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Quantum BioPharma Announces First Person with Multiple Sclerosis (MS) Scanned in Joint Study with Massachusetts General Hospital

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Quantum BioPharma (NASDAQ: QNTM) has announced the first successful scan of a multiple sclerosis (MS) patient in a joint study with Massachusetts General Hospital (MGH). The study utilizes a novel PET tracer [18F]3F4AP to monitor myelin integrity and demyelination in MS patients. The scanning was performed using a new GE Signa PET-MR scanner, which allows simultaneous PET and MRI imaging, improving spatial and temporal coregistration while reducing patient scan time. This imaging technique could potentially serve as a biomarker to measure the effectiveness of drugs like Quantum's investigational MS drug Lucid-21-302. The PET tracer, developed by Dr. Pedro Brugarolas at MGH, has shown promising results in previous animal and human studies, demonstrating high sensitivity to demyelinated lesions and favorable pharmacokinetics.
Quantum BioPharma (NASDAQ: QNTM) ha annunciato la prima scansione riuscita di un paziente con sclerosi multipla (SM) in uno studio congiunto con il Massachusetts General Hospital (MGH). Lo studio utilizza un nuovo tracciante PET [18F]3F4AP per monitorare l'integrità della mielina e la demielinizzazione nei pazienti con SM. La scansione è stata eseguita con un nuovo scanner GE Signa PET-MR, che consente immagini PET e MRI simultanee, migliorando la coregistrazione spaziale e temporale e riducendo il tempo di scansione per il paziente. Questa tecnica di imaging potrebbe diventare un biomarcatore per misurare l'efficacia di farmaci come Lucid-21-302, il farmaco sperimentale per la SM di Quantum. Il tracciante PET, sviluppato dal Dr. Pedro Brugarolas al MGH, ha mostrato risultati promettenti in studi precedenti su animali e umani, dimostrando elevata sensibilità alle lesioni demielinizzate e farmacocinetica favorevole.
Quantum BioPharma (NASDAQ: QNTM) ha anunciado el primer escaneo exitoso de un paciente con esclerosis múltiple (EM) en un estudio conjunto con el Massachusetts General Hospital (MGH). El estudio utiliza un nuevo trazador PET [18F]3F4AP para monitorear la integridad de la mielina y la desmielinización en pacientes con EM. El escaneo se realizó con un nuevo escáner GE Signa PET-MR, que permite imágenes simultáneas de PET y MRI, mejorando la corrección espacial y temporal y reduciendo el tiempo de escaneo para el paciente. Esta técnica de imagen podría servir como un biomarcador para medir la efectividad de medicamentos como Lucid-21-302, el fármaco experimental para EM de Quantum. El trazador PET, desarrollado por el Dr. Pedro Brugarolas en MGH, ha mostrado resultados prometedores en estudios previos en animales y humanos, demostrando alta sensibilidad a las lesiones desmielinizantes y farmacocinética favorable.
Quantum BioPharma(NASDAQ: QNTM)는 매사추세츠 종합병원(MGH)과 공동 연구에서 다발성 경화증(MS) 환자에 대한 최초의 성공적인 스캔을 발표했습니다. 이 연구는 새로운 PET 트레이서 [18F]3F4AP를 사용하여 MS 환자의 미엘린 무결성과 탈수초 현상을 모니터링합니다. 스캔은 새로운 GE Signa PET-MR 스캐너를 사용하여 PET와 MRI 이미지를 동시에 촬영함으로써 공간적 및 시간적 정합성을 향상시키고 환자의 스캔 시간을 단축했습니다. 이 영상 기술은 Quantum의 실험적 MS 약물인 Lucid-21-302와 같은 약물의 효과를 측정하는 바이오마커로 활용될 가능성이 있습니다. PET 트레이서는 MGH의 Pedro Brugarolas 박사가 개발했으며, 이전 동물 및 인간 연구에서 탈수초 병변에 높은 민감도와 우수한 약동학적 특성을 보여주었습니다.
Quantum BioPharma (NASDAQ : QNTM) a annoncé la première analyse réussie d’un patient atteint de sclérose en plaques (SEP) dans une étude conjointe avec le Massachusetts General Hospital (MGH). L’étude utilise un nouveau traceur PET [18F]3F4AP pour surveiller l’intégrité de la myéline et la démyélinisation chez les patients SEP. L’analyse a été réalisée avec un nouvel appareil GE Signa PET-MR, permettant une imagerie PET et IRM simultanée, améliorant la corrélation spatiale et temporelle tout en réduisant le temps de scan pour le patient. Cette technique d’imagerie pourrait potentiellement servir de biomarqueur pour mesurer l’efficacité de médicaments tels que Lucid-21-302, le médicament expérimental contre la SEP développé par Quantum. Le traceur PET, développé par le Dr Pedro Brugarolas au MGH, a montré des résultats prometteurs lors d’études précédentes sur animaux et humains, démontrant une grande sensibilité aux lésions démyélinisées et une pharmacocinétique favorable.
Quantum BioPharma (NASDAQ: QNTM) hat die erste erfolgreiche Untersuchung eines Multiple-Sklerose-(MS)-Patienten im Rahmen einer gemeinsamen Studie mit dem Massachusetts General Hospital (MGH) bekanntgegeben. Die Studie verwendet einen neuartigen PET-Tracer [18F]3F4AP, um die Myelinintegrität und Demyelinisierung bei MS-Patienten zu überwachen. Die Untersuchung wurde mit einem neuen GE Signa PET-MR-Scanner durchgeführt, der simultane PET- und MRT-Bildgebung ermöglicht, wodurch die räumliche und zeitliche Registrierung verbessert und die Untersuchungszeit für Patienten verkürzt wird. Diese Bildgebungstechnik könnte als Biomarker dienen, um die Wirksamkeit von Medikamenten wie Quantum's experimentellem MS-Medikament Lucid-21-302 zu messen. Der PET-Tracer, entwickelt von Dr. Pedro Brugarolas am MGH, zeigte in früheren Tier- und Humanstudien vielversprechende Ergebnisse mit hoher Sensitivität für demyelinisierte Läsionen und günstiger Pharmakokinetik.
Positive
  • Novel PET imaging technique shows promise in monitoring MS treatment effectiveness
  • Partnership with prestigious Massachusetts General Hospital strengthens research credibility
  • Technology could potentially accelerate development and validation of company's MS drug Lucid-21-302
  • Previous studies of [18F]3F4AP showed favorable results in both animals and humans
Negative
  • Study is still in early stages with only first patient scanned
  • No direct evidence yet of technology's effectiveness in measuring drug responses
  • Uncertain timeline for validation and implementation of the imaging technique

