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Foghorn Therapeutics (FHTX) 2025 Conference Transcript
2025-06-05 20:45
Summary of Foghorn Therapeutics (FHTX) Conference Call Company Overview - **Company**: Foghorn Therapeutics (FHTX) - **Event**: Jefferies Global Healthcare Conference - **Date**: June 05, 2025 Industry Focus - **Industry**: Biotechnology, specifically targeting chromatin regulatory systems and cancer therapies Key Points and Arguments Chromatin Regulatory System and BAF Complex - Foghorn Therapeutics focuses on the chromatin regulatory system, which is crucial for gene expression, likening it to an architect (regulatory system) and blueprints (genes) [3][4] - Approximately **20% of all cancers** have mutations in the BAF complex, and about **50% of cancers** relate to chromatin biology [4] Clinical Pipeline - The company is currently in clinical stages with a **Phase 1 trial** for a selective SMARCA2 inhibitor (FHD-909) in collaboration with Eli Lilly [6] - The next **12 to 18 months** are expected to be significant for the company with potential data releases [6][7] Challenges in Drug Development - Developing drugs targeting the chromatin system is challenging due to the complexity of proteins and their paralogs, which often share high sequence similarity [10][11] - Issues include purification difficulties and the intrinsic disorder of some proteins, making it hard to find selective chemical matter [12] Patient Enrollment and Selection Criteria - The Phase 1 trial includes patients with various tumor types, specifically those with **SMARCA4 mutations** [15] - Approximately **10% of non-small cell lung cancer (NSCLC)** patients have SMARCA4 mutations, with **60-70%** of those being loss-of-function mutations [19][20] Efficacy Expectations - The company aims for a response rate of **10-20%** in refractory patients, which would be considered promising compared to existing treatments [25][26] - Patients with SMARCA4 mutations have a worse prognosis and lower response rates to existing therapies [20][21][22] Combination Therapy Potential - There is interest in exploring combination therapies with KRAS inhibitors and immune checkpoint inhibitors, pending monotherapy efficacy results [39][40] - The timeline for potential combination studies is expected around **2026**, depending on the results of the ongoing trials [41] CBP and EP300 Programs - Foghorn is developing selective degraders for CBP and EP300, with potential applications in various cancers, including gastric and bladder cancers [44][48] - The CBP program is set to begin IND-enabling studies in the second half of 2025, with EP300 following closely behind [47][48] Upcoming Milestones - Key milestones include updates on the FHD-909 program, CBP, and EP300, with potential IND submissions in the next year [54][58] - The company anticipates significant data releases in the **October timeframe** related to ongoing studies [57] Additional Important Information - The company emphasizes the importance of a homogeneous patient population for clinical trials to avoid confusion in data interpretation [31] - Foghorn aims to avoid interim data releases to provide clearer insights into trial outcomes [32] - The therapeutic window for their compounds appears promising based on preclinical data, suggesting better tolerability compared to previous dual inhibitors [35][36] This summary encapsulates the critical insights from the conference call, highlighting the company's strategic focus, clinical developments, and future expectations in the biotechnology sector.
Foghorn Therapeutics to Participate in Four Upcoming Investor Conferences
GlobeNewswire News Room· 2025-05-22 11:00
CAMBRIDGE, Mass., May 22, 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 that management will participate in Evercore Biotech Diamonds in the Rough Virtual Event, TD Cowen’s 6th Annual Oncology Innovation Summit, Jefferies Global Healthcare Conference 2025 and Goldman Sachs 46th Annual Global Healthcare Conference 2025. With an in ...
Foghorn Therapeutics(FHTX) - 2025 Q1 - Quarterly Report
2025-05-14 11:07
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 ...
Foghorn Therapeutics(FHTX) - 2025 Q1 - Quarterly Results
2025-05-14 11:05
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]
Foghorn Therapeutics to Participate in the Citizens Life Sciences Conference
GlobeNewswire News Room· 2025-05-05 11:00
Company Overview - Foghorn Therapeutics Inc. is a clinical-stage biotechnology company focused on developing a new class of medicines that address serious diseases by correcting abnormal gene expression [1][3] - The company utilizes its proprietary Gene Traffic Control® platform to identify and validate drug targets within the chromatin regulatory system, with an initial emphasis on oncology [3] Upcoming Events - Management will participate in the Citizens Life Sciences Conference on May 7-8, 2025, in New York, NY, with a presentation scheduled for May 7, 2025, at 9:30 a.m. EST by CEO Adrian Gottschalk [1][2] - In addition to the conference, management will engage in one-on-one meetings on the same day [2] Product Development - Foghorn Therapeutics is developing multiple product candidates aimed at treating genetically determined dependencies within the chromatin regulatory system, particularly in the oncology sector [3] - The company's broad pipeline has the potential to significantly impact the lives of patients suffering from a variety of diseases [1]
Foghorn Therapeutics Appoints Neil Gallagher and Stuart Duty to its Board of Directors
GlobeNewswire News Room· 2025-05-01 11:00
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 ...
Foghorn Therapeutics(FHTX) - 2025 FY - Earnings Call Transcript
2025-04-29 17:00
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]
Foghorn Therapeutics(FHTX) - 2025 FY - Earnings Call Presentation
2025-04-29 16:47
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 ...
Foghorn Therapeutics Presents New Preclinical Data on Selective SMARCA2 Inhibitor FHD-909 and Selective CBP and Selective EP300 Degrader Programs and Provides Pipeline Update
Globenewswire· 2025-04-28 20:05
- 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 ...
Flagship Pioneering Unveils Etiome to Pioneer Preemptive Healthcare
Prnewswire· 2025-04-24 10:00
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]