Enveric Biosciences Announces New U.S. Patents Supporting EVM301 Series and EVM201 Series Compounds

Rhea-AI Summary

Enveric Biosciences (NASDAQ: ENVB), a biotechnology company focused on neuroplastogenic therapeutics, announced the issuance of two U.S. patents (Nos. 12,133,856 and 12,138,276) for its EVM301 series molecules, bringing the total to 11 patents. These patents cover novel psilocybin derivative compounds and their pharmaceutical formulations. Enveric's lead candidate, EB-003, targets anxiety, depression, and addiction disorders, showing potential for promoting neuroplasticity without hallucinogenic effects. Additionally, two other patents (Nos. 12,065,404 and 12,077,498) were issued for EVM201 series prodrugs, protecting novel tryptamine derivatives. Enveric has licensed its EVM201 series to MycoMedica Life Sciences and announced out-licensing deals with MycoMedica and Aries Science & Technology, positioning Enveric to focus on EB-003 development and establish potential future income streams.

Positive

• Issuance of two new U.S. patents for EVM301 series, expanding intellectual property portfolio.
• Lead candidate EB-003 shows potential for neuroplasticity without hallucinogenic effects.
• Out-licensing deals with MycoMedica and Aries Science & Technology establish potential future income streams.

Negative

• No immediate clinical trial data or revenue reported for EB-003 or other compounds.

Insights

Patent Law Expert

The issuance of four new U.S. patents significantly strengthens Enveric's intellectual property portfolio, particularly for their lead compound EB-003 and out-licensed assets. The two patents for EVM301 series provide expanded protection for novel psilocybin derivatives and formulations, while the two patents for EVM201 series protect their prodrug technology licensed to MycoMedica. This robust IP protection creates substantial barriers to entry and increases the commercial value of both their in-house development programs and licensing deals. The broad claims covering composition, formulation and manufacturing methods suggest a well-structured patent strategy that could provide market exclusivity well into the future. The timing aligns well with their pre-clinical progress on EB-003 and recent out-licensing activities.

Biotech Research Analyst

The development strategy for EB-003 shows promising commercial potential by targeting key differentiating features: oral administration and non-hallucinogenic effects while maintaining neuroplastogenic properties. These characteristics could provide significant advantages in the mental health therapeutics market, particularly for anxiety, depression and addiction disorders. The company's dual approach of advancing EB-003 while monetizing non-core assets through licensing deals with MycoMedica and Aries demonstrates efficient resource allocation. The Psybrary™ platform, containing over 1,000 tryptamine derivatives, represents a valuable asset for future development candidates and potential licensing opportunities. This strategic focus on EB-003 while maintaining revenue potential from licensed assets presents a balanced approach to drug development.

New patents provide additional composition of matter and methods of use claims for Enveric’s EVM301 series neuroplastogenic molecules, and recently out-licensed tryptamine-derived prodrugs, including EB-002, a new chemical entity psilocin prodrug

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of anxiety, depression, and addiction disorders, today announced that the United States Patent and Trademark Office (USPTO) has issued two U.S. Patents, Nos. 12,133,856 (the ‘856 patent) and 12,138,276,(the ‘276 patent) bringing the total number of issued patents supporting its EVM301 series molecules to 11. The claims of the ‘856 patent and the ‘276 patent expand the range of protection for novel, non-obvious multi-substituent and halogenated psilocybin derivative compounds and pharmaceutical formulations containing such compounds, respectively.

Enveric’s EB-003 compound emerged as Enveric’s lead candidate from its EVM301 series of molecules and was generated from its molecular library, Psybrary™, a proprietary catalogue of over 1,000 tryptamine derivatives that incorporates receptor engagement and functional data to correlate structure with biological activity. EB-003 is intended to target anxiety, depression, and addiction disorders. Recent announcements have highlighted the promising pre-clinical data demonstrating the potential for the EB-003 compound to promote neuroplasticity and be orally administered at doses believed to be efficacious without hallucinogenic effect, both of which we believe to be key criteria of commercial and regulatory interest.

