Quantum Biopharma's 2024 Financial Statements Show Strong Improvements in Cash, Working Capital, Operating Efficiency and the Removal of Material Uncertainty Related to Going Concern
Completion of unbuzzdTM Clinical Trial and Multiple Sclerosis Drug Lucid-21-302 Phase 1 Trial Advance Company's Pipeline of Products and Assets
TORONTO, ONTARIO / ACCESS Newswire / March 28, 2025 / Quantum BioPharma Ltd. (NASDAQ:QNTM)(CSE:QNTM)(FRA:0K91) ('Quantum BioPharma' or the 'Company'),has reported its financial and operational results for the fourth quarter and year ended December 31, 2024.
Fourth Quarter and Full Year 2024 Financial Results
The company's strong balance sheet and overall progress enabled it to remove its Material Uncertainty Related to Going Concern. Management is confident that there is sufficient working capital as of December 31, 2024 to carry out its operations over the next twelve months. Management believes there is sufficient cash on hand to sustain basic operations beyond January 2027.
Cash and cash equivalents totaled $12.1 million USD as of December 31, 2024, compared to $11.1 million USD as of December 31, 2023.
For the year ended December 31, 2024, Operating Expenses were reduced to $16.1 million USD compared to $23.8 million USD in the same period of 2023, an improvement of over 32%.
Accounts payable have been significantly reduced from 4.4 million USD at December 31, 2024, compared to less than 1M USD as of the date of filing these Financial Statements. Net cash used in operations was $6.9 million USD for the year ended December 31, 2024, compared to $10.8 million USD in the same period of 2023 an improvement of 36 %.
For the year ended December 31, 2024, external research and development fees increased to $6.1 million USD compared to $3.9 million USD in the same period of 2023 as a result of advancing key clinical assets.
For the year ended December 31, 2024, General and Administrative expenses increased to $9.4 million USD compared to $9.0 million USD in the same period of 2023 as a result of advancing key clinical assets.
For the year ended December 31, 2024, Net Loss was $14.9 million USD, compared to $18.2 million USD for the same period of 2023 an improvement of 18 %.
Fourth Quarter & Subsequent 2024 Corporate Highlights
unbuzzd
Completed a double-blind, randomized, placebo-controlled crossover design clinical trial (NCT06505239) of dietary supplement product unbuzzd, investigating its effects on alcohol intoxication and alcohol metabolism.
Results of data analysis show definitively that unbuzzd accelerated the rate at which Blood Alcohol Concentration ('BAC') was reduced in study subjects, while simultaneously reducing the symptoms of intoxication and hangover.
Licensee Celly Nutrition Corp. ('Celly') signed a master distribution agreement with FUSION Distribution Group across Puerto Rico, The Caribbean, and Parts of Central and South America to bring unbuzzd to new markets through FUSION's robust distribution network.
Celly launched unbuzzd powder sticks in 2024 in the USA only and sales are increasing organically quarter over quarter. unbuzzd is available on amazon.com and unbuzzd.com.
Awaiting approval of filing submitted to Health Canada for approval to sell unbuzzed in Canada.
Celly engaged a leading New York Investment Bank to raise up to $10 million USD in capital and explore an initial public offering on a major US public exchange, subject to regulatory approval.
rekvry™
Development of a formulation has begun for rekvry - an alcohol misuse treatment for emergency and hospital settings. The Company believes that rekvry fulfills an unmet need in healthcare settings, reducing the costs and burden on healthcare resources and staff.
Multiple Sclerosis Drug Lucid-21-302 ('Lucid-MS')
Completed Phase 1 multiple ascending dose clinical trial.
Final safety review committee ('SRC') meeting was held after completion of the trial and found that Lucid-MS was well-tolerated with no safety concerns. No serious adverse events were reported during the trial.
Safety review committee subsequently recommended commencing dosing of the second cohort in its trial entitled 'A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of Lucid-21-302 in Healthy Adult Participants.'
Commenced a toxicology study to be completed in 2025.
The Company has begun preparing for an FDA submission in 2025.
Additional Highlights
Dual listed on Upstream, a MERJ Exchange market and global securities trading app, under the ticker symbol 'QNTM'.
Purchased $3.5 million worth of Bitcoin (BTC) and other cryptocurrencies to diversify its Treasury, allowing for future financings and other transactions to be carried out in cryptocurrency.
