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Enveric Biosciences CEO Issues Letter to Shareholders

Enveric Biosciences CEO Issues Letter to Shareholders

CAMBRIDGE, Mass.–(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 anxiety, depression, and addiction disorders, today announced that Joseph Tucker, Ph.D., CEO and Director, has issued a Letter to Shareholders to provide an update on the Company’s development program and recent events. The full text of the letter follows.

A MESSAGE FROM OUR CHIEF EXECUTIVE OFFICER

To Our Valued Shareholders,

This is a very exciting time in the growth and evolution of Enveric. We have successfully completed a strategic reshaping of the company to focus our business and development operations towards the advancement of EB-003 as our lead product. We believe EB-003 offers Enveric the greatest opportunity to drive shareholder value given its potential to be a first-in-class neuroplastogenic molecule that could address multiple, difficult-to-treat neuropsychiatric indications. We additionally recently unveiled an exciting new series of drug candidates in our pipeline, the EVM401 Series.

The EB-003 Value Proposition

At Enveric, we believe that in order to maximize the possibility of achieving regulatory approval and widespread market acceptance, the hallucinatory effect of psychedelic-inspired drug candidates must be reduced or eliminated completely. The June 2024 Advisory Committee for Lykos Therapeutics’ MDMA-assisted therapy spotlighted some of the challenges facing first generation psychedelic molecules undergoing development for neuropsychiatry indications. In particular, the concerns around separating placebo effect from drug efficacy can present significant hurdles to regulatory approval, since in the presence of hallucinations it will not be possible to keep the patients blinded to the treatment assigned.

Based on these and other factors, Enveric made the strategic decision in early 2024 to elevate our non-hallucinogenic neuroplastogen drug candidate, EB-003, to be the Company’s lead product candidate. We are focusing our resources to EB-003’s development and the EVM401 Series pipeline compounds. Beyond streamlining the regulatory review and approval process, minimizing hallucinations should also strengthen our case in seeking an outpatient treatment label, which we believe would have a significant impact on patient, healthcare provider, and health care system acceptance of EB-003.

EB-003: An Orally Bioavailable, Brain-Delivered Neuroplastogen

In 2024, we generated data that demonstrated EB-003’s ability to bind to the 5-HT2A receptor and induce neuroplasticity, the hypothesized mechanism of action for neuroplastogens. We also demonstrated EB-003 does not elicit a significant head twitch response (“HTR”) in mice. HTR is a behavioral model used to predict the likelihood of a drug candidate to induce hallucinations when administered to humans. We next produced preclinical data that confirmed EB-003 has the potential to be delivered orally and to penetrate the brain at levels anticipated to elicit the desired therapeutic effect.

We are now focused on completing the studies required for EB-003’s Investigational New Drug (“IND”) application. Once we have a pre-IND meeting with the U.S. Food and Drug Administration (“FDA”), we should be poised to advance EB-003 into Phase 1 clinical trials.

Building Additional Value from Our Portfolios of Patented Technologies

We were pleased to enter into two licensing agreements during 2024, deriving additional value from our portfolio of patented product candidates. We entered into agreements with Aries Science & Technology, which plans to develop and market Enveric’s patented product for radiation dermatitis, and MycoMedica Life Sciences, which intends to develop and market Enveric’s patented drug candidate, EB-002, for neuropsychiatric disorders.

This business development momentum has continued into 2025. We recently entered into two additional licensing agreements with Restoration Biologics, which expects to develop and market Enveric’s patented Cannabinoid-COX-2 conjugate compounds for use in treating joint disease. We believe that out-licensing our non-core assets has the potential to generate non-dilutive revenue and build shareholder value.

We continue to strengthen and expand the intellectual property estate for our lead drug candidate, EB-003, and for additional new technologies that emerge from our discovery process. We were recently granted several additional U.S. patents for our EVM301 series of neuroplastogenic molecules, as well as for our now out-licensed EVM201 series, including EB-002.

Recently, we were pleased to receive a U.S. patent for a new series of mescaline-inspired drug candidates, which the company has unveiled as the first patent protecting its EVM401 Series. We will be revealing more in the future about this new group of drug candidates.

Positioning Enveric for Long-Term Growth

Enveric is at the forefront of the new field of neuroplastogens focused on providing entirely new treatment options for patients with neuropsychiatric disorders, an area of medicine that has been without substantial innovation for many years. Our goal is ambitious, but we are energized by the potential of EB-003 to be a first-in-class neuroplastogen designed to promote neuroplasticity, without inducing hallucinations.

The past two years have presented a challenging fundraising environment for innovative drug development companies, including Enveric. Recognizing this, we elected to streamline and manage operations to conserve our financial resources until the capital markets environment became more receptive to innovative drug development. We are hopeful that the markets are beginning to show signs of improvement, which is why we recently effected a reverse stock split and closed a public offering of common stock and warrants, raising approximately $5 million in gross proceeds; our first offering of this type in approximately two years.

As 2025 is underway, we believe the Company is well positioned to cement its leadership role in the industry by advancing the development of our innovative drug candidate, EB-003, for the treatment of neuropsychiatric conditions. We eagerly look forward to advancing toward clinical trials and ultimately receiving regulatory approval, so we can bring EB-003, and later our EVM401 Series candidates, to the market in support of our twin goals of improving the lives of patients and generating value for our shareholders.

Sincerely,

Joseph Tucker, Ph.D.

CEO and Director

Enveric Biosciences

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™, 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 all other novel, patented Psybrary™ 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: successfully outlicense patented PsybraryTM drug candidates to third-party licensees; negotiate and finalize definitive agreements based on any of its out-licensing term sheets and for licensees to perform pursuant to the terms thereof; 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.

Investor Relations

Tiberend Strategic Advisors, Inc.

David Irish

(231) 632-0002

[email protected]

Media Relations

Tiberend Strategic Advisors, Inc.

Casey McDonald

(646) 577-8520

[email protected]

KEYWORDS: Massachusetts United States North America Canada

INDUSTRY KEYWORDS: Mental Health Health Neurology Research Science Pharmaceutical Biotechnology

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