ISFIYA, Israel, Nov. 16, 2016 /PRNewswire/ -- Check-Cap Ltd.
(the "Company" or "Check-Cap") (NASDAQ: CHEK, CHEKW), a clinical
stage medical diagnostics company engaged in the development of an
ingestible capsule for preparation-free, colorectal cancer
screening, today provided a corporate update and announced its
financial results for the third quarter and nine months ended
September 30, 2016.
"During the past quarter, we continued to advance our ongoing
clinical program and the optimization of the Check-Cap System,
while executing on additional corporate priorities," said
Bill Densel, CEO of Check-Cap.
"Recently, additional clinical data related to safety, capsule
transit, and capsule correlation to colonoscopic findings were
presented at leading gastroenterology professional society meetings
in the United States and
Europe, and we remain on track to
file a CE Mark submission in the first half of 2017."
Recent Highlights:
- Preliminary data demonstrating safety, polyp identification and
location in clinical studies evaluating the Company's non-invasive
system for preparation-free examination of the colon were presented
at the American College of Gastroenterology (ACG) Annual Scientific
Meeting and the United European Gastroenterology Week (UEGW).
Financial Results for the Third Quarter Ended September 30, 2016
Research and development expenses, net were $1 million in the three months ended September 30, 2016, compared to $1.6 million in the same period in 2015. This
decrease was primarily due to a $536,000 increase in participation of the Office
of Chief Scientist (OCS) (pro-rated credited to R&D expenses),
and a $123,000 decrease in
subcontractors and materials. This decrease was partially offset by
an increase of $78,000 in salary and
related expenses and $28,000 increase
in cost of registration of patents.
General and administrative expenses were $0.8 million in the three months ended
September 30, 2016, compared to
$1.4 million in the same period in
2015. This decrease was primarily due to a decrease in personnel
related cost of $485,000, a decrease
in share based compensation of $158,000 and a decrease in professional fees of
$95,000. This decrease was partially
offset by an increase of $48,000 in
facility cost and an increase of $69,000 in other general and administrative
expenses.
Operating loss was $1.8 million
for the three months ended September 30,
2016, compared to $3 million
in the same period in 2015.
Finance income, net was $61,000 in
the three months ended September 30,
2016, and consisted primarily of $88,000 of finance income (comprised of
$54,000 in exchange rate differences
and $34,000 in interest income on
short-term deposits) offset by $27,000 of finance expenses (comprised primarily
of $25,000 of changes in
royalties).
Finance expenses, net was $94,000
in the three months ended September 30,
2015, consisted primarily of $78,000 of exchange rate differences and
$15,000 of changes in royalties.
Net loss was $1.7 million in the
three months ended September 30,
2016, compared to $3.1 million
in the same period in 2015.
Non-GAAP net loss was $1.4 million
in the three months ended September 30,
2016, compared to $2.6 million
in the same period in 2015.
Cash, cash equivalents and short-term bank deposit totaled
$13.5 million at September 30, 2016, compared to $9.4 million at June
30, 2016. Check-Cap's cash balance as of September 30, 2016 included - net proceeds from
our August 2016 registered direct
offering, and grants received from the OCS amounting to
$845,000 (of a total $1.25 million approved grant).
Financial Results for the Nine Months Ended September 30, 2016
Research and development expenses, net were $3.9 million in the nine months ended
September 30, 2016, compared to
$4.3 million in the same period in
2015. This decrease was primarily due to a $1.1 million increase in participation of the OCS
(pro-rated credited to R&D expenses) and a decrease of
$472,000 in share-based compensation
and a $103,000 decrease in materials.
This decrease was partially offset by an increase of $1.2 million in salary and related expenses and a
$124,000 increase in the cost of
registration of patents, depreciation and other research and
development expenses.
