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Cullinan Therapeutics — Third Quarter 2026 Earnings Summary

  • Financial Performance:

    • Cash, cash equivalents, short- and long-term investments, and interest receivable totaled $313.8 million as of September 30, 2026, down from $439.0 million as of December 31, 2025.
    • Research and development expenses were $40.2 million for the quarter ended September 30, 2026, compared to $42.0 million in the same period in 2025.
    • General and administrative expenses were $12.4 million for the quarter ended September 30, 2026, compared to $13.6 million in the same period in 2025.
    • Net loss was $49.4 million for the quarter ended September 30, 2026, compared to $50.6 million in the same period in 2025.
    • For the nine months ended September 30, 2026, total operating expenses were $163.6 million compared to $186.4 million in the prior year period; net loss was $152.8 million compared to $169.2 million.
    • Interest income was $3.3 million for the quarter ended September 30, 2026, compared to $5.1 million in the same period in 2025.
    • Total assets were $322.6 million as of September 30, 2026, compared to $448.4 million as of December 31, 2025.
    • Total stockholders' equity was $281.3 million as of September 30, 2026, compared to $408.7 million as of December 31, 2025.
    • The company expects its cash resources to provide a runway into 2029 under its current operating plan.
  • Business Segments and Product Lines:

    • CLN-978 (CD19xCD3 T cell engager): Data from a multi-dose regimen in SLE, RA, and Sjögren's disease involving approximately 20 patients will be shared in December, focusing on clinical activity, biomarkers, and safety.
    • Velinotamig (BCMAxCD3 T cell engager): A global Phase 1/2 basket study in relapsing and refractory immune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (wAIHA) was initiated in October following U.S. FDA IND clearance and Australian HREC clearance.
    • Velinotamig (China): Data from Genrix Bio's Phase 1/2 study in China showed rapid and marked reductions in proteinuria in 5 of 7 SLE patients, with 4 achieving complete renal response and a favorable safety profile.
    • CLN-049 (FLT3xCD3 T cell engager): A potentially registrational Phase 2 study in relapsed/refractory AML was initiated in October, incorporating a dose-optimization phase before a single-arm expansion cohort.
    • CLN-049 (Combination): A Phase 1/2 study evaluating CLN-049 in combination with venetoclax and azacitidine in newly diagnosed AML was initiated in November.
    • Zipalertinib: Taiho Oncology initiated an NDA submission for zipalertinib plus chemotherapy in first-line EGFR ex20ins NSCLC under the FDA Real-Time Oncology Review program, with completion expected in November.
    • Zipalertinib (Monotherapy): An NDA for zipalertinib monotherapy in relapsed EGFR ex20ins NSCLC remains under review with a PDUFA target action date of February 27, 2027.
    • Zipalertinib (REZILIENT2): New data from Cohort C presented at ESMO Congress 2026 reinforced intracranial antitumor activity in patients with active brain metastases.
  • Management Commentary and Tone:

    • Nadim Ahmed, President and CEO, stated that progress underscores the company's ability to execute across a differentiated portfolio, citing clinical success and regulatory progress of zipalertinib.
    • Management expressed focus on strengthening leadership in the T cell engager space, with multiple upcoming clinical catalysts and regulatory milestones.
    • The company highlighted a strong balance sheet as a key factor in translating momentum into patient progress and shareholder value.
  • Other Key Points:

    • Cullinan is eligible to receive $30 million and $100 million upon U.S. regulatory approvals for zipalertinib in the 2L and 1L EGFR ex20ins NSCLC settings, respectively.
    • The company is entitled to a 50/50 profit share in the U.S. for zipalertinib.
    • Updated efficacy and safety data from the CLN-049 Phase 1 dose escalation study will be presented at the 2026 ASH Annual Meeting on December 13, 2026.
    • The Phase 3 REZILIENT3 trial for zipalertinib plus chemotherapy met its primary endpoint at interim analysis, demonstrating statistically significant and clinically meaningful improvement in median progression-free survival compared to chemotherapy alone.
Company
CULLINAN THERAPEUTICS INC
Sector
Healthcare
Industry
Biotechnology