Quantum BioPharma (QNTM) advances Lucid-MS with FDA IND for Phase 2 MS trial

Rhea-AI Filing Summary

Quantum BioPharma Ltd. has submitted an Investigational New Drug (IND) application to the U.S. FDA for Lucid-21-302 (Lucid-MS), a first-in-class drug candidate for multiple sclerosis. The filing supports a planned Phase 2 clinical trial targeting demyelination, a core driver of MS progression.

The IND package includes nonclinical pharmacology, toxicology, manufacturing and quality data. Phase 1 trials of Lucid-MS were completed and described as safe and well-tolerated. Quantum outlines an expected timeline with FDA feedback and Phase 2 trial initiation targeted for Q2 2026 and interim Phase 2 data projected in Q4 2026.

The company highlights MS as a major global market, citing 2.8 million patients worldwide and a therapeutic market projected to exceed $38 billion by 2030. It also describes a diversified business model combining clinical development of Lucid-MS with consumer health revenues from UNBUZZD™ via a 7% royalty structure and retained economic rights.

Insights

Biopharma pipelines analyst

IND filing advances Lucid-MS into planned Phase 2 with defined milestones.

Quantum BioPharma has progressed Lucid-MS by submitting an IND to the FDA, moving from completed Phase 1 safety studies toward a planned Phase 2 efficacy trial in multiple sclerosis. The drug’s demyelination-targeting mechanism differentiates it from many immune-modulating MS therapies.

The company provides a clear development path: IND submitted in March 2026, anticipated FDA response and Phase 2 start in Q2 2026, and projected interim Phase 2 data in Q4 2026. These anchors frame upcoming value-inflection points, though outcomes will depend on FDA clearance and clinical results.

Management links this clinical program with a diversified platform, including UNBUZZD™ consumer health royalties and strategic investments. That mix aims to generate operational cash while advancing Lucid-MS, but actual impact will hinge on MS trial data and market adoption for both therapeutics and consumer products.

Key Figures

IND submission date: March 2026 Anticipated FDA response: Q2 2026 Planned Phase 2 start: Q2 2026 +6 more

9 metrics

IND submission date March 2026 Lucid-MS IND submitted to FDA

Anticipated FDA response Q2 2026 Expected feedback on Lucid-MS IND

Planned Phase 2 start Q2 2026 Target initiation of Lucid-MS Phase 2 trial

Projected Phase 2 interim data Q4 2026 Planned Lucid-MS interim readout

MS patients worldwide 2.8 million people Global multiple sclerosis prevalence

MS market size projection $38 billion Therapeutic market projected by 2030

UNBUZZD initial royalty rate 7% of sales Until $250 million cumulative payments

UNBUZZD perpetual royalty 3% of sales After $250 million threshold reached

Ownership in Unbuzzd Wellness Inc. 19.84% As of December 31, 2025

Key Terms

Investigational New Drug (IND), Phase 2 clinical trial, demyelination, neuroprotection, +2 more

6 terms

Investigational New Drug (IND) regulatory

"announced that it has formally submitted an Investigational New Drug (IND) application"

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

Phase 2 clinical trial medical

"supports Quantum’s planned Phase 2 clinical trial evaluating its first-in-class therapeutic treatment"

A phase 2 clinical trial is a research study that tests a new medical treatment or drug to see if it is effective and safe for a specific condition. It involves a larger group of people than earlier trials and helps determine whether the treatment should move forward to more extensive testing. For investors, successful phase 2 results can signal potential for future approval and commercial success, while setbacks may indicate challenges ahead.

demyelination medical

"therapeutic treatment targeting demyelination, advancing Quantum BioPharma’s strategic growth"

Demyelination is the loss or damage of the protective sheath (myelin) that surrounds nerve fibers, similar to how stripped insulation makes electrical wires slower and more error-prone. It matters to investors because diseases or treatments that cause or prevent demyelination can drive clinical trial outcomes, regulatory scrutiny, and long-term costs for healthcare companies; evidence of demyelination can change a drug’s safety profile and therefore a company’s market value.

