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Foghorn TherapeuticsADocument history
Earnings documents stored for FHTX.
Investor releaseQuarter not tagged2026-08-06Foghorn Therapeutics Provides Second Quarter 2026 Financial and Corporate Update
GlobeNewswire
Foghorn Therapeutics Provides Second Quarter 2026 Financial and Corporate Update
- FHD-909 (LY4050784) Phase 1 dose-escalation trial advancing as planned with non-small cell lung cancer (NSCLC) as the primary target population - Selective EP300 degraders with potential to treat multiple myeloma and other hematological malignancies advancing; IND targeted in 2027 - Accelerating a novel oral small molecule in immunology and inflammation toward IND in 2027 - Strong balance sheet with cash, cash equivalents, and marketable securities of approximately $168 million; cash runway into the first half of 2028 WATERTOWN, Mass., Aug. 06, 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 provided a financial and corporate update in conjunction with the Company’s 10-Q filing for the second quarter ended June 30, 2026. With an initial focus in oncology, Foghorn’s Gene Traffic Control® Platform and resulting broad pipeline have the potential to transform the lives of people suffering from a wide spectrum of diseases. “Our FHD-909 trial in collaboration with Lilly continues to advance through dose escalation, with an initial focus on SMARCA4-mutant NSCLC, a setting where effective treatment options remain limited and outcomes poor,” said Adrian Gottschalk, President and Chief Executive Officer of Foghorn Therapeutics. Mr. Gottschalk continued, “We are excited to advance our wholly-owned pipeline toward the clinic. Beyond oncology, we are now extending the reach of our platform with an undisclosed program in immunology and inflammation. We are targeting an IND in 2027 for this asset, underscoring the breadth of our platform and demonstrating its potential across multiple therapeutic areas. In oncology, our Selective EP300 degrader program in multiple myeloma has shown improved safety and efficacy versus clinical benchmarks, while our Selective CBP degrader, FHT-171, has demonstrated strong anti-tumor activity and tolerability in heavily pretreated ER+ breast cancer models. Together, these programs reflect the significant opportunity we see to expand our pipeline and create value across multiple therapeutic areas.” Program Overview and Upcoming Milestones FHD-909 (LY4050784). FHD-909 is a first-in-class oral SMARCA2 selective inhibitor that has demonstrated in preclinical studies to have high…Read full documentShow less
- FHD-909 (LY4050784) Phase 1 dose-escalation trial advancing as planned with non-small cell lung cancer (NSCLC) as the primary target population - Selective EP300 degraders with potential to treat multiple myeloma and other hematological malignancies advancing; IND targeted in 2027 - Accelerating a novel oral small molecule in immunology and inflammation toward IND in 2027 - Strong balance sheet with cash, cash equivalents, and marketable securities of approximately $168 million; cash runway into the first half of 2028 WATERTOWN, Mass., Aug. 06, 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 provided a financial and corporate update in conjunction with the Company’s 10-Q filing for the second quarter ended June 30, 2026. With an initial focus in oncology, Foghorn’s Gene Traffic Control® Platform and resulting broad pipeline have the potential to transform the lives of people suffering from a wide spectrum of diseases. “Our FHD-909 trial in collaboration with Lilly continues to advance through dose escalation, with an initial focus on SMARCA4-mutant NSCLC, a setting where effective treatment options remain limited and outcomes poor,” said Adrian Gottschalk, President and Chief Executive Officer of Foghorn Therapeutics. Mr. Gottschalk continued, “We are excited to advance our wholly-owned pipeline toward the clinic. Beyond oncology, we are now extending the reach of our platform with an undisclosed program in immunology and inflammation. We are targeting an IND in 2027 for this asset, underscoring the breadth of our platform and demonstrating its potential across multiple therapeutic areas. In oncology, our Selective EP300 degrader program in multiple myeloma has shown improved safety and efficacy versus clinical benchmarks, while our Selective CBP degrader, FHT-171, has demonstrated strong anti-tumor activity and tolerability in heavily pretreated ER+ breast cancer models. Together, these programs reflect the significant opportunity we see to expand our pipeline and create value across multiple therapeutic areas.” Program Overview and Upcoming Milestones FHD-909 (LY4050784). FHD-909 is a first-in-class oral SMARCA2 selective inhibitor that has demonstrated in preclinical studies to have high selectivity over its closely-related paralog SMARCA4, two proteins that are the catalytic engines across all forms of the BAF complex. Selectively blocking SMARCA2 activity is a promising synthetic lethal strategy intended to induce tumor death while sparing healthy cells. SMARCA4 is mutated in up to 10% of NSCLC and implicated in a significant number of solid tumors. Across lines of therapy, significant unmet needs remain for patients with SMARCA4 (BRG1)-mutant cancers with both poor response rates and short progression-free survival. Phase 1 trial on track. Enrollment in the first-in-human Phase 1 multi-center trial of FHD-909 is progressing well. The trial in patients with NSCLC as the primary target population is on track, following the dosing of the first patient in October 2024. Robust and durable preclinical data for FHD-909 plus anti-PD-1 antibody. Preclinical data have demonstrated complete tumor regression in syngeneic efficacy models of FHD-909 in combination with an anti-PD-1 antibody, with no tumor regrowth observed after dosing was halted. An immune memory effect was further supported by tumor rejection upon rechallenge in treated animals. Ongoing strategic collaboration with Lilly. Foghorn is collaborating with Lilly to develop novel oncology medicines, including a 50/50 U.S. co-development and co-commercialization agreement for its selective SMARCA2 oncology program that includes both a selective inhibitor and a selective degrader, as well as an additional undisclosed oncology target. The collaboration, the research term of which will expire in December 2026, also includes three discovery programs from Foghorn’s proprietary Gene Traffic Control® platform. I&I Novel Oral Small Molecule. Foghorn is advancing a novel oral small molecule in immunology and inflammation (I&I). IND targeted in 2027. Selective EP300 degrader program. These degraders are being developed for the treatment of hematological malignancies and prostate cancer. Attempts to selectively drug EP300 have been challenging due to the high level of similarity between EP300 and CBP, while dual inhibition of CBP/EP300 has been associated with dose limiting toxicities. EP300 lineage dependencies are established in multiple myeloma (MM) and diffuse large b-cell lymphoma (DLBCL). EP300 degrader program outperforms clinical benchmark. Preclinical data highlight the therapeutic potential in multiple myeloma, including superior anti-tumor activity with complete responses, compared to clinical benchmark dual CBP/EP300 inhibitor inobrodib, superior safety by body weight loss and platelet counts over dual degradation, and tumor regression in a multiple myeloma xenograft model of acquired pomalidomide resistance. IND targeted in 2027, with a focus in MM and DLBCL. Selective CBP degrader program. These degraders selectively target CBP, an acetyltransferase closely related to EP300. CBP lineage dependencies are established in several cancers, including breast cancer, and there is also a synthetic relationship in EP300-mutated cancers, which include endometrial, cervical, ovarian, bladder, and colorectal cancer. Attempts to selectively drug CBP have been challenging due to the high level of similarity between the two proteins, while dual inhibition of CBP/EP300 has been associated with dose-limiting toxicities. CBPd-171 shows strong therapeutic potential in ER+ breast cancer. Preclinical data for our lead Selective CBP degrader, CBPd-171, highlighted strong anti-tumor activity as a monotherapy in PDX models of heavily pretreated ER+ breast cancer, favorable preclinical in vivo tolerability profile, and high selectivity and potent CBP degradation with clear on-target transcriptional effects. We have developed a long-acting injectable (LAI) formulation for weekly subcutaneous administration to support convenient and patient-friendly dosing. The CBPd-171 timeline has been delayed due to an unexpected operational issue at a third-party contract research organization supporting the in vivo animal models. The Company will provide updated guidance once available. Selective ARID1B degrader program. These degraders selectively target and degrade ARID1B and are being positioned as synthetic lethal opportunities for ARID1A-mutated cancers. ARID1A is the most mutated subunit in the BAF complex and amongst the most mutated proteins in cancer. These mutations lead to a dependency on ARID1B in several types of cancer, including endometrial, gastric, bladder and NSCLC. Attempts to selectively drug ARID1B have been challenging because of the high degree of similarity between ARID1A and ARID1B and the fact that ARID1B has no enzymatic activity to target. ARID1B is a major synthetic lethal target implicated in up to 5% of all solid tumors. First-in-class Selective ARID1B degrader program. Robust degradation with potential for oral bioavailability demonstrated preclinically across our cereblon-based Selective ARID1B degraders. Foghorn is developing cereblon-based bifunctional degraders achieving selective degradation of ARID1B and modulation of downstream target genes consistent with ARID1B pathway disruption. Platform. Foghorn continues to advance its chromatin biology and degrader platform with investments in molecular glues, RIPTACs and induced proximity. Second Quarter 2026 Financial Highlights Collaboration Revenue. Collaboration revenue was $16.1 million for the three months ended June 30, 2026, compared to $7.6 million for the three months ended June 30, 2025. The $8.5 million increase was driven by a $14.2 million cumulative catch-up adjustment to reflect updated future costs primarily due to the scheduled expiration of the research term in December 2026 partially offset by the timing of work performed under the Lilly Collaboration Agreement. Research and Development Expenses. Research and development expenses were $18.5 million for the three months ended June 30, 2026, compared to $21.8 million for the three months ended June 30, 2025. The $3.3 million decrease is attributed to a decrease in Lilly-partnered program costs, decreases in facilities and IT-related expenses, a decrease in FHD-286 costs, and decreases in personnel-related costs partially offset by an increase in early development and other external costs. General and Administrative Expenses. General and administrative expenses were $6.4 million for the three months ended June 30, 2026, compared to $6.9 million for the three months ended June 30, 2025. This $0.5 million decrease was primarily due to lower facilities and IT-related expenses. Net Loss. Net loss was $7.2 million for the three months ended June 30, 2026, compared to a net loss