In addition, Enveric announced that the USPTO has issued two other U.S. Patents, No. 12,065,404 (the ‘404 patent) and 12,077,498 (the ’498 patent), related to its EVM201 series prodrug molecules. The claims of the ‘404 patent and ‘498 patent protect novel, non-obvious C4-carboxylic acid-substituted tryptamine derivative compounds and pharmaceutical drug formulations containing such compounds, and methods of making such compounds, respectively. These compounds are prodrugs intended to treat neurological disorders. Enveric recently announced that it licensed its EVM201 Series to MycoMedica Life Sciences (MycoMedica). These additional patents strengthen and underscore the potential value to Enveric and MycoMedica, which plans to develop the lead EVM201 Series compound EB-002.

“These patent issuances from the USPTO add important pillars to Enveric’s intellectual property portfolio as we continue to distinguish the pre-clinical performance of our tryptamine-based molecules under development for the treatment of mental health disorders from others on the market or under development,” said Joseph Tucker, Ph.D., Director and CEO of Enveric. “Importantly, with our focus squarely on our EVM301 Series, we expect to continue uncovering positive data highlighting the promising properties of EB-003, which is designed to capitalize on the potential for inducing neuroplasticity without causing hallucinations that can meet key commercial and regulatory criteria to advance to clinical trials.”

Enveric has announced out-licensing deals with MycoMedica and Aries Science & Technology, which positions Enveric to focus its resources on development of its lead compound EB-003. These deals establish potential future income streams to support the development and commercialization of Enveric’s pipeline candidates.

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, Psybrary™, Enveric has created a robust intellectual property portfolio of new chemical entities for specific mental health indications. Enveric’s lead molecule, EB-003, is a potential first-in-class neuroplastogen designed to promote neuroplasticity, without inducing hallucinations, in patients suffering from difficult-to-address mental health disorders. Enveric is focused on advancing EB-003 towards clinical trials for the treatment of neuropsychiatric disorders while out-licensing all other novel, patented Psybrary™ drug candidates to third-party licensees advancing non-competitive market strategies for patient care. 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,” “explores,” “schedules,” “seeks,” “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. Forward-looking statements may include statements regarding beliefs, plans, expectations, or intentions regarding the future and are based on the beliefs of management as well as assumptions made by and information currently available to management. 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: successfully outlicense patented Psybrary™ drug candidates to third-party licensees; negotiate and finalize definitive agreements based on any of its out-licensing term sheets and for licensees to perform pursuant to the terms thereof; finalize and submit its IND filing to the U.S. Food and Drug Administration; 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.

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Investor Relations

Tiberend Strategic Advisors, Inc.

David Irish

(231) 632-0002

dirish@tiberend.com

Media Relations

Tiberend Strategic Advisors, Inc.

Casey McDonald

(646) 577-8520

cmcdonald@tiberend.com

Source: Enveric Biosciences

FAQ

What are the new patents issued to Enveric Biosciences?

The new patents issued are Nos. 12,133,856 and 12,138,276 for EVM301 series molecules and Nos. 12,065,404 and 12,077,498 for EVM201 series prodrugs.

What is Enveric Biosciences' lead candidate for treating mental health disorders?

Enveric's lead candidate is EB-003, designed to treat anxiety, depression, and addiction disorders.

What is the significance of the new patents for Enveric Biosciences?

The new patents strengthen Enveric's intellectual property portfolio and protect novel psilocybin and tryptamine derivative compounds, enhancing the company's market position.

How do the new patents impact Enveric Biosciences' business strategy?

The new patents allow Enveric to focus on developing EB-003 and establish potential future income streams through out-licensing deals with MycoMedica and Aries Science & Technology.

What is the stock symbol for Enveric Biosciences?

The stock symbol for Enveric Biosciences is ENVB.