Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) Reaches

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Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) Reaches Key Midpoint Milestone in Multiple Sclerosis Imaging Study


Disseminated on behalf of Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) and may include paid advertising.

- Before any new drug or diagnostic technology can be used widely, it must pass through a series of structured studies designed to answer specific questions.

- The milestone highlighted in Quantum BioPharma’s announcement is that patient enrollment in a key pilot study has reached its halfway mark.

- Preliminary analyses show a robust signal in acute MS lesions, along with potential sensitivity to gray matter lesions.

Clinical studies are among the most demanding and consequential undertakings in medicine. They require years of planning, careful patient selection, rigorous data collection and ongoing regulatory oversight, all in pursuit of a single goal — generating reliable evidence that a new drug, device or diagnostic tool is both safe and effective. Without this structured process, promising laboratory discoveries would never make the leap to treatments that physicians can confidently prescribe and patients can trust. Quantum BioPharma (NASDAQ: QNTM) (CSE: QNTM), a biopharmaceutical company focused on neurodegenerative and metabolic disorders, recently announced in its collaborative imaging study with Massachusetts General Hospital (“MGH”) that the study has reached the halfway point in patient enrollment and early imaging results could support development of its multiple sclerosis drug candidate: Lucid-MS.

Studies of this kind sit at the center of how medicine advances. Before any new drug or diagnostic technology can be used widely, it must pass through a series of structured studies designed to answer specific questions: Does the approach work as intended? Is it safe? And can it reliably detect or measure what researchers claim it can? Imaging studies, in particular, often serve a dual purpose. They can validate new diagnostic tools while also generating data that helps assess how well an experimental treatment is performing inside the body.

This is especially important in diseases such as multiple sclerosis, where progression and treatment response have traditionally been difficult to measure with precision. Standard imaging techniques can show overall lesion activity, but they often cannot directly distinguish between damaged myelin with intact underlying nerve fibers and more severe, irreversible nerve damage. A tool capable of making that distinction would give researchers a clearer picture of whether a therapy is genuinely protecting or repairing the nervous system, rather than simply masking symptoms.

That clarity matters not just for individual patients but for the broader drug-development pipeline. Regulatory agencies increasingly look for objective, quantifiable biomarkers that can demonstrate a drug’s biological effect, not just its impact on symptoms. Qualified biomarkers can reduce uncertainty in regulatory decision-making, support more efficient clinical trial design and help identify patient populations most likely to demonstrate treatment effects, potentially reducing study size and duration while providing earlier evidence of drug activity. For smaller biopharmaceutical companies developing novel mechanisms, having access to this kind of precise measurement tool can be a meaningful advantage in both clinical development and conversations with regulators and potential partners.

Quantum BioPharma’s MGH collaboration is built around a novel positron emission tomography (“PET”) imaging technique using the tracer [¹⁸F]3F4AP, developed by Dr. Pedro Brugarolas, an investigator in the radiology department at MGH and assistant professor at Harvard Medical School. The technique is designed to directly assess demyelinated neurons that still have intact axons, offering a more precise way to track demyelination, the process underlying MS, than has previously been available.

Highlighted in the announcement is that patient enrollment in the study has now reached its halfway mark. Reaching the midpoint of enrollment is a meaningful operational step in any clinical study, as it indicates the trial is progressing on schedule and moving closer to having a dataset large enough to draw more confident conclusions.

The second highlight concerns the imaging results themselves. According to the company, the first cohort of participants has been imaged using both advanced PET/MR and total-body PET platforms. Preliminary analyses show a robust signal in acute MS lesions, along with potential sensitivity to gray matter lesions. If these early findings hold up as enrollment continues, the company believes the imaging approach could provide a more direct and quantitative way to measure myelin loss and repair over time.

“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, VP of 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 such as Lucid-MS that aim to protect and restore the myelin sheath in MS.”

Brugarolas stated that being able to directly quantify demyelinated lesions with intact axons in living patients addresses an important gap in MS research. “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,” he said.

The company noted that this imaging platform could play a role in the continued development of Lucid-MS, its investigational compound designed to inhibit demyelination by targeting protein arginine deiminase 2 (“PAD2”), an enzyme implicated in myelin degradation. Lucid-MS previously completed phase 1 clinical trials with a favorable safety profile, and the company submitted an Investigational New Drug (“IND”) application for a phase 2 trial to the U.S. Food and Drug Administration in March 2026.

For a company such as Quantum BioPharma, this type of progress represents more than a procedural checkbox. Multiple sclerosis affects more than 2.8 million people worldwide, and while treatments exist to manage the immune response, no therapy has yet demonstrated the ability to reliably halt or reverse the underlying nerve damage that drives long-term disability. The combination of a novel imaging tool that can directly visualize that damage and a drug candidate designed to address it at the source puts Quantum BioPharma in a distinctive position. Reaching the halfway point in enrollment, with early imaging data already showing meaningful impact, suggests the science is holding up under real-world clinical conditions, and that the path toward a more complete picture of both the disease and the therapy’s potential is coming steadily into view.

For more information, visit www.QuantumBioPharma.com.

NOTE TO INVESTORS: The latest news and updates relating to QNTM are available in the company’s newsroom at https://nnw.fm/QNTM

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