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Adicet Bio Reports Fourth Quarter and Full Year 2025 Financial Results and Highlights Recent Company Progress

  • Adicet Bio reported strong enrollment momentum in its Phase 1 prula-cel autoimmune program with clinical updates expected in the first half of 2026 & second half of 2026.
  • The company achieved FDA alignment to enable outpatient dosing of prula-cel for lupus nephritis (LN) & systemic lupus erythematosus (SLE) patients.
  • A regulatory filing for ADI-212 in metastatic castration-resistant prostate cancer (mCPRC) is planned for the third quarter of 2026, with enrollment expected to begin in the fourth quarter of 2026 pending clearance.
  • Prula-cel holds Fast Track Designation from the FDA for relapsed/refractory Class III/IV LN, refractory SLE with extrarenal involvement, & systemic sclerosis (SSc).
  • Adicet plans to meet with the FDA in the second quarter of 2026 to discuss pivotal trial design & expects to initiate a pivotal study in LN or LN & SLE patients in the second half of 2026.
  • The first patient was dosed in October 2025 in a Phase 1 study of prula-cel for treatment-refractory rheumatoid arthritis (RA) to evaluate reduced conditioning requirements.
  • ADI-212 is a next-generation gamma delta T cell therapy targeting prostate-specific membrane antigen (PSMA) with preclinical data presented in October 2025.
  • R&D expenses were $25.0 million for the three months ended December 31, 2025, & $99.1 million for the full year 2025.
  • G&A expenses were $6.9 million for the three months ended December 31, 2025, & $23.0 million for the full year 2025.
  • Net loss was $30.5 million ($2.94 per share) for the three months ended December 31, 2025, & $116.8 million ($16.95 per share) for the full year 2025.
  • Cash, cash equivalents, & short-term investments totaled $158.5 million as of December 31, 2025, with funds expected to cover operating expenses into the second half of 2027.
  • The company raised $74.8 million in net proceeds through an equity offering in October 2025.