Cogent Biosciences, Inc.

Company Overview

Business Model: Cogent Biosciences, Inc. is a clinical-stage biotechnology company focused on developing precision therapies for genetically defined diseases. Its approach involves designing rational precision therapies to treat the underlying cause of disease and improve patient lives. The Company currently generates no revenue from product sales, with future revenue generation dependent on the successful regulatory approval and commercialization of its product candidates, beginning with bezuclastinib.

Market Position: The Company's most advanced program is bezuclastinib (CGT9486), a highly selective tyrosine kinase inhibitor designed to potently inhibit the KIT D816V mutation and other mutations in KIT exon 17. The KIT D816V mutation is responsible for driving Systemic Mastocytosis (SM), a serious and rare disease, while exon 17 mutations are found in advanced gastrointestinal stromal tumors (GIST). Bezuclastinib's preclinical profile, characterized by selectivity against kinases associated with off-target toxicities and limited blood-brain-barrier penetration, suggests potential for a best-in-class clinical profile. Cogent Biosciences, Inc. estimates a global annual market opportunity of over $4 billion for bezuclastinib in combination with sunitinib as a potential second-line treatment for GIST, approximately $3.5 billion for Non-Advanced Systemic Mastocytosis (NonAdvSM), and approximately $500 million for Advanced Systemic Mastocytosis (AdvSM). The Company faces significant competition from major pharmaceutical and biotechnology companies, including Blueprint Medicines (a Sanofi company), Novartis AG, Pfizer Inc., Bayer HealthCare Pharmaceuticals Inc., Deciphera Pharmaceuticals, LLC., a member of Ono Pharmaceuticals, Co. Ltd, Incyte, Taiho Pharmaceutical Co. Ltd, GSK plc, Elevar Therapeutics Inc., TransThera Sciences (Nanjing), Inc., Tyra Biosciences Inc., Abbisko Therapeutics Co., Ltd., HutchMed (China) Limited, and Amgen Inc.

Recent Strategic Developments:

• Bezuclastinib (Systemic Mastocytosis):
  • Reported positive top-line results from the SUMMIT Phase 2 trial in NonAdvSM in July 2025, with full results in December 2025.
  • Reported positive top-line results from the APEX Phase 2 trial in AdvSM in December 2025.
  • Submitted the first New Drug Application (NDA) for NonAdvSM in December 2025.
  • Expects to submit an NDA for AdvSM in the first half of 2026.
  • The FDA granted Breakthrough Therapy Designation for bezuclastinib in NonAdvSM patients previously treated with avapritinib and in patients with Smoldering Systemic Mastocytosis (SSM) in October 2025.
  • The FDA and European Medicines Agency (EMA) have granted orphan drug designation for bezuclastinib for the treatment of Mastocytosis.
  • Initiated an expanded access program in the United States in 2025 for eligible SM patients.
  • Expects commercial launch in the United States in the second half of 2026, pending regulatory approval.
• Bezuclastinib (Gastrointestinal Stromal Tumors):
  • Announced positive top-line results from the PEAK Phase 3 trial in November 2025, demonstrating a substantial and highly statistically significant clinical benefit on the primary endpoint of Progression Free Survival (PFS). Median PFS was 16.5 months for the bezuclastinib combination versus 9.2 months for sunitinib monotherapy, reducing the risk of disease progression or death by 50%.
  • The FDA agreed to accept the NDA for bezuclastinib in combination with sunitinib for GIST under the Real-Time Oncology Review (RTOR) program in January 2026, with submission initiated shortly thereafter and expected to complete in April 2026.
  • The FDA granted Breakthrough Therapy Designation for bezuclastinib in combination with sunitinib for GIST patients previously treated with imatinib in January 2026.
  • Bezuclastinib has been granted orphan drug designation for the treatment of GIST by the FDA and the EMA.
  • Expects commercial launch in the United States in the second half of 2026, pending regulatory approval.
  • Expects to initiate a Phase 2 trial investigating the benefit of the bezuclastinib combination for first-line GIST patients with exon 9 mutations in mid-2026.
  • Initiated an expanded access program in the United States in 2025 for GIST patients.
  • A Phase 2 clinical trial of bezuclastinib plus sunitinib in later line GIST patients, sponsored by the Sarcoma Alliance for Research through Collaboration and in collaboration with The Life Raft Group and Dana-Farber Cancer Institute, was initiated in May 2024.
• Pipeline Expansion:
  • An ongoing Phase 1 study of CGT4859, a novel internally developed FGFR2/3 inhibitor, is actively enrolling patients with tumors bearing FGFR2/3 mutations, including advanced cholangiocarcinoma. Clinical data from this study are expected in 2026.
  • A Phase 1 dose escalation study of CGT4255, a CNS-penetrant, selective mutant ErbB2 inhibitor, was initiated in the fourth quarter of 2025 following FDA Investigational New Drug (IND) clearance.
  • IND-enabling studies have been completed for CGT6297, a selective PI3Kα inhibitor, and an IND application was submitted in the fourth quarter of 2025. A Phase 1 dose escalation study is expected to initiate in the first quarter of 2026.
  • Preclinical programs include a potent and selective KRAS inhibitor and a novel, wild-type-sparing, JAK2 V617F mutant-selective inhibitor, with IND submissions planned for both programs in 2026.

