FHTX 10-K & 10-Q changes, risk factors and insider trading
Foghorn Therapeutics Inc. · Nasdaq · Pharmaceutical Preparations · CIK 1822462 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “Our use of artificial intelligence and machine learning exposes us to operational, regulatory, legal, and ethical risks that could adversely affect our business, reputation, financial condition, and results of operations.”
Removed heading “We are an “emerging growth company,” and the reduced disclosure requirements applicable to emerging growth companies may make our common stock less attractive to investors.”
Largest changes
“Our use of artificial intelligence and machine learning exposes us to operational, regulatory, legal, and ethical risks that could adversely affect our business, reputation, financial condition, and results of operations.”see in full comparison
“Additionally, the emergence of AI and other technologies may contribute to other risks, including those related to regulation, litigation, compliance issues, ethical concerns, confidentiality, and data privacy or security. For example, regulatory uncertainty related to AI or other emerging technologies may require additional resources to adjust business practices to comply with developing laws.”see in full comparison
“Additionally, in its 2024 decision in Loper Bright Enterprises v. Raimondo, the U.S. Supreme Court overruled the “Chevron doctrine,” which gives deference to regulatory agencies’ statutory interpretations in litigation against federal government agencies, such as the FDA, the Centers for Medicare & Medicaid Services (“CMS”) and other federal agencies where the law is ambiguous. The Loper decision could result in additional legal challenges to regulations and guidance issued by federal agencies, including the FDA and the CMS, on which we rely. …”see in full comparison
“We are an “emerging growth company,” and the reduced disclosure requirements applicable to emerging growth companies may make our common stock less attractive to investors.”see in full comparison
Our results of operations could be adversely affected by general conditions in the global economy and financial markets, including inflation, rising interest rates, economic sanctions or other restrictions on international commerce, natural disasters, pandemics, political instability, ongoing and potential global armed conflicts andsee in full comparisonwars, including the Russia-Ukraine war, the Israeli-Palestine Conflict, and attacks in the Red Sea.wars. A severe or prolonged economic downturn, or additional global financial or political crises, could result in a variety of risks to our business, including weakened demand for our product candidates, if approved, or our ability to raise additional capital when needed on acceptable terms, if at all. A weak or declining economy could also strain our suppliers, possibly resulting in supply disruption. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions.
“We procure and deploy certain AI and machine learning technologies across our operations. For example, we use AI systems such as AlphaFold and ColabFold, to predict protein structures where experimentally solved crystal structures are not available in the Protein Data Bank. While these tools may create efficiencies, they also introduce risks related to data quality, transparency, model reliability, cybersecurity, intellectual property, privacy, discrimination, liability, and vendor/supply chain dependencies. …”see in full comparison
Full comparison: every changed paragraph (29)
Since inception, we have incurred significant operating losses. As of December 31, 2024,2025, we had an accumulated deficit of $558.2$632.5 million. We have financed our operations primarily through private placements of our preferred stock and our IPO; our former collaboration agreement with Merck; our strategic collaboration with Lilly and Lilly’s concurrent investment in our equity; and proceeds from the January 2026 Offering and May 2024 Offering.Offering; our IPO and private placements of our preferred stock; and our former collaboration agreement with Merck Sharp & Dohme Corp. For further information about our collaborations and Lilly’s equity investment, see “Business—Strategic Collaboration with Lilly.” We have devoted all of our efforts to research and development. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. The net losses we incur may fluctuate significantly from quarter to quarter. We anticipate that our expenses will increase substantially if and as we:
WeCurrently, we have one Lilly-partnered product candidate, FHD-909, in Phase 1 clinical development. In December 2024, we announced our decisions to discontinue the independent clinical development of FHD-286 in combination with decitabine in patients with relapsed and/or refractory acute myeloid leukemia. We have not initiated clinical development of our other current product candidates and expect that it will be many years, if ever, before we have a product candidate ready for commercialization. To become and remain profitable, we must develop and, either directly or through collaborators, eventually commercialize a medicine or medicines with significant market potential. This will require us to be successful in a range of challenging activities, including identifying product candidates, completing preclinical testing and clinical trials of product candidates, obtaining marketing approval for these product candidates, manufacturing, marketing, and selling those medicines for which we may obtain marketing approval, and satisfying any post-marketing requirements. We may never succeed in these activities and, even if we do, may never generate revenues that are significant or large enough to achieve profitability. We are unable to predict the extent of any future losses or when we will become profitable, if at all. If we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.
Our results of operations could be adversely affected by general conditions in the global economy and financial markets, including inflation, rising interest rates, economic sanctions or other restrictions on international commerce, natural disasters, pandemics, political instability, ongoing and potential global armed conflicts and wars, including the Russia-Ukraine war, the Israeli-Palestine Conflict, and attacks in the Red Sea.wars. A severe or prolonged economic downturn, or additional global financial or political crises, could result in a variety of risks to our business, including weakened demand for our product candidates, if approved, or our ability to raise additional capital when needed on acceptable terms, if at all. A weak or declining economy could also strain our suppliers, possibly resulting in supply disruption. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions.
We are not be able to exert unilateral control over the development of product candidates when part of a collaboration.
Under ourthe Lilly Collaboration Agreement, we influence, but do not control, the development activity of any of the product candidates covered by the Lilly Collaboration Agreement, including FHD-909. This may result in delayed and/or diminished visibility and predictability of certain aspects of development strategy, which may impact timelines, costs, and ultimate success of the product candidate.
•factors we may not be able to control, such as current or potential pandemics that may limit patients, principal investigators or staff or clinical site availability.
A key element of our strategy is to use and expand our Gene Traffic Control platform to build a pipeline of product candidates and progress these product candidates through clinical development for the treatment of various cancers and other therapeutic areas. Although ourOur research and development efforts to date have resulted in our discovery and preclinical development of FHD- 909, FHD-286, and FHD-609909 for the treatment of cancer,cancer. However, FHD-909 and any other cancer product candidates we may advance into the clinic may not be safe or effective as cancer treatments, and we may not be able to develop any other product candidates. We may not be successful in identifying further targets in the chromatin regulatory system that are relevant in cancer, or other diseases, and which can be “basketed” into a group that is large enough to present a sufficient commercial opportunity or that is druggable with one chemical compound. Even if we are successful in building our pipeline of product candidates, the potential product candidates that we identify may not be suitable for clinical development or generate acceptable clinical data, including as a result of being shown to have unacceptable toxicity or other characteristics that indicate that they are unlikely to be products that will receive marketing approval from the FDA or other regulatory authorities or achieve market acceptance. If we do not successfully develop and commercialize product candidates, we will not be able to generate product revenue in the future, which likely would result in significant harm to our financial position and adversely affect our stock price.
The current presidential administration and federal government could adopt legislation, regulation, orders or policies that adversely affect our business, including by creating a more challenging and costly environment to pursue the development and commercialization of our current or future product candidates. The impending uncertainty could present new challenges or potential opportunities as we navigate the clinical development and approval process for our product candidates.
