JUPW maybe the next JAZZ
JUPW Acquisition Reported
$28 Million Revenue for 2020
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Jupiter
Wellness, Inc. (NASDAQ: JUPW) is a leading developer of Herbal based
medical therapeutics and wellness products. The JUPW clinical pipeline
of prescription enhanced skin care therapeutics address indications including
eczema, burns, herpes cold sores, and skin cancer. JUPW generates
revenues from a growing line of proprietary over-the-counter skincare products
including its flagship CaniSun™ sunscreen and other wellness brands sold
through its robust distribution platform.
JUPW is NASDAQ listed and has an attractive share structure
with only
11,410,188 shares currently outstanding.
Ø JUPW Advances Clinical Pipeline of Topical
Treatments
On
April 29th JUPW announced an update on its clinical pipeline
of Herbal based therapeutic topical formulations including JW-100 for the treatment
of eczema, JW-200 for skin cancer, JW-300 for burns, and JW-400 for herpes cold
sores.
Commenced
Patient Enrollment for Skin Cancer: Study Completion Expected Q4 2021
The
JUPW JW-200 is designed to provide action and relief in the treatment of
Actinic Keratosis (AK), the most common precancer that forms on skin as a
result of exposure to ultraviolet (UV) rays. The objective of this double
blinded, placebo-controlled study is to evaluate the efficacy of JW-200 in both
the treatment and prevention of disease, with a primary efficacy endpoint of
the percentage of patients with complete clearance of AK lesions. An estimated
120 adults diagnosed with AK will be recruited, with an expected study
completion date of Q4 2021.
The
Skin Cancer Foundation estimates 58 million Americans have one or more AK
lesions which appear as raised, scaly discolored patches on sun-exposed skin.
Left untreated, approximately 20% of AK lesions progress to squamous cell
carcinoma. The skin cancer treatment market was $8.19 billion 2019 and is
estimated to reach $14.55 billion by 2027.
Patient
Recruitment Started for First Degree Burns: Topline Data Expected Q4 2021
The
JUPW JW-300 is being evaluated in a clinical study for the treatment of
first-degree burns resulting from sun exposure. The double blinded,
placebo-controlled trial is recruiting an estimated 44 patients who have first
degree burns induced by UVB irradiation. The primary endpoint is the reduction
in erythema within 24 hours of treatment. The trial is expected to be completed
in Q3 2021, with topline data expected Q4 2021.
Preparing
for Upcoming IND Meeting with U.S. FDA for Eczema Phase I/II Study
JUPW is preparing for a meeting in Q3 2021 with the
U.S. Food and Drug Administration (FDA) regarding the Company's Investigational
New Drug (IND) application that it expects to file. JUPW will propose
its clinical protocol for a Phase I/II study based on the efficacy and safety
shown in the recently completed exploratory study of JW-100 for the treatment
of atopic dermatitis (eczema). The study showed that JW-100 cleared or reduced
eczema following two weeks of use in more than half of the subjects, achieving
ISGA clear or almost clear (1 or 2) with at least a 2-grade improvement from
baseline after treatment, versus 20% and 15% in the CBD-only and placebo arms.
The
global eczema market is valued at $10 billion and is expected to grow at a CAGR
of 13% through 2025. Ten percent of the U.S. population, or 31.6 million
people, have eczema, and according to NationalEczema.org, 86% of people are not satisfied with their
current treatment.
JW-400
for Treatment of Herpes Cold Sores Expected to Commence Recruitment Q4 2021
The
double blind, placebo controlled JUPW study is now preparing for
recruitment of 40 patients with recurrent herpes labialis infection (HSV) who
had their initial infection more than one year prior. The primary endpoint is
the duration of the herpes labialis episode. The herpes simplex virus treatment
market was $4.8 billion in 2017. Nearly half of Americans age14-29 have HSV-1,
known as the cold sore virus.
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On
April 20th JUPW announced it has signed a non-binding Letter
of Intent with JustCBD and its affiliates to purchase 51% of JustCBD for $30
million in cash. Per the Letter of Intent, JustCBD would also receive a put
option to sell, at its sole discretion, the remaining 49% of JustCBD to JUPW
for an additional $30 million in a combination of JUPW common stock (not
to exceed 25% of the outstanding shares of JUPW) and preferred shares,
both valued at $5.00 per share.
