Shares of Foghorn Therapeutics Inc. (FHTX) have been struggling lately and have lost 5.1% over the past week. However, a hammer chart pattern was formed in its last trading session, which could mean that the stock found support with bulls being able to counteract the bears. So, it could witness a trend reversal down the road.While the formation of a hammer pattern is a technical indication of nearing a bottom with potential exhaustion of selling pressure, rising optimism among Wall Street analysts about the ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 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 June 30, 2025 OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ (Exact Name of Registrant as Specified in its Charter) ______________________ Dela ...

Exhibit 99.1 Foghorn Therapeutics Provides Second Quarter 2025 Financial and Corporate Update FHD-909 (LY4050784) Phase 1 dose escalation trial in SMARCA4 (BRG1) mutated cancers, with non-small cell lung cancer (NSCLC) as the primary target population, is enrolling well and remains on track Preclinical synergistic benefit of FHD-909 in combination with pembrolizumab and KRAS inhibitors reinforces significant potential in NSCLC Selective CBP degrader on track for IND-enabling studies, targeting an IND in 202 ...

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.

Core Insights - Foghorn Therapeutics Inc. is a clinical-stage biotechnology company focused on developing a new class of medicines aimed at correcting abnormal gene expression to treat serious diseases, with an initial emphasis on oncology [1][3] Company Participation in Events - Management will participate in several key industry events, including the 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 [1][2] - A webcast of the presentations will be available for 30 days on the company's website [2] Company Overview - Foghorn Therapeutics is developing its proprietary Gene Traffic Control® platform to identify and validate drug targets within the chromatin regulatory system, focusing on genetically determined dependencies [3] - The company is advancing multiple product candidates specifically in the oncology sector [3]

