6-K
Check-Cap Ltd (MBAI)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934
For May 2021
Commission File No. 001-36848
Check-Cap Ltd.
Check-Cap Building
Abba Hushi Avenue
P.O. Box 1271
Isfiya, 30090
Mount Carmel, Israel
(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES.)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____
The financial statements included in the press release attached as Exhibit 99.1 to this Form 6-K are being incorporated by reference into the Post-Effective Amendment No. 1 to the Form S-8 Registration Statement File No. 333-203384, Form S-8 Registration Statement File No. 333-226490, and into the Form F-3 Registration Statements File Nos. 333-211065, 333-225789 and 333-248200.
Other Information
On May 12, 2021, Check-Cap Ltd. provided certain corporate updates and announced its financial results for the first quarter of 2021. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
| Exhibit | |
|---|---|
| Exhibit No. | Description |
| 99.1 | Press Release, dated May 12, 2021 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Check-Cap Ltd. | ||
|---|---|---|
| By: | /s/ Alex Ovadia | |
| Name: Alex Ovadia | ||
| Date: May 12, 2021 | Title: Chief Executive Officer |
Exhibit 99.1
Check-Cap Reports First Quarter 2021 Financial Results and Corporate Update
ISFIYA, Israel, May 12, 2021 -- Check-Cap Ltd. (the "Company" or "Check-Cap") (NASDAQ: CHEK), (NASDAQ: CHEKZ), a clinical stage medical diagnostics company advancing the development of C-Scan®, the first and only patient-friendly, preparation-free screening test, to detect polyps before they may transform into colorectal cancer(CRC), today announced financial results for the first quarter ended March 31, 2021 and provided a corporate update.
Q1 2021 and Recent Highlights:
| • | The U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational Device Exemption (IDE) application permitting Check-Cap to begin a pivotal study of C-Scan in the U.S. |
|---|---|
| • | The FDA has granted the Company Breakthrough Device Designation for C-Scan. |
| --- | --- |
| • | The Company continues to scale up manufacturing to support upcoming clinical trials, primarily the Company’s U.S. pivotal study. |
| --- | --- |
| • | Due to technical issues associated with a single source supplier, the Company has recently experienced some manufacturing delays, but continues to expand its entire production process to meet its target manufacturing capacity. The Company<br> expects a delay in its clinical trials, including the initiation of the U.S. pivotal trial, which is now projected to begin by the end of the first quarter of 2022. |
| --- | --- |
| • | Strengthened balance sheet during the first quarter of 2021 through a total of $19.2 million proceeds from warrant exercises. Cash and cash equivalents, restricted cash and short-term bank deposits as of March 31, 2021 were $34.0 million. |
| --- | --- |
“We met a crucial milestone this quarter with the FDA approval of the IDE to begin the pivotal trial of C-Scan in the U.S.,” said Alex Ovadia, chief executive officer of Check-Cap. “While we anticipate a slight delay in our clinical trials, including the U.S. pivotal trial initiation, now projected for March 2022, we are laser-focused on advancing manufacturing activities to ensure a successful trial launch. We look forward to continuing to advance C-Scan as a colorectal cancer screening patient-friendly solution that has potential to enable early intervention and cancer prevention.”
Financial Results for the First Quarter Ended March 31, 2021
Research and development expenses were $2.4 million for the three months ended March 31, 2021, compared to $2.5 million for the same period in 2020. The decrease is primarily due to a $0.3 million grant received from the Israel Innovation Authority, which amount is reduced from research and development expenses, and $0.2 million decrease in other expenses and clinical-related expenses, offset in part by a $0.2 million increase in material and subcontractors’ expenses and $0.2 million increase in salary and related expense.
General and administrative expenses were $1.2 million for the three months ended March 31, 2021, compared to $1.0 million for the same period in 2020. The increase is primarily due to a $0.2 million increase in professional services and other expenses.
Operating loss was $3.6 million for the three months ended March 31, 2021, compared to $3.4 million for the same period in 2020.
Finance expense was $9,000 for the three months ended March 31, 2021, compared to $12,000 for the same period in 2020.
Net loss was $3.6 million for the three months ended March 31, 2021, compared to $3.4 million for the same period in 2020.
