el Aviv, Israel, Aug. 29, 2018 (GLOBE NEWSWIRE) -- Kitov Pharma Ltd. (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company, today provided a corporate update and reported financial results for the six months ended June 30, 2018.
“The first half of 2018 has been a transformational period for Kitov,” said Kitov’s CEO, Isaac Israel. “Most importantly, we received U.S. Food and Drug Administration (FDA) approval to market Consensi™ (amlodipine and celecoxib) oral tablets for the simultaneous treatment of pain caused by osteoarthritis, as well as hypertension. We are now focused on securing an optimal U.S. commercialization partner for Consensi™ in the U.S. who has the capability to execute a successful product launch and provide Kitov with a solid on-going revenue stream.”
“Moreover, we are excited about the continued progress we have achieved in advancing NT-219, our promising cancer therapy drug candidate,” continued Mr. Israel. “We have generated compelling pre-clinical results for NT-219 to date, and expect to submit an Investigational New Drug application to the FDA and to initiate clinical trials for NT-219 in 2019.”
“Finally, following our recent fund raise of approximately $8.1 million in gross proceeds, we are supported by a strong balance sheet with approximately $11.8 million in cash and deposits and no debt as of June 30, 2018,” concluded Mr. Israel.
Recent Corporate Highlights:
Expected Upcoming Milestones:
The information contained below should be read in conjunction with (1) our Unaudited Condensed Consolidated Interim Financial Statements as of June 30, 2018, and for the six months then ended; and, (2) our audited consolidated financial statements for the year ended December 31, 2017, which appears in the Company’s Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 5, 2018, as well as the other information contained in such Annual Report on Form 20-F and in our Registration Statements and Prospectuses filed with the SEC.
Financial Results for Six Months Ended June 30, 2018
Revenues for the six months ended June 30, 2018 were $1.0 million, consisting of an up-front payment from Changshan Biochemical Pharmaceutical Co., Ltd. in accordance with the terms of the License Agreement for Consensi™. There were no revenues in the six months ended June 30, 2017.
Research and development expenses for the six months ended June 30, 2018, were $2.8 million, an increase of 13%, compared to $2.5 million for the six months ended June 30, 2017. The increase resulted primarily from higher expenses related to pre-clinical trials for NT-219, partially offset by a reduction in expenses related to Consensi™, following submission of the NDA in 2017 and receipt of FDA approval in May 2018.
General and administrative expenses for the six months ended June 30, 2018, were $3.4 million, an increase of 34%, compared to $2.5 million for the six months ended June 30, 2017. The increase resulted from increases in legal fees, as well as increases in business development and other advisory services and officers’ and directors’ insurance.
Other income for the six months ended June 30, 2018, was $0.9 million, representing a reversal of other expenses of $1.0 million for the six months ended June 30, 2017, which consisted of the fair value of rights granted to Taoz, a minority shareholder in TyrNovo, upon the Company’s acquisition of Taoz’s shares in TyrNovo in June 2018, net of expenses associated with the acquisition.
Finance expense for the six months ended June 30, 2018, was $0.8 million and was primarily related to the valuation of non-registered warrants issued in 2017 and expenses related to non-registered warrants issued in 2018. Finance income for the six months ended June 30, 2017, was $0.1 million and was primarily related to interest on bank deposits.
The Company’s net loss for the six months ended June 30, 2018, amounted to $5.2 million, compared with a loss of $6.0 million for the corresponding period in 2017.
Balance Sheet Highlights
About Kitov Pharmaceuticals
Kitov Pharma (Kitov Pharma Ltd.; NASDAQ/TASE: KTOV) is an innovative biopharmaceutical drug development company. Leveraging deep regulatory and clinical-trial expertise, Kitov’s veteran team of healthcare and business professionals maintains a proven track record in streamlined end-to-end drug development and approval. Kitov’s flagship combination drug, Consensi™ achieved the primary efficacy endpoints for its Phase III and Phase III/IV clinical trials, and was approved by the FDA for patients suffering from osteoarthritis pain and hypertension. NT219, which is developed by its majority-owned subsidiary, TyrNovo Ltd., is a novel patented small molecule designed to overcome cancer drug resistance that is currently in pre-clinical development. By lowering development risk and cost through fast-track regulatory approval of innovative therapeutic candidates, Kitov is committed to delivering rapid ROI and long-term potential to investors, while making a meaningful impact on people’s lives.