NAPLES, Fla., Aug. 18, 2021 /PRNewswire/ -- Enveric
Biosciences (NASDAQ: ENVB) ("Enveric" or the
"Company"), a patient-first biotechnology company developing novel
therapeutic drugs to improve the quality of life for cancer
patients, Chief Executive Officer, David Johnson, today is issuing an open letter
to shareholders.
Dear Fellow Shareholders:
As we approach our annual stockholder meeting on September 14, 2021 and the expected closing of
the transaction with MagicMed Industries Inc. ("MagicMed"), we
believe we are well-positioned to emerge as a next-generation
neuroscience platform. We expect the pending transaction to
complement our existing product development activities, which are
focused on physical symptoms, with a platform of novel,
psychedelics that addresses the large mental health challenges
related to CNS indications such as PTSD, anxiety, depression and
pain.
We filed our second quarter and first half of 2021 financials
last Friday with the SEC, which demonstrates our strong balance
sheet of approximately $20 million in
cash, no debt and an efficient capital table, affording us the
flexibility to be opportunistic about further M&A possibilities
and in executing on our current business plan.
We also increased R&D spend during the first half of 2021
and, after the proposed transaction with MagicMed, plan on further
investments in mental health initiatives with potential for true
disruption in this patient care segment, solidifying our unique
position as one of the few NASDAQ-listed mental health
companies.
We recognize that the public markets have been difficult for
microcap companies in this space for the past several months, and
remain committed to executing on our business plan to maximize
shareholder value moving forward.
Acquisition of MagicMed
To date, Enveric's focus has been in the discovery and
development of cannabinoid-based therapeutic drugs for patients who
suffer from the side effects of cancer therapy. Indications
such as Radiation Induced Dermatitis and Chemotherapy Induced
Peripheral Neuropathy represent a very large market opportunity and
the current standard of care has seen minimal clinical
innovation.
Our development activities, however, revealed an even larger
opportunity related to a side effect in cancer therapy known as
'Cancer Related Distress' (CRD) derived from anxiety, depression
and PTSD arising from the diagnosis, treatment protocol or a
patient's concerns about the future. While working to
address the physical issues associated with cancer therapy, as a
patient-centric company, it became evident that patients also had
significant struggles with the mental aspect of their
diagnosis. Scientific evidence published by leading academic
institutions such as John Hopkins
and Yale show the promise of
psychedelic molecules as an effective and exciting approach in
treating mental health. The FDA's approval of Janssen's SPRAVATO®
(eskatamine) and its designation of "Breakthrough Therapy" for a
Psilocybin and MDMA, further bolsters this published research.
It was with this lens that we started looking for the right
partner to enter this space. We have been excited about
MagicMed since we first met them. Their library of
Intellectual Property for Generation 3molecules, together with
their use of Artificial Intelligence, we believe will allow the
combined company to address many of the issues not only within our
desired cancer indications, but well beyond in this extensive arena
of societal mental health problems. In fact, we now believe there
is a potential to disrupt the entire market through our IP
strategy, which is a very exciting proposition for patients and our
shareholders alike.
Dr. Joseph Tucker, current CEO of
MagicMed and incoming CEO of Enveric upon the expected closing, and
I agree, quite passionately, that mental health is a major global
crisis with inadequate current therapies. With a market estimated
at more than $250 billion in
North America alone, the combined
company will be uniquely positioned to bring significant value in
the form of efficacious, reliable, life-changing therapies for the
patients we seek to serve.
The proposed transaction with MagicMed has now cleared the
regulatory approvals and is currently awaiting a shareholder vote
of both Enveric and MagicMed shareholders on matters related to the
proposed transaction. We expect the proposed transaction to
close late in the third quarter or very early in the fourth
quarter.
Other key points of progress
Building a World Class Team
To support our growing
business, Enveric and MagicMed plan to come together with a very
deep and experienced leadership team, while continuously looking
for further enhancements. In the second quarter, we announced
that Carter Ward had joined the
company as our CFO. Carter comes to Enveric with years of Public
Company experience in the Life Sciences space, as well as a KPMG
pedigree.