Geographic Footprint: The Company's corporate headquarters are located in Waltham, Massachusetts, and its research and laboratory space is in Boulder, Colorado. Clinical trials are global and multicenter. Cogent Biosciences, Inc. plans to commercialize bezuclastinib in the United States and select international markets. All of the Company's tangible assets are held in the United States.

Financial Performance

Revenue Analysis

Profitability Metrics:

• Gross Margin: N/A (No product sales revenue)
• Operating Margin: N/A (No product sales revenue)
• Net Margin: N/A (No product sales revenue)

Investment in Growth:

• R&D Expenditure: $269.8 million (N/A% of revenue)
• Capital Expenditures: $1.6 million
• Strategic Investments:
  • Paid $5.0 million to Plexxikon Inc., a Daiichi Sankyo subsidiary, in Q4 2025 for regulatory milestones related to bezuclastinib.
  • An additional $15.0 million may become payable to Plexxikon Inc. in the next twelve months for further regulatory milestones.
  • Significant investment in building an internal commercial organization in preparation for the planned commercial launch of bezuclastinib.

Business Segment Analysis

Cogent Biosciences, Inc. manages its operations as a single operating segment for the purposes of assessing performance and making operating decisions. The Chief Executive Officer, as the chief operating decision maker, evaluates segment performance based on consolidated net loss and allocates resources on a total company basis.

Research and Development Programs

Financial Performance (Direct External R&D Expenses):

• Revenue: $0 billion
• Bezuclastinib: $120.1 million (-0.7% YoY)
• Early-stage, preclinical and discovery programs: $40.1 million (+42.5% YoY)
• R&D personnel related (including stock-based compensation): $87.1 million (+31.9% YoY)
• Laboratory supplies, facility related and other: $22.5 million (+27.5% YoY)
• Total Research and Development Expenses: $269.8 million (+15.9% YoY)

Product Portfolio:

• Bezuclastinib (CGT9486):
  • Systemic Mastocytosis (SM): Positive top-line results reported for SUMMIT (NonAdvSM) and APEX (AdvSM) Phase 2 trials in 2025. NDAs submitted for NonAdvSM (December 2025) and expected for AdvSM (H1 2026). Received FDA Breakthrough Therapy Designation for specific SM patient populations and Orphan Drug Designation from FDA and EMA for Mastocytosis. Expanded access programs are active.
  • Gastrointestinal Stromal Tumors (GIST): Positive top-line results from PEAK Phase 3 trial reported November 2025, showing a 50% reduction in risk of disease progression or death. NDA submission initiated January 2026 under FDA Real-Time Oncology Review (RTOR) program, expected to complete April 2026. Received FDA Breakthrough Therapy Designation for GIST patients previously treated with imatinib and Orphan Drug Designation from FDA and EMA for GIST. Expanded access programs are active. A Phase 2 trial for first-line GIST patients with exon 9 mutations is expected to initiate mid-2026.
• CGT4859 (FGFR2/3 inhibitor): Currently in Phase 1 study for tumors bearing FGFR2/3 mutations, including advanced cholangiocarcinoma. Clinical data expected in 2026.
• CGT4255 (ErbB2 inhibitor): Initiated a Phase 1 dose escalation study in Q4 2025 following FDA IND clearance, targeting actionable and underserved ErbB2 mutations in solid tumors and CNS-involved indications.
• CGT6297 (PI3Kα inhibitor): IND application submitted in Q4 2025, with a Phase 1 dose escalation study expected to initiate in Q1 2026. This wild-type-sparing inhibitor targets PI3Kα mutations prevalent in many solid tumors.
• Research Programs: Preclinical development is underway for a potent and selective KRAS inhibitor and a novel, wild-type-sparing, JAK2 V617F mutant-selective inhibitor, with IND submissions planned for both in 2026.