Closed multiple tranches of financing for $2.5 million USD
Cash and cash equivalents totaled $12.1 million USD as of December 31, 2024.
Management Commentary
'The fourth quarter of 2024 and early 2025 were highlighted by continued development of our robust pipeline of products and assets focused on addressing significant unmet needs in brain disorders and alcohol health, with three near-term monetization events.' said Zeeshan Saeed, CEO of Quantum BioPharma. 'We launched unbuzzd, our rapid alcohol detoxification beverage, in 2024 with a first-to-market scientifically formulated powder stick for this fast-growing consumer product category. We are now building a multi-channel distribution strategy with upcoming launches with our distribution partner FUSION across Puerto Rico and the Asian American Trade Associations Council.
'Recently we completed a double-blinded, randomized, placebo-controlled crossover design clinical trial of unbuzzd, investigating its effects on alcohol intoxication and alcohol metabolism. Key findings from the clinical trial included statistically significant results that unbuzzd dramatically and rapidly reduced blood alcohol concentration in study participants. The rate at which BAC was lowered was, on average for most participants, more than 40 percent faster within 30 minutes of consuming unbuzzd compared to control subjects. The trial also showed rapid improvements in alertness, improvements in physiological changes due to intoxication, reduced perceived impairment and mental fatigue and hangover relief, all with no side effects. Following these highly positive results from the clinical study, Celly Nutrition is exploring an IPO on a major US public exchange.
'We also made significant progress with our MS program, completing a Phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety and pharmacokinetics of Lucid-21-302 in healthy adult participants. Lucid-MS is a first-in-class, non-immunomodulatory, neuroprotective compound for the treatment of MS. It is a patented New Chemical Entity ('NCE') that has a unique mechanism of action. Lucid-MS was deemed safe and well-tolerated in healthy participants by the safety review committee, and we are optimistic about the potential of Lucid-MS to protect myelin in MS patients as it represents a new direction in the treatment of this disease. We are now looking ahead to our Phase 2 trial as we work towards our goals of drug approval and commercialization.
'Operationally, we took several steps to strengthen our balance sheet and expand our reach in the capital markets to execute on upcoming milestones. Following highly positive results from the unbuzzd clinical study, our licensee Celly Nutrition Corporation, the company behind unbuzzd, engaged a leading New York Investment Bank to raise up to $10 million USD in capital and explore an initial public offering on a major US public exchange, subject to requisite regulatory approval. A dual listing on Upstream is now providing us the opportunity to access a global investor base outside of the U.S., unlocking liquidity and enhancing price discovery while globalizing the opportunity to invest in the company. Over the last several months, we have continued to purchase Bitcoin and other cryptocurrencies as part of our strategic efforts, reflecting our belief in the potential of cryptocurrencies to provide a return on investment for shareholders and to provide some hedge against the dollar.
'Looking ahead, we are focused on the imminent unbuzzd launch with FUSION Distribution across Puerto Rico and expanding the availability of unbuzzd through e-commerce. We are launching affiliate, ambassador, and social media programs to further market unbuzzd's potential to provide relief from inebriation and accelerate alcohol metabolism. We are encouraged by the strong safety and tolerability profile of Lucid-MS and are actively exploring the most expeditious path to advance this program to patients. We look forward to additional milestone announcements in the coming months as we work to develop novel solutions for brain and inflammatory disorders,' concluded Saeed.
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 25.71% (as of June 30, 2024) 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 visit www.quantumbiopharma.com.
Forward Looking Information
This press release contains certain 'forward-looking statements' within the meaning of applicable Canadian securities law. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions or future events or performance (often, but not always, identified by words or phrases such as 'believes', 'anticipates', 'expects', 'is expected', 'scheduled', 'estimates', 'pending', 'intends', 'plans', 'forecasts', 'targets', or 'hopes', or variations of such words and phrases or statements that certain actions, events or results 'may', 'could', 'would', 'will', 'should' 'might', 'will be taken', or 'occur' and similar expressions) are not statements of historical fact and may be forward-looking statements. The forward-looking information and forward-looking statements contained herein include, but are not limited to, statements regarding: 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.; MZ playing a key role in assisting the Company to enhance its market awareness and foster productive, continuing dialogues with shareholders and other market participants; MZ being engaged by the Company for the MZ Initial Period; MZ working with the Company to develop and implement a comprehensive capital markets strategy designed to increase the Company's visibility throughout the investment community; MZ campaign highlighting how Quantum BioPharma is developing a robust pipeline of products and assets focused on addressing significant unmet needs in brain disorders and alcohol health; and the Company's approach to treatments in brain disorders and alcohol health representing a tremendous revenue potential.
