Latest news with #Lucid-MS
Toronto Star
5 days ago
- Business
- Toronto Star
Quantum BioPharma Signs Agreement to Manufacture Oral Drug Formulation of its Potential Breakthrough Drug Lucid-21-302 (Lucid-MS) for Use in its Upcoming Phase 2 Multiple Sclerosis Trial
TORONTO, Aug. 11, 2025 (GLOBE NEWSWIRE) — Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (Upstream: QNTM) ('Quantum BioPharma' or the 'Company'), a biopharmaceutical company dedicated to innovative therapies for neurodegenerative disorders, today announces through its subsidiary, Huge Biopharma Australia Pty Ltd., that it has signed an agreement with a leading contract development and manufacturing organization (CDMO) to manufacture an oral drug formulation of Lucid-MS. The oral formulation of Lucid-MS will serve as the drug product for the Company's Phase 2 clinical trial, which will test the efficacy on humans of Lucid-MS as a possible treatment for people to gain back mobility lost with multiple sclerosis (MS). To date numerous animal models over the past decade showed Lucid-MS helped those animals regain their ability to walk. Videos can be seen at Lucid-MS 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, which is a hallmark of MS and other neurogenerative diseases and is characterized by damage to the myelin sheath surrounding nerve fibers.
Toronto Star
08-08-2025
- Business
- Toronto Star
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
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: 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. ARTICLE CONTINUES BELOW '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 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 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 and on the EDGAR section of the United States Securities and Exchange Commission's website at 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@ Telephone: (833) 571-1811 Investor Relations Investor Relations: IR@ General Inquiries: info@
Yahoo
05-08-2025
- Business
- Yahoo
Quantum Biopharma Reports Positive Phase 1 Safety For Multiple Sclerosis Drug
Quantum Biopharma Ltd. (NASDAQ:QNTM) announced on Tuesday that its subsidiary Huge Biopharma Australia has received the clinical study report for a Phase 1, randomized, double-blind, placebo-controlled multiple ascending dose trial evaluating the safety and pharmacokinetics of Lucid-MS in healthy adults. The report confirms that daily dosing of Lucid-MS posed no safety or tolerability concerns, clearing a critical regulatory milestone and supporting the compound's advancement. Lucid-MS is a first-in-class, non-immunomodulatory, neuroprotective compound with a unique mechanism of action for the treatment of multiple sclerosis (MS).It is a patented New Chemical Entity (NCE) that has been shown in preclinical models to prevent demyelination, which is a hallmark of MS and other neurogenerative diseases and is characterized by damage to the myelin sheath surrounding nerve fibers. "The CSR allows us to advance the clinical development of Lucid-MS as it is a critical component of the investigational new drug (IND) application with the FDA," said Dr. Andrzej Chruscinski, Vice-President of Clinical and Scientific Affairs at Quantum BioPharma. "Results and observations from the first-in-human studies including this MAD investigation give us the confidence that Lucid-MS is safe and tolerable in healthy volunteers," noted Dr. Lakshmi P. Kotra, Director at Quantum BioPharma and Professor at the University of Toronto, who led the discovery of the compound. According to Benzinga Pro, QNTM stock has gained over 388% in the past year. Investors can gain exposure to the stock via AdvisorShares Psychedelics ETF (NYSE:PSIL). Price Action: At last check Tuesday, QNTM shares were trading lower by 8.63% to $25.40. Read Next:Photo via Shutterstock Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? This article Quantum Biopharma Reports Positive Phase 1 Safety For Multiple Sclerosis Drug originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
18-06-2025
- Business
- Yahoo
Singular Research Reports on Quantum BioPharma Ltd.'s Strategic Advances and Pipeline Progress
Los Angeles, California--(Newsfile Corp. - June 18, 2025) - Singular Research, a leading provider of independent research on small-cap companies, today released its analysis of Quantum BioPharma Ltd.'s (NASDAQ: QNTM) continued progress across its innovative pipeline of treatments for brain disorders and alcohol health. A link to the report is available here: Clinical Development Milestones Quantum BioPharma has achieved significant progress with its FSD202 program, receiving human ethics review committee (HREC) approval for a Phase 2 clinical trial targeting nociplastic pain in patients with Idiopathic Mast Cell Activation Syndrome (MCAS). The randomized, double-blind trial will enroll 60 patients who will receive FSD202 or placebo twice daily for 56 consecutive days, with the primary outcome measuring decrease in average daily pain intensity from baseline to Day 28. This advancement addresses a significant unmet medical need, as no cure currently exists for MCAS, and FSD202 has potential applications across a wide range of inflammatory diseases. The Company continues to advance its flagship Lucid-MS program, expecting to file an IND application package for Lucid-21-302 with the U.S. FDA in Q4 2025. A successful IND filing would represent a critical validation milestone and enable advancement to Phase 2 trials for this proprietary compound designed to treat progressive Multiple Sclerosis through a non-immunomodulatory approach. To support this development, Quantum BioPharma has initiated a joint study with Massachusetts General Hospital using PET imaging to evaluate Lucid-MS efficacy, with the first patient already scanned using this technique as a potential biomarker. Strategic Business Developments The Company's subsidiary Celly Nutrition has changed its name to Unbuzzd Wellness Inc. and engaged leading audit firm MNP LLP to conduct PCAOB audits in preparation for a potential initial public offering. This IPO preparation will provide access to capital for enhanced marketing and distribution of the