Quantum Biopharma Ltd【QNTM】株式ニュース

Quantum BioPharma Reaches Key Midpoint Milestone in Groundbreaking Imaging Study with Massachusetts General Hospital

May 18, 2026

Quantum BioPharma (NASDAQ: QNTM) reported a key midpoint milestone in its collaborative PET imaging study with Massachusetts General Hospital, with patient enrollment at 50% and encouraging preliminary imaging data.

The study uses novel tracer [¹8F]3F4AP to quantify demyelination in multiple sclerosis and support development of Quantum’s investigational therapy Lucid-MS, which showed favorable Phase 1 safety and preclinical myelin-protective effects. An IND for a Phase 2 trial was submitted to the FDA in March 2026.

Positive
• Patient enrollment at midpoint in MGH collaborative PET imaging study
• Preliminary PET data show robust signal in acute MS lesions
• [¹8F]3F4AP previously showed high sensitivity to demyelinated lesions
• Lucid-MS demonstrated favorable safety and tolerability in Phase 1 trials
• Lucid-MS preclinical models showed prevention and reversal of myelin breakdown
• IND for Lucid-MS Phase 2 trial submitted to FDA in March 2026

Negative
None

Promising Early Data Strengthens Potential of Novel PET Technology to Advance Development of Lucid-MS for Multiple Sclerosis

TORONTO, May 18, 2026 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (“Quantum” or the “Company”), a biopharmaceutical company focused on advancing innovative therapies and technologies, today announced a significant milestone in its collaborative study with Massachusetts General Hospital (MGH): patient enrollment has reached the halfway mark, accompanied by encouraging preliminary imaging results. This pioneering study is designed to validate a novel positron emission tomography (PET) imaging technique capable of directly assessing demyelinated neurons with intact axons and tracking demyelination in patients with multiple sclerosis (MS)—a critical step toward transforming how disease progression and treatment response are measured.

At the center of this effort is the PET tracer [¹8F]3F4AP, developed by Pedro Brugarolas, an investigator in the Department of Radiology at MGH and Assistant Professor at Harvard Medical School. In prior preclinical and clinical studies, [¹8F]3F4AP demonstrated high sensitivity for detecting demyelinated lesions along with favorable pharmacokinetics, positioning it as a promising biomarker for monitoring myelin damage and repair.

Importantly, early data from the ongoing study reinforce this potential. The first cohort of participants has been successfully imaged using both advanced PET/MR and total-body PET platforms. Preliminary analyses indicate robust signal in acute MS lesions and potential sensitivity to gray matter lesions.

If validated, this imaging approach could represent a major advancement in MS research and drug development—enabling more precise, real-time measurement of how therapies impact myelin preservation and regeneration. Such capabilities may significantly enhance the evaluation of next-generation treatments, including Quantum’s investigational candidate, Lucid-MS (Lucid-21-302).

“We are excited to reach this important midpoint in our study with MGH and encouraged by the strength of the preliminary imaging data,” said Dr. Andrzej Chruscinski, Vice-President, Scientific and Clinical Affairs at Quantum BioPharma. “PET imaging with [¹8F]3F4AP has the potential to fundamentally change how we assess demyelination—providing a direct window into axonal health and enabling us to more clearly demonstrate the impact of therapies like Lucid-MS that aim to protect and restore the myelin sheath in MS.”

“From a scientific perspective, the ability to directly quantify demyelinated lesions with intact axons in vivo represents an important unmet need in multiple sclerosis research,” said Dr. Pedro Brugarolas of Massachusetts General Hospital. “If further validated, this imaging approach could provide a more direct and quantitative measure of myelin loss and repair, which may help improve the evaluation of disease mechanisms and therapeutic response in MS.”

Looking ahead, the Company believes that this novel biomarker platform could play a pivotal role in accelerating the development of effective treatments for MS such as Lucid-MS by delivering more accurate and actionable insights into disease activity over time.

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 most existing therapies focus primarily on modulating the immune response rather than addressing the underlying neurodegeneration. By targeting protein arginine deiminase 2 (PAD2), a key enzyme implicated in myelin degradation, Lucid-MS has demonstrated in preclinical models the ability to prevent and reverse myelin breakdown—offering the potential for a truly disease-modifying therapy in an indication with limited options.

The Phase 2 clinical 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. The successful completion of Phase 1 supports advancement into this next pivotal study, which is designed to generate meaningful clinical data across both clinical and radiological endpoints. The IND submission for Phase 2 approval has been submitted to the FDA in March 2026.