neuroprotection medical

"Lucid-MS is designed to provide neuroprotection through the inhibition of demyelination"

Neuroprotection are treatments or strategies aimed at preventing or slowing damage to nerve cells in the brain and nervous system, much like a helmet protects a cyclist’s head. Investors care because successful neuroprotective therapies can delay progression of chronic brain disorders, shape clinical trial design and regulatory approval paths, and create large, long-term markets for drugs or devices that preserve patients’ function and reduce healthcare costs.

royalty payments financial

"includes royalty payments of 7% of sales from unbuzzd™ until payments to Quantum BioPharma total $250 million"

Payments made to the owner of an asset, patent, trademark, mineral right, or creative work in exchange for permission to use it; they are typically a percentage of sales or a fixed fee per unit sold. For investors, royalty payments represent a steady income stream tied to the underlying product’s sales performance, similar to collecting rent from tenants — predictable cash flow that can reduce risk or add value when evaluating a company’s revenue sources.

forward-looking statements regulatory

"Certain information in this news release constitutes forward-looking statements under applicable securities laws"

Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.

Form 6-K: How Foreign Companies Report to the SEC →

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

Form 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of April 2026

Commission File Number: 001-39152

Quantum BioPharma Ltd.
(Translation of registrant's name into English)

1 Adelaide Street East, Suite 801
Toronto, Ontario M5C 2V9
(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ X ]      Form 40-F [   ]

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

		Quantum BioPharma Ltd.
		(Registrant)
Date: April 1, 2026		/s/ Donal Carroll
		Donal Carroll
		Chief Financial Officer

EXHIBIT INDEX

Exhibit Number		Description
99.1		Press Release dated April 1, 2026

EXHIBIT 99.1

Quantum BioPharma Submits Investigational New Drug (IND) Application to United States Food and Drug Administration (FDA) for Lucid-MS Phase Two Clinical Trial in Multiple Sclerosis

TORONTO, April 01, 2026 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (“Quantum BioPharma” or the “Company”), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions, today announced that it has formally submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Lucid-21-302 (Lucid-MS), its new drug candidate for the treatment of multiple sclerosis (MS). This milestone IND submission supports Quantum’s planned Phase 2 clinical trial evaluating its first-in-class therapeutic treatment targeting demyelination, advancing Quantum BioPharma’s strategic growth in the global neurological market.

Milestone IND submission supports planned phase-2 clinical trial evaluating First-in-Class therapeutic treatment targeting demyelination to advance Quantum BioPharma’s strategic growth in global neurological market.

This strategic milestone represents a significant advancement in Quantum BioPharma's clinical development pipeline and underscores the Company's commitment to delivering innovative therapeutic solutions for patients suffering from debilitating neurological conditions.

Comprehensive IND Submission and Development Timeline

The IND submission includes data from nonclinical pharmacology and toxicology studies, along with manufacturing and quality information, to support initiation of the planned Phase 2 clinical trial. Subject to FDA clearance, Quantum BioPharma intends to initiate the Phase 2 study as soon as possible.

Phase 1 Clinical Trials	Completed	✓ Safe & Well-Tolerated
IND Submission to FDA	March 2026	✓ Submitted
Anticipated FDA Response	Q2 2026	Pending
Phase 2 Trial Initiation	Q2 2026	Planned
Phase 2 Interim Data	Q4 2026	Projected

First-in-Class Therapeutic Innovation

Lucid-MS is designed to provide neuroprotection through the inhibition of demyelination—a key driver of disease progression in MS. This innovative mechanism represents a differentiated therapeutic approach in the global MS market, where many existing therapies primarily focus on modulating the immune system rather than addressing the underlying neurodegeneration.

The planned Phase 2 trial will evaluate the efficacy, safety, and tolerability of Lucid-MS in people with MS. In prior Phase 1 clinical trials, Lucid-MS demonstrated a favorable safety profile and was well-tolerated in healthy participants providing a strong foundation for continued development.

