Kalytera Therapeutics, Inc. (TSX VENTURE: KALY and OTCQB: KALTF) (the “Company” or “Kalytera”) today reported financial results for the third quarter of 2018. (All dollars U.S. unless otherwise noted.)
The Company recorded net income of approximately $1.8 million ($0.01 per Common Share) in the third quarter of 2018, compared with a net loss of approximately $1.2 million ($0.01 per Common Share) in the third quarter of 2017. This increase in net income of approximately $3.0 million from third quarter 2017 to third quarter 2018 is mainly due to an offset of $12.9 million recorded in general and administrative expense due to a change in assumptions made in the assessment of the fair value of the Company’s contingent liability relating to the acquisition of Talent Biotechs Ltd. (“Talent”) in 2017, balanced against an increase of approximately $9.9 million in other expenses arising out of impairment to the value of the Talent intellectual property. This was offset by an increase of approximately $1.8 million in research and development expenditures that the Company incurred as it advanced and expanded its clinical development program in prevention of acute GVHD, and an increase in finance expenses of $230,000.
Research and development expenditures increased to approximately $1.9 million in Q3 2018 from $20,000 in Q3 2017 due primarily to an increase in costs relating to the advancement of the Company’s ongoing Phase 2 clinical trial in the prevention of acute graft versus host disease.
General and administrative expenses remained consistent in the third quarter of 2018 at $785,000, compared to $796,000 in the third quarter of 2017, after excluding the offset in the amount of approximately $12.9 million arising from the change in the fair value of contingent liabilities related to the Talent acquisition as described above. General and administrative expenses increased in third quarter 2018 compared with third quarter 2017 in the categories of consulting fees, insurance costs, investor relations expenditures, and salaries and benefits resulting from hiring Kalytera’s Chief Financial Officer, which increases were offset by a decrease in expenditures related to legal and professional fees and office and other expenses.
At September 30, 2018, the Company’s cash and cash equivalents decreased to $966 from $3,686 at December 31, 2017. Working capital at September 30, 2018 decreased to ($4,291) as compared to ($209) at December 31, 2017. The decrease in the Company’s working capital was mainly due to the increase in the amount of current liabilities due to the former shareholders of Talent.
The Company funds its operating costs through a combination of cash and equity payments to its creditors. The Company’s largest creditor during calendar 2018 and calendar 2019 will be the Salzman Group of Israel. Under agreements with the Salzman Group, the Company may elect to pay amounts due to the Salzman Group in either cash or through the issuance of common shares. The Company believes that it has sufficient cash to fund its cash operating costs (costs that will be paid in cash to creditors other than the Salzman Group) beyond year-end 2018, including expenses for the clinical development of its lead product program, CBD in the prevention of GVHD.
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 GVHD and treatment of acute and chronic pain.
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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 ris k 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.