of $17.9 million for the three months ended June 30, 2025. Cash, Cash Equivalents, and Marketable Securities. As of June 30, 2026, the Company had $167.6 million in cash, cash equivalents, and marketable securities, providing cash runway into the first half of 2028. About FHD-909 FHD-909 (LY4050784) is a potent, first-in-class, allosteric, and orally available small molecule that selectively inhibits the ATPase activity of SMARCA2 (BRM) over its closely related paralog SMARCA4 (BRG1), two proteins that are the catalytic engines across all forms of the BAF complex, one of the key regulators of the chromatin regulatory system. In preclinical studies, tumors with mutations in SMARCA4 rely on SMARCA2 for their survival. FHD-909 has shown significant anti-tumor activity across multiple SMARCA4-mutant lung tumor models. About Foghorn Therapeutics Foghorn® Therapeutics is discovering and developing a novel class of medicines targeting genetically determined dependencies within the chromatin regulatory system. Through its proprietary scalable Gene Traffic Control® platform, Foghorn is systematically studying, identifying, and validating potential drug targets within the chromatin regulatory system. The Company is developing product candidates in oncology and in immunology & inflammation. Visit our website at www.foghorntx.com for more information on the Company, and follow us on X and LinkedIn. Forward-Looking Statements This press release contains “forward-looking statements.” Forward-looking statements include statements regarding the Company’s clinical and preclinical programs, including the ongoing Phase 1 trial evaluating FHD-909 in SMARCA4-mutated cancers, selective CBP and selective EP300 degrader programs, selective ARID1B degrader program, the novel oral small molecule in immunology and inflammation, and other preclinical product candidates, expected timing of clinical data, expected cash runway, expected timing of regulatory filings, and research efforts and other statements identified by words such as “could,” “may,” “might,” “will,” “likely,” “anticipates,” “intends,” “plans,” “seeks,” “believes,” “estimates,” “expects,” “continues,” “projects” and similar references to future periods. Forward-looking statements are based on our current expectations and assumptions regarding capital market conditions, our business, the economy and other future conditions. Because forward-looking statements relate to the future, by their nature, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. As a result, actual results may differ materially from those contemplated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include regional, national or global political, economic, business, competitive, market and regulatory conditions, including risks relating to our clinical trials and other factors set forth under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission. Any forward-looking statement made in this press release speaks only as of the date on which it is made. Contact:Karin Hellsvik, Foghorn Therapeutics [email protected]
Investor releaseQuarter not tagged2026-07-28Acadia Healthcare (ACHC) Surpasses Q2 Earnings and Revenue Estimates
Zacks
Acadia Healthcare (ACHC) Surpasses Q2 Earnings and Revenue Estimates
Acadia Healthcare (ACHC) came out with quarterly earnings of $0.38 per share, beating the Zacks Consensus Estimate of $0.33 per share. This compares to earnings of $0.83 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +15.15%. A quarter ago, it was expected that this provider of inpatient behavioral health care services would post earnings of $0.28 per share when it actually produced earnings of $0.37, delivering a surprise of +32.14%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Acadia Healthcare, which belongs to the Zacks Medical - Hospital industry, posted revenues of $865.84 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 2.50%. This compares to year-ago revenues of $869.23 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Acadia Healthcare shares have added about 129% since the beginning of the year versus the S&P 500's gain of 8.3%. While Acadia Healthcare has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Acadia Healthcare was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near fut…Read full documentShow less
Acadia Healthcare (ACHC) came out with quarterly earnings of $0.38 per share, beating the Zacks Consensus Estimate of $0.33 per share. This compares to earnings of $0.83 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +15.15%. A quarter ago, it was expected that this provider of inpatient behavioral health care services would post earnings of $0.28 per share when it actually produced earnings of $0.37, delivering a surprise of +32.14%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Acadia Healthcare, which belongs to the Zacks Medical - Hospital industry, posted revenues of $865.84 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 2.50%. This compares to year-ago revenues of $869.23 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Acadia Healthcare shares have added about 129% since the beginning of the year versus the S&P 500's gain of 8.3%. While Acadia Healthcare has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Acadia Healthcare was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.50 on $871.47 million in revenues for the coming quarter and $1.50 on $3.4 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Hospital is currently in the bottom 12% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Foghorn Therapeutics Inc. (FHTX), another stock in the broader Zacks Medical sector, has yet to report results for the quarter ended June 2026. This company is expected to post quarterly loss of $0.23 per share in its upcoming report, which represents a year-over-year change of +17.9%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Foghorn Therapeutics Inc.'s revenues are expected to be $8.12 million, up 7.4% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Acadia Healthcare Company, Inc. (ACHC) : Free Stock Analysis Report Foghorn Therapeutics Inc. (FHTX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-05-11The Foghorn Therapeutics Inc. (NASDAQ:FHTX) First-Quarter Results Are Out And Analysts Have Published New Forecasts
Simply Wall St.
The Foghorn Therapeutics Inc. (NASDAQ:FHTX) First-Quarter Results Are Out And Analysts Have Published New Forecasts
Foghorn Therapeutics Inc. (NASDAQ:FHTX) shareholders are probably feeling a little disappointed, since its shares fell 5.1% to US$4.44 in the week after its latest first-quarter results. Revenues fell -59% short of what the analysts had expected, coming in at US$3.3m. Statutory losses were somewhat milder than expected, coming in with a loss of US$0.29 per share. This is an important time for investors, as they can track a company's performance in its report, look at what experts are forecasting for next year, and see if there has been any change to expectations for the business. We thought readers would find it interesting to see the analysts latest (statutory) post-earnings forecasts for next year. Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. Taking into account the latest results, the current consensus from Foghorn Therapeutics' ten analysts is for revenues of US$28.8m in 2026. This would reflect a satisfactory 2.2% increase on its revenue over the past 12 months. The loss per share is expected to greatly reduce in the near future, narrowing 28% to US$0.92. Before this latest report, the consensus had been expecting revenues of US$33.3m and US$1.17 per share in losses. So there's been quite a change-up of views after the recent consensus updates, withthe analysts making a serious cut to their revenue forecasts while also reducing the estimated losses the business will incur. View our latest analysis for Foghorn Therapeutics The consensus price target was broadly unchanged at US$11.44, implying that the business is performing roughly in line with expectations, despite adjustments to both revenue and earnings estimates. It could also be instructive to look at the range of analyst estimates, to evaluate how different the outlier opinions are from the mean. Currently, the most bullish analyst values Foghorn Therapeutics at US$14.00 per share, while the most bearish prices it at US$9.00. These price targets show that analysts do have some differing views on the business, but the estimates do not vary enough to suggest to us that some are betting on wild success or utter failure. Of course, another way to look at these forecasts is to place them into context against the industry itself. We would highlight that Foghorn Therapeutics' revenue growth is expected to slow, with the forecast 2…Read full documentShow less
Foghorn Therapeutics Inc. (NASDAQ:FHTX) shareholders are probably feeling a little disappointed, since its shares fell 5.1% to US$4.44 in the week after its latest first-quarter results. Revenues fell -59% short of what the analysts had expected, coming in at US$3.3m. Statutory losses were somewhat milder than expected, coming in with a loss of US$0.29 per share. This is an important time for investors, as they can track a company's performance in its report, look at what experts are forecasting for next year, and see if there has been any change to expectations for the business. We thought readers would find it interesting to see the analysts latest (statutory) post-earnings forecasts for next year. Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. Taking into account the latest results, the current consensus from Foghorn Therapeutics' ten analysts is for revenues of US$28.8m in 2026. This would reflect a satisfactory 2.2% increase on its revenue over the past 12 months. The loss per share is expected to greatly reduce in the near future, narrowing 28% to US$0.92. Before this latest report, the consensus had been expecting revenues of US$33.3m and US$1.17 per share in losses. So there's been quite a change-up of views after the recent consensus updates, withthe analysts making a serious cut to their revenue forecasts while also reducing the estimated losses the business will incur. View our latest analysis for Foghorn Therapeutics The consensus price target was broadly unchanged at US$11.44, implying that the business is performing roughly in line with expectations, despite adjustments to both revenue and earnings estimates. It could also be instructive to look at the range of analyst estimates, to evaluate how different the outlier opinions are from the mean. Currently, the most bullish analyst values Foghorn Therapeutics at US$14.00 per share, while the most bearish prices it at US$9.00. These price targets show that analysts do have some differing views on the business, but the estimates do not vary enough to suggest to us that some are betting on wild success or utter failure. Of course, another way to look at these forecasts is to place them into context against the industry itself. We would highlight that Foghorn Therapeutics' revenue growth is expected to slow, with the forecast 2.9% annualised growth rate until the end of 2026 being well below the historical 32% p.a. growth over the last five years. Compare this against other companies (with analyst forecasts) in the industry, which are in aggregate expected to see revenue growth of 22% annually. So it's pretty clear that, while revenue growth is expected to slow down, the wider industry is also expected to grow faster than Foghorn Therapeutics. The most obvious conclusion is that the analysts made no changes to their forecasts for a loss next year. On the negative side, they also downgraded their revenue estimates, and forecasts imply they will perform worse than the wider industry. Even so, long term profitability is more important for the value creation process. The consensus price target held steady at US$11.44, with the latest estimates not enough to have an impact on their price targets. With that said, the long-term trajectory of the company's earnings is a lot more important than next year. We have forecasts for Foghorn Therapeutics going out to 2028, and you can see them free on our platform here. Don't forget that there may still be risks. For instance, we've identified 2 warning signs for Foghorn Therapeutics (1 can't be ignored) you should be aware of. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Investor releaseQuarter not tagged2026-05-07CorMedix (CRMD) Earnings Expected to Grow: What to Know Ahead of Next Week's Release
