Purple Biotech .(PPBT) - 2019 Q4 - Annual Report

Key Information Selected Financial Data The company reported stable revenues of $1.0 million in 2019 and 2018, with a persistent operating loss of $7.2 million in 2019 and stable total assets of $14.7 million Selected Consolidated Statement of Operations Data (U.S. Dollars in thousands) | Indicator | 2019 (thousands USD) | 2018 (thousands USD) | 2017 (thousands USD) | | :--- | :--- | :--- | :--- | | Revenues | 1,000 | 1,000 | 100 | | Research and development expenses | 2,674 | 5,268 | 4,640 | | General and administrative expenses | 6,078 | 5,195 | 6,397 | | Operating loss | 7,156 | 7,826 | 11,966 | | Loss for the year | 5,893 | 5,569 | 12,913 | | Loss per ordinary share (Basic and diluted) | (0.30) | (0.39) | (1.37) | Selected Consolidated Statement of Financial Position Data (U.S. Dollars in thousands) | Indicator | As of Dec 31, 2019 (thousands USD) | As of Dec 31, 2018 (thousands USD) | | :--- | :--- | :--- | | Cash and cash equivalents | 4,385 | 5,163 | | Working capital | 4,756 | 5,200 | | Total assets | 14,718 | 14,723 | | Total liabilities | (3,859) | (3,719) | | Total equity | 10,859 | 11,004 | - The company uses a non-IFRS measure, Adjusted Operating Loss, which excludes non-cash share-based compensation expenses, to assess operational performance. For 2019, the Adjusted Operating Loss was $5.88 million, compared to an IFRS operating loss of $7.16 million[34] Risk Factors The company faces significant risks related to its financial condition, business operations, industry, legal proceedings, intellectual property, and publicly traded securities Risks Related to Financial Condition and Capital Requirements - The company has a history of operating losses, accumulating a deficit of approximately $49.5 million through December 31, 2019, and expects to incur significant additional losses in the future[40] - Future operations are dependent on raising additional capital to fund research, development, and commercialization of its therapeutic candidates, particularly the oncology pipeline (NT219 and CM-24)[42] - The company's revenue is dependent on a limited portfolio, primarily the successful commercialization of its one FDA-approved drug, Consensi™, and the development of its two oncology candidates[41] Risks Related to Business and Regulatory Matters - The company relies heavily on third parties for critical functions, including conducting CMC (Chemistry, Manufacturing, and Controls), preclinical studies, and clinical trials, which reduces direct control over these activities[67] - There is a risk of substantial delays in clinical trials for CM-24 and NT219 due to factors like regulatory consensus, patient recruitment, and potential clinical holds. The COVID-19 pandemic introduces additional uncertainty regarding trial conduct[94][96] - The company's subsidiary, TyrNovo, has obligations to the Israel Innovation Authority (IIA) for grants received, which require royalty payments from future revenues and restrict the transfer of manufacturing and know-how outside of Israel[142][146] - The recent coronavirus (COVID-19) outbreak may adversely affect operations, including potential disruptions to clinical trials, supply chains, and regulatory reviews, as the FDA has postponed most foreign inspections[133][134][135] Risks Related to Our Industry - The pharmaceutical and biotechnology industry is highly competitive, with many larger companies possessing greater resources for R&D, marketing, and manufacturing[158][159] - Commercial success is heavily dependent on adequate coverage and reimbursement from third-party payers (government and private insurance), which is uncertain and may not be sufficient to ensure profitability[162][165] - Legislative and regulatory reforms in the U.S. healthcare system, such as changes to the Affordable Care Act, could negatively impact drug pricing, reimbursement, and market access, thereby harming future business[170][171][173] Risks Related to Legal Proceedings and Intellectual Property - The company has been involved in multiple legal proceedings, including class action lawsuits in the U.S. and Israel, and a formal investigation by the Israeli Securities Authority (ISA) concerning public disclosures[191] - In August 2019, the company reached a