On May 8, 2024 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, reported 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 (Press release, Enveric Biosciences, MAY 8, 2024, View Source [SID1234642874]).

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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.