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Quantum BioPharma Announces Very Promising Results from the Massachusetts General Hospital Scientists on the Novel Positron Emission Tomography (PET) Tracer Used to Detect and Monitor Demyelination in Multiple Sclerosis Patients

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Quantum BioPharma (NASDAQ: QNTM) announced promising results from Massachusetts General Hospital (MGH) scientists regarding a novel PET tracer [18F]3F4AP for detecting and monitoring demyelination in Multiple Sclerosis (MS) patients. The study, published in the European Journal of Nuclear Medicine and Molecular Imaging, demonstrated the tracer's ability to detect differences across MS lesions not visible through conventional MRI.

Led by Drs. Pedro Brugarolas and Eric Klawiter at MGH and funded by NIH, the research revealed the tracer's excellent properties for brain imaging. This breakthrough could be particularly significant for monitoring the effectiveness of Quantum's investigational MS drug, Lucid-21-302, in protecting the myelin sheath in MS patients.

Quantum BioPharma (NASDAQ: QNTM) ha annunciato risultati promettenti ottenuti da scienziati del Massachusetts General Hospital (MGH) riguardo a un nuovo tracciante PET, [18F]3F4AP, per rilevare e monitorare la demielinizzazione nei pazienti con sclerosi multipla (SM). Lo studio, pubblicato sull'European Journal of Nuclear Medicine and Molecular Imaging, ha dimostrato la capacità del tracciante di individuare differenze nelle lesioni della SM non visibili con la risonanza magnetica convenzionale.

Guidata dai dottori Pedro Brugarolas ed Eric Klawiter al MGH e finanziata dal NIH, la ricerca ha evidenziato le eccellenti proprietà del tracciante per l'imaging cerebrale. Questa scoperta potrebbe essere particolarmente rilevante per monitorare l'efficacia del farmaco sperimentale di Quantum per la SM, Lucid-21-302, nel proteggere la guaina mielinica nei pazienti affetti da SM.

Quantum BioPharma (NASDAQ: QNTM) anunció resultados prometedores obtenidos por científicos del Massachusetts General Hospital (MGH) sobre un nuevo trazador PET [18F]3F4AP para detectar y monitorear la desmielinización en pacientes con esclerosis múltiple (EM). El estudio, publicado en el European Journal of Nuclear Medicine and Molecular Imaging, demostró la capacidad del trazador para detectar diferencias en las lesiones de EM que no son visibles mediante resonancia magnética convencional.

Dirigida por los doctores Pedro Brugarolas y Eric Klawiter en MGH y financiada por el NIH, la investigación reveló las excelentes propiedades del trazador para la imagen cerebral. Este avance podría ser especialmente significativo para monitorear la efectividad del medicamento experimental de Quantum para EM, Lucid-21-302, en la protección de la vaina de mielina en pacientes con EM.

Quantum BioPharma (NASDAQ: QNTM)는 매사추세츠 종합병원(MGH) 과학자들이 개발한 새로운 PET 추적자 [18F]3F4AP가 다발성 경화증(MS) 환자의 탈수초화를 감지하고 모니터링하는 데 유망한 결과를 발표했습니다. 유럽 핵의학 및 분자 영상 저널(European Journal of Nuclear Medicine and Molecular Imaging)에 게재된 이 연구는 기존 MRI로는 보이지 않는 MS 병변 간의 차이를 추적자가 감지할 수 있음을 보여주었습니다.

MGH의 Pedro Brugarolas 박사와 Eric Klawiter 박사가 주도하고 NIH가 자금을 지원한 이 연구는 뇌 영상에 적합한 뛰어난 추적자 특성을 밝혀냈습니다. 이 돌파구는 Quantum의 실험적 MS 약물 Lucid-21-302가 MS 환자의 미엘린 수초를 보호하는 효과를 모니터링하는 데 특히 중요할 수 있습니다.

Quantum BioPharma (NASDAQ : QNTM) a annoncé des résultats prometteurs obtenus par des chercheurs du Massachusetts General Hospital (MGH) concernant un nouveau traceur TEP [18F]3F4AP destiné à détecter et surveiller la démyélinisation chez les patients atteints de sclérose en plaques (SEP). L'étude, publiée dans l'European Journal of Nuclear Medicine and Molecular Imaging, a démontré la capacité du traceur à détecter des différences au sein des lésions SEP non visibles par IRM conventionnelle.

Dirigée par les Drs Pedro Brugarolas et Eric Klawiter au MGH et financée par le NIH, la recherche a révélé d'excellentes propriétés du traceur pour l'imagerie cérébrale. Cette avancée pourrait être particulièrement importante pour le suivi de l'efficacité du médicament expérimental de Quantum pour la SEP, Lucid-21-302, dans la protection de la gaine de myéline chez les patients.

Quantum BioPharma (NASDAQ: QNTM) gab vielversprechende Ergebnisse von Wissenschaftlern des Massachusetts General Hospital (MGH) bezüglich eines neuartigen PET-Tracers [18F]3F4AP zur Erkennung und Überwachung der Demyelinisierung bei Multiple-Sklerose-(MS-)Patienten bekannt. Die Studie, veröffentlicht im European Journal of Nuclear Medicine and Molecular Imaging, zeigte die Fähigkeit des Tracers, Unterschiede in MS-Läsionen zu erkennen, die mit herkömmlicher MRT nicht sichtbar sind.

