Cullinan Reports Wider Loss In Q4, Updates Milestones

Cullinan Management

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(RTTNews) - Cullinan Therapeutics, Inc. (CGEM), a clinical-stage biopharmaceutical company, Wednesday announced wider net loss for the fourth quarter, compared to the previous year.

Quarterly net loss attributable to Cullinan was $50.7 million, wider than loss of $47.6 million in the prior year. Research and development expenses were $42.9 million, compared to $40.5 million for the same period in 2024.

For the full year 2025, net loss attributable to Cullinan widened to $219.9 million from $167.4 million in the prior year. R&D expenses for the full year was $187.4 million, compared to $142.9 million a year ago.

Cullinan's portfolio and 2026 Milestones

Cullinan's develops therapies for autoimmune diseases and cancer, and its clinical-stage pipeline includes CLN-978 and Velinotamig under the immunology category, and CLN-049 and Zipalertinib under the oncology category.

-CLN-978

Cullinan is developing CLN-978 and is evaluating it for the treatment of Systemic Lupus Erythematosus, Rheumatoid arthritis, and Sjögren's disease in phase 1 trials dubbed as OUTRACE.

Initial data of CLN-978 in Rheumatoid arthritis are expected in the second quarter of 2026, and repeat-dosing data are expected in the third quarter of 2026.

Initial data of CLN-978 in Systemic Lupus Erythematosus is expected in the second quarter of 2026.

Initial data of CLN-978 in Sjögren's disease is anticipated in the fourth quarter of 2026.

-Velinotamig

In June 2025, Cullinan entered into an agreement with Genrix for Velinotamig, a T-cell engager under evaluation for relapsed/refractory multiple myeloma.

Genrix Bio is currently enrolling patients with autoimmune diseases in a Phase 1 study in China.

The primary evaluation will be for Systemic Lupus Erythematosus, and the initial data is expected in the fourth quarter of 2026.

Following completion of the study, Cullinan will conduct all further development of Velinotamig in autoimmune diseases.

-CLN-049

CLN-049 is in phase 1 trials for acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS).

Cullinan plans to share an update on the dose-escalation portion of the Phase 1 study in patients with relapsed/refractory AML or MDS in the second half of 2026.

In the second quarter of 2026, the company expects to initiate monotherapy dose expansion cohorts in patients with relapsed/refractory AML and TP53m AML

In the fourth quarter of 2026, Cullinan expects to complete enrollment in the dose-expansion cohort to determine the recommended Phase 2 dose for an expected single-arm pivotal registrational trial.

Also, in the fourth quarter of 2026, the company plans to initiate a Phase 1/2 combination study in frontline AML.

In parallel, enrollment is ongoing in a l Phase 1 study in patients with AML and measurable residual disease immediately following induction therapy.

-Zipalertinib

Taiho Oncology is developing Zipalertinib, in collaboration with Cullinan, and it is currently in the Phase 3 REZILIENT3 trial evaluating the combination of Zipalertinib and chemotherapy as a potential first-line treatment for adults with previously untreated locally advanced or metastatic non-small cell lung cancer.

In February, Taiho completed enrollment in the pivotal REZILIENT3 study for 1L EGFR ex20ins NSCLC. Taiho expects to obtain top-line results by the end of 2026.

As of December 31, 2025, cash and cash equivalents were $439.0 million and are expected to provide runway into 2029 under its current operating plan, noted Cullinan.

CGEM has traded between $5.68 and $16.74 in the last year. The stock closed Tuesday's trade at $14.91, down 2.61%.In the premarket, CGEM is up 0.07% at $14.92.