The current administration has also undertaken significant efforts to reduce the size and spending of the federal government, including at the FDA. A significant reduction in the FDA’s workforce or the FDA’s budget, or other disruptions at the FDA, could materially impact the FDA’s ability to engage in a variety of activities that may affect our business, including routine regulatory and oversight activities. The current administration has substantially reduced the FDA’s workforce and may make further reductions, which may lead to disruptions and delays in the FDA’s review and oversight of our product candidates and impact the FDA’s ability to provide timely feedback on our development programs. Further, reductions in workforce in divisions of the FDA responsible for overseeing the importation of pharmaceutical and biological goods may delay our manufacturing timelines. Additionally, reductions in the FDA’s review or inspection divisions could extend review timelines, delay or prevent pre-approval inspections and limit opportunities for FDA feedback on pending applications. Further, FDA may pursue legislative, regulatory or policy changes regarding the standards or processes for approving drug and biological products that we may be unable to satisfy. Any of these actions may delay or limit our ability to obtain FDA approval and commercialize our product candidates.
Additionally, the current administration has discussed several changes to the reach and oversight of the FDA, which could affect its relationship with the pharmaceutical industry, transparency in decision making and ultimately the cost and availability of prescription drugs.
As of December 31, 2024,2025, we had 112106 full-time employees. Our ability to compete in the highly competitive biotechnology and pharmaceutical industries depends upon our ability to attract and retain highly qualified managerial, scientific and medical personnel. We conduct our operations at our facilities in Cambridge,Watertown, Massachusetts. The Massachusetts region is headquarters to many other biopharmaceutical companies and many academic and research institutions. Competition for skilled personnel in our market is intense and may limit our ability to hire and retain highly qualified personnel on acceptable terms or at all. Additionally, changes to U.S. immigration and work authorization laws and regulations, including those that restrain the flow of scientific and professional talent, can be significantly affected by political forces and levels of economic activity. Our business may be materially adversely affected if legislative or administrative changes to immigration or visa laws and regulations impair our hiring processes and goals or projects involving personnel who are not U.S. citizens.
Our use of artificial intelligence and machine learning exposes us to operational, regulatory, legal, and ethical risks that could adversely affect our business, reputation, financial condition, and results of operations.
We procure and deploy certain AI and machine learning technologies across our operations. For example, we use AI systems such as AlphaFold and ColabFold, to predict protein structures where experimentally solved crystal structures are not available in the Protein Data Bank. While these tools may create efficiencies, they also introduce risks related to data quality, transparency, model reliability, cybersecurity, intellectual property, privacy, discrimination, liability, and vendor/supply chain dependencies. Errors or bias in AI outputs, inadequate monitoring, or insufficient documentation could impair clinical development, manufacturing quality, or commercial activities, resulting in delays, higher costs or reputational harm.
Additionally, the emergence of AI and other technologies may contribute to other risks, including those related to regulation, litigation, compliance issues, ethical concerns, confidentiality, and data privacy or security. For example, regulatory uncertainty related to AI or other emerging technologies may require additional resources to adjust business practices to comply with developing laws.
Currently, our patent portfolio primarily consists of provisional patent applications and patent applications filed pursuant to the Patent Cooperation Treaty (the “PCT”), both of which do not themselves issue as patents. We have three issued U.S. patents related to FHD-286 and one issued U.S. patent related to FHD-909. In order to continue to pursue protection based on provisional patent applications, we will need to file PCT, foreign applications and/or U.S. non-provisional patent applications prior to applicable deadlines. In order to continue to pursue protection based on PCT applications, we will need to file national phase applications in the U.S. and ex-U.S. jurisdictions prior to applicable deadlines. Even then, patents may never issue from our patent applications, or the scope of any patent may not be sufficient to provide a competitive advantage.
The degree of patent protection we require to successfully commercialize our product candidates may be unavailable or severely limited in some cases and may not adequately protect our rights or permit us to gain or keep any competitive advantage. We cannot provide any assurances that any of our pending patent applications will issue, or that any of our pending patent applications that mature into issued patents will include claims with a scope sufficient to protect FHD-286, FHD-909,FHD-909 or our other current or future product candidates. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States. Furthermore, patents have a limited lifespan. In the United States, the natural expiration of a patent is generally twenty years after it is filed. Various extensions may be available; however, the life of a patent, and the protection it affords, is limited. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with adequate and continuing patent protection sufficient to exclude others from commercializing products similar or identical to our product candidates, including generic versions of such products.
There is currently significant uncertainty about the future relationship between the U.S. and various other countries, including China, with respect to trade policies, treaties, tariffs, taxes, and other limitations on cross-border operations. The U.S. government has made and continues to make significant additional changes in U.S. trade policy and may continue to take future actions that could negatively impact U.S. trade. For example, legislation has been introducedpassed in Congress to limit certain U.S. biotechnology companies from using equipment or services produced or provided by select Chinese biotechnology companies, and others in Congress have advocated for the use of existing executive branch authorities to limit those Chinese service providers’ ability to engage in business in the U.S. We cannot predict what actions may ultimately be taken with respect to trade relations between the United States and China or other countries, what products and services may be subject to such actions or what actions may be taken by the other countries in retaliation. If we are unable to obtain or use services from existing service providers or become unable to export or sell our products to any of our customers or service providers, our business could be materially and adversely affected.
Our current and future activities, including our relationships with healthcare providers, physicians, and third-party payorspayors, willmay be subject to applicable anti-kickback, fraud and abuse, anti-bribery, transparency and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, and diminished profits and future earnings.
Our current and future activities, including arrangements with third-party payors and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we research, market, sell, and distribute our medicines for which we obtain marketing approval. Restrictions under applicable federal and state healthcare laws and regulations include the following, some of which will not apply unless or until we have a marketed product:
•federal laws, including the Medicaid Drug Rebate Program, that require pharmaceutical manufacturers to calculate, certify and report certain calculated product prices to the government or provide certain discounts or rebates to government authorities or private entities, often as a condition of reimbursement under government healthcare programs; and
•analogous state and foreign laws and regulations, such as state anti-kickback, anti-bribery and false claims laws, which may apply to healthcare items or services that are reimbursed by non-governmental third-party payors, including private insurers, as well as other state laws that require companies to comply with specific compliance standards, restrict financial interactions between companies and healthcare providers, require companies to report information related to payments to health care providers, marketing expenditures or pricing, or require the licensing or registration of sales representatives.representatives or regulate the manufacture and distribution of drugs and biological products, imposing extensive record-keeping, licensing, storage and security requirements.
Additionally, in its 2024 decision in Loper Bright Enterprises v. Raimondo, the U.S. Supreme Court overruled the “Chevron doctrine,” which gives deference to regulatory agencies’ statutory interpretations in litigation against federal government agencies, such as the FDA, the Centers for Medicare & Medicaid Services (“CMS”) and other federal agencies where the law is ambiguous. The Loper decision could result in additional legal challenges to regulations and guidance issued by federal agencies, including the FDA and the CMS, on which we rely. Any such legal challenges, if successful, could have a material impact on our business. Additionally, the Loper decision may result in increased regulatory uncertainty, inconsistent judicial interpretations, and other impacts to the agency rulemaking process, any of which could adversely impact our business and operations. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action or as a result of legal challenges, either in the U.S. or abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, our business could be materially harmed.
