Kalytera Therapeutics, Inc. (TSX VENTURE: KLY and OTCQB: KALTF) (the “Company” or “Kalytera”) is pleased to announce that the European Patent Office has issued a Notice of Allowance for EU Patent Application Number 14791611.8 covering the use of cannabidiol (“CBD”) in the treatment of graft versus host disease (“GVHD”). Kalytera has exclusive worldwide rights to this patent through an Exclusive License Agreement with MOR Research Applications, Ltd. of Israel.
Securing a European patent for this proprietary technology represents an important step forward for Kalytera in its program to develop and commercialize CBD for prevention and treatment of this serious and life-threatening disease.
“We are delighted to receive this Notice of Allowance from the European Patent Office,” said Robert Farrell, J.D., Kalytera’s President and Chief Executive Officer. “Patients receiving bone marrow transplants are at high risk of developing acute GVHD, a complication that occurs when the transplanted donor cells attack the patient’s organs, including the skin, GI tract, liver, lungs, and eyes. There are currently no FDA approved therapies for the prevention of acute GVHD.”
To complete the procedures for issuance of this EU patent, Kalytera must prepare and file translations of the patent claims into French and German. Kalytera will complete these procedures prior to the January 2020 deadline, and expects that the EU patent will issue shortly thereafter. This will be the third issued patent that Kalytera will have received for the use of CBD in the prevention and treatment of GVHD. In April and May last year, Kalytera announced that it had received notice of issuance from the U.S. Patent and Trademark Office for its two U.S. patents covering the use of CBD in the prevention and treatment of GVHD. In addition to its U.S. and EU patents, Kalytera has also obtained four orphan drug designations for the treatment and prevention of GVHD in the U.S. and Europe.
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 EU Patent Office. Upon the issuance of the EU patent, Kalytera will become obligated to make an additional cash payment to the former Talent shareholders. The amount of such additional payment is currently under discussion and negotiation between Kalytera and the former Talent shareholders.
Potential Out-License of GVHD Program to Corporate Partner
Kalytera is pursuing a corporate partnering strategy for its GVHD program, primarily because this could be a source of non-dilutive financing for the planned Phase 3 clinical study that will begin next year, as well as a source of potential revenues from up-front license fees, milestone payments and royalties. The Company is responding to due diligence requests from potential partners, and has engaged Echelon Wealth Partners to assist in managing this process.
Kalytera Therapeutics, Inc. is pioneering the development of CBD therapeutics. Through its proven leadership, drug development expertise, and intellectual property portfolio, Kalytera seeks to establish a leading position in the development of CBD medicines for a range of important unmet medical needs, with an initial focus on the prevention and treatment of GVHD.
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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 may produce unfavourable results. 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.