Foghorn Therapeutics(FHTX) - 2025 Q2 - Quarterly Results

Executive Summary & Corporate Update 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] - Preclinical synergistic benefit of FHD-909 in combination with pembrolizumab and KRAS inhibitors reinforces significant potential in NSCLC[1] - 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] - 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] Program Overview and Upcoming Milestones 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) 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][13] - 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] - 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] Ongoing Strategic Collaboration with Lilly 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] - The collaboration also encompasses three discovery programs from Foghorn's proprietary Gene Traffic Control platform[4] Selective CBP Degrader Program 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] - 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][11] - On track for IND-enabling studies, targeting an Investigational New Drug (IND) application in 2026[1][11] Selective EP300 Degrader Program 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] - 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] - Program update expected in Q4 2025[1][11] Selective ARID1B Degrader Program 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] - Developed highly potent and selective small molecule binders to ARID1B and successfully achieved selective degradation of ARID1B[12] - Program update expected in Q4 2025[1][12] Chromatin Biology and Degrader Platform 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] Second Quarter 2025 Financial Highlights 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 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 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] - G&A decrease primarily due to lower consulting costs and lower facilities and IT related expenses[16] Net Loss 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 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][16] About Foghorn Therapeutics 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] - Utilizes its proprietary scalable Gene Traffic Control platform to systematically study, identify, and validate potential drug targets[14] - The company is developing multiple product candidates in oncology[1][14] Forward-Looking Statements 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] - 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] - 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][17] Financial Statements 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 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 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 This section provides contact details for inquiries regarding Foghorn Therapeutics - Contact person for Foghorn Therapeutics Inc. is Karin Hellsvik[22] - Email for inquiries: khellsvik@foghorntx.com[22]