The U.S. and many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the healthcare system that could prevent or delay marketing approval of our current or future product candidates or any future product candidates, restrict or regulate post-approval activities and affect our ability to profitably sell a product for which we obtain marketing approval. In particular, in the U.S., there have been and continue to be a number of legislativereform initiatives at the federal and state level to contain healthcare costs, including specifically the cost of drugs. For example, the implementation of the IRA enacted in 2022 was intended in part to address the high cost of prescription drugs. The IRA includes caps on Medicare Part D out-of-pocket costs, Medicare Part B and Part D drug price inflation rebates, a new Medicare Part D manufacturer discount drug program and a drug price negotiation program for certain high spend Medicare Part B and D drugs. Although the impact of theThe IRA remainshas uncertainhad pendingand ongoing implementation, the IRA it is likely towill have aan ongoing significant effect on the healthcare industry and prescription drug pricing overall. As another example, under the current presidential administration, there has also been executive and administrative action taken that is intended to reduce the cost of prescription drugs to third party payors and to consumers. See “Business Section—Government Regulation—Current and Future Healthcare Reform Legislation.”
Changes in regulations,law, statutesregulation or the interpretation of existing regulationspolicy could impact our business in the future by requiring, for example: (i) changes to our manufacturing arrangements, (ii) additions or modifications to product labeling, (iii) the recall or discontinuation of our products or (iv) additional record-keeping requirements. Further, healthcare reform may result in changes to payment methodologies, the implementation of pharmaceutical and biological product price controls, and reductions in Medicare and other healthcare funding.funding or restrictions on access to covered healthcare services. If any such changes were to be imposed, they could adversely affect the operation of our business.
AdoptionExecutive, oflegislative newor legislationregulatory health care reform initiatives at the federal or state level could affect demand for, or pricing of, our current or future products if approved for sale. We cannot, however, predict the ultimate content, timing or effect of any federal and statesuch reform efforts. There is no assurance that federal or state health caresuch reform will not adversely affect our future business and financial results.
Our ability to obtain coverage and adequate reimbursement for our product candidates by governmental healthcare programs, private health insurers, and other third-party payors will have an effect on our ability to successfully commercialize our product candidates. We cannot be sure that coverage and reimbursement will be available for our product candidates or any future product candidate that we may develop, and any reimbursement that may become available may not be adequate or may be decreased or eliminated in the future. No uniform policy for coverage and reimbursement for products exists among third-party payors in the United States. Therefore, coverage and reimbursement for products can differ significantly from payor to payor. As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our product candidates to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. To obtain coverage and reimbursement, we may have to offer discounts on our products. Even if we obtain coverage and reimbursement, third party payors may implement mechanisms to control utilization. If reimbursement is not available or is available only at limited levels, we may not be able to successfully commercialize our product candidates and may not be able to obtain a satisfactory financial return on our product candidates.
We are an “emerging growth company,” and the reduced disclosure requirements applicable to emerging growth companies may make our common stock less attractive to investors.
We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and may remain an emerging growth company for up to five years. For so long as we remain an emerging growth company, we are permitted and plan to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not emerging growth companies. These exemptions include not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002 (“SOX”), not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, reduced disclosure obligations regarding executive compensation, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. As a result, the information we provide stockholders will be different than the information that is available with respect to other public companies. In this annual report, we have not included all of the executive compensation related information that would be required if we were not an emerging growth company. We cannot predict whether investors will find our common stock less attractive if we rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock, and our stock price may be more volatile.
In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This allows an emerging growth company to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected not to “opt out” of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, we will adopt the new or revised standard at the time private companies adopt the new or revised standard and will do so until such time that we either (i) irrevocably elect to “opt out” of such extended transition period or (ii) no longer qualify as an emerging growth company. Therefore, the reported results of operations contained in our consolidated financial statements may not be directly comparable to those of other public companies.
Management's Discussion & Analysis (MD&A)
New heading “Gain on Lease Modification”
New heading “January 2026 Offering”
Removed heading “Provision for income taxes”
Largest changes
“In July 2020, we entered into a Research Collaboration and Exclusive License Agreement with Merck Sharp & Dohme Corp. (“Merck”) (the “Merck Collaboration Agreement”), pursuant to which we agreed to apply our proprietary Gene Traffic Control platform to discover and develop novel therapeutics. Under the Merck Collaboration Agreement, we granted Merck exclusive global rights to develop and commercialize drugs that target dysregulation of a single transcription factor. Under the terms of the Merck Collaboration Agreement, we received a nonrefundable upfront payment of $15.0 million from Merck. …”see in full comparison
“•experience significant operating cost increases as a result of increased inflation or increased tariffs;”see in full comparison
“For the year ended December 31, 2025, we recorded a non-cash impairment of long-lived assets charge of $5.9 million for the abandonment of leasehold improvements in connection with the Company’s main office lease and relocation to Watertown, MA, in December 2025 (See Note 10 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K). For the year ended December 31, 2024, we recorded a non-cash impairment of long-lived assets charge of $2.4 million related to the sublease of office space at the Company’s prior headquarters in Cambridge, MA.”see in full comparison
Full comparison: every changed paragraph (61)
At present, we are working on more than eightseven programs with one clinical-stage drug candidate currently in Phase 1 development. We have discovered highly selective chemical matter for some of the most challenging targets in oncology including SMARCA2 (BRM), CBP, EP300EP300, and ARID1B,ARID1B as well as other undisclosed targets. We believe our current pipeline has the potential to help more than 500,000 cancer patients. We take a small molecule modality agnostic approach to drugging targets which includes protein degraders, allosteric enzymatic inhibitors, and transcription factor disruptors. We are a biology first companycompany, which means we focus first on the underlying genetics and biology of a disease relevant target and then leverage the most appropriate drugging approach to impact the disease biology.
Since our inception, we have focused substantially all of our resources on building our Gene Traffic Control platform, organizing and staffing our company, business planning, conducting discovery and research activities, raising capital, protecting our trade secrets, filing patent applications, identifying potential product candidates, undertaking preclinical studies and clinical trial activities, establishing arrangements with third parties for the manufacture of initial quantities of our product candidates and component materials and initiating two strategic collaborations. We do not have any products approved for sale and have not generated any revenue from product sales.
On December 10, 2021, we entered into a collaboration agreement (the “Lilly Collaboration Agreement”) with Eli Lilly and Company (“Lilly”), for which we received an upfront payment of $300.0 million in January 2022 (see Note 8 to our notes to consolidated financial statements included elsewhere in this Annual Report on Form 10-K). Concurrent with the Lilly Collaboration Agreement, we also entered into a stock purchase agreement (the “Lilly SPA”) with Lilly whereby we issued and sold Lilly 4,000,000 shares of our common stock, par value $0.0001 per share (“Common Stock”), at a price of $20.00 per share, resulting in net proceeds of $80.0 million, of which $42.2 million was allocated to equity upon the issuance of our common stock.