Key Growth Drivers: Primary factors driving segment performance include the successful progression and positive outcomes of bezuclastinib's registrational trials, the receipt of expedited regulatory designations (Breakthrough Therapy, RTOR), and the expansion of the Company's pipeline through its internally developed programs. The anticipated commercial launch of bezuclastinib in H2 2026 is a significant near-term growth driver.

Capital Allocation Strategy

Shareholder Returns:

• Share Repurchases: Not disclosed.
• Dividend Payments: Cogent Biosciences, Inc. has never declared or paid any cash dividends on its capital stock and currently intends to retain all available funds and future earnings for business operations.
• Dividend Yield: N/A
• Future Capital Return Commitments: No specific future capital return commitments were disclosed.

Balance Sheet Position (as of December 31, 2025):

• Cash and Equivalents: $312.0 million
• Short-term Marketable Securities: $588.8 million
• Total Cash, Cash Equivalents and Marketable Securities: $900.8 million
• Total Debt: $222.9 million (Convertible senior notes, net)
• Net Cash Position: $677.9 million
• Credit Rating: Not disclosed.
• Debt Maturity Profile: The Company has $230.0 million aggregate principal amount of 1.625% Convertible Senior Notes due November 15, 2031.

Cash Flow Generation (Year Ended December 31, 2025):

• Operating Cash Flow: $(264.4) million
• Free Cash Flow: $(266.0) million (calculated as operating cash flow less capital expenditures of $1.6 million)
• Cash Conversion Metrics: Not explicitly disclosed.

Operational Excellence

Production & Service Model: Cogent Biosciences, Inc. does not own or operate any manufacturing facilities and relies entirely on third parties for the manufacture of its drug candidates for preclinical, clinical, and future commercial supply. The Company's drug candidates are small molecules, which can be manufactured from readily available starting materials using reliable and reproducible synthetic processes amenable to scale-up. The Company expects to continue enhancing its manufacturing processes to produce safer, more effective, superior dosing, and cost-effective drug candidates.

Supply Chain Architecture: Key Suppliers & Partners:

• API and Drug Product Manufacturers: The Company relies on single-source third-party suppliers for the active pharmaceutical ingredient (API) and drug product used in bezuclastinib.
• Clinical Trial Conduct: Independent investigators, medical institutions, and Contract Research Organizations (CROs) are engaged to conduct preclinical studies and clinical trials.
• Research & Discovery Support: Third-party vendors and collaborators, including some located in China, support research and discovery efforts.

Facility Network:

• Corporate Headquarters: The Company's current corporate headquarters are in Waltham, Massachusetts, occupying approximately 17,749 square feet under a sublease expiring in September 2026. A new lease agreement for approximately 31,518 square feet of office space in Waltham, Massachusetts, will commence in May 2026, replacing the existing headquarters.
• Research & Development: The Company leases approximately 44,657 square feet of office and laboratory space in Boulder, Colorado, under a lease with an initial term of 12 years, expiring in June 2035, with options for three successive five-year extensions.

Operational Metrics: Operational metrics such as capacity utilization, efficiency measures, or quality indicators are not explicitly disclosed in the filing.

Market Access & Customer Relationships

Go-to-Market Strategy: Distribution Channels:

• Direct Sales: Cogent Biosciences, Inc. is building an internal commercial organization in the United States, expected to include up to 100 additional employees, to support the commercial launch of bezuclastinib.
• Channel Partners: The Company evaluates potential collaborations, partnerships, and licensing opportunities to enhance the value of its existing programs and leverage strategic partners' capabilities, particularly in international markets.
• Digital Platforms: Not explicitly detailed.