unbuzzd™ formulation, a natural product designed to expedite alcohol metabolism and reduce Blood Alcohol Content. Quantum BioPharma maintains a 20.11% stake in Unbuzzd Wellness, positioning the Company to benefit from the subsidiary's growth trajectory. Quantum BioPharma has continued diversifying its treasury holdings toward Bitcoin, with total BTC investment reaching $5 million as of June 10, 2025. Additionally, the Company announced plans for a special dividend comprising Contingent Value Rights (CVRs) to be issued on a 1:1 basis to shareholders. These CVRs are linked to potential litigation proceeds exceeding $700 million related to alleged stock manipulation, with each CVR entitling holders to a pro rata share of 10-50% of any proceeds received. Q1 2025 Financial Performance Quantum BioPharma reported no revenues for Q1 2025 as the Company remains in clinical development stage. General and administrative expenses decreased 31% to $1.32 million compared to Q1 2024, reflecting disciplined cost management while advancing clinical programs. Research and development expenditure increased significantly to $1.65 million, reflecting reinitiated development efforts for the FSD202 drug candidate. The Company maintained cash and cash equivalents of $3.5 million as of March 31, 2025, with management confirming sufficient liquidity to advance clinical assets and meet operational requirements through Q1 2027. Pipeline Overview Quantum BioPharma maintains a robust pipeline addressing critical unmet medical needs across brain disorders and alcohol health. The Company's lead programs include Lucid-MS, a proprietary compound for progressive Multiple Sclerosis utilizing a unique non-immunomodulatory approach; FSD202, an ultra-micronized palmitoylethanolamide formulation targeting MCAS and other inflammatory diseases; and unbuzzd™, a natural formulation designed to expedite alcohol metabolism and reduce Blood Alcohol Content. Research Methodology: Singular Research conducts comprehensive analysis using risk-adjusted discounted cash flow models and peer comparable methodologies to evaluate clinical-stage biotechnology companies. The firm maintains Buy-Venture rating reflecting the early-stage nature and significant potential of Quantum BioPharma's innovative pipeline. Contact: Singular Research818-222-6234research@ About Singular Research Singular Research aims to be the most trusted supplier of independent research, providing unbiased research on small-cap companies. Visit for more information. About Quantum BioPharma Ltd. Quantum BioPharma Ltd. (NASDAQ: QNTM) is a clinical-stage biotechnology company dedicated to pioneering treatments for critical gaps in brain disorders and alcohol health. The Company's pipeline includes innovative therapies targeting Multiple Sclerosis, Mast Cell Activation Syndrome, and alcohol metabolism enhancement. Disclaimer: This press release contains forward-looking statements and analysis based on current information. Actual results may differ materially from those projected. For full disclosures, please visit To view the source version of this press release, please visit Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
13-06-2025
- Business
- Yahoo
Quantum BioPharma Announces Intention to Declare Special Dividend of Contingent Value Rights (CVRs) Linked to Future Litigation Settlement Proceeds
TORONTO, June 13, 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, is pleased to announce its intention to declare a special dividend consisting of Contingent Value Rights (the 'CVRs') to be issued on a 1:1 basis to holders of the Company's Class B Subordinate Voting Shares. Each CVR will entitle the holder to receive a pro rata portion of a minimum of 10% and a maximum of 50% of the net proceeds, ultimately recovered by the Company, if any, in connection with its legal action against CIBC World Markets, RBC Dominion Securities, and others (collectively, the 'Banks'), which seeks damages in excess of USD$700+ million related to alleged stock price manipulation and spoofing (the 'Litigation'). The Board will approve the exact pay-out percentage at a later date. The record date for the proposed special dividend has not yet been set, and the Company will provide further updates in due course. The CVRs: Will not be listed on any exchange or marketplace; Will be non-transferable and non-assignable; Will not carry interest or voting rights; Will be redeemable only for cash, and only in the event that the Company receives net proceeds from a resolution of the Litigation (whether by settlement or final judgment). 'Shareholders are our biggest asset. This proposed special dividend underscores our commitment to ensuring our shareholders benefit directly from the outcome of this significant litigation,' said Zeeshan Saeed, CEO of Quantum BioPharma. 'We are aligning interests by creating a legally enforceable right that rewards holders if and when value is recovered.' The issuance of the CVRs remains subject to necessary approvals, regulatory requirements, and finalization of tax, legal, and operational matters. There can be no assurance that any Litigation proceeds will be received or that the CVRs will result in any payment to holders. 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 Forward-Looking Information This news release contains "forward-looking information" within the meaning of applicable Canadian and U.S. securities legislation. Generally, but not always, forward-looking information and statements can be identified by the use of words such as "plans", "expects", "intends", "estimates", "intends", "anticipates", or "believes" or the negative connotation thereof or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might" or "will be taken", "occur" or "be achieved" or the negative connotation thereof. "Forward-looking information" includes statements about: the Company's focus on the research and development of Lucid-MS to prevent and reverse myelin degradation; the Company's Lucid-21-302 clinical development program in multiple sclerosis advancing towards human phase-2 efficacy trials; the Company's intention to retain 100% of the rights to develop products for pharmaceutical and