The Lilly Collaboration Agreement generally provides that Lilly and Foghorn will co-develop and co-commercialize certain “joint” programs for the U.S., and these joint programs will be subject to a U.S. profit and expense share. Outside the U.S., the joint programs are subject to a world-wide research and development expense share and ex-U.S. royalties. The joint programs include the selective SMARCA2 oncology program that includes both a selective inhibitor (FHD-909) and a selective degrader, as well as an additional undisclosed oncology target. The collaboration also includes three discovery programs that will leverage Foghorn’s proprietary Gene Traffic Control platform which are subject to customary royalties and milestones and are not subject to co-development, co-commercialization rights.
FHD-909 was transitioned to Lilly during the third quarter of 2023, which triggered the 50/50 cost share for the SMARCA2 programs. Costs related to the cost-share are included in research and development expenses on the consolidated statements of operations and comprehensive loss.
In October 2024, the first patient was dosed in a Phase 1 dose escalation study of FHD-909, a selective allosteric ATPase inhibitor of SMARCA2, developed in collaboration with Lilly.
As part of our collaboration with Eli Lilly and Company (“Lilly”), a Phase 1 dose escalation study dosed its first patient in October of 2024 with FHD-909, a selective allosteric ATPase inhibitor of SMARCA2.
During the third quarter of 2023, we transitioned FHD-909 to Lilly which triggered the 50/50 cost share for the SMARCA2 programs. Costs related to the cost-share are included in research and development expenses on the consolidated statements of operations and comprehensive loss.
Since our inception, we have focused substantially all of our resources on building our Gene Traffic Control platform, organizing and staffing our company, business planning, raising capital, conducting discovery and research activities, protecting our trade secrets, filing patent applications, identifying potential product candidates, undertaking preclinical studies and clinical trial activities, establishing arrangements with third parties for the manufacture of initial quantities of our product candidates and component materials and initiating two strategic collaborations. We do not have any products approved for sale and have not generated any revenue from product sales.
On December 10, 2021, we entered into a collaboration agreement (the “Lilly Collaboration Agreement”) with Lilly, for which we received an upfront payment of $300.0 million in January 2022 (see Note 8 to our notes to consolidated financial statements included elsewhere in this Annual Report on Form 10-K). Concurrent with the Lilly Collaboration Agreement, we also entered into a stock purchase agreement (the “Lilly SPA”) with Lilly whereby we issued and sold Lilly 4,000,000 shares of our common stock at a price of $20.00 per share, resulting in net proceeds of $80.0 million, of which $42.2 million was allocated to equity upon the issuance of our common stock.
In the fourth quarter of 2025, the Company utilized its at-the-market facility (the “ATM Facility”) to sell 101,174 shares of its Common Stock for proceeds of $0.5 million.
On January 9, 2026, the Company entered into securities purchase agreements (the “Purchase Agreements”) with certain leading life sciences investors (the “Investors”), relating to the issuance and sale of 2,030,314 shares of its Common Stock and, in lieu of Common Stock, pre-funded warrants to purchase 5,421,250 shares of Common Stock (the “Pre-Funded Warrants”). The Company sold the shares of Common Stock and Pre-Funded Warrants together with two series of warrants, Series 1 Warrants and Series 2 Warrants, to purchase an aggregate of 7,451,564 shares of the Common Stock (the “Series Warrants”). The Pre-Funded Warrants were exercisable immediately upon issuance at an initial exercise price of $0.0001 per share and have a term of 20 years. The shares of Common Stock, or Pre-Funded Warrants, as applicable, and the accompanying Series Warrants were immediately separable and were issued separately, but they were purchased together in the offering.
The Series Warrants were immediately exercisable. Each Series 1 Warrant has an initial exercise price of $13.42 per share of Common Stock, subject to certain adjustments, and expires on June 30, 2027. Each Series 2 Warrant has an initial exercise price of $20.13 per share of Common Stock, subject to certain adjustments, and expires on December 31, 2030. For the Series Warrants, the Investor may elect to receive, in lieu of shares of Common Stock, pre-funded warrants to purchase an equivalent number of shares of Common Stock. The offering (the “January 2026 Offering”) closed on January 13, 2026, resulting in gross proceeds of approximately $50 million before offering expenses, and excluding any proceeds the Company may receive upon exercise of the Pre-Funded Warrants and Series Warrants.
•experience significant operating cost increases as a result of increased inflation or increased tariffs;
Because of the numerous risks and uncertainties associated with pharmaceutical product development,development and the current geopolitical and economic and trade environment, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.
To date, we have not generated any revenue from product sales and do not expect to do so in the near future. If our development efforts for our product candidates are successful and result in regulatory approval or licenses with third parties, we may generate revenue in the future from product sales, milestone payments under our existing collaboration agreementsagreement or payments from other license agreements that we may enter into with third parties.
In December of 2021, we entered into a strategic collaboration with Lilly to create novel oncology medicines by applying Foghorn’s proprietary Gene Traffic Control platform. The collaboration includes a U.S. co-development and co-commercialization agreement for the aforementioned selective SMARCA2 (BRM) oncology program and an additional undisclosed oncology target. In addition, the collaboration includes three additional discovery programs using Foghorn’s proprietary Gene Traffic Control platform. Under the terms of the collaboration, Foghorn received upfront consideration of $300.0 million in cash pursuant to the Lilly Collaboration Agreement, together with an equity investment by Lilly of $80.0 million in shares of Foghorn commonCommon stockStock pursuant to the Lilly SPA.
In the third quarter of 2023, we transitioned the Selective SMARCA2 Selective inhibitor, FHD-909, to Lilly, for which Lilly will lead and we will participate and share in 50% of the costs until at least registrational trials. Costs incurred will continue to be included in research and development expenses on the consolidated statements of operations and comprehensive loss.
We recognized total deferred revenue of $337.8 million related to the Lilly Collaboration Agreement and the Lilly SPA, which included the $300.0 million upfront payment under the Lilly Collaboration Agreement as well as $37.8 million allocated to deferred revenue from the gross proceeds of the Lilly SPA to be recognized over the performance period. For the years ended December 31, 20242025 and 2023,2024, we recognized $22.6$30.9 million and $17.1$22.6 million, respectively, of revenue under the Lilly Collaboration Agreement and, as of December 31, 2024,2025, we had $280.1$249.2 million of deferred revenue related to the above mentioned upfront payment and revenue allocation remaining on our consolidated balance sheets. In September 2023 we re-evaluated our estimates related to the Lilly Collaboration Agreement. As a result of this re-evaluation, expected future costs increased over the course of the Lilly Collaboration Agreement, resulting in an adjustment that decreased revenue by $3.2 million for the year ended December 31, 2023.
In July 2020, we entered into a Research Collaboration and Exclusive License Agreement with Merck Sharp & Dohme Corp. (“Merck”) (the “Merck Collaboration Agreement”), pursuant to which we agreed to apply our proprietary Gene Traffic Control platform to discover and develop novel therapeutics. Under the Merck Collaboration Agreement, we granted Merck exclusive global rights to develop and commercialize drugs that target dysregulation of a single transcription factor. Under the terms of the Merck Collaboration Agreement, we received a nonrefundable upfront payment of $15.0 million from Merck. In the third quarter of 2022, we achieved a research milestone related to the Merck Collaboration Agreement and received a $5.0 million milestone payment from Merck.
