ADDED
As of March 31, 2026, there were 36,281,252 shares of common stock, par value $ 0.0001 per share, of the registrant issued and outstanding.
These risks and uncertainties include, but are not limited to, the following risks, uncertainties and other factors: Our substantial amount of indebtedness associated with the convertible promissory notes issued in connection with the Standby Equity Purchase Agreement may adversely affect our cash flow and our ability to operate our business, remain in compliance with debt covenants and make payments on our indebtedness.
Low trading volume in our common stock may limit or prevent our ability to draw on the Standby Equity Purchase Agreement to pay down the convertible promissory notes.
We have not generated meaningful revenue from product sales to date, have incurred significant net losses since our inception, and expect to continue to incur significant net losses for the foreseeable future; Our management has concluded that factors raise substantial doubt about our ability to continue as a going concern and our auditor has included an explanatory paragraph relating to our ability to continue as a going concern in its audit report for the fiscal years ended December 31, 2025 and 2024.
Our business and future prospects with the Nugevia brand and our pharmaceutical products are significantly dependent on our exclusive, worldwide license agreement with Aquanova.
Any adverse development related to this license agreement could materially and adversely affect our operations, financial condition, and results of operations.
The clinical trials of our product candidate may not demonstrate safety and efficacy to the satisfaction of the FDA, EMA or other comparable foreign regulatory authorities or otherwise produce positive results and the results of preclinical studies and early clinical trials may not be predictive of future results.
We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
ii We may not be successful in our efforts to develop our proprietary drug delivery platform, JOTROL , to build a pipeline of indications.
The FDA, EMA and other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction.
REMOVED
(the Company, we or us ) is a clinical stage research and development company.
We have developed a unique resveratrol platform product primarily targeting treatment of neuro-inflammation.
Our platform product, JOTROL, an enhanced oral formulation of resveratrol, has many potential indications of use for rare diseases.
In the larger disease areas, we are primarily targeting Parkinson s Disease and Mild Cognitive Impairment/early Alzheimer s disease.
Business Overview The Company s platform product, JOTROL, is an enhanced orally administered resveratrol formulation designed and intended to deliver therapeutically relevant, safe levels of resveratrol.
This platform has many potential indications of use for rare diseases, which include Mucopolysaccharidoses Type 1, Friedreich s ataxia and MELAS.
In the larger disease areas, we are primarily targeting Parkinson s Disease and Mild Cognitive Impairment/early Alzheimer s disease.
Currently available resveratrol products are associated with severe gastrointestinal (GI) side effects at the dose levels we believe are needed for therapeutic effect.
Our belief, that a high dose of resveratrol is needed for therapeutic effects, is based on available scientific literature, preclinical trial results conducted in mice and rats, and previously conducted human trials with resveratrol.
We believe that JOTROL, based on the results from our Phase I clinical trial conducted at the University of Miami and completed in 2021 ( Miami Clinical Trial ), has the potential to deliver a therapeutically effective dose of resveratrol in the blood stream without causing any severe side effects.