Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Commission File Number: 001-39634 ______________________ Foghorn Therapeutics Inc. (Exact Name of Registrant as Specified in its Charter) ______________________ FORM 10-Q _____________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT ...

Financial Performance - Foghorn Therapeutics reported collaboration revenue of $6.0 million for Q1 2025, up from $5.1 million in Q1 2024, driven by advancements in programs under the Lilly Collaboration Agreement[15] - Research and development expenses decreased to $21.6 million in Q1 2025 from $25.5 million in Q1 2024, attributed to reduced costs in FHD-286 and personnel-related expenses[15] - General and administrative expenses were $7.2 million for Q1 2025, down from $7.7 million in Q1 2024, primarily due to lower consulting costs[19] - The net loss for Q1 2025 was $18.8 million, compared to a net loss of $25.0 million in Q1 2024, reflecting improved financial performance[19] - As of March 31, 2025, Foghorn had cash, cash equivalents, and marketable securities totaling $220.6 million, providing a cash runway into 2027[19] Clinical Development - The ongoing Phase 1 trial of FHD-909 is targeting SMARCA4 mutated cancers, with non-small cell lung cancer (NSCLC) as the primary focus[5] - FHD-909 has shown synergistic activity in combination with pembrolizumab and KRAS inhibitors, supporting further clinical exploration[1] - The Selective CBP degrader program is on track for IND-enabling studies, targeting an IND submission in 2026[1] - Foghorn's Selective EP300 degrader program demonstrated anti-proliferative activity in various hematological malignancies, with updates expected in H2 2025[14] - The company has successfully achieved selective degradation of ARID1B and plans to provide an update on this program in H2 2025[15]

CAMBRIDGE, Mass., May 01, 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 announced the election of Neil Gallagher, M.D., Ph.D., and Stuart Duty, to its Board of Directors. “Neil and Stuart are experienced leaders with decades of deep and multifaceted understanding of the biotechnology industry,” said Adrian Gottschalk, President and Chief E ...

Financial Data and Key Metrics Changes - The company reported a strong cash position of $243 million as of December 2024, providing a cash runway into 2027 [42] Business Line Data and Key Metrics Changes - FHD-909 is highlighted as a highly selective oral inhibitor of SMARCA2, with multibillion-dollar potential, particularly targeting SMARCA4 mutated non-small cell lung cancer [5][6] - The collaboration with Eli Lilly, initiated in December 2021, is noted as one of the largest deals for preclinical programs in the industry, with significant upfront payment and downstream participation for the company [7] Market Data and Key Metrics Changes - SMARCA4 mutations are found in approximately 5% of all human cancers, with non-small cell lung cancer showing about 10% prevalence of these mutations [11] - The median overall survival for patients with SMARCA4 mutations in metastatic non-small cell lung cancer is reported at 8 months, compared to 15 months for wild-type counterparts [12] Company Strategy and Development Direction - The company aims to develop FHD-909 as a standard frontline therapy for patients with non-small cell lung cancer harboring SMARCA4 mutations, addressing a significant unmet medical need [28][29] - The strategy includes defining the potential added benefit of FHD-909 in combination with leading therapies such as pembrolizumab and platinum-based combinations [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of FHD-909 to change the treatment landscape for patients with SMARCA4 mutations, emphasizing the urgent need for novel agents in this area [29] - The company is focused on advancing its proprietary pipeline programs, including selective CBP and EP300 degraders, which are expected to enhance its position in oncology [31][32] Other Important Information - The company is currently enrolling patients in the monotherapy dose-finding portion of the FHD-909 study, with plans for combination studies in anticipation of successful dose escalation [29] - The proprietary pipeline includes three additional programs that are advancing toward the clinic, showcasing the company's commitment to innovative cancer therapies [31] Q&A Session Summary Question: Can you enrich the backfill cohorts for specific characteristics? - Yes, the company can select specific doses and backfill those levels with specific indications and SMARCA4 alterations [45] Question: How will trial progress be communicated? - The company intends to align with Eli Lilly on clinical data disclosure, aiming to communicate results at the end of dose escalation [46] Question: Are SMARCA4 alterations detectable through standard panels? - Yes, SMARCA4 alterations can be detected using conventional FDA-approved NGS panels and immunohistochemistry [61] Question: What is the therapeutic index for FHD-909? - The dosing holidays at the higher dose were due to accumulation in rodents, not a lack of tolerability, indicating a favorable therapeutic window [62] Question: What is the potential for the ARED1B degrader program? - The company is excited about the selective degradation of ARED1B and is waiting for a complete story before disclosing further updates [74] Question: Will there be partnerships for the proprietary pipeline? - The company is not in a rush to partner but anticipates that strategic partnerships will be beneficial as they progress their proprietary pipeline [76]

AACR April 2025 April 29, 2025 • Targeting SMARCA2-Dependent Tumors with FHD-909 (LY4050784) • Advancing Multiple Additional First-in-Class Anticancer Agents Forward Looking Statements This presentation 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 presentation are forward- looking statements. In some cases, you can identify forward-loo ...

- FHD-909 (LY4050784) advancing in Phase 1 trial in SMARCA4 (BRG1) mutated cancers, with non-small cell lung cancer (NSCLC) as the primary target population - Preclinical synergistic anti-tumor activity of FHD-909 in combination with pembrolizumab and KRAS inhibitors supports clinical exploration - Selective CBP degrader combination approaches show promise in preclinical ER+ breast cancer models - Further preclinical characterization of the therapeutic potential of the Selective EP300 degrader program to t ...

