CAMBRIDGE, Mass. – Enveric Biosciences, Inc (NASDAQ: ENVB), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders, today announced that it has signed a non-binding term sheet with an undisclosed biotechnology development and commercialization company (“Licensee”) to exclusively out-license two patent families of Methods for Treating Breast Cancer and Other Cancers for development through additional discovery and preclinical stages using cannabinoids in combination with chemotherapeutic drugs to treat cancer.
In an historic move on Tuesday April 30, 2024, the Biden administration moved to reschedule marijuana, one source of cannabinoids, as a Schedule III controlled substance. The action followed study by the U.S. Department of Health and Human Services (“HHS”), recommendations by both HHS and the Department of Justice (“DOJ”), and support from the U.S. Drug Enforcement Agency (“DEA”) that acknowledge the medical benefits of this class of drugs. Enveric applauds the move by the Biden administration which enjoys bi-partisan Congressional support and advances the development of medical uses of much needed drugs.
Under the terms of the agreement with Enveric, the Licensee will receive an exclusive, global license to the methods, and devices and drugs developed to practice the methods, which feature using cannabinoids in combination with chemotherapeutic drugs and will assume responsibility for all future preclinical and clinical development on a royalty-bearing basis for all human and animal pharmaceutical applications.
Assuming certain conditions are met, the Licensee will pay Enveric a License Execution Fee and development and sales milestones up to $61 Million, and royalties (ranging from 2.5% up to 10%) on all future sales. The Licensee also has a cash Buyout Option.
Based on preliminary work performed by a renowned UK-based research hospital, it is believed that the methods of using novel treatment regimens that include cannabinoids combinations have potentially a significant impact for patients living with breast and other cancers. It is anticipated that the Licensee may advance these methods into the next stages of development, and further into clinical trials which would demonstrate a major value driver for both Enveric and the Licensee.
“We are excited to see the Licensee taking this innovative approach in effort to advance a novel treatment based on our discovery,” said Joseph Tucker, Ph.D., Director and CEO of Enveric. “We look forward to partnering with the Licensee and are confident in their leadership to translate these discoveries into promising treatments for cancer patients. Importantly, this agreement further supports Enveric’s discovery capabilities and its ability to advance novel treatments for cancer and to make them available for others to pursue commercially outside the company with strong future potential upside to Enveric.”
Breast Cancer alone has approximately 311,000 new cases diagnosed annually in the US, and over 4 million women have a history of, or are in treatment, for breast cancer in the US. The licensed methods also apply to many other forms of cancer that afflict millions more patients in the US.
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 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
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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,” “proposed,” “is expected,” “budgets,” “scheduled,” “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 historical statements and 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: negotiate and finalize definitive agreements based on the out-licensing term sheets and perform pursuant to the terms thereof; carry out successful clinical programs in Australia; 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. The out-licensing term sheets identified herein are non-binding and may not result in definitive agreements or attainment of the licensing fees referenced therein.
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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