ISFIYA, Israel, Nov. 5, 2018 /PRNewswire/ -- Check-Cap Ltd. (the "Company" or "Check-Cap") (NASDAQ: CHEK) (NASDAQ: CHEKW), (NASDAQ: CHEKZ), a clinical-stage medical diagnostics company engaged in the development of C-Scan®, a preparation free capsule-based screening method for the prevention of colorectal cancer through the detection of precancerous polyps, announced today financial results for the third quarter and nine months ended September 30, 2018.
Recent Highlights
- Submitted an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) that, if approved, would allow the Company to initiate a U.S. pilot study of the C-Scan system by the end of 2018, in collaboration with GE Healthcare as manufacturing partner.
- Received approval from the Israeli Ministry of Health, the Medical Device Division (AMAR) to initiate commercial sales in Israel of the C-Scan system that received CE Mark approval in January 2018.
- Announced on September 04, 2018, encouraging interim results from its ongoing post-CE approval study of its C-Scan® System Version 3, demonstrating 76% sensitivity (P=0.0038) and 80% specificity. Final results from the study are expected in 2Q 2019.
Alex Ovadia, Chief Executive Officer of Check-Cap, stated: "Despite strong evidence that screening can decrease the incidence of colorectal cancer, the lack of patient-friendly screening options continues to present an obstacle to adherence. We believe that the C-Scan system addresses all major barriers to standard screening methods, offering a screening option for those unable or unwilling to undergo colonoscopy. During the third quarter, we made significant progress toward our goal of commercializing the C-Scan system Version 3 in Israel, the EU and major markets worldwide. Most notably, we submitted an IDE to the FDA and are preparing to initiate a U.S. pilot study in collaboration with our manufacturing partner, GE Healthcare. We believe that the C-Scan system has the potential to make a meaningful impact on the rates of colorectal cancer screening and precancerous polyp detection, and we look forward to making this novel technology available to patients worldwide."
Financial Results for the Third Quarter Ended Sept. 30, 2018
Net research and development expenses were $1.9 million in the three months ended September 30, 2018, compared to $1.6 million in the same period in 2017. The increase is primarily attributable to a $232,000 increase in other R&D expenses primarily associated with the Company's post CE approval study of the C-Scan system and the IDE submission to the FDA, as well as a $52,000 decrease in grants received from the Israel Innovation Authority (IIA), which was reflected as a credit to research and development expenses.
General and administrative expenses were $937,000 in the three months ended September 30, 2018, compared to $810,000 in the same period in 2017. The increase was primarily due to a $62,000 increase in professional fees and $35,000 of expenses related our annual general meeting of shareholders which was held in September 2018.
Operating loss was $2.8 million for the three months ended September 30, 2018, compared to $2.4 million in the same period in 2017.
Net finance income was $99,000 in the three months ended September 30, 2018, compared to $10,000 in the same period in 2017.
Net loss was $2.7 million in the three months ended September 30, 2018, compared to $2.4 million in the same period in 2017.
Non-GAAP net loss was $2.6 million in the three months ended September 30, 2018, compared to $2.0 million in the same period in 2017.
Cash, cash equivalents and short-term bank deposit totaled $17.6 million at September 30, 2018, compared to $20 million at June 30, 2018.
Financial Results for the Nine Months Ended September 30, 2018
Net research and development expenses were $5.2 million in the nine months ended September 30, 2018, compared to $5.4 million in the same period in 2017. The decrease is primarily attributable to a $511,000 decrease in salaries and related expenses as a result of a reduction in head count in 2018 and a $66,000 decrease in share-based compensation. The decrease was partially offset by a $325,000 increase in other R&D expenses associated with the Company's post CE approval study of the C–Scan system and the IDE submission to the FDA, as well as a $52,000 decrease in grants received from the IAA, which was credited to research and development expenses.
