• MindBio to develop the novel psilocin prodrug for neuropsychiatric indications utilizing microdosing to reduce or eliminate hallucinogenic impact of psychedelic compounds

CAMBRIDGE, Mass. / May 14, 2024 / Business Wire / 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 depression, anxiety, and addiction disorders, today announced that it has signed a non-binding term sheet to out-license a class of Novel Psilocin Prodrugs (“NPP”) to Vancouver, BC-based MindBio Therapeutics (CNSX: MBIO)(“MindBio”), a clinical stage biopharma company, which is pioneering novel treatments for psychiatric conditions using microdoses of psychedelic medicines.

Enveric’s NPP molecules are designed to be metabolized specifically to release therapeutic levels of systemic psilocin at varying rates. Enveric has generated a library of NPP compounds protected by an issued US patent, and further claimed in two pending US patent applications and three international Patent Corporation Treaty (PCT) patent applications. The library of NPP compounds includes molecules with varying properties such as enhanced gastrointestinal (GI) stability, increased absorption properties, and variable cleavable substitutions producing altered pharmacokinetic properties.

Pursuant to the terms of the non-binding term sheet, MindBio will seek to advance a drug candidate from the NPP class for neuropsychiatric indications such as depression. The term sheet states that upon entering into a definitive agreement, MindBio would receive an exclusive, global license to the formulations, drugs, method of use, and devices developed to utilize the compound from Enveric and would assume responsibility for all future preclinical, clinical, and commercial development on a royalty-bearing basis for all human and animal pharmaceutical applications.

If a definitive agreement is entered into and certain conditions are met, MindBio would pay Enveric development and sales milestones up to an aggregate $66.5 Million and royalties (ranging from 2.5% up to 10%) on all future sales. The license would include the right to sublicense and cash buyout options.

“We look forward to working with MindBio’s team, which is pioneering an important part of the exciting psychedelic space, focused on controlling dose to reduce or eliminate hallucinations associated with these powerful compounds,” said Joseph Tucker, Ph.D., Director and CEO of Enveric. “This non-binding term sheet highlights the potential synergies between the Enveric and MindBio approaches to leveraging psychedelic-based compounds to target specific signaling pathways in the brain for the treatment of neuropsychiatric conditions.”

“We are pleased to explore an opportunity to draw on the molecular discovery engine at Enveric and believe this novel and patented asset significantly strengthens our intellectual property pipeline and aligns with our strategy to develop innovative, protected compounds with fine-tuned formulation and dosing strategies,” said Chief Executive Officer of MindBio, Justin Hanka. “We look forward to the prospect of progressing this asset into clinical trials as we seek to bring important and beneficial therapies to patients in need.”

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.

About MindBio Therapeutics

MindBio Therapeutics (CNSX: MBIO) is a leading biotech/biopharma company focused on creating novel and emerging treatments for mental health conditions and is conducting world first take-home Microdosing (MB22001) human clinical trials. MB22001 is MindBio’s lead candidate drug, a proprietary titratable form of Lysergic Acid Diethylamide (LSD) designed for take-home microdosing. MindBio is a leader in microdosing of psychedelic medicines and is advancing its drug and technology protocols through clinical trials. MindBio has developed a multi-disciplinary platform for developing treatments and is involved in psychedelic medicine development and digital therapeutics, has completed Phase 1 clinical trials in 80 healthy participants and has completed a Phase 2A clinical trial in patients with Major Depressive Disorder, both trials with positive top line data reported. Currently underway are two Phase 2B trials, one in cancer patients experiencing existential distress and another in patients with Major Depressive Disorder. The Company is also approved for multiple Phase 2A/Phase 2B trials in women’s health. MindBio invests in research that forms the basis for developing novel and clinically proven treatments including digital technologies and interventions to treat debilitating health conditions such as depression, anxiety and other related mental health conditions.

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,” “budgets,” “explores,” “scheduled,” “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 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 any of its out-licensing term sheets and for licensees to 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 sheet identified herein is non-binding and may not result in a definitive agreement or attainment of the licensing fees or royalties 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.