Quantum BioPharma Signs Phase 2 Study Start-Up Agreement With Thermo Fisher’s PPD CRO for First-in-Class MS Candidate Lucid-MS

• Quantum BioPharma Ltd. (NASDAQ: QNTM), a Toronto-based biopharmaceutical company, has signed a Study Start-Up Agreement with the PPD clinical research business within Thermo Fisher Scientific — a leading global CRO with extensive CNS and multiple sclerosis trial experience — to implement the Phase 2 clinical trial of Lucid-21-302 (Lucid-MS), Quantum’s patented first-in-class neuroprotective candidate for progressive multiple sclerosis.

• The agreement initiates formal study start-up activities including regulatory submissions, ethics approvals, site selection and management, patient recruitment strategy, data management, and related clinical research services — following FDA clearance to proceed with the randomized, double-blind, placebo-controlled Phase 2 study received in August 2026.

Quantum BioPharma Ltd. (NASDAQ: QNTM; FRA: 0K91), a biopharmaceutical company focused on developing innovative therapies and technologies, announced on October 6, 2026, from Toronto, Canada, that it has entered into a Study Start-Up Agreement with the PPD clinical research business within Thermo Fisher Scientific to implement the Phase 2 clinical trial of Lucid-21-302, known as Lucid-MS, for the treatment of multiple sclerosis. The SUA marks the initiation of formal study start-up activities and represents a significant operational milestone following the company’s receipt of FDA clearance to proceed with the planned Phase 2 study in August 2026.

The PPD clinical research business within Thermo Fisher Scientific is a leading global CRO with extensive experience supporting clinical development programs across therapeutic areas including CNS and multiple sclerosis. Under the terms of the agreement, PPD will support Quantum BioPharma in implementing the Phase 2 clinical trial — covering study start-up activities and related clinical research services spanning regulatory submissions, ethics approvals, site selection and management, patient recruitment strategy and execution, data management, and regulatory compliance. The engagement transitions Quantum BioPharma’s Lucid-MS program from IND approval into active clinical operations under a CRO partner with established MS trial infrastructure and global site network capabilities.

Lucid-MS is Quantum BioPharma’s patented, first-in-class neuroprotective candidate designed to inhibit demyelination in patients with progressive multiple sclerosis — an area of substantial unmet medical need within a global MS therapeutics market anticipated to reach approximately $38.62 billion by 2030. The planned Phase 2 trial is designed as a randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of Lucid-MS in people with MS. The SUA with PPD follows a binding Letter of Intent signed with Allucent in March 2026, which had originally been announced as the CRO partner for the Phase 2 program — with PPD now contracted as the implementing CRO following FDA clearance.

The engagement reflects the growing role of Thermo Fisher’s PPD clinical research business in supporting early-stage biotech sponsors advancing novel CNS candidates into pivotal clinical programs. For small- and mid-cap biopharma companies like Quantum BioPharma — operating with defined capital runways and high clinical execution risk — the selection of an established CRO with deep MS trial experience and global operational infrastructure is a risk-mitigation decision as much as a capability decision, reducing the probability of enrollment, site, and regulatory delays that have historically derailed CNS Phase 2 programs at the study start-up stage.

“We are pleased to enter into a contract with the clinical research business of Thermo Fisher as we advance the Lucid-MS program toward Phase 2. Following FDA clearance to proceed with the Phase 2 study, initiating study start-up activities with a leading global CRO with extensive CNS and MS experience represents an important next step.”

Zeeshan Saeed, Chief Executive Officer, Quantum BioPharma