Customer Portfolio: Enterprise Customers:

• Target Patient Populations: The Company targets patients living with Non-Advanced Systemic Mastocytosis (NonAdvSM), Advanced Systemic Mastocytosis (AdvSM), and Gastrointestinal Stromal Tumors (GIST).
• Strategic Partnerships: Collaborations include the Sarcoma Alliance for Research through Collaboration, The Life Raft Group, and Dana-Farber Cancer Institute for a Phase 2 GIST clinical trial.
• Customer Concentration: Not applicable as the Company is pre-commercial.

Geographic Revenue Distribution:

• Currently, Cogent Biosciences, Inc. has no product sales revenue.
• The Company expects to launch bezuclastinib commercially in the United States in the second half of 2026.
• Plans include evaluating select international markets for commercialization.

Competitive Intelligence

Market Structure & Dynamics

Industry Characteristics: The pharmaceutical and biotechnology industries are characterized by rapidly advancing technologies, intense competition, and a strong emphasis on proprietary drugs. The development and commercialization of new products are highly competitive, with numerous companies, academic institutions, and research organizations pursuing therapies for genetically defined diseases. The industry faces significant uncertainty regarding insurance coverage and reimbursement for newly approved products, alongside increasing efforts by governmental and third-party payors to control healthcare costs through measures such as drug price negotiations and inflation rebates.

Competitive Positioning Matrix:

Direct Competitors

Primary Competitors:

• Systemic Mastocytosis (SM):
  • Blueprint Medicines (a Sanofi company): Avapritinib (approved for AdvSM and NonAdvSM).
  • Novartis AG: Midostaurin (approved for AdvSM patients with KIT D816V mutation) and imatinib (approved for AdvSM patients without KIT D816V mutation or mutational status unknown).
• Gastrointestinal Stromal Tumors (GIST):
  • Novartis AG: Imatinib (first-line standard of care).
  • Pfizer Inc.: Sunitinib (second-line standard of care).
  • Bayer HealthCare Pharmaceuticals Inc.: Regorafenib (third-line standard of care).
  • Deciphera Pharmaceuticals, LLC., a member of Ono Pharmaceuticals, Co. Ltd: Ripretinib (fourth-line standard of care).
• Cholangiocarcinoma (FGFR-related):
  • Incyte: Pemigatinib.
  • Taiho Pharmaceutical Co. Ltd: Futibatinib.

Emerging Competitive Threats: The Company may face competition from other drug candidates in preclinical or clinical development for SM, GIST, and cholangiocarcinoma from companies such as Elevar Therapeutics Inc., TransThera Sciences (Nanjing), Inc., Tyra Biosciences Inc., Abbisko Therapeutics Co., Ltd., HutchMed (China) Limited, and Amgen Inc. New entrants, disruptive technologies, and alternative solutions also pose competitive threats.

Competitive Response Strategy: Cogent Biosciences, Inc.'s strategy is to discover, develop, and commercialize best-in-class therapies that have a meaningful impact for patients with genetically defined diseases. This includes advancing bezuclastinib toward regulatory approval and commercialization in the United States and select international markets, evaluating potential collaborations, and exploring the clinical utility of its pipeline candidates (CGT4859, CGT4255, CGT6297) and preclinical programs (KRAS, JAK2).

Risk Assessment Framework

Strategic & Market Risks

Market Dynamics: The Company's business is highly dependent on the success of its bezuclastinib program and its ability to discover and develop additional product candidates. The precise incidence and prevalence for target patient populations of its drug candidates (GIST and SM) are not established with precision, and market opportunities may be smaller than estimated. Interim, "top-line," and preliminary data from clinical trials may change as more patient data become available. The commercial success of any future approved drugs, including bezuclastinib, will depend on market acceptance by physicians, patients, third-party payors, and the medical community. The Company faces an inherent risk of product liability from clinical testing and commercialization. Information from expanded access studies may not reliably predict efficacy in company-sponsored trials and could lead to adverse events.