The
closing of the transaction is subject to the completion of due diligence, the
negotiation and execution of definitive transaction agreements, availability of
financing and any necessary regulatory approvals. There can be no assurance
that the transaction will be consummated. A condition of the closing of the
transaction is that JUPW will enter into a 3-year management operating
agreement whereby key members of the JustCBD management team will be retained
by JUPW. In addition, it is anticipated that JustCBD will receive
representation on the JUPW board of directors.
JustCBD
is a leading global manufacturer, retailer and wholesaler of consumer CBD
products with over 300 SKUs across a wide variety of categories. Preliminary
unaudited 2020 consolidated financial statements of JustCBD and its affiliates
show approximately $28 million of revenue. JustCBD has engaged a leading SEC audit
firm to complete its audit, which audit is in process.
JUPW management believes this acquisition will be
highly accretive to JUPW and its shareholders and puts the Company at
the forefront of CBD consumer related products on the market today.
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On
April 16th JUPW announced it has appointed Dr. Glynn Wilson
as Chief Science Officer, Rich Miller as Chief Compliance Officer, and Ryan
Allison as Chief Operating Officer. Over the past quarters, JUPW has
grown its CBD-based consumer wellness business to include 40 products across
seven brands in six categories, while also advancing its clinical pipeline with
three indications in Phase 1 equivalent studies and one indication ready for an
Investigational New Drug (IND) application with the U.S. Food and Drug
Administration (FDA) based on a successful Phase 1 equivalent which met its
primary endpoint.
Dr.
Glynn Wilson, who continues to serve as Chairman of the Board and was formerly
Head of R&D at JUPW, will now serve as Chief Science Officer
overseeing the JUPW pipeline of clinical indications including eczema.
Should JW-100 continue to show similar efficacy in advanced stage trials, the JUPW
lead product candidate would address a $10 billion global market, in which
a competing product is projected to reach $2 billion in annual sales. Dr.
Wilson will guide the development strategy and clinical design for the JUPW
CBD-based topical product candidates for indications including skin cancer,
burns, and herpes cold sores, all of which are currently in Phase 1 equivalent
human trials. Dr. Wilson was formerly Head of Drug Delivery at SmithKline
Beecham and was Founder, CEO and Chairman of TapImmune, a developer of cancer
vaccines.
Rich
Miller continues to serve as a Director for JUPW and now moves into the
newly created position of Chief Compliance Officer overseeing regulatory
affairs for securities, CBD-based products, JUPW subsidiaries,
manufacturing, and international trade. As JUPW expands through both
organic growth and acquisition, Mr. Miller serves a critical role in assuring
the Company defines best practices in innovation as a leader in its industry
segments.
Ryan
Allison, formerly Vice President of Business Development, moves into the
position of Chief Operating Officer overseeing growth as JUPW
capitalizes on unprecedented opportunities in the CBD pharma and wellness
space. Mr. Allison is a strong leader who has been at the forefront of building
high-performance, data-driven organizations and business infrastructure
throughout his career across many industries including healthcare and the
federal government. Earlier in his career Mr. Allison served at VMware where he
was an early member of the cloud computing team and an instrumental player in
securing a foothold in the infant cloud landscape, a market segment VMware
continues to lead in today.
Ø
On
March 11th JUPW announced that SRM Entertainment was on track
for the month of March to produce its highest monthly sales since the wholly
owned subsidiary was acquired in December of 2020.
SRM
designs, manufactures, and sells creative products and services globally to
customers including Fortune 500 companies with a focus in the hospitality
industry and the world's most iconic theme parks in locations including
Orlando, Florida, Southern California, and other high profile cities worldwide.
JUPW made a strategic decision to make an investment in
the hard-hit theme park and hospitality industry and acquire SRM to keep a
quality operation active through the pandemic. With hospitality venues and
theme parks starting to move towards fully re-opening, JUPW is seeing a
significant increase in purchase orders and shipments.
For
additional information on Jupiter Wellness, Inc. (JUPW) visit http://www.jupiterwellnessinc.com/
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