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Foghorn Therapeutics Highlights January Equity Financing, Program Progress and Strategic Objectives for 2026
Globenewswire· 2026-01-10 03:20
Core Insights - Foghorn Therapeutics has successfully raised $50 million in equity financing, which is set to close on January 13, 2026, at a 30% premium to the stock price on January 9, 2026, indicating strong investor confidence in the company's vision and execution [2][3] - The company is advancing its Phase 1 dose-escalation trial of FHD-909, targeting SMARCA4-mutant cancers, particularly non-small cell lung cancer (NSCLC), which has a poor prognosis [1][4] - Foghorn is on track to make its Selective CBP and EP300 degrader programs IND-ready in 2026, with promising preclinical data supporting their efficacy in various cancers [1][10][11] Financial Overview - The company has a strong balance sheet with approximately $208.9 million in cash, cash equivalents, and marketable securities, which will support ongoing investments in its pipeline and extend its cash runway into the first half of 2028 [1][12] - The recent equity financing will allow the company to continue its strategic objectives and development of its oncology pipeline [2][3] Pipeline Development - FHD-909 is a first-in-class oral SMARCA2 selective inhibitor, showing high selectivity and potential for inducing tumor death while sparing healthy cells, particularly in SMARCA4-mutant cancers [4] - The Selective CBP degrader program is focused on ER+ breast cancer and aims to overcome challenges associated with dual inhibition of CBP/EP300, while the Selective EP300 degrader program targets hematological malignancies [6][7] - The Selective ARID1B degrader program is also advancing, targeting ARID1A-mutated cancers, with potential for oral delivery and selective degradation [8][16] Strategic Collaborations - Foghorn is collaborating with Lilly on a 50/50 co-development and co-commercialization agreement for its selective SMARCA2 oncology program, which includes both a selective inhibitor and a selective degrader [5]
3 Cancer Stocks to Buy Amid Rapid Advances in Cancer Treatment
ZACKS· 2025-12-18 16:40
Industry Overview - The global oncology market is evolving significantly due to rising cancer incidence and rapid scientific advancements, with the American Cancer Society estimating approximately 2.04 million new cancer diagnoses and over 618,000 cancer-related deaths in the U.S. by 2025 [2] - Aging populations and lifestyle-related risk factors are contributing to higher cancer prevalence, leading to sustained growth in healthcare spending on oncology [2] Innovation in Cancer Care - Breakthroughs in immunotherapies, targeted treatments, and personalized vaccines are expanding therapeutic options beyond conventional chemotherapy and radiation [3] - Immune-based strategies, including checkpoint inhibitors and CAR-T therapies, are harnessing the body's immune system to target tumors, while targeted therapies focus on specific genetic alterations [3] - Emerging technologies like genomic sequencing, AI, and machine learning are enhancing biomarker discovery and supporting earlier diagnosis, improving survival rates and quality of life across several cancer types [4] Pharmaceutical Investment - Major pharmaceutical companies, including Novartis, AstraZeneca, Johnson & Johnson (J&J), Pfizer, AbbVie, Merck, Bristol Myers Squibb, and Eli Lilly, are investing aggressively in oncology portfolios with new therapies such as antibody-drug conjugates and bispecific antibodies [5] - Smaller biotech firms are also crucial in driving innovation through partnerships, licensing agreements, and acquisitions [5] Market Dynamics - Oncology is considered one of the most durable and attractive segments within the global healthcare sector for long-term investors, supported by ongoing innovation and favorable reimbursement dynamics [6] Company Focus: Johnson & Johnson - J&J's oncology segment currently accounts for approximately 27% of its total revenues, with oncology sales rising 20.6% to $18.52 billion in the first nine months, driven by key products like Darzalex and Erleada [9] - J&J's oncology pipeline has gained momentum with promising developments in colorectal and head and neck cancers, and the company expects its oncology sales to reach $50 billion by the end of the decade [10][12] - J&J is also enhancing its oncology pipeline through M&A, including a recent agreement to acquire