EVM-301 Series
- Presented and published leading scientific research describing
development and screening methods for non-hallucinogenic,
neuroplastogenic drug candidates in Enveric’s EVM301 Series of
candidates targeting the treatment of mental health disorders
- Announced AI-powered drug candidate generation engine surpassed
1000 compounds discovered and analyzed in Psybrary™ portfolio of
psychedelic-inspired therapeutic candidates
- Published research describing a key cane toad enzyme and its
application to the biosynthesis of novel indolethylamine-type drug
candidates with potential use in psychiatric medicine
- Granted U.S. Patent (USPTO No. 11,752,130) providing claims to
novel composition of matter and pharmaceutical drug formulations
for a family of carboxylated derivatives of tryptamine-based drug
candidates
EB-373
- Granted U.S. Patent (USPTO No. 11,707,447) encompassing novel
compositions of matter and pharmaceutical drug formulations for
prodrugs utilizing C4-carbonothioate-substituted tryptamine
derivative compounds
- Reported results from preclinical studies exploring the
metabolic profile and the safety of lead candidate EB-373, a next
generation psilocin prodrug targeting psychiatric disorders
- Highlighted results from animal studies demonstrating oral
bioavailability and favorable safety profile for EB-373
- Completed manufacturing of EB-373 to supply drug material for
completion of preclinical program
Enveric Biosciences, Inc. (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
provided a corporate update and reported financial results for the
third quarter of 2023 ended September 30, 2023.
“The third quarter of 2023 was a period of significant progress
for our team as we completed several initiatives that served to
enhance the value of our differentiated neuroplastogenic
small-molecule therapeutics as we advance towards the clinic,” said
Joseph Tucker, Ph.D., Director and CEO of Enveric. “Key to this
effort, we significantly strengthened our IP estate across our
development portfolio, highlighted by new patents from the United
States Patent and Trademark Office (USPTO) for our EVM301 Series of
novel non-hallucinogenic molecules and for EB-373, our lead EVM201
Series prodrug product candidate. The patents encompass composition
of matter and pharmaceutical drug formulations related to the
EVM301 Series and composition of matter and pharmaceutical drug
formulations pertaining to EB-373. Additionally, we filed six
non-U.S. applications related to the EVM301 Series, received
several U.S. Notices of Allowance for claims related to the EVM301
Series and EB-373, and filed a new application for our AI-based
computational methods for identifying and optimizing novel
tryptamine derivatives. Our expectation is the USPTO will grant
patents based on the Notices of Allowance, which would continue to
increase the value of our technologies and further distinguish
Enveric’s science as groundbreaking and unique.”
Dr. Tucker added: “Through the third quarter of 2023 and into
Q4, we have showcased the leading drug discovery and research
engine behind our EVM301 Series of compounds, with several
publications and presentations in academic settings, establishing a
leading position in the psychedelic and psychedelic-inspired drug
development industry to deliver next-generation treatments, with
low- and non-hallucinogenic compounds. We look forward to several
key milestones during the remainder of 2023, including
identification of a lead candidate from the EVM301 Series by
year-end. With this lead candidate identified, we anticipate
initiating a thorough and expedited preclinical development program
in 2024 in preparation for an Investigational New Drug
application.”
“As part of our objective to ensure clinical readiness, the
third quarter was also characterized by completing key
manufacturing and preclinical activities needed to file for
regulatory clearance to begin a first in human clinical trial of
EB-373. We announced favorable results from exploratory animal
studies, which demonstrated oral bioavailability and well-tolerated
side effects for EB-373. The outcome of these animal studies
indicated potential for EB-373 to reduce GI upset and vomiting as
well as rapid onset of action and systemic clearance, improving on
the pharmacokinetic characteristics of psilocybin. Additionally,
further preclinical work assessing absorption, distribution,
metabolism, and excretion (ADME) assays demonstrated rapid
conversion of EB-373 to the active metabolite psilocin,” concluded
Dr. Tucker.
THIRD QUARTER AND RECENT PROGRAM UPDATES
- Presented and published leading scientific research describing
development and screening methods for non-hallucinogenic,
neuroplastogenic drug candidates in Enveric’s EVM301 Series of
candidates targeting the treatment of mental health disorders
- Showcased drug candidate generation engine surpassing 1000
compounds discovered and analyzed in Psybrary™ Portfolio of
psychedelic-inspired therapeutic candidates
- Published research describing a key cane toad enzyme and its
application to the biosynthesis of novel indolethylamine-type drug
candidates with potential use in psychiatric medicine
- Reported results from preclinical studies exploring the
metabolic profile and the safety of lead candidate EB-373, a next
generation psilocin prodrug targeting psychiatric disorders.
Reported favorable preclinical absorption, distribution,
metabolism, and excretion (ADME) and toxicology assays demonstrated
rapid conversion of EB-373 to the active metabolite psilocin
- Completed manufacturing of EB-373 to supply drug material for
completion of preclinical program with resulting high purity of
prodrug product that allows Enveric and partners to ship EB-373
without being subject to restrictions required for controlled
substances
- Continued to drive value with growing IP portfolio across
therapeutic pipeline and filed provisional patent application to
support AI-based computational methods for identifying and
optimizing novel tryptamine derivatives
- Granted USPTO No. 11,707,447 encompassing compositions of
matter and pharmaceutical drug formulations for prodrugs utilizing
C4-substituted tryptamine derivatives and
C4-carbonothiate-substituted tryptamine derivatives
- Granted USPTO No. 11,752,130 providing claims to novel
composition of matter and pharmaceutical drug formulations for a
family of carboxylated derivatives of tryptamine-based drug
candidates
THIRD QUARTER 2023 FINANCIAL RESULTS
Net loss attributable to shareholders was $2.82 million for the
third quarter ended September 30, 2023, including $0.16 million in
net non-cash income, with a basic and diluted loss per share of
$1.30, as compared to a net loss of $2.60 million and non-cash
income of $2.29 million, with primary and diluted loss per share of
$1.46 per share for the quarter ended September 30, 2022.
Net cash used in operations for the quarter ended September 30,
2023, was $2.98 million, consisting of a $2.82 million net loss,
adjusted by a net of $0.16 million in non-cash income and changes
in asset and liability balances of $0.23 million.
As of September 30, 2023, the Company had cash and cash
equivalents of $4.27 million.
About Enveric
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, the
EVM201 Series, comprises next generation synthetic prodrugs of the
active metabolite, psilocin. Enveric is developing the first
product from the EVM201 Series – EB-373 – for the treatment of
psychiatric disorders. Enveric is also advancing its second
program, the EVM301 Series, expected to offer a first-in-class, new
approach to the treatment of difficult-to-address mental health
disorders, mediated by the promotion of neuroplasticity without
also inducing hallucinations in the patient. 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, 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: 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 on 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; 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 cannabinoid clinical development pipeline assets; the
ability to continue as a going concern; manage its future growth
effectively; achieve the intended benefits of the cost reduction
plan to the extent or as quickly as anticipated; transition from
third-party service providers supporting R&D efforts to
internal science teams without any adverse impact on Enveric’s
ongoing and planned clinical trials; and engage the cost reduction
plan efforts without negatively impacting Enveric’s business
operations and reputation.
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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version on businesswire.com: https://www.businesswire.com/news/home/20231113261127/en/
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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