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

Quantum BioPharma (NASDAQ: QNTM) submitted an IND to the FDA on April 1, 2026 for Lucid-MS, a first-in-class candidate targeting demyelination in multiple sclerosis.

Rhea-AI Summary

Quantum BioPharma (NASDAQ: QNTM) submitted an IND to the FDA on April 1, 2026 for Lucid-MS, a first-in-class candidate targeting demyelination in multiple sclerosis. Phase 1 was completed and found Lucid-MS safe and well-tolerated.

Subject to FDA clearance (anticipated Q2 2026), the company plans Phase 2 initiation in Q2 2026 with interim data projected for Q4 2026. The company highlights a diversified platform including a consumer health product with a 7% royalty revenue stream and cites a global MS market opportunity (~$38B by 2030) affecting ~2.8M people.

Positive

• IND submission to FDA for Lucid-MS (March/April 2026)
• Phase 1 completed: safe and well-tolerated
• Planned Phase 2 initiation in Q2 2026 (subject to clearance)
• Diversified revenue: consumer health 7% royalty supports R&D funding

Negative

• FDA response pending (anticipated Q2 2026), could delay Phase 2
• Efficacy in patients unproven until Phase 2 interim data (Q4 2026)

Argus Apr 1 session

-8.70% close to close Open Argus

Details

News Market Reaction – QNTM

In the Apr 1 session, QNTM declined 8.70%, reflecting a notable negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved -8.7% in the session following this news. A negative reaction despite this IND step ...

Analysis

The stock moved -8.7% in the session following this news. A negative reaction despite this IND step would fit Quantum’s pattern of inconsistent responses to Lucid‑MS milestones, where some positive updates have coincided with double‑digit declines. The company remains at an early, pre‑revenue stage and trades well below its 200‑day MA, which can amplify downside swings. In such scenarios, attention typically centers on regulatory risk, trial‑execution complexity, and the gap between today’s IND progress and eventual Phase 2 efficacy data.

Key Figures

IND submission date: March 2026 Anticipated FDA response: Q2 2026 Phase 2 initiation: Q2 2026 +4 more

IND submission date

March 2026

Lucid‑MS IND filed with FDA

Anticipated FDA response

Q2 2026

Expected IND feedback timeline

Phase 2 initiation

Q2 2026

Planned Lucid‑MS Phase 2 trial start

Phase 2 interim data

Q4 2026

Projected Lucid‑MS interim readout

MS prevalence

2.8 million people

Global multiple sclerosis patient population

MS market size

$38 billion

Projected MS therapeutic market by 2030

UNBUZZD royalty rate

7% royalty

Consumer health product revenue stream

Previous Clinical trial Reports

5 past events · Latest: Mar 30

Same Type 5 events

1. Mar 30

   Phase 2 LOI

   24h Move

   -10.3%

   Signed LOI with Allucent to execute planned Lucid‑MS Phase 2 trial.

2. Mar 23

   Unbuzzd trial data

   24h Move

   +38.4%

   Peer‑reviewed Unbuzzd trial showed faster alcohol reduction and symptom relief.

3. Oct 02

   Toxicity reports

   24h Move

   +9.5%

   Final 90‑day toxicity and toxicokinetic reports supporting Lucid‑MS IND filing.

4. Oct 01

   Clinical advisor hire

   24h Move

   +0.8%

   Added renowned MS expert as clinical advisor for Lucid‑MS trial design.

5. Aug 11

   Manufacturing deal

   24h Move

   -10.1%

   Signed CDMO deal to manufacture oral Lucid‑MS for planned Phase 2 trial.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

investigational new drug (ind), food and drug administration (fda), phase 2 clinical trial, demyelination, +3 more

7 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.

food and drug administration (fda) regulatory

"Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA)"

A U.S. government agency that reviews and approves drugs, medical devices, vaccines, food safety measures and related products before they reach the market. Think of it as a gatekeeper whose decisions, inspections and safety warnings can make or break a product’s ability to sell; investors watch FDA actions closely because approvals speed revenue and failed reviews, delays or recalls can sharply change a company’s value.

phase 2 clinical trial medical

"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

"first-in-class therapeutic treatment targeting demyelination, advancing Quantum BioPharma’s"

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.

multiple sclerosis medical

"new drug candidate for the treatment of multiple sclerosis (MS)"

A chronic neurological disease in which the immune system damages the protective coating (like insulation on electrical wires) around nerves, disrupting signals between the brain and body and causing symptoms such as numbness, weakness, vision problems, fatigue and mobility issues. It matters to investors because the unpredictability and long-term nature of the condition drive ongoing demand for treatments, influence the value of companies developing therapies, affect healthcare costs and shape regulatory and reimbursement decisions.

royalty financial

"UNBUZZD™ rapid alcohol metabolizer | Revenue generation via 7% royalty"

A royalty is a payment made to the owner of a resource or asset—such as a patent, mineral rights, or creative work—whenever others use or profit from it. For investors, royalties provide a steady stream of income without owning the entire asset, similar to earning a small commission each time a product is sold or a service is used. This makes royalties an important factor in valuing certain types of investments.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did QNTM announce about its IND submission for Lucid-MS on April 1, 2026?

Quantum BioPharma submitted an IND to the FDA for Lucid-MS to support a Phase 2 trial. According to Quantum BioPharma, the submission includes nonclinical pharmacology, toxicology, and manufacturing information to enable patient evaluation.

When does QNTM expect an FDA decision and Phase 2 start for Lucid-MS (QNTM)?

Quantum BioPharma anticipates an FDA response in Q2 2026 and plans Phase 2 initiation in Q2 2026 if cleared. According to Quantum BioPharma, timing depends on FDA clearance and operational readiness to begin patient enrollment.

What were Lucid-MS Phase 1 results reported by Quantum BioPharma (QNTM)?

Lucid-MS completed Phase 1 with a favorable safety profile and was well-tolerated in healthy participants. According to Quantum BioPharma, these results support progression to patient-focused Phase 2 efficacy and safety evaluation.

What clinical milestones does Quantum BioPharma (QNTM) project for Lucid-MS in 2026?

The company projects Phase 2 initiation in Q2 2026 and interim data by Q4 2026. According to Quantum BioPharma, these milestones follow IND submission and depend on FDA clearance and trial enrollment progress.

How does Lucid-MS differ from existing multiple sclerosis treatments from QNTM's perspective?

Lucid-MS targets demyelination and neuroprotection, rather than primarily modulating the immune system. According to Quantum BioPharma, this represents a differentiated approach aimed at addressing underlying neurodegeneration in MS.

How is Quantum BioPharma (QNTM) funding R&D without immediate shareholder dilution?

Quantum BioPharma cites a diversified model combining clinical programs with consumer health revenue, notably a 7% royalty on UNBUZZD. According to Quantum BioPharma, this supports operational cash and research funding without new equity issuance.