To support our growing R&D capabilities and team, we have
leased a new discovery facility at the University of Calgary, increasing the efficiency
and focus of our R&D activities. In addition, we have just
agreed to double our team in Calgary to allow them to accelerate
our ability to synthesize and screen more drug candidates.
Finally, we have brought in other new skill sets in Project
Management, Clinical Research and a new Scientific Advisory Board
Member, Dr. Arash from Cedar Sinai Hospital in Los Angeles
Progressing our Pipeline
- EV101 has now been given approval for a Phase 1/2 trial in Tel
Aviv. We will continue to look at the best pathway forward for
this initiative.
- EV102 continues to make progress in our development program and
still shows signs that this could be in the clinic in the first
half of 2022.
- EV104 is a discovery stage program for Pain, creating a Proof
of Principal on the Diverse Bio Assets we licensed in Q1 of
2021.
Expansion of Intellectual Property
Enveric Biosciences was granted US patent number 11,090,275 on
August 17th. This US
patent is the first of three pending patent portfolios directed to
cancer treatment using cannabidiol (CBD) owned by Enveric. This
patent is part of a larger strategy to build a large and
strong Patent portfolio. It is an exciting milestone for the
company.
Outlook of Combined Company
The combination of Enveric and MagicMed is expected to uniquely
and immediately propel us to emerge as a powerful drug discovery
and clinical stage mental health biotechnology company, bringing
forward novel therapies to improve the standard of care and unmet
medical needs globally.
Our focus is very clear:
- Continue to progress our pipeline into and through the
clinic
- Close the MagicMed Industries transaction and start to utilize
their Psybrary to protect, expand and develop new psychedelic drug
candidates, starting with PTSD for cancer
- Opportunistically look for external development ways to add
value to Enveric
I want to thank our shareholders for their support as we
approach our September
14th stockholder meeting. As always, we look
forward to hearing from you. Please email our investor relations
department for more information – EnvericBio@KCSA.com.
Sincerely,
David Johnson,
Chairman and CEO
Enveric Biosciences
About Enveric Biosciences
Enveric Biosciences is
a patient-first biotechnology company developing rigorously tested,
novel cannabinoid medicines to improve quality of life for cancer
patients. Initial indications include radiodermatitis, a common and
often severe side effect of radiation therapy, and
chemotherapy-induced neuropathy. For more information, please
visit https://www.enveric.com/.
Additional Information About the Amalgamation and Where to
Find It
This communication may be deemed to be solicitation material in
respect of the proposed transaction between the Company and
MagicMed. In connection with the proposed transaction, the Company
has filed relevant materials with the Securities and Exchange
Commission (the "SEC"), including a registration statement on Form
S-4, as amended (File No. 333-257272), that includes a proxy
statement and prospectus. The registration statement was declared
effective by the SEC on July 9, 2021,
and the proxy statement/prospectus was mailed or otherwise
disseminated to stockholders of the Company. Enveric has also filed
and may file other relevant documents with the SEC regarding the
proposed transaction. THE COMPANY URGES INVESTORS AND STOCKHOLDERS
TO READ THE PROXY STATEMENT/PROSPECTUS AND OTHER RELEVANT DOCUMENTS
FILED OR TO BE FILED WITH THE SEC WHEN THEY BECOME AVAILABLE
BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT
THE COMPANY, THE PROPOSED TRANSACTION AND RELATED MATTERS.
Investors and stockholders can obtain free copies of the proxy
statement/prospectus and other documents filed by the Company with
the SEC (when they become available) through the website maintained
by the SEC at www.sec.gov. In addition, investors and stockholders
can obtain free copies of the proxy statement/prospectus and other
documents filed by the Company with the SEC by contacting Investor
Relations by mail at Enveric Biosciences, Inc., Attn: Investor
Relations, 4851 Tamiami Trail N, Suite 200, Naples, FL 34103. Stockholders are urged to
read the proxy statement/prospectus and the other relevant
materials when they become available before making any voting or
investment decision with respect to the proposed transaction.