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=4&type=page&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents Foghorn Therapeutics Inc.'s unaudited condensed consolidated financial statements, detailing financial position, operations, and cash flows, alongside notes on accounting policies and significant events [Condensed Consolidated Balance Sheets](index=4&type=page&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets decreased to **$258.7 million** from **$284.0 million** at year-end 2024, primarily due to reduced marketable securities, resulting in a total stockholders' deficit of **$61.7 million** Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $61,026 | $55,454 | | Marketable securities | $159,561 | $188,293 | | **Total Assets** | **$258,691** | **$283,982** | | Deferred revenue (Current & Non-current) | $274,112 | $280,063 | | **Total Liabilities** | **$320,343** | **$329,510** | | **Total stockholders' deficit** | **($61,652)** | **($45,528)** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=page&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the three months ended March 31, 2025, collaboration revenue increased to **$6.0 million**, operating expenses decreased to **$28.9 million**, and the net loss narrowed to **$18.8 million** or **($0.30)** per share Q1 2025 vs Q1 2024 Statement of Operations (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Collaboration revenue | $5,952 | $5,050 | | Research and development | $21,626 | $25,534 | | General and administrative | $7,239 | $7,710 | | **Loss from operations** | **($22,913)** | **($28,194)** | | **Net loss** | **($18,834)** | **($25,016)** | | Net loss per share | ($0.30) | ($0.59) | [Condensed Consolidated Statements of Cash Flows](index=7&type=page&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For Q1 2025, net cash used in operating activities improved to **$24.0 million**, with **$29.4 million** provided by investing activities, resulting in **$62.7 million** in cash, cash equivalents, and restricted cash at period-end Q1 2025 vs Q1 2024 Cash Flow Summary (in thousands) | Cash Flow Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($23,968) | ($29,345) | | Net cash provided by investing activities | $29,401 | $27,095 | | Net cash provided by financing activities | $139 | $1,167 | | **Net increase (decrease) in cash** | **$5,572** | **($1,083)** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=page&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's business, going concern assessment, accounting policies, and financial statement line items, including the Lilly collaboration and a recent **$102.8 million** stock offering - In May 2024, the company completed a public offering of common stock and pre-funded warrants, resulting in net proceeds of **$102.8 million**[27](index=27&type=chunk)[40](index=40&type=chunk) - The company has a significant collaboration with Eli Lilly, which includes co-development and co-commercialization for two programs and discovery activities for three additional programs, serving as the sole source of the company's revenue[51](index=51&type=chunk) - As of March 31, 2025, the unsatisfied performance obligation related to the Lilly collaboration was **$274.1 million**, expected to be recognized as revenue through 2029 or beyond[59](index=59&type=chunk) - Management has concluded that the company's cash, cash equivalents, and marketable securities are sufficient to fund operations and capital expenditures for at least 12 months from the financial statement issuance date[28](index=28&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=page&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's business overview, Q1 2025 financial results, and liquidity, highlighting the Gene Traffic Control platform, pipeline updates, and a **$102.8 million** May 2024 financing [Overview](index=16&type=page&id=Overview) Foghorn is a clinical-stage biotech company focused on correcting abnormal gene expression through its Gene Traffic Control platform, with key pipeline updates including the discontinuation of FHD-286 and the dosing of FHD-909 in collaboration with Lilly, supported by a recent **$102.8 million** equity financing - The company is focused on its proprietary Gene Traffic Control platform to develop medicines targeting the chromatin regulatory system, which is implicated in about **50%** of all cancers[74](index=74&type=chunk)[75](index=75&type=chunk) - Key pipeline updates include discontinuing the independent development of FHD-286 in AML and dosing the first patient in the Phase 1 study of FHD-909, a SMARCA2 inhibitor, in collaboration with Lilly[77](index=77&type=chunk) - In May 2024, the company raised net proceeds of **$102.8 million** from a public offering of common stock and pre-funded warrants[81](index=81&type=chunk)[82](index=82&type=chunk) [Results of Operations](index=21&type=page&id=Results%20of%20Operations) For Q1 2025, collaboration revenue increased to **$6.0 million**, while research and development expenses decreased by **$3.9 million** due to program discontinuations, leading to a narrowed net loss Comparison of Results of Operations (in thousands) | Line Item | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration revenue | $5,952 | $5,050 | $902 | | Research and development | $21,626 | $25,534 | ($3,908) | | General and administrative | $7,239 | $7,710 | ($471) | | **Net loss** | **($18,834)** | **($25,016)** | **$6,182** | - The **$3.9 million** decrease in R&D expenses was primarily driven by a **$2.5 million** reduction in FHD-286 costs and a **$1.8 million** decrease in other research costs, partially offset by a **$0.7 million** increase in costs for Lilly-partnered programs like FHD-909[109](index=109&type=chunk)[110](index=110&type=chunk) [Liquidity and Capital Resources](index=22&type=page&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company held **$220.6 million** in cash, cash equivalents, and marketable securities, expecting current capital to fund operations for at least the next twelve months - As of March 31, 2025, the company held **$220.6 million** in cash, cash equivalents, and marketable securities[113](index=113&type=chunk) - The company expects its current cash position is sufficient to fund operating expenses and capital expenditure requirements for at least the next twelve months[120](index=120&type=chunk) Cash Flow Summary (in thousands) | Period | Net cash used in operating activities | | :--- | :--- | | Q1 2025 | ($23,968) | | Q1 2024 | ($29,345) | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=24&type=page&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is a smaller reporting company and is not required to provide the information for this item - As a smaller reporting company, Foghorn Therapeutics is not required to provide quantitative and qualitative disclosures about market risk[125](index=125&type=chunk) [Item 4. Controls and Procedures](index=24&type=page&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of March 31, 2025[126](index=126&type=chunk) - No material changes to the internal control over financial reporting occurred during the three months ended March 31, 2025[127](index=127&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=25&type=page&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings - The company is not currently involved in any litigation or legal proceedings that are expected to have a material adverse effect on its business[129](index=129&type=chunk) [Item 1A. Risk Factors](index=25&type=page&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 - No material changes have been made to the risk factors disclosed in the company's 2024 Annual Report on Form 10-K[130](index=130&type=chunk) [Item 5. Other Information](index=25&type=page&id=Item%205.%20Other%20Information) The company states that none of its directors or officers entered into, modified, or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the first quarter of 2025 - During the three months ended March 31, 2025, no directors or officers entered into, modified, or terminated any Rule 10b5-1 trading arrangements or non-Rule 10b5-1 trading arrangements[131](index=131&type=chunk) [Item 6. Exhibits](index=26&type=page&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications by the Principal Executive Officer and Principal Financial Officer, and XBRL data files

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]

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]

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]