Summary of Foghorn Therapeutics FY Conference Call Company Overview - **Company**: Foghorn Therapeutics (NasdaqGM:FHTX) - **Focus**: Targeting the chromatin regulatory system and the BAF complex, primarily in oncology [2][3] Industry Insights - **Oncology Relevance**: Approximately 50% of cancers have dependencies or mutations related to chromatin regulation, highlighting the importance of this area in cancer biology [2] - **Targeting Challenges**: The similarity between proteins in the BAF complex (e.g., SMARCA2 and SMARCA4) complicates selective targeting due to their 90%-95% similarity [3][4] Key Programs and Developments SMARCA2 Program - **Scientific Rationale**: SMARCA2 is targeted due to its synthetic-lethal relationship with SMARCA4, where loss of SMARCA4 increases dependency on SMARCA2 in cancer cells [6][7] - **Clinical Data**: Patients with SMARCA4 mutations show significantly worse prognosis in non-small cell lung cancer, with response rates dropping from approximately 40% to 20% [7] - **Market Opportunity**: In the U.S., about 22,000 non-small cell lung cancer patients have SMARCA4 mutations, with an estimated 11,000-17,000 potentially having loss of function [8] Clinical Trials - **Current Status**: The SMARCA2 inhibitor FHD-909 is in phase one trials, with ongoing dose escalation and no maximum tolerated dose reached yet [16][17] - **Study Design**: The trial includes various cancer histologies with a focus on non-small cell lung cancer patients with SMARCA4 mutations [15] - **Expected Outcomes**: Anticipation of a go/no-go decision for dose expansion in the first half of 2026 [16] CBP and EP300 Programs - **Mechanism**: CBP and EP300 are sister proteins involved in histone acetylation, with challenges in dual inhibition leading to myelosuppressive effects [21][22] - **Commercial Opportunity**: Targeting CBP could address approximately 20,000-25,000 patients with specific mutations, while EP300 shows potential in hematological malignancies [23][24] ARID1B Program - **Target Validation**: ARID1B is a highly mutated target in cancer, with Foghorn being the only company to develop selective binders for this target [27][28] - **Development Status**: The program is in hit-to-lead stage, with in vivo proof of concept expected in 2026 [29] Additional Insights - **Combination Studies**: The company recognizes the importance of combination therapies in oncology and plans to explore both monotherapy and combination regimens in future studies [18][19] - **Clinical Risks**: Acknowledgment of the risks associated with being first to market, particularly in the context of the SMARCA2 program [9][10] Conclusion Foghorn Therapeutics is positioned in a promising niche within oncology, focusing on challenging targets related to chromatin regulation. The company is advancing several innovative programs, particularly in SMARCA2, CBP, and EP300, with significant market opportunities and ongoing clinical trials that could lead to impactful treatments for cancer patients.

Core Insights - Top Wall Street analysts have revised their outlook on several prominent stocks, indicating a shift in market sentiment and potential investment opportunities [1] Group 1 - Analysts have made changes to ratings, including upgrades, downgrades, and initiations for various stocks [1] - There is a specific mention of AARD stock, suggesting it may be a focus for potential buyers based on analyst opinions [1]