General and administrative expenses were $2.4 million in the nine months ended September 30, 2018, compared to $2.5 million in the same period in 2017. The decrease was primarily due to a decrease of $861,000 in share-based compensation, of which $502,000 relates to reversal of expenses associated with an equity award to the Company's former CEO which was forfeited as a result of his separation from employment. The decrease was partially offset by a $376,000 increase in salary and related expenses primarily due to a onetime payment to the Company's former CEO as a result of his separation from employment, a $199,000 increase in professional expenses and a $144,000 increase in other general and administrative expenses.
Operating loss was $7.6 million for the nine months ended September 30, 2018, compared to $7.9 million in the same period in 2017.
Net finance income was $108,000 in the nine months ended September 30, 2018, compared to $80,000 in the same period in 2017.
Net loss was $7.5 million in the nine months ended September 30, 2018, compared to $7.9 million in the same period in 2017.
Non-GAAP net loss was $7.7 million in the nine months ended September 30, 2018, compared to $7.1 million in the same period in 2017.
A reconciliation of GAAP results to non-GAAP results is provided below.
Net cash used in operating activities was $7.3 million in the nine months ended September 30, 2018, compared to $7.0 million in the same period in 2017.
The number of outstanding ordinary shares as of September 30, 2018, was 5,329,891.
[Financial Tables to Follow]
About Check-Cap
Check-Cap is a clinical-stage medical diagnostics company developing C-Scan®, an ingestible capsule-based device 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.
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.
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 for the year ended December 31, 2017 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.
CHECK CAP LTD | ||||||
CONSOLIDATED UNAUDITED BALANCE SHEETS | ||||||
(U.S. dollars in thousands, except share and per share data) | ||||||
September 30, 2018 | December 31, 2017 | |||||
Assets | ||||||
Current assets | ||||||
Cash and cash equivalents | 8,485 | 6,997 | ||||
Short-term bank deposit | 9,080 | - | ||||
Prepaid expenses and other current assets | 496 | 406 | ||||
Total current assets | 18,061 | 7,403 | ||||
Non-current assets | ||||||
Property and equipment, net | 435 | 503 | ||||
Total non-current assets | - | 503 | ||||
Total assets | 18,496 | 7,906 | ||||
Liabilities and shareholders' equity | ||||||
Current liabilities | ||||||
Accounts payable and accruals | ||||||
Trade | 813 | 608 | ||||
Other | 308 | 347 | ||||
Other current liabilities | 9 | 5 | ||||
Employees and payroll accruals | 951 | 602 | ||||
Total current liabilities | 2,081 | 1,562 | ||||
Non-current liabilities | ||||||
Royalties provision | 479 | 439 | ||||
Total non-current liabilities | 479 | 439 | ||||
Shareholders' equity | ||||||
Share capital | 3,455 | 974 | ||||
Additional paid-in capital | 72,678 | 57,643 | ||||
Accumulated deficit | (60,197) | (52,712) | ||||
Total shareholders' equity |
15,936 | 5,905 | ||||
Total liabilities and shareholders' equity | 18,496 | 7,906 | ||||
CHECK CAP LTD | ||||||||||||||||||||||||||||
CONSOLIDATED UNAUDITED STATEMENTS OF OPERATIONS | ||||||||||||||||||||||||||||
(U.S. dollars in thousands, except share and per share data) | ||||||||||||||||||||||||||||
Nine months ended |
Three months ended | |||||||||||||||||||||||||||
September 30, | September 30, | |||||||||||||||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||||||||||||||
Research and development expenses, net | 5,222 | 5,437 | 1,865 |
1,564 | ||||||||||||||||||||||||
