QNTM Clinical trials

Quantum BioPharma Signs Agreement to Manufacture Oral Drug Formulation of its Potential Breakthrough Drug Lucid-21-302 (Lucid-MS) for Use in its Upcoming Phase 2 Multiple Sclerosis Trial

Published August 11, 2025 at 11:40 AM

TORONTO, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (Upstream: QNTM) (“Quantum BioPharma” or the “Company”), a biopharmaceutical company dedicated to innovative therapies for neurodegenerative disorders, today announces through its subsidiary, Huge Biopharma Australia Pty Ltd., that it has signed an agreement with a leading contract development and manufacturing organization (CDMO) to manufacture an oral drug formulation of Lucid-MS. The oral formulation of Lucid-MS will serve as the drug product for the Company’s Phase 2 clinical trial, which will test the efficacy on humans of Lucid-MS as a possible treatment for people to gain back mobility lost with multiple sclerosis (MS). To date numerous animal models over the past decade showed Lucid-MS helped those animals regain their ability to walk. Videos can be seen at https://www.quantumbiopharma.com/lucid-ms.

Related Questions

How will the agreement with the CDMO affect QNTM's cash burn and capital requirements in the near term? What is the expected timeline for the Phase 2 trial and when can we expect data readouts? What is the size of the market opportunity for an oral MS therapy compared to existing disease‑modifying therapies and competitors like Biogen, Roche, and Novartis? Will the oral formulation of Lucid‑MS enable a broader patient population or improve compliance versus the current formulation? What are the projected revenues and pricing strategy for Lucid‑MS if Phase 2 is successful and moves to Phase 3? What are the key milestones and regulatory filing dates associated with the Phase 2 trial and subsequent IND/NDAs? What is the size and terms of the CDMO agreement (e.g., upfront payments, milestone payments, royalties, cost per batch)? How much manufacturing capacity is secured and does it support future Phase 3 scale‑up? What are the risks of manufacturing delays or quality issues with the CDMO that could impact trial timelines? How does the oral formulation’s pharmacokinetic profile compare to the pre‑clinical data and the currently studied formulation? What is the current cash runway and will the company need to raise additional equity or debt to fund the Phase 2 trial? How might this news influence short‑term trading volume and volatility for QNTM? What are the potential dilution effects from any financing associated with the trial and manufacturing partnership? How does the recent news compare with peers’ recent Phase 2 announcements in neuro‑degenerative or MS space? What are the potential upside and downside scenarios for Lucid‑MS based on historical success rates of Phase 2 MS trials?