Kalytera Announces Issuance of Second Patent Covering the Use of CBD in Graft Versus Host Disease
Kalytera Therapeutics, Inc. (TSX VENTURE: KALY and OTCQB: KALTF) (the "Company" or "Kalytera") today announced
that the U.S. Patent and Trademark Office ("USPTO") issued U.S. Patent No. 9,956,182 with claims covering the use of
cannabidiol ("CBD") for the prevention and treatment of acute and chronic forms of graft versus host disease
("GVHD"). Kalytera has exclusive worldwide rights to this issued patent through an Exclusive License Agreement with MOR
Research Applications, Ltd. of Israel (“Mor”).
GVHD is a multisystem disorder that is a life-threatening complication commonly occurring after bone marrow transplant
procedures. GVHD occurs when the transplanted donor cells attack the patient’s organs, including the skin, gastrointestinal tract,
liver, lungs and eyes. GVHD is associated with acute and chronic illness, infections, disability, reduced quality of life and
death.
In November 2017, Kalytera announced that it had received notice from the USPTO that the application for this patent would be
allowed. The issuance of this patent by the USPTO is the final step in the patent application process, and provides patent coverage
to Kalytera for the use of CBD in the prevention and treatment of acute and chronic forms of GVHD through May 2034 under the
Exclusive License Agreement with Mor.
This is the second patent covering the use of CBD in GVHD that Kalytera has received in the past three weeks. On April 19,
Kalytera announced that the USPTO had issued U.S. Patent No. 9,889,100 B2 with claims covering the use of CBD for the treatment of
severe and refractory GVHD.
“We are delighted by the issuance of this second patent for CBD in the treatment and prevention of GVHD,” said Robert Farrell,
President and CEO of Kalytera. “We now have very strong intellectual property protection that will provide us with market
exclusivity for the use of CBD in GVHD through early 2034.”
Mr. Farrell went on to state that, “Our program for prevention of GVHD is in Phase 2 clinical testing, and later this year we
will begin a Phase 3 pivotal registration study in the treatment of GVHD. With our GVHD program advancing into the final phases of
clinical testing, we will now begin seeking regional partners for commercialization of this product outside of North America. Such
partnering agreements can provide non-dilutive sources of funding through licensing, milestone and royalty revenue
opportunities.”
The commercial opportunity for Kalytera’s CBD product in the treatment and prevention of GVHD is large. According to the January
2018 Market Forecast Report by DelveInsight Perspective, the potential size of the market for a successful product in the seven
major jurisdictions (the U.S., Germany, France, Italy, Spain, the U.K. and Japan) is estimated to be more than USD $408 million in
2018, and could grow to approximately USD $1.3 billion by 2027.
Kalytera acquired its program in the prevention and treatment of GVHD in February 2017 through the acquisition of Talent
Biotechs, Ltd. of Israel ("Talent"). Under its agreement with the former Talent shareholders, Kalytera is obligated to make
additional contingent payments to the former Talent shareholders upon the achievement of certain milestones, including upon the
issuance of patents by the USPTO. Upon the earlier issuance of U.S. Patent No. 9,889,100 B2 by the USPTO, Kalytera became obligated
to make a payment to the former Talent shareholders of 2,883,535 common shares, and a cash payment of USD $2 million. With the
issuance of U.S. Patent No. 9,956,182 by the USPTO, Kalytera is now obligated to make an additional cash payment to the former
Talent shareholders of USD $2 million.
About Kalytera Therapeutics
Kalytera Therapeutics, Inc. ("Kalytera") is pioneering the development of a next generation of cannabinoid therapeutics.
Through its proven leadership, drug development expertise, and 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 and the treatment of acute and chronic pain.
Cautionary Statements
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture
Exchange) accepts responsibility for the adequacy or accuracy of this release.
This press release may contain certain forward-looking information and statements ("forward-looking information") within the
meaning of applicable Canadian securities legislation, that are not based on historical fact, including without limitation in
respect of its product candidate pipeline, planned clinical trials, regulatory approval prospects, intellectual property objectives
and other statements containing the words "believes", "anticipates", "plans", "intends", "will", "should", "expects", "continue",
"estimate", "forecasts" and other similar expressions. 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 depending on, among
other things, the risk that future clinical studies may not proceed as expected, or at all, or may produce unfavourable results,
and the risk that applicable regulatory approvals may not be obtained in a timely manner or at all. Kalytera undertakes no
obligation to comment on analyses, expectations or statements made by third parties, its securities, or financial or operating
results (as applicable). Although Kalytera believes that the expectations reflected in forward-looking information in this press
release are reasonable, such forward-looking information has been based on expectations, factors and assumptions concerning future
events which may prove to be inaccurate and are subject to numerous risks and uncertainties, certain of which are beyond Kalytera's
control. The forward-looking information contained in this press release is expressly qualified by this cautionary statement and is
made as of the date hereof. Kalytera disclaims any intention and has no obligation or responsibility, except as required by law, to
update or revise any forward-looking information, whether as a result of new information, future events or otherwise.
Kalytera Therapeutics, Inc.
Robert Farrell, 888-861-2008
President, CEO
info@kalytera.co
or
Colwell Capital Corp.
Graeme Dick, 1-403-561-8989
graeme@colwellcapital.com
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