On January 8, 2026 Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, reported a corporate update and shared anticipated business highlights for 2026.

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"We have built strong momentum with CLN-978 and are pleased to share that we have completed multiple dose cohorts in our OUTRACE RA and OUTRACE SLE studies, and we have initiated dosing in our Sjögren’s disease study. This significant progress positions us to deliver the first company sponsored data with a CD19 T cell engager in autoimmune diseases. Throughout 2026, we will deliver data across all three indications, including important repeat dosing data in rheumatoid arthritis," said Nadim Ahmed, President and CEO of Cullinan Therapeutics.

"Our CLN-049 program continues to advance following the presentation of compelling efficacy and favorable safety data at ASH (Free ASH Whitepaper) 2025, which we believe enables an accelerated approval pathway. We plan to complete dose expansion in relapsed/refractory AML and TP53m AML to rapidly determine a recommended Phase 2 dose, while also initiating a frontline combination study this year. Additionally, 2026 marks a pivotal milestone for zipalertinib, as Taiho completes the rolling NDA submission in the beginning of the year, and completes enrollment in the frontline study REZILIENT3 in the first half of 2026. In summary, we are focused on generating multiple catalysts for our two high-priority T cell engager programs, CLN-978 and CLN-049, positioning us for a transformative year ahead."

Portfolio Highlights and Anticipated 2026 Milestones

Immunology

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CLN-978 (CD19xCD3 bispecific T cell engager): Rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and Sjögren’s disease (SjD)
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OUTRACE RA
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Dose escalation is ongoing, and patients are currently being enrolled to the 30-microgram dose cohort. The 10- and 20-microgram dose cohorts are complete with no dose-limiting toxicities observed.
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In Q2 2026, the Company plans to share initial data from the single target dose escalation portion of the study with a focus on safety and B cell depletion in peripheral blood and tissue, additional biomarker data, and preliminary clinical activity data.
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In Q3 2026, the Company plans to share initial repeat dosing data, including B cell depletion in peripheral blood and tissue, additional biomarker data, and preliminary clinical activity data.
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OUTRACE SLE
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Dose escalation is ongoing, and patients are currently being enrolled in the 30-microgram dose cohort. The 10- and 20-microgram dose cohorts are complete with no dose-limiting toxicities observed.
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In Q2 2026, the Company plans to share initial data from Part A (single target dose escalation) with a focus on safety and B cell depletion in peripheral blood, additional biomarker data, and preliminary clinical activity data.
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OUTRACE SjD
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The Company has initiated patient dosing, and enrollment is ongoing in the 10-microgram dose cohort.
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In Q4 2026, the Company plans to share initial data from Part A (single target dose escalation) with a focus on safety and B cell depletion in peripheral blood and tissue, additional biomarker data, and preliminary clinical activity data.

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Velinotamig (BCMAxCD3 bispecific T cell engager): Autoimmune diseases
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In December 2025, Genrix Bio initiated a Phase 1 study in China in patients with autoimmune diseases, and initial clinical data from the study will be shared in Q4 2026. Cullinan intends to use the data generated to accelerate global clinical development of the program. Following the completion of the Genrix Bio Phase 1 study, Cullinan will conduct all further development of velinotamig in autoimmune diseases.
Oncology

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CLN-049 (FLT3xCD3 bispecific T cell engager): Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
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In December 2025, CLN-049 received Fast Track designation for the treatment of relapsed/refractory AML from the U.S. FDA and, in an oral presentation at the 2025 ASH (Free ASH Whitepaper) Annual Meeting, the Company shared compelling clinical data in a heavily pretreated all-comer population of patients with relapsed/refractory AML. The Company plans to share an update from the dose escalation portion of the study in H2 2026.
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In Q2 2026, the Company expects to initiate monotherapy dose expansion cohorts in patients with relapsed/refractory AML and TP53m AML. In Q4 2026, the Company expects to complete enrollment for dose expansion to determine the recommended Phase 2 dose (RP2D) for an expected single arm pivotal registrational trial.
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In Q4 2026, the Company plans to initiate a Phase 1/2 combination study in frontline AML.
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Enrollment also continues in a parallel Phase 1 study in patients with AML and measurable residual disease (MRD) immediately following induction therapy.

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Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC
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In November 2025, Taiho initiated a rolling submission of an NDA seeking accelerated approval of zipalertinib for the treatment of patients with relapsed EGFR ex20ins NSCLC. Taiho expects completion of the NDA submission in Q1 2026.
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Taiho expects to complete enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC in H1 2026.
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Cullinan is eligible to receive up to $130 million in payments for U.S. regulatory milestones and a 50/50 profit share in the U.S.

Cash Position and Cash Runway

Unaudited preliminary cash, cash equivalents, short- and long-term investments, and interest receivable were $439.0 million as of December 31, 2025. Consistent with prior guidance, Cullinan expects its cash resources to provide runway into 2029 under its current operating plan.

The Company expects to report its fourth quarter and full-year 2025 financial results in late February 2026 which will contain additional information required for a more complete understanding of the Company’s financial position and results of operations as of and for the year ended December 31, 2025.

(Press release, Cullinan Oncology, JAN 8, 2026, View Source [SID1234661850])