Halda Therapeutics [11] Company Focus: ImmunityBio - ImmunityBio's lead drug, Anktiva, was approved for treating BCG-unresponsive non-muscle invasive bladder cancer, generating $74.7 million in sales with a 467% increase in volume [13] - The drug is under review in the EU, and ImmunityBio is evaluating Anktiva for expanded use in other cancer indications [15] Company Focus: Foghorn Therapeutics - Foghorn Therapeutics is developing precision therapies targeting genetically driven vulnerabilities, with a collaboration with Lilly to co-develop its selective SMARCA2 oncology program [17] - Foghorn's lead candidate, FHD-909, is advancing in a phase I study for SMARCA4-mutated cancers, with initial data expected in 2026 [17][18]
Foghorn Therapeutics (NasdaqGM:FHTX) FY Conference Transcript
2025-12-04 15:12
Summary of Foghorn Therapeutics FY Conference Call Company Overview - Foghorn Therapeutics is a clinical stage biotech company focused on precision oncology, particularly in chromatin regulation, which is relevant to approximately 50% of cancers [2][3] Core Programs and Partnerships - The company is developing various programs, including classical enzymatic inhibitors and protein degradation approaches [2] - The 909 study, in partnership with Eli Lilly, targets the SMARC-II program and is expected to make a decision on expansion in the first half of next year [3][4] Data Disclosure and Development Plans - Foghorn plans to disclose material data regarding the 909 program, especially if Lilly decides to proceed with expansion [4][5] - The intent is to move quickly into front-line settings, particularly in combination with pembrolizumab and chemotherapy for metastatic non-small cell lung cancer [5][6] Competitive Landscape - Prelude's recent decision to halt their SMARC-II program is not seen as a negative indicator for Foghorn's target, as Foghorn believes their approach has better target coverage [6][9] - Foghorn emphasizes the importance of achieving high levels of target inhibition (IC90 or DC90) for effective treatment responses [7][10] Clinical Trial Progress - Enrollment in the 909 study has been strong, with 15 sites in the U.S. and additional sites opening in Japan and Europe [11][12] - The company is now backfilling cohorts with patients who have specific SMARCA4 mutations, focusing on those with significant loss of function [12][16] Patient Characteristics and Market Opportunity - The target patient population includes third and fourth-line non-small cell lung cancer patients, who have poor prognosis and limited treatment options [17][18] - Foghorn aims to demonstrate better response rates and overall survival compared to existing treatments, with a focus on achieving a duration of response of four months or more [18][21] Future Directions and Pipeline - Foghorn is also developing programs targeting ARID1B and CBP EP300, with plans for in vivo proof of concept and IND submissions in the coming year [25][26][27] - The company is optimistic about its unique approach to targeting these areas, which have not been extensively explored in the clinical setting [26][27] Conclusion - Foghorn Therapeutics is positioned to make significant advancements in the oncology space, particularly with its 909 program in collaboration with Eli Lilly, and has a promising pipeline of additional therapeutic targets [28]
Foghorn Therapeutics to Participate in the 8th Annual Evercore Healthcare Conference
Globenewswire· 2025-11-25 12:00
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 [1][3] - The company will participate in the 8th Annual Evercore Healthcare Conference from December 2-4, 2025, highlighting its focus on oncology and the potential of its Gene Traffic Control platform [1][2] Company Overview - Foghorn Therapeutics is engaged in discovering and developing medicines that target genetically determined dependencies within the chromatin regulatory system [3] - The company utilizes its proprietary Gene Traffic Control platform to systematically study, identify, and validate potential drug targets [3] - Foghorn is developing multiple product candidates specifically in the oncology sector [3] Event Participation - Management will participate in a fireside chat on December 4, 2025, at 9:10 a.m. EST, with a webcast available for 30 days [2][4] - The company will also engage in one-on-one meetings during the conference [4]
Does Foghorn Therapeutics (FHTX) Have the Potential to Rally 133.27% as Wall Street Analysts Expect?
