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:
● |
Received FDA approval to market Consensi™ in the U.S. |
|
|
● |
Signed a License Agreement for Consensi™ for the territory of China
with Hebei Changshan Biochemical Pharmaceutical Co., Ltd., a
leading Chinese pharmaceutical company; Received $1 million down
payment and entitled to receive additional milestone payments of up
to $8.5 million, as well as potential double-digit royalties |
|
|
● |
Raised $8,150,000 in gross proceeds through a registered direct
offering |
|
|
● |
Completed the acquisition of additional shares in TyrNovo from
unaffiliated minority shareholders; Kitov now holds 97% of
TyrNovo’s issued and outstanding shares, with the remaining 3% held
by the TyrNovo founder and CTO |
|
|
● |
Reported positive pre-clinical data from NT219 demonstrating its
dose-dependent anti-tumor efficacy, supporting planned IND in
2019 |
|
|
● |
Entered into a Stipulation of Settlement with respect to the
two U.S. shareholder class-action lawsuits; settlement
consideration of $2.0 million expected to be fully covered by
Kitov’s insurance carriers |
Expected Upcoming
Milestones:
● |
Secure a U.S. commercialization partner for Consensi™ |
|
|
● |
Product launch of Consensi™ in the U.S. by our commercialization
partner |
|
|
● |
Expand global commercialization network for Consensi™ to additional
territories |
|
|
● |
Initiate regulatory approval process for Consensi™ in China and
South Korea, by our partners |
|
|
● |
Complete GLP toxicology studies for NT-219 |
|
|
● |
Complete manufacturing of GMP NT-219 drug product for clinical
trials |
|
|
● |
Submit an IND and initiate clinical trials 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,
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
● |
Cash,
cash equivalents and short-term deposits totaled $11.8 million at
June 30, 2018, compared to 7.4 million on December 31, 2017. The
increase compared to December 31, 2017, reflects net cash of
approximately $7.4 million raised in a direct registered offering
completed in June 2018, plus revenues of $1.0 million, less cash
used in operations. |
|
|
● |
Shareholders equity totaled $10.7 million, including $0.5 million
in non-controlling interests as of June 30, 2018, compared to $8.7
million as of December 31, 2017. |
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.
Forward-Looking Statements
Certain statements in this press release that
are forward-looking and not statements of historical fact are
forward-looking statements within the meaning of the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements may be identified by the use of
forward-looking words such as “believe”, “expect”, “intend”,
“plan”, “may”, “should”, “could”, “might”, “seek”, “target”,
“will”, “project”, “forecast”, “continue” or “anticipate” or their
negatives or variations of these words or other comparable words or
by the fact that these statements do not relate strictly to
historical matters. You should not place undue reliance on these
forward-looking statements, which are not guarantees of future
performance. Forward-looking statements reflect our current views,
expectations, beliefs or intentions with respect to future events,
and are subject to a number of assumptions, involve known and
unknown risks, many of which are beyond our control, as well as
uncertainties and other factors that may cause our actual results,
performance or achievements to be significantly different from any
future results, performance or achievements expressed or implied by
the forward-looking statements. Important factors that could cause
or contribute to such differences include, among others, risks
relating to: risks and uncertainties associated with obtaining
court approval of the proposed settlement of the two U.S.
shareholder class-action lawsuits, the number of plaintiffs who may
opt-out of the proposed settlement, and whether any proposed
settlement is appealed; the fact that drug development and
commercialization involves a lengthy and expensive process with
uncertain outcomes; our ability to successfully develop and
commercialize our pharmaceutical products; the expense, length,
progress and results of any clinical trials; the lack of sufficient
funding to finance the clinical trials; the impact of any changes
in regulation and legislation that could affect the pharmaceutical
industry; the difficulty in receiving the regulatory approvals
necessary in order to commercialize our products; the difficulty of
predicting actions of the U.S. Food and Drug Administration or any
other applicable regulator of pharmaceutical products; the
regulatory environment and changes in the health policies and
regimes in the countries in which we operate; the uncertainty
surrounding the actual market reception to our pharmaceutical
products once cleared for marketing in a particular market; the
introduction of competing products; patents attained by
competitors; dependence on the effectiveness of our patents and
other protections for innovative products; our ability to obtain,
maintain and defend issued patents with protective claims; the
commencement of any patent interference or infringement action; our
ability to prevail, obtain a favorable decision or recover damages
in any such action; and the exposure to litigation, including
patent litigation, and/or regulatory actions; the continued
uncertainty surrounding an investigation by the Israel Securities
Authority into our historical public disclosures and the potential
impact of such investigation on the trading of our securities or on
our clinical, commercial and other business relationships; or on
receiving the regulatory approvals necessary in order to
commercialize our products; the uncertainty of the impact of such
investigation and/or the proposed settlement of the two U.S.