General and administrative expenses were $2.8 million in the nine months ended
September 30, 2016, compared to
$5.1 million in the same period in
2015. This decrease was primarily due to a decrease in share-based
compensation of $1.6 million, a
$619,000 decrease in personnel
related expenses and a $160,000
decrease in professional fees and other general and administrative
related expenses. This decrease was partially offset by an increase
of $71,000 in facility cost.
Operating loss was $6.6 million
for the nine months ended September 30,
2016, compared to $9.4 million
in the same period in 2015.
Finance income, net was $204,000
in the nine months ended September 30,
2016, and consisted primarily of $222,000 of finance income (comprised of
$117,000 in exchange rate differences
and $105,000 of interest income on
short-term deposits) and $18,000 of
finance expenses (comprised primarily of $12,000 of changes in royalties and $5,000 bank fees).
Finance income, net was $91,000 in
the nine months ended September 30,
2015, and consisted primarily of $176,000 of finance income (comprised primarily
of $174,000 in revaluation of fair
value of preferred shares warrants) and $85,000 of finance expenses (comprised of
$42,000 of changes in royalties and
$43,000 of interest expenses and bank
fees).
Net loss was $6.4 million in the
nine months ended September 30, 2016,
compared to $9.3 million in the same
period in 2015.
Non-GAAP net loss was $5.4 million
in the nine months ended September 30,
2016, compared to $6.3 million
in the same period in 2015.
Net cash used in operating activities was $6.2 million in the nine months ended
September 30, 2016, compared to
$6.3 million in the same period in
2015.
A reconciliation of GAAP results to non-GAAP results is provided
below.
The number of outstanding ordinary shares as of September 30, 2016 and October 31, 2016 was 13,555,794 and 14,455,075,
respectively.
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,
changes in royalties provision and revaluation of warrants to
purchase preferred shares. 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 the world's first ingestible capsule system for
preparation-free, minimally-invasive colorectal cancer
screening.
The capsule utilizes innovative ultra-low dose X-ray and
wireless communication technologies to scan the inside of the colon
as it moves naturally, while the patient follows his or her normal
daily routine. After passage, the system generates a 3D
map of the inner surface of the colon which enables detection of
polyps and cancer. Designed to increase the willingness of
individuals to participate in recommended colorectal cancer
screening, the Check-Cap system addresses many frequently-cited
barriers, including laxative bowel preparation, invasiveness, and
sedation. The Check-Cap 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 to Follow
CHECK CAP
LTD
CONSOLIDATED
UNAUDITED BALANCE SHEETS
(U.S. dollars in
thousands, except share and per share data)
|
|
|
|
September
30,
|
|
|
December
31,
|
|
|
|
2016
|
|
|
2015
|
|
Assets
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
11,456
|
|
|
|
9,392
|
|
Restricted
cash
|
|
|
-
|
|
|
|
46
|
|
Short-term
investments
|
|
|
2,014
|
|
|
|
4,811
|
|
Prepaid expenses and
other current assets
|
|
|
515
|
|
|
|
680
|
|
Total current
assets
|
|
|
13,985
|
|
|
|
14,929
|
|
|
|
|
|
|
|
|
|
|
Non-current
assets
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