Cash and cash equivalents, restricted cash and short-term bank deposits as of March 31, 2021 were $34.0 million as compared to $18.1 million as of December 31, 2020. During the first quarter of 2021, certain warrant holders exercised warrants to purchase an aggregate 24,204,682 ordinary shares, which had been issued in 2020, at exercise prices ranging from $0.75-$0.80, which generated total gross proceeds of approximately $19.2 million to the Company.
The number of outstanding ordinary shares as of March 31, 2021 was 70,468,260. As of May 10, 2021, the number of our outstanding ordinary shares was 70,472,316.
About Check-Cap
Check-Cap is a clinical stage medical diagnostics company aiming to redefine colorectal cancer (CRC) screening through the introduction of C-Scan®, the first and only patient-friendly preparation-free screening test to detect polyps before they may transform into colorectal cancer to enable early intervention and cancer prevention. The Company’s disruptive capsule-based screening technology aims to significantly increase screening adherence worldwide and help millions of people to stay healthy through preventive CRC screening. C-Scan uses an ultra-low dose X-ray capsule, an integrated positioning, control and recording system, as well as proprietary software to generate a 3D map of the inner lining of the colon as it travels naturally along the gastrointestinal tract. C-Scan is non-invasive and requires no sedation. Unlike other capsule technologies, it requires no bowel preparation, allowing the patients to continue their daily routine with no interruption. C-Scan is not intended to replace colonoscopy. A positive C-Scan result should be followed by colonoscopy.
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 "Forward-looking Statements" and "Risk Factors" in the Company's Annual Report on Form 20-F for the year ended December 31, 2020 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.
Investor Contacts
Irina Koffler
LifeSci Advisors, LLC
646.970.4681
ikoffler@lifesciadvisors.com
Meirav Gomeh-Bauer
LifeSci Advisors, LLC
+972(0)-54-476-4979
Meirav@lifesciadvisors.com
CHECK CAP LTD.
CONSOLIDATED UNAUDITED BALANCE SHEETS
(U.S. dollars in thousands except share and per share data)
| March 31, | December 31, | |||||
|---|---|---|---|---|---|---|
| 2 0 2 1 | 2 0 2 0 | |||||
| Assets | ||||||
| Current assets | ||||||
| Cash and cash equivalents | 15,194 | 7,703 | ||||
| Restricted cash | 350 | 350 | ||||
| Short-term bank deposit | 18,470 | 10,079 | ||||
| Prepaid expenses and other current assets | 440 | 285 | ||||
| Total current assets | 34,454 | 18,417 | ||||
| Non-current assets | ||||||
| Property and equipment, net | 847 | 823 | ||||
| Operating lease | 1,223 | 398 | ||||
| Total non-current assets | 2,070 | 1,221 | ||||
| Total assets | 36,524 | 19,638 | ||||
| Liabilities and shareholders' equity | ||||||
| Current liabilities | ||||||
| Accounts payable and accruals | ||||||
| Trade | 1,028 | 862 | ||||
| Other | 295 | 345 | ||||
| Employees and payroll accruals | 1,718 | 1,510 | ||||
| Operating lease liabilities | 327 | 264 | ||||
| Total current liabilities | 3,368 | 2,981 | ||||
| Non-current liabilities | ||||||
| Royalties provision | 196 | 154 | ||||
| Operating lease liabilities | 856 | 125 | ||||
| Total non-current liabilities | 1,052 | 279 | ||||
| Shareholders' equity | ||||||
| Share capital, Ordinary shares, 2.4 NIS par value (360,000,000 authorized shares as of March 31, 2021 and December 31, 2020; 70,468,260 and 46,239,183 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively) | 49,763 | 31,646 | ||||
| Additional paid-in capital | 76,890 | 75,715 | ||||
| Accumulated deficit | (94,549 | ) | (90,983 | ) | ||
| Total shareholders' equity | 32,104 | 6,234 | ||||
| Total liabilities and shareholders' equity | 36,524 | 19,638 |
CHECK CAP LTD.
CONSOLIDATED UNAUDITED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
| Three months ended | ||||
|---|---|---|---|---|
| March 31, | ||||
| 2021 | 2020 | |||
| Research and development expenses, net | 2,406 | 2,462 | ||
| General and administrative expenses | 1,151 | 957 | ||
| Operating loss | 3,557 | 3,419 | ||
| Finance loss, net | 9 | 12 | ||
| Loss before income tax | 3,566 | 3,431 | ||
| Net loss for the period | 3,566 | 3,431 | ||
| Comprehensive loss | 3,566 | 3,431 | ||
| Loss per share: | ||||
| Net loss per ordinary share basic and diluted | 0.05 | 0.34 | ||
| Weighted average number of ordinary shares outstanding - basic and diluted | 68,071,059 | 9,971,098 |
CHECK CAP LTD.
