SAN FRANCISCO & TEL AVIV, Israel--(
BUSINESS WIRE)--
Kalytera Therapeutics, Inc. (TSX VENTURE: KALY and OTCQB: KALTF) (the "
Company" or "
Kalytera") today reported financial results for the year-ended December 31, 2017. (All dollars U.S. unless otherwise noted.)
The Company did not generate any revenue from product sales in 2017, and recorded a net loss of approximately $31.9 million ($0.26 per Common Share), compared with approximately $11.6 million ($0.39 per Common Share) in 2016. The increase in net loss in 2017 was primarily due to non-cash, finance related expenses of approximately $7.9 million recorded in the fourth quarter of 2017 in connection with the valuation of the debentures and warrants that the Company issued in its private placement financing in December 2017; non-cash, finance related expenses of approximately $9 million recorded in the fourth quarter of 2017 in connection with the issuance costs of the debentures and warrants that the Company issued in its private placement financing in December 2017; other non-cash, finance related expense of approximately $9.6 million related to the valuation of the Company’s contingent liabilities at December 31, 2017 that were recorded as part of the Talent Biotechs, Ltd. acquisition; and other non-operating expenses of $331,000 recorded in the third quarter of 2017.
Operating Expenses
Research and development expenses for 2017 were approximately $1.7 million, compared to approximately $1.6 million in 2016. The slight increase in research and development expenses was primarily due to an increase in sponsored research costs as well as costs incurred relating to the invention of the Company's patent pending CBD prodrugs and start-up costs for the Company’s clinical-trials evaluating CBD in the prevention and treatment of GVHD.
General administration expenses for 2017 were approximately $3.2 million, compared to approximately $3.5 million in 2016. The slight decrease in general administration expenses was primarily due to a decrease in consulting fees paid by the Company in 2017, compared with the amount of consulting fees paid in 2016.
As of December 31, 2017, the Company had cash and cash equivalents of approximately $3.7 million, compared with $673,000 as of December 31, 2016. Subsequent to year-end 2017, the Company’s U.S. patent application for the use of CBD in the treatment of GVHD issued as U.S. Patent No. 9,889,100 B2, and as a result Kalytera is now obligated to make a $2 million payment and to issue 2,883,535 Common Shares to the former shareholders of Talent Biotechs, Ltd. When the second patent is formally issued (expected to occur on or about May 1, 2018), this will trigger an additional contingent payment in the amount of $2 million. The Company does not currently have sufficient working capital to fully fund such obligations or to continue to fund the Company’s operations without raising additional capital in the near term.
The Company plans to raise additional capital through equity financing in the near term to finance the payments to the former Talent shareholders and its working capital requirements and the clinical development of its lead product program, CBD in the treatment and prevention of GVHD. The Company may also seek to enter into an arrangement with former Talent shareholders in order to defer its payment obligations, however, there can be no assurance that such an arrangement will be successfully entered into. If the Company is able to successfully defer its payment obligations to former Talent shareholders, or is able to raise sufficient funds to do so, the Company’s current working capital may be sufficient to fund the Company’s operations through the third quarter of 2018.
About Kalytera Therapeutics
Kalytera Therapeutics, Inc. ("Kalytera") 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 GVHD and 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 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.
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