Adicet Bio, Inc.

Anticipated development plans for ADI-001 are as follows:

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The Company plans to request a meeting with the U.S. Food and Drug Administration (FDA) in first quarter of 2026 to inform Phase 2 pivotal trial design with a study anticipated to commence in second quarter of 2026. SLE and LN patient enrollment to the ongoing Phase 1 is expected to continue until the Phase 2 pivotal study is open for enrollment.

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The Phase 1 program is now open for enrollment of patients with systemic sclerosis (SSc), idiopathic inflammatory myopathy, stiff person syndrome, anti-neutrophil cytoplasmic autoantibody associated vasculitis and rheumatoid arthritis (RA). There are more than 25 clinical sites globally open for enrollment for the Phase 1 study of ADI-001 in autoimmune indications.

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Below are the anticipated milestones for ADI-001 through end of 2026:

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First half of 2026:

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SLE and LN clinical update

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Alignment with FDA on pivotal study design in LN or LN/SLE

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Initiate pivotal study in LN or LN/SLE

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Clinical update in SSc

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Potential clinical update in other autoimmune indications

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Second half of 2026:

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SLE and LN clinical update

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Clinical update in SSc

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Clinical update in RA with cyclophosphamide/fludarabine vs cyclophosphamide only conditioning

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Potential clinical update in other autoimmune indications

For ADI-212, the Company plans to submit a regulatory filing for the treatment of metastatic castration-resistant prostate cancer in the first quarter of 2026, followed by plans to initiate enrollment in the second quarter of 2026. The Company plans to provide initial clinical data in the second half of 2026.