shareholder class-action lawsuits on the Israeli class action civil
litigation in connection with the investigation which is still
continuing, and other factors that are discussed in our in our
Annual Report on Form 20-F for the year ended December 31, 2017 and
in our other filings with the SEC, including our cautionary
discussion of risks and uncertainties under ‘Risk Factors’ in our
Registration Statements, Prospectuses and Annual Reports. These are
factors that we believe could cause our actual results to differ
materially from expected results. Other factors besides those we
have listed could also adversely affect us. Any forward-looking
statement in this press release speaks only as of the date which it
is made. We disclaim any intention or obligation to publicly update
or revise any forward-looking statement, or other information
contained herein, whether as a result of new information, future
events or otherwise, except as required by applicable law. You are
advised, however, to consult any additional disclosures we make in
our reports to the SEC, which are available on the SEC’s website,
http://www.sec.gov
Condensed Consolidated Unaudited Interim Statements of Financial
Position as of
|
|
|
June 30, 2018 |
|
|
December 31, 2017 |
|
|
|
|
USD thousand |
|
|
USD thousand |
|
Assets |
|
|
|
|
|
|
|
Cash and cash
equivalents |
|
|
|
5,363 |
|
|
|
3,947 |
|
Short term
deposits |
|
|
|
6,467 |
|
|
|
3,488 |
|
Other current
assets |
|
|
|
344 |
|
|
|
548 |
|
Total current
assets |
|
|
|
12,174 |
|
|
|
7,983 |
|
|
|
|
|
|
|
|
|
|
|
Fixed assets, net |
|
|
|
30 |
|
|
|
28 |
|
|
|
|
|
|
|
|
|
|
|
Intangible assets |
|
|
|
6,172 |
|
|
|
6,172 |
|
Total
assets |
|
|
|
18,376 |
|
|
|
14,183 |
|
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
Accounts payable |
|
|
|
767 |
|
|
|
215 |
|
Other payables |
|
|
|
2,159 |
|
|
|
1,746 |
|
Derivative
liabilities |
|
|
|
4,318 |
|
|
|
2,012 |
|
Total current
liabilities |
|
|
|
7,244 |
|
|
|
3,973 |
|
|
|
|
|
|
|
|
|
|
|
Non - current
liabilities |
|
|
|
|
|
|
|
|
|
Derivative
liability |
|
|
|
- |
|
|
|
1,030 |
|
Post-employment benefit
liabilities |
|
|
|
470 |
|
|
|
492 |
|
|
|
|
|
470 |
|
|
|
1,522 |
|
Equity |
|
|
|
|
|
|
|
|
|
Share capital, no par
value |
|
|
|
- |
|
|
|
- |
|
Share premium |
|
|
|
44,437 |
|
|
|
35,979 |
|
Receipts on account of
warrants |
|
|
|
7,415 |
|
|
|
7,415 |
|
Capital reserve for
share-based payments |
|
|
|
1,713 |
|
|
|
1,725 |
|
Capital reserve from
transactions with related parties |
|
|
|
761 |
|
|
|
761 |
|
Capital reserve from
transactions with non- controlling interest |
|
|
|
(859 |
) |
|
|
- |
|
Accumulated loss |
|
|
|
(43,325 |
) |
|
|
(38,472 |
) |
Equity attributable to
owners of the Company |
|
|
|
10,142 |
|
|
|
7,408 |
|
Non-controlling
interests |
|
|
|
520 |
|
|
|
1,280 |
|
Total
equity |
|
|
|
10,662 |
|
|
|
8,688 |
|
|
|
|
|
|
|
|
|
|
|
Total
liabilities and equity |
|
|
|
18,376 |
|
|
|
14,183 |
|
Condensed Consolidated Unaudited Interim
Statements of Operations and Other Comprehensive
Income
|
|
|
For the six months ended June 30 |
|
|
|
|
2018 |
|
|
2017 |
|
|
|
|
USD thousand |
|
|
USD thousand |
|
|
|
|
|
|
|
|
|
Revenues |
|
|
|
1,000 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
Research and
development expenses |
|
|
|
2,842 |
|
|
|
2,516 |
|
General and
administrative expenses |
|
|
|
3,394 |
|
|
|
2,524 |
|
Other expenses
(income), net |
|
|
|
(866 |
) |
|
|
1,029 |
|
|
|
|
|
|
|
|
|
|
|
Total
expenses |
|
|
|
5,370 |
|
|
|
6,069 |
|
|
|
|
|
|
|
|
|
|
|
Operating
loss |
|
|
|
4,370 |
|
|
|
6,069 |
|
|
|
|
|
|
|
|
|
|
|
Finance expense |
|
|
|
837 |
|
|
|
7 |
|
Finance income |
|
|
|
(24 |
) |
|
|
(63 |
) |
Finance expense
(income), net |
|
|
|
813 |
|
|
|
(56 |
) |
|
|
|
|
|
|
|
|
|
|
Loss for the
period |
|
|
|
5,183 |
|
|
|
6,013 |
|
|
|
|
|
|
|
|
|
|
|
Loss
attributable to: |
|
|
|
|
|
|
|
|
|
Owners of the
Company |
|
|
|
4,853 |
|
|
|
5,824 |
|
Non-controlling
interests |
|
|
|
330 |
|
|
|
189 |
|
|
|
|
|
5,183 |
|
|
|
6,013 |
|
|
|
|
|
|
|
|
|
|
|
Loss per share |
|
|
|
|
|
|
|
|
|
Basic and diluted loss
per share - USD |
|
|
|
0.02 |
|
|
|
0.04 |
|
|
|
|
|
|
|
|
|
|
|
Number of shares used
in calculation |
|
|
|
248,117,119 |
|
|
|
163,781,022 |
|
Contact:
Simcha Rock, Chief Financial Officer and Director
+972-3- 9333121 ext. #105
simcha@kitovpharma.com
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