About Quantum BioPharma Ltd.
Quantum 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 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 invented UNBUZZD™ and spun out its OTC version to a company, Unbuzzd Wellness Inc. (“Unbuzzd”) (formerly, Celly Nutrition Corp.), led by industry veterans. Quantum retains ownership of 19.84% (as of March 31, 2026) of Unbuzzd at www.unbuzzd.com. The agreement with Unbuzzd also includes royalty payments of 7% of sales from unbuzzd™ until payments to Quantum total $250 million. Once $250 million is reached, the royalty drops to 3% in perpetuity. Quantum retains 100% of the rights to develop similar products or alternative formulations specifically for pharmaceutical and medical uses.

Forward Looking Information
This news release contains “forward-looking information” and “forward-looking statements” within the meaning of applicable Canadian and United States securities laws (collectively, “forward-looking statements”). Forward-looking statements in this release include, but are not limited to, statements regarding: the continued advancement and completion of the collaborative imaging study with Massachusetts General Hospital (“MGH”); the potential validation and future utility of the [¹8F]3F4AP PET imaging technique; the ability of the imaging platform to assess demyelination, myelin integrity and treatment response in multiple sclerosis (“MS”); the potential application of the imaging technology in future clinical trials and drug development programs; the therapeutic potential, efficacy, safety, and development of Lucid-MS (Lucid-21-302); the anticipated initiation, timing, design, regulatory progress, and outcomes of the Company’s planned Phase 2 clinical trial; the review of the Company’s IND submission by the U.S. Food and Drug Administration (“FDA”); and the potential for Lucid-MS to become a disease-modifying therapy for MS.

Forward-looking statements are frequently identified by words such as “expects”, “anticipates”, “believes”, “intends”, “plans”, “may”, “will”, “could”, “potential”, “continue”, “aims”, “designed”, and similar expressions intended to identify forward-looking statements.

These forward-looking statements are based on management’s current expectations, assumptions, and beliefs, including assumptions relating to: the continued progression of the MGH imaging study; the reproducibility and clinical relevance of preliminary imaging data; the ability of the Company to continue advancing Lucid-MS through clinical development; the availability of funding and resources; favorable regulatory interactions and approvals; and the continued advancement of scientific and clinical research relating to MS and demyelinating diseases.

Forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results, performance, or achievements to differ materially from those expressed or implied herein. Such risks and uncertainties include, among others: the possibility that preliminary imaging results may not be replicated in larger patient populations; risks associated with clinical trial enrollment, timing, delays, costs, or outcomes; uncertainty regarding regulatory approvals, including FDA review of the IND submission; scientific and technological uncertainties; changes in market conditions or competitive developments; the Company’s ability to obtain additional financing; and risks relating to the biotechnology and pharmaceutical industries generally.

Readers are cautioned not to place undue reliance on forward-looking statements, as actual results may differ materially from those expressed or implied by such statements. Although the Company believes that the assumptions and expectations reflected in the forward-looking statements are reasonable as of the date of this news release, no assurance can be given that such assumptions or expectations will prove to be correct.

The forward-looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement and are made as of the date hereof. The Company undertakes no obligation to update or revise any forward-looking statements contained herein, whether as a result of new information, future events or otherwise, except as required by applicable securities laws.

Contacts:
Quantum BioPharma Ltd.
Zeeshan Saeed, Founder, CEO and Executive Co-Chairman of the Board
Email: Zsaeed@quantumbiopharma.com
Telephone: (833) 571-1811

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Quantum BioPharma Announces Peer-Reviewed Journal Publication of Groundbreaking Clinical Trial With Unbuzzd

March 23, 2026

Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (“Quantum BioPharma” or the “Company”), "Company"), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions, announced the peer-reviewed publication of the double-blind, randomized, placebo-controlled crossover design clinical trial (NCT06505239) of its dietary supplement product, ‘unbuzzd’, comprising of a proprietary blend of vitamins and supplements developed by a world-class team of scientists at Quantum BioPharma. The trial, which investigated the effects of unbuzzd on alcohol intoxication and alcohol metabolism, was published here in the World Journal of Pharmaceutical and Medical Research (2026, volume 12, issue 3, pages 446-467).

