Quantum BioPharma announces agreement to prepare IND application for Lucid-21-302, aimed at treating multiple sclerosis.
Quiver AI Summary
Quantum BioPharma Ltd. has announced an agreement with a global pharmaceutical contract research organization to prepare an Investigational New Drug (IND) application package for Lucid-21-302 (Lucid-MS) aimed at treating multiple sclerosis (MS). This IND application is a critical step toward initiating a Phase 2 clinical trial for Lucid-MS, a patented neuroprotective compound designed to prevent demyelination, which contributes to MS and other neurodegenerative diseases. CEO Zeeshan Saeed expressed optimism about this agreement, targeting submission to the US FDA in Q4 2025. Quantum BioPharma is focused on innovative treatments for neurodegenerative disorders and maintains a portfolio that includes strategic investments and its subsidiary, Lucid Psycheceuticals Inc.
Potential Positives
- Quantum BioPharma signed an agreement with a global pharmaceutical contract research organization to prepare an IND application for Lucid-21-302, moving closer to initiating a Phase 2 trial for multiple sclerosis treatment.
- Lucid-21-302 is a first-in-class, neuroprotective compound with a unique mechanism of action, which may provide a novel treatment option for multiple sclerosis.
- The successful IND application could significantly advance Quantum BioPharma's pipeline and enhance its position in the biopharmaceutical market focused on neurodegenerative diseases.
- Quantum BioPharma retains ownership of a substantial stake (20.11%) in Celly Nutrition and will receive substantial royalty payments, indicating strong potential for revenue growth from its innovative products.
Potential Negatives
- Despite the positive tone of the announcement, the press release heavily emphasizes the uncertainties and risks associated with the forward-looking statements regarding the IND application and the Phase 2 trial, which could indicate potential challenges ahead.
- The company is still in the preclinical phase and has not yet initiated the Phase 2 trial, which may cast doubt on the timeline and feasibility of its drug development plans.
- The reliance on royalties from Celly Nutrition for future revenue could signify a lack of diversified income streams, limiting financial stability until the product reaches significant sales thresholds.
FAQ
What is Lucid-21-302?
Lucid-21-302, also known as Lucid-MS, is a first-in-class, non-immunomodulatory neuroprotective compound for treating multiple sclerosis.
What is the purpose of the IND application?
The IND application is necessary to initiate a Phase 2 trial of Lucid-21-302 with the US FDA.
When does Quantum BioPharma expect to submit the IND?
Quantum BioPharma aims to submit the IND application to the FDA in Q4 2025.
What makes Lucid-MS unique?
Lucid-MS has a unique mechanism of action and is designed to prevent demyelination, which is a key factor in multiple sclerosis.
Who can I contact for more information about Quantum BioPharma?
For more information, you can contact Zeeshan Saeed at Zsaeed@quantumbiopharma.com or the Investor Relations team at IR@QuantumBioPharma.com.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
Full Release
TORONTO, May 20, 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, today announces that it has signed an agreement with a global pharmaceutical contract research organization to prepare an IND (Investigational New Drug) application package for Lucid-21-302 (Lucid-MS) with the US FDA. A successful IND application will allow Quantum Biopharma to move forward with a Phase 2 trial of Lucid-21-302 in people with multiple sclerosis (MS).
Lucid-21-302 is a first-in-class, non-immunomodulatory, neuroprotective compound with a unique mechanism of action for the treatment of MS. It is a patented New Chemical Entity (NCE) that has been shown in preclinical models to prevent demyelination, a known cause of MS and other neurogenerative diseases characterized by damage to the myelin sheath surrounding nerve fibers.
“We are pleased to announce that we have signed this agreement to prepare the IND application package, which we hope to submit to the FDA in Q4 2025. This agreement takes us a step closer to initiating the phase 2 trial of Lucid-21-302, a first-in-class treatment for MS,” said Zeeshan Saeed, CEO of Quantum BioPharma.
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
”), led by industry veterans. Quantum BioPharma retains ownership of 20.11% (as of March 31, 2025) of Celly Nutrition at
www.unbuzzd.com
. The agreement with Celly Nutrition 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
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