Die Forschung, geleitet von Dr. Pedro Brugarolas und Dr. Eric Klawiter am MGH und finanziert durch das NIH, offenbarte die hervorragenden Eigenschaften des Tracers für die Gehirnbildgebung. Dieser Durchbruch könnte besonders bedeutsam sein, um die Wirksamkeit des experimentellen MS-Medikaments von Quantum, Lucid-21-302, beim Schutz der Myelinscheide bei MS-Patienten zu überwachen.

Positive
  • PET tracer successfully detected MS lesions not visible through conventional MRI
  • Potential biomarker for monitoring effectiveness of Quantum's MS drug Lucid-21-302
  • Study validation from prestigious Massachusetts General Hospital scientists
  • NIH funding support demonstrates scientific credibility
Negative
  • Drug Lucid-21-302 is still in investigational phase
  • Further evaluation of imaging agent still needed

Insights

Promising PET tracer detects MS lesions invisible to MRI, potentially accelerating development of Quantum's MS drug by providing precise myelin measurement.

This published research on the [18F]3F4AP PET tracer represents a significant advancement in multiple sclerosis monitoring capabilities. Unlike conventional MRI, which has limitations in assessing myelin integrity, this tracer can detect previously invisible lesion differences - a critical capability in a disease characterized by demyelination. The study's credibility is substantial, coming from Massachusetts General Hospital researchers, published in a peer-reviewed journal, and funded by the NIH.

What makes this particularly valuable for Quantum BioPharma is the tracer's potential as a biomarker to measure the effectiveness of their investigational compound Lucid-21-302. In MS drug development, demonstrating neuroprotective effects has been historically challenging due to limitations in imaging technology. This PET tracer could provide objective evidence of myelin protection or repair – exactly what would be needed to demonstrate Lucid-21-302's efficacy.

The ongoing collaboration between Quantum and MGH suggests a strategic approach to creating an integrated therapeutic-diagnostic package. If successfully implemented, this could accelerate clinical trials by providing more sensitive endpoints and potentially reduce the time and cost of bringing Lucid-21-302 to market. For MS patients, this represents progress toward treatments with measurable neuroprotective effects rather than just symptom management or broad immunomodulation.

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

TORONTO, Aug. 08, 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 Positron Emission Tomography (PET) tracer used in a joint study with Massachusetts General Hospital (MGH) scientists shows the ability to capture differences across lesions in multiple sclerosis (MS) patients, which may prove highly useful for monitoring myelin integrity and demyelination in MS.

A leading study by Drs. Pedro Brugarolas and Eric Klawiter of MGH, published in the European Journal of Nuclear Medicine and Molecular Imaging on August 5, 2025 (link to paper: https://link.springer.com/article/10.1007/s00259-025-07454-1), and funded by the National Institutes of Health (NIH), evaluated the PET tracer [18F]3F4AP in healthy controls and in people with MS. This tracer was developed by Dr. Pedro Brugarolas, an investigator in the Department of Radiology at MGH and Assistant Professor at Harvard Medical School.

In this study, [18F]3F4AP was found to have excellent properties for imaging the human brain and, critically and importantly, was able to detect differences across lesions not visible by conventional MRI. These findings suggest that the tracer holds significant promise and potential as a key biomarker to monitor changes in demyelination in MS, and, importantly, myelin changes in response to Quantum Biopharma’s investigational and potentially breakthrough neuroprotective drug, Lucid-21-302.

“The published study shows that the PET tracer is highly promising as a biomarker to detect and monitor lesions in people with MS,” said Dr. Andrzej Chruscinski, Vice-President, Scientific and Clinical Affairs at Quantum Biopharma. “The ongoing collaborative study with MGH seeks to further evaluate the imaging agent and its potential to demonstrate the effectiveness of drugs, such as Lucid-21-302 (Lucid-MS) that can protect the myelin sheath in 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, Celly Nutrition Corp. (“Celly Nutrition”), now Unbuzzd Wellness Inc., led by industry veterans. Quantum BioPharma retains ownership of 20.10% (as of June 30, 2025) of Unbuzzd Wellness Inc. at www.unbuzzd.com. 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 visit www.quantumbiopharma.com.

Forward Looking Information

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 are the key findings of QNTM's PET tracer study for Multiple Sclerosis?

The PET tracer [18F]3F4AP demonstrated excellent brain imaging properties and successfully detected MS lesions not visible through conventional MRI, showing potential as a biomarker for monitoring myelin changes.

Who conducted the research for Quantum BioPharma's MS imaging study?

The study was led by Drs. Pedro Brugarolas and Eric Klawiter at Massachusetts General Hospital, with Dr. Brugarolas being an investigator in the Department of Radiology at MGH and Assistant Professor at Harvard Medical School.

How could the PET tracer benefit Quantum BioPharma's MS drug development?

The PET tracer could serve as a key biomarker to monitor the effectiveness of Quantum's investigational drug Lucid-21-302 in protecting the myelin sheath in MS patients.

When was the QNTM Multiple Sclerosis study published?

The study was published in the European Journal of Nuclear Medicine and Molecular Imaging on August 5, 2025.

Who funded Quantum BioPharma's MS imaging research?

The study was funded by the National Institutes of Health (NIH).
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