|
439
|
|
|
|
369
|
|
Total non-current
assets
|
|
|
439
|
|
|
|
369
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
|
14,424
|
|
|
|
15,298
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
shareholders' equity
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
Accounts payable and
accruals
|
|
|
|
|
|
|
|
|
Trade
|
|
|
513
|
|
|
|
577
|
|
Other
|
|
|
136
|
|
|
|
245
|
|
Other current
liabilities
|
|
|
11
|
|
|
|
13
|
|
Employees and payroll
accruals
|
|
|
619
|
|
|
|
1,238
|
|
|
|
|
|
|
|
|
|
|
Total current
liabilities
|
|
|
1,279
|
|
|
|
2,073
|
|
|
|
|
|
|
|
|
|
|
Non-current
liabilities
|
|
|
|
|
|
|
|
|
Royalties
provision
|
|
|
589
|
|
|
|
577
|
|
Total non-current
liabilities
|
|
|
589
|
|
|
|
577
|
|
|
|
|
|
|
|
|
|
|
Shareholders'
equity
|
|
|
|
|
|
|
|
|
Share
capital
|
|
|
689
|
|
|
|
599
|
|
Ordinary share of NIS
0.2 par value-Authorized: 57,500,000 shares at December 31,
2015 and September 30, 2016; Issued and outstanding: 11,811,709 and
13,555,794 shares at December 31, 2015 and September 30, 2016,
respectively
|
|
|
|
|
|
|
|
|
Additional paid-in
capital
|
|
|
52,406
|
|
|
|
46,164
|
|
Accumulated
deficit
|
|
|
(40,539)
|
|
|
|
(34,115)
|
|
Total
shareholders' equity
|
|
|
12,556
|
|
|
|
12,648
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
and shareholders' equity
|
|
|
14,424
|
|
|
|
15,298
|
|
CHECK CAP
LTD
CONSOLIDATED
UNAUDITED STATEMENTS OF OPERATIONS
(U.S. dollars in
thousands, except share and per share data)
|
|
|
|
Nine months ended
September 30,
|
|
|
Three months ended
September 30,
|
|
|
|
2016
|
|
|
2015
|
|
|
2016
|
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development expenses, net
|
|
|
3,870
|
|
|
|
4,301
|
|
|
|
988
|
|
|
|
1,603
|
|
General and
administrative expenses
|
|
|
2,758
|
|
|
|
5,109
|
|
|
|
766
|
|
|
|
1,410
|
|
Operating
loss
|
|
|
6,628
|
|
|
|
9,410
|
|
|
|
1,754
|
|
|
|
3,013
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance income
(expenses), net
|
|
|
204
|
|
|
|
91
|
|
|
|
61
|
|
|
|
(94)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss for the
period
|
|
|
6,424
|
|
|
|
9,319
|
|
|
|
1,693
|
|
|
|
3,107
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per ordinary
share (in USD) Basic and diluted
|
|
|
0.47
|
|
|
|
0.81
|
|
|
|
0.11
|
|
|
|
0.23
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of ordinary shares outstanding - basic and diluted (in
thousands)
|
|
|
13,794
|
|
|
|
11,438
|
|
|
|
14,817
|
|
|
|
13,276
|
|
CHECK CAP
LTD
CONSOLIDATED
UNAUDITED STATEMENTS OF CASH FLOWS
(U.S. dollars in
thousands, except share and per share data)
|
|
|
|
Nine months
ended
September
30,
|
|
|
|
2016
|
|
|
2015
|
|
CASH FLOWS FROM
OPERATING ACTIVITIES
|
|
|
|
|
|
|
Net loss for the
period
|
|
|
(6,424)
|
|
|
|
(9,319)
|
|
Adjustments required
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Revaluation of fair
value of warrants to purchase preferred share
|
|
|
-
|
|
|
|
(174)
|
|
Depreciation and
amortization
|
|
|
96
|
|
|
|
62
|
|
Share-based
compensation
|
|
|
1,053
|
|
|
|
3,169
|
|
Financial income,
net
|
|
|
(124)
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Changes in assets
and liabilities items:
|
|
|
|
|
|
|
|
|
Decrease (increase)
in prepaid and other current assets and non-current
assets
|
|
|
165
|
|
|
|
(217)
|
|
Increase (decrease)
in trade accounts payable, accruals and other current
liabilities
|
|
|
(324)
|
|
|
|
129
|
|
Decrease in employees
