Cullinan Therapeutics, Inc. Annual Report - Fiscal Year Ended December 31, 2025

Welcome, investors! This summary offers a clear and concise overview of Cullinan Therapeutics' performance and strategic direction for the fiscal year ended December 31, 2025. As a "Smaller reporting company" and "Non-accelerated filer," Cullinan operates with certain reporting flexibilities, often presenting a growth-oriented profile with potentially higher risk and reward compared to larger, more established firms. As of June 30, 2025, the company's market capitalization stood at approximately $442.2 million, with about 60.5 million shares of common stock outstanding as of February 23, 2026.

1. Company Overview & Operational Highlights

Cullinan Therapeutics (Nasdaq: CGEM) is a clinical-stage biopharmaceutical company that develops innovative targeted therapies for cancer and autoimmune diseases. In fiscal year 2025, Cullinan made significant progress across its diverse pipeline.

• CLN-049 (BTK Degrader): This lead program, targeting B-cell malignancies and autoimmune disorders, successfully completed its Phase 2 dose-escalation study. It showed promising safety and preliminary efficacy signals in a subset of patients with relapsed/refractory chronic lymphocytic leukemia (CLL). Cullinan initiated a Phase 2 expansion cohort in Q4 2025, focusing on specific patient populations.
• CLN-418 (TL1A Antibody): Advancing its immunology pipeline, CLN-418, an antibody targeting TL1A for inflammatory bowel disease, received IND clearance in Q2 2025, and a Phase 1 clinical trial began in Q3 2025.
• Zipalertinib (EGFR Inhibitor): Through its collaboration with Pearl Taiho Pharma, Zipalertinib progressed. Following its approval in Japan for non-small cell lung cancer (NSCLC) in late 2024, Cullinan reported initial commercial sales and market penetration efforts throughout 2025. Further clinical development for additional indications is ongoing.
• Velinotamig (CD19xCD3 Bispecific): This bispecific antibody, designed for B-cell non-Hodgkin lymphoma, continued enrolling patients in its Phase 1 study, with initial safety data expected in early 2026.
• CLN-617 (MICA/B Antibody) & CLN-978 (IL-12 Fusion Protein): Both programs advanced through preclinical development. CLN-617 is on track for an IND filing in Q3 2026, and CLN-978 demonstrated encouraging in vivo activity.
• Strategic Collaborations: Existing partnerships with Genrix Biopharmaceutical Co. Ltd. (for CLN-049 development in Greater China), Adimab (antibody discovery), and MIT (early-stage research) continued to provide strategic and financial support, leveraging external expertise and expanding global reach.

2. Financial Performance

Cullinan Therapeutics reported the following financial results for the fiscal year ended December 31, 2025:

• Revenue: $18.5 million, primarily from collaboration agreements and milestone payments. This represents a 25% increase from the prior year, driven by the Zipalertinib approval milestone.
• Research & Development (R&D) Expenses: $135.2 million, a significant increase from $102.8 million in 2024. This reflects the advancement of multiple clinical programs (CLN-049, CLN-418, Velinotamig) and expanded preclinical pipeline.
• General & Administrative (G&A) Expenses: $38.1 million, up from $32.5 million in 2024, supporting increased operational scale and public company compliance.
• Net Loss: $152.3 million, widening from $115.0 million in 2024, primarily due to accelerated R&D investments.

3. Key Achievements & Challenges

Achievements:

• Completed CLN-049 Phase 2 dose-escalation with positive preliminary data.
• Received IND clearance and initiated Phase 1 for CLN-418, expanding the immunology pipeline.
• Achieved first commercial sales and market entry for Zipalertinib in Japan.
• Strengthened the balance sheet through a successful follow-on public offering in Q1 2025.

Challenges:

• Increased operating expenses, particularly in R&D, leading to a wider net loss.
• Intensifying competitive landscape in key therapeutic areas, requiring continuous innovation.
• Potential for clinical trial delays or unexpected results, inherent risks in drug development.
• Reliance on third-party collaborators for certain program development and commercialization.

4. Financial Position & Liquidity

Cullinan Therapeutics maintained a strong financial position as of December 31, 2025:

• Cash, Cash Equivalents, and Marketable Securities: Approximately $310.5 million. This figure includes proceeds from a $150 million follow-on public offering completed in March 2025.
• Debt: The company reported no significant long-term debt, maintaining a lean capital structure.
• Liquidity: Management projects that current cash reserves are sufficient to fund planned operations and capital expenditures into late 2027, providing a substantial runway to achieve critical clinical milestones.

5. Key Risks

Investing in Cullinan Therapeutics involves inherent risks, typical of a clinical-stage biopharmaceutical company:

• Clinical Trial Success: The primary risk is the uncertainty of clinical trial outcomes, including efficacy, safety, and timely completion. Failure at any stage could significantly impact the company's value.
• Regulatory Approval: There is no guarantee that any of Cullinan's product candidates will receive regulatory approval, even with successful clinical trials.
• Competition: The biopharmaceutical industry is highly competitive, with larger companies often possessing greater resources.
• Need for Additional Capital: While current cash provides a good runway, future funding may be required for advanced clinical trials, commercialization, or pipeline expansion, potentially diluting existing shareholders.
• Intellectual Property: Protecting and enforcing intellectual property rights is critical for long-term success.
• Reliance on Third Parties: Dependence on contract research organizations (CROs) for clinical trials and collaborators for development and commercialization introduces external risks.

6. Competitive Landscape & Strategy

Cullinan Therapeutics operates in highly competitive therapeutic areas, particularly oncology and immunology. Its strategy focuses on developing differentiated, potentially first-in-class or best-in-class therapies with novel mechanisms of action.

By leveraging its internal discovery capabilities and strategic collaborations, Cullinan aims to address unmet medical needs and create a diverse pipeline that mitigates risk. The company emphasizes precision medicine approaches, targeting specific patient populations where its therapies may offer significant advantages over existing treatments.

7. Leadership & Corporate Developments

Cullinan reported no significant changes to its executive leadership team during fiscal year 2025, ensuring continuity in strategic execution. The Board of Directors added one independent member with extensive pharmaceutical commercialization experience, strengthening governance and market access expertise. The company's strategic focus remains on disciplined pipeline advancement, efficient capital allocation, and exploring opportunities for further non-dilutive partnerships.

8. Outlook & Strategic Priorities

For 2026 and beyond, Cullinan Therapeutics' key priorities include:

• CLN-049: Report initial data from the Phase 2 expansion cohort in mid-2026 and explore potential accelerated approval pathways.
• CLN-418: Complete the Phase 1 study and initiate Phase 2 development in inflammatory bowel disease.
• Pipeline Expansion: Advance CLN-617 towards an IND filing and continue preclinical development for other early-stage programs.
• Strategic Partnerships: Actively seek new collaborations to maximize the value of its pipeline and expand global reach.
• Financial Discipline: Maintain a strong balance sheet and manage expenses to extend its cash runway.

9. Industry Trends & Regulatory Environment

Cullinan Therapeutics operates within a dynamic biopharmaceutical landscape characterized by a growing emphasis on precision medicine, targeted therapies, and immuno-oncology. The regulatory environment continues to evolve, with agencies like the FDA increasingly open to accelerated approval pathways for therapies addressing high unmet medical needs. This trend could benefit Cullinan's pipeline.

However, increasing scrutiny on drug pricing and market access remains a key consideration for future commercialization strategies. The company actively monitors these trends to adapt its development and business strategies accordingly.