Operational & Execution Risks

Supply Chain Vulnerabilities: The Company relies on third parties for manufacturing drug candidates, with single-source suppliers for bezuclastinib's API and drug product. The loss of any of these sole suppliers could significantly harm the business. Third-party manufacturers may not comply with cGMP regulations, leading to sanctions or delays. The Company also relies on independent investigators, CROs, CMOs, and strategic partners to conduct clinical trials and assist with research, discovery, manufacturing, and supply activities. Clinical trials are expensive, time-consuming, and difficult to design and implement, with potential for delays in patient enrollment or unforeseen events. If unacceptable side effects are identified, development may need to be abandoned or limited. The Company may also face challenges in developing companion diagnostic tests for its drug candidates.

Financial & Regulatory Risks

Market & Financial Risks: Cogent Biosciences, Inc. has incurred net losses since its inception and anticipates continued losses, requiring additional capital to finance planned operations. Its indebtedness, including $230.0 million in Convertible Notes, could limit cash flow and impair its ability to satisfy obligations. The Company may be unable to raise funds to repurchase Notes or pay cash amounts due upon maturity or conversion. The accounting method for the Notes could adversely affect reported financial condition and results. Future sales and issuances of common stock could result in additional dilution. The Company's ability to use net operating losses and tax credit carryforwards may be subject to limitations under Section 382 of the Internal Revenue Code.

Regulatory & Compliance Risks: Regulatory authorities, including the FDA, may disagree with the Company's regulatory plan, potentially requiring additional clinical trials or denying approval. Evolving regulatory standards, including changes in government leadership or judicial decisions, make it difficult to predict the likelihood of marketing approval. Even if regulatory approval is received, the Company will be subject to ongoing regulatory obligations and review, which may result in significant additional expense or restrictions. Pharmaceutical product marketing is subject to substantial regulation, and any failure to comply with applicable statutes or regulations can adversely affect the business. The impact of healthcare legislation and other changes in healthcare spending is unknown and may adversely affect the business model. The Company is exposed to the risk of misconduct or other improper activities by its employees, contractors, partners, and vendors, including noncompliance with regulatory standards. Potential liability related to the privacy of health information obtained from clinical trials exists under various U.S. federal and state laws, as well as EU and UK data privacy regulations.

Geopolitical & External Risks

Geopolitical Exposure: Not explicitly detailed, but general risks include natural disasters, epidemic or pandemic disease outbreaks, trade wars, political unrest, or other local events that could disrupt the business or operations of third-party vendors and collaborators. Cybersecurity: The Company's business and operations are increasingly dependent on information technology systems and infrastructure, making them vulnerable to system failures or unauthorized access. Such events could result in data loss, security incidents, or operational disruptions.

Innovation & Technology Leadership

Research & Development Focus: Cogent Biosciences, Inc.'s research and development efforts are focused on pioneering best-in-class, small molecule therapeutics for genetically defined diseases. Core Technology Areas:

• KIT D816V and Exon 17 Mutations: Bezuclastinib, a highly selective tyrosine kinase inhibitor.
• FGFR2/3 Mutations: CGT4859, a selective and potent FGFR2/3 inhibitor.
• ErbB2 Mutations: CGT4255, a CNS-penetrant, selective mutant ErbB2 inhibitor.
• PI3Kα Mutations: CGT6297, a wild-type-sparing PI3Kα inhibitor.
• KRAS Mutations: Preclinical program for a potent and selective KRAS inhibitor.
• JAK2 V617F Mutation: Preclinical program for a novel, wild-type-sparing, JAK2 V617F mutant-selective inhibitor.

Innovation Pipeline:

• Bezuclastinib: NDAs submitted or planned for NonAdvSM, AdvSM, and GIST in 2025/2026. A Phase 2 trial for first-line GIST (exon 9 mutations) is expected to initiate mid-2026.
• CGT4859: Phase 1 study ongoing, with clinical data expected in 2026.
• CGT4255: Phase 1 study initiated in Q4 2025.
• CGT6297: IND submitted in Q4 2025, with a Phase 1 study expected to initiate in Q1 2026.
• KRAS & JAK2 Programs: Preclinical development, with IND submissions planned for 2026.

