Check-Cap(CHEK) - 2019 Q4 - Annual Report

PART I ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS Information regarding the identity of directors, senior management, and advisers is not required for this report - Information on directors, senior management, and advisers is not required for this filing[34][35][36] ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE Offer statistics and expected timetable information is not required for this report - Offer statistics and expected timetable information is not required[37] ITEM 3. KEY INFORMATION This section provides key information about the company, including selected financial data, capitalization, and a comprehensive overview of risk factors related to its financial position, business operations, regulatory environment, intellectual property, Israeli operations, share ownership, and taxation A. Selected financial data The selected consolidated financial data, prepared in accordance with U.S. GAAP, highlights the company's historical financial performance and position for the years ended December 31, 2015-2019, showing consistent net losses and a decrease in total shareholders' equity Consolidated Statements of Operations Data (US$ in thousands, except per share data) | Indicator | 2019 | 2018 | 2017 | 2016 | 2015 | | :-------------------------------------- | :----- | :----- | :----- | :----- | :----- | | Research and development expenses, net | 10,474 | 7,618 | 6,837 | 5,491 | 5,837 | | General and administrative expenses | 3,595 | 3,445 | 3,164 | 3,571 | 6,626 | | Operating loss | 14,069 | 11,063 | 10,001 | 9,062 | 12,463 | | Finance income, net | 233 | 473 | 236 | 244 | 173 | | Loss before income tax | 13,836 | 10,590 | 9,765 | 8,818 | 12,290 | | Taxes on income | - | (1) | 6 | 8 | - | | Net loss | 13,836 | 10,589 | 9,771 | 8,826 | 12,290 | | Comprehensive loss | 13,823 | 10,602 | 9,771 | 8,826 | 12,290 | | Net loss per ordinary share, basic and diluted | 1.73 | 2.61 | 6.72 | 7.31 | 12.67 | Consolidated Balance Sheet Data (US$ in thousands, except per share data) | Indicator | 2019 | 2018 | 2017 | 2016 | 2015 |\n| :------------------------------ | :---- | :---- | :---- | :---- | :---- |\n| Cash and cash equivalents | 7,685 | 8,572 | 6,997 | 11,639| 9,392 |\n| Working capital | 5,633 | 12,763| 5,841 | 10,514| 12,856|\n| Total assets | 9,429 | 15,436| 7,906 | 12,295| 15,298|\n| Capital stock | 83,371| 76,344| 58,617| 53,348| 46,763|\n| Total shareholders' equity (deficiency) | 6,234 | 13,030| 5,905 | 10,407| 12,648| - Operating expenses include share-based compensation: $0.5 million (2019), $0.7 million (2017), $1.2 million (2016), $3.7 million (2015), and a negative $65,000 (2018) due to forfeitures[43] - Research and development expenses are net of grants from the Israel Innovation Authority (IIA) and BIRD Foundation: $0.1 million (2019), $0.2 million (2018), $1.1 million (2017), $0.3 million (2016), $0.6 million (2015)[43] B. Capitalization and indebtedness Information regarding capitalization and indebtedness is not required for this report - Information on capitalization and indebtedness is not required[46] C. Reasons for the Offer and Use of Proceeds Reasons for the offer and use of proceeds information is not required for this report - Reasons for the offer and use of proceeds information is not required[47] D. Risk factors This section outlines various significant risks that could materially and adversely affect the company's business, financial condition, and results of operations, categorized by financial position, business operations, regulatory compliance, intellectual property, Israeli operations, share ownership, and taxation Risks Related to Our Financial Position Persistent net losses and a $77.1 million accumulated deficit raise going concern doubts, requiring additional funding for C-Scan system development - The company has incurred net losses of $13.8 million in 2019, $10.6 million in 2018, and $9.8 million in 2017[52] - As of December 31, 2019, the accumulated deficit was $77.1 million[52][53] - Recurring operating losses raise substantial doubt about the company's ability to continue as a going concern, as noted by its independent registered public accounting firm[53] - Additional funding is required to complete development and commercialization of the C-Scan system, with current capital projected to fund operations only into July 2020[54][55] Risks Related to Our Business The company faces significant challenges in commercializing its C-Scan system, including obtaining regulatory approvals, demonstrating clinical effectiveness, scaling manufacturing, establishing sales channels, and achieving market acceptance against established competitors - The company has CE Mark approval for the C-Scan system in the European Union (valid until January 1, 2023) and approval in Israel (valid until March 31, 2022), but has not yet received approvals in other key jurisdictions like the United States[58][59] - Future success depends on completing product development, demonstrating sufficient clinical evidence, obtaining regulatory approvals, generating significant revenues, and manufacturing at acceptable costs[59] - The company relies on single-source suppliers for critical C-Scan system components (motor, X-ray detectors, X-ray source, batteries, ASIC), posing risks of supply disruption and delays[87] - The company depends on third parties (CROs, clinical investigators) to manage clinical studies, data collection, and patient enrollment, which can lead to costs and delays beyond its control[93][94] Risks Related to Regulations The company's C-Scan system is subject to extensive and costly regulatory processes, particularly in the U.S. (FDA clearance/approval via de novo reclassification or PMA) and internationally, with potential delays or non-compliance severely impacting commercialization - The company plans to submit a direct de novo reclassification petition for its C-Scan system in the U.S., aiming to demonstrate low to moderate risk, but FDA may require the more costly and lengthy PMA process[120][125][126] - Clinical trials are expensive, lengthy, and uncertain; failure at any stage or inadequate data can prevent regulatory approval or market acceptance[135][136][141] - Modifications to the C-Scan system or future products may require new regulatory clearances or approvals, potentially leading to recalls or marketing cessation[146][147] - The C-Scan system's use of iodinated oral contrast medium may classify it as a drug-device combination product, complicating regulatory review and potentially requiring drug approvals for the contrast agent[1