TEL AVIV, Israel, August 17, 2016 /PRNewswire/ --
Kitov Pharmaceuticals Holdings Ltd. (NASDAQ/TASE: KTOV), an
innovative biopharmaceutical company focused on late stage drug
development, today issued its financial reports for the first half
of 2016, ending June 30, 2016.
"We have advanced according to plan in the clinical, chemistry,
regulatory, and intellectual property areas of KIT-302's
development," remarked Kitov's CEO, Isaac
Israel. "We are on track to submit our NDA for KIT-302
anticipated for the end of 2016. We are committed to extending our
pipeline of drugs with cutting edge technologies, and to continue
securing the intellectual property rights over our proprietary
assets in order to maximize value to our shareholders."
Highlights and achievements during the first
half of 2016, and to date:
- Completion of KIT-302's pharmacokinetic (PK) bioequivalence
(BE) study, successfully meeting the FDA's standards for
establishing bioequivalence to the reference drugs
- Completion of manufacturing and of initial stability testing of
pivotal batches of KIT-302 required for registration with the
FDA
- Pre-NDA meeting with FDA and subsequent receipt of meeting
minutes
- Receipt of Notice of Allowance and subsequent issuance of a
patent from the U.S. Patent and Trademark Office for claims
covering important treatment methodologies, which form the basis of
KIT-302
- Follow-on public offering for an equity raise on NASDAQ of
$12 million, gross
Expected upcoming significant milestones:
- Issuance of KIT-302's clinical trial full study report
- Completion of six-month stability testing of KIT-302
- Submission to the FDA of the New Drug Application for
KIT-302
- Initiation of a renal function clinical trial to demonstrate
the beneficial effects of KIT-302 on kidney function
The information contained below should be read in conjunction
with (1) our Unaudited Condensed Consolidated Interim Financial
Statements as of June 30, 2016, and
for the six months then ended; and (2) our
audited consolidated financial statements for the year ended
December 31, 2015, which appears in
the Company's Annual Report on Form 20-F filed with
the Securities and Exchange Commission on March 18, 2016, 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, 2016
Research and development expenses for the six months ended
June 30, 2016 were $1,964 thousand, an increase of $961 thousand, or 94%, compared to $1,003 thousand for the six months ended
June 30, 2015. The increase resulted
primarily from expenses deriving from our strategic cooperation
agreement with Dexcel Ltd.
General and administrative expenses for the six months ended
June 30, 2016 were $1,194 thousand, an increase of $575 thousand or 93%, compared to $619 thousand for the six months ended
June 30, 2015. The increase resulted
from increase in business travel, salaries and related expenses and
expenses related to our securities being listed on the NASDAQ since
November 2015.
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. Finance expense for the six months
ended June 30, 2015 was $55 thousand and is primarily related to exchange
rate differences.
The Company's net loss for the six months ended June 30, 2016 amounted to $3,037 thousand, compared with a loss of
$1,682 thousand for the corresponding
period in 2015.
Balance Sheet Highlights
- Cash, cash equivalents and short-term deposits totaled
$8,433 thousand as of June 30, 2016, compared to $10,558 thousand on December 31, 2015. The decrease compared to
December 31, 2015 reflects the cash
used in operations during the first half of 2016.
- Shareholders' equity totaled $7,072
thousand as of June 30, 2016,
compared to $9,429 thousand as of
December 31, 2015.
The above balance sheet data as of June
30, 2016 do not reflect the follow-on public offering on the
NASDAQ, which closed on July 5, 2016,
pursuant to which the Company raised approximately an additional
USD 10.7 million, net.
For the full document of the unaudited condensed consolidated
interim financial statements as of, and for the six months ended,
June 30, 2016, please see:
http://kitovpharma.investorroom.com/sec-filings.
About Kitov Pharmaceuticals
Kitov Pharmaceuticals (NASDAQ/TASE: KTOV) is an innovative
biopharmaceutical company focused on late-stage drug development.
Leveraging deep regulatory and clinical-trial expertise, Kitov's
veteran team of healthcare professionals maintains a proven track
record in streamlined end-to-end drug development and approval.
Kitov's pipeline currently features two combination drugs intended
to treat osteoarthritis pain and hypertension simultaneously,
including one that achieved the primary efficacy endpoint for its
Phase III clinical trial. By lowering development risk and cost
through fast-track regulatory approval of novel late-stage
therapeutics, Kitov plans to deliver rapid ROI and long-term
potential to investors, while making a meaningful impact on
people's lives. For more information on Kitov, the content of which
is not part of this press release, please visit
http://www.kitovpharma.com.
Forward-Looking Statements
This press release contains forward-looking statements about the
Company's expectations, beliefs and intentions. Forward-looking
statements can 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. These
forward-looking statements involve certain risks and uncertainties,
including, among others, the risk that drug development involves a
lengthy and expensive process with uncertain outcome; the Company's
ability to successfully develop and commercialize its
pharmaceutical product; the length, progress and results of any
clinical trials; the introduction of competing products; the impact
of any changes in regulation and legislation that could affect the
pharmaceutical industry; the difficulty in receiving the regulatory
approvals to commercialize the Company's products; the lack of
sufficient funding to finance the clinical trials; the difficulty
of predicting actions of the USA FDA; the regulatory
environment and changes in the health policies and regimes in the
countries in which we operate; changes in the global pharmaceutical
industry; patents attained by competitors; dependence on the
effectiveness of the Company's patents and other protections for
innovative products; the Company's ability to obtain, maintain and
defend issued patents with protective claims; the issuance and term
of patents; the commencement of any patent interference or
infringement action; the Company's ability to prevail in or obtain
a favorable decision in any such action; the Company's ability to
recover damages in any such action; and the exposure to litigation,
including patent litigation, and/or regulatory actions. Any
forward-looking statement in this press release speaks only as of
the date of this press release. The Company undertakes no
obligation to publicly update or review any forward-looking
statement, whether as a result of new information, future
developments or otherwise, except as may be required by any
applicable securities laws. More detailed information about the
risks and uncertainties affecting the Company is contained under
the heading "Risk Factors" in Kitov Pharmaceuticals Holdings Ltd.'s
Registration Statement on Form F-1 filed with the SEC (file number
333-211477), which is available on the SEC's website,
http://www.sec.gov.
Contact:
Simcha Rock
Chief Financial Officer
+972-3-9333121 ext. #105
simcha@kitovpharma.com
SOURCE Kitov Pharmaceuticals Holdings Ltd.