• Enveric and Aries recently announced a Licensing Agreement for patented topical product aimed at treating radiation dermatitis, which impacts approximately two million cancer patients per year and has a market opportunity estimated at $400 million annually

CAMBRIDGE, Mass. / Aug 13, 2024 / Business Wire / Enveric Biosciences (NASDAQ: ENVB) (“Enveric”), a biotechnology company dedicated to the development of novel neuroplastogens for the treatment of neuropsychiatric disorders, and Aries Science & Technology (“Aries”), a developer of encapsulation technologies, today announced that Patent No. 12,059,393 was issued on August 13, 2024, to Enveric’s wholly-owned subsidiary, Akos Biosciences, Inc. (“Akos”).

We believe the newly issued intellectual property strengthens Enveric’s patent portfolio. On July 15, 2024, Enveric announced entering into a Licensing Agreement between Aries and Akos for the clinical development of Enveric’s now-patented topical product for radiation dermatitis and other conditions (“Licensing Agreement”).

“The additional patent issuance greatly enhances investment potential in the subsidiary being formed by Aries to advance a CBD-based lotion, which has demonstrated promising preliminary results in early-stage animal tests conducted by Enveric,” said Dr. Ramanathan Lalgudi, Founder and CEO of Aries. “We believe the newly issued patent is key to launching a protectable and proprietary formulation, as we work to develop treatments to reduce the side effects and increase the tolerance of radiation therapy and enhance the life of millions of cancer patients suffering from radiation dermatitis.”

Aries earlier announced its nomination of Hari Harikumar, Ph.D., as Chairman-elect of an Aries subsidiary being formed to advance this opportunity. Dr. Harikumar is a successful techno-commercial entrepreneur having experience with multiple companies.

“We believe the patent issuance and Aries’ commitment to this novel technology strongly validates both the potential economic and commercial benefit of Enveric’s innovations and our commitment to providing solutions that address patient needs,” said Joseph Tucker, Ph.D., CEO of Enveric. “We deeply value Enveric’s relationship with Aries and are confident in their ability to develop the CBD product and bring it to patients.”

“The out-licensing of the CBD-related technology, and our ongoing relationship with Aries, supports Enveric’s mission by allowing us to focus our resources on the development of our lead neuroplastogen drug candidate, EB-003, for the treatment of critical neuropsychiatric disorders,” said Dr. Tucker.

Under the terms of the Licensing Agreement with Aries, assuming success in meeting all conditions in the Licensing Agreement, Enveric will be eligible to receive aggregate milestone payments of up to $61 million, as well as tiered royalties ranging from 2.5% to 10% on future sales.

About Aries Science and Technology LLC

Aries has research laboratories In Columbus, Ohio and possesses deep technical expertise relevant to the envisioned product forms. Aries is planning to establish an investable subsidiary focused on completing development, commercialization and launch of the topical product and projects a potential product pipeline featuring multiple patented formulations.

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, the 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.

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: negotiate and finalize definitive agreements based on the any of its out-licensing term sheets and perform pursuant to the terms thereof; 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.