Kalytera Therapeutics, Inc. (TSXV:KALY, OTCQB:KALTF) (the “Company” or “Kalytera”) today announced the termination of its pre-clinical development programs in the treatment of bone disease. The Company has determined that additional investments of time and resources in these programs are not appropriate given the other opportunities in its product development pipeline.
The terminated programs were evaluating three synthetic endocannabinoid compounds, KAL436, KAL439 and KAL671, in bone fracture healing, and osteogenesis imperfecta and osteoporosis. In connection with the termination of these programs, Kalytera has terminated its License Agreement with Yissum Research Development Company of the Hebrew University of Jerusalem, Ltd. (“Yissum”), under which Kalytera had licensed rights to KAL436, KAL439 and KAL671.
“The decision to terminate these programs is part of our overall strategy to focus on the development of cannabinoid therapeutics, rather than synthetic endocannabinoid compounds,” stated Robert Farrell, President and CEO of Kalytera. “We will now accelerate and expand our programs evaluating cannabidiol (“CBD”) in prevention and treatment of graft versus host disease (“GVHD”), and our newly announced program evaluating a novel cannabinoid/naproxen conjugate in treatment of acute and chronic pain.” Mr. Farrell continued, “We would like to thank the researchers from Hebrew University for their pioneering work in the field of cannabinoid science. Our decision to terminate these programs does not reflect a negative assessment of the compounds licensed from Yissum, but is, instead, a change in the Company’s product development strategy.”
As previously announced on March 20, 2018, Kalytera has entered into an exclusive, worldwide license with respect to its novel cannabinoid/naproxen conjugate with Beetlebung Pharma, Ltd. (“Beetlebung”). As consideration for the exclusive license with Beetlebung, Kalytera will provide a combination of upfront payments (USD $25,000 plus historical patent costs), royalties equal to a single-digit percentage of Net Sales (as defined in the license agreement), sublicensing fees in the event that Kalytera sublicenses its rights under the license, and future contingent milestone payments payable in cash and securities. Cash milestone payments are due upon recruitment of the first subject in Phase 1a, Phase 2a and pivotal registration clinical trials, and upon receipt of regulatory approvals in the United States, the UK, Europe and Japan. Following receipt of regulatory approval by the FDA, and subject to the approval of the TSX Venture Exchange, Kalytera will issue to Beetlebung 6,500,000 common shares of the Company, and will make an additional cash payment equal to the amount of any positive difference between (i) the value of 5% of Kalytera’s outstanding common shares based on the closing price of such shares on the date on which such FDA regulatory approval is announced and (ii) the value (based on the same closing price) of the Kalytera common shares being issued to Beetlebung. In connection with the license agreement, Kalytera has also entered into a master services agreement pursuant to which Beetlebung will provide significant research, development, clinical trial research, manufacturing and related support services in connection with the development and commercialization of the licensed technology. Kalytera may terminate the license agreement together with the master services agreement at any time.
October 2017 Stock Option Grant
As a separate matter, the Company would like to clarify the terms of stock option grants made to certain directors, officers and consultants of the Company, as previously disclosed as a subsequent event in Kalytera’s financial statements for the interim period ending September 30, 2017 and in its management’s discussion and analysis thereon. On October 8, 2017, the Company granted stock options to purchase a total of 7,717,671 common shares to its officers, directors and consultants. The options have an exercise price of C$0.12 per common share. These options include 539,879 options granted to consultants of the Company, which vested immediately upon grant. The remaining options consist of options to purchase 5,473,442 common shares granted to Robert Farrell, the Company’s Chief Executive Officer; options to purchase 1,022,610 common shares granted to Ron Erickson, the Chair of the Board; and options to purchase 681,740 common shares granted to Jeff Paley, an independent member of the Board. One-third of the options granted to directors and officers will vest on October 8, 2018 with the remaining two-thirds vesting in twenty-four (24) equal monthly installments commencing November 2018.
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 GVHD and treatment of acute and chronic pain.
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Beetlebung Pharma Limited (BPL), an Israeli affiliate of SG International, focuses on the discovery and development of novel cannabis-related pharmaceutical therapeutics. SG International (the “Salzman Group”) provides clinical management and other services to Kalytera in connection with Kalytera’s programs evaluating CBD in the prevention and treatment of graft versus host disease. BPL has invented a broad range of cannabinoid new chemical entities in therapeutic areas encompassing pain, inflammation, autoimmunity, ischemia-reperfusion injury, and central nervous system injury. BPL is also active in the development of novel formulations of existing cannabinoids, terpenes, and sesquiterpenes that may contribute to the entourage effect. To provide scientific support for its pharmaceutical programs, BPL carries out biological research on terpenoid cell signaling and pharmacology in its basic research laboratories. In an effort to lower cost of goods of complex cannabinoid molecules intended for pharmaceutical use, BPL has invented a series of more efficient synthetic routes for manufacture of cannabidiol and related cannabinoids and is conducting process scale-up research in its pilot plant facilities to advance these products to the stage of commercial manufacturing. BPL is a private, closely held corporation.
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 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.