Zacks
CorMedix (CRMD) Earnings Expected to Grow: What to Know Ahead of Next Week's Release
Wall Street expects a year-over-year increase in earnings on higher revenues when CorMedix (CRMD) reports results for the quarter ended March 2026. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on May 14. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This pharmaceutical and medical device company is expected to post quarterly earnings of $0.35 per share in its upcoming report, which represents a year-over-year change of +16.7%. Revenues are expected to be $109.85 million, up 181.1% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 35.71% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's pre…Read full documentShow less
Wall Street expects a year-over-year increase in earnings on higher revenues when CorMedix (CRMD) reports results for the quarter ended March 2026. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on May 14. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This pharmaceutical and medical device company is expected to post quarterly earnings of $0.35 per share in its upcoming report, which represents a year-over-year change of +16.7%. Revenues are expected to be $109.85 million, up 181.1% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 35.71% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For CorMedix, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -10.15%. On the other hand, the stock currently carries a Zacks Rank of #4. So, this combination makes it difficult to conclusively predict that CorMedix will beat the consensus EPS estimate. While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that CorMedix would post earnings of $0.86 per share when it actually produced earnings of $0.61, delivering a surprise of -29.07%. Over the last four quarters, the company has beaten consensus EPS estimates three times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. CorMedix doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Among the stocks in the Zacks Medical - Biomedical and Genetics industry, Foghorn Therapeutics Inc. (FHTX), is soon expected to post loss of $0.28 per share for the quarter ended March 2026. This estimate indicates a year-over-year change of +6.7%. This quarter's revenue is expected to be $9.24 million, up 55.3% from the year-ago quarter. Over the last 30 days, the consensus EPS estimate for Foghorn Therapeutics has been revised 3.5% down to the current level. Nevertheless, the company now has an Earnings ESP of 0.00%, reflecting an equal Most Accurate Estimate. When combined with a Zacks Rank of #3 (Hold), this Earnings ESP makes it difficult to conclusively predict that Foghorn Therapeutics will beat the consensus EPS estimate. Over the last four quarters, the company surpassed consensus EPS estimates two times. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report CorMedix Inc (CRMD) : Free Stock Analysis Report Foghorn Therapeutics Inc. (FHTX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-05-07Sarepta Therapeutics (SRPT) Q1 Earnings and Revenues Top Estimates
Zacks
Sarepta Therapeutics (SRPT) Q1 Earnings and Revenues Top Estimates
Sarepta Therapeutics (SRPT) came out with quarterly earnings of $3.16 per share, beating the Zacks Consensus Estimate of $0.9 per share. This compares to a loss of $3.42 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +253.07%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.71 per share when it actually produced a loss of $3.58, delivering a surprise of -404.23%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Sarepta Therapeutics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $730.8 million for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 56.20%. This compares to year-ago revenues of $744.86 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Sarepta Therapeutics shares have added about 1.3% since the beginning of the year versus the S&P 500's gain of 6%. While Sarepta Therapeutics has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Sarepta Therapeutics was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future…Read full documentShow less
Sarepta Therapeutics (SRPT) came out with quarterly earnings of $3.16 per share, beating the Zacks Consensus Estimate of $0.9 per share. This compares to a loss of $3.42 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +253.07%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.71 per share when it actually produced a loss of $3.58, delivering a surprise of -404.23%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Sarepta Therapeutics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $730.8 million for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 56.20%. This compares to year-ago revenues of $744.86 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Sarepta Therapeutics shares have added about 1.3% since the beginning of the year versus the S&P 500's gain of 6%. While Sarepta Therapeutics has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Sarepta Therapeutics was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $1.06 on $446.54 million in revenues for the coming quarter and $3.90 on $1.74 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the bottom 40% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Foghorn Therapeutics Inc. (FHTX), another stock in the same industry, has yet to report results for the quarter ended March 2026. This company is expected to post quarterly loss of $0.28 per share in its upcoming report, which represents a year-over-year change of +6.7%. The consensus EPS estimate for the quarter has been revised 3.5% lower over the last 30 days to the current level. Foghorn Therapeutics Inc.'s revenues are expected to be $9.24 million, up 55.2% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Sarepta Therapeutics, Inc. (SRPT) : Free Stock Analysis Report Foghorn Therapeutics Inc. (FHTX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-05-07Foghorn Therapeutics Provides First Quarter 2026 Financial and Corporate Update
GlobeNewswire
Foghorn Therapeutics Provides First Quarter 2026 Financial and Corporate Update
- FHD-909 (LY4050784) Phase 1 dose-escalation trial on track; preclinical combination data with anti-PD-1 antibody demonstrates potential for robust and durable regression with anti-tumor immune memory - Selective CBP degrader FHT-171 advancing for the treatment of ER+ breast cancer with IND anticipated in 2027 -Selective EP300 degraders with potential in multiple myeloma and other hematological malignancies with IND anticipated in 2027 - Strong balance sheet with cash, cash equivalents, and marketable securities of approximately $184 million; cash runway into the first half of 2028 WATERTOWN, Mass., May 07, 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 provided a financial and corporate update in conjunction with the Company’s 10-Q filing for the quarter ended March 31, 2026. With an initial focus in oncology, Foghorn’s Gene Traffic Control® Platform and resulting broad pipeline have the potential to transform the lives of people suffering from a wide spectrum of diseases. “Our lead program, FHD-909, continues to advance through dose escalation in collaboration with Lilly. The trial is enriching for NSCLC patients with SMARCA4 mutations, where outcomes remain especially poor and deteriorate with later lines of therapy,” said Adrian Gottschalk, President and Chief Executive Officer of Foghorn Therapeutics. “At this year’s American Association for Cancer Research (AACR) Annual Meeting, we presented compelling preclinical data demonstrating the potential of FHD-909 in combination with an anti-PD-1 antibody to drive complete, durable tumor regression and anti-tumor immune memory.” Mr. Gottschalk continued, “Across our wholly owned pipeline, we reported new preclinical data highlighting strong anti-tumor activity and tolerability for our Selective CBP degrader FHT-171 in heavily pretreated ER+ breast cancer models, improved safety and efficacy versus clinical benchmark for our Selective EP300 degrader in multiple myeloma, and robust target degradation with potential for oral bioavailability for our cereblon-based selective ARID1B degraders. Together, these programs expand our reach in difficult-to-treat cancers, and we look forward to sharing further progress throughout the year.” Program Overv…Read full documentShow less
- FHD-909 (LY4050784) Phase 1 dose-escalation trial on track; preclinical combination data with anti-PD-1 antibody demonstrates potential for robust and durable regression with anti-tumor immune memory - Selective CBP degrader FHT-171 advancing for the treatment of ER+ breast cancer with IND anticipated in 2027 -Selective EP300 degraders with potential in multiple myeloma and other hematological malignancies with IND anticipated in 2027 - Strong balance sheet with cash, cash equivalents, and marketable securities of approximately $184 million; cash runway into the first half of 2028 WATERTOWN, Mass., May 07, 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 provided a financial and corporate update in conjunction with the Company’s 10-Q filing for the quarter ended March 31, 2026. With an initial focus in oncology, Foghorn’s Gene Traffic Control® Platform and resulting broad pipeline have the potential to transform the lives of people suffering from a wide spectrum of diseases. “Our lead program, FHD-909, continues to advance through dose escalation in collaboration with Lilly. The trial is enriching for NSCLC patients with SMARCA4 mutations, where outcomes remain especially poor and deteriorate with later lines of therapy,” said Adrian Gottschalk, President and Chief Executive Officer of Foghorn Therapeutics. “At this year’s American Association for Cancer Research (AACR) Annual Meeting, we presented compelling preclinical data demonstrating the potential of FHD-909 in combination with an anti-PD-1 antibody to drive complete, durable tumor regression and anti-tumor immune memory.” Mr. Gottschalk continued, “Across our wholly owned pipeline, we reported new preclinical data highlighting strong anti-tumor activity and tolerability for our Selective CBP degrader FHT-171 in heavily pretreated ER+ breast cancer models, improved safety and efficacy versus clinical benchmark for our Selective EP300 degrader in multiple myeloma, and robust target degradation with potential for oral bioavailability for our