CONSOLIDATED UNAUDITED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY
(U.S. dollars in thousands, except share and per share data)
| Amount | Additional<br><br> <br>paid-in capital | Accumulated<br><br> <br>deficit | Total shareholders’<br><br> <br>equity | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Balance as of January 1, 2021 | 46,239,183 | $ | 31,646 | $ | 75,715 | $ | (90,983 | ) | $ | 16,378 | ||
| Exercise of warrants, net of issuance expenses in an amount of 22 | 24,204,682 | 18,099 | 1,120 | - | 19,219 | |||||||
| RSU’s vesting | 24,395 | 18 | (18 | ) | - | |||||||
| Share-based compensation | - | - | 73 | - | 73 | |||||||
| Net loss | - | - | - | (3,566 | ) | (3,566 | ) | |||||
| Balance as of March 31, 2021 | 70,468,260 | $ | 49,763 | $ | 76,890 | $ | (94,549 | ) | $ | 32,104 |
All values are in US Dollars.
| Amount | Additional<br><br> <br>paid-in capital | Accumulated<br><br> <br>deficit | Total shareholders’<br><br> <br>equity | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Balance as of January 1, 2020 | 8,272,908 | $ | 5,407 | $ | 77,964 | $ | (77,137 | ) | $ | 6,234 | ||
| Issuance of ordinary shares in private placement, net of issuance expenses in an amount of 30 | 2,720,178 | 1,894 | 2,837 | - | 4,731 | |||||||
| RSU’s vesting | 6,633 | 4 | (4 | ) | - | |||||||
| Share-based compensation | - | - | 123 | - | 123 | |||||||
| Net loss | - | - | - | (3,431 | ) | (3,431 | ) | |||||
| Balance as of March 31, 2020 | 10,999,719 | $ | 7,305 | $ | 80,920 | $ | (80,568 | ) | $ | 7,657 |
All values are in US Dollars.
CHECK-CAP LTD.
CONSOLIDATED UNAUDITED STATEMENTS OF CASH FLOWS
(U.S. dollars in thousands, except share and per share data)
| Three months ended | ||||||
|---|---|---|---|---|---|---|
| March 31, | ||||||
| 2021 | 2020 | |||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||
| Net loss | (3,566 | ) | (3,431 | ) | ||
| Adjustments required to reconcile net loss to net cash used in operating activities: | ||||||
| Depreciation | 43 | 34 | ||||
| Share-based compensation | 73 | 123 | ||||
| Financial income, net | (57 | ) | (15 | ) | ||
| Changes in assets and liabilities items: | ||||||
| Decrease (increase) in prepaid and other current assets and non-current assets | (142 | ) | 101 | |||
| Increase (decrease) in trade accounts payable, accruals and other current liabilities | 85 | (325 | ) | |||
| Increase in employees and payroll accruals | 208 | 78 | ||||
| Increase in royalties provision | 42 | 2 | ||||
| Net cash used in operating activities | (3,314 | ) | (3,433 | ) | ||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||
| Purchase of property and equipment | (33 | ) | (57 | ) | ||
| Investment in short-term bank and other deposits | (8,381 | ) | (2,258 | ) | ||
| Net cash provided by (used in) investing activities | (8,414 | ) | (2,315 | ) | ||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||
| Exercise of warrants into ordinary shares, net of issuance expenses | 19,219 | - | ||||
| Issuance of ordinary shares in private placement, net of issuance expenses | - | 4,731 | ||||
| Net cash provided by financing activities | 19,219 | 4,731 | ||||
| Net increase (decrease) in cash, cash equivalents and restricted cash | 7,491 | (1,017 | ) | |||
| Cash, cash equivalents and restricted cash at the beginning of the period | 8,053 | 8,035 | ||||
| Cash, cash equivalents and restricted cash at the end of the period | 15,544 | 7,018 | ||||
| Supplemental disclosure of non-cash flow information: | ||||||
| Purchase of property and equipment included in accounts payable and accrued expenses | 32 | 59 | ||||
| Assets acquired under operating leases | 916 | - | ||||
| Supplemental disclosure of cash flow information |