Foghorn Therapeutics(FHTX)
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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 Provides First Quarter 2025 Financial and Corporate Update
GlobeNewswire News Room· 2025-05-14 11:00
Core Insights - Foghorn Therapeutics is advancing its FHD-909 (LY4050784) in a Phase 1 dose escalation trial targeting SMARCA4 (BRG1) mutated cancers, primarily focusing on non-small cell lung cancer (NSCLC) [1][11] - The company presented data at the AACR Annual Meeting showing synergistic effects of FHD-909 in combination with pembrolizumab and KRAS inhibitors, supporting further clinical exploration [1][11] - Foghorn has a strong financial position with $220.6 million in cash and equivalents as of March 31, 2025, providing a cash runway into 2027 [1][19] Pipeline Progress - FHD-909 is a first-in-class oral SMARCA2 selective inhibitor, demonstrating high selectivity over SMARCA4, with potential applications in various cancers [7][16] - The Selective CBP degrader program is showing promise in ER+ breast cancer, with preclinical data indicating combinatorial benefits with existing therapies [12][9] - The Selective EP300 degrader program is advancing, showing anti-proliferative activity in hematological malignancies, with updates expected in H2 2025 [10][18] Corporate Developments - Foghorn appointed Neil Gallagher, M.D., Ph.D., and Stuart Duty to its Board of Directors, enhancing its leadership team with extensive experience in drug development and finance [4] - The company hosted its second annual Chromatin Regulation Summit, focusing on targeted protein degradation and induced proximity, featuring industry experts [5][6] Financial Performance - Collaboration revenue increased to $6.0 million for Q1 2025, up from $5.1 million in Q1 2024, driven by advancements in programs under the Lilly collaboration [19] - Research and development expenses decreased to $21.6 million in Q1 2025 from $25.5 million in Q1 2024, attributed to reduced costs in various areas [19] - The net loss for Q1 2025 was $18.8 million, an improvement from a net loss of $25.0 million in Q1 2024 [19][22]
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
Core Insights - Foghorn Therapeutics Inc. has elected Neil Gallagher, M.D., Ph.D., and Stuart Duty to its Board of Directors, enhancing its leadership team with experienced professionals in biotechnology and finance [1][2]. Company Overview - Foghorn Therapeutics is a clinical-stage biotechnology company focused on developing a new class of medicines that correct abnormal gene expression to treat serious diseases, particularly in oncology [1][5]. - The company utilizes its proprietary Gene Traffic Control® platform to identify and validate drug targets within the chromatin regulatory system [5]. Leadership Experience - Dr. Neil Gallagher has over 20 years of experience in drug development across various therapeutic areas, including oncology, and currently serves as President and Head of Research and Development at Syndax Pharmaceuticals [3]. - Stuart Duty brings over 30 years of experience in finance and investment banking within the biotechnology sector, having held senior roles at Guggenheim Securities and other firms [4]. Strategic Goals - The addition of Gallagher and Duty to the Board is expected to leverage their strategic insights to advance Foghorn's pipeline, which aims to develop selective therapies for challenging cancer targets [2][4]. - Dr. Gallagher expressed confidence in Foghorn's potential to address unmet medical needs and change treatment paradigms for multiple cancer types [2].
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
Core Insights - Foghorn Therapeutics Inc. is advancing its clinical-stage pipeline, particularly focusing on FHD-909, a selective SMARCA2 inhibitor, which is currently in Phase 1 trials targeting SMARCA4 mutated cancers, primarily non-small cell lung cancer (NSCLC) [1][2][5] Group 1: FHD-909 Program - FHD-909 demonstrates synergistic anti-tumor activity when combined with chemotherapy, KRAS inhibitors, and pembrolizumab, warranting further clinical exploration [1][4] - The ongoing Phase 1 trial of FHD-909 is evaluating patients with SMARCA4 mutations who have exhausted standard treatment options, with a focus on NSCLC and other advanced solid tumors [5][9] - Preclinical studies indicate that FHD-909 selectively inhibits SMARCA4 mutant cancer cells and shows robust anti-tumor efficacy in xenograft models [4][13] Group 2: Selective CBP and EP300 Degrader Programs - The Selective CBP degrader program shows promise in preclinical models, indicating potential benefits in solid tumors beyond EP300-mutant cancers [6][10] - Initial preclinical data for the Selective EP300 degrader program suggests significant anti-cancer activity in hematological malignancies, with ongoing characterization of its therapeutic potential [7][11] - The Selective ARID1B degrader program is also in development, targeting a synthetic lethal mechanism implicated in up to 5% of all solid tumors [8][16] Group 3: Upcoming Events and Presentations - Foghorn management will hold a virtual investor event on April 29, 2025, to discuss pipeline updates, including the FHD-909 program and other ongoing research efforts [2][12] - A poster presentation on the Selective EP300 degrader program is scheduled for April 30, 2025, at the AACR Annual Meeting [2][7]
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]
Foghorn Therapeutics to Host Virtual Investor Event to Review Pipeline Updates in Conjunction with 2025 AACR Annual Meeting
Globenewswire· 2025-04-15 11:00
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]
Foghorn Therapeutics Announces New Preclinical Data for Selective SMARCA2 Inhibitor FHD-909 and Selective CBP and EP300 Degrader Programs at 2025 AACR Meeting
Globenewswire· 2025-03-25 20:35
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]