cereblon-based selective ARID1B degraders. Together, these programs expand our reach in difficult-to-treat cancers, and we look forward to sharing further progress throughout the year.” Program Overview and Upcoming Milestones FHD-909 (LY4050784). FHD-909 is a first-in-class oral SMARCA2 selective inhibitor that has demonstrated in preclinical studies to have high selectivity over its closely related paralog SMARCA4, two proteins that are the catalytic engines across all forms of the BAF complex. Selectively blocking SMARCA2 activity is a promising synthetic lethal strategy intended to induce tumor death while sparing healthy cells. SMARCA4 is mutated in up to 10% of NSCLC patients and implicated in a significant number of solid tumors. Across lines of therapy, significant unmet needs remain for patients with SMARCA4 (BRG1)-mutant cancers with both poor response rates and short progression-free survival. Phase 1 trial on track. Enrollment in the first-in-human Phase 1 multi-center trial of FHD-909 is progressing well. The trial in patients with NSCLC as the primary target population is on track, following the dosing of the first patient in October 2024. Robust and durable preclinical data for FHD-909 plus anti-PD-1 antibody. New preclinical data presented at AACR demonstrated complete regression in preclinical syngeneic efficacy models of FHD-909 in combination with an anti-PD-1 antibody, with tumors failing to regrow after dosing halted. An immune memory effect was supported by tumor rejection upon rechallenge in animals treated with FHD-909 plus an anti-PD-1 antibody. Pending the decision to move into dose expansion portion of trial, Foghorn and Lilly anticipate evaluating FHD-909 in combination studies in the front-line setting of NSCLC. Ongoing strategic collaboration with Lilly. Foghorn is collaborating with Lilly to develop novel oncology medicines, including a 50/50 U.S. co-development and co-commercialization agreement for its selective SMARCA2 oncology program that includes both a selective inhibitor and a selective degrader, as well as an additional undisclosed oncology target. The collaboration also includes three discovery programs from Foghorn’s proprietary Gene Traffic Control® platform. Selective CBP degrader program. Foghorn's Selective CBP degrader targets CBP, an acetyltransferase closely related to EP300. CBP lineage dependencies are established in several cancers, including breast cancer. Attempts to selectively drug CBP have been challenging due to the high level of similarity between the two proteins, while dual inhibition of CBP/EP300 has been associated with dose-limiting toxicities. CBPd-171 shows strong therapeutic potential in ER+ breast cancer. New preclinical data for lead Selective CBP degrader CBPd-171 presented at this year’s AACR highlighted strong anti-tumor activity as a monotherapy in PDX models of heavily pretreated ER+ breast cancer, favorable tolerability profile in preclinical in vivo studies, and high selectivity and potent CBP degradation with clear on-target transcriptional effects. A long-acting injectable (LAI) formulation has been optimized for subcutaneous administration on a weekly schedule, supporting convenient and patient-friendly dosing. Investigational New Drug (IND)-enabling studies anticipated in 2026 with expected IND in 2027. Selective EP300 degrader program. Foghorn is developing a Selective EP300 degrader for the treatment of hematological malignancies and prostate cancer. Attempts to selectively drug EP300 have been challenging due to the high level of similarity between EP300 and CBP, while dual inhibition of CBP/EP300 has been associated with dose-limiting toxicities. EP300 lineage dependencies are established in diffuse large b-cell lymphoma (DLBCL), multiple myeloma (MM) and other hematological malignancies. EP300 degrader program outperforms clinical benchmark. New preclinical data presented at this year’s AACR for our Selective EP300 degraders highlight the therapeutic potential in multiple myeloma including superior anti-tumor activity with complete responses, compared to clinical benchmark dual CBP/EP300 inhibitor inobrodib, superior safety by body weight loss and platelet counts over dual degradation, and tumor regression in a multiple myeloma xenograft model of acquired pomalidomide resistance. IND-enabling studies anticipated in 2026 with expected IND in 2027. Selective ARID1B degrader program. Foghorn's Selective ARID1B degrader targets and degrades ARID1B in ARID1A-mutated cancers. ARID1A is the most mutated subunit in the BAF complex and amongst the most mutated proteins in cancer. These mutations lead to a dependency on ARID1B in several types of cancer, including endometrial, gastric, gastroesophageal junction, bladder and NSCLC. Attempts to selectively drug ARID1B have been challenging because of the high degree of similarity between ARID1A and ARID1B and the fact that ARID1B has no enzymatic activity to target. ARID1B is a major synthetic lethal target implicated in up to 5% of all solid tumors. First-in-class Selective ARID1B degrader program. New preclinical data at this year’s AACR meeting demonstrated robust degradation with potential for oral bioavailability across our cereblon-based Selective ARID1B degraders. Foghorn’s cereblon-based bifunctional degraders achieve selective degradation of ARID1B and modulation of downstream target genes consistent with ARID1B pathway disruption. Advancing towards in vivo proof of concept in 2026. Chromatin Biology and Degrader Platform. Foghorn continues to advance its chromatin biology and degrader platform with investments in long-acting injectables, oral delivery, and induced proximity. First Quarter 2026 Financial Highlights Collaboration Revenue. Collaboration revenue was $3.3 million for the three months ended March 31, 2026, compared to $6.0 million for the three months ended March 31, 2025. The $2.7 million decrease was driven by the timing of work performed under the Lilly Collaboration Agreement. Research and Development Expenses. Research and development expenses were $18.3 million for the three months ended March 31, 2026, compared to $21.6 million for the three months ended March 31, 2025. The $3.3 million decrease is attributed to a decrease in Lilly-partnered program costs, decreases in facilities and IT-related expenses, a decrease in FHD-286 costs, and decreases in personnel-related costs partially offset by an increase in early development and other external costs. General and Administrative Expenses. General and administrative expenses were $6.6 million for the three months ended March 31, 2026, compared to $7.2 million for the three months ended March 31, 2025. This $0.6 million decrease was primarily due to lower facilities and IT-related expenses. Net Loss. Net loss was $19.9 million for the three months ended March 31, 2026, compared to a net loss of $18.8 million for the three months ended March 31, 2025. Cash, Cash Equivalents, and Marketable Securities. As of March 31, 2026, the Company had $183.6 million in cash, cash equivalents, and marketable securities, providing cash runway into the first half of 2028. About FHD-909 FHD-909 (LY4050784) is a potent, first-in-class, allosteric, and orally available small molecule that selectively inhibits the ATPase activity of SMARCA2 (BRM) over its closely related paralog SMARCA4 (BRG1), two proteins that are the catalytic engines across all forms of the BAF complex, one of the key regulators of the chromatin regulatory system. In preclinical studies, tumors with mutations in SMARCA4 rely on SMARCA2 for their survival. FHD-909 has shown significant anti-tumor activity across multiple SMARCA4-mutant lung tumor models. About Foghorn Therapeutics Foghorn® Therapeutics is discovering and developing a novel class of medicines targeting genetically determined dependencies within the chromatin regulatory system. Through its proprietary scalable Gene Traffic Control® platform, Foghorn is systematically studying, identifying, and validating potential drug targets within the chromatin regulatory system. The Company is developing multiple product candidates in oncology. Visit our website at www.foghorntx.com for more information on the Company, and follow us on X and LinkedIn. Forward-Looking Statements This press release contains “forward-looking statements.” Forward-looking statements include statements regarding the Company’s clinical and preclinical programs, including the ongoing Phase 1 trial evaluating FHD-909 in SMARCA4-mutated cancers, selective CBP and selective EP300 degrader programs, selective ARID1B degrader program and other preclinical product candidates, expected timing of clinical data, expected cash runway, expected timing of regulatory filings, and research efforts and other statements identified by words such as “could,” “may,” “might,” “will,” “likely,” “anticipates,” “intends,” “plans,” “seeks,” “believes,” “estimates,” “expects,” “continues,” “projects” and similar references to future periods. Forward-looking statements are based on our current expectations and assumptions regarding capital market conditions, our business, the economy and other future conditions. Because forward-looking statements relate to the future, by their nature, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. As a result, actual results may differ materially from those contemplated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include regional, national or global political, economic, business, competitive, market and regulatory conditions, including risks relating to our clinical trials and other factors set forth under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission. Any forward-looking statement made in this press release speaks only as of the date on which it is made. Contact: Karin Hellsvik, Foghorn Therapeutics Inc. [email protected]
Investor releaseQuarter not tagged2026-05-06Foghorn Therapeutics Inc. (FHTX) May Report Negative Earnings: Know the Trend Ahead of Q1 Release
Zacks
Foghorn Therapeutics Inc. (FHTX) May Report Negative Earnings: Know the Trend Ahead of Q1 Release
The market expects Foghorn Therapeutics Inc. (FHTX) to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended March 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $0.28 per share in its upcoming report, which represents a year-over-year change of +6.7%. Revenues are expected to be $9.24 million, up 55.3% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 3.53% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A p…Read full documentShow less
