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Sep 30
Adicet Bio Q3 2025 Earnings Report
Adicet Bio reported its financial results and operational highlights for the third quarter ended September 30, 2025.
Key Takeaways
Adicet Bio reported a net loss of $26.9 million for Q3 2025, an improvement from $30.5 million in Q3 2024. The company's R&D and G&A expenses both decreased, contributing to the reduced loss. Adicet also announced positive preliminary safety and efficacy data from its Phase 1 clinical trial of ADI-001 in lupus nephritis and systemic lupus erythematosus, and successfully raised $74.8 million in net proceeds from a registered direct offering, extending its cash runway into the second half of 2027.
Net loss for Q3 2025 was $26.9 million, an improvement from $30.5 million in the same period last year.
Research and Development expenses decreased to $22.9 million in Q3 2025 from $26.3 million in Q3 2024.
General and Administrative expenses decreased to $5.1 million in Q3 2025 from $6.9 million in Q3 2024.
The company successfully raised $74.8 million in net proceeds from a registered direct offering in October 2025, extending its cash runway into the second half of 2027.
Adicet Bio
Adicet Bio
Forward Guidance
Adicet Bio plans to request a meeting with the FDA in Q1 2026 to discuss the pivotal trial design for ADI-001, with initiation anticipated in Q2 2026. The company also expects to submit a regulatory filing for ADI-212 in mCRPC in Q1 2026 and share initial clinical data in H2 2026. The recent capital raise has extended the cash runway into H2 2027.
Positive Outlook
- Company plans to request a meeting with the FDA in Q1 2026 to inform potentially pivotal ADI-001 trial design.
- Initiation of the potentially pivotal ADI-001 study is anticipated to commence in Q2 2026.
- On track to share clinical update from Phase 1 study of ADI-001 in LN, SLE, and SSc in H1 2026.
- Plan to submit regulatory filing for ADI-212 in metastatic castration-resistant prostate cancer (mCRPC) in Q1 2026.
- Recent capital raise extended projected cash runway into H2 2027.
Challenges Ahead
- Clinical updates for ADI-001 in treatment-refractory RA patients are expected in H2 2026, indicating a longer timeline for this specific program.
- Initial clinical data for ADI-212 program is subject to regulatory clearance to proceed with a clinical trial, introducing a potential delay.
- The company's ability to execute on its strategy, including obtaining requisite regulatory approvals, is subject to risks and uncertainties.
- Clinical studies may fail to demonstrate adequate safety and efficacy of product candidates, which could prevent, delay, or limit regulatory approval.
- Regulatory approval processes are lengthy, time-consuming, and inherently unpredictable.