Lucid-21-302 - (Lucid-MS)

June 1, 2026: Quantum BioPharma Ltd. (NASDAQ: QNTM; CSE: QNTM; FRA: 0K91) said the FDA has placed its Investigational New Drug (IND) application for Lucid-21-302 (Lucid-MS), a multiple sclerosis candidate, on clinical hold following FDA correspondence dated May 28, 2026. The hold requires submission of additional information requested by the agency before the planned clinical study can proceed. Quantum said it is reviewing the FDA’s comments and plans to work with the FDA, advisors, and development partners to prepare and submit a response package, stating it believes the issues are addressable.

As a result of the clinical hold, the company withdrew previously disclosed timelines for FDA review, initiation of the planned Phase 2 trial, and anticipated interim data milestones, noting these timelines should not be relied upon pending further regulatory interactions.

Separately, the company disclosed that Dr. Lakshmi P. Kotra resigned as a director and from all positions effective June 1, 2026, and will remain as a senior clinical advisor.