Check-Cap Reports First Quarter 2017 Financial Results

May 9, 2017 7:05 AM UTC

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:

InvestorsDavid CareyLazar Partners Ltd.+1-212-867-1768[email protected]

Vivian CervantesPCG Advisory+1-212-554-5482[email protected]

MediaErich Sandoval or Rob SawyerLazar Partners Ltd.+1-213-908-6226 or +1-212-843-0209[email protected]   [email protected] 

 

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.



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