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.
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