Insights

Quantum's MS imaging study with MGH could improve efficacy testing for their investigational drug Lucid-21-302 through enhanced demyelination monitoring.

Quantum BioPharma has reached a significant milestone in its joint clinical study with Massachusetts General Hospital (MGH) by completing the first PET scan of a multiple sclerosis patient using the novel tracer [18F]3F4AP. This advancement is particularly meaningful as it potentially establishes a critical biomarker pathway for the company's investigational MS drug Lucid-21-302 (Lucid-MS).

The study utilizes MGH's newly installed combined GE Signa PET-MR scanner, which allows simultaneous PET and MRI imaging. This technology represents a significant improvement over traditional sequential scanning by enhancing spatial and temporal coregistration while reducing patient scan time. Previous studies have already shown that the [18F]3F4AP tracer demonstrates high sensitivity to demyelinated lesions with favorable pharmacokinetics.

The real value proposition here is the potential creation of a more precise methodology for measuring drug efficacy in MS treatments. Current MS drug development faces significant challenges in accurately quantifying remyelination or neuroprotection. If validated, this imaging technique would provide Quantum with a competitive advantage in demonstrating the efficacy of Lucid-21-302 through objective, measurable outcomes rather than relying solely on clinical symptoms or conventional MRI techniques that have limitations in detecting repair.

While this represents an early-stage development, the collaboration with MGH and Dr. Brugarolas (Harvard Medical School) adds significant credibility to Quantum's research approach. The successful implementation of this imaging biomarker could potentially accelerate the clinical development timeline for Lucid-21-302 by providing earlier signals of efficacy and more precise endpoints for clinical trials.