General and administrative expenses | 2,372 | 2,506 | 937 |
810 | ||||||||||||||||||||||||
Operating loss | 7,594 | 7,943 | 2,802 |
2,374 | ||||||||||||||||||||||||
Finance income (expenses), net | 108 | 80 | 99 |
(10) | ||||||||||||||||||||||||
Loss before tax | 7,486 | 7,863 | 2,703 |
2,384 | ||||||||||||||||||||||||
Tax expenses (gains) on income | (1) | 6 | - |
- | ||||||||||||||||||||||||
Net loss for the period | 7,485 | 7,869 | 2,703 |
2,384 | ||||||||||||||||||||||||
Net loss per ordinary share basic and diluted | 2.07 | 5.25 | 0.50 |
1.38 | ||||||||||||||||||||||||
Weighted average number of ordinary shares | 3,622 | 1,500 | 5,356 | 1,723 | ||||||||||||||||||||||||
CHECK-CAP LTD. | |||||||||
CONSOLIDATED UNAUDITED STATEMENTS OF CASH FLOWS | |||||||||
(U.S. dollars in thousands, except per share data) | |||||||||
Nine months ended September 30, | |||||||||
2018 | 2017 | ||||||||
CASH FLOWS FROM OPERATING ACTIVITIES | |||||||||
Net loss for the period | (7,485) | (7,869) | |||||||
Adjustments required to reconcile net loss to net cash used in operating activities: | |||||||||
Depreciation and amortization | 118 |
115 | |||||||
Share-based compensation | (271) |
657 | |||||||
Financial expense, net |
(43) | (155) | |||||||
Changes in assets and liabilities items: | |||||||||
Decrease in prepaid and other current assets and non-current assets |
(90) |
(73) | |||||||
Increase in trade accounts payable, accruals and other current liabilities | 60 |
64 | |||||||
Increase in employees and payroll accruals |
349 |
162 | |||||||
Increase in royalties provision |
40 |
78 | |||||||
Net cash used in operating activities |
(7,322) |
(7,021) | |||||||
CASH FLOWS FROM INVESTING ACTIVITIES | |||||||||
Purchase of property and equipment |
(14) |
(221) | |||||||
Short-term investments |
(9,000) |
- | |||||||
Net cash used in investing activities |
(9,014) |
(221) | |||||||
CASH FLOWS FROM FINANCING ACTIVITIES | |||||||||
Exercise of pre-funded warrants into ordinary shares |
4 |
82 | |||||||
Issuance of ordinary shares in the June 2017 RD Offering, net of issuance expenses in an amount of $349 |
- |
2,308 | |||||||
Issuance of ordinary shares in the 2018 Public Offering, net of issuance expenses in an amount of $2,381 |
17,858 |
- | |||||||
Net cash provided by financing activities |
17,862 |
2,390 | |||||||
Effect of exchange rate changes on cash and cash equivalents |
(38) |
153 | |||||||
Net increase (decrease) in cash and cash equivalents |
1,488 |
(4,699) | |||||||
Cash and cash equivalents at the beginning of the period |
6,997 |
11,639 | |||||||
Cash and cash equivalents at the end of the period |
8,485 |
6,940 | |||||||
CHECK-CAP LTD. | ||||||||||||||||
SUPPLEMENTAL RECONCILIATION OF GAAP TO NON-GAAP RESULTS | ||||||||||||||||
(U.S. dollars in thousands) | ||||||||||||||||
Nine months ended | Three months ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
GAAP net loss for the period | (7,485) | (7,869) | (2,703) | (2,384) | ||||||||||||
Share-based compensation (1) | (271) | 657 | 122 | 310 | ||||||||||||
Changes in royalties | 40 | 78 | 15 | 29 | ||||||||||||
Non-GAAP net loss for the period | (7,716) | (7,134) | (2,566) | (2,045) | ||||||||||||
(1) Share-based compensation: | ||||||||||||||||
Research and development expenses, net | 115 | 182 | 81 | 108 | ||||||||||||
General and administrative expenses: | ||||||||||||||||
General and administrative expenses | 116 | 475 | 41 | 202 | ||||||||||||
One time reversal of equity award to the Company's Former CEO | (502) | - | - | - | ||||||||||||
(271) | 657 | 122 | 310 | |||||||||||||
Investor Contacts
Jeremy Feffer
LifeSci Advisors, LLC
212-915-2568
jeremy@lifesciadvisors.com
Meirav Gomeh-Bauer
LifeSci Advisors, LLC
+972(0)-54-476-4979
Meirav@lifesciadvisors.com
SOURCE Check-Cap Ltd.
