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Enveric Biosciences Announces Patent Granted for Drug Candidate

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Enveric Biosciences announces that the United States Patent and Trademark Office has granted Patent No. 11,945,778 for its drug candidate EB-002. This new patent expands Enveric’s intellectual property by covering methods of treatment for a broad range of brain neurological disorders including sleep disorders, depression, substance-related disorders, and headaches.

EB-002, a next-generation psilocin prodrug initially developed for neuropsychiatric disorders such as anxiety, now holds three US patents covering its compositions, formulations, and methods of treatment. CEO Joseph Tucker highlights that this enhanced patent protection will help accelerate EB-002's clinical development and broaden its applicability to a wider patient population.

Positive
  • US Patent No. 11,945,778 granted for EB-002, expanding its intellectual property protection.
  • Patent covers methods of treating a broad range of brain neurological disorders, including sleep disorders, depression, substance-related disorders, and headaches.
  • EB-002 now holds three US patents, enhancing its potential for broader clinical applications.
  • Increased patent protection may accelerate clinical development and de-risk the drug candidate.
Negative
  • None.

The issuance of US Patent No. 11,945,778 for Enveric Biosciences’ EB-002 drug candidate significantly strengthens the company's intellectual property (IP) portfolio. Broad patent claims offer Enveric a competitive edge by potentially preventing other companies from developing similar treatments for a wide range of neurological disorders. This enhances the exclusivity of EB-002, which is important for protecting market share and maximizing future revenue streams.

Patents are fundamental in the pharmaceutical industry as they provide a period of market exclusivity usually lasting 20 years from the filing date, permitting the company to recoup research and development (R&D) expenses. In this case, the broad claims covering multiple neurological disorders, including sleep disorders, depression and headaches, suggest extensive market potential and long-term revenue prospects for Enveric.

However, while patents contribute to derisking drug development, they do not guarantee market success. The practical efficacy and safety of EB-002 for these indications must still be validated through clinical trials and regulatory approvals are necessary for commercialization. Moreover, the financial burden of clinical trials and the competitive landscape, particularly in the neuropsychiatric drug market, can impact the potential financial benefits.

From a financial perspective, the new patent bolsters Enveric Biosciences’ asset value. Intellectual property is considered an intangible asset and can significantly enhance the company’s valuation. The expanded patent coverage can attract increased investor confidence and potential partnerships or acquisitions, as it reduces the risk of market entry by competitors.

However, it's essential to keep in mind Enveric's current financial health and market position. The company’s ability to finance ongoing R&D and conduct the necessary clinical trials will be important for the patent’s potential to translate into financial gains. Investors should consider the company’s cash reserves, debt levels and burn rate. Furthermore, the biotech sector often experiences volatility and while the patent news is positive, other factors such as trial results and broader market conditions will influence stock performance.

In the short term, the news could lead to a positive uptick in share price due to increased investor sentiment. Long-term financial benefits will depend on the successful development and commercialization of the drug.

US patent includes broad claims for treating brain neurological disorders

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel neuroplastogens for the treatment of neuropsychiatric disorders, today announces the expansion of protection for potential clinical indications for its EB-002 drug candidate through the issuance of Patent No. 11,945,778 by the United States Patent and Trademark Office.

We believe the US patent issuance significantly increases the Company’s current intellectual property protection of EB-002 by adding methods of treatment that claim a broad field of brain neurological disorders. The methods of treatment intend to apply to neurological disorders such as sleep disorders, depression, substance-related disorders, and headaches. EB-002 is Enveric’s next generation psilocin prodrug being developed for neuropsychiatric disorders, initially anxiety. EB-002 now has additional patent protection supporting the enhanced potential to both expand into additional neurological conditions and serve a broad range of patient populations.

Joseph Tucker, Ph.D., CEO of Enveric, stated, “EB-002, the lead compound that emerged from Enveric’s EVM201 screening program, now enjoys US patent coverage under three issued patents that claim: compositions and pharmaceutical formulations of EB-002 and closely related similar compounds (US 11,707,447), methods of making the molecules (US 11,845,726), and now methods of treating a broad range of brain neurological disorders using EB-002 and related compounds (US 11,945,778). PCT patent applications are also pending.”

“Enveric believes that deploying comprehensive patent portfolios to protect lead drug development candidates helps to derisk and accelerate clinical development, furthering the Company’s efforts to rapidly bring this new drug to patients,” Dr. Tucker added.

About Enveric Biosciences

Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders. Leveraging its unique discovery and development platform, the Psybrary™, Enveric has created a robust intellectual property portfolio of new chemical entities for specific mental health indications. Enveric’s lead program, EB-003, is a first-in-class approach to the treatment of difficult-to-address mental health disorders designed to promote neuroplasticity without inducing hallucinations in the patient. Enveric is also developing EB-002, formerly EB-373, a next generation synthetic prodrug of the active metabolite, psilocin, being studied as a treatment of psychiatric disorders. Enveric is headquartered in Naples, FL with offices in Cambridge, MA and Calgary, AB Canada. For more information, please visit www.enveric.com.

Forward-Looking Statements

This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as “plans,” “expects” or “does not expect,” “proposes,” “budgets,” “schedules,” “estimates,” “forecasts,” “intends,” “anticipates” or “does not anticipate,” or “believes,” or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, should, would, or might occur or be achieved. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the ability of Enveric to: negotiate and finalize definitive agreements based on the any of its out-licensing term sheets and perform pursuant to the terms thereof; carry out successful clinical programs; achieve the value creation contemplated by technical developments; avoid delays in planned clinical trials; establish that potential products are efficacious or safe in preclinical or clinical trials; establish or maintain collaborations for the development of therapeutic candidates; obtain appropriate or necessary governmental approvals to market potential products; obtain future funding for product development and working capital on commercially reasonable terms; scale-up manufacture of product candidates; respond to changes in the size and nature of competitors; hire and retain key executives and scientists; secure and enforce legal rights related to Enveric’s products, including patent protection; identify and pursue alternative routes to capture value from its research and development pipeline assets; continue as a going concern; and manage its future growth effectively.

A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric’s filings with the Securities and Exchange Commission, including Enveric’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Investor Relations

Tiberend Strategic Advisors, Inc.

Daniel Kontoh-Boateng

(862) 213-1398

dboateng@tiberend.com

Media Relations

Tiberend Strategic Advisors, Inc.

Casey McDonald

(646) 577-8520

cmcdonald@tiberend.com

Source: Enveric Biosciences

FAQ

What recent patent has Enveric Biosciences received for EB-002?

Enveric Biosciences has received US Patent No. 11,945,778 for methods of treating brain neurological disorders using EB-002.

What disorders does the new patent for EB-002 cover?

The new patent for EB-002 covers treatments for sleep disorders, depression, substance-related disorders, and headaches.

How many patents does EB-002 now hold?

EB-002 now holds three US patents covering its compositions, formulations, and methods of treatment.

Why is the new patent for EB-002 significant?

The new patent is significant because it expands the intellectual property protection and potentially accelerates clinical development, reducing risks associated with the drug candidate.

Enveric Biosciences, Inc.

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