settlement (Enforcement Arrangement) with the ISA regarding claims of negligent disclosures in 2014 and 2015. The company agreed to pay a fine of NIS 1.5 million (approx. $430,000), and the ISA discontinued its criminal investigation[193][195] - The U.S. class action lawsuits were settled for an aggregate consideration of $2.0 million, which was funded by insurance carriers. The settlement contained no admission of wrongdoing[192] - The company's success depends on its ability to obtain and enforce patent protection for its therapeutic candidates. There is a risk that pending applications may not be issued or that issued patents may be circumvented or challenged by competitors[203][205] Risks Related to Operations in Israel - As an Israeli-incorporated company with principal offices in Israel, operations may be adversely affected by political, economic, and military instability in the region[225] - It may be difficult for U.S. investors to enforce U.S. judgments against the company and its officers and directors, as most reside and have assets outside the U.S[217] - Provisions of Israeli law and the company's articles of association, such as rules on mergers and tender offers, may delay or prevent a change of control[230] - A portion of the company's expenses are in currencies other than the U.S. dollar (e.g., New Israeli Shekel - NIS), exposing the company to currency fluctuation risks[235] Risks Related to ADSs and Ordinary Shares - The company received a notice from NASDAQ on July 8, 2019, for failing to meet the minimum bid price requirement of $1.00 per ADS. It was granted a second 180-day compliance period ending July 6, 2020, to regain compliance, failure of which could result in delisting[247] - As a "foreign private issuer," the company is permitted to follow certain home country (Israeli) corporate governance practices instead of NASDAQ requirements, which may result in less protection for investors compared to U.S. domestic issuers[262] - The company may be classified as a Passive Foreign Investment Company (PFIC) for U.S. federal income tax purposes, which could result in adverse tax consequences for U.S. investors[260][261] - The company is an "emerging growth company" under the JOBS Act, allowing it to take advantage of reduced disclosure requirements, which may make its shares less attractive to some investors[280] Information on the Company History and Development of the Company Kitov Pharma, incorporated in Israel in 1968, has evolved into a clinical-stage biopharmaceutical company through strategic acquisitions and recent public offerings, raising $6 million in March 2020 - The company acquired FameWave Ltd., developer of the oncology therapeutic candidate CM-24, in a transaction that closed in January 2020[286][288] - In January 2017, the company acquired a majority equity stake in TyrNovo Ltd., developer of the oncology therapeutic candidate NT219[284] - In March 2020, the company closed a public offering of ADSs, Pre-funded Warrants, and investor warrants, raising gross proceeds of $6 million[287] Business Overview Kitov Pharma is a clinical-stage biopharmaceutical company focused on developing therapies for oncology and pain & hypertension, leveraging its pipeline and strategic collaborations - The company's business is structured into two main operating segments: Oncology (CM-24 and NT219) and Pain and Hypertension (Consensi™)[295][296] - The strategic focus is on advancing first-in-class therapies for cancer, leveraging clinical and regulatory expertise, and expanding the oncology pipeline through acquisitions and licensing[294][314] Oncology Segment - CM-24: A humanized monoclonal antibody targeting CEACAM1, a novel immune checkpoint. A Phase 1/2 study in combination with nivolumab (Opdivo®) for non-small cell lung cancer is planned for the second half of 2020, under a clinical collaboration with Bristol Myers Squibb[297][299][311] - NT219: A small molecule targeting cancer drug resistance pathways IRS1/2 and STAT3. The company plans to submit an Investigational New Drug (IND) application in the first half of 2020 to begin a Phase 1/2 study in combination with cetuximab for head and neck cancer and as a monotherapy for advanced solid tumors[298][299][328] Pain and Hypertension Segment - Consensi™: An