Group 1: Earnings Performance - Foghorn Therapeutics Inc. reported a quarterly loss of $0.25 per share, better than the Zacks Consensus Estimate of a loss of $0.31, representing an earnings surprise of +19.35% [1] - The company posted revenues of $8.15 million for the quarter ended September 2025, surpassing the Zacks Consensus Estimate by 1.12% and showing an increase from $7.81 million year-over-year [2] - Over the last four quarters, the company has surpassed consensus EPS estimates two times and topped consensus revenue estimates once [2] Group 2: Stock Performance and Outlook - Foghorn Therapeutics shares have declined approximately 25.2% since the beginning of the year, contrasting with the S&P 500's gain of 15.1% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.28 on revenues of $9.7 million, and for the current fiscal year, it is -$1.18 on revenues of $31.3 million [7] - The estimate revisions trend for Foghorn Therapeutics was mixed ahead of the earnings release, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market [6] Group 3: Industry Context - The Medical - Biomedical and Genetics industry, to which Foghorn Therapeutics belongs, is currently in the top 40% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Financial Performance - The company has reported net losses of $52.6 million for the nine months ended September 30, 2025, and $86.6 million for the year ended December 31, 2024, with an accumulated deficit of $610.8 million as of September 30, 2025[90]. - The company has not generated any revenue from product sales to date and does not expect to do so in the near future[95]. - Collaboration revenue for Q3 2025 was $8.2 million, up from $7.8 million in Q3 2024, reflecting a 4.4% increase attributed to advancements under the Lilly Collaboration Agreement[116]. - For the nine months ended September 30, 2025, collaboration revenue reached $21.7 million, compared to $19.7 million in the same period of 2024, marking a 10.1% increase[117]. - Other income, net for Q3 2025 was $2.7 million, down from $4.7 million in Q3 2024, a decrease of 42.6%[123]. - For the nine months ended September 30, 2025, other income, net was $9.9 million, compared to $11.6 million in the same period of 2024, a decrease of 14.7%[124]. Research and Development - The company is currently working on more than seven programs, with one clinical-stage drug candidate in Phase 1 development, targeting over 500,000 cancer patients[83]. - The company expects significant increases in operating expenses as it continues its research and development activities and prepares for commercialization[91][107]. - The company anticipates that its research and development expenses may increase unpredictably due to geopolitical and economic factors[105]. - Research and development expenses for Q3 2025 were $20.0 million, down from $24.7 million in Q3 2024, a decrease of 19%[118]. - For the nine months ended September 30, 2025, research and development expenses totaled $63.4 million, a decrease of 14.3% from $74.0 million in the same period of 2024[119]. - The company expects expenses to increase substantially due to ongoing clinical activities, including the Phase 1 clinical trial of FHD-909 partnered with Lilly[133]. Financial Position and Cash Flow - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $180.3 million[125]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $63.8 million, an improvement from $75.9 million in the same period of 2024[126]. - For the nine months ended September 30, 2025, operating activities used $63.8 million of cash, compared to $75.9 million for the same period in 2024, reflecting a decrease of 15.5%[127][128]. - The net loss for the nine months ended September 30, 2025, was $52.6 million, down from $67.1 million in the prior year, indicating an improvement of approximately 21.1%[127][128]. - Net cash provided by investing activities for the nine months ended September 30, 2025, was $98.8 million, a significant increase compared to a net cash used of $52.2 million in the same period of 2024[129][130]. - Financing activities generated $0.4 million in net cash for the nine months ended September 30, 2025, a sharp decline from $105.4 million in the prior year[131][132]. - The company may need to seek additional financing sooner than planned due to potential inaccuracies in its cash flow estimates, particularly in light of recent market volatility affecting the biotech industry[133][134]. - If sufficient capital is not raised, the company may have to curtail or discontinue research and development programs or commercialization efforts[134]. - As of the report date, the company anticipates that its cash, cash equivalents, and marketable securities will be sufficient to fund operations for at least twelve months[133]. Collaboration and Agreements - The collaboration with Eli Lilly includes a 50/50 co-development and co-commercialization agreement for the SMARCA2 oncology program, with the potential to receive up to $1.3 billion in development and commercialization milestones[96][98]. - The company received an upfront payment of $300 million from the Lilly Collaboration Agreement and $80 million from the Lilly SPA, totaling $380 million in cash[85][96]. - As of September 30, 2025, the company recognized total deferred revenue of $337.8 million related to the Lilly Collaboration Agreement and the Lilly SPA[101]. - FHD-909, a selective allosteric ATPase inhibitor of SMARCA2, was transitioned to Lilly in Q3 2023, triggering a 50/50 cost share for the SMARCA2 programs[87][100]. General and Administrative Expenses - General and administrative expenses for Q3 2025 were $6.7 million, a decrease of 4.6% from $7.0 million in Q3 2024[120]. - For the nine months ended September 30, 2025, general and administrative expenses were $20.8 million, down from $22.0 million in the same period of 2024, a decrease of 5.5%[121]. Tax and Accounting - The company has recorded a full valuation allowance against its net deferred tax assets due to a history of cumulative net losses and does not expect to have taxable income in the current year[110]. - Recent accounting pronouncements that may impact the company's financial position are disclosed in the quarterly report[137]. Off-Balance Sheet Arrangements - The company currently has no off-balance sheet arrangements as defined by SEC regulations[136].