and payroll accruals
|
|
|
(619)
|
|
|
|
(31)
|
|
Increase in royalties
provision
|
|
|
12
|
|
|
|
42
|
|
Net cash used in
operating activities
|
|
|
(6,165)
|
|
|
|
(6,339)
|
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM
INVESTING ACTIVITIES
|
|
|
|
|
|
|
|
|
Purchase of property
and equipment
|
|
|
(166)
|
|
|
|
(206)
|
|
Decrease in
restricted deposit
|
|
|
46
|
|
|
|
-
|
|
Proceeds from
(investment in) short-term bank deposits, net
|
|
|
2,811
|
|
|
|
(6,800)
|
|
Net cash provided
by (used in) investing activities
|
|
|
2,691
|
|
|
|
(7,006)
|
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM
FINANCING ACTIVITIES
|
|
|
|
|
|
|
|
|
Receipt of short-term
loan from bank
|
|
|
-
|
|
|
|
1,000
|
|
Repayment of
short-term loan from bank
|
|
|
-
|
|
|
|
(1,000)
|
|
Issuance of ordinary
shares upon exercise of stock options by employees
|
|
|
-
|
|
|
|
16
|
|
Exercise of warrants
into ordinary shares
|
|
|
34
|
|
|
|
29
|
|
Issuance of ordinary
shares in the IPO, net of issuance expenses
|
|
|
-
|
|
|
|
10,947
|
|
Issuance of ordinary
shares in the private placement, net of issuance
expenses
|
|
|
-
|
|
|
|
11,021
|
|
Issuance of ordinary
shares in the registered direct offering, net of issuance
expenses
|
|
|
1,123
|
|
|
|
-
|
|
Grant of pre-funded
warrants in the registered direct offering, net of issuance
expenses
|
|
|
4,271
|
|
|
|
-
|
|
Net cash provided
by financing activities
|
|
|
5,428
|
|
|
|
22,013
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange
rate changes on cash and cash equivalents
|
|
|
110
|
|
|
|
-
|
|
Net increase in
cash and cash equivalents
|
|
|
2,064
|
|
|
|
8,668
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents at the beginning of the period
|
|
|
9,392
|
|
|
|
1,075
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents at the end of the period
|
|
|
11,456
|
|
|
|
9,743
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non Cash financing
activities :
Issuance expenses in
the registered direct offering
|
|
|
149
|
|
|
|
-
|
|
CHECK-CAP
LTD.
SUPPLEMENTAL
RECONCILIATION OF GAAP TO NON-GAAP RESULTS
(U.S. dollars in
thousands)
|
|
|
|
Nine months ended
September 30,
|
|
|
Three months ended
September 30,
|
|
|
|
2016
|
|
|
2015
|
|
|
2016
|
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss for the
period
|
|
|
(6,424)
|
|
|
|
(9,319)
|
|
|
|
(1,693)
|
|
|
|
(3,107)
|
|
Share-based
compensation (1)
|
|
|
1,053
|
|
|
|
3,169
|
|
|
|
259
|
|
|
|
480
|
|
Changes in
royalties
|
|
|
12
|
|
|
|
42
|
|
|
|
25
|
|
|
|
15
|
|
Financial income
related to revaluation of fair value of preferred shares
warrants
|
|
|
-
|
|
|
|
(174)
|
|
|
|
-
|
|
|
|
-
|
|
Non-GAAP net loss
for the period
|
|
|
(5,359)
|
|
|
|
(6,282)
|
|
|
|
(1,409)
|
|
|
|
(2,612)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Share-based
compensation:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development expenses, net
|
|
|
207
|
|
|
|
679
|
|
|
|
45
|
|
|
|
108
|
|
General and
administrative expenses
|
|
|
846
|
|
|
|
2,490
|
|
|
|
214
|
|
|
|
372
|
|
|
|
|
1,053
|
|
|
|
3,169
|
|
|
|
259
|
|
|
|
480
|
|
CONTACT:
Investors
David Carey
Lazar Partners Ltd.
212-867-1768
dcarey@lazarpartners.com
Vivian Cervantes
PCG Advisory
212-554-5482
vivian@pcgadvisory.com
Media
Erich Sandoval or Rob Sawyer
Lazar Partners Ltd.
213-908-6226 or 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-third-quarter-2016-financial-results-300363784.html
SOURCE Check-Cap Ltd.