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:
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CHECK CAP LTD |
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CONSOLIDATED UNAUDITED BALANCE SHEETS |
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(U.S. dollars in thousands, except share and per share data) |
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March 31, |
December 31, |
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2017 |
2016 |
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Asset |
|||||||
|
Current assets |
|||||||
|
Cash and cash equivalents |
9,380 |
11,639 |
|||||
|
Prepaid expenses and other current assets |
441 |
242 |
|||||
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Total current assets |
9,821 |
11,881 |
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Non-current assets |
|||||||
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Property and equipment, net |
460 |
414 |
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Total non-current assets |
460 |
414 |
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Total assets |
10,281 |
12,295 |
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|
Liabilities and shareholders' equity |
|||||||
|
Current liabilities |
|||||||
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Accounts payable and accruals |
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|
Trade |
586 |
393 |
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Other |
238 |
235 |
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Other current liabilities |
11 |
11 |
|||||
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Employees and payroll accruals |
921 |
728 |
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Total current liabilities |
1,756 |
1,367 |
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Non-current liabilities |
|||||||
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Royalties provision |
545 |
521 |
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Total non-current liabilities |
545 |
521 |
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Shareholders' equity |
|||||||
|
Share capital |
793 |
771 |
|||||
|
Additional paid-in capital |
52,783 |
52,577 |
|||||
|
Accumulated deficit |
(45,596) |
(42,941) |
|||||
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Total shareholders' equity |
7,980 |
10,407 |
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Total liabilities and shareholders' equity |
10,281 |
12,295 |
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CHECK-CAP LTD. |
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CONSOLIDATED UNAUDITED STATEMENTS OF OPERATIONS |
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(U.S. dollars in thousands, except per share data) |
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Three months ended March 31, |
||||||||
|
2017 |
2016 |
|||||||
|
Research and development expenses, net |
1,877 |
1,802 |
||||||
|
General and administrative expenses |
886 |
1,098 |
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Operating loss |
2,763 |
2,900 |
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Finance income, net |
110 |
158 |
||||||
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Loss before tax |
2,653 |
2,742 |
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Taxes on income |
3 |
- |
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Net loss |
2,656 |
2,742 |
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Net loss per ordinary share basic and diluted |
0.16 |
0.21 |
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Weighted average number of ordinary shares outstanding |
16,427 |
13,279 |
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CHECK-CAP LTD. |
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CONSOLIDATED UNAUDITED STATEMENTS OF CASH FLOWS |
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(U.S. dollars in thousands, except per share data) |
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|
Three months ended March 31, |
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|
2017 |
2016 |
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|
CASH FLOWS FROM OPERATING ACTIVITIES |
||||||||
|
Net loss for the period |
(2,656) |
(2,742) |
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Adjustments required to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
36 |
31 |
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Share-based compensation |
214 |
436 |
||||||
|
Financial income, net |
(138) |
- |
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Changes in assets and liabilities items: |
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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 |
||||||
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Increase (decrease) in employees and payroll accruals |
193 |
(211) |
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Increase (decrease) in royalties provision |
24 |
(24) |
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Net cash used in operating activities |
(2,346) |
(2,460) |
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CASH FLOWS FROM INVESTING ACTIVITIES |
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Purchase of property and equipment |
(66) |
(42) |
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Proceeds from short-term investments |
- |
1,811 |
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Net cash provided by (used in) investing activities |
(66) |
1,769 |
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CASH FLOWS FROM FINANCING ACTIVITIES |
||||||||
|
Exercise of warrants into ordinary shares |
15 |
6 |
||||||
|
Net cash provided by financing activities |
15 |
6 |
||||||
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Effect of exchange rate changes on cash and cash equivalents |
138 |
- |
||||||
|
Net decrease in cash and cash equivalents |
(2,259) |
(685) |
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|
Cash and cash equivalents at the beginning of the period |
11,639 |
9,392 |
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Cash and cash equivalents at the end of the period |
9,380 |
8,707 |
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CHECK-CAP LTD. |
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SUPPLEMENTAL RECONCILIATION OF GAAP TO NON-GAAP RESULTS |
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(U.S. dollars in thousands) |
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|
Three months ended March 31, |
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|
2017 |
2016 |
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|
GAAP net loss for the period |
(2,656) |
(2,742) |
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|
Share-based compensation (1) |
214 |
436 |
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Changes in royalties |
24 |
(24) |
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Non-GAAP net loss for the period |
(2,418) |
(2,330) |
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(1) Share-based compensation: |
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Research and development expenses, net |
44 |
96 |
|||||||||||||
|
General and administrative expenses |
170 |
340 |
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|
214 |
436 |
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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
SOURCE Check-Cap Ltd.