[Executive Summary & Corporate Update](index=1&type=section&id=Executive%20Summary%20%26%20Corporate%20Update) Foghorn Therapeutics provides an update on its clinical programs, including FHD-909 and selective CBP degrader, alongside a strong financial position with cash runway into 2028 - **FHD-909 (LY4050784) Phase 1 dose escalation trial** in SMARCA4 mutated cancers, with **non-small cell lung cancer (NSCLC)** as the primary target population, is enrolling well and remains on track[1](index=1&type=chunk) - Preclinical synergistic benefit of **FHD-909** in combination with **pembrolizumab** and **KRAS inhibitors** reinforces significant potential in **NSCLC**[1](index=1&type=chunk) - Selective **CBP degrader** is on track for IND-enabling studies, targeting an **IND in 2026**, and has shown encouraging activity in **ER+ breast cancer**[1](index=1&type=chunk) - Strong balance sheet with cash, cash equivalents, and marketable securities of **$198.7 million** as of **June 30, 2025**, providing a cash runway into **2028**[1](index=1&type=chunk) [Program Overview and Upcoming Milestones](index=1&type=section&id=Program%20Overview%20and%20Upcoming%20Milestones) This section details the progress of Foghorn's clinical and preclinical programs, highlighting key developments and anticipated milestones across its therapeutic pipeline [FHD-909 (LY4050784)](index=2&type=section&id=FHD-909%20(LY4050784)) FHD-909, a first-in-class oral SMARCA2 selective inhibitor, is progressing well in its Phase 1 trial for SMARCA4 mutated solid tumors, with NSCLC as the primary target. Preclinical data supports its use in combination therapies - **FHD-909** is a first-in-class oral **SMARCA2 selective inhibitor** that has demonstrated high selectivity over its closely related paralog **SMARCA4** in preclinical studies[3](index=3&type=chunk)[13](index=13&type=chunk) - Enrollment in the first-in-human **Phase 1 multi-center trial of FHD-909** is progressing well, with the first patient dosed in **October 2024**, targeting **NSCLC** as the primary population[5](index=5&type=chunk) - Preclinical data presented at **AACR** demonstrates enhanced anti-tumor activity of **FHD-909** in combination with standard-of-care chemotherapies, **anti-PD-1 pembrolizumab**, and several novel **KRAS inhibitors** in **NSCLC** animal models[5](index=5&type=chunk) [Ongoing Strategic Collaboration with Lilly](index=2&type=section&id=Ongoing%20strategic%20collaboration%20with%20Lilly) Foghorn's collaboration with Lilly includes a 50/50 U.S. co-development and co-commercialization agreement for its selective SMARCA2 oncology program and three discovery programs from Foghorn's Gene Traffic Control platform - Collaboration with **Lilly** includes a **U.S. 50/50 co-development and co-commercialization agreement** for its selective **SMARCA2 oncology program**, which includes both a selective inhibitor and a selective degrader[4](index=4&type=chunk) - The collaboration also encompasses **three discovery programs** from Foghorn's proprietary **Gene Traffic Control platform**[4](index=4&type=chunk) [Selective CBP Degrader Program](index=2&type=section&id=Selective%20CBP%20degrader%20program) The Selective CBP degrader program targets EP300-mutated cancer cells, showing promising preclinical combination benefits in ER+ breast cancer and other solid tumors, with an IND target in 2026 - Selectively targets **CBP** in **EP300-mutated cancer cells**, exploiting a synthetic lethal relationship when **EP300** is mutated[4](index=4&type=chunk) - Preclinical data presented at **AACR** showed combination benefit with approved chemotherapies and targeted agents in solid tumors beyond **EP300-mutant cancers**, including synergistic activity with **paclitaxel** and **CDK4/6 inhibitor abemaciclib** in **ER+ breast cancer**[6](index=6&type=chunk)[11](index=11&type=chunk) - On track for **IND-enabling studies**, targeting an Investigational New Drug (**IND**) application in **2026**[1](index=1&type=chunk)[11](index=11&type=chunk) [Selective EP300 Degrader Program](index=3&type=section&id=Selective%20EP300%20degrader%20program) Foghorn is developing a Selective EP300 degrader for hematological malignancies and prostate cancer, demonstrating robust anti-tumor activity and synergistic effects with standard-of-care treatments, with a program update expected in Q4 2025 - Developing a Selective **EP300 degrader** for the treatment of **hematological malignancies** and **prostate cancer**, addressing challenges due to high similarity between **EP300** and **CBP**[7](index=7&type=chunk) - Demonstrated robust anti-tumor activity across a range of **hematological malignancies** in vitro (**DLBCL, MM, follicular lymphoma**) and synergistic combination activity with **SoC** in both **DLBCL** and **MM**[11](index=11&type=chunk) - Program update expected in **Q4 2025**[1](index=1&type=chunk)[11](index=11&type=chunk) [Selective ARID1B Degrader Program](index=3&type=section&id=Selective%20ARID1B%20degrader%20program) The Selective ARID1B degrader program targets ARID1B in ARID1A-mutated cancers, having successfully achieved selective degradation with potent and selective small molecule binders. A program update is anticipated in Q4 2025 - Selectively targets and degrades **ARID1B** in **ARID1A-mutated cancers**, which are implicated in up to **5% of all solid tumors**[8](index=8&type=chunk) - Developed highly potent and selective small molecule binders to **ARID1B** and successfully achieved selective degradation of **ARID1B**[12](index=12&type=chunk) - Program update expected in **Q4 2025**[1](index=1&type=chunk)[12](index=12&type=chunk) [Chromatin Biology and Degrader Platform](index=3&type=section&id=Chromatin%20Biology%20and%20Degrader%20Platform) Foghorn continues to invest in and advance its proprietary chromatin biology and degrader platform, focusing on innovations in novel ligases, long-acting injectables, oral delivery, and induced proximity - Continued advancement of the **chromatin biology and degrader platform** with investments in **novel ligases, long-acting injectables, oral delivery, and induced proximity**[9](index=9&type=chunk) [Second Quarter 2025 Financial Highlights](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Highlights) This section presents the key financial results for the second quarter of 2025, including collaboration revenue, operating expenses, net loss, and cash position [Collaboration Revenue](index=3&type=section&id=Collaboration%20Revenue) Collaboration revenue increased by 9.7% in Q2 2025, primarily driven by the continued advancement of programs under the Lilly Collaboration Agreement Collaboration Revenue Performance | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change (YoY) | | :------------------- | :--------------------- | :--------------------- | :----------- | | Collaboration Revenue | $7,557 | $6,888 | +9.7% | [Operating Expenses](index=4&type=section&id=Operating%20Expenses) Both Research and Development (R&D) and General and Administrative (G&A) expenses decreased in Q2 2025 compared to Q2 2024, contributing to improved operational efficiency Operating Expenses Breakdown | Expense Type | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change (YoY) | | :------------------------ | :--------------------- | :--------------------- | :----------- | | Research and Development | $21,792 | $23,797 | -8.4% | | General and Administrative | $6,862 | $7,325 | -6.3% | - **R&D decrease** attributed to lower **FHD-286 costs**, personnel-related costs, early development and other research external costs, and facilities and IT-related expenses, partially offset by an increase in **Lilly-partnered programs**[16](index=16&type=chunk) - **G&A decrease** primarily due to lower consulting costs and lower facilities and IT related expenses[16](index=16&type=chunk) [Net Loss](index=4&type=section&id=Net%20Loss) The company reported a reduced net loss of $17.9 million in Q2 2025, an improvement from the $23.0 million net loss in Q2 2024 Net Loss Summary | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change (YoY) | | :------- | :--------------------- | :--------------------- | :----------- | | Net Loss | $(17,936) | $(22,979) | -22.0% | Net Loss Per Share and Shares Outstanding | Metric | Q2 2025 | Q2 2024 | | :------------------------------------------------ | :------ | :------ | | Net loss per share attributable to common stockholders—basic and diluted | $(0.28) | $(0.45) | | Weighted average common shares outstanding—basic and diluted | 62,978,219 | 51,580,310 | [Cash Position and Runway](index=4&type=section&id=Cash%2C%20Cash%20Equivalents%2C%20and%20Marketable%20Securities) As of June 30, 2025, Foghorn maintained a strong cash position of $198.7 million in cash, cash equivalents, and marketable securities, extending its cash runway into 2028 Cash, Cash Equivalents, and Marketable Securities | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------------- | :----------------------------- | :------------------------------- | | Cash, cash equivalents and marketable securities | $198,665 | $243,747 | - Cash runway extends into **2028**[1](index=1&type=chunk)[16](index=16&type=chunk) [About Foghorn Therapeutics](index=4&type=section&id=About%20Foghorn%20Therapeutics) Foghorn Therapeutics is a biotechnology company focused on developing novel medicines by targeting genetically determined dependencies within the chromatin regulatory system - **Foghorn Therapeutics** is discovering and developing a novel class of medicines targeting genetically determined dependencies within the **chromatin regulatory system**[14](index=14&type=chunk) - Utilizes its proprietary scalable **Gene Traffic Control platform** to systematically study, identify, and validate potential drug targets[14](index=14&type=chunk) - The company is developing **multiple product candidates in oncology**[1](index=1&type=chunk)[14](index=14&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This section outlines the nature of forward-looking statements within the report, emphasizing inherent risks and uncertainties that could cause actual results to differ - This press release contains **forward-looking statements** regarding the Company's ongoing **Phase 1 trial of FHD-909**, pre-clinical product candidates, expected timing of clinical data, expected cash runway, expected timing of regulatory filings, and research efforts[15](index=15&type=chunk) - **Forward-looking statements** are based on current expectations and assumptions but are subject to inherent uncertainties, risks, and changes in circumstances that could cause actual results to differ materially[15](index=15&type=chunk) - Important factors that could cause actual results to differ materially are set forth under the heading **'Risk Factors'** in the Company's **Annual Report on Form 10-K**[15](index=15&type=chunk)[17](index=17&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) This section provides the company's condensed consolidated financial statements, including balance sheets and statements of operations, for the reported periods [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The condensed consolidated balance sheets show the company's financial position, with total assets decreasing from $283.98 million at December 31, 2024, to $226.24 million at June 30, 2025 Condensed Consolidated Balance Sheets Data | (In thousands) | June 30, 2025 | December 31, 2024 | | :-------------------------------------- | :------------ | :---------------- | | Cash, cash equivalents and marketable securities | $198,665 | $243,747 | | All other assets | $27,571 | $40,235 | | **Total assets** | **$226,236** | **$283,982** | | Deferred revenue, total | $266,554 | $280,063 | | All other liabilities | $36,341 | $49,447 | | **Total liabilities** | **$302,895** | **$329,510** | | Total stockholders' deficit | $(76,659) | $(45,528) | | **Total liabilities and stockholders' deficit** | **$226,236** | **$283,982** | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The condensed consolidated statements of operations reflect an increase in collaboration revenue and a decrease in operating expenses, leading to a reduced net loss for the three months ended June 30, 2025, compared to the prior year Condensed Consolidated Statements of Operations Data | (In thousands, except share and per share amounts) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :------------------------------------------------- | :------------------------------- | :------------------------------- | | Collaboration revenue | $7,557 | $6,888 | | Operating expenses: | | | | Research and development | $21,792 | $23,797 | | General and administrative | $6,862 | $7,325 | | Impairment of long-lived assets | — | $2,398 | | **Total operating expenses** | **$28,654** | **$33,520** | | Loss from operations | $(21,097) | $(26,632) | | Total other income, net | $3,161 | $3,653 | | **Net loss** | **$(17,936)** | **$(22,979)** | | Net loss per share attributable to common stockholders—basic and diluted | $(0.28) | $(0.45) | | Weighted average common shares outstanding—basic and diluted | 62,978,219 | 51,580,310 | [Contact Information](index=7&type=section&id=Contact) This section provides contact details for inquiries regarding Foghorn Therapeutics - Contact person for **Foghorn Therapeutics Inc.** is Karin Hellsvik[22](index=22&type=chunk) - Email for inquiries: **khellsvik@foghorntx.com**[22](index=22&type=chunk)