On August 9, 2023 we received notice from Merck that it was terminating the Merck Collaboration Agreement effective November 7, 2023. At the time of notice, no material obligations remained under the Merck Collaboration Agreement. As such, we recognized the remaining $16.1 million of deferred revenue, related to the original $15.0 million upfront payment and $5.0 million milestone payment received from Merck, as revenue, for year ended December 31, 2023.
For the year ended December 31, 2023, we recognized $17.0 million of revenue under the Merck Collaboration Agreement. As of December 31, 2024 and 2023, we had no deferred revenue related to the upfront payment and milestone achievement remaining on our consolidated balance sheets.
•expenses incurred in connection with our research programs and preclinical and clinical development of our product candidates, including under agreements with third parties, such as consultants and contractors,contractors and contract research organizations (“CROs”), and our collaboration partner;
We expect that our research and development expenses may increase in the future as we advance our programs into clinical development and continue our discovery, research and preclinical activities in the near term and in the future. At this time, we cannot accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of any product candidates we may develop. A change in the outcome of any number of variables with respect to product candidates we may develop could significantly change the costs and timing associated with the development of that product candidate. We may never succeed in obtaining regulatory approval for any product candidates we may develop. In addition, given the uncertainties associated with the current geopolitical and economic and trade environment, our research and development expenses may increase in an unpredictable manner.
General and administrative expenses consist primarily of personnel-related costs, including salaries, benefits, and stock-based compensation, for employees engaged in executive, legal, finance and accountingaccounting, legal, and other administrative functions. General and administrative expenses also include professional fees for legal, patent, consulting, investor and public relations, human resources, and accounting and audit services as well as direct and allocated facility-related costs.
Since our inception, we have not recorded any federal or state income tax benefits for the net losses we have incurred in any year or for our federal or state earned research and development tax credits, due to our uncertainty of realizing a benefit from those items. During the yearyears ended December 31, 2023,2025 and 2024, we recorded ano provision for income taxes related to the $300.0 million upfront payment from the Lilly Collaboration Agreement which was recognized as taxable income during that year, and the required capitalization of research and development costs pursuant to Internal Revenue Code Section 174.taxes. As of December 31, 2024,2025, we had federal net operating loss carryforwards of $52.3$198.5 million, which may be available to offset future taxable income. The federal net operating loss can be carried forward indefinitely but are limited to offset 80% of annual taxable income. As of December 31, 2024,2025, we also had U.S. federal and state research and development tax credit carryforwards of $7.2$9.4 million and $3.7 million, respectively, which may be available to reduce future tax liabilities and expire at various dates beginning in 2043 and 2037, respectively. Due to our history of cumulative net losses since inception and uncertainties surrounding our ability to generate future taxable income, we have recorded a full valuation allowance against our net deferred tax assets at each balance sheet date. We do not expect to have taxable income in the current year.
On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted in the U.S. The OBBBA provides for, among other things, the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework and the restoration of favorable tax treatment for certain business provisions. The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. The Company has evaluated the impact of the OBBBA and determined that it does not have a material impact on the Company’s consolidated financial statements. The most significant impact is the provision allowing for immediate expensing of certain research and development expenses. The Company has implemented the two-year accelerated expensing under the OBBBA causing the previously capitalized US R&D expenses, amortized over 5 years, to be accelerated over two years. Note that the Company will continue to assess its overall business up until the filing of the 2025 federal tax return and may change its election under IRC Section 174A if it determines there is a more beneficial position.
We received significant non-refundable upfront payments under our collaboration agreements with Lilly, from which we recognize revenue over time using the cost-to-cost method. Under the cost-to-cost method, the extent of progress towards completion is measured based on the ratio of actual costs incurred to the total estimated costs expected upon satisfying the identified single performance obligation. In estimating the total costs to satisfy our performance obligation, we are required to make significant estimates including an estimate of the expected time and expected internal and external costs to fulfill the performance obligation. In developing these estimates we consider historical experience, relevant entity-specific factors, known market trends and conditions, and a variety of other factors we believe are relevant to estimating the total cost to fulfill the performance obligation. We periodically evaluate estimates against the actual time and costs incurred as well as any anticipated changes to the timing or estimated costs. Any cumulative effect of revisions to the total estimated costs to complete our performance obligation will be recorded in the period in which the changes are identified, and amounts can be reasonably estimated. While such revisions will have no impact on our cash flows, aA significant change in these assumptions and estimates could have a material impact on the timing and amount of revenue recognized in future periods and the classification of deferred revenue between short-term and long-term.
Under ourthe collaborationLilly agreements,Collaboration Agreement, revenue is recognized based on the work performed during the period. Collaboration revenue was $30.9 million for the year ended December 31, 2025, compared to $22.6 million for the year ended December 31, 2024, compared to $34.2 million for the year ended December 31, 2023.2024. The decreaseincrease in collaboration revenue is attributed to: continued advancement of programs under the Lilly Collaboration Agreement.
•a decrease in Merck collaboration revenue recognition of $17.0 million, driven by the termination of the Merck Collaboration Agreement in 2023 and the subsequent recognition of the remaining deferred revenue, partially offset by an increase in Lilly collaboration revenue recognition of $5.5 million due to continued advancement of programs under the Lilly Collaboration Agreement.
•a decrease in FHD-286 costs of $10.2 million due to the discontinuation of both the independent development of FHD-286 in combination with decitabine in patients with relapsed and/or refractory AML, resulting in the shutdown of the Phase 1 clinical trial, and termination of the independent development of FHD-286 in patients with uveal melanoma; and
•a decrease in personnel-related costs of $9.0 million, including a $1.9 million decrease in stock-based compensation expense, due to decreased headcount in our research and development function compared to prior year;
•a decrease in early development and other research external costs of $7.0 million; which was entirely driven by decreased FHD-609 spend due to the shutdown of the Phase 1 clinical trial in synovial sarcoma and SMARCAB1-loss tumors;
•a decrease in facilities and IT related expenses and other costs of $2.4$1.8 million primarily due to the June 2025 lease modification (see Note 10 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K) and decreased headcount in our research and development function compared to prior year; and
•a decrease in early development and other research external costs of $1.7 million which was driven by decreased FHD-609 spend due to the shutdown of the Phase 1 clinical trial in synovial sarcoma and SMARCAB1-loss tumors and a decrease in preclinical research costs due to program progression; and
•a decrease in personnel-related costs of $0.5 million, primarily driven by a $0.6 million decrease in stock-based compensation expense due to a lower weighted average expense per award compared to prior year, partially offset by increased payroll taxes period over period; and
•an increase in Lilly partnered programs of $3.3$5.2 million,million primarily driven by initiation of the Phase 1 dose escalation study of FHD-909. We expect these costs to continue to increase with increasing enrollment and potential future clinical advancement of FHD-909;FHD-909.
•a decrease in facilities and IT related expenses and other costs of $0.9 million primarily due to the June 2025 lease modification (see Note 10 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K).
