ISFIYA, Israel, May 9, 2017 /PRNewswire/ -- Check-Cap Ltd. (the
"Company" or "Check-Cap") (NASDAQ: CHEK; NASDAQ: CHEKW), a
clinical-stage medical diagnostics company engaged in the
development of C-Scan®, an ingestible capsule for
preparation-free, colorectal cancer screening, today provided a
corporate update and announced its financial results for the three
months ended March 31, 2017.
"Throughout the past quarter, we continued to advance our
clinical trial to support CE Marking for the C-Scan® system and
plan to submit our CE Mark application during the summer of this
year, " said Bill Densel, CEO of
Check-Cap. "Having completed the first critical phase of our
ongoing collaboration with GE Healthcare, we are very encouraged in
our progress to develop and validate high-volume manufacturing of
X-ray source production and assembly for use in future U.S.
clinical trials."
Financial Results for the First Quarter Ended March 31, 2017
Research and development expenses, net were $1.9 million in the three months ended
March 31, 2017, compared to
$1.8 million in the same period in
2016. This increase was primarily due to the initiation of the
Company's trial to support CE Marking for the C-Scan® system.
General and administrative expenses were $890,000 in the three months ended March 31, 2017, compared to $1.1 million in the same period in 2016. This
decrease was primarily due to a decrease in share-based
compensation ($170,000).
Operating loss was $2.8 million in
the three months ended March 31,
2017, compared to an operating loss of $2.9 million in the same period in 2016.
Finance income, net was $110,000
in the three months ended March 31,
2017, compared to $158,000 in
the same period in 2016.
Net loss was $2.7 million in the
three months ended March 31, 2017,
compared to $2.7 million in the same
period in 2016.
Non-GAAP net loss, as defined below, was $2.4 million in the three months ended
March 31, 2017, compared to
$2.3 million in the same period in
2016. A reconciliation of GAAP results to non-GAAP results is
provided below.
Cash, cash equivalents and short-term bank deposits totaled
$9.4 million as of March 31, 2017, compared with $11.6 million as of December 31, 2016.
Net cash used in operating activities was $2.3 million in the three months ended
March 31, 2017, compared to
$2.5 million in the same period in
2016.
The number of outstanding ordinary shares as of March 31, 2017 was 15,629,696.
Use of Non-GAAP Financial Results
In addition to disclosing financial results calculated in
accordance with U.S. GAAP, the Company's financial results
release contains Non-GAAP financial measures of net loss for the
period that exclude the effects of share-based compensation and
changes in royalties provision. The Company's management believes
the Non-GAAP financial information provided in this release is
useful to investors' understanding and assessment of the Company's
on-going operations. Management also uses both GAAP and
Non-GAAP information in evaluating and operating business
internally and as such deemed it important to provide all this
information to investors. The Non-GAAP financial measures disclosed
by the Company should not be considered in isolation or as a
substitute for, or superior to, financial measures calculated in
accordance with GAAP, and the financial results calculated in
accordance with GAAP and reconciliations to those financial
statements should be carefully evaluated. Reconciliations between
GAAP measures and Non-GAAP measures are provided later in this
press release.
About Check-Cap
Check-Cap is a clinical-stage medical diagnostics company
developing C-Scan®, the first capsule-based system for
preparation-free colorectal cancer screening.
Utilizing innovative ultra-low dose X-ray and wireless
communication technologies, the capsule generates information on
the contours of the inside of the colon as it passes
naturally. This information is used to create a 3D map of the
colon, which allows physicians to look for polyps and other
abnormalities. Designed to improve the patient experience and
increase the willingness of individuals to participate in
recommended colorectal cancer screening, C-Scan® removes many
frequently-cited barriers, such as laxative bowel preparation,
invasiveness and sedation. The C-Scan® system is currently not
cleared for marketing in any jurisdiction.
Legal Notice Regarding Forward-Looking Statements
This press release contains "forward-looking statements."