Core Insights - Etiome has launched an AI-powered platform called Temporal Biodynamics™, which is the first end-to-end solution designed to detect diseases and preempt their progression before they become severe [1][7] - The company has received an initial investment of $50 million from Flagship Pioneering to develop this platform and its initial pipeline of preemptive medicines [1][8] - Etiome aims to shift healthcare practices from reactive to preemptive, focusing on serious and progressive diseases such as metabolic, neurodegenerative, pre-cancerous, and autoimmune diseases [3][4] Company Overview - Etiome was founded as part of Flagship Pioneering's Preemptive Health and Medicine Initiative, which seeks to improve health outcomes by preventing diseases before they manifest [1][6] - The company utilizes a combination of multimodal population-level data and single-cell omics, enhanced by artificial intelligence, to gain insights into disease progression [2][4] - Etiome's founding team includes experts in biology, omics, and AI, with leadership from notable figures such as Avak Kahvejian and Scott Lipnick [4][5] Technology and Innovation - The Temporal Biodynamics™ platform allows for the accurate characterization of disease biostages and the identification of stage-specific biomarkers, known as Biostage Markers [2][3] - The platform's proprietary phenotype-aware AI isolates temporal shifts in genes and proteins, enabling the development of targeted medicines that can alter disease progression [2][3] - Etiome's approach is designed to ensure that patients receive the right treatment at the right time, potentially slowing, stopping, or reversing disease progression [2][3] Market Focus - Etiome is targeting large populations affected by serious diseases with clear unmet needs, aiming to reduce morbidity and healthcare costs while extending healthy lifespans [3][4] - The company envisions a future where preemptive interventions can prevent suffering and save lives, thereby lowering overall healthcare expenses [4][6]

Core Insights - Foghorn Therapeutics is set to present new preclinical combination data for FHD-909, a potential first-in-class selective SMARCA2 inhibitor targeting non-small cell lung cancer (NSCLC) [1][2] - The company will also share updates on its Selective CBP and EP300 degrader programs, along with an overview of the Selective ARID1B degrader program during a virtual investor event on April 29, 2025 [1][2][3] Company Overview - FHD-909 (LY4050784) is an allosteric, orally available small molecule that selectively inhibits the ATPase activity of SMARCA2, showing significant anti-tumor activity in preclinical studies involving SMARCA4 mutant lung tumor models [4] - Foghorn Therapeutics focuses on developing a novel class of medicines that target genetically determined dependencies within the chromatin regulatory system, utilizing its Gene Traffic Control platform to identify and validate drug targets [5]

Core Insights - Foghorn Therapeutics is advancing FHD-909 (LY4050784), a first-in-class selective SMARCA2 inhibitor, in an ongoing Phase 1 trial targeting SMARCA4 mutated cancers, primarily focusing on non-small cell lung cancer (NSCLC) [1][2] - New preclinical data will be presented at the 2025 AACR Annual Meeting, showcasing the potential of FHD-909 in combination with chemotherapy, pembrolizumab, and KRAS inhibitors [1][2] - The company is also presenting preclinical data on its Selective CBP and EP300 degrader programs, which have demonstrated strong anti-tumor activities [2] FHD-909 Details - FHD-909 is an allosteric, orally available small molecule that selectively inhibits the ATPase activity of SMARCA2 over SMARCA4, crucial for the BAF complex's function [6] - Preclinical studies indicate that tumors with SMARCA4 mutations depend on SMARCA2 for their BAF function, highlighting the therapeutic potential of FHD-909 [6] Presentation Information - An oral presentation titled "LY4050784, a selective inhibitor of SMARCA2, demonstrates synergistic activity in combinations with pembrolizumab or KRAS inhibitors" will take place on April 28, 2025 [3] - Poster presentations will cover the Phase 1 trial design for FHD-909 and preclinical data for the Selective CBP and EP300 degrader programs [4][5] Company Overview - Foghorn Therapeutics is focused on developing a novel class of medicines that target genetically determined dependencies within the chromatin regulatory system [7] - The company utilizes its Gene Traffic Control platform to identify and validate potential drug targets, with multiple oncology product candidates in development [7]

Core Insights - Lila Sciences is developing the world's first scientific superintelligence platform and fully autonomous labs aimed at accelerating discovery in life, chemical, and materials sciences [1][8] - The company has successfully raised $200 million in seed financing to support the development of its AI platform and infrastructure for rapid scaling [2][8] - Lila's mission is to leverage AI to enhance the scientific method, enabling the design and execution of experiments at unprecedented scales [3][5] Company Overview - Lila Sciences was founded in 2023 within Flagship Pioneering's labs and aims to apply AI across all aspects of the scientific method [1][8] - The company is led by a team with diverse expertise in AI, security, commercial strategy, and various scientific fields, including renowned geneticist George Church as Chief Scientist [7][8] Technological Advancements - The Lila platform combines generative AI with scalable autonomous science units to optimize experimentation across scientific domains [3][4] - The platform has demonstrated superior performance in various areas, including: - Large language models (LLMs) with advanced reasoning capabilities on scientific problems [6] - Generation of optimal genetic medicine constructs that outperform existing therapeutics [6] - Discovery of novel antibodies and catalysts for green hydrogen production [6] - Design of new materials for industrial-scale carbon capture [6] Strategic Partnerships - Lila's platform will be open to partnerships across life and material sciences industries to foster solutions in human health and sustainability [4][5]