The market expects Foghorn Therapeutics Inc. (FHTX) to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended March 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $0.28 per share in its upcoming report, which represents a year-over-year change of +6.7%. Revenues are expected to be $9.24 million, up 55.3% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 3.53% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Foghorn Therapeutics, the Most Accurate Estimate is the same as the Zacks Consensus Estimate, suggesting that there are no recent analyst views which differ from what have been considered to derive the consensus estimate. This has resulted in an Earnings ESP of 0%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination makes it difficult to conclusively predict that Foghorn Therapeutics will beat the consensus EPS estimate. While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Foghorn Therapeutics would post a loss of$0.28 per share when it actually produced a loss of -$0.34, delivering a surprise of -21.43%. Over the last four quarters, the company has beaten consensus EPS estimates two times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Foghorn Therapeutics doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Among the stocks in the Zacks Medical - Biomedical and Genetics industry, Fate Therapeutics (FATE), is soon expected to post loss of $0.29 per share for the quarter ended March 2026. This estimate indicates a year-over-year change of +9.4%. This quarter's revenue is expected to be $1.75 million, up 7.4% from the year-ago quarter. Over the last 30 days, the consensus EPS estimate for Fate Therapeutics has been revised 1.3% up to the current level. Nevertheless, the company now has an Earnings ESP of +4.00%, reflecting a higher Most Accurate Estimate. When combined with a Zacks Rank of #3 (Hold), this Earnings ESP indicates that Fate Therapeutics will most likely beat the consensus EPS estimate. Over the last four quarters, the company surpassed consensus EPS estimates three times. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Foghorn Therapeutics Inc. (FHTX) : Free Stock Analysis Report Fate Therapeutics, Inc. (FATE) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2025-11-05Foghorn Therapeutics Provides Third Quarter 2025 Financial and Corporate Update
GlobeNewswire
Foghorn Therapeutics Provides Third Quarter 2025 Financial and Corporate Update
Ongoing FHD-909 (LY4050784) Phase 1 dose escalation trial in SMARCA4 (BRG1)-mutated cancer remains on track with non-small cell lung cancer (NSCLC) as the primary target population Selective CBP degrader entered non-GLP toxicology studies in Q4 2025 with potential in EP300-mutant cancers and ER+ breast cancer; IND-ready in 2026 Robust preclinical anti-tumor activity and favorable tolerability across hematological malignancies differentiate novel, Selective EP300 degrader from dual CBP/EP300 approaches Selective ARID1B degrader advancing towards in vivo proof of concept in 2026 with relevance in up to 5% of solid tumors Strong balance sheet with cash, cash equivalents, and marketable securities of $180.3 million as of September 30, 2025; cash runway into 2028 CAMBRIDGE, Mass., Nov. 05, 2025 (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 provided a financial and corporate update in conjunction with the Company’s 10-Q filing for the quarter ended September 30, 2025. The Company also announced that Chief Financial Officer, Kristian Humer, will be departing to pursue another opportunity. “This quarter marked continued execution across our portfolio, reinforcing our leadership in developing novel precision therapies with broad applicability across cancers,” said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. “FHD-909, in collaboration with Lilly, is advancing in a Phase 1 dose escalation trial for the treatment of SMARCA4-mutated cancers with a focus on NSCLC. Based on our preclinical monotherapy and combination data, we are enthusiastic about the development of FHD-909 with the goal of developing it as a front-line therapy in NSCLC. Our strategic collaboration with Lilly provides the necessary strategic and financial resources to develop FHD-909.” Mr. Gottschalk continued, “Momentum is strong for our wholly-owned, first-in-class selective degrader programs targeting CBP, EP300 and ARID1B with program updates highlighted during our recent virtual investor event. Our Selective CBP degrader, with potential in ER+ breast cancer, entered non-GLP toxicology studies in Q4 2025 and is advancing towards IND in 2026, and our Selective EP300 degrader continues to show broad spectrum efficac…Read full documentShow less
Ongoing FHD-909 (LY4050784) Phase 1 dose escalation trial in SMARCA4 (BRG1)-mutated cancer remains on track with non-small cell lung cancer (NSCLC) as the primary target population Selective CBP degrader entered non-GLP toxicology studies in Q4 2025 with potential in EP300-mutant cancers and ER+ breast cancer; IND-ready in 2026 Robust preclinical anti-tumor activity and favorable tolerability across hematological malignancies differentiate novel, Selective EP300 degrader from dual CBP/EP300 approaches Selective ARID1B degrader advancing towards in vivo proof of concept in 2026 with relevance in up to 5% of solid tumors Strong balance sheet with cash, cash equivalents, and marketable securities of $180.3 million as of September 30, 2025; cash runway into 2028 CAMBRIDGE, Mass., Nov. 05, 2025 (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 provided a financial and corporate update in conjunction with the Company’s 10-Q filing for the quarter ended September 30, 2025. The Company also announced that Chief Financial Officer, Kristian Humer, will be departing to pursue another opportunity. “This quarter marked continued execution across our portfolio, reinforcing our leadership in developing novel precision therapies with broad applicability across cancers,” said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. “FHD-909, in collaboration with Lilly, is advancing in a Phase 1 dose escalation trial for the treatment of SMARCA4-mutated cancers with a focus on NSCLC. Based on our preclinical monotherapy and combination data, we are enthusiastic about the development of FHD-909 with the goal of developing it as a front-line therapy in NSCLC. Our strategic collaboration with Lilly provides the necessary strategic and financial resources to develop FHD-909.” Mr. Gottschalk continued, “Momentum is strong for our wholly-owned, first-in-class selective degrader programs targeting CBP, EP300 and ARID1B with program updates highlighted during our recent virtual investor event. Our Selective CBP degrader, with potential in ER+ breast cancer, entered non-GLP toxicology studies in Q4 2025 and is advancing towards IND in 2026, and our Selective EP300 degrader continues to show broad spectrum efficacy across hematological malignancies and favorable tolerability in preclinical studies, differentiating it from dual CBP/EP300 approaches. Our Selective ARID1B degrader is progressing towards in vivo proof-of-concept in 2026 with potential in up to 5% of all solid tumors including endometrial, gastric, gastroesophageal junction, bladder and non-small cell lung cancer. Backed by our strong balance sheet and a cash runway into 2028, we are focused on delivering breakthrough therapies that harness the broad therapeutic potential of protein degradation and chromatin regulation. Finally, I want to thank Kristian for his leadership and commitment during his time at Foghorn. He has been a valued member of the team, and I wish him well in his future endeavors.” Program Overview and Upcoming Milestones FHD-909 (LY4050784). FHD-909 is a first-in-class oral SMARCA2 selective inhibitor that has demonstrated in preclinical studies to have high selectivity over its closely-related paralog SMARCA4, two proteins that are the catalytic engines across all forms of the BAF complex. Selectively blocking SMARCA2 activity is a promising synthetic lethal strategy intended to induce tumor death while sparing healthy cells. SMARCA4 is mutated in up to 10% of NSCLC alone and implicated in a significant number of solid tumors. Phase 1 trial enrolling well. Enrollment in the first-in-human Phase 1 multi-center trial of FHD-909, with NSCLC as the primary target population, is progressing well and the study remains on track. Synergistic preclinical data of FHD-909 in combination with pembrolizumab and KRAS inhibitors. Preclinical data demonstrates enhanced anti-tumor activity of FHD-909 in combination with standard-of-care (SoC) chemotherapies, anti-PD-1 pembrolizumab and several novel KRAS inhibitors in NSCLC animal models. The combination data will inform further development plans of FHD-909. Ongoing strategic collaboration with Lilly. Foghorn is collaborating with Lilly to develop novel oncology medicines, including a U.S. 50/50 U.S. co-development and co-commercialization agreement for its selective SMARCA2 oncology program that includes both a selective inhibitor and a selective degrader, as well as an additional undisclosed oncology target. The collaboration also includes three discovery programs. Selective CBP degrader program. Foghorn's Selective CBP degrader selectively targets CBP, an acetyltransferase closely related to EP300 designed to target a synthetic relationship in EP300-mutated cancers, which includes endometrial, cervical, ovarian, bladder and colorectal cancer. Attempts to selectively drug CBP have been challenging due to the high level of similarity between the two proteins, while dual inhibition of CBP/EP300 has been associated with dose-limiting toxicities. CBP lineage dependencies are also established in several cancers, including ER+ breast cancer. Selective CBP degrader program, IND-ready anticipated in 2026. In October 2025, preclinical data for Selective CBP degrader with potential in EP300-mutated cancers and in ER+ breast cancer was presented during a Foghorn virtual investor event which included: Highly potent and selective lead candidate CBPd-171 advancing to dose range finding toxicology studies in Q4 2025 Anti-tumor activity in EP300 mutant solid tumors and in CBP dependent cancers, including promising potential in ER+ breast cancer No significant impact on platelet counts and megakaryocytes spared with CBPd-171 Long Acting Injectable (LAI) formulation optimized for subcutaneous injection weekly or every other week for convenient administration Selective EP300 degrader program. Foghorn is developing a Selective EP300 degrader for the treatment of hematological malignancies and prostate cancer. Attempts to selectively drug EP300 have been challenging due to the high level of similarity between EP300 and CBP, while dual inhibition of CBP/EP300 has been associated with dose limiting toxicities. EP300 lineage dependencies are established in multiple myeloma (MM) and diffuse large b-cell lymphoma (DLBCL). Selective EP300 Degrader program, with a focus in MM and DLBCL, IND-enabling studies expected in 2026. In October 2025 Foghorn presented efficacy and safety of Selective EP300 degraders in preclinical models of hematological malignancies which included: Broad anti-tumor activity in over 70% of all heme sub-lineages tested VHL based selective degrader shows impressive efficacy in MM without hematological toxicities including thrombocytopenia EP300 degraders show full efficacy in IMiD-resistant MM cell lines Tolerability profile with widespread potential for combinations ARID1B degrader program. Foghorn's Selective ARID1B degrader selectively targets and degrades ARID1B in ARID1A-mutated cancers. ARID1A is the most mutated subunit in the BAF complex and amongst the most mutated proteins in cancer. These mutations lead to a dependency on ARID1B in several types of cancer, including endometrial, gastric, gastroesophageal junction, bladder and NSCLC. Attempts to selectively drug ARID1B have been challenging because of the high degree of similarity between ARID1A and ARID1B and the fact that ARID1B has no enzymatic activity to target. ARID1B is a major synthetic lethal target implicated in up to 5% of all solid tumors. Selective ARID1B degrader program advancing towards in vivo proof of concept in 2026. In October 2025, data for Selective ARID1B degrader was presented at the TPD and Induced Proximity Summit and during