FDA-approved (May 31, 2018) fixed-dose combination of celecoxib (for osteoarthritis pain) and amlodipine besylate (for hypertension)[301][384] - Commercial launch in the U.S. is expected in May 2020 through partner Coeptis Pharmaceuticals. The company is eligible for up to $99.5 million in milestones, reimbursements, and royalties from this agreement[388][389][412] - Exclusive commercialization agreements are also in place for South Korea with Kuhnil Pharmaceutical and for China with Hebei Changshan Biochemical Pharmaceutical Co., Ltd[410][411] Intellectual Property - Consensi™: Protected by U.S. patents covering the method of use (expiring up to 2030) and the oral dosage composition (expiring up to 2029)[441][442] - CM-24 (FameWave): Portfolio includes five patent families covering the anti-CEACAM1 antibody and its uses, with granted patents in the U.S., Europe, and other jurisdictions, providing protection into the 2030s[415][422] - NT219 (TyrNovo): Portfolio includes six patent families covering the compounds and their use in treating cancer and other disorders, with granted patents in the U.S. and Europe providing protection into the late 2020s and early 2030s[429][438] Government Regulations and Funding - The company is subject to extensive regulation by the FDA in the U.S., as well as authorities in Israel and Europe, covering all aspects of drug development, manufacturing, and marketing[450] - Consensi™ was approved via the Section 505(b)(2) NDA pathway, which allows reliance on existing data for previously approved drugs, potentially expediting the process[463] - The company's subsidiary, TyrNovo, has received grants from the Israel Innovation Authority (IIA) totaling approximately NIS 5.5 million, which are subject to royalty payments and restrictions on transferring manufacturing and know-how outside of Israel[484][491] Organizational Structure Kitov Pharma Ltd. is an Israeli company with two key subsidiaries: wholly-owned FameWave Ltd. and majority-owned TyrNovo Ltd - The corporate structure consists of the parent company, Kitov Pharma Ltd., and its subsidiaries: wholly-owned FameWave Ltd. and majority-owned (98.47%) TyrNovo Ltd[494] Property, Plant and Equipment The company leases all its facilities and does not own any real property, with its principal executive offices located in Tel-Aviv, Israel - The company leases all its facilities and does not own any real property. Its main offices are located in Tel-Aviv, Israel[496] Operating and Financial Review and Prospects Operating Results The company reported stable revenues of $1.0 million in 2019, with a significant 49.3% decrease in R&D expenses and an 8.6% improvement in operating loss to $7.2 million Comparison of Operating Results (Years Ended December 31, in thousands of USD) | Item | 2019 (thousands USD) | 2018 (thousands USD) | Change (%) | | :--- | :--- | :--- | :--- | | Revenues | 1,000 | 1,000 | 0.0% | | R&D Expenses | 2,674 | 5,268 | (49.3%) | | SG&A Expenses (net) | 5,482 | 4,452 | 23.1% | | Operating Loss | 7,156 | 7,826 | (8.6%) | | Net Loss | 5,893 | 5,569 | 5.8% | - The decrease in R&D expenses in 2019 was primarily due to lower costs related to the clinical development of Consensi™ following its FDA approval in May 2018[532] - The increase in SG&A expenses in 2019 was mainly due to a $0.9 million annual fee paid to the FDA for Consensi™, which will be covered by the company's U.S. marketing partner from 2020 onwards[533] Liquidity and Capital Resources The company's liquidity is primarily from equity offerings, with $4.4 million in cash as of December 31, 2019, supplemented by $8.7 million in subsequent financing, deemed sufficient for the next 12 months - As of December 31, 2019, the company had $4.4 million in cash and cash equivalents[549] - Subsequent to year-end, the company raised $3.5 million in a private placement in January 2020 and a net amount of approximately $5.2 million in a public offering in March 2020[549] - Management believes existing working capital is sufficient to meet requirements for at least the next twelve months, but substantial additional funds will be needed for long-term development plans[506][550] - Net cash used in operating activities decreased to $5.6 million in 2019 from $8.5 million in 2018, primarily due to