Immunic: IDMC confirms Phase 3 ENSURE trials not futile, recommends continue as planned; CALLIPER data April 2025

IMMUNIC, INC.

IDMC recommended ENSURE-1 and ENSURE-2 continue unchanged; predetermined futility criteria not met.
Sample size deemed appropriate to address primary endpoint of time to first relapse; no upsizing needed.
Top-line data from Phase 2 CALLIPER trial in progressive MS expected April 2025.
ENSURE program completion on track: ENSURE-1 in Q2 2026, ENSURE-2 in H2 2026.
Immunic remains blinded; drug vidofludimus calcium is a Nurr1 activator for relapsing MS.

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