a Foghorn virtual investor event which included: Developed VHL and cereblon based bifunctional degraders with potential for oral delivery Selective degradation of ARID1B achieved Modulation of downstream target genes following ARID1B degradation Degrader Platform. Foghorn continues to advance its degrader platform with investments in novel ligases, long-acting injectables, oral delivery, and induced proximity. Corporate Update Leadership. Chief Financial Officer, Kristian Humer, will be departing from the company, with his last day being November 14, 2025. A formal search for a successor has begun. Third Quarter 2025 Financial Highlights Collaboration Revenue. Collaboration revenue was $8.2 million for the three months ended September 30, 2025, compared to $7.8 million for the three months ended September 30, 2024. The increase was driven by the continued advancement of programs under the Lilly Collaboration Agreement. Research and Development Expenses. Research and development expenses were $20.0 million for the three months ended September 30, 2025, compared to $24.7 million for the three months ended September 30, 2024. The decrease is attributed to a decrease in FHD-286 costs, decreases in 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. General and Administrative Expenses. General and administrative expenses were $6.7 million for the three months ended September 30, 2025, compared to $7.0 million for the three months ended September 30, 2024. This decrease was primarily due to lower facilities and IT related expenses. Net Loss. Net loss was $15.8 million for the three months ended September 30, 2025, compared to a net loss of $19.1 million for the three months ended September 30, 2024. Cash, Cash Equivalents, and Marketable Securities. As of September 30, 2025, the Company had $180.3 million in cash, cash equivalents, and marketable securities, providing cash runway into 2028. About FHD-909 FHD-909 (LY4050784) is a potent, first-in-class, allosteric, and orally available small molecule that selectively inhibits the ATPase activity of SMARCA2 (BRM) over its closely related paralog SMARCA4 (BRG1), two proteins that are the catalytic engines across all forms of the BAF complex, one of the key regulators of the chromatin regulatory system. In preclinical studies, tumors with mutations in SMARCA4 rely on SMARCA2 for their survival. FHD-909 has shown significant anti-tumor activity across multiple SMARCA4-mutant lung tumor models. About Foghorn Therapeutics Foghorn® Therapeutics is discovering and developing a novel class of medicines targeting genetically determined dependencies within the chromatin regulatory system. Through its proprietary scalable Gene Traffic Control® platform, Foghorn is systematically studying, identifying, and validating potential drug targets within the chromatin regulatory system. The Company is developing multiple product candidates in oncology. Visit our website at www.foghorntx.com for more information on the Company, and follow us on X and LinkedIn. Forward-Looking Statements This press release contains “forward-looking statements.” Forward-looking statements include statements regarding the Company’s ongoing Phase 1 trial of FHD-909 in SMARCA4-mutated cancers, preclinical product candidates, expected timing of regulatory filings, including INDs, clinical data, expected cash runway, expected timing of regulatory filings, and research efforts and other statements identified by words such as “could,” “may,” “might,” “will,” “likely,” “anticipates,” “intends,” “plans,” “seeks,” “believes,” “estimates,” “expects,” “continues,” “projects” and similar references to future periods. Forward-looking statements are based on our current expectations and assumptions regarding capital market conditions, our business, the economy and other future conditions. Because forward-looking statements relate to the future, by their nature, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. As a result, actual results may differ materially from those contemplated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include regional, national or global political, economic, business, competitive, market and regulatory conditions, including risks relating to our clinical trials and other factors set forth under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission. Any forward-looking statement made in this press release speaks only as of the date on which it is made. Contact: Karin Hellsvik, Foghorn Therapeutics Inc. [email protected]
Investor releaseQuarter not tagged2025-08-05Foghorn Therapeutics Provides Second Quarter 2025 Financial and Corporate Update
GlobeNewswire
Foghorn Therapeutics Provides Second Quarter 2025 Financial and Corporate Update
FHD-909 (LY4050784) Phase 1 dose escalation trial in SMARCA4 (BRG1) mutated cancers, with non-small cell lung cancer (NSCLC) as the primary target population, is enrolling well and remains on track Preclinical synergistic benefit of FHD-909 in combination with pembrolizumab and KRAS inhibitors reinforces significant potential in NSCLC Selective CBP degrader on track for IND-enabling studies, targeting an IND in 2026 Continued progress on Selective EP300 degrader and Selective ARID1B degrader, with program updates expected in Q4 2025 Strong balance sheet with cash, cash equivalents, and marketable securities of $198.7 million as of June 30, 2025; cash runway into 2028 CAMBRIDGE, Mass., Aug. 05, 2025 (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 provided a financial and corporate update in conjunction with the Company’s 10-Q filing for the quarter ended June 30, 2025. With an initial focus in oncology, Foghorn’s Gene Traffic Control® Platform and resulting broad pipeline have the potential to transform the lives of people suffering from a wide spectrum of diseases. “We continue to make meaningful progress advancing our pipeline to treat a wide range of cancers,” said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. “The FHD-909 dose escalation trial, which is part of our strategic collaboration with Lilly, is enrolling well and remains on track. Additionally, preclinical synergistic activity of FHD-909 in combination with KRAS inhibitors and pembrolizumab supports clinical exploration of FHD-909 in difficult-to-treat NSCLC.” Mr. Gottschalk continued, “Our wholly owned selective degrader programs targeting CBP, EP300 and ARID1B, continue to advance with strong momentum. Our Selective CBP degrader has shown encouraging activity in ER+ breast cancer with potential beyond EP300-mutant tumors, and we are targeting an IND in 2026. Additionally, we anticipate program updates in the fourth quarter of 2025 for both our Selective EP300 degrader, which has shown robust anti-tumor activity across a range of hematologic malignancies, and our Selective ARID1B degrader, which has achieved selective targeted degradation. Backed by a strong balance sheet and a cash runway into 2028, we are well…Read full documentShow less
FHD-909 (LY4050784) Phase 1 dose escalation trial in SMARCA4 (BRG1) mutated cancers, with non-small cell lung cancer (NSCLC) as the primary target population, is enrolling well and remains on track Preclinical synergistic benefit of FHD-909 in combination with pembrolizumab and KRAS inhibitors reinforces significant potential in NSCLC Selective CBP degrader on track for IND-enabling studies, targeting an IND in 2026 Continued progress on Selective EP300 degrader and Selective ARID1B degrader, with program updates expected in Q4 2025 Strong balance sheet with cash, cash equivalents, and marketable securities of $198.7 million as of June 30, 2025; cash runway into 2028 CAMBRIDGE, Mass., Aug. 05, 2025 (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 provided a financial and corporate update in conjunction with the Company’s 10-Q filing for the quarter ended June 30, 2025. With an initial focus in oncology, Foghorn’s Gene Traffic Control® Platform and resulting broad pipeline have the potential to transform the lives of people suffering from a wide spectrum of diseases. “We continue to make meaningful progress advancing our pipeline to treat a wide range of cancers,” said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. “The FHD-909 dose escalation trial, which is part of our strategic collaboration with Lilly, is enrolling well and remains on track. Additionally, preclinical synergistic activity of FHD-909 in combination with KRAS inhibitors and pembrolizumab supports clinical exploration of FHD-909 in difficult-to-treat NSCLC.” Mr. Gottschalk continued, “Our wholly owned selective degrader programs targeting CBP, EP300 and ARID1B, continue to advance with strong momentum. Our Selective CBP degrader has shown encouraging activity in ER+ breast cancer with potential beyond EP300-mutant tumors, and we are targeting an IND in 2026. Additionally, we anticipate program updates in the fourth quarter of 2025 for both our Selective EP300 degrader, which has shown robust anti-tumor activity across a range of hematologic malignancies, and our Selective ARID1B degrader, which has achieved selective targeted degradation. Backed by a strong balance sheet and a cash runway into 2028, we are well positioned to further advance our differentiated programs.” Program Overview and Upcoming Milestones FHD-909 (LY4050784). FHD-909 is a first-in-class oral SMARCA2 selective inhibitor that has demonstrated in preclinical studies to have high selectivity over its closely related paralog SMARCA4, two proteins that are the catalytic engines across all forms of the BAF complex. Selectively blocking SMARCA2 activity is a promising synthetic lethal strategy intended to induce tumor death while sparing healthy cells. SMARCA4 is mutated in up to 10% of NSCLC alone and implicated in a significant number of solid tumors. Phase 1 trial enrolling well and remains on track. Enrollment in the first-in-human Phase 1 multi-center trial of FHD-909 is progressing well. The trial in patients with NSCLC as the primary target population is on track, following the dosing of the first patient in October 2024. At the American Association for Cancer Research (AACR) Annual Meeting in April 2025, Lilly presented, on behalf of the collaboration, the clinical study design poster for the Phase 1 trial evaluating FHD-909 in patients with SMARCA4 mutated locally advanced or metastatic solid tumors who have exhausted standard treatment options. The primary target population is NSCLC. Synergistic preclinical data of FHD-909 in combination with pembrolizumab and KRAS inhibitors. Preclinical data presented at AACR demonstrates enhanced anti-tumor activity of FHD-909 in combination with standard-of-care (SoC) chemotherapies, anti-PD-1 pembrolizumab and several novel KRAS inhibitors in NSCLC animal models. The combination data will inform further development plans of FHD-909. Ongoing strategic collaboration with Lilly. Foghorn is collaborating with Lilly to develop novel oncology medicines, including a U.S. 50/50 U.S. co-development and co-commercialization agreement for its selective SMARCA2 oncology program that includes both a selective inhibitor and a selective degrader, as well as an additional undisclosed oncology target. The collaboration also includes three discovery programs from Foghorn’s proprietary Gene Traffic Control® platform. Selective CBP degrader program. Foghorn's Selective CBP degrader selectively targets CBP in EP300-mutated cancer cells, which are found in various