Full Press Release Details
Pharma Reports Year End 2018 Financial Results and Provides Business Update
AVIV, Israel, February 7, 2019 -- Kitov Pharma (NASDAQ/TASE: KTOV), an innovative pharmaceutical company, today reported its unaudited
financial results for the year ended December 31, 2018 and provided a business update.
& Achievements in 2018 and to Date:
are very proud of the major achievement of gaining FDA approval for our lead drug candidate, Consensi , as well as the excellent
progress we have made in our NT-219 pre-clinical development program during 2018," stated Isaac Israel, Chief Executive
Officer of Kitov Pharma. "We are working productively with Coeptis Pharmaceuticals and its outstanding team to launch Consensi
in the U.S. market to create better patient compliance and improved treatment for people living with osteoarthritis pain and hypertension.
Additionally, we are very satisfied with the on-target execution of our NT-219 oncology program and we look forward to initiating
clinical trials later this year. We are committed to continuing to unlock substantial value in our business by leveraging our
team's deep regulatory expertise and drug development experience, complemented by targeted business development efforts,
in order to maximize the potential of our therapeutic candidates. We strengthened our balance sheet recently with the additional
gross financing of $6 million in January 2019 as we progress with our goals to achieve a major clinical milestone with NT-219."
- Small Molecule Oncology Drug
is a first-in-class small molecule targeting both Insulin Receptor Substrates (IRS) 1/2 and Signal Transducer and Activator of
Transcription 3 (STAT3), two signal proteins that are part of an anti-cancer drug resistance mechanism.
NT-219 achievements include:
a combination drug that simultaneously treats pain caused by osteoarthritis and treats hypertension, is comprised of two FDA approved
drugs, celecoxib (Celebrex ), a non-steroidal anti-inflammatory drug (NSAID) for the treatment of pain caused by osteoarthritis,
and amlodipine besylate (Norvasc ) a drug designed to treat hypertension. Hypertension is one of the side effects of using
NSAIDs including celecoxib.
under patent protection in the U.S. until 2030, and will be the only NSAID whose labeling indicates a reduction of blood pressure
and consequent risk reduction of heart attack, stroke, and death. The therapy may contribute to improved patient compliance and
improved patient health, thereby lowering overall health care costs.
currently has three signed licensing and distribution agreements for the drug in the U.S., China and South Korea. The Company
believes that successful commercialization of Consensi in the U.S. by Coeptis Pharmaceuticals will be a transformational
value-creating event for Kitov.
Consensi accomplishments include:
Significant Upcoming Kitov Milestones for 2019:
Results for the Year Ended December 31, 2018
and development expenses for the year ended December 31, 2018 were $5.3 million, an increase of $0.7 million, or 15.2%, compared
to $4.6 million for the year ended December 31, 2017. The increase resulted primarily from higher expenses in 2018 associated
with NT-219 preclinical and CMC development. Kitov expects a similar level of R&D expenditure, mainly for the development
and administrative expenses, including reimbursement from insurance for legal fees, for the year ended December 31, 2018 were
$4.5 million, a decrease of $1.9 million, or 29.7%, compared to $6.4 million for the year ended December 31, 2017. The decrease
resulted primarily from higher legal expenses in 2017 associated with class action claims and reimbursement for these legal fees
operating loss for the year ended December 31, 2018 amounted to $7.8 million, compared with an operating loss of $12 million for
the year ended December 31, 2017, a 35% decrease. The decrease in operating loss reflects $1 million in revenue in 2018 and the
significant decrease in general and administrative expenses as mentioned above during 2018 offset by an increase in research and
development expenses.
net loss for the year ended December 31, 2018 amounted to $5.6 million, compared with a net loss of $12.9 million for the year
ended December 31, 2017 as a result of the decrease in operating loss mentioned above, finance income of $2.3 million in 2018,
mainly a result of decrease in fair value of derivatives compared to finance expenses of $1 million in 2017, mainly a result of
increase in fair value of derivatives.
held $6.7 million in cash, cash equivalents and short-term bank deposits as of December 31, 2018. After the end of 2018, Kitov
raised a net of $5.5 million through an offering in January 2019.
