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Enveric Biosciences Reports Second Quarter 2024 Financial and Corporate Results Prioritized EB-003 as lead development candidate. EB-003 is a novel, non-hallucinogenic neuroplastogenic molecule designed to treat severe m

Key Takeaway: Enveric Biosciences reported its financial and corporate results for the second quarter of 2024, emphasizing the prioritization of EB-003 as its lead development candidate. EB-003 is a novel, non-hallucinogenic molecule designed to treat difficult mental health disorders, showing promising preclinical results. The company plans to file for Investigational New Drug status and begin human trials by the end of 2025. Meanwhile, Enveric also secured licensing agreements and significantly reduced its net losses compared to the previous year, although it ended the quarter with limited cash reserves.

Market Sentiment Analysis

POSITIVE FACTORS

  • Prioritization of EB-003 as lead development candidate is a strategic decision.
  • Preclinical results show oral bioavailability and significant brain exposure for EB-003.
  • Potential for EB-003 to treat difficult mental health disorders without inducing hallucinogenic effects.
  • Positive financial results with reduced losses compared to the same period last year.

CONCERNS & RISKS

  • Despite prioritizing EB-003, losses attributable to stockholders amount to $1.7 million.
  • The company had a relatively low cash-on-hand of $3.5 million, which may impact its operations.
  • Uncertainties regarding the successful negotiation of definitive agreements for out-licensing.

Full Press Release Details

Biosciences Reports Second Quarter 2024 Financial and Corporate Results
EB-003 as lead development candidate. EB-003 is a novel, non-hallucinogenic neuroplastogenic molecule designed to treat severe mental
preclinical results confirming oral bioavailability and significant brain exposure of EB-003, supporting expedited development strategy
business development activities to maximize assets developed using AI-backed drug discovery engine, with multiple deals in advanced stages
offering potential to contribute value to stockholders
Mass., August 12, 2024 - 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 second quarter ended June 30, 2024.
second quarter of 2024 was marked by the prioritization of EB-003 as our lead development candidate. This strategic decision was made
based on the potential for EB-003 to be a first-in-class neuroplastogenic molecule that can address multiple, difficult-to-treat mental
health disorders without inducing the hallucinogenic effect common to N,N-Dimethyltryptamine (DMT) and related analogs," said Joseph
Tucker, Ph.D., Director and CEO of Enveric. "We believe EB-003's differentiated properties set it apart from other drugs
in this class and address many of the challenges facing psychedelic-derived drugs, including the ability to conduct truly blinded placebo-controlled
clinical trials and the potential to administer the therapy in an outpatient setting without psychotherapy support. Adding to the excitement
with EB-003, recently completed pre-clinical research indicated the potential for the drug candidate to be delivered via oral administration
and penetrate the brain at levels expected to elicit the desired therapeutic effect."
Tucker continued, "Given the value potential of EB-003, we are accelerating its evaluation in several in vivo animal efficacy
models to determine the optimal therapeutic indication for clinical development and expected dose range as we prepare for a pre-Investigational
New Drug ("IND") meeting with the U.S. Food and Drug Administration in early 2025. This timeline should then allow for the
filing of an IND application by the third quarter of 2025 and initiation of a first-in-human clinical trial of EB-003 by the end of 2025."
Tucker concluded, "Complementing our EB-003 development efforts, during the second quarter we expanded our initiative to secure
out-licensing opportunities involving proprietary drug candidates identified through Enveric's drug discovery engine and other
compounds owned by the company. We were pleased to enter into a licensing agreement with Aries Science & Technology for our patented
radiation dermatitis topical product and enter into a number of non-binding term sheets, which collectively have the potential to generate
non-dilutive revenue, which could support Enveric's ability to advance its lead asset, EB-003, and further build stockholder value."
QUARTER AND RECENT UPDATES
Product and Business Development Highlights:
Signed non-binding term sheets to pursue the exclusive out-licensing of new chemical entities for pharmaceutical and non-pharmaceutical applications in joint disease
Signed non-binding term sheet with undisclosed licensee for the exclusive license to patented methods of treating breast and other cancers using cannabinoids
Provided strategic outlook and pipeline update, elevating EB-003 to lead development candidate
Confirmed oral bioavailability and significant brain exposure preclinical studies of EB-003, supporting expedited development with IND filing and first patient dosed expected in 2025
Announced patent granted for drug candidate
Signed licensing agreement with Aries Science & Technology with plans to clinically develop and market Enveric's patented product for radiation dermatitis
QUARTER FINANCIAL RESULTS
loss attributable to stockholders was $1.7 million for the second quarter ended June 30, 2024, including $0.4 million in net non-cash
expense, with a basic and diluted loss per share of $0.23, as compared to a net loss of $6.40 million, including $1.6 million in net
non-cash expense, with a basic and diluted loss per share of $3.04 for the quarter ended June 30, 2023. The Company had cash-on-hand
of $3.5 million for the quarter ended June 30, 2024.
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.
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.
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.
Strategic Advisors, Inc.
Strategic Advisors, Inc.

Frequently Asked Questions

What is EB-003 designed to treat?

EB-003 is created to treat severe mental health disorders like depression and anxiety.

When is the first human trial for EB-003 expected?

The first human trial for EB-003 is anticipated to start by the end of 2025.

What recent agreement was signed by Enveric Biosciences?

Enveric Biosciences signed a licensing agreement with Aries Science & Technology.

What phase is EB-003 in its development process?

EB-003 has been prioritized as the lead candidate and is in preclinical evaluation.

How much cash did Enveric have as of June 30, 2024?

Enveric had $3.5 million in cash on hand as of June 30, 2024.

Last updated: Aug 12, 2024