Joint Clinical Study with Massachusetts General Hospital Could Pave the Way for Testing Efficacy of Quantum’s Investigational MS drug, Lucid-21-302

TORONTO, June 17, 2025 (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, announces that the first person with multiple sclerosis (MS) has been scanned in a joint study with Massachusetts General Hospital (MGH) scientists to validate a novel positron emission tomography (PET) imaging technique to monitor myelin integrity and demyelination in MS. The study is evaluating the PET tracer [18F]3F4AP, which was developed by Dr. Pedro Brugarolas, an investigator in the department of Radiology at MGH and Assistant Professor at Harvard Medical School. In previous studies in animals and humans, [18F]3F4AP was found to be highly sensitive to demyelinated lesions and have favourable pharmacokinetics, suggesting that it holds promise as a biomarker to monitor changes in demyelination in response to remyelinating or neuroprotective drugs in MS.

The PET scan in the person with MS was performed on a newly installed combined GE Signa PET-MR scanner at MGH. This scanner allows for the PET [18F]3F4AP imaging signal to be acquired simultaneously with the MRI improving the spatial and temporal coregistration of the PET. In the future, this technique may be highly useful for monitoring, over time, demyelination in central nervous system lesions. This novel biomarker and technique may lead to a more accurate measurement of responses to drugs that prevent demyelination and/or promote remyelination. The new combined PET-MR scanner at MGH also improves the patient experience by reducing the time needed to complete both scans.

“We are excited that the study has started and that we are learning more about the potential of this novel PET biomarker to directly visualize and measure demyelinated axons in the central nervous system,” said Dr. Andrzej Chruscinski, Vice-President, Scientific and Clinical Affairs at Quantum Biopharma. “PET imaging with [18F]3F4AP holds promise as a biomarker to measure the efficacy of drugs that can protect the myelin sheath in MS such as Lucid-21-302 (Lucid-MS).”

Dr. Brugarolas, principal investigator of the study at MGH added, “PET/MR studies are complex and the team at the MGH PET Core has been phenomenal. By employing the latest technologies, we hope to learn more about how [18F]3F4AP PET can enhance MRI for monitoring demyelination and, by doing so, facilitate the development of novel treatments for people with MS.”

About Quantum BioPharma Ltd.

Quantum BioPharma (NASDAQ: QNTM) 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. (formerly Celly Nutrition Corp.), led by industry veterans. Quantum BioPharma retains ownership of 20.11% (as of March 31, 2025) of Unbuzzd Wellness Inc. The agreement with Unbuzzd Wellness Inc. 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 products 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.

For more information on Quantum BioPharma, please visit www.quantumbiopharma.com.

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. Forward-looking statements in this news release include statements related to such.

Forward-looking information in this press release are based on certain assumptions and expected future events.

These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to additional information relating to Quantum BioPharma, including its annual information form, can be located on the SEDAR+ website at www.sedarplus.ca and on the EDGAR section of the United States Securities and Exchange Commission’s website at www.sec.gov for a more complete discussion of such risk factors and their potential effects.

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: (833) 571-1811

Investor Relations
Investor Relations: IR@QuantumBioPharma.com
General Inquiries: info@QuantumBioPharma.com


FAQ

What is the purpose of Quantum BioPharma's (QNTM) joint study with Massachusetts General Hospital?

The study aims to validate a novel PET imaging technique using [18F]3F4AP tracer to monitor myelin integrity and demyelination in multiple sclerosis patients, potentially helping measure the effectiveness of MS treatments.

How does the new GE Signa PET-MR scanner benefit MS patients in the QNTM study?

The scanner allows simultaneous PET and MRI imaging, improving spatial and temporal coregistration while reducing the total time patients need to complete both scans.

What are the previous research findings for Quantum BioPharma's PET tracer [18F]3F4AP?

In previous animal and human studies, the tracer demonstrated high sensitivity to demyelinated lesions and favorable pharmacokinetics, suggesting potential as a biomarker for monitoring MS treatment responses.

How could this imaging technology impact Quantum BioPharma's (QNTM) MS drug development?

The technology could serve as a biomarker to measure the efficacy of drugs like Quantum's investigational MS drug Lucid-21-302, potentially improving the development and validation process.

Who is leading the QNTM-MGH joint study on MS imaging?

The study's principal investigator is Dr. Pedro Brugarolas, an investigator in MGH's Radiology department and Assistant Professor at Harvard Medical School.
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