Results for the 6 Months Period Ended December 31, 2018
and development expenses for the six-month period ended December 31, 2018 were $2.4 million, an increase of $0.3 million, or 14.3%,
compared to $2.1 million for 2nd half of 2017. The increase resulted primarily from higher expenses in 2018 associated
with preclinical and CMC development for NT-219.
and administrative expenses, including reimbursement from insurance for legal fees, for the six-month period ended December 31,
2018 were $1.1 million, a decrease of $2.8 million, or 71.8%, compared to $3.9 million for the six-month period ended December
31, 2017. The decrease resulted primarily from decrease in legal and consulting expenses, reimbursement from insurance and decrease
in salary related expenses including ESOP costs in 2018.
operating loss for the six-month period ended December 31, 2018 amounted to $3.5 million, compared with an operating loss of $6.0
million for the six-month period ended December 31, 2017. The decrease in operating loss reflects the significant decrease in
general and administrative expenses as mentioned above during 2018.
net loss for the six-month period ended December 31, 2018 amounted to $0.4 million, compared with a net loss of $6.9 million for
the six-month period ended December 31, 2017.
Unaudited Statements of Financial Position
| As of December 31, | ||||||||
| 2018 | 2017 | |||||||
| USD thousands | USD thousands | |||||||
| Assets | ||||||||
| Cash and cash equivalents | 5,163 | 3,947 | ||||||
| Short term deposits | 1,521 | 3,488 | ||||||
| Other current assets | 1,830 | 548 | ||||||
| Total current assets | 8514 | 7,983 | ||||||
| Fixed assets, net | 37 | 28 | ||||||
| Intangible assets | 6,172 | 6,172 | ||||||
| Total assets | 14,723 | 14,183 | ||||||
| Liabilities | ||||||||
| Accounts payable | 705 | 215 | ||||||
| Other payables | 2,055 | (*) 1,746 | ||||||
| Derivative instruments | 554 | 2,012 | ||||||
| Total current liabilities | 3,314 | 3,973 | ||||||
| Non-current liabilities | ||||||||
| Derivative instruments | - | 1,030 | ||||||
| Post-employment benefit liabilities | 405 | 492 | ||||||
| Total non - current liabilities | 405 | 1,522 | ||||||
| Equity | ||||||||
| Share capital, no par value | - | - | ||||||
| Share premium | 44,597 | 35,979 | ||||||
| Receipts on account of warrants | 7,982 | 7,415 | ||||||
| Capital reserve for share-based payments | 1,714 | 1,725 | ||||||
| Capital reserve from transactions with related parties | 761 | 761 | ||||||
| Capital reserve from transactions with non- controlling interest | (859 | ) | - | |||||
| Accumulated loss | (43,672 | ) | (*) (38,472 | ) | ||||
| Equity attributable to owners of the Company | 10,523 | 7,408 | ||||||
| Non-controlling interests | 481 | 1,280 | ||||||
| Total equity | 11,004 | 8,688 | ||||||
| Total liabilities and equity | 14,723 | 14,183 |
Unaudited Statements of Operations and Other Comprehensive Income
| For the year ended December 31, | For the six months ended December 31, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| USD thousands | USD thousands | USD thousands | USD thousands | |||||||||||||
| Revenues | 1,000 | (*) 100 | - | (*) 100 | ||||||||||||
| Research and development expenses | 5,268 | 4,640 | 2,426 | 2,124 | ||||||||||||
| General and administrative expenses | 5,195 | (*) 6,397 | 1,801 | (*) 3,873 | ||||||||||||
| Reimbursement of legal fees | (743 | ) | - | (743 | ) | - | ||||||||||
| Other expenses (income) | (894 | ) | 1,029 | (28 | ) | - | ||||||||||
| Total operating expenses | 8,826 | 12,066 | 3,456 | 5,997 | ||||||||||||
| Operating loss | 7,826 | 11,966 | 3,456 | 5,897 | ||||||||||||
