Kalytera Applies for $5 Million R&D Grant from IIA
April 17 2017 - 8:30AM
Kalytera Therapeutics, Inc. (TSXV:KALY), a clinical stage
biopharmaceutical company developing next generation
cannabinoid-derived therapeutics, today announced it has applied
for a $5 million grant from the Israel Innovation Authority (“IIA”)
to fund development of its portfolio of novel cannabidiol (“CBD”)
prodrugs.
IIA, formerly known as the Office of the Chief Scientist of the
Ministry of Economy (or “MATIMOP”), which is responsible for the
country’s innovation policy, is an independent and impartial public
entity that operates for the benefit of the Israeli innovation
ecosystem and Israeli economy as a whole.
Many of the world’s top-tier biopharmaceutical scientists, CROs
and expert research facilities specializing in cannabis are located
in Israel, including several of Kalytera’s senior scientific staff
and advisors. Accordingly, Israel is widely acknowledged as the
global center for FDA and EMEA-compliant pharmaceutical research on
cannabis and its molecular constituents such as CBD. It is the
ideal location for Kalytera, whose business model is to develop
cannabidiol-derived, FDA-approved medicines for global
distribution.
Kalytera has applied for the grant to support further
development of its portfolio of novel cannabidiol prodrugs, all of
which were invented by Kalytera. Kalytera’s CBD prodrugs are listed
below:
- K-1012, indicated for Acute Respiratory Distress Syndrome
(“ARDS”), with an estimated 280,000 patients just in the US and a
$700 million addressable market.
- K-1022, indicated for Ulcerative Colitis (also known as
Irritable Bowel Syndrome, or “IBS”), with an estimated 800,000 US
patients and a $10 billion addressable market.
- K-1032, indicated for Acne Vulgaris, with an estimated 45
million patients in the US and the five other major markets with a
$4 billion addressable market.
- K-1052, being studied as an Inducible Nitric Oxide Synthase
Inhibitor, indicated for Sepsis Associated Renal Failure &
Severe Traumatic Brain Injury (“TBI”) with an estimated 216,000
patients in the US and the five other major markets with a $2.4
billion addressable market.
In addition to its portfolio of prodrugs, the Company is
developing a portfolio of CBD analogue or synthetic derivative
drugs for the treatment of bone disease or disorders:
- KAL436 and KAL439, two compounds Kalytera is investigating to
assess their potential ability to improve bone fracture healing.
KAL436 and KAL439 are both synthetic derivative compounds of CBD
that have been structurally modified to enhance solubility in water
to improve potency.
In the U.S., bone fractures account for an estimated 10.2
million visits to hospitals and physician offices. Worldwide, more
than 50 million fractures occur every year. Osteoporosis is the
most common cause of fractures and the prevalence of it and low
bone mass is expected to increase in coming years due primarily to
the aging of the population.
- KAL671, a unique synthetic fatty acid amide and an
endocannabinoid-like molecule that may restore bone in persons
suffering from osteoporosis, the most common bone disease. The
global osteoporosis drugs market was valued at $8.4 billion in 2013
and is projected to reach $8.9 billion by 2020.
The Company anticipates receiving a decision from the IIA on its
grant application in the third quarter of this year. The grant, if
approved, will be non-dilutive to shareholders in the form of a
conditional, non-recourse loan to be paid back from future
royalties.
Commenting on its recent IIA grant application, Dr. Andrew L.
Salzman, CEO of Kalytera, said, “Kalytera is developing an entirely
new generation of CBD-derived medicines -- for FDA and EMEA
pathways to commercialization -- offering increased efficacy and
far less side effects (improved safety profile) to treat serious
and chronic disease. Our science is viewed favorably by the
biotechnology industry and is a strong candidate for grants such as
those offered by the IIA.
“We have a world-class management team, and Boards of Directors
and Advisors, composed of cannabis biotech industry leaders in
Israel and the US enabling Kalytera to capitalize on opportunities
worldwide to bring our proprietary pipeline of drugs to clinical
stage and commercialization,” he added. “Concurrently with our
research on the prodrugs and synthetic compounds, we are advancing
our clinical research on CBD to treat GvHD, whose data from a
recent Phase 2a study announced February 22, were encouraging.”
About KalyteraKalytera (TSXV:KALY) is a
clinical-stage pharmaceutical company pioneering the development of
a next generation of cannabinoid therapeutics. Through its proven
leadership, drug development expertise, and growing intellectual
property portfolio, Kalytera seeks to establish a leading position
in the development of novel cannabinoid medicines for a range of
important unmet medical needs -- with an initial focus on Graft
versus Host Disease (“GvHD”).
Kalytera is also developing a new class of proprietary
cannabidiol (“CBD”) therapeutics. CBD is a remarkable compound that
has shown activity against a number of pharmacological targets.
However, there are limitations associated with CBD, including its
poor oral bioavailability which greatly limits the efficacy of
medical marijuana edible products that contain a high level of
CBD.
Kalytera is developing innovative CBD formulations and prodrugs
intended for commercialization as FDA and EMEA-approved
prescription medications in an effort to overcome these
limitations, and to target specific disease sites within the body.
Kalytera has filed composition of matter and method of use patents
covering its novel inventions to reinforce its barriers to
entry.
Safe HarborThis news release may contain
“forward-looking information” within the meaning of applicable
securities laws. Although Kalytera believes in light of the
experience of its officers and directors, current conditions and
expected future developments and other factors that have been
considered appropriate, that the expectations reflected in this
forward-looking information are reasonable, undue reliance should
not be placed on them because Kalytera can give no assurance that
they will prove to be correct. Readers are cautioned to not place
undue reliance on forward-looking information. Actual results and
developments may differ materially from those contemplated by these
statements. The statements in this press release are made as of the
date of this release. Kalytera undertakes no obligation to comment
on analyses, expectations or statements made by third-parties in
respect of Kalytera, its securities, or its respective financial or
operating results (as applicable). Kalytera disclaims any intent or
obligation to update publicly any forward-looking information,
whether as a result of new information, future events or results or
otherwise, other than as required by applicable securities
laws.
Company Contact
Robert Farrell
President, COO and CFO
Phone: (888) 861-2008
Email: ir@kalytera.co
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