Words such as "may," "should," "could," "would," "predicts,"
"potential," "continue," "expects," "anticipates," "future,"
"intends," "plans," "believes," "estimates," and similar
expressions, as well as statements in future tense, often signify
forward-looking statements. Forward-looking statements should not
be read as a guarantee of future performance or results and may not
be accurate indications of when such performance or results will be
achieved. Forward-looking statements are based on information that
the Company has when those statements are made or management's good
faith belief as of that time with respect to future events, and are
subject to risks and uncertainties that could cause actual
performance or results to differ materially from those expressed in
or suggested by the forward-looking statements. For a discussion of
these and other risks that could cause such differences and that
may affect the realization of forward-looking statements, please
refer to the "Special Note On Forward-looking Statements" and "Risk
Factors" in the Company's Annual Report on Form 20-F and other
filings with the Securities and Exchange Commission (SEC).
Investors and security holders are urged to read these documents
free of charge on the SEC's web site at
http://www.sec.gov. The Company assumes no obligation to
publicly update or revise its forward-looking statements as a
result of new information, future events or otherwise.
Financial Tables Follow:
CHECK CAP
LTD
|
CONSOLIDATED
UNAUDITED BALANCE SHEETS
|
(U.S. dollars
in thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
March
31,
|
|
December
31,
|
|
|
|
2017
|
|
2016
|
|
Asset
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
9,380
|
|
|
11,639
|
|
Prepaid expenses and
other current assets
|
|
|
441
|
|
|
242
|
|
Total current
assets
|
|
|
9,821
|
|
|
11,881
|
|
|
|
|
|
|
|
|
|
Non-current
assets
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
|
460
|
|
|
414
|
|
Total non-current
assets
|
|
|
460
|
|
|
414
|
|
Total
assets
|
|
|
10,281
|
|
|
12,295
|
|
|
|
|
|
|
|
|
|
Liabilities and
shareholders' equity
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
Accounts payable and
accruals
|
|
|
|
|
|
|
|
Trade
|
|
|
586
|
|
|
393
|
|
Other
|
|
|
238
|
|
|
235
|
|
Other current
liabilities
|
|
|
11
|
|
|
11
|
|
Employees and payroll
accruals
|
|
|
921
|
|
|
728
|
|
Total current
liabilities
|
|
|
1,756
|
|
|
1,367
|
|
|
|
|
|
|
|
|
|
Non-current
liabilities
|
|
|
|
|
|
|
|
Royalties
provision
|
|
|
545
|
|
|
521
|
|
Total non-current
liabilities
|
|
|
545
|
|
|
521
|
|
|
|
|
|
|
|
|
|
Shareholders'
equity
|
|
|
|
|
|
|
|
Share
capital
|
|
|
793
|
|
|
771
|
|
Additional paid-in
capital
|
|
|
52,783
|
|
|
52,577
|
|
Accumulated
deficit
|
|
|
(45,596)
|
|
|
(42,941)
|
|
Total
shareholders' equity
|
|
|
7,980
|
|
|
10,407
|
|
|
|
|
|
|
|
|
|
Total liabilities
and shareholders' equity
|
|
|
10,281
|
|
|
12,295
|
|
CHECK-CAP
LTD.
|
CONSOLIDATED
UNAUDITED STATEMENTS OF OPERATIONS
|
(U.S.
dollars in thousands, except per share data)
|
|
|
|
Three months
ended
March
31,
|
|
|
|
2017
|
|
|
2016
|
|
|
|
|
|
Research and
development expenses, net
|
|
|
1,877
|
|
|
|
1,802
|
|
General and
administrative expenses
|
|
|
886
|
|
|
|
1,098
|
|
Operating
loss
|
|
|
2,763
|
|
|
|
2,900
|
|
|
|
|
|
|
|
|
|
|
Finance income,
net
|
|
|
110
|
|
|
|
158
|
|
Loss before
tax
|
|
|
2,653
|
|
|
|
2,742
|
|
Taxes on
income
|
|
|
3
|
|
|
|
-
|
|
Net
loss
|
|
|
2,656
|
|
|
|
2,742
|
|
|
|
|
|
|
|
|
|
|
Net loss per
ordinary share basic and diluted
|
|
|
0.16
|
|
|
|
0.21
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of ordinary shares outstanding
- basic and diluted (in thousands)
|
|
|
16,427
|
|
|
|
13,279
|
|
CHECK-CAP
LTD.