| Net change in fair value of derivatives | (2,740 | ) | 1,049 | (3,197 | ) | 1,049 | ||||||||||
| Finance expenses | 576 | 26 | 196 | 19 | ||||||||||||
| Finance income | (93 | ) | (128 | ) | (69 | ) | (65 | ) | ||||||||
| Finance expenses (income), net | (2,257 | ) | 947 | (3,070 | ) | 1,003 | ||||||||||
| Loss for the year | 5,569 | 12,913 | 386 | 6,900 | ||||||||||||
| Other comprehensive loss Items that will not be classified to profit or loss | ||||||||||||||||
| Re-measurement of defined benefit liability | - | 95 | - | 95 | ||||||||||||
| Total comprehensive loss for the year | 5,569 | 13,008 | 386 | 6,995 | ||||||||||||
| Loss attributable to: | ||||||||||||||||
| Owners of the Company | 5,200 | 12,177 | 349 | 6,353 | ||||||||||||
| Non-controlling interests | 369 | 736 | 37 | 547 | ||||||||||||
| 5,569 | 12,913 | 386 | 6,900 | |||||||||||||
| Total comprehensive loss attributable to: | ||||||||||||||||
| Owners of the Company | 5,200 | 12,272 | 349 | 6,448 | ||||||||||||
| Non-controlling interests | 369 | 736 | 37 | 547 | ||||||||||||
| 5,569 | 13,008 | 386 | 6,995 | |||||||||||||
| Loss per share data | ||||||||||||||||
| Basic and diluted loss per share - USD | 0.39 | (**) 1.38 | 0.02 | (**) 0.65 | ||||||||||||
| Number of shares used in calculating basic and diluted loss per share | 14,205,301 | 9,456,952 | 15,975,408 | 10,704,180 |
Unaudited Statements of Cash Flow
| For the year ended December 31, | For the six months ended December 31, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| USD thousands | USD thousands | USD thousands | USD thousands | |||||||||||||
| Cash flows from operating activities: | ||||||||||||||||
| Loss for the year | (5,569 | ) | (*) (12,913 | ) | (386 | ) | (*) (6,900 | ) | ||||||||
| Adjustments: | ||||||||||||||||
| Depreciation | 7 | 4 | 4 | 2 | ||||||||||||
| Finance expense (income), net | (2,257 | ) | 947 | (3,070 | ) | 1,003 | ||||||||||
| Share-based payments | 773 | 2,308 | 161 | 1,025 | ||||||||||||
| Expenses (income) in regards with settlement with a minority shareholder of a subsidiary | (894 | ) | 1,000 | (28 | ) | - | ||||||||||
| (7,940 | ) | (8,654 | ) | (3,319 | ) | (4,870 | ) | |||||||||
| Changes in assets and liabilities: | ||||||||||||||||
| Changes in other receivables | (1,111 | ) | (273 | ) | (1,313 | ) | 263 | |||||||||
| Changes in accounts payable | 393 | (491 | ) | (132 | ) | (251 | ) | |||||||||
| Changes in other payables | 241 | (*) 650 | (171 | ) | (*) 1,048 | |||||||||||
| Changes in post-employment benefit liabilities | (63 | ) | 141 | (63 | ) | (126 | ) | |||||||||
| (540 | ) | 27 | (1,679 | ) | 934 | |||||||||||
| Net cash used in operating activities | (8,480 | ) | (8,627 | ) | (4,998 | ) | (3,936 | ) | ||||||||
| Cash flows from investing activities: | ||||||||||||||||
| Acquisition of subsidiary | - | (1,732 | ) | - | - | |||||||||||
| Decrease (increase) in short term deposits | 1,967 | 4,411 | 5,028 | 4,054 | ||||||||||||
| Interest received | 93 | 106 | 69 | 106 | ||||||||||||
| Acquisition of fixed assets | (16 | ) | (13 | ) | (11 | ) | (10 | ) | ||||||||
| Net cash provided by (used in) investing activities | 2,044 | 2,772 | 5,086 | 4,150 | ||||||||||||
| Cash flows from financing activities: | ||||||||||||||||
| Repayment of loans from related parties | - | (130 | ) | - | - | |||||||||||
| Short-term credit from bank | - | (16 | ) | - | - | |||||||||||
| Proceeds from issuance of shares and ADSs | 4,683 | 2,419 | - | 2,419 | ||||||||||||
| Share and ADS issuance expenses paid | (407 | ) | (245 | ) | - | (245 | ) | |||||||||
| Proceeds from issuance of warrants | 3,467 | 1,107 | - | 1,107 | ||||||||||||