cancer types, including bladder, gastric, and endometrial cancers. CBP and EP300 are closely related acetyltransferases, and when EP300 is mutated, this creates a synthetic lethal relationship that the therapy exploits. Attempts to selectively drug CBP have been challenging due to the high level of similarity between the two proteins, while dual inhibition of CBP/EP300 has been associated with dose-limiting toxicities. Presented preclinical combination data with Selective CBP degrader in ER+ breast cancer. In April 2025, preclinical data showing Selective CBP degraders have combination benefit with approved chemotherapies and targeted agents in solid tumors beyond EP300-mutant cancers was presented as a poster at the AACR Annual Meeting. Synergistic combination activity demonstrated including with paclitaxel and CDK4/6 inhibitor abemaciclib in ER+ breast cancer. Findings support combination opportunities for selective CBP degraders in solid tumors beyond EP300-mutant cancers. On track for IND-enabling studies, targeting an IND in 2026. Selective EP300 degrader program. Foghorn is developing a Selective EP300 degrader for the treatment of hematological malignancies and prostate cancer. Attempts to selectively drug EP300 have been challenging due to the high level of similarity between EP300 and CBP, while dual inhibition of CBP/EP300 has been associated with dose limiting toxicities. EP300 lineage dependencies are established in diffuse large b-cell lymphoma (DLBCL) and multiple myeloma (MM). Presented preclinical data showing combination with DLBCL and MM SoC in April 2025. Anti-tumor activity in a broad range of hematological malignancies in vitro, including DLBCL, MM, and follicular lymphoma. Combination of EP300 degrader with SoC in both DLBCL and MM are highly synergistic in vitro. Selective EP300 degradation is effective in IMiD-resistant MM cell lines. Program update expected in Q4 2025. Selective ARID1B degrader program. Foghorn's Selective ARID1B degrader selectively targets and degrades ARID1B in ARID1A-mutated cancers. ARID1A is the most mutated subunit in the BAF complex and amongst the most mutated proteins in cancer. These mutations lead to a dependency on ARID1B in several types of cancer, including ovarian, endometrial, colorectal, and bladder. Attempts to selectively drug ARID1B have been challenging because of the high degree of similarity between ARID1A and ARID1B and the fact that ARID1B has no enzymatic activity to target. ARID1B is a major synthetic lethal target implicated in up to 5% of all solid tumors. Developed highly potent and selective binders. Preclinical data demonstrated potent and selective small molecule binders to ARID1B. Selective degradation of ARID1B achieved. Foghorn has successfully selectively degraded ARID1B. Program update expected in Q4 2025. Chromatin Biology and Degrader Platform. Foghorn continues to advance its chromatin biology and degrader platform with investments in novel ligases, long-acting injectables, oral delivery, and induced proximity. Second Quarter 2025 Financial Highlights Collaboration Revenue. Collaboration revenue was $7.6 million for the three months ended June 30, 2025, compared to $6.9 million for the three months ended June 30, 2024. The increase was driven by the continued advancement of programs under the Lilly Collaboration Agreement. Research and Development Expenses. Research and development expenses were $21.8 million for the three months ended June 30, 2025, compared to $23.8 million for the three months ended June 30, 2024. The decrease is attributed to a decrease in FHD-286 costs, decreases in 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. General and Administrative Expenses. General and administrative expenses were $6.9 million for the three months ended June 30, 2025, compared to $7.3 million for the three months ended June 30, 2024. This decrease was primarily due to lower consulting costs and lower facilities and IT related expenses. Net Loss. Net loss was $17.9 million for the three months ended June 30, 2025, compared to a net loss of $23.0 million for the three months ended June 30, 2024. Cash, Cash Equivalents, and Marketable Securities. As of June 30, 2025, the Company had $198.7 million in cash, cash equivalents, and marketable securities, providing cash runway into 2028. About FHD-909 FHD-909 (LY4050784) is a potent, first-in-class, allosteric, and orally available small molecule that selectively inhibits the ATPase activity of SMARCA2 (BRM) over its closely related paralog SMARCA4 (BRG1), two proteins that are the catalytic engines across all forms of the BAF complex, one of the key regulators of the chromatin regulatory system. In preclinical studies, tumors with mutations in SMARCA4 rely on SMARCA2 for their survival. FHD-909 has shown significant anti-tumor activity across multiple SMARCA4-mutant lung tumor models. About Foghorn Therapeutics Foghorn® Therapeutics is discovering and developing a novel class of medicines targeting genetically determined dependencies within the chromatin regulatory system. Through its proprietary scalable Gene Traffic Control® platform, Foghorn is systematically studying, identifying, and validating potential drug targets within the chromatin regulatory system. The Company is developing multiple product candidates in oncology. Visit our website at www.foghorntx.com for more information on the Company, and follow us on X and LinkedIn. Forward-Looking Statements This press release contains “forward-looking statements.” Forward-looking statements include statements regarding the Company’s ongoing Phase 1 trial of FHD-909 in SMARCA4-mutated cancers, pre-clinical product candidates, expected timing of clinical data, expected cash runway, expected timing of regulatory filings, and research efforts and other statements identified by words such as “could,” “may,” “might,” “will,” “likely,” “anticipates,” “intends,” “plans,” “seeks,” “believes,” “estimates,” “expects,” “continues,” “projects” and similar references to future periods. Forward-looking statements are based on our current expectations and assumptions regarding capital market conditions, our business, the economy and other future conditions. Because forward-looking statements relate to the future, by their nature, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. As a result, actual results may differ materially from those contemplated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include regional, national or global political, economic, business, competitive, market and regulatory conditions, including risks relating to our clinical trials and other factors set forth under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission. Any forward-looking statement made in this press release speaks only as of the date on which it is made. Contact: Karin Hellsvik, Foghorn Therapeutics Inc. [email protected]
Investor releaseQuarter not tagged2025-05-14Foghorn Therapeutics Provides First Quarter 2025 Financial and Corporate Update
GlobeNewswire
Foghorn Therapeutics Provides First Quarter 2025 Financial and Corporate Update
FHD-909 (LY4050784) advancing in Phase 1 dose escalation trial in SMARCA4 (BRG1) mutated cancers, with non-small cell lung cancer (NSCLC) as the primary target population Data presented at AACR show synergistic activity with FHD-909 in combination with pembrolizumab and KRAS inhibitors and support clinical exploration Selective CBP degrader on track for IND-enabling studies, targeting IND in 2026 Continued progress on Selective EP300 degrader and Selective ARID1B degrader with program updates expected in H2 2025 Strong balance sheet with cash, cash equivalents, and marketable securities of $220.6 million as of March 31, 2025, provides cash runway into 2027 CAMBRIDGE, Mass., May 14, 2025 (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 provided a financial and corporate update in conjunction with the Company’s 10-Q filing for the quarter ended March 31, 2025. With an initial focus in oncology, Foghorn’s Gene Traffic Control® Platform and resulting broad pipeline have the potential to transform the lives of people suffering from a wide spectrum of diseases. “In the first quarter, we continued to progress our novel partnered and proprietary programs, and we were pleased to share more details on the pipeline progress at this year’s AACR annual meeting. The FHD-909 Phase 1 dose escalation trial is proceeding apace. Importantly, the FHD-909 combination data with chemotherapies, KRAS inhibitors and pembrolizumab, that was shared at AACR, reinforces the expansive potential of the selective SMARCA2 inhibitor program in non-small cell lung cancer,” said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. “Initial data defining potential combination opportunities in ER+ breast cancer for our Selective CBP degrader program are encouraging and support potential beyond EP300-mutant cancers. Our Selective EP300 degrader program continues to show anti-proliferative activity in a broad range of hematological malignancies. And lastly, as previously reported, we have achieved selective degradation for our Selective ARID1B program and look forward to providing a program update in 2025.” Mr. Gottschalk continued, “These advancements with FHD-909 and our pipeline programs underscore our track record a…Read full documentShow less
FHD-909 (LY4050784) advancing in Phase 1 dose escalation trial in SMARCA4 (BRG1) mutated cancers, with non-small cell lung cancer (NSCLC) as the primary target population Data presented at AACR show synergistic activity with FHD-909 in combination with pembrolizumab and KRAS inhibitors and support clinical exploration Selective CBP degrader on track for IND-enabling studies, targeting IND in 2026 Continued progress on Selective EP300 degrader and Selective ARID1B degrader with program updates expected in H2 2025 Strong balance sheet with cash, cash equivalents, and marketable securities of $220.6 million as of March 31, 2025, provides cash runway into 2027 CAMBRIDGE, Mass., May 14, 2025 (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 provided a financial and corporate update in conjunction with the Company’s 10-Q filing for the quarter ended March 31, 2025. With an initial focus in oncology, Foghorn’s Gene Traffic Control® Platform and resulting broad pipeline have the potential to transform the lives of people suffering from a wide spectrum of diseases. “In the first quarter, we continued to progress our novel partnered and proprietary programs, and we were pleased to share more details on the pipeline progress at this year’s AACR annual meeting. The FHD-909 Phase 1 dose escalation trial is proceeding apace. Importantly, the FHD-909 combination data with chemotherapies, KRAS inhibitors and pembrolizumab, that was shared at AACR, reinforces the expansive potential of the selective SMARCA2 inhibitor program in non-small cell lung cancer,” said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. “Initial data defining potential combination opportunities in ER+ breast cancer for our Selective CBP degrader program are encouraging and support potential beyond EP300-mutant cancers. Our Selective EP300 degrader program continues to show anti-proliferative activity in a broad range of hematological malignancies. And lastly, as previously reported, we have achieved selective degradation for our Selective ARID1B program and look forward to providing a program update in 2025.” Mr. Gottschalk