Gain on Lease Modification
For the year ended December 31, 2025, we recorded a gain on lease modification of $1.6 million resulting from the remeasurement of the right-of-use asset and lease liabilities in connection with the Company’s main office lease and relocation to Watertown, MA, in December 2025 (See Note 10 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K). For the year ended December 31, 2024, the Company recorded no gain on lease modification.
•a decrease in personnel-related costs of $3.4 million, including a $2.4 million decrease in stock-based compensation expense, due to decreased headcount in our general and administrative function compared to prior year;
•a decrease in professional and consulting costs of $0.9 million, primarily due to decreased legal and consultant fees compared to prior year; and
•an increase in facility and IT related expense of $0.3 million, primarily due to increased repair and maintenance costs compared to prior year.
For the year ended December 31, 2025, we recorded a non-cash impairment of long-lived assets charge of $5.9 million for the abandonment of leasehold improvements in connection with the Company’s main office lease and relocation to Watertown, MA, in December 2025 (See Note 10 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K). For the year ended December 31, 2024, we recorded a non-cash impairment of long-lived assets charge of $2.4 million related to the sublease of office space at the Company’s prior headquarters in Cambridge, MA.
For the year ended December 31, 2024, we recorded a non-cash impairment of long-lived assets charge of $2.4 million related to the sublease of office space at the Company’s main office in Cambridge, MA (see Note 10 to our notes to consolidated financial statements included elsewhere in this Annual Report on Form 10-K). There were no impairment charges for the year ended December 31, 2023.
Total other income, net was $12.1 million for the year ended December 31, 2025, compared to $16.1 million for the year ended December 31, 2024. The decrease was due to decreased interest income due to a lower average balance of marketable securities during the period and decreased sublease income due to the conclusion of both subleases during 2025 (see Note 10 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K).
Total other income, net was $16.1 million for the year ended December 31, 2024, compared to $13.7 million for the year ended December 31, 2023. The increase in total other income, net was primarily due to sublease income related to the new sublease entered into in 2024 of 15,700 square feet at the Company’s main office in Cambridge, MA (see Note 10) and higher average cash balances during the year.
Provision for income taxes
For the year ended December 31, 2024, we did not record an income tax provision. For the year ended December 31, 2023, we recorded an income tax provision of $4.2 million. The income tax provision is primarily driven by the current federal and state taxes related to the $300.0 million upfront payment for Lilly Collaboration Agreement, which will be recognized as taxable income in the related year, and the required capitalization of research and development costs pursuant to Internal Revenue Code Section 174.
Since our inception in October 2015, we have incurred significant operating losses. We expect to incur significant expenses and operating losses for the foreseeable future as we support our continued research activities and development of our programs and platform. Through December 31, 2024,2025, we have funded our operations with proceeds from our initial public offering (“IPO”) in October 2020, sales of preferred stock, term loans, an upfront payment of $15.0 million we received in July 2020 under the Research Collaboration and Exclusive License Agreement (the “Merck Collaboration Agreement,Agreement”) with Merck Sharp & Dohme Corp. (“Merck”), proceeds we received in December 2021 under the Lilly SPA of $80.0 million; an upfront payment of $300.0 million received in January 2022 under the Lilly Collaboration Agreement; a payment of $5.0 million received from Merck under the Merck Collaboration Agreement in the third quarter of 2022 for the achievement of a research milestone; and net proceeds of $102.8 million, after deducting underwriting discounts, commissions and other offering expenses, from the May 2024 Offering.Offering; and net proceeds from our ATM Facility of $0.5 million. As of December 31, 2024,2025, we had cash, cash equivalents and marketable securities of $243.7$158.9 million.
January 2026 Offering
On January 9, 2026, the Company entered into the Purchase Agreements with the Investors, relating to the issuance and sale of 2,030,314 shares of its Common Stock and, in lieu of Common Stock, Pre-Funded Warrants to purchase 5,421,250 shares of Common Stock. The Company sold the shares of Common Stock and Pre-Funded Warrants together with Series Warrants, consisting of Series 1 Warrants and Series 2 Warrants to purchase an aggregate of 7,451,564 shares of the Common Stock. The Pre-Funded Warrants were exercisable immediately upon issuance at an initial exercise price of $0.0001 per share and have a term of 20 years. The shares of Common Stock, or Pre-Funded Warrants, as applicable, and the accompanying Series Warrants were immediately separable and were issued separately, but they were purchased together in the offering.
The Series Warrants were immediately exercisable. Each Series 1 Warrant has an initial exercise price of $13.42 per share of Common Stock, subject to certain adjustments, and expires on June 30, 2027. Each Series 2 Warrant has an initial exercise price of $20.13 per share of Common Stock, subject to certain adjustments, and expires on December 31, 2030. For the Series Warrants, the Investor may elect to receive, in lieu of shares of Common Stock, pre-funded warrants to purchase an equivalent number of shares of Common Stock.
The offering price for the shares of Common Stock is $6.71 per share (or $6.7099 for each Pre-Funded Warrant, which equals the price per share of the Common Stock less the exercise price of the Pre-Funded Warrants). The aggregate gross proceeds to the Company from this offering were approximately $50.0 million before any offering expenses, and excluding any proceeds the Company may receive upon exercise of the Pre-Funded Warrants and Series Warrants. No underwriter or placement agent participated in the offering.
For the year ended December 31, 2025, operating activities used $86.1 million of cash, resulting from our net loss of $74.3 million to fund our operations and by changes in our operating assets and liabilities of $32.1 million partially offset by net non-cash charges of $20.3 million. Net cash used in changes in our operating assets and liabilities for the year ended December 31, 2025 consisted primarily of a decrease of $30.9 million in deferred revenue resulting from the recognition of revenue on the upfront payments received in connection with our collaboration agreements and a $6.7 million decrease in operating lease liabilities, partially offset by a $5.5 million net increase in working capital.
For the year ended December 31, 2023, operating activities used $118.1 million of cash, resulting from our net loss of $98.4 million to fund our operations and by changes in our operating assets and liabilities of $41.9 million partially offset by net non-cash charges of $22.2 million. Net cash provided by changes in our operating assets and liabilities for the year ended December 31, 2023 consisted primarily of a decrease of $34.2 million in deferred revenue resulting from the recognition of revenue on the upfront payments received in connection with our collaboration agreements, a $7.5 million decrease in operating lease liabilities and a $0.2 million net decrease in working capital.
For the year ended December 31, 2025, net cash provided by investing activities was $112.0 million consisting of $243.3 million of marketable securities maturing partially offset by $131.2 million of purchases of marketable securities and $0.1 million in purchases of property and equipment.
For the year ended December 31, 2023, net cash provided by investing activities was $144.5 million primarily due to $219.6 million of marketable securities maturing, offset by $73.9 million of purchases of marketable securities and $1.2 million in purchases of property and equipment.
For the year ended December 31, 2024, net cash provided by financing activities was $105.4 million, consisting of net proceeds from the offering of our common stock and pre-funded warrants of $102.8 million, after deducting underwriting discounts, commissions and other offering expenses that have been paid in during the twelve months ended December 31, 2024 and $2.6 million net proceeds from the exercise of common stock options and the employee stock purchase plan.
