WATERTOWN, Mass., Feb. 03, 2026 (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 that management will participate in the Guggenheim Emerging Outlook: Biotech Summit, being held February 11-12, 2026, in New York, NY. With an initial focus in oncology, Foghorn’s Gene Traffic Control® platform and resulting broad pipeline have the potential ...

Several biotech and healthcare stocks posted notable gains in after-hours trading on Friday, driven by regulatory developments, financing updates, and investor sentiment.Atossa Therapeutics, Inc. (ATOS) rose 12.98% to $0.69, up $0.080 after announcing that the U.S. Food and Drug Administration's Office of Orphan Products Development granted Orphan Drug Designation to (Z)-endoxifen for the treatment of Duchenne muscular dystrophy. The designation marks a significant milestone for the company's pipeline.Immu ...

Financing Details - Foghorn Therapeutics Inc. closed a $50 million registered direct financing at a 30% premium, selling 2,030,314 shares at $6.71 per share [1] - The offering included pre-funded warrants for up to 5,421,250 shares at $6.7099 each and series warrants for up to 3,725,782 shares at $13.42 and another 3,725,782 shares at $20.13 [1] - The gross proceeds from the offering were approximately $50 million, excluding proceeds from the exercise of series warrants [1] Investor Participation - Existing shareholders such as BVF Partners, Deerfield Management, Flagship Pioneering, and a leading biotech mutual fund participated in the financing [2] - No underwriter or placement agent was involved in the offering [2] Company Overview - Foghorn Therapeutics is focused on developing a new class of medicines that target genetically determined dependencies within the chromatin regulatory system [4] - The company utilizes its Gene Traffic Control platform to identify and validate potential drug targets, with multiple product candidates in oncology [4]

Collaboration and Financials - FHD-909 is being developed in collaboration with Lilly, with a significant agreement signed in December 2021, including $300 million cash and $80 million in common stock[9] - The collaboration includes a 50/50 U.S. economic split on the SMARCA2-target program and potential royalties ranging from low double-digit to 20s[9] - The collaboration with Lilly is expected to yield up to $1.3 billion in potential milestones across three programs[9] - Foghorn's cash position is $158.9 million, providing a runway into 2028, with a potential market impact on approximately 2.5 million patients[48] Clinical Development and Pipeline - FHD-909 is currently in Phase 1 clinical trials, targeting SMARCA4-mutant cancers, which account for approximately 10% of NSCLC and up to 5% of all solid tumors[12][14] - FHD-909 aims to become a first-line treatment for SMARCA4-mutant NSCLC, addressing significant unmet medical needs in this patient population[15][16] - The company is advancing multiple preclinical assets towards INDs, including selective inhibitors for SMARCA2, CBP, EP300, and ARID1B[10] - The selective SMARCA2 inhibitor FHD-909 is partnered with Lilly, with a $380 million upfront payment and is currently in Phase 1 trials[48] Efficacy and Mechanism of Action - The overall response rate (ORR) for patients with SMARCA4 mutations is significantly lower compared to those without, highlighting the urgent need for targeted therapies[17] - FHD-909 leverages a synthetic lethal relationship between SMARCA2 and mutated SMARCA4, representing a promising strategy in precision medicine[12][13] - FHD-909 demonstrated significant tumor regression in SMARCA4-mutant NSCLC models at tolerated doses, with a maximum dose of 60 mg/kg[52] - In vivo studies show that combining FHD-909 with cisplatin and pemetrexed enhances antitumor effects, resulting in significant tumor regression[54] - FHD-909 exhibits synergistic activity when combined with KRAS inhibitors in vitro, indicating potential for enhanced therapeutic efficacy[56] - FHD-909 sensitized tumor cells to pembrolizumab, resulting in enhanced anti-tumor activity, with pembrolizumab alone showing no effect compared to vehicle control[59] - Combination of FHD-909 with olomorasib demonstrated synergistic antitumor activity with a significant p-value of <0.05 in NCI-H2030 models[57] - FHD-909 combined with pan-KRAS inhibitor resulted in sustained tumor regression, also showing a significant p-value of <0.05 for the combination group[58] Preclinical Assets and Future Developments - The selective CBP degrader, FHT-171, is IND-ready in 2026, with a focus on CBP-dependent and EP300-mutant cancers, showing increased tolerability compared to non-selective compounds[24] - IND-enabling studies for selective EP300 degraders are planned for 2026, focusing on improved tolerability and deeper efficacy responses compared to non-selective molecules[32] - The selective EP300 degrader EP300d-007 shows superior efficacy in IMiD resistant multiple myeloma models, achieving deeper responses compared to pomalidomide and inobrodib[38] - The ARID1A mutation incidence in endometrial cancers is approximately 66,000 per year in the U.S., with ARID1B being a major synthetic lethal target[41] - The ARID1B degrader treatment has shown effects on downstream target genes, progressing towards in vivo proof-of-concept[47] - The company is advancing multiple preclinical assets towards INDs, including selective degraders for ARID1B and EP300[48] Safety and Tolerability - No significant impact on platelet counts was observed following treatment with selective CBP and EP300 degraders, indicating a favorable safety profile[35] - The long-acting injectable formulation of CBPd-171 enables weekly subcutaneous delivery, showing comparable efficacy to daily injections in gastric cancer models[30] Degradation Mechanisms - Selective degradation of CBP leads to reduced expression of estrogen receptor target genes, resulting in cancer cell growth inhibition[25] - The selective EP300 degrader shows anti-proliferative activity across a broad range of hematological malignancies, with approximately 70% of tested cell lines being sensitive[33] - EP300 degradation results in significant tumor growth inhibition in multiple myeloma and DLBCL models, with fold selectivity exceeding 1000x for certain compounds[34] - Experimental kinetic analysis indicates that degradation rates are crucial for determining the efficiency of protein degraders, with slower rates leading to partial degradation[62] - Prelude's SMARCA2 (VHL) degrader achieved improved degradation metrics compared to SMARCA2 (CRBN) degrader, indicating faster action at high concentrations[64] - Foghorn's analysis of degradation rates aligns with published data, confirming the efficacy of their degraders in achieving significant protein degradation[65]

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]

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]

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]

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]

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].

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]