platform with investments in novel ligases, long-acting injectables, oral delivery and induced proximity.

Full Year 2024 Financial Highlights

• Collaboration revenues. Collaboration revenues were $22.6 million for the year ended December 31, 2024, compared to $34.2 million for the year ended December 31, 2023. The decrease year-over-year was primarily driven by revenue recognized under the Merck collaboration due to the termination of the agreement in 2023 and subsequent recognition of the remaining deferred revenue.
  
• Research and development expenses. Research and development expenses were $94.5 million for the year ended December 31, 2024, compared to $109.7 million for the year ended December 31, 2023. This decrease was primarily due to costs associated with decreased headcount, partially offset by an increase in spend in our Lilly collaboration programs.
  
• General and administrative expenses. General and administrative expenses were $28.4 million for the year ended December 31, 2024, compared to $32.4 million for the year ended December 31, 2023. This decrease was primarily due to costs associated with decreased headcount.
  
• Net loss. Net loss was $86.6 million for the year ended December 31, 2024, compared to a net loss of $98.4 million for the year ended December 31, 2023.
  
• Cash, cash equivalents and marketable securities. As of December 31, 2024, the Company had $243.7 million in cash, cash equivalents and marketable securities, providing cash runway into 2027.
  

About FHD-909
FHD-909 (a.k.a. LY4050784) is a highly potent, allosteric and orally available small molecule that selectively inhibits the ATPase activity of BRM (SMARCA2) over its closely related paralog BRG1 (SMARCA4), two proteins that are the catalytic engines across all forms of the BAF complex, one of the key regulators of the chromatin regulatory system. In preclinical studies, tumors with mutations in BRG1 rely on BRM for BAF function. FHD-909 has shown significant anti-tumor activity across multiple BRG1-mutant lung tumors.

About Foghorn Therapeutics
Foghorn^® Therapeutics is discovering and developing a novel class of medicines targeting genetically determined dependencies within the chromatin regulatory system. Through its proprietary scalable Gene Traffic Control^® platform, Foghorn is systematically studying, identifying and validating potential drug targets within the chromatin regulatory system. The Company is developing multiple product candidates in oncology. Visit our website at www.foghorntx.com for more information on the Company, and follow us on X and LinkedIn.

Forward-Looking Statements
This press release contains “forward-looking statements.” Forward-looking statements include statements regarding the Company’s clinical trials, product candidates and research efforts and other statements identified by words such as “could,” “may,” “might,” “will,” “likely,” “anticipates,” “intends,” “plans,” “seeks,” “believes,” “estimates,” “expects,” “continues,” “projects” and similar references to future periods. Forward-looking statements are based on our current expectations and assumptions regarding capital market conditions, our business, the economy and other future conditions. Because forward-looking statements relate to the future, by their nature, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. As a result, actual results may differ materially from those contemplated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include regional, national or global political, economic, business, competitive, market and regulatory conditions, including risks relating to our clinical trials and other factors set forth under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission. Any forward-looking statement made in this press release speaks only as of the date on which it is made.

Condensed Consolidated Balance Sheets
(In thousands)
	Dec. 31, 2024				Dec. 31, 2023
Cash, cash equivalents and marketable securities	$	243,747			$	234,057
All other assets		40,235				51,859
Total assets	$	283,982			$	285,916
Deferred revenue, total	$	280,063			$	302,665
All other liabilities		49,447				60,441
Total liabilities		329,510				363,106
Total stockholders’ deficit		(45,528	)			(77,190	)
Total liabilities and stockholders’ deficit	$	283,982			$	285,916

Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
	Twelve Months Ended December 31,
		2024				2023
Collaboration revenue	$	22,602			$	34,155
Operating expenses:
Research and development		94,528				109,689
General and administrative		28,359				32,372
Impairment of long-lived assets		2,398				—
Total operating expenses		125,285				142,061
Loss from operations		(102,683	)			(107,906	)
Total other income, net		16,063				13,706
Loss before income taxes		(86,620	)			(94,200	)
Provision for income taxes		—				(4,226	)
Net loss	$	(86,620	)		$	(98,426	)
Net loss per share attributable to common stockholders—basic and diluted	$	(1.58	)		$	(2.34	)
Weighted average common shares outstanding—basic and diluted		54,899,432				41,974,484

Contact:

Karin Hellsvik, Foghorn Therapeutics Inc.
khellsvik@foghorntx.com

FAQ

What is the current cash position of Foghorn Therapeutics (FHTX) and how long will it last?

FHTX has $243.7 million in cash, cash equivalents, and marketable securities as of December 31, 2024, providing runway into 2027.

When did FHTX begin Phase 1 trials for FHD-909 and what is its target?

FHTX dosed its first patient with FHD-909 in October 2024, targeting SMARCA4 mutated cancers, primarily non-small cell lung cancer (NSCLC).

How did Foghorn's (FHTX) financial performance change in 2024 compared to 2023?

FHTX's net loss improved to $86.6M from $98.4M, while revenues decreased to $22.6M from $34.2M, and R&D expenses reduced to $94.5M from $109.7M.

What upcoming milestones does FHTX have planned for 2025?

FHTX will present FHD-909 combination data with pembrolizumab and KRAS inhibitors at AACR 2025, and provide an ARID1B degrader program update later in 2025.