Cullinan Therapeutics (CGEM) Unveils 2026 Milestones and Corporate Update
CAMBRIDGE, Mass., January 08, 2026 (GLOBE NEWSWIRE) — Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing innovative therapies for autoimmune diseases and cancer, has announced significant updates and milestones for 2026. With a strong cash position and several studies progressing, Cullinan is strategically positioned for a transformative year ahead.
Overview of Upcoming Data and Milestones
Cullinan Therapeutics expects crucial data readouts for its lead product, CLN-978, across all three autoimmune indications in 2026. This includes data from single-dose and repeat dosing studies. Additionally, the company plans to complete ongoing monotherapy expansion cohorts for CLN-049, which is aimed at treating acute myeloid leukemia (AML), and to initiate a combination study by Q4 2026. The rolling NDA submission for zipalertinib, another promising therapy, is anticipated to conclude in Q1 2026.
Financial Health and Projections
Cullinan Therapeutics reported a preliminary cash position of $439.0 million as of December 31, 2025, indicating a robust financial runway into 2029 under its current operations. This solid foundation enables the company to advance multiple clinical programs while maintaining operational flexibility.
- $439 million in cash and investments reported as of December 31, 2025
- Operational runway projected through 2029
- Fourth quarter and full-year 2025 financial results expected to be reported in late February 2026
Key Updates on Clinical Programs
President and CEO Nadim Ahmed expressed optimism about the ongoing progress with CLN-978. The company has completed multiple dose cohorts in its OUTRACE RA and OUTRACE SLE studies and begun dosing for the Sjögren’s disease study. Ahmed stated, “This significant progress positions us to deliver the first company-sponsored data with a CD19 T cell engager in autoimmune diseases.”
In 2026, data will be shared across all three indications, including important repeat dosing information for rheumatoid arthritis:
- OUTRACE RA: Ongoing dose escalation with plans for data in Q2 and Q3 2026
- OUTRACE SLE: Continued escalation with updates expected by mid-2026
- OUTRACE SjD: Patient dosing initiated, with data anticipated in Q4 2026
Similarly, CLN-049 has recently received Fast Track designation from the U.S. FDA for relapsed/refractory AML. The company aims to complete dose expansion cohorts and anticipates a pivotal trial by Q4 2026.
Strategic Collaborations and Therapeutic Advancements
In partnership with Taiho Oncology, Cullinan's zipalertinib is progressing towards filing for accelerated approval for patients with relapsed EGFR ex20ins NSCLC. The completion of the NDA submission and enrollment in the pivotal study is expected in the first half of 2026, marking another significant advancement for Cullinan in the oncology sector.
About Cullinan Therapeutics
Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is committed to developing potential first- or best-in-class therapies for autoimmune diseases and cancer. The company harnesses its expertise in T cell engagers and aims to establish new care standards for patients. To learn more about Cullinan's initiatives, visit cullinantherapeutics.com.
Forward-Looking Statements
This update contains forward-looking statements regarding Cullinan Therapeutics' future expectations and plans, including the development timelines of various product candidates. Actual results may differ, and the company undertakes no obligation to update any of these forward-looking statements.