Cullinan Therapeutics (CGEM) Q4 2025 earnings summary

Executive summary

• Multiple clinical milestones expected in 2026, including initial and repeat dosing data for CLN-978 in SLE and RA, and initial data in Sjögren's disease.

• Oncology portfolio advances with completed rolling NDA for zipalertinib and full enrollment of the REZILIENT3 study; top-line results expected by year-end 2026.

• CLN-049 to advance to registrational development in AML following compelling clinical data and FDA Fast Track Designation.

Financial highlights

• Cash and investments totaled $439.0 million as of December 31, 2025, providing runway into 2029.

• Research and development expenses were $42.9 million for Q4 2025 (up from $40.5 million in Q4 2024) and $187.4 million for FY 2025 (up from $142.9 million in FY 2024).

• General and administrative expenses were $12.3 million for Q4 2025 and $54.2 million for FY 2025.

• Net loss was $50.7 million for Q4 2025 (vs. $47.6 million in Q4 2024) and $219.9 million for FY 2025 (vs. $167.4 million in FY 2024).

Outlook and guidance

• Initial clinical data for CLN-978 in SLE and RA expected in Q2 2026; repeat dosing data in RA in Q3 2026; initial data in Sjögren's disease in Q4 2026.

• Update from CLN-049 Phase 1 dose escalation in AML/MDS planned for H2 2026; monotherapy dose expansion to start in Q2 2026.

• Top-line results from REZILIENT3 frontline study for zipalertinib expected by year-end 2026.