“This IND submission is supported by a comprehensive preclinical research package designed to characterize the safety profile of Lucid-MS and support its evaluation in patients. The data we've compiled reflects many years of dedicated scientific research. We look forward to working with the FDA as we progress toward clinical evaluation of this novel approach to prevent disease progression in MS," said Dr. Andrzej Chruscinski, Vice-President, Scientific and Clinical Affairs at Quantum BioPharma.

Strategic Market Opportunity

Multiple sclerosis affects approximately 2.8 million people worldwide (source: https://pmc.ncbi.nlm.nih.gov Atlas of MS, Third Edition (PMC/NCBI)), representing a significant global healthcare challenge and substantial market opportunity for innovative treatments. The MS therapeutic market is projected to exceed $38 billion by 2030 according to Grand View Research www.grandviewresearch.com, driven by increasing diagnosis rates and demand for disease-modifying therapies.

Quantum BioPharma's differentiated approach—targeting demyelination directly—positions Lucid-MS to address unmet patient needs and potentially capture meaningful market share in this growing segment.

Zeeshan Saeed, CEO of Quantum BioPharma added, “The submission of our IND marks an important milestone in the advancement of Lucid-MS into clinical development for multiple sclerosis. We believe our approach targeting demyelination represents a differentiated strategic position in a field where significant innovation is needed. This milestone reflects our commitment to shareholder value creation through disciplined investment in high-potential therapeutic programs.”

“Our approach of combining clinical development with consumer health products like unbuzzd, targets sustainable revenue streams that support continued research and development operational cash without shareholder dilution. We remain focused on executing our growth strategy while advancing potentially transformative treatments for MS patients in need."

Quantum BioPharma’s Diversified Business Platform

Quantum BioPharma's diversified business platform targets growth through multiple potential value drivers:

Clinical Development	Lucid-MS Phase 2 trial	High-value therapeutic innovation
Consumer Health	UNBUZZD™ rapid alcohol metabolizer	Revenue generation via 7% royalty
Strategic Investments	FSD Strategic Investments Inc.	Digital assets

About Quantum BioPharma Ltd.

Quantum BioPharma is a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative and metabolic disorders and alcohol misuse disorders with drug candidates in different stages of development. Through its wholly owned subsidiary, Lucid Psycheceuticals Inc. (“Lucid”), Quantum BioPharma is focused on the research and development of its lead compound, Lucid-MS. Lucid-MS is a patented new chemical entity shown to prevent and reverse myelin degradation, the underlying mechanism of multiple sclerosis, in preclinical models. Quantum BioPharma invented UNBUZZD™ and spun out its OTC version to a company, Unbuzzd Wellness Inc. (“UWI”), led by industry veterans. Quantum BioPharma retains ownership of 19.84% (as of December 31, 2025) of UWI at www.unbuzzd.com. The agreement with UWI also includes royalty payments of 7% of sales from unbuzzd™ until payments to Quantum BioPharma total $250 million. Once $250 million is reached, the royalty drops to 3% in perpetuity. Quantum BioPharma retains 100% of the rights to develop similar product or alternative formulations specifically for pharmaceutical and medical uses.

Forward-Looking Information

Certain information in this news release constitutes forward-looking statements under applicable securities laws. Any statements that are contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements are often identified by terms such as “planned”, “may”, “should”, “anticipate”, “expect”, “potential”, “believe”, “intend”, “targeting” or the negative of these terms and similar expressions.

Readers are cautioned that the foregoing list is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.

Forward-looking statements contained in this press release are expressly qualified by this cautionary statement and reflect the Company’s expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events or results or otherwise or to explain any material difference between subsequent actual events and such forward- looking information, except as required by applicable law.

Contacts:

Quantum BioPharma Ltd.
Zeeshan Saeed, Founder, CEO and Executive Co-Chairman of the Board
Email: Zsaeed@quantumbiopharma.com
Telephone: (416) 854-8884

Investor Relations
Email: ir@quantumbiopharma.com, info@quantumbiopharma.com
Website: www.quantumbiopharma.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/e16adc7c-2200-4f53-bb33-b8dd37e4c1aa

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 PRESS RELEASE 16.4 KB