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Enveric Biosciences Reports First Quarter 2024 Financial and Corporate Results

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Enveric Biosciences (NASDAQ: ENVB) reported financial and corporate results for the first quarter of 2024, ending March 31. The company unveiled seven classes of novel drug candidates from its Psybrary™ and PsyAI™ platforms. A business development campaign resulted in seven non-binding term sheets with four strategic partners, potentially totaling $410 million in milestone payments plus future royalties. Enveric's lead drug candidate, EB-003, is advancing towards an IND application and Phase 1 clinical trial. Proceeds from warrant exercises and investment options raised $4.5 million. The company's net loss for Q1 2024 was $2.46 million, with cash-on-hand at $6.36 million.

Positive
  • Unveiled seven classes of novel drug candidates.
  • Executed seven non-binding term sheets with four strategic partners totaling up to $410 million in potential milestone payments plus future royalties.
  • Advanced lead drug candidate, EB-003, towards an IND application and Phase 1 clinical trial.
  • Raised $4.5 million through warrants and investment options.
  • Net loss reduced to $2.46 million in Q1 2024 from $4.80 million in Q1 2023.
  • Cash-on-hand at $6.36 million by the end of Q1 2024.
Negative
  • Net loss of $2.46 million for Q1 2024.
  • Basic and diluted loss per share of $0.61.
  • Potential uncertainty in converting non-binding term sheets into definitive agreements.

Insights

Enveric Biosciences has reported a mixed bag of financial results. The $2.46 million net loss attributable to stockholders for the first quarter of 2024, although a reduction from the previous year’s loss of $4.80 million, still indicates that the company is in a challenging financial position. One encouraging sign is the company’s cash-on-hand of $6.36 million, which provides some buffer for ongoing operations.

From a financial standpoint, the potential milestone payments of approximately $410 million from strategic partners are highly significant. While these are non-binding agreements, successfully converting them into definitive agreements could provide a substantial influx of non-dilutive capital. This would be instrumental in advancing Enveric’s lead preclinical asset, EB-003 and perhaps mitigating future financial strain.

However, investors should approach these agreements with caution. Non-binding term sheets are not guaranteed revenue and depend on the company meeting specific development and sales milestones. It’s essential to monitor how these agreements progress.

The progress reported on EB-003 is noteworthy. This drug candidate, designed to provide antidepressant and anxiolytic effects without hallucinogenic side effects, could offer a novel treatment for neuropsychiatric disorders. If successful in its IND filing and subsequent Phase 1 trials, EB-003 stands to meet a significant unmet medical need. It's promising that Enveric has received interest from strategic partners in the pharmaceutical industry for this candidate.

Understanding neuroplastogen as a term is important here. Neuroplastogens are compounds believed to promote neural plasticity, assisting in the brain’s ability to adapt and reorganize itself. These could potentially offer more predictable and durable treatment benefits for conditions like depression and anxiety.

Investors should watch for the results of the Phase 1 clinical trial closely. Positive outcomes could boost investor confidence and potentially lead to higher valuations, but the challenges of drug development mean there is also significant risk involved.

Enveric’s strategic move to execute seven non-binding term sheets with potential milestone payments totaling up to $410 million suggests a strong business development initiative. Engaging with four strategic partners to out-license drug candidates derived from psychedelic and cannabinoid structures diversifies the company’s portfolio and spreads potential risks.

Market dynamics favor innovative treatments in the realms of depression, anxiety and addiction disorders, especially those that can be administered conveniently on an outpatient basis. Enveric’s focus on non-hallucinogenic compounds could carve a niche market. Nevertheless, the reliance on converting non-binding term sheets into definitive agreements adds an element of uncertainty.

For retail investors, it’s important to track how these term sheets evolve. The successful execution of these agreements will likely be a key determinant in Enveric’s future revenue streams and stock performance. Ensuring that these partnerships translate into financial gain is critical for Enveric to sustain its R&D and stay competitive.

Revealed seven classes of promising novel drug candidates discovered using Enveric’s Psybrary™ and PsyAI™ drug discovery and artificial intelligence (AI) platforms

Launched business development campaign that resulted in the execution of seven non-binding term sheets with four strategic partners that upon entering into definitive agreements and performing pursuant to the terms thereof could potentially total up to approximately $410 Million in milestone payments, plus future royalties

Leading non-hallucinogenic neuroplastogen drug candidate, EB-003, continues to advance toward IND filing and subsequent Phase 1 clinical trial

Proceeds raised from the exercise of warrants, preferred investment options, and inducement warrants total $4.5 million

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 depression, anxiety, and addiction disorders, today provided a corporate update and reported financial results for the first quarter of 2024 ended March 31, 2024.

