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Quantum BioPharma (QNTM) lines up Allucent for Lucid-MS Phase 2 trial

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Rhea-AI Filing Summary

Quantum BioPharma Ltd. has signed a binding Letter of Intent with global CRO Allucent to support a planned Phase 2 clinical trial of Lucid-21-302 (Lucid-MS) for multiple sclerosis. The company expects to initiate this Phase 2 study in the second quarter of 2026, subject to regulatory approvals and finalization of the clinical trial design and operations.

Lucid-MS is described as a first-in-class new chemical entity aimed at providing neuroprotection by inhibiting demyelination, a key driver of MS progression, offering a differentiated approach versus immune-modulating therapies. The release highlights an MS prevalence of about 2.8 million people worldwide and a therapeutic market projected to exceed $38 billion by 2030.

Quantum BioPharma also outlines its broader portfolio, including a 19.84% ownership (as of December 31, 2025) in Unbuzzd Wellness Inc., rights to royalties of 7% of unbuzzd™ sales until a total of $250 million is paid and 3% thereafter, and a tax loss carry forward of approximately C$130 million that could offset future taxable profits.

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Insights

LOI with Allucent advances Lucid-MS into planned Phase 2 while non-core royalties and tax assets support long-term optionality.

The binding LOI with Allucent anchors Quantum BioPharma’s transition of Lucid-MS into a planned Q2 2026 Phase 2 trial. As a specialized CNS-focused CRO, Allucent is expected to handle start-up, global site management, recruitment, data management and regulatory support, which can be critical execution levers in mid-stage neurology studies.

Lucid-MS targets demyelination, positioning it in an emerging neuroprotective niche within an MS market projected to exceed $38 billion by 2030. While this underscores potential upside, actual value will depend on Phase 2 efficacy, safety and biomarker readouts referenced in the design description.

Outside the MS program, the company details cash-flow–linked assets: a 19.84% stake in Unbuzzd Wellness as of December 31, 2025, royalties of 7% of unbuzzd™ sales until $250 million is paid then 3% thereafter, plus a roughly C$130 million tax loss carry forward. These features could enhance future economics if product sales or profits materialize, but timing and scale remain dependent on later commercial outcomes.

 

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 March 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: March 30, 2026     /s/ Donal Carroll    
  Donal Carroll
  Chief Financial Officer
  


EXHIBIT INDEX

 

Exhibit Number Description
  
99.1 Press Release dated March 30, 2026

EXHIBIT 99.1

Quantum BioPharma Signs Binding Letter Of Intent With Allucent To Conduct Phase 2 Clinical Trial In Multiple Sclerosis

Strategic Partnership with Global Clinical Research Organization (CRO) Signifies Advancement in Clinical Development of Lucid-21-302 (Lucid-MS), a Novel First-in-Class Treatment Inhibiting Demyelination

TORONTO, March 30, 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 entered into a binding Letter of Intent (LOI) with Allucent, a global contract research organization with extensive experience supporting central nervous system clinical trials, to support the planned Phase 2 clinical trial of Lucid-MS for the treatment of multiple sclerosis (MS).

This strategic partnership represents a significant milestone in Quantum BioPharma's clinical development pipeline and underscores the Company's commitment to advancing a potentially innovative solution for those MS patients suffering from debilitating mobility conditions unlike any solution in the market today.

The planned Phase 2 trial will evaluate the efficacy, safety and tolerability of Lucid-MS in people with MS. Quantum BioPharma expects to initiate the Phase 2 trial in the second quarter of 2026, subject to regulatory approvals and finalization of the clinical trial design and operational arrangements.

Under the terms of the LOI, Allucent will provide comprehensive clinical trial services designed to support efficient execution and data integrity throughout the study:

   
Study Start-UpRegulatory submissions, ethics approvalsAccelerated trial initiation
Site Selection & ManagementGlobal site network coordinationOptimal patient access
Patient RecruitmentEnrollment strategy and executionEfficient trial completion
Data ManagementCollection, analysis, reportingRigorous clinical data integrity
Regulatory SupportAgency interactions, complianceStreamlined development pathway
   

The parties will finalize a more comprehensive and definitive services agreement in the coming weeks, solidifying this strategic partnership.

First-in-Class Potential Therapeutic Innovation for MS

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 treatments primarily focus on modulating the immune system rather than addressing the underlying neurodegeneration.