lower operating losses and changes in working capital[554] Trend Information As a pharmaceutical development company, predicting outcomes is challenging, with primary expenditures on R&D fluctuating based on clinical trial activities - The company's primary expenditure is on research and development, and the level of this spending is dependent on the progress and results of its CMC, preclinical, and clinical trial activities[559] Off-Balance Sheet Arrangements The company is not a party to any material off-balance sheet arrangements - The company has no material off-balance sheet arrangements[560] Contractual Obligations As of December 31, 2019, the company had total contractual obligations of approximately $2.0 million, primarily comprising purchase and operating lease obligations Contractual Obligations as of December 31, 2019 (U.S. dollars in thousands) | Obligation Type | Total (thousands USD) | Less than 1 year (thousands USD) | 1-3 years (thousands USD) | 3-5 years (thousands USD) | More than 5 years (thousands USD) | | :--- | :--- | :--- | :--- | :--- | :--- | | Operating Lease Obligations | 259 | 59 | 220 | - | - | | Purchase Obligations | 1,444 | 1,444 | - | - | - | | Other Long-term Liabilities | 285 | - | - | 285 | - | | Total | 1,988 | 1,503 | 220 | 285 | - | Directors, Senior Management and Employees Directors and Senior Management The company's leadership includes Chairman Dr. Eric Rowinsky and CEO Isaac Israel, supported by an experienced senior management team in key functional areas - The Board of Directors is chaired by Eric Rowinsky, M.D., an expert in oncology drug development[565] - Isaac Israel serves as the Chief Executive Officer and a Director[565][566] - The senior management team includes Gil Efron as Deputy CEO and CFO, Gil Ben-Menachem as VP of Business Development, Hadas Reuveni as VP of R&D, Michael Schickler as Head of Clinical Operations, and Bertrand Liang as Chief Medical Officer[565] Compensation Aggregate compensation for all directors and office holders totaled approximately $3.0 million in 2019, with the CEO being the highest compensated at $749,866 - Aggregate compensation paid to all directors and office holders for the year ended December 31, 2019, was approximately $3.0 million[591] 2019 Compensation for Five Most Highly Compensated Office Holders (USD) | Name | Position | Salary/Fees (USD) | Bonus (USD) | Share-Based Payment (USD) | Total (USD) | | :--- | :--- | :--- | :--- | :--- | :--- | | Isaac Israel | CEO and Director | 391,459 | 173,025 | 185,382 | 749,866 | | Gil Efron | CFO and Deputy CEO | 262,621 | 94,286 | 222,282 | 579,189 | | Dr. Hadas Reuveni | VP of R&D | 217,489 | 79,288 | 179,325 | 476,101 | | Dr. Gil Ben-Menachem | VP Business Development | 218,211 | 51,003 | 123,595 | 392,809 | | Dr. J. Paul Waymack | Former Chairman | 195,120 | 65,040 | 7,993 | 268,153 | - Non-executive directors receive an annual fee of $40,000, plus additional fees for committee service, capped at $47,000 annually. The Chairman receives an annual fee of $60,000[581] Board Practices The company's seven-member board is staggered into three classes, with five independent directors, and adheres to NASDAQ independence rules while opting out of certain Israeli external director requirements - The board of directors is comprised of seven members and is divided into three staggered classes, with each class serving a three-year term[620][627] - The company has elected to "opt out" of the Israeli Companies Law requirement to appoint external directors, and instead complies with NASDAQ's director independence and committee composition requirements[623][624] - The Audit Committee consists of three independent directors, all of whom are determined to be audit committee financial experts[638][639] - The Compensation Committee consists of two independent directors and is responsible for recommending the compensation policy and approving terms of employment for officers and directors[641][642] Employees As of December 31, 2019, the company had nine full-time employees and consultants, primarily in business development and R&D, subject to Israeli labor laws Employee and Consultant Headcount by Function (as of Dec 31) | Function | 2019 | 2018 | 2017 | | :--- | :--- | :--- | :--- | | Business Development, General & Admin | 6 | 6 | 6 | | Research & Development | 3 | 4 | 3 | | Total | 9 | 10 | 9 | Share Ownership As of March 16, 2020, directors, senior management, and employees collectively owned 3.80% of outstanding shares, with the CEO holding 1.22% - As of March 16, 2020, all directors, senior management, and employees as a group beneficially owned 1,541,716 ordinary shares, representing 3.80% of the company[698] - CEO Isaac Israel is the largest individual beneficial owner among the management and board, holding 1.22% of the company's shares[698][699] - The company has a 2016 Equity-Based Incentive Plan with 7,500,000 ordinary shares reserved for issuance[700] Major Shareholders and Related Party Transactions Major Shareholders As of March 16, 2020, several entities became major shareholders, with M. Arkin (1999) Ltd. holding 11.0% and others holding approximately 9.9% each Beneficial Ownership of 5% or Greater Shareholders (as of March 16, 2020) | Shareholder | Percentage Ownership | | :--- | :--- | | M. Arkin (1999) Ltd. | 11.0% | | OrbiMed Israel Partners Limited Partnership | 9.9% | | Pontifax Group | 9.9% | | Armistice Capital Master Fund, Ltd. | 9.9% | | CVI Investments, Inc. | 9.9% | - The significant shareholdings of M. Arkin, OrbiMed, and Pontifax Group resulted from the acquisition of FameWave in January 2020, where they exchanged their FameWave shares for Kitov ADSs and warrants and made a concurrent cash investment[716][717][718] - The significant shareholdings of Armistice Capital and CVI Investments resulted from their participation in the March 2020 public offering[720][721] Related Party Transactions The company engaged in related party transactions primarily with its subsidiaries, including a $2 million loan to FameWave Ltd. and services provided to TyrNovo Ltd. at cost plus 5% - The company provided a loan of up to approximately $2 million to FameWave Ltd. to facilitate the acquisition of CM-24 intellectual property rights, which became an intercompany loan after the acquisition closed[725][726] - Kitov Pharma provides services to its subsidiary TyrNovo Ltd. and is reimbursed at cost plus 5% under a formal services agreement[727] Financial Information Consolidated Statements and Other Financial Information This section details the company's significant legal proceedings, including settled U.S. class actions for $2.0 million and an ISA investigation, and confirms no cash dividends are expected - The company does not expect to pay cash dividends in the foreseeable future, retaining earnings for business growth and development[771] Legal Proceedings - The company settled an investigation by the Israeli Securities Authority (ISA) via an Enforcement Arrangement in August 2019, agreeing to pay a fine of NIS 1.5 million (approx. $430,000) to resolve claims of negligent disclosures in 2014-2015. The ISA discontinued its criminal investigation[737][744] - Related U.S. class action lawsuits filed in New York and California were settled in March 2019 for an aggregate of $2.0 million, funded by the company's insurance carriers, with no admission of wrongdoing[764][765] - A 2015 class action motion and related 2017 motions in Israel are still ongoing. Following the ISA settlement, a stay on these proceedings was lifted[730][750][752] Significant Changes No significant changes have occurred since December 31, 2019, beyond those already disclosed in the annual report - No significant changes have occurred since December 31, 2019, except as otherwise disclosed in the annual report[773] The Offer and Listing Offer and Listing Details The company's ordinary shares trade on TASE, while its ADSs and warrants trade on NASDAQ, where it is currently addressing a minimum bid price deficiency - The company's ADSs (KTOV) and public warrants (KTOVW) are traded on the NASDAQ Capital Market, while its ordinary shares (KTOV) are traded on the Tel Aviv Stock Exchange[774] - The company is not in compliance with NASDAQ's minimum bid price rule of $1.00 per share and was granted a second 180-day compliance period, ending July 6, 2020, to resolve the deficiency[775] Additional Information Memorandum and Articles of Association The company's articles of association detail its authorized share capital, staggered board, quorum requirements, and