Kitov Pharmaceuticals Provides Corporate Update and Reports First Half 2017 Financial Results
TEL AVIV, Israel, Aug. 16, 2017 /PRNewswire/ -- Kitov Pharmaceuticals Holdings Ltd. (KTOV) (KTOV), an innovative biopharmaceutical company, today provided a corporate update and reported financial results for the first half of 2017, ending June 30, 2017.
"We are pleased with the significant progress we have achieved during the recent months. Thanks to the intensive, dedicated and professional work of our staff, investigators and CROs, we recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for KIT-302, our lead drug candidate developed to simultaneously treat pain caused by osteoarthritis and to treat hypertension," said Kitov's CEO, Isaac Israel. "We are confident in the quality of the submitted package, and look forward to a response from the FDA shortly regarding whether the NDA is complete and acceptable for filing.
"In addition, we have expanded our pipeline with NT-219, a promising cancer therapy candidate, through the acquisition of a controlling interest in TyrNovo. Results from pre-clinical studies of NT-219, a small molecule, demonstrated its efficacy in overcoming drug resistance in a variety of cancers and in combination with multiple pharmacologic cancer therapies. We are focused on advancing this highly promising therapeutic candidate into clinical trials in 2018 in order to provide enhanced treatment options to cancer patients.
"With the completion of the recent equity offering, we are well positioned to accomplish our strategic initiatives in 2018. Our plan is to continue growing Kitov as an innovative, emerging pharmaceutical company. Our mission is to leverage the significant potential of our product development pipeline to create long-term shareholder value."
Recent Corporate Highlights:
Submitted an NDA to the FDA for KIT-302
Signed a definitive License Agreement for KIT-302 for the territory of South Korea with Kuhnil Pharmaceutical Co. Ltd., a leading South Korea-based pharmaceutical company
Received waiver from FDA for the $2 Million New Drug Application fee for KIT-302
Completed recruitment of our renal function clinical trial to demonstrate the beneficial effects of KIT-302 on kidney function
Acquired a controlling interest in TyrNovo
Completed an equity offering for gross proceeds of $3.5 million
Expected Upcoming Milestones:
FDA filing of our NDA for KIT-302
Top-line results of our renal function clinical trial for KIT-302
Additional marketing agreements for the distribution of KIT-302
Pre-IND meeting with the FDA for NT-219
The information contained below should be read in conjunction with (1) our Unaudited Condensed Consolidated Interim Financial Statements as of June 30, 2017, and for the six months then ended; and, (2) our audited consolidated financial statements for the year ended December 31, 2016, which appears in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission on May 1, 2017, as well as the other information contained in such Annual Report on Form 20-F and in our Registration Statement on Form F-1 filed with the SEC (file number 333-211477).
Financial Results for Six Months Ended June 30, 2017
Research and development expenses for the six months ended June 30, 2017 were $2,516 thousand, an increase of $552 thousand, or 28%, compared to $1,964 thousand for the six months ended June 30, 2016. The increase resulted primarily from expenses deriving from preparation of our NDA submission to the FDA for KIT-302, our renal function clinical trial for KIT-302, and pre-clinical trials for NT-219.
General and administrative expenses for the six months ended June 30, 2017 were $2,524 thousand, an increase of $1,330 thousand or 111%, compared to $1,194 thousand for the six months ended June 30, 2016. The increase resulted from increases in salaries and benefits and directors' fees, legal fees in connection with the Taoz settlement and the class action lawsuits, and officers' and directors' insurance.
Other expenses for the six months ended June 30, 2017 were $1,029 thousand, consisting of the fair value of rights granted to Taoz, a minority shareholder in TyrNovo, following the acquisition of TyrNovo.
Finance income, net for the six months ended June 30, 2017 was $56 thousand and is primarily related to interest on bank deposits. Finance income, net for the six months ended June 30, 2016 was $121 thousand and is primarily related to derivative instruments that expired during the period.
The Company's net loss for the six months ended June 30, 2017 amounted to $6,013 thousand, compared with a loss of $3,037 thousand for the corresponding period in 2016.
Balance Sheet Highlights
Cash, cash equivalents and short-term deposits totaled $8,132 thousand as of June 30, 2017, compared to $14,657 thousand on December 31, 2016. The decrease compared to December 31, 2016 reflects the cash used in operations and the cash used in the acquisition of TyrNovo during the first half of 2017. In July 2017 the Company raised approximately $3.1 million, net in a direct registered offering.
Shareholders' equity totaled $12,471 thousand, including $1,827 in non-controlling interests as of June 30, 2017, compared to $13,385 thousand as of December 31, 2016.