For the year ended December 31, 2023,2025, net cash provided by financing activities was $1.8$1.0 million, consisting of $0.5 million net proceeds from the sale of common stock under our ATM Facility and $0.5 million net proceeds from the exercise of common stock options and the employee stock purchase plan.
What changed in the latest 10-Q
Risk Factors
For a discussion of potential risks or uncertainties, please see “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025. There have been no material changes to the risk factors disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025.
No wording changes found in this section.
Full comparison: every changed paragraph (0)
Management's Discussion & Analysis (MD&A)
Largest changes
We recognized total deferred revenue of $337.8 million related to the Lilly Collaboration Agreement and the Lilly SPA, which included the $300.0 million upfront payment under the Lilly Collaboration Agreement as well as $37.8 million allocated to deferred revenue from the gross proceeds of the Lilly SPA to be recognized over the performance period. For the three months endedsee in full comparisonMarchJune31,30, 2026 and 2025, we recognized$3.3$16.1 million and$6.0$7.6 million, respectively, of revenue under the Lilly Collaboration Agreement. For the six months ended June 30, 2026 and 2025, we recognized $19.3 million and $13.5 million, respectively, of revenue under the Lilly Collaboration Agreement. Included in the three and six months ended June 30, 2026 revenue amounts was 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. As ofMarchJune31,30, 2026, we had$245.9$229.8 million of deferred revenue related to the above mentioned upfront payment and revenue allocation remaining on our condensed consolidated balance sheets.
“Collaboration revenue was $19.3 million for the six months ended June 30, 2026, compared to $13.5 million for the six months ended June 30, 2025. The increase in collaboration revenue is attributed to the $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.”see in full comparison
“General and administrative expenses were $12.9 million for the six months ended June 30, 2026, compared to $14.1 million for the six months ended June 30, 2025. The decrease is primarily attributed to a decrease in facilities and IT related expenses and other costs of $1.0 million primarily driven by a reduction in rent and building maintenance costs associated with the Company’s new office lease in Watertown, Massachusetts.”see in full comparison
“Other income, net was $3.3 million for the six months ended June 30, 2026, compared to $7.2 million for the six months ended June 30, 2025. The decrease was primarily due to decreased sublease income due to the conclusion of the Company’s subleases in 2025 and decreased interest income due to a lower average balance of marketable securities period over period.”see in full comparison
“•a decrease in FHD-286 costs of $1.4 million due to the decision to discontinue both the independent development of FHD-286 in combination with decitabine in patients with relapsed and/or refractory AML, resulting in the shutdown of the Phase 1 clinical trial, and independent development of FHD-286 in patients with uveal melanoma; and”see in full comparison
During thesee in full comparisonthreesix months endedMarchJune31,30, 2026, operating activities used$25.3$43.1 million of cash, resulting from our net loss of$19.9$27.1 million to fund our operations and by changes in our operating assets and liabilities of$8.2$21.5 million partially offset by net non-cash charges of$2.8$5.5 million. Net cash used by changes in our operating assets and liabilities for thethreesix months endedMarchJune31,30, 2026 consisted primarily of a$5.5 million net decrease in working capital and adecrease of$3.3$19.3 million in deferred revenue resulting from the recognition of revenue on the upfront payments received in connection with the Lilly Collaboration Agreement and a $3.8 million net decrease in working capital partially offset by a$0.6$1.6 million increase in operating lease liabilities.
Full comparison: every changed paragraph (29)
Foghorn is a clinical stage, precision therapeutics biotechnology company pioneering a new class of medicines that treat serious diseases by correcting abnormal gene expression through selectively targeting the chromatin regulatory system, an untapped opportunity for therapeutic intervention in oncology and with potential in a wide spectrum of other diseases including immunology and inflammation.inflammation (“I&I”).
AtOur present,current wepipeline areconsists working onof more than seven programs with one clinical-stage drug candidate currently in Phase 1 development. We have discovered highly selective chemical matter for some of the most challenging targets in oncology and I&I, including SMARCA2 (BRM), CBP, EP300, and ARID1B as well as other undisclosed targets. We believe our current pipeline has the potential to help more than 500,000 cancer patients. We take a small molecule, modality agnostic approach to drugging targets which includes protein degraders, allosteric enzymatic inhibitors, and transcription factor disruptors. We are a biology-first company, which means we focus first on the underlying genetics and biology of a disease relevant target and then leverage the most appropriate drugging approach to impact the disease biology.
In December 2024, we announced our decision to discontinue the independent development of FHD-286 in combination with decitabine in patients with relapsed and/or refractory acute myeloid leukemia.
We have incurred significant operating losses since our inception. For the threesix months ended MarchJune 31,30, 2026 and the year ended December 31, 2025, we reported net losses of $19.9$27.1 million and $74.3 million, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $652.3$659.5 million. We expect to continue to incur significant expenses and increasing operating losses for at least the next several years. Our ability to generate any product revenue or product revenue sufficient to achieve profitability will depend on the successful development and eventual commercialization of one or more product candidates we are developing or may develop.
We recognized total deferred revenue of $337.8 million related to the Lilly Collaboration Agreement and the Lilly SPA, which included the $300.0 million upfront payment under the Lilly Collaboration Agreement as well as $37.8 million allocated to deferred revenue from the gross proceeds of the Lilly SPA to be recognized over the performance period. For the three months ended MarchJune 31,30, 2026 and 2025, we recognized $3.3$16.1 million and $6.0$7.6 million, respectively, of revenue under the Lilly Collaboration Agreement. For the six months ended June 30, 2026 and 2025, we recognized $19.3 million and $13.5 million, respectively, of revenue under the Lilly Collaboration Agreement. Included in the three and six months ended June 30, 2026 revenue amounts was 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. As of MarchJune 31,30, 2026, we had $245.9$229.8 million of deferred revenue related to the above mentioned upfront payment and revenue allocation remaining on our condensed consolidated balance sheets.
Comparison of the Three and Six Months Ended MarchJune 31,30, 2026 and 2025
The following table summarizes our results of operations for three and six months ended MarchJune 31,30, 2026 and 2025:
Collaboration revenue was $3.3$16.1 million for the three months ended MarchJune 31,30, 2026, compared to $6.0$7.6 million for the three months ended MarchJune 31,30, 2025. The decreaseincrease in collaboration revenue is attributed to the $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.
Collaboration revenue was $19.3 million for the six months ended June 30, 2026, compared to $13.5 million for the six months ended June 30, 2025. The increase in collaboration revenue is attributed to the $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.
