EB-003, Enveric’s lead product candidate, is protected by a different patent family that includes an issued U.S. patent and pending U.S. and international patents, all of which are separate and distinct from the patent that appears relevant to Bretisilocin

CAMBRIDGE, Mass.--(BUSINESS WIRE)--

Enveric Biosciences ( ENVB ) (“Enveric” or the “Company”), a biotechnology company advancing next-generation neuroplastogenic small molecules to address psychiatric and neurological disorders, today announced that it has hired intellectual property powerhouse Fish and Richardson P.C. to contest a Post-Grant Review (PGR) petition filed by Gilgamesh Pharmaceuticals (Gilgamesh) against Enveric’s issued U.S. Patent No. 12,138,276 (the’276 patent,) entitled, “Halogenated psilocybin derivatives and methods of using.”

Enveric’s ’276 patent includes claims that appear relevant to the Bretisilocin (GM-2505) molecule currently in clinical trials, which AbbVie agreed to acquire on August 25, 2025 in a definitive transaction valued at up to $1.2 billion (AbbVie to Acquire Gilgamesh Pharmaceuticals' Bretisilocin, a Novel, Investigational Therapy for Major Depressive Disorder, Expanding Psychiatry Pipeline).

The Gilgamesh PGR petition specifically targets claims that may be relevant to Bretisilocin and other claims of the ‘276 patent. Enveric’s ’276 patent family also includes one additional issued U.S. patent, a pending U.S. application, and related international patent applications in Australia, Canada, China, Europe, Japan, Mexico, and South Korea.

The Enveric ’276 patent family does not cover the pipeline of Enveric’s proprietary therapeutic candidates, such as EB-003, which are protected under separate, distinct patent families. Enveric’s intellectual property portfolio, including the ’276 patent family, includes 26 issued U.S. patents and a total of 60 pending national and international applications covering five programs.

Enveric’s product pipeline features

EB-003, a differentiated therapeutic candidate with dual agonism at 5-HT1B and 5-HT2A receptors in development for depression and anxiety, which is advancing toward the filing of an IND to begin human clinical trials;

The EVM-401 series of small molecules discovered through its proprietary research platform; and

Three programs and related patent portfolios that have been successfully out-licensed to third parties for development1,2,3.

Under those licenses, Enveric is eligible to receive aggregate upfront, development, and sales milestones potentially totaling up to $205 million, plus royalties on future sales.

“Enveric has built a diversified product pipeline and a broad intellectual property estate designed to deliver novel solutions for serious neuropsychiatric conditions,” said Dr. Joseph Tucker, Chief Executive Officer of Enveric Biosciences ( ENVB ). “As major pharmaceutical companies pursue novel approaches in this field, Enveric has gained attention and is well positioned with differentiated patented molecules, national and international patent portfolios, and multiple programs advancing toward clinical development directly and through licensees. Enveric will vigorously defend its intellectual property and take all steps necessary to maximize the value of its intellectual property for shareholders.”

References

Aries Science & Technology and Enveric Biosciences Announce Licensing Agreement – July 15, 2024

Enveric Biosciences Signs Out-Licensing Agreement with MycoMedica Life Sciences for EB-002 – November 12, 2024

Enveric Biosciences ( ENVB ) and Restoration Biologics Announce Licensing Agreements to Treat Joint Disease – February 4, 2025

About Enveric Biosciences ( ENVB )

Enveric Biosciences ( ENVB ) is a biotechnology company focused on developing next-generation, small-molecule neuroplastogenic therapeutics that address unmet needs in psychiatric and neurological disorders. By leveraging a differentiated drug discovery platform and a growing library of protected chemical structures, Enveric is advancing a pipeline of novel compounds designed to promote neuroplasticity without hallucinogenic effects. Enveric’s lead candidate, EB-003, is the first known compound designed to selectively engage both 5-HT₂A and 5-HT₁B receptors to deliver fast-acting, durable antidepressant and anxiolytic effects with outpatient convenience.

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: 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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Source: Enveric Biosciences ( ENVB )