“We believe the first quarter of 2024 was a highly productive period for Enveric as the Company continued to advance development of the lead neuroplastogen drug candidate, EB-003, in preparation for an Investigational New Drug (IND) application and the expected initiation of a planned clinical development program,” said Joseph Tucker, Ph.D., Director and CEO of Enveric. “We continue to receive significant interest from strategic partners in the pharmaceutical industry for new drug candidates that target depression and anxiety disorders. We believe there is a need for new therapeutics that could potentially provide the anxiolytic and antidepressant properties clinically reported in the literature for certain psychedelic compounds without, at the same time, inducing the hallmark hallucinatory effects that defines such agents.”

Tucker continued, “Enveric anticipates that eliminating the hallucinogenic activity could allow for more convenient outpatient dosing and result in more predictable and durable treatment benefit to patients. EB-003 was designed specifically to address this major safety profile deficiency in the first-generation psychedelic approach to treating neuropsychiatric illness, and we are excited to advance its development.”

Tucker added, “In addition to progress with EB-003, we believe the first quarter confirmed the value produced by Enveric’s drug discovery engine with the unveiling of more than one thousand proprietary drug candidates generated to date, around which the Company has built a substantial intellectual property estate. Through the first quarter and moving into the second quarter of 2024, we have received interest from potential strategic out-licensing partners in these molecules by executing seven distinct non-binding terms sheets with four separate biotechnology companies. The new business relationships, if finalized in definitive agreements, offer a potential source of non-dilutive revenue through the Company meeting certain development and sales milestones, which could support Enveric’s ability to advance its lead asset, EB-003, and further build shareholder value.”

FIRST QUARTER AND RECENT UPDATES

Corporate, Product and Business Development Highlights:

  • Unveiled library of drug candidates, protected by Enveric’s intellectual property portfolio, that spans seven distinct molecule classes
  • Launched targeted business development campaign to unlock value from Enveric’s library of drug candidates through potential out-licensing
  • Executed seven non-binding out-license term sheets distributed among four strategic partners. The drug candidates to be potentially out-licensed are derived from both psychedelic and cannabinoid structures, and target cancer, joint disease, and neuropsychiatric indications
  • The seven term sheets, if converted into definitive agreements and the Company performs pursuant to the terms thereof, could represent an aggregate in milestone payments that could total up to approximately $410 Million, plus future royalties
  • Further advanced Enveric’s lead preclinical asset, EB-003, in support of upcoming IND submission and subsequent initiation of a Phase 1 clinical trial

FOURTH QUARTER AND FISCAL YEAR ENDED 2023 FINANCIAL RESULTS

Net loss attributable to stockholders was $2.46 million for the first quarter ended March 31, 2024, including $0.42 million in net non-cash expense, with a basic and diluted loss per share of $0.61, as compared to a net loss of $4.80 million, including $.46 million in net non-cash expense, with a basic and diluted loss per share of $2.31 for the quarter ended March 31, 2023. The Company had cash-on-hand of $6.36 million for the quarter ended March 31, 2024.

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.

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,” “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 any of its 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.

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.

Daniel Kontoh-Boateng

(862) 213-1398

dboateng@tiberend.com

Media Relations

Tiberend Strategic Advisors, Inc.

Casey McDonald

(646) 577-8520

cmcdonald@tiberend.com

Source: Enveric Biosciences

FAQ

What financial results did Enveric Biosciences report for Q1 2024?

Enveric Biosciences reported a net loss of $2.46 million for the first quarter of 2024.

What is Enveric Biosciences' lead drug candidate?

Enveric Biosciences' lead drug candidate is EB-003, a non-hallucinogenic neuroplastogen.

How much potential milestone payments could Enveric's new partnerships total?

Enveric's new partnerships could potentially total up to approximately $410 million in milestone payments plus future royalties.

How much cash-on-hand did Enveric have at the end of Q1 2024?

Enveric had $6.36 million in cash-on-hand at the end of Q1 2024.

What was the basic and diluted loss per share for Enveric in Q1 2024?

The basic and diluted loss per share was $0.61 for the first quarter of 2024.

What platforms did Enveric use to discover their new drug candidates?

Enveric used its Psybrary™ and PsyAI™ drug discovery and AI platforms to discover new drug candidates.

How much money did Enveric raise through warrants and investment options?

Enveric raised $4.5 million through the exercise of warrants and investment options.

Enveric Biosciences, Inc.

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