The publication can be viewed by clicking the following link: https://zenodo.org/records/18873638

The clinical trial, designed to mirror real-life situations where people would consume unbuzzd after reaching an alcohol inebriated state included healthy male and female study participants between the ages of 21 and 43, with weights ranging from 119 to 232 pounds. Participants first drank measured quantities of alcohol to achieve a Blood Alcohol Concentration (“BAC”) between 0.07% and 0.11% followed by ingestion of either unbuzzd or placebo. BAC was then further monitored as well as vital signs and symptoms of intoxication. unbuzzd accelerated the rate at which BAC was reduced in participants, while simultaneously reducing the symptoms of intoxication, impairment and hangover. These results were statistically significant compared to placebo.

Key findings from the clinical trial include:

• Accelerated Alcohol Metabolism: unbuzzd dramatically and rapidly reduced blood alcohol concentration in study participants. The rate at which BAC was lowered was on average for most participants more than 40 percent faster within the first 30 minutes of consuming unbuzzd compared to when participants consumed placebo.

• The faster reduction of BAC after consuming unbuzzd was statistically significant compared to the placebo and was observed in both males and females as shown in the figure below from the publication (note: FSD-F2R6 is the scientific name of the unbuzzd formulation). The continued acceleration of alcohol metabolism was also seen at subsequent BAC measurements over a four-hour period.

• Rapid Improvements in Alertness: Study participants reported statistically significant improvement in alertness as soon as 30 minutes after consuming unbuzzd. Participants felt more alert making fewer cognitive errors within 30 minutes of consuming unbuzzd, significantly outperforming placebo results.

• Rapid Improvements in Physiologic Changes due to Intoxication: unbuzzd lessened the elevation in heart rate and the drop in blood pressure that often accompanies alcohol intoxication, stabilizing both. This result was noted as statistically significant.

• Reduced Perceived Impairment and Mental Fatigue: unbuzzd helped alleviate perceived impairment and mental fatigue caused by alcohol intoxication.

• Hangover Relief: Participants in this study noted a statistically significant reduction in hangover symptoms. This included reduced cognitive and physical impairment, and reduced headache compared to placebo results, at both four hours (67 percent reduction in headache severity) and eight hours after consuming unbuzzd.

• No Side Effects: unbuzzd was well-tolerated by all study participants, with no reported adverse side effects.

“The unbuzzd clinical trial has now been published in a peer-reviewed international journal, and the trial confirms the exceptional overall efficacy of unbuzzd to help reduce the acute effects of alcohol intoxication and hangover, all without causing adverse side effects,” said Dr. Andrzej Chruscinski, Vice President of Clinical and Scientific Affairs at Quantum Biopharma. “We are thrilled to report this outcome.”

Anthony Durkacz, Founder and Executive Co-Chairman of Quantum BioPharma added, “The science and medical communities for centuries have believed there is no way to significantly speed up alcohol metabolism once it is in your bloodstream; your liver processes it at a largely constant rate of approximately one standard drink per hour, and that the only sobering agent is time. This publication validates unbuzzd as a responsible aid to reduce BAC, alleviate signs of alcohol intoxication, and assists with the dreaded hangover. Consumers can use unbuzzd knowing there is a peer-reviewed scientific publication with clinical trial evidence of the product’s efficacy.”

The formula for unbuzzd is licensed to Unbuzzd Wellness Inc. and is currently available at www.unbuzzd.com and www.amazon.com. unbuzzd is a registered trademark of Unbuzzd Wellness Inc.

Individual results may vary. unbuzzd is a dietary supplement. Consuming unbuzzd after alcohol ingestion does not permit you to operate a vehicle. Drink responsibly. DO NOT DRINK AND DRIVE.

About Unbuzzd Wellness Inc.
Unbuzzd Wellness inc., a non-trading but fully reporting public issuer, stands as a pioneering force in the wellness and recovery supplement landscape. unbuzzd has been developed by a world-class R&D team in pharmacology and medicine, with a commitment to innovation and quality. A proprietary blend of vitamins, minerals, and herbs, unbuzzd helps your body process alcohol faster, restore mental alertness, and improve cognition so you can drink responsibly and drink refreshingly. unbuzzd appeals to a broad target audience of alcohol consumers who want to have a good time, be in control, and still feel great the next day.

unbuzzd ready-to-mix powder sticks are available in 3-pack, 8-pack, and 18-pack formats at https://unbuzzd.com.

Individual results may vary. unbuzzd is a dietary supplement. Consuming unbuzzd after alcohol ingestion does not permit you to operate a vehicle. Drink responsibly. DO NOT DRINK AND DRIVE.

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 19.86% (as of September 30, 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.

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

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