Forward-looking information in this news release are based on certain assumptions and expected future events, namely: 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.; MZ will play a key role in assisting the Company to enhance its market awareness and foster productive, continuing dialogues with shareholders and other market participants; MZ will be engaged by the Company for the MZ Initial Period; MZ will work with the Company to develop and implement a comprehensive capital markets strategy designed to increase the Company's visibility throughout the investment community; the MZ campaign will highlight how Quantum BioPharma is developing a robust pipeline of products and assets focused on addressing significant unmet needs in brain disorders and alcohol health; and the Company's approach to treatments in brain disorders and alcohol health will have a tremendous revenue potential.
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: 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 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.; MZ will not play a key role in assisting the Company to enhance its market awareness and foster productive, continuing dialogues with shareholders and other market participants; MZ will not be engaged by the Company for the MZ Initial Period; MZ will not work with the Company to develop and implement a comprehensive capital markets strategy designed to increase the Company's visibility throughout the investment community; the MZ campaign will not highlight how Quantum BioPharma is developing a robust pipeline of products and assets focused on addressing significant unmet needs in brain disorders and alcohol health; the Company's approach to treatments in brain disorders and alcohol health will not have a tremendous revenue potential; and the risks discussed in the Company's Annual Report on Form 20-F for the fiscal year ended December 31, 2024 and registration statement on Form F-3 containing a base shelf prospectus, each 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.
The reader is urged to refer 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.
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4 hours ago
- Business Wire
Sarepta Provides Safety Update for ELEVIDYS and Initiates Steps to Strengthen Safety in Non-Ambulatory Individuals with Duchenne
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today provided a safety update regarding ELEVIDYS (delandistrogene moxeparvovec-rokl), the only approved gene therapy for patients with Duchenne muscular dystrophy, and steps the Company is taking to strengthen the safety profile in non-ambulatory patients. These steps follow a second reported case of acute liver failure (ALF) resulting in death. The cases of ALF to date have both occurred in non-ambulatory individuals with Duchenne. Sarepta extends its deepest sympathies to the affected families and care teams. Key Safety Initiatives Evaluating and Enhancing Immunosuppressive Regimen: As part of a comprehensive review of safety data, Sarepta is taking proactive steps to mitigate the risk of acute liver failure in non-ambulatory patients. Sarepta is working to immediately convene an independent group of leading experts in Duchenne and liver health to consider an enhanced immunosuppression regimen for ELEVIDYS. This panel will evaluate data and assess our proposed regimen, which includes sirolimus and is supported by preclinical data demonstrating the effectiveness of additional immunosuppression in moderating liver enzyme elevations, a key factor in mitigating potential safety events. Sarepta will share the panel's recommendations with the U.S. Food & Drug Administration (FDA), and implementation of any new regimen will be subject to FDA guidance and allowance. Suspending Shipments of ELEVIDYS for Non-Ambulatory Patients: Sarepta is temporarily suspending shipments of ELEVIDYS for non-ambulatory patients while an enhanced immunosuppressive regimen is evaluated, discussed with regulatory bodies, and put in place. For ambulatory patients, no treatment changes are being proposed and the current practice of administering corticosteroids before and after ELEVIDYS infusion, along with post-treatment monitoring, remains the same. ENVISION Study Paused: Sarepta has voluntarily paused dosing in the ENVISION clinical study (also known as Study SRP-9001-303). FDA concurs with this action. The pause will allow for the evaluation of a protocol amendment to incorporate an enhanced immunosuppressive regimen for the non-ambulatory patient cohort and incorporate any additional feedback from the FDA. Regulatory alignment is needed before screening and dosing in ENVISION may resume. ENVISION is a global, randomized, double-blind, placebo-controlled trial evaluating ELEVIDYS in older ambulatory and non-ambulatory individuals living with Duchenne muscular dystrophy. In the U.S., it serves as the confirmatory trial required under the FDA's accelerated approval pathway for non-ambulatory patients. 'Our paramount priority is the safety and well-being of the patients we serve. We are taking immediate, decisive steps to better understand and mitigate the risk of acute liver failure, including enhancing the immunosuppressive regimen, for those with Duchenne who are non-ambulatory,' said Louise Rodino-Klapac, Ph.D., chief scientific officer and head of research & development, Sarepta. 