The following table summarizes our research and development expenses for the three and six months ended MarchJune 31,30, 2026 and 2025:
Research and development expenses were $18.3$18.5 million for the three months ended MarchJune 31,30, 2026, compared to $21.6$21.8 million for the three months ended MarchJune 31,30, 2025. The decrease is attributed to the following:
Research and development expenses were $36.8 million for the six months ended June 30, 2026, compared to $43.4 million for the six months ended June 30, 2025. The decrease is attributed to the following:
•a decrease in Lilly partnered programs of $6.8 million, primarily driven by the timing of certain costs related to the Phase 1 dose escalation study of FHD-909; and
•a decrease in facilities and IT related expenses and other costs of $3.6 million primarily driven by a reduction in rent and building maintenance costs associated with the Company’s new office lease in Watertown, Massachusetts; and
•a decrease in FHD-286 costs of $1.4 million due to the decision to discontinue both the independent development of FHD-286 in combination with decitabine in patients with relapsed and/or refractory AML, resulting in the shutdown of the Phase 1 clinical trial, and independent development of FHD-286 in patients with uveal melanoma; and
•a decrease in personnel related costs of $1.0 million, including a $0.3 million decrease in stock-based compensation expense, due to decreased headcount in our research and development function compared to prior period; partially offset by
•an increase in early development and other research external costs of $6.1 million, which was due to continued investment and development of our platform and early research pipeline.
The following table summarizes our general and administrative expenses for the three and six months ended MarchJune 31,30, 2026 and 2025:
General and administrative expenses were $6.6$6.4 million for the three months ended MarchJune 31,30, 2026, compared to $7.2$6.9 million for the three months ended MarchJune 31,30, 2025. The decrease is primarily attributed to a decrease in facilities and IT related expenses and other costs of $0.5 million primarily driven by a reduction in rent and building maintenance costs associated with the Company’s new office lease in Watertown, Massachusetts.
General and administrative expenses were $12.9 million for the six months ended June 30, 2026, compared to $14.1 million for the six months ended June 30, 2025. The decrease is primarily attributed to a decrease in facilities and IT related expenses and other costs of $1.0 million primarily driven by a reduction in rent and building maintenance costs associated with the Company’s new office lease in Watertown, Massachusetts.
Other income, net was $1.7$1.6 million for the three months ended MarchJune 31,30, 2026, compared to $4.1$3.2 million for the three months ended MarchJune 31,30, 2025. The decrease was primarily due to decreased sublease income due to the conclusion of the Company’s subleases in 2025 and decreased interest income due to a lower average balance of marketable securities period over period.
Other income, net was $3.3 million for the six months ended June 30, 2026, compared to $7.2 million for the six months ended June 30, 2025. The decrease was primarily due to decreased sublease income due to the conclusion of the Company’s subleases in 2025 and decreased interest income due to a lower average balance of marketable securities period over period.
Since our inception in October 2015, we have incurred significant operating losses. We expect to incur significant expenses and operating losses for the foreseeable future as we support our continued research activities and development of our programs and platform. Through MarchJune 31,30, 2026, we have funded our operations with proceeds from our initial public offering (“IPO”) in October 2020, sales of preferred stock, term loans, an upfront payment of $15.0 million we received in July 2020 under the Research Collaboration and Exclusive License Agreement (the “Merck Collaboration Agreement”) with Merck Sharp & Dohme Corp. (“Merck”), proceeds we received in December 2021 under the Lilly SPA of $80.0 million; an upfront payment of $300.0 million received in January 2022 under the Lilly Collaboration Agreement; a payment of $5.0 million received from Merck under the Merck Collaboration Agreement in the third quarter of 2022 for the achievement of a research milestone; net proceeds of $102.8 million, after deducting underwriting discounts, commissions and other offering expenses, from the May 2024 Offering; net proceeds from our ATM Facility of $0.5 million; and net proceeds of $49.7 million, after deducting offering costs of $0.3 million, from the January 2026 Offering. As of MarchJune 31,30, 2026, we had cash, cash equivalents and marketable securities of $183.6$167.6 million.
During the threesix months ended MarchJune 31,30, 2026, operating activities used $25.3$43.1 million of cash, resulting from our net loss of $19.9$27.1 million to fund our operations and by changes in our operating assets and liabilities of $8.2$21.5 million partially offset by net non-cash charges of $2.8$5.5 million. Net cash used by changes in our operating assets and liabilities for the threesix months ended MarchJune 31,30, 2026 consisted primarily of a $5.5 million net decrease in working capital and a decrease of $3.3$19.3 million in deferred revenue resulting from the recognition of revenue on the upfront payments received in connection with the Lilly Collaboration Agreement and a $3.8 million net decrease in working capital partially offset by a $0.6$1.6 million increase in operating lease liabilities.
During the threesix months ended MarchJune 31,30, 2025, operating activities used $24.0$45.0 million of cash, resulting from our net loss of $18.8$36.8 million to fund our operations and by changes in our operating assets and liabilities of $9.3$17.0 million partially offset by net non-cash charges of $4.2$8.8 million. Net cash used by changes in our operating assets and liabilities for the threesix months ended MarchJune 31,30, 2025 consisted primarily of a $6.0decrease of $13.5 million decrease in deferred revenue resulting from the recognition of revenue on the upfront payments received in connection with the Lilly Collaboration Agreement, a $2.3$4.6 million decrease in operating lease liabilities andpartially offset by a $1.1 million net decreaseincrease in working capital.
During the threesix months ended MarchJune 31,30, 2026, net cash used in investing activities was $17.7$20.7 million consisting of $66.9$104.0 million of purchases of marketable securities partially offset by $49.2$83.4 million of marketable securities maturing.
During the threesix months ended MarchJune 31,30, 2025, net cash provided by investing activities was $29.4$63.2 million consisting of $80.6$156.5 million of marketable securities maturing partially offset by $51.1$93.3 million of purchases of marketable securities.
During the threesix months ended MarchJune 31,30, 2026, net cash provided by financing activities was $49.8 million consisting of net proceeds from the offering of our common stock, prefunded warrants, and series warrants of $49.7 million, after deducting offering costs that had been paid during the threesix months ended MarchJune 31,30, 2026 and net proceeds of $0.1 million from the exercise of common stock options and the 2020 Employee Stock Purchase Plan (“ESPP”).
During the threesix months ended MarchJune 31,30, 2025, net cash provided by financing activities was $0.1$0.4 million consisting of net proceeds from the exercise of common stock options and the ESPP.
FHTX insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-04-10 | Gottschalk Adrian |
Gift | 59,208 | — | — |
| 2026-04-10 | Gottschalk Adrian |
Gift | 59,208 | — | — |
| 2026-04-09 | Gottschalk Adrian |
Gift | 47,497 | — | — |
| 2026-04-09 | Gottschalk Adrian |
Gift | 47,497 | — | — |
Well-known investors holding FHTX (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Renaissance Technologies | 2026-06-30 | 377,936 | $1.8M | 0.0% | Reduced 7% |
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 158,822 | $775.1K | 0.0% | Reduced 21% |
| AQR Capital Management (Cliff Asness) | 2026-06-30 | 66,239 | $323.2K | 0.0% | Added 103% |
| Millennium Management (Israel Englander) | 2026-06-30 | 53,509 | $261.1K | 0.0% | Added 81% |
| Point72 Asset Management (Steve Cohen) | 2026-06-30 | 27,646 | $132.1K | — | Sold out |
| Two Sigma Investments | 2026-06-30 | 12,445 | $60.7K | 0.0% | New position |