“Lucid-MS is a First-in-Class, New Chemical Entity, Therapeutic Innovation designed to provide neuroprotection through the inhibition of demyelination, a key driver of disease progression in MS,” said Andrzej Chruscinski, Vice-President, Scientific and Clinical Affairs at Quantum BioPharma. “This innovative mechanism represents a differentiated therapeutic approach in the global MS market where an estimated 2.8 million people suffer and where many existing treatments primarily focus on modulating the immune system rather than addressing the underlying neurodegeneration. This Phase 2 trial will evaluate efficacy, safety and tolerability, while exploring the relationship between this mechanism and established clinical and radiographic markers of disease activity.”

“We are pleased to engage Allucent, a global CRO with extensive experience in Phase 2 and Phase 3 central nervous system trials, including prior MS studies, as we advance our clinical program,” said Zeeshan Saeed, CEO of Quantum BioPharma. “Their therapeutic expertise and global operational capabilities are expected to support the efficient execution of our Phase 2 trial. Our research continues to demonstrate the potential of this novel approach to transform MS patient outcomes.”

Why Allucent: Global CRO Excellence

Allucent is a global, specialty contract research organization designed for small and mid-sized biopharma, delivering integrated clinical, regulatory, and operational expertise across complex programs, including neuroscience. Their proven track record in CNS and MS trials makes them an ideal partner for advancing Lucid-MS through Phase 2.

  
Deep CNS/MS Trial ExperienceDisease-specific expertise
Global Operational FootprintAccess to diverse patient populations
Integrated Strategy & ExecutionEfficient program delivery
Regulatory ExcellenceStreamlined agency interactions
Data Management RigorHigh-quality clinical evidence
  

“We’re proud to partner with Quantum BioPharma in advancing their neuro-degenerative clinical program in multiple sclerosis,” said Paula Brown Stafford, CEO of Allucent. “Our team brings deep experience in CNS and MS trials, along with an integrated model that aligns strategy and execution, helping ensure programs are delivered efficiently and with the rigor these complex studies demand.”

Market Opportunity and Growth Strategy

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.


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

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. Additionally, Quantum BioPharma retains a large tax loss carry forward of approximately C$130 million and could be utilized in the future to offset tax payable obligations against future profits. Quantum BioPharma retains 100% of the rights to develop similar product or alternative formulations specifically for pharmaceutical and medical uses. Quantum BioPharma maintains a portfolio of strategic investments through its wholly owned subsidiary, FSD Strategic Investments Inc., which represents loans secured by residential or commercial property.

About Allucent

Allucent is a global, specialty CRO designed for small and mid-sized biopharma, delivering integrated clinical, regulatory, and operational expertise across complex programs, including neuroscience. Visit www.Allucent.com for more information.

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 “may”, “should”, “anticipate”, “expect”, “potential”, “believe”, “intend” 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 chart accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/a869efcb-3a0d-4fdc-994f-d7a71596a887

FAQ

What did Quantum BioPharma (QNTM) announce regarding its multiple sclerosis drug Lucid-MS?

Quantum BioPharma signed a binding LOI with CRO Allucent to support a planned Phase 2 clinical trial of Lucid-MS in multiple sclerosis. The trial will assess efficacy, safety and tolerability, advancing the company’s neuroprotective candidate targeting demyelination, a key driver of MS progression.

When does Quantum BioPharma (QNTM) expect to start the Phase 2 Lucid-MS trial?

Quantum BioPharma expects to initiate the Phase 2 clinical trial of Lucid-MS in the second quarter of 2026. This timing is subject to regulatory approvals and completion of the final clinical trial design and operational arrangements with Allucent and other stakeholders.

How large is the multiple sclerosis market referenced by Quantum BioPharma (QNTM)?

The company cites that multiple sclerosis affects approximately 2.8 million people worldwide and notes the MS therapeutic market is projected to exceed $38 billion by 2030. This context supports the commercial potential for innovative treatments like Lucid-MS targeting demyelination directly.

What royalty terms does Quantum BioPharma (QNTM) receive from unbuzzd™ sales?

Quantum BioPharma earns a 7% royalty on unbuzzd™ sales until cumulative payments to the company reach $250 million. After that threshold is met, the royalty rate decreases to 3% in perpetuity, providing a long-duration revenue stream linked to product performance.

What ownership stake does Quantum BioPharma (QNTM) hold in Unbuzzd Wellness Inc.?

Quantum BioPharma retains a 19.84% ownership stake in Unbuzzd Wellness Inc. as of December 31, 2025. This equity interest complements its royalty rights and preserves exposure to potential upside from the over-the-counter version of the UNBUZZD™ product.

What tax asset does Quantum BioPharma (QNTM) disclose in this report?

Quantum BioPharma reports a tax loss carry forward of approximately C$130 million. This asset could be used in the future to offset tax payable obligations against future profits, potentially improving net earnings when the company becomes sustainably profitable.

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