exclusive forum provisions, which may affect change of control - Authorized share capital is 250,000,000 ordinary shares and 50,000,000 non-voting senior preferred shares[784] - The articles of association include an exclusive forum provision, designating courts in Tel Aviv, Israel, or the federal district court for the District of New York for certain types of shareholder litigation[827] - The board of directors is staggered into three classes, which can have an anti-takeover effect[835] Material Contracts The company has several material contracts, including the FameWave Ltd. acquisition, a U.S. commercialization agreement for Consensi™, and a manufacturing agreement for CM-24 clinical supply - FameWave Acquisition: Acquired 100% of FameWave in exchange for 8,075,610 ADSs and warrants to purchase 4,037,805 additional ADSs. The deal included a concurrent $3.5 million private placement by key FameWave shareholders[838][839][841] - Coeptis Commercialization Agreement (U.S.): Amended in October 2019, this agreement for Consensi™ entitles Kitov to 20% royalties on net sales (with minimums) and up to $99.5 million in milestone and reimbursement payments[854] - Rentschler Manufacturing Agreement: Engaged Rentschler Biopharma to manufacture CM-24 batches for clinical studies for a total of $6.4 million over two years[855] Exchange Controls There are currently no material Israeli currency control restrictions on payments of dividends or proceeds from the sale of the company's securities, although legislation remains in effect that could allow for such controls to be imposed by administrative action - No material Israeli currency control restrictions currently affect payments of dividends or proceeds from security sales, though the government retains the power to impose them[859] Taxation This section summarizes Israeli and U.S. federal income tax considerations, including potential Passive Foreign Investment Company (PFIC) classification for U.S. Holders and Israeli tax rates - The Israeli corporate tax rate is 23%. Capital gains for non-controlling individual shareholders are generally taxed at 25%, and dividends at 25%[865][868][874] - The company believes it may be classified as a Passive Foreign Investment Company (PFIC) for the 2020 tax year, which could have adverse U.S. federal income tax consequences for U.S. Holders[896] - The Foreign Account Tax Compliance Act (FATCA) imposes a 30% withholding tax on certain payments to foreign financial institutions and other non-U.S. entities unless they comply with specific reporting requirements[914] Quantitative and Qualitative Disclosures About Market Risk The company's primary market risk is foreign currency exchange exposure, particularly to the New Israeli Shekel (NIS), while interest rate risk is considered immaterial - The main market risk is foreign currency exposure, particularly between the U.S. dollar and the New Israeli Shekel (NIS), as a portion of expenses are denominated in NIS[929] Sensitivity to U.S. Dollar / NIS Exchange Rate Changes (as of Dec 31, 2019, in thousands of USD) | Change in Exchange Rate | Impact on Income (Loss) (thousands USD) | | :--- | :--- | | 5% Down | (72) | | 2% Down | (29) | | 2% Up | 29 | | 5% Up | 72 | - Interest rate and credit risks are considered immaterial as liquid instruments are invested in short-term deposits with a major, highly-rated Israeli bank[926][927] Description of Securities Other Than Equity Securities This section describes the company's American Depositary Shares (ADSs) and Series A Warrants, including their trading venue, exercise price of $3.78 per ADS, and expiration date - Each American Depositary Share (ADS) represents one ordinary share and is traded on the NASDAQ Capital Market[936] - The Series A Warrants are exercisable at a price of $3.78 per ADS and expire on November 25, 2020[942][944] - A cashless exercise provision for the Series A Warrants is available if a registration statement covering the underlying shares is not effective and no exemption is available[943] Controls and Procedures As of December 31, 2019, management concluded that the company's disclosure controls and internal control over financial reporting were effective - Management concluded that as of December 31, 2019, the company's disclosure controls