Agomelatine

CAMBRIDGE, Mass. – 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 psychiatric and neurological disorders, today announced the issuance of a new U.S. patent (USPTO Number 12,187,679). The patent strengthens Enveric’s intellectual property portfolio and covers a structurally diverse class of novel molecules with potential therapeutic applications in the treatment of sleep and central nervous system (CNS) disorders. The newly granted patent, titled, “Hydroxylated Psilocybin Derivatives and Methods of Using,” expands Enveric’s proprietary drug discovery platform and includes a unique subset of compounds that demonstrate selective binding to the melatonin MT1 receptor-an established, therapeutic target known to regulate circadian rhythm and sleep-wake cycles. These molecules were identified through Enveric’s structure-activity screening efforts. Melatonin signaling is a clinically validated pathway in the treatment of sleep and mood disorders. Several approved therapies leverage this mechanism of action, including ramelteon (Rozerem®), a selective MT1/MT2 agonist approved by the FDA for insomnia, and agomelatine (Valdoxan®), an MT1/MT2 agonist and 5-HT C antagonist approved in Europe for major depressive disorder (MDD). These drugs provide market validation for targeting melatonergic pathways. Among the diverse molecules covered by the patent, select compounds exhibit potential to act as MT1-selective agonists, positioning them as promising candidates for the development of innovative sleep therapeutics. Some of these compounds also display more complex pharmacological profiles, engaging both melatonin and other CNS-relevant receptor systems. This receptor diversity may enable differentiated therapeutic approaches across a range of psychiatric and neurological indications. The Company believes this new patent enhances the strength of its drug discovery platform and supports continued expansion of its CNS-focused strategy targeting high-value therapeutic markets. Dr. Joseph Tucker, CEO of Enveric Biosciences, commented “This newly issued patent adds to the growing body of intellectual property that underpins our pipeline of next-generation neuroplastogenic therapeutics. The inclusion of selective melatonin receptor-binding compounds broadens our ability to target sleep disorders, a prevalent category representing a multi-billion-dollar annual market. This intellectual property milestone strengthens our strategic position to advance differentiated candidates in areas where current treatment options remain limited or suboptimal.” 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 psychiatric and neurological disorders. Leveraging its unique discovery and development Psybrary™ platform, which houses proprietary information on the use and development of existing and novel molecules for specific mental health indications, Enveric seeks to develop a robust intellectual property portfolio of novel drug candidates. 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 other novel, patented Psybrary™ platform 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: 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. View source version on businesswire.com: https://www.businesswire.com/news/home/20250603483507/en/ 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