|
CONSOLIDATED
UNAUDITED STATEMENTS OF CASH FLOWS
|
(U.S. dollars in
thousands, except per share data)
|
|
|
|
Three months
ended
March
31,
|
|
|
|
2017
|
|
|
2016
|
|
CASH FLOWS FROM
OPERATING ACTIVITIES
|
|
|
|
Net loss for the
period
|
|
|
(2,656)
|
|
|
|
(2,742)
|
|
Adjustments required
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation and
amortization
|
|
|
36
|
|
|
|
31
|
|
Share-based
compensation
|
|
|
214
|
|
|
|
436
|
|
Financial income,
net
|
|
|
(138)
|
|
|
|
-
|
|
Changes in assets
and liabilities items:
|
|
|
|
|
|
|
|
|
Increase (decrease)
in prepaid and other current assets and non-current
assets
|
|
|
(199)
|
|
|
|
32
|
|
Increase in trade
accounts payable, accruals and other current liabilities
|
|
|
180
|
|
|
|
18
|
|
Increase (decrease)
in employees and payroll accruals
|
|
|
193
|
|
|
|
(211)
|
|
Increase (decrease)
in royalties provision
|
|
|
24
|
|
|
|
(24)
|
|
Net cash used in
operating activities
|
|
|
(2,346)
|
|
|
|
(2,460)
|
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM
INVESTING ACTIVITIES
|
|
|
|
|
|
|
|
|
Purchase of property
and equipment
|
|
|
(66)
|
|
|
|
(42)
|
|
Proceeds from
short-term investments
|
|
|
-
|
|
|
|
1,811
|
|
Net cash provided
by (used in) investing activities
|
|
|
(66)
|
|
|
|
1,769
|
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM
FINANCING ACTIVITIES
|
|
|
|
|
|
|
|
|
Exercise of warrants
into ordinary shares
|
|
|
15
|
|
|
|
6
|
|
Net cash provided
by financing activities
|
|
|
15
|
|
|
|
6
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange
rate changes on cash and cash equivalents
|
|
|
138
|
|
|
|
-
|
|
Net decrease in
cash and cash equivalents
|
|
|
(2,259)
|
|
|
|
(685)
|
|
Cash and cash
equivalents at the beginning of the period
|
|
|
11,639
|
|
|
|
9,392
|
|
Cash and cash
equivalents at the end of the period
|
|
|
9,380
|
|
|
|
8,707
|
|
CHECK-CAP
LTD.
|
SUPPLEMENTAL
RECONCILIATION OF GAAP TO NON-GAAP RESULTS
|
(U.S.
dollars in thousands)
|
|
|
|
Three months
ended
March
31,
|
|
|
|
2017
|
|
2016
|
GAAP net loss for the
period
|
|
|
(2,656)
|
|
|
(2,742)
|
Share-based
compensation (1)
|
|
|
214
|
|
|
436
|
Changes in
royalties
|
|
|
24
|
|
|
(24)
|
Non-GAAP net loss
for the period
|
|
|
(2,418)
|
|
|
(2,330)
|
(1) Share-based
compensation:
|
|
|
|
|
|
|
Research and
development expenses, net
|
|
|
44
|
|
|
96
|
General and
administrative expenses
|
|
|
170
|
|
|
340
|
|
|
|
214
|
|
|
436
|
|
|
|
|
|
|
|
CONTACT:
Investors
David Carey
Lazar Partners Ltd.
+1-212-867-1768
dcarey@lazarpartners.com
Vivian Cervantes
PCG Advisory
+1-212-554-5482
vivian@pcgadvisory.com
Media
Erich Sandoval or Rob Sawyer
Lazar Partners Ltd.
+1-213-908-6226 or +1-212-843-0209
esandoval@lazarpartners.com
rsawyer@lazarpartners.com
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/check-cap-reports-first-quarter-2017-financial-results-300454045.html
SOURCE Check-Cap Ltd.