'We are deeply saddened by the loss of a second patient and extend our heartfelt condolences to the patient's family and his care team during this incredibly difficult time. Duchenne muscular dystrophy is a devastating disease that profoundly affects lives and often cuts them far too short. With more than 900 individuals treated to-date, we know how much hope families place in new treatment options like ELEVIDYS – and we are committed to honoring that hope by acting swiftly, guided by scientific rigor and the insights of leading experts, to strengthen safety for all future patients.' Commitment to Long-Term Safety and Understanding Sarepta remains committed to a thorough approach and the highest standards of patient safety and scientific rigor. The event has been reported to FDA and global health authorities and will inform ongoing discussions around a potential label update to reflect the risk of severe ALF and additional immune management strategies for non-ambulatory patients. While elevated liver enzymes are a known class effect of all AAV-based gene therapies, the exact mechanism behind AAV-related liver toxicity remains unclear. Current evidence suggests it is likely driven by an adaptive immune response. The Company will provide additional updates as appropriate. Investor Conference Call Details Sarepta will be hosting a conference call and webcast to discuss this update and provide an update on the Company's business on Monday, June 16, 2025, at 8:00 am Eastern time. The event will be webcast live under the investor relations section of Sarepta's website at: and following the event a replay will be archived there for one year. Interested parties participating by phone will need to register using this online form. After registering for dial-in details, all phone participants will receive an auto-generated e-mail containing a link to the dial-in number along with a personal PIN number to use to access the event by phone. About ELEVIDYS (delandistrogene moxeparvovec-rokl) ELEVIDYS (delandistrogene moxeparvovec-rokl) is a single-dose, adeno-associated virus (AAV)-based gene transfer therapy for intravenous infusion designed to address the underlying genetic cause of Duchenne muscular dystrophy – mutations or changes in the DMD gene that result in the lack of dystrophin protein – through the delivery of a transgene that codes for the targeted production of ELEVIDYS micro-dystrophin in skeletal muscle. ELEVIDYS is indicated for the treatment of Duchenne muscular dystrophy (DMD) in individuals at least 4 years of age. For patients who are ambulatory and have a confirmed mutation in the DMD gene For patients who are non-ambulatory and have a confirmed mutation in the DMD gene. The DMD indication in non-ambulatory patients is approved under accelerated approval based on expression of ELEVIDYS micro-dystrophin in skeletal muscle. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). IMPORTANT SAFETY INFORMATION CONTRAINDICATION: ELEVIDYS is contraindicated in patients with any deletion in exon 8 and/or exon 9 in the DMD gene. WARNINGS AND PRECAUTIONS: Infusion-related Reactions: Infusion-related reactions, including hypersensitivity reactions and anaphylaxis, have occurred during or up to several hours following ELEVIDYS administration. Closely monitor patients during administration and for at least 3 hours after the end of infusion. If symptoms of infusion-related reactions occur, slow, or stop the infusion and give appropriate treatment. Once symptoms resolve, the infusion may be restarted at a lower rate. ELEVIDYS should be administered in a setting where treatment for infusion-related reactions is immediately available. Discontinue infusion for anaphylaxis. Acute Serious Liver Injury: Acute serious liver injury has been observed with ELEVIDYS, and administration may result in elevations of liver enzymes (such as GGT, GLDH, ALT, AST) or total bilirubin, typically seen within 8 weeks. Patients with preexisting liver impairment, chronic hepatic condition, or acute liver disease (e.g., acute hepatic viral infection) may be at higher risk of acute serious liver injury. Postpone ELEVIDYS administration in patients with acute liver disease until resolved or controlled. Prior to ELEVIDYS administration, perform liver enzyme test and monitor liver function (clinical exam, GGT, and total bilirubin) weekly for the first 3 months following ELEVIDYS infusion. Continue monitoring if clinically indicated, until results are unremarkable (normal clinical exam, GGT, and total bilirubin levels return to near baseline levels). Systemic corticosteroid treatment is recommended for patients before and after ELEVIDYS infusion. Adjust corticosteroid regimen when indicated. If acute serious liver injury is suspected, consultation with a specialist is recommended. Immune-mediated Myositis: In clinical trials, immune-mediated myositis has been observed approximately 1 month following ELEVIDYS infusion in patients with deletion mutations involving exon 8 and/or exon 9 in the DMD gene. Symptoms of severe muscle weakness, including dysphagia, dyspnea, and hypophonia, were observed. Limited data are available for ELEVIDYS treatment in patients with mutations in the DMD gene