| Warrants issuance expenses paid | (301 | ) | (114 | ) | - | (114 | ) | |||||||||
| Receipts from warrant exercise | 515 | - | - | - | ||||||||||||
| Interest paid | (169 | ) | (26 | ) | (162 | ) | (18 | ) | ||||||||
| Net cash provided by financing activities: | 7,788 | 2,995 | (162 | ) | 3,149 | |||||||||||
| Net increase (decrease) in cash and cash equivalents | 1,352 | (2,860 | ) | (74 | ) | 3,363 | ||||||||||
| Cash and cash equivalents at the beginning of the period | 3,947 | 6,758 | 5,363 | 527 | ||||||||||||
| Effect of translation adjustments on cash and cash equivalents | (136 | ) | 49 | (126 | ) | 57 | ||||||||||
| Cash and cash equivalents at end of the period | 5,163 | 3,947 | 5,163 | 3,947 |
US Prescribing Information, including BOXED WARNING and Medication Guide is available at: www.consensi.com.
is a combination of amlodipine besylate, a calcium channel blocker, and celecoxib, a nonsteroidal anti-inflammatory drug (NSAID),
indicated for patients for whom treatment with amlodipine for hypertension and celecoxib for osteoarthritis are appropriate. Lowering
blood pressure reduces the risk of fatal and nonfatal CV events, primarily strokes and myocardial infarctions.
is only available in a celecoxib strength of 200 mg and is only to be taken once daily.
Safety Information (ISI) for Consensi
following ISI is based on the Highlights section of the U.S. Prescribing Information for Consensi . Please consult the full
Prescribing Information for all of the labelled safety information for Consensi .
anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial
infarction and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use.
contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
cause an increased risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration and perforation of the
stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly
patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
is contraindicated in patients with a known hypersensitivity to amlodipine, celecoxib or any of its inactive ingredients.
is contraindicated in patients with a known history of asthma, urticaria or other allergic-type reactions after taking aspirin
or other NSAIDs and in the setting of CABG surgery.
is contraindicated in patients with known demonstrated allergic-type reactions to sulfonamides.
warnings and precautions related to Consensi include the following:
should be warned about the potential signs and symptoms of hepatotoxicity and hepatic failure. Physicians should discontinue
Consensi if abnormal liver tests persist or worsen, or if clinical signs and symptoms of liver disease develop.
taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Physicians should carefully
monitor blood pressure.
hypotension is possible, particularly in patients with severe aortic stenosis.
angina and acute myocardial infarction, particularly in patients with severe obstructive coronary artery disease, is possible.
should avoid use of Consensi in patients with severe heart failure.
should monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia, and avoid
the use of Consensi in patients with advanced renal disease.
should seek emergency help if an anaphylactic reaction occurs.
is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).
should discontinue Consensi at the first appearance of skin rash or other signs of hypersensitivity.
such as Consensi can cause premature Closure of Fetal Ductus Arteriosus.
use in pregnant women starting at 30 weeks of gestation.
should monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
is not recommended in patients with moderate or severe hepatic impairment or severe renal insufficiency.