Intellectual Property Portfolio: The Company relies on a combination of patents, confidentiality agreements, trade secret protection, and license agreements.

• Bezuclastinib: Exclusive worldwide rights are licensed from Plexxikon Inc., a Daiichi Sankyo subsidiary. Issued U.S. and foreign patents covering bezuclastinib and its therapeutic uses are expected to expire in 2033 and 2034, respectively, without considering potential patent term extensions. Patent applications covering methods of making bezuclastinib and intermediates could provide exclusivity through at least 2041. The Company also owns patent families for an optimized formulation (potential exclusivity through at least 2043) and methods of administering bezuclastinib (potential exclusivity through at least 2046).
• FGFR2/3: Two patent families cover compositions of matter and methods of use, with one issued U.S. patent and pending applications, potentially providing exclusivity through at least 2044.
• ErbB2: One patent family covers compositions of matter and methods of use, with pending applications, potentially providing exclusivity through at least 2044.
• KRAS: One patent family covers compositions of matter and methods of use, with a pending international application, potentially providing exclusivity through at least 2045.
• PI3K: One patent family covers compositions of matter and methods of use, with a pending international application, potentially providing exclusivity through at least 2044.
• JAK: One patent family covers compositions of matter and methods of use, with a pending international application, potentially providing exclusivity through at least 2045.
• IP Litigation: The Company is not currently a party to any legal proceedings involving patent rights.

Technology Partnerships:

• Plexxikon Inc., a Daiichi Sankyo subsidiary: Exclusive worldwide license for bezuclastinib.
• Sarcoma Alliance for Research through Collaboration, The Life Raft Group, and Dana-Farber Cancer Institute: Collaboration for a Phase 2 GIST clinical trial.

Leadership & Governance

Executive Leadership Team

Leadership Continuity: The Company is highly dependent on its key management, scientific, and medical personnel. It has experienced significant growth and expects to continue expanding its research, development, and commercial capabilities, including building an internal commercial organization.

Board Composition: The Board of Directors, both as a whole and at the committee level, oversees the most significant risks facing the Company. The Audit Committee, composed solely of independent directors, is designated to oversee cybersecurity risks and receives periodic updates on cybersecurity and information technology matters. The full Board receives updates on cybersecurity risks at least annually.

Human Capital Strategy

Workforce Composition (as of December 31, 2025):

• Total Employees: 258 full-time employees.
• Geographic Distribution: Employees are primarily located at the corporate headquarters in Waltham, Massachusetts, and the research facility in Boulder, Colorado.
• Skill Mix: The workforce includes management, scientific, medical, research, development, manufacturing, general and administrative, and commercial personnel.

Talent Management: Acquisition & Retention: The Company's future success depends on its ability to attract and retain a diverse group of highly skilled employees. It offers comprehensive compensation packages, including competitive base pay, incentive compensation, and equity programs. Benefits include a 401(k) plan with employer match, healthcare and insurance benefits, paid time off, paid family and medical leave, flexible work schedules, and various health and wellness programs. Diversity & Development: The Company provides development programs to enable continued learning and growth. Its Code of Business Conduct and Ethics promotes core values of respect, integrity, collaboration, innovation, trust, and excellence.

• Employee Relations: The Company considers its employee relations to be good.
• Labor Relations: None of the employees are represented by a labor union or covered under a collective bargaining agreement.

Regulatory Environment & Compliance

Regulatory Framework: The Company's drug development, approval, and commercialization activities are extensively regulated by government authorities in the United States (e.g., FDA) and other countries and jurisdictions (e.g., EMA in the European Union, MHRA in the UK). Industry-Specific Regulations:

