Cullinan Posts Wider Loss as Drug Pipeline Advances
The biotech reported a first-quarter net loss of $49.7 million, up from $48.5 million a year earlier.
Cullinan Therapeutics (CGEM) reported deeper losses in the first quarter as the clinical-stage biotechnology company expanded development of its autoimmune and oncology drug candidates. Net loss reached $49.7 million, or $0.72 a share, compared with $48.5 million, or $0.71 a share, a year earlier. Revenue was absent in both periods.
The quarter marked a step forward for Cullinan’s lead asset, CLN-978, which demonstrated dose-dependent B-cell depletion in peripheral blood and tissue across systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) cohorts. In newly disclosed Phase 1 data, 71% of SLE patients achieved a ≥4-point reduction in the hybrid SLE Disease Activity Index (hSLEDAI), while one RA patient reached DAS28-ESR remission. The company also reported >80% B-cell reduction in 82% of SLE patients at doses of 20 µg or higher, with half reaching below the limit of quantification.
Research and development expenses rose to $42.1 million from $40.5 million in the year-ago quarter, reflecting broader clinical activity. Full-year 2025 R&D spending climbed to $187.4 million from $142.9 million in 2024, as Cullinan advanced multiple programs. Cash and investments stood at $393.3 million at March 31, down from $438.96 million at the end of 2025.
CLN-978’s safety profile was bolstered by multi-dose regimen data, with three administrations of 20 µg showing no new dose-limiting toxicities. The company also initiated dosing in the 10-µg cohort of the OUTRACE Sjögren’s disease (SjD) study, a new segment not previously disclosed. Separately, Cullinan completed a rolling new drug application (NDA) submission for zipalertinib in the first quarter, accelerating its prior timeline.
In oncology, CLN-049 received FDA Fast Track designation for relapsed or refractory acute myeloid leukemia (AML) in December 2025, a milestone not mentioned in earlier disclosures. The company plans to share initial multi-dose data for CLN-978 in RA in the third quarter of 2026.