in exons 1 to 17 and/or exons 59 to 71. Patients with deletions in these regions may be at risk for a severe immune-mediated myositis reaction. Advise patients to contact a physician immediately if they experience any unexplained increased muscle pain, tenderness, or weakness, including dysphagia, dyspnea, or hypophonia, as these may be symptoms of myositis. Consider additional immunomodulatory treatment (immunosuppressants [e.g., calcineurin-inhibitor] in addition to corticosteroids) based on patient's clinical presentation and medical history if these symptoms occur. Myocarditis: Acute serious myocarditis and troponin-I elevations have been observed following ELEVIDYS infusion in clinical trials. If a patient experiences myocarditis, those with pre-existing left ventricle ejection fraction (LVEF) impairment may be at higher risk of adverse outcomes. Monitor troponin-I before ELEVIDYS infusion and weekly for the first month following infusion and continue monitoring if clinically indicated. More frequent monitoring may be warranted in the presence of cardiac symptoms, such as chest pain or shortness of breath. Advise patients to contact a physician immediately if they experience cardiac symptoms. Preexisting Immunity against AAVrh74: In AAV-vector based gene therapies, preexisting anti-AAV antibodies may impede transgene expression at desired therapeutic levels. Following treatment with ELEVIDYS, all patients developed anti-AAVrh74 antibodies. Perform baseline testing for presence of anti-AAVrh74 total binding antibodies prior to ELEVIDYS administration. ELEVIDYS administration is not recommended in patients with elevated anti-AAVrh74 total binding antibody titers greater than or equal to 1:400. Adverse Reactions: The most common adverse reactions (incidence ≥5%) reported in clinical studies were vomiting, nausea, liver injury, pyrexia, and thrombocytopenia. Report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You may also report side effects to Sarepta Therapeutics at 1-888-SAREPTA (1-888-727-3782). For further information, please see the full Prescribing Information. About Sarepta Therapeutics Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold leadership positions in Duchenne muscular dystrophy (Duchenne) and limb-girdle muscular dystrophies (LGMDs) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. For more information, please visit or follow us on LinkedIn, X, Instagram and Facebook. Internet Posting of Information We routinely post information that may be important to investors in the 'For Investors' section of our website at We encourage investors and potential investors to consult our website regularly for important information about us. Forward-Looking Statements This statement contains 'forward-looking statements.' Any statements that are not statements of historical fact may be deemed to be forward-looking statements. Words such as 'believe,' 'anticipate,' 'plan,' 'expect,' 'will,' 'may,' 'intend,' 'prepare,' 'look,' 'potential,' 'possible' and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements relating to our future operations, research and development programs, clinical trials, ELEVIDYS, the potential benefits of an enhanced immunosuppression regimen in dosing in non-ambulatory patients, and expected plans and milestones, including providing additional updates as appropriate and engaging with regulators on an enhanced immunosuppressive regimen for dosing in non-ambulatory patients. Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: different methodologies, assumptions and applications we use to assess particular safety or efficacy parameters may yield different statistical results, and even if we believe the data collected from clinical trials are positive, these data may not be sufficient to support approval by the FDA or other global regulatory authorities; success in clinical trials, especially if based on a small patient sample, does not ensure that later clinical trials will be successful, and the results of future research may not be consistent with past positive results or with advisory committee recommendations, or may fail to meet regulatory approval requirements for the safety and efficacy of product candidates; our products or product candidates may be perceived as insufficiently effective, unsafe or may result in unforeseen adverse events; our products or product candidates may cause undesirable side effects that result in significant negative consequences following any marketing approval; we may not be able to comply with all FDA requests in a timely manner or at all; the possible impact of regulations and regulatory decisions by the FDA and other regulatory agencies on our business; and those risks identified under the heading 'Risk Factors' in our most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company, which you are encouraged to review. Any of the foregoing risks could materially and adversely affect the Company's business, results of operations and the trading price of Sarepta's common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review the SEC filings made by Sarepta. We caution investors not to place considerable reliance on the forward-looking statements contained herein. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof, except as required by law.