• Drug Development & Approval: This includes compliance with Good Laboratory Practice (GLP) for preclinical studies, Investigational New Drug (IND) submissions, Institutional Review Board (IRB) approvals, Current Good Manufacturing Practices (cGMPs) for manufacturing, Good Clinical Practice (GCP) for clinical trials, and New Drug Application (NDA) submissions. Expedited review programs such as Fast Track Designation, Priority Review, Accelerated Approval, Breakthrough Therapy Designation, and Real-Time Oncology Review (RTOR) are utilized.
• Post-Approval Regulation: Approved products are subject to ongoing requirements for recordkeeping, periodic reporting, product sampling and distribution, advertising and promotion, adverse event reporting, and continued compliance with cGMPs and GCPs. Risk Evaluation and Mitigation Strategies (REMS) may be required.
• Pricing & Reimbursement: Coverage and reimbursement from governmental healthcare programs (e.g., Medicare, Medicaid) and commercial payors are critical. In the U.S., the Inflation Reduction Act (IRA) provides new authorities to curb drug costs, including price negotiation and inflation rebates. In the EU, member states control prices and reimbursement levels, often influenced by Health Technology Assessments (HTA).
• Healthcare Laws & Regulations: Arrangements with healthcare providers, physicians, third-party payors, and customers are subject to fraud and abuse laws (e.g., federal Anti-Kickback Statute, False Claims Act, HIPAA), the federal Foreign Corrupt Practices Act (FCPA), and the federal Physician Payments Sunshine Act, as well as similar state and foreign laws.
• Data Privacy & Security: The collection, use, disclosure, and protection of personal information, including health-related information, are governed by numerous U.S. federal and state laws (e.g., HIPAA, HITECH Act, CCPA) and foreign legislation (e.g., EU GDPR, UK GDPR).

Trade & Export Controls: The Company's business is affected by laws and regulations governing the import and export of drugs and biologic products.

Legal Proceedings: Cogent Biosciences, Inc. is not currently a party to any material legal proceedings.

Tax Strategy & Considerations

Tax Profile: Cogent Biosciences, Inc. has incurred net losses since its inception and has not recorded any current or deferred tax benefit, establishing a full valuation allowance against its deferred tax assets.

• Effective Tax Rate: 0.0% for the years ended December 31, 2025, 2024, and 2023.
• Net Operating Loss (NOL) Carryforwards (as of December 31, 2025):
  • U.S. federal: $428.3 million (of which $425.0 million can be carried forward indefinitely but is limited to offsetting 80% of taxable income per year; the remainder begins to expire in 2035).
  • State: $170.8 million (begin to expire in 2035).
• Tax Credit Carryforwards (as of December 31, 2025):
  • U.S. federal R&D: $28.8 million (begin to expire in 2040).
  • State R&D: $6.0 million (begin to expire in 2035).
  • Federal Orphan Drug: $37.1 million (begin to expire in 2041).
• Valuation Allowance: A full valuation allowance of $311.0 million was established against deferred tax assets as of December 31, 2025, due to the Company's history of cumulative net losses and lack of commercialized products.
• Tax Reform Impact: The Inflation Reduction Act of 2022 implements a 1% excise tax on certain stock buybacks. The Tax Cuts and Jobs Act requires amortization of R&D expenditures. The One Big Beautiful Bill Act (2025) permits immediate expensing of domestic U.S. R&D expenses incurred in tax years beginning 2025, with no material impact on the consolidated financial statements determined from this legislation.

Insurance & Risk Transfer

Risk Management Framework: Cogent Biosciences, Inc. has developed and maintains processes to assess, identify, and manage cybersecurity risks, covering both internally managed IT systems and key business functions/sensitive data managed by third-party service providers. These processes are led by the Vice President, IT, who reports to the Chief Technology Officer, and include controls, technologies, systems, penetration and vulnerability testing, data recovery testing, security audits, and ongoing risk assessments. The Company also conducts periodic employee trainings on cyber and information security. It complies with the EU-U.S. Data Privacy Framework (DPF), UK Extension to the EU-U.S. DPF, and Swiss-U.S. DPF, and retains VeraSafe, LLC as its Data Protection Officer for EU and UK GDPR compliance. Cybersecurity is integrated into the overall enterprise risk management framework, with the Audit Committee overseeing these risks.

Insurance Coverage: The Company maintains a cybersecurity risk insurance policy.

Risk Transfer Mechanisms: In the ordinary course of business, the Company may provide indemnification to vendors, lessors, business partners, and other parties, including for intellectual property infringement claims. It also has indemnification agreements with its directors and executive officers. The maximum potential amount of future payments under these agreements is, in many cases, unlimited.