medical uses; the Company's intention to maintain a portfolio of strategic investments through FSD Strategic Investments Inc.; the Company's intention to declare a special dividend consisting of CVRs with the terms and conditions of which are subject to various considerations as outlined herein; the Board's approval of the pay-out percentage and each CVR will entitle the holder to receive a pro rata portion of a minimum of 10% of the net proceeds, if any, ultimately recovered by the Company in connection with the Litigation. Such forward-looking information and statements are based on numerous assumptions, including: the Company's assessment of market conditions, its ability to gain market share, and its potential competitive edge are accurate; the Company will have the ability to carry out its plans with respect to its new innovation and offerings, including its ability to conduct research and development of Lucid-MS; the Company's Lucid-21-302 clinical development program in multiple sclerosis will advance towards human phase-2 efficacy trials; the Company will retain 100% of the rights to develop similar product or alternative formulations specifically for pharmaceutical and medical uses; the Company will seek new business opportunities; the Company will increase efficiency in its processes and partnerships; the Company will have the ability to carry out its other goals and objectives the Company's intention to maintain a portfolio of strategic investments through FSD Strategic Investments Inc.; the Company's ability to declare a special dividend consisting of CVRs with the terms and conditions outlined herei; including obtaining legal and regulatory approvals for the CVR's; the Company's ability to prevail in the Litigation and or reach a settlement with the Banks which results in net proceeds being available for distribution to the holders of the Company's Class B Subordinating Voting Shares in the amounts set forth in the CVR's, as approved by the Company. Forward-looking information and statements involve known and unknown risks, uncertainties, and other factors, that may cause actual events, performance, or achievements in future periods to differ materially from any projections of future events or results expressed or implied by such forward-looking information or statements, including but not limited to: the Company's inability to retain 100% of the rights to develop products for pharmaceutical or medical uses; the Company's inability to enhance its drug or product development capabilities and/or maintain a portfolio of strategic investments; the Company's Lucid-21-302 clinical development program in multiple sclerosis not advancing towards human phase-2 efficacy trials; the Company will not have the ability to carry out its other goals and objectives the Company's intention to maintain a portfolio of strategic investments through FSD Strategic Investments Inc.; the Company's early stage of development; government regulation; market acceptance for its products; rapid technological change; dependence on key personnel; dependence on the Company's strategic partners; the fact that preclinical product development is uncertain, and the Company's products may never advance past clinical trials; the fact that results of preclinical studies and early-stage clinical trials may not be predictive of the results of later stage clinical trials; the uncertain outcome, cost, and timing of product development activities, preclinical studies and clinical trials of the Company; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; the potential inability to obtain or maintain regulatory approval of the Company's products; the introduction of competing products that are safer, more effective or less expensive than, or otherwise superior to, the Company's products; the initiation, conduct, and completion of preclinical studies and clinical trials may be delayed, adversely affected or impacted by unforeseen issues; the potential inability to obtain adequate financing; the potential inability to obtain or maintain intellectual property protection for the Company's products; risks that the Company's intellectual property and technology won't have the intended impact on the Company and/or its business; the Company's inability to realize upon the stated claims of product benefits and effectiveness; the Company's inability to realize upon its stated claims of market potential and consumer demand; the Company's will not declare a special dividend consisting of CVRs with the terms and conditions of which are subject to various considerations as outlined herein; each CVR will not entitle the holder to receive a pro rata portion of a minimum of 15% of the net proceeds ultimately recovered by the Company in connection with the litigation. and the risks discussed in the Company's Annual Report on Form 20-F for the fiscal year ended December 31, 2024 filed with the SEC on March 28, 2025, as amended with Amendment No. 1 to the Form 20-F filed with the SEC on March 31, 2025,, under the heading 'Risk Factors'. These factors should be considered carefully, and readers should not place undue reliance on the forward-looking statements. Readers are cautioned that the foregoing list is not exhaustive. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements. Forward-looking statements contained in this news 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. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in the forward-looking information or implied by forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that forward-looking information and statements will prove to be accurate, as actual results and future events could differ materially from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on forward-looking statements or information. The Company undertakes no obligation to update or reissue forward-looking information as a result of new information or events except as required by applicable securities laws. Contacts: Quantum BioPharma Saeed, Founder, CEO and Executive Co-Chairman of the BoardEmail: Zsaeed@ Telephone: (833) 571-1811 Investor RelationsInvestor Relations: ir@ Inquiries: info@ in to access your portfolio
