Product Development Highlights:
- Selected neuroplastogen lead candidate EB-003, a potential
first-in-class therapeutic option for addressing difficult-to-treat
mental health disorders by promoting neuroplasticity without
inducing hallucinations.
- Started IND-enabling preclinical activities for EB-002 and
completed important repeat-dose toxicology studies, genotoxicity
studies, and key cardiac, respiratory, and CNS safety pharmacology
studies.
Corporate and Business Development Highlights:
- Signed three non-binding term sheets with an undisclosed
biotechnology company to pursue the out-licensing of three classes
of compounds from the Company’s extensive portfolio of assets.
- Signed two additional non-binding term sheets with a second
undisclosed biotechnology company to pursue the out-licensing of
pharmaceutical and non-pharmaceutical applications of cannabinoid
conjugate compounds.
- Expanded intellectual property portfolio through Q1 2024 with
seven patent issuances protecting composition of matter and methods
of use claims governing Enveric’s EVM301 Series of drug candidates
and four patent issuances protecting Enveric’s EVM201 Series of
drug candidates.
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 fourth
quarter of 2023 and fiscal year ended December 31, 2023.
“The fourth quarter of 2023 and early 2024 was a significant
period for Enveric, highlighted by the selection of EB-003 as our
lead development candidate. We believe EB-003 is a groundbreaking,
neuroplastogen drug candidate that offers the potential to treat
severe mental health disorders without the hallucinogenic effect
typically associated with psychedelic-based molecules,” said Joseph
Tucker, Ph.D., Director and CEO of Enveric. “Based on numerous
discussions with large pharmaceutical companies, mental health
professionals, and leading researchers, we believe it is evident
that widespread market acceptance of psychedelic-inspired drugs
will ultimately be determined by the ability to administer such
medications in an outpatient setting. We believe minimizing the
hallucinatory effect will be key to seizing this opportunity and
was critical in our decision to select EB-003 as our lead product
candidate of the EVM301 series. We now look forward to advancing
preclinical activities in early 2024 in support of filing an IND
for EB-003 as we seek to introduce a new treatment paradigm for
depression and anxiety disorders.”
Dr. Tucker continued, “The decision to designate EB-003 as our
lead candidate was the culmination of an extensive design and
evaluation process. This effort included the creation of more than
one thousand compounds around which we have built a substantial
intellectual property estate, increasing the attractiveness of
these molecules for further development. Already in 2024, we have
seen returns on this strategy in the form of out-licensing
agreements as partners recognize the value of our innovative
compounds that are protected with strong intellectual property and
have the potential to exapand therapeutic options for patients with
depression and anxiety. We will attempt to pursue additional
out-licensing and partnership opportunities throughout the year as
we continue to advance discussions with multiple possible partner
companies.”
Dr. Tucker concluded, “During the fourth quarter, we also
continued to progress IND-enabling preclinical work for EB-002,
completing important repeat-dose toxicology studies, genotoxicity
studies, as well as cardiac, respiratory markers, and CNS safety
pharmacology studies. We expect to finalize all preclinical
activities for EB-002 soon, making the asset Phase 1 ready in
2024.”
FOURTH QUARTER AND YEAR END UPDATES
Pipeline Advances and Highlight
- Selected EB-003 as lead drug candidate from the Company’s
next-generation EVM301 Series based on the molecule’s
pharmacological properties and it’s potential to be a
first-in-class treatment that addresses difficult-to-treat mental
health disorders.
- Presented two posters at the 6th Neuropsychiatric Drug
Development Summit and two posters at the Canadian Chemical
Engineering Conference (CSChE 2023) providing an update on the
Company’s near-term selection EB-003 and highlighting key
preclinical examinations of EB-002, a novel prodrug of
psilocin.
- Published cover article in the Journal of Medicinal Chemistry,
a peer-reviewed journal published by the American Chemical Society,
describing the development EB-002.
- Progressed preclinical development of psilocin prodrug, EB-002,
with GLP-toxicology and safety pharmacology studies, repeat dose
toxicology studies, as well as cardiac, respiratory, CNS safety
pharmacology studies, an in vitro hERG current study, and
genotoxicity studies.
Expanded Business Development and Out-Licensing Opportunities
in 2023 and 2024
- Signed three non-binding term sheets with an undisclosed
biotechnology company to pursue the out-licensing of three classes
of compounds; future development and sales milestone payments and
execution fees for the three licenses could total up to $200
million.
- Signed two non-binding term sheets with a second undisclosed
biotechnology company to pursue the out-licensing of cannabinoid
conjugate compounds for pharmaceutical and non-pharmaceutical
applications for the treatement of joint diseases; future
development and sales milestone payments and execution fees for the
two licenses could total up to $61 million.
- Surpassed one thousand synthesized compounds discovered and
characterized in our PsybraryTM portfolio of novel
psychedelic-inspired molecules, following the acceleration of our
AI-backed platform tailored for specific applications in the
management of mental health disorders.
- Continued to strengthen our intellectual property portfolio,
receiving ten patent issuances from the United States Patent and
Trademark Office.
FOURTH QUARTER AND FISCAL YEAR ENDED 2023 FINANCIAL
RESULTS
Net loss attributable to stockholders was $3.44 million for the
fourth quarter ended December 31, 2023, including $1.48 million in
net non-cash expense, with a basic and diluted loss per share of
$1.46, as compared to a net loss of $8.80 million, including $4.48
million in net non-cash expense, with a basic and diluted loss per
share of $4.89 for the quarter ended December 31, 2022.
On December 28, 2023, the Company completed a warrant inducement
transaction with two investors in which existing warrants were
repriced and exercised and new warrants were issued to the
investors. The cash proceeds from that transaction were received on
January 4, 2024. Subsequently, on February 29, 2024, approximately
90% of the new warrants were also exercised. The gross proceeds to
the Company from the two warrant exercises totaled approximately
$4.5 million.
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,” “is expected,” “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 the out-licensing term sheets it has
entered into 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.
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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
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