continued, “These advancements with FHD-909 and our pipeline programs underscore our track record and leadership in engineering promising selective therapeutics. With our robust balance sheet and cash runway into 2027, we are in a strong position to deliver significant value with differentiated, high-impact therapeutics in 2025 and beyond.” Recent Corporate Updates Data presented at American Association for Cancer Research (AACR) Annual Meeting. In April 2025, Foghorn presented new preclinical data highlighting pipeline progress for potential first-in-class medicines including FHD-909, a SMARCA2 (BRM) selective inhibitor, and the Selective CBP degrader program and Selective EP300 degrader program. Two Appointments to Board of Directors. In May, Foghorn announced the appointments of Neil Gallagher, M.D., Ph.D. and Stuart Duty, to its Board of Directors. Dr. Gallagher brings over 20 years of executive experience at pharmaceutical and biopharmaceutical organizations leading drug development programs across several therapeutic areas, including oncology. Currently he serves as the President, Head of Research and Development at Syndax Pharmaceuticals and held prior clinical development leadership roles at AbbVie, Amgen, Novartis, and AstraZeneca. Mr. Duty has over 30 years of executive experience in finance and investment banking in biotechnology and specialty pharmaceuticals. Most recently, he served as a Senior Managing Director at Guggenheim Securities, LLC where he advised senior executives and boards on a range of financing activities and strategic transactions. Previously, he held senior roles at Piper Jaffray and Montgomery Securities and operating roles at Oracle Partners and Curative Technologies. Second Annual Chromatin Regulation Summit. In May 2025, Foghorn hosted its “Chromatin Regulation Summit: Targeted Protein Degradation and Induced Proximity,” at their corporate headquarters in Cambridge, Massachusetts. The live event featured presentations and panel discussions with world-renowned industry and academic key opinion leaders on current and future applications of targeted protein degradation and induced proximity modalities for the treatment of disease. Program Overview and Upcoming Milestones FHD-909 (LY4050784). FHD-909 is a first-in-class oral SMARCA2 selective inhibitor that has demonstrated in preclinical studies to have high selectivity over its closely related paralog SMARCA4, two proteins that are the catalytic engines across all forms of the BAF complex. Selectively blocking SMARCA2 activity is a promising synthetic lethal strategy intended to induce tumor death while sparing healthy cells. SMARCA4 is mutated in up to 10% of NSCLC alone and implicated in a significant number of solid tumors. Advancing Phase 1 trial. Ongoing enrollment and dose escalation in the first-in-human Phase 1, multicenter trial for FHD-909 in SMARCA4 mutated cancers, with NSCLC as the primary target population following the dosing of the first patient in October 2024. At the AACR Annual Meeting in April 2025, Lilly presented, on behalf of the collaboration, the clinical study design poster for the Phase 1 trial evaluating FHD-909 in patients with SMARCA4 mutated locally advanced or metastatic solid tumors who have exhausted standard treatment options. The primary target population is NSCLC. Presented synergistic preclinical data of FHD-909 in combination with pembrolizumab and KRAS inhibitors. Also at the AACR Annual Meeting in April 2025, Lilly, on behalf of the collaboration, made an oral presentation of new preclinical data demonstrating 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. The combination data will inform further development plans of FHD-909. Ongoing strategic collaboration with Lilly. Collaborating with Lilly to create novel oncology medicines that includes a U.S. 50/50 co-development and co-commercialization agreement for Foghorn’s selective SMARCA2 oncology program, including a selective inhibitor and a selective degrader, and an additional undisclosed oncology target. The collaboration also includes three discovery programs from Foghorn’s proprietary Gene Traffic Control® platform. Selective CBP degrader program. Selectively targets CBP in EP300-mutated cancer cells found in many types of cancer, including bladder, gastric, and endometrial cancers. CBP and EP300 are highly similar acetyltransferases that create a synthetic lethal relationship when EP300 is mutated. Attempts to selectively drug CBP have been challenging due to the high level of similarity between the two proteins, while dual inhibition of CBP/EP300 has been limited by dose-limiting toxicities. Presented preclinical combination data with Selective degrader CBP in ER+ breast cancer. In April 2025, preclinical data showing Selective CBP degraders have combinatorial benefit with approved chemotherapies and targeted agents in solid tumors beyond EP300-mutant cancers was presented as a poster at the AACR Annual Meeting Synergistic combination activity demonstrated including with paclitaxel and CDK4/6 inhibitor abemaciclib in ER+ breast cancer Findings support combination opportunities for selective CBP degraders in solid tumors beyond EP300-mutant cancers On track for IND-enabling studies, targeting IND in 2026. Selective EP300 degrader program. Selective degradation of EP300 for the treatment of hematopoietic malignancies and prostate cancer. Attempts to selectively drug EP300 have been challenging due to the high level of similarity between EP300 and CBP, while dual inhibition of CBP/EP300 has been limited by dose limiting toxicities. EP300 lineage dependencies are established in multiple myeloma and diffuse large B cell lymphoma. Presented preclinical data showing combination with diffuse large b-cell lymphoma (DLBCL) and multiple myeloma (MM) Standard-of-Care Treatment (SoC). In April 2025, preclinical data for the Selective EP300 degrader program demonstrating biological activity in hematological malignancies was presented at the AACR Annual Meeting. Anti-proliferative activity in a broad range of hematological malignancies in vitro, including DLBCL, MM, and follicular lymphoma Combination of EP300 degrader with SoC in both DLBCL and MM are highly synergistic in vitro. Selective EP300 degradation is effective in IMiD-resistant MM cell lines. Program update expected in H2 2025. Selective ARID1B degrader program. Selectively targets and degrades ARID1B in ARID1A-mutated cancers. ARID1A is the most mutated subunit in the BAF complex and amongst the most mutated proteins in cancer. These mutations lead to a dependency on ARID1B in several types of cancer, including ovarian, endometrial, colorectal and bladder. Attempts to selectively drug ARID1B have been challenging because of the high degree of similarity between ARID1A and ARID1B and the fact that ARID1B has no enzymatic activity to target. ARID1B is a major synthetic lethal target implicated in up to 5% of all solid tumors. Developed highly potent and selective binders. Preclinical data demonstrated potent and selective small molecule binders to ARID1B. Selective degradation of ARID1B achieved. Foghorn has successfully selectively degraded ARID1B and expects to provide an update on the Selective ARID1B degrader program in H2 2025. Chromatin Biology and Degrader Platform. Foghorn continues to advance its chromatin biology and degrader platform with investments in novel ligases, long-acting injectables, oral delivery, and induced proximity. First Quarter 2025 Financial Highlights Collaboration Revenue. Collaboration revenue was $6.0 million for the three months ended March 31, 2025, compared to $5.1 million for the three months ended March 31, 2024. The increase was driven by the continued advancement of programs under the Lilly Collaboration Agreement. Research and Development Expenses. Research and development expenses were $21.6 million for the three months ended March 31, 2025, compared to $25.5 million for the three months ended March 31, 2024. The decrease is attributed to a decrease in FHD-286 costs of $2.5 million, decreases in personnel-related costs, early development and other research external costs and facilities and IT-related expenses of $2.1 million, partially offset by an increase in Lilly-partnered programs of $0.7 million. General and Administrative Expenses. General and administrative expenses were $7.2 million for the three months ended March 31, 2025, compared to $7.7 million for the three months ended March 31, 2024. This decrease was primarily due to lower consulting costs. Net Loss. Net loss was $18.8 million for the three months ended March 31, 2025, compared to a net loss of $25.0 million for the three months ended March 31, 2024. Cash, Cash Equivalents, and Marketable Securities. As of March 31, 2025, the Company had $220.6 million in cash, cash equivalents, and marketable securities, providing expected cash runway into 2027. About FHD-909FHD-909 (LY4050784) is a potent, first-in-class, allosteric, and orally available small molecule that selectively inhibits the ATPase activity of SMARCA2 (BRM) over its closely related paralog SMARCA4 (BRG1), two proteins that are the catalytic engines across all forms of the BAF complex, one of the key regulators of the chromatin regulatory system. In preclinical studies, tumors with mutations in SMARCA4 rely on SMARCA2 for their survival. FHD-909 has shown significant anti-tumor activity across multiple SMARCA4 mutant lung tumor models. About Foghorn TherapeuticsFoghorn® Therapeutics is discovering and developing a novel class of medicines targeting genetically determined dependencies within the chromatin regulatory system. Through its proprietary scalable Gene Traffic Control® platform, Foghorn is systematically studying, identifying, and validating potential drug targets within the chromatin regulatory system. The Company is developing multiple product candidates in oncology. Visit our website at www.foghorntx.com for more information on the Company, and follow us on X and LinkedIn. Forward-Looking StatementsThis press release contains “forward-looking statements.” Forward-looking statements include statements regarding the Company’s ongoing Phase 1 trial of FHD-909 in SMARCA4-mutated cancers, pre-clinical product candidates, expected timing of clinical data, expected cash runway, expected timing of regulatory filings, and research efforts and other statements identified by words such as “could,” “may,” “might,” “will,” “likely,” “anticipates,” “intends,” “plans,” “seeks,” “believes,” “estimates,” “expects,” “continues,” “projects” and similar references to future periods. Forward-looking statements are based on our current expectations and assumptions regarding capital market conditions, our business, the economy and other future conditions. Because forward-looking statements relate to the future, by their nature, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. As a result, actual results may differ materially from those contemplated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include regional, national or global political, economic, business, competitive, market and regulatory conditions, including risks relating to our clinical trials and other factors set forth under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission. Any forward-looking statement made in this press release speaks only as of the date on which it is made. Contact:Karin Hellsvik, Foghorn Therapeutics [email protected]

