Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 08, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2022 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2022 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-37769 | |
Entity Registrant Name | VBI Vaccines Inc/BC | |
Entity Central Index Key | 0000764195 | |
Entity Tax Identification Number | 00-0000000 | |
Entity Incorporation, State or Country Code | A1 | |
Entity Address, Address Line One | 160 Second Street | |
Entity Address, Address Line Two | Floor 3 | |
Entity Address, City or Town | Cambridge | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02142 | |
City Area Code | 617 | |
Local Phone Number | 830-3031 | |
Title of 12(b) Security | Common Shares, no par value per share | |
Trading Symbol | VBIV | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 258,257,494 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
CURRENT ASSETS | ||
Cash | $ 82,414 | $ 121,694 |
Accounts receivable, net | 135 | 8 |
Inventory, net | 4,050 | 2,576 |
Prepaid expenses | 1,685 | 2,373 |
Other current assets | 4,468 | 3,633 |
Total current assets | 92,752 | 130,284 |
NON-CURRENT ASSETS | ||
Other long-term assets | 1,396 | 1,259 |
Property and equipment, net | 11,015 | 11,037 |
Right of use assets | 3,382 | 3,344 |
Intangible assets, net | 61,379 | 62,091 |
Goodwill | 2,237 | 2,261 |
Total non-current assets | 79,409 | 79,992 |
TOTAL ASSETS | 172,161 | 210,276 |
CURRENT LIABILITIES | ||
Accounts payable | 5,617 | 4,280 |
Other current liabilities | 24,380 | 26,941 |
Current portion of deferred revenues | 864 | 526 |
Current portion of long-term debt | 8,780 | |
Current portion of lease liability | 891 | 839 |
Total current liabilities | 40,532 | 32,586 |
NON-CURRENT LIABILITIES | ||
Deferred revenues, net of current portion | 1,878 | 2,277 |
Long-term debt, net of debt discount and current portion | 21,163 | 28,441 |
Lease liability, net of current portion | 2,507 | 2,516 |
Liabilities for severance pay | 523 | 574 |
Total non-current liabilities | 26,071 | 33,808 |
COMMITMENTS AND CONTINGENCIES (NOTE 14) | ||
STOCKHOLDERS’ EQUITY | ||
Common shares (unlimited authorized; no par value) (June 30, 2022 - issued and outstanding 258,257,494; December 31, 2021 - issued and outstanding 258,250,273) | 442,286 | 442,235 |
Additional paid-in capital | 83,757 | 81,583 |
Accumulated other comprehensive income (loss) | 22,774 | (1,565) |
Accumulated deficit | (443,259) | (378,371) |
Total stockholders’ equity | 105,558 | 143,882 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 172,161 | $ 210,276 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | 6 Months Ended | 12 Months Ended |
Jun. 30, 2022 | Dec. 31, 2021 | |
Statement of Financial Position [Abstract] | ||
Common Stock, shares authorized | Unlimited | Unlimited |
Common stock, no par value | $ 0 | $ 0 |
Common stock, shares issued | 258,257,494 | 258,250,