and procedures were effective[952] - Management concluded that the company's internal control over financial reporting was effective as of December 31, 2019[955] - The annual report does not include an auditor's attestation report on internal control over financial reporting, as the company is exempt as an emerging growth company under the JOBS Act[957] Corporate Governance and Other Matters Audit Committee Financial Expert The board of directors has determined that three members of its audit committee, Mr. Tzror, Mr. Steinberg, and Ms. Stern-Raff, qualify as "audit committee financial experts" as defined by SEC rules - The board has identified Mr. Tzror, Mr. Steinberg, and Ms. Stern-Raff as audit committee financial experts[959] Code of Ethics The company has adopted a Code of Business Conduct and Ethics that applies to all employees, including its senior financial officers. The code is available on the company's website - A Code of Business Conduct and Ethics has been adopted and applies to all employees, including the CEO and CFO[960] Principal Accountant Fees and Services The company paid its independent auditor, Somekh Chaikin (KPMG Israel), $116,000 in 2019 and $88,000 in 2018, primarily for audit and tax services Principal Accountant Fees (in thousands of U.S. dollars) | Fee Type | 2019 (thousands USD) | 2018 (thousands USD) | | :--- | :--- | :--- | | Audit fees | 81 | 70 | | Tax fees | 35 | 18 | | Total | 116 | 88 | Corporate Governance As a foreign private issuer, the company follows Israeli corporate governance practices, differing from NASDAQ rules in areas like shareholder approval and quorum requirements - The company relies on the "foreign private issuer exemption" to follow Israeli corporate governance practices in several areas, including shareholder approval requirements, quorum for meetings, and director nominations[967] - Key differences from NASDAQ rules include not requiring shareholder approval for establishing or amending most equity compensation plans and having a lower quorum requirement (25%) for shareholder meetings[969][972] Financial Statements Consolidated Statements of Financial Position As of December 31, 2019, the company reported stable total assets of $14.7 million, with $4.4 million in cash and $10.9 million in total equity Consolidated Statements of Financial Position (in thousands of USD) | | Dec 31, 2019 (thousands USD) | Dec 31, 2018 (thousands USD) | | :--- | :--- | :--- | | Total current assets | 8,302 | 8,514 | | Intangible assets | 6,172 | 6,172 | | Total assets | 14,718 | 14,723 | | Total current liabilities | 3,546 | 3,314 | | Total non-current liabilities | 313 | 405 | | Total liabilities | 3,859 | 3,719 | | Total equity | 10,859 | 11,004 | Consolidated Statements of Operations and other Comprehensive Loss For the year ended December 31, 2019, the company reported $1.0 million in revenues, an operating loss of $7.2 million, and a net loss of $5.9 million Consolidated Statements of Operations (in thousands of USD, except per share data) | | 2019 (thousands USD) | 2018 (thousands USD) | 2017 (thousands USD) | | :--- | :--- | :--- | :--- | | Revenues | 1,000 | 1,000 | 100 | | Research and development expenses | 2,674 | 5,268 | 4,640 | | Sales, general and administrative expenses | 6,078 | 5,195 | 6,397 | | Operating Loss | 7,156 | 7,826 | 11,966 | | Finance expenses (income), net | (1,479) | (2,257) | 947 | | Loss for the year | 5,893 | 5,569 | 12,913 | | Basic and diluted loss per share - USD | (0.30) | (0.39) | (1.37) | Consolidated Statements of Cash Flows For the year ended December 31, 2019, net cash used in operating activities was $5.6 million, offset by $5.2 million from financing activities, resulting in a net decrease in cash to $4.4 million Consolidated Statements of Cash Flows (in thousands of USD) | | 2019 (thousands USD) | 2018 (thousands USD) | 2017 (thousands USD) | | :--- | :--- | :--- | :--- | | Net cash used in operating activities | (5,581) | (8,480) | (8,627) | | Net cash provided by (used in) investing activities | (449) | 2,044 | 2,772 | | Net cash provided by financing activities | 5,233 | 7,788 | 2,995 | | Net (decrease) increase in cash and cash equivalents | (797) | 1,352 | (2,860) | | Cash and cash equivalents at end of the year | 4,385 | 5,163 | 3,947 |