ZACKS· 2025-11-19 15:57
Core Viewpoint - Foghorn Therapeutics Inc. (FHTX) has seen a 23.3% increase in share price over the past four weeks, closing at $5.02, with analysts suggesting a potential upside of 133.3% based on a mean price target of $11.71 [1][11]. Price Targets and Analyst Estimates - The mean price target is derived from seven short-term estimates, with a standard deviation of $2.06, indicating variability among analysts [2]. - The lowest price target of $9.00 suggests a 79.3% increase, while the highest target of $14.00 indicates a potential surge of 178.9% [2]. - A low standard deviation signifies strong agreement among analysts regarding the stock's price movement [9]. Earnings Estimates and Analyst Agreement - Analysts have shown increasing optimism about FHTX's earnings prospects, as evidenced by a positive trend in earnings estimate revisions [11]. - The Zacks Consensus Estimate for the current year has risen by 2.6% over the past month, with three estimates increasing and no negative revisions [12]. - FHTX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13]. Caution on Price Targets - While price targets are commonly referenced by investors, their reliability is often questioned, as they can mislead rather than guide [7][10]. - Analysts may set overly optimistic price targets due to business incentives, which can inflate expectations [8]. - Despite the skepticism surrounding price targets, a consensus direction can provide a useful starting point for further research [9][14].
Foghorn Therapeutics (NasdaqGM:FHTX) 2025 Conference Transcript
2025-11-19 11:32
Summary of Foghorn Therapeutics Conference Call Company Overview - **Company**: Foghorn Therapeutics (NasdaqGM:FHTX) - **Industry**: Clinical-stage oncology focused on chromatin biology - **Key Focus**: Regulating gene expression through drug discovery targeting previously undrugged proteins [3][4] Core Programs and Partnerships - **Main Compound**: Partnership with Eli Lilly focusing on SMARCA2, established with a deal worth approximately $300 million upfront and $80 million in equity [4][9] - **Current Status**: In a 50/50 cost-sharing phase for the SMARCA2 program, with a decision on dose expansion expected in the first half of 2026 [9][13] - **Other Proprietary Programs**: Targets include CBP, EP300, and ARID, with ongoing development towards IND submissions over the next 12-18 months [4][10] Drug Discovery and Development - **Unique Platform**: Foghorn has developed a platform to study large protein assemblies, enabling selective drugging of challenging targets like SMARCA2 and SMARCA4 [6][8] - **Challenges**: Historically, finding selective drugs for SMARCA2 and SMARCA4 has been difficult due to their high similarity (90% identical) [8][10] - **Efficacy Benchmarks**: For SMARCA4 mutant non-small cell lung cancer, the response rate is significantly lower (20%) compared to wild-type patients (40+%) [15][16] Clinical Insights - **Current Trials**: The SMARCA2 inhibitor (FHD-909) is in a phase one dose escalation study targeting patients with SMARCA4 mutations [12][13] - **Expected Outcomes**: Aiming for a response rate of at least 15% in the fourth-line setting, with plans to move into frontline settings based on preclinical data [17][20] Competitive Landscape - **Resistance Mechanisms**: No known resistance mechanisms for SMARCA2 inhibitors or degraders have been identified yet [21] - **Screening Process**: SMARCA4 mutations are routinely screened in major cancer centers, facilitating patient enrollment in clinical trials [23] Future Directions - **Combination Therapies**: Plans to explore combinations with pembrolizumab and chemotherapy for enhanced efficacy in SMARCA4 mutant patients [24][25] - **Pipeline Development**: Focus on multiple myeloma for EP300 degraders, with IND-enabling studies expected by late 2026 [29][30] Financial Position - **Cash Reserves**: As of Q3, Foghorn has $180 million, projected to last into early 2028, covering ongoing programs and potential future financing needs [39] Strategic Partnerships - **Partnership Philosophy**: Foghorn is open to partnerships for proprietary programs, emphasizing the need for strategic capabilities that small biotechs may lack [36][37] Conclusion - **Outlook**: Foghorn Therapeutics is positioned for significant developments in oncology, particularly with its innovative approach to chromatin biology and strategic partnerships, while maintaining a solid financial foundation for future growth [39][40]
Foghorn Therapeutics (NasdaqGM:FHTX) FY Conference Transcript
2025-11-10 17:00
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.
This Aardvark Therapeutics Analyst Begins Coverage On A Bullish Note; Here Are Top 3 Initiations For Friday - Foghorn Therapeutics (NASDAQ:FHTX), Aardvark Therapeutics (NASDAQ:AARD)
Benzinga· 2025-11-07 18:57
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]
Foghorn Therapeutics Inc. (FHTX) Reports Q3 Loss, Beats Revenue Estimates
ZACKS· 2025-11-05 14:16
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]
Foghorn Therapeutics(FHTX) - 2025 Q3 - Quarterly Report
2025-11-05 12:04
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].