Participants in the Solicitation
The Company and MagicMed, and each of their respective directors
and executive officers and certain of their other members of
management and employees, may be deemed to be participants in the
solicitation of proxies in connection with the proposed
transaction. Additional information regarding these persons and
their interests in the proposed transaction is included in the
proxy statement/prospectus relating to the proposed transaction
that was filed with the SEC. These documents can be obtained free
of charge from the sources indicated above.
No Offer or Solicitation
This press release does not constitute an offer to sell or the
solicitation of an offer to buy any securities, or a solicitation
of any vote or approval, nor shall there be any sale of securities
in any jurisdiction in which such offer, solicitation or sale would
be unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. No offering of securities
shall be made except by means of a prospectus meeting the
requirements of Section 10 of the Securities Act of 1933, as
amended.
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. You can generally identify forward-looking statements by
the use of forward-looking terminology such as "anticipate,"
"believe," "budgets," "continue," "could," "estimate," "expect,"
"explore," "evaluate," "forecasts," "intend," "scheduled," "may,"
"might," "plan," "potential," "predict," "project," 'proposed,"
"seek," "should," or "will," or the negative thereof or other
variations thereon or comparable terminology. These forward-looking
statements are only predictions and involve known and unknown risks
and uncertainties, many of which are beyond the Company's and
MagicMed's control. Statements in this press release regarding the
Company, MagicMed and the combined company that are
forward-looking, including projections as to the anticipated
benefits of the proposed transaction, the impact of the proposed
transaction on the Company's and MagicMed's business and future
financial and operating results, the amount and timing of synergies
from the proposed transaction, expectations regarding capital
structure following the closing of the proposed transaction, the
combined company's pipeline, intellectual property protection and
R&D spend, and the closing date for the proposed transaction,
are based on management's estimates, assumptions and projections,
and are subject to significant uncertainties and other factors,
many of which are beyond the Company's and MagicMed's control.
These factors include, among other things, the combined company's
ability to execute successfully its strategic plans, including its
business development strategy, the expiration of patents or data
protection on certain products, including assumptions about the
combined company's ability to retain patent exclusivity of certain
products, the impact and result of governmental investigations, the
combined company's ability to obtain necessary regulatory approvals
or obtaining these without delay, the risk that the combined
company's products prove to be commercially successful or that
contractual milestones will be achieved. Similarly, there are
uncertainties relating to a number of other important factors,
including: results of clinical trials and preclinical studies,
including subsequent analysis of existing data and new data
received from ongoing and future studies; the content and timing of
decisions made by the U.S. FDA and other regulatory authorities,
investigational review boards at clinical trial sites and
publication review bodies; the ability to enroll patients in
planned clinical trials; unplanned cash requirements and
expenditures; the amount of funds the combined company requires for
its product candidates; competitive factors; the ability to obtain,
maintain and enforce patent and other intellectual property
protection for any product candidates; the ability to maintain key
collaborations; the impact of the ongoing COVID-19 pandemic on the
combined company's results of operations and business plan and the
global economy; and general economic and market conditions.
Additional information concerning these risks, uncertainties and
assumptions can be found in the Company's filings with the SEC,
including the risk factors discussed in the Company's most recent
Annual Report on Form 10-K, as updated by its Quarterly Reports on
Form 10-Q and future filings with the SEC.
Investor Contacts
Valter Pinto / Allison
Soss
KCSA Strategic Communications
212.896.1254 / 212.896.1267
valter@kcsa.com / asoss@kcsa.com
Media Contacts
Caitlin
Kasunich / Raquel Cona
KCSA Strategic Communications
212.896.1241 / 212.896.1204
ckasunich@kcsa.com / rcona@kcsa.com
Filed by Enveric Biosciences, Inc.
Pursuant to Rule 425 of the Securities Act of 1933
and deemed filed pursuant to Rule 14a-6
of the Securities Exchange Act of 1934
Commission File No.: 001-38286
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SOURCE Enveric Biosciences