Core Insights - Foghorn Therapeutics is advancing its pipeline, particularly focusing on FHD-909, a first-in-class oral SMARCA2 selective inhibitor, which is currently in a Phase 1 dose escalation trial targeting non-small cell lung cancer (NSCLC) [1][3][4] - The company has shown promising preclinical data indicating synergistic effects of FHD-909 when combined with pembrolizumab and KRAS inhibitors, suggesting significant potential in treating difficult-to-treat NSCLC [2][4] - Foghorn's selective degrader programs targeting CBP, EP300, and ARID1B are progressing well, with updates expected in Q4 2025 and an IND application for the Selective CBP degrader anticipated in 2026 [2][6][12] Financial Overview - As of June 30, 2025, Foghorn reported cash, cash equivalents, and marketable securities totaling $198.7 million, providing a cash runway into 2028 [1][18] - Collaboration revenue for the three months ended June 30, 2025, was $7.6 million, an increase from $6.9 million in the same period in 2024, driven by advancements in programs under the Lilly Collaboration Agreement [10][21] - The net loss for the three months ended June 30, 2025, was $17.9 million, compared to a net loss of $23.0 million for the same period in 2024, indicating improved financial performance [18][21] Pipeline and Development Programs - FHD-909 is designed to selectively inhibit SMARCA2, which is crucial for the survival of tumors with SMARCA4 mutations, and has shown significant anti-tumor activity in preclinical models [3][13] - The Selective CBP degrader program targets EP300-mutated cancer cells and has shown encouraging activity in ER+ breast cancer, with potential applications beyond EP300-mutant tumors [2][6][11] - The Selective EP300 degrader is being developed for hematological malignancies and prostate cancer, with updates expected in Q4 2025 [7][11] - The Selective ARID1B degrader targets ARID1B in ARID1A-mutated cancers, which are prevalent in various solid tumors, and has achieved selective degradation in preclinical studies [8][12] Strategic Collaborations - Foghorn is collaborating with Lilly under a 50/50 co-development and co-commercialization agreement for FHD-909, which is currently enrolling patients in a Phase 1 trial [4][5] - The collaboration aims to develop novel oncology medicines, leveraging both companies' strengths in drug development [4][5]

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]

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]

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]

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].

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]