Financial Performance - Collaboration revenue increased to $8.2 million for Q3 2025, up from $7.8 million in Q3 2024, driven by advancements in programs under the Lilly Collaboration Agreement[14] - Net loss for Q3 2025 was $15.8 million, compared to a net loss of $19.1 million in Q3 2024, reflecting improved financial performance[18] - Total operating expenses for Q3 2025 were $26.7 million, down from $31.7 million in Q3 2024[22] - General and administrative expenses were $6.7 million for Q3 2025, down from $7.0 million in Q3 2024, primarily due to lower facilities and IT-related expenses[18] - Research and development expenses decreased to $20.0 million in Q3 2025 from $24.7 million in Q3 2024, attributed to reduced costs in FHD-286 and personnel-related expenses[14] - As of September 30, 2025, the company had $180.3 million in cash, cash equivalents, and marketable securities, providing a cash runway into 2028[18] Research and Development - FHD-909 is in a Phase 1 dose escalation trial targeting SMARCA4-mutated cancers, with non-small cell lung cancer (NSCLC) as the primary focus[1] - The Selective CBP degrader program is advancing towards IND readiness in 2026, with promising preclinical data for ER+ breast cancer[7] - The Selective ARID1B degrader program is progressing towards in vivo proof-of-concept in 2026, targeting up to 5% of solid tumors[9] Collaboration - The company is collaborating with Lilly under a 50/50 co-development and co-commercialization agreement for its selective SMARCA2 oncology program[4]

Core Insights - Foghorn Therapeutics is advancing its clinical programs, particularly FHD-909, a first-in-class oral SMARCA2 selective inhibitor, in a Phase 1 trial targeting SMARCA4-mutated cancers, primarily non-small cell lung cancer (NSCLC) [1][2][3] - The company is developing several selective degrader programs, including Selective CBP, EP300, and ARID1B degraders, with promising preclinical data indicating robust anti-tumor activity and favorable tolerability [2][6][7][8] - Foghorn has a strong financial position with $180.3 million in cash and equivalents as of September 30, 2025, providing a cash runway into 2028 [1][19] FHD-909 Program - FHD-909 is designed to selectively inhibit SMARCA2, showing significant anti-tumor activity in preclinical models of SMARCA4-mutant lung tumors [3][14] - The ongoing Phase 1 trial is progressing well, with enrollment on track and preclinical data supporting its combination with standard therapies [4][2] Selective Degrader Programs - The Selective CBP degrader is entering non-GLP toxicology studies with potential applications in EP300-mutant cancers and ER+ breast cancer, aiming for IND readiness in 2026 [1][12] - The Selective EP300 degrader is showing broad efficacy across hematological malignancies, with IND-enabling studies expected in 2026 [1][7][12] - The Selective ARID1B degrader is advancing towards in vivo proof of concept in 2026, targeting ARID1A-mutated cancers, which represent up to 5% of solid tumors [1][8][13] Financial Performance - Collaboration revenue increased to $8.2 million for Q3 2025, up from $7.8 million in Q3 2024, driven by advancements in programs under the Lilly collaboration [19] - Research and development expenses decreased to $20.0 million in Q3 2025 from $24.7 million in Q3 2024, attributed to reduced costs in various areas [19] - The net loss for Q3 2025 was $15.8 million, an improvement from a net loss of $19.1 million in the same quarter of the previous year [19][22] Leadership Update - The Chief Financial Officer, Kristian Humer, will be leaving the company, with a search for a successor already underway [10]

Core Viewpoint - The conference call focuses on Foghorn's proprietary programs, particularly the selective ARID1B degrader, along with updates on other programs like selective CBP and EP300 degraders [2][4]. Group 1: Company Overview - Karin Hellsvik, Vice President of Investor Relations and Corporate Affairs, leads the call and emphasizes the focus on Foghorn's selective ARID1B degrader and other proprietary programs [2]. - Adrian Gottschalk, President and CEO, will provide an overview of the company's recent progress [4]. Group 2: Pipeline Updates - The call will include updates on the progress of Foghorn's proprietary pipeline programs, specifically ARID1B, CBP, and EP300, along with new data presented [4].

Group 1 - The article does not provide any specific content related to a company or industry [1]

Foghorn Therapeutics FY Conference Call Summary Company Overview - **Company**: Foghorn Therapeutics (NasdaqGM:FHTX) - **Date of Call**: October 30, 2025 - **Focus**: Updates on proprietary programs including selective ARID1B, CBP, and EP300 degraders [1][2][3] Key Industry Insights - **Chromatin Regulatory System**: Foghorn Therapeutics targets the chromatin regulatory system, which is implicated in cancer, with mutations found in up to 50% of tumors [4][5] - **Market Opportunity**: Successful drugs targeting this biology represent multi-billion-dollar opportunities [5] Core Programs and Developments 1. **FHD-909** - **Description**: First-in-class selective oral small molecule inhibitor of SMARCA2, targeting tumors with SMARCA4 mutations [7] - **Clinical Trial**: Currently enrolling patients in a phase 1 dose escalation trial in the US and Japan, focusing on non-small cell lung cancer patients with SMARCA4 mutations [8] - **Timeline**: Anticipated decision on dose expansion by Lilly in the first half of 2026 [8] 2. **Selective ARID1B Degrader** - **Significance**: First to publicly demonstrate robust degradation of ARID1B, targeting a population with ARID1A mutations found in approximately 5% of solid tumors [9][10] - **Clinical Context**: ARID1A mutations accelerate tumor genesis and promote metastases, indicating a high unmet medical need [17] - **Progress**: Achieved 80% degradation in preclinical models, with in vivo proof of concept expected in 2026 [19][20] 3. **Selective CBP Degrader** - **Target Population**: Potential in EP300 mutated cancers and ER-positive breast cancer, with over 200,000 cases diagnosed annually in the US [24][25] - **Mechanism**: Selective degradation of CBP could provide a wider therapeutic window than dual CBP/EP300 inhibitors, avoiding hematological toxicities [24][27] - **Development Status**: Pre-development candidate CBP degrader (CPPD171) is on track for IND readiness in 2026 [10][28] 4. **Selective EP300 Degrader** - **Target Indications**: Significant potential in hematological malignancies, particularly multiple myeloma, with approximately 100,000 patients in the US potentially benefiting [31][32] - **Clinical Validation**: Previous dual CBP/EP300 inhibitors have shown compelling results in multiple myeloma, supporting the approach [34] - **Development Timeline**: Tracking towards IND-enabling studies in 2026 [38] Additional Insights - **Mechanistic Understanding**: Foghorn emphasizes a biology-first approach, focusing on novel biology and targets, with a deep mechanistic understanding of the chromatin regulatory system [5][6] - **Partnership Strategy**: The company is considering partnerships for larger tumor types, particularly in breast cancer and multiple myeloma, to leverage resources for clinical studies [80][81] - **Feedback from Conferences**: Positive feedback received on the selective degradation of ARID1B, indicating significant interest and curiosity from industry peers [83] Conclusion Foghorn Therapeutics is advancing a robust pipeline of selective degraders targeting critical components of the chromatin regulatory system, with significant potential to address unmet medical needs in various cancers. The company is on track for key milestones in 2026, including IND readiness for multiple programs.

Core Insights - Foghorn Therapeutics Inc. is advancing its Selective ARID1B, Selective CBP, and Selective EP300 degrader programs, showcasing significant progress in addressing challenging cancer targets [1][2] Selective ARID1B Degrader Program - The Selective ARID1B degrader targets a dependency found in up to 5% of solid tumors, including endometrial, gastric, gastroesophageal junction, bladder, and non-small cell lung cancer [3][5] - The program is advancing towards in vivo proof of concept expected in 2026, with recent data presented at the TPD and Induced Proximity Summit [4][5] Selective CBP Degrader Program - The Selective CBP degrader is on track for non-GLP toxicology studies in Q4 2025, with potential applications in EP300-mutant cancers and ER+ breast cancer, aiming for IND readiness in 2026 [5][8] - The program is designed to overcome challenges associated with dual inhibition of CBP and EP300, which have shown dose-limiting toxicities [7][9] Selective EP300 Degrader Program - The Selective EP300 degrader is focused on hematological malignancies such as multiple myeloma and diffuse large b-cell lymphoma, with IND-enabling studies planned for 2026 [9][10] - This program demonstrates encouraging anti-tumor efficacy and favorable tolerability in preclinical studies, differentiating itself from dual CBP/EP300 approaches [5][10] Company Overview - Foghorn Therapeutics is developing a novel class of medicines targeting genetically determined dependencies within the chromatin regulatory system, utilizing its Gene Traffic Control platform [11]