Kalytera Therapeutics, Inc. (TSX VENTURE: KALY and OTCQB: KALTF) (the “Company” or “Kalytera”) today announced that the Company has elected to issue 13,085,677 common shares of the Company (“Common Shares”) to The Salzman Group in payment of invoices issued under the payments agreement announced on June 15, 2018 (the “June 2018 Agreement”). Under the June 2018 Agreement, The Salzman Group and its affiliates provide general and administrative support services, study set-up work for planned studies in connection with use of CBD in treatment of GVHD, and research and development work in connection with Kalytera’s exclusive license of cannabidiol-naproxen conjugates for treatment of pain.
The June 2018 Agreement was amended today to change the scope of the services provided thereunder. Additional services to be provided relate to a proposed Phase I clinical study to evaluate any effect of food on the pharmacokinetics of CBD, a proposed Phase I clinical study to investigate any drug-drug interactions with CBD, studies in respect of the use of CBD in prevention of GVHD, a proposed in-vitro mechanism of action study of CBD, and a proposed pre-clinical study to evaluate the efficacy of CBD in protecting against intestinal mucosal injury. This amendment of the June 2018 Agreement and the issuance of shares in payment of invoices for these additional services is subject to any TSXV approval required in connection with the amendment.
There has been no increase in the maximum dollar amount of services eligible for payment in shares under the June 2018 Agreement. As previously announced, the term of the June 2018 Agreement will expire on March 1, 2019.
The invoiced amounts to be paid in Common Shares to The Salzman Group total to the amount of US$714,197 (or C$942,168.68 based on the daily average exchange rate for January 30, 2019 published by the Bank of Canada). The number of Common Shares to be issued is based on a deemed issue price of C$0.072 per Common Share, being 90% of the closing price of the Common Shares on the TSXV on January 30, 2019, the trading day prior to the Company’s election to pay the invoiced amounts in Common Shares. The Common Shares are expected to be issued to The Salzman Group on or about February 1, 2019 subject to any required TSXV approval.
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 (“GVHD”).
Kalytera also intends to develop a new class of proprietary cannabidiol (“CBD”) therapeutics. CBD is a versatile compound that has shown activity against a number of pharmacological targets. However, there are limitations associated with natural CBD, including its poor oral bioavailability. Kalytera will seek to develop innovative CBD formulations and prodrugs in an effort to overcome these limitations, and to target specific disease sites within the body. Kalytera intends to file composition of matter and method of use patents covering its novel inventions, with the goal of limiting future competition.
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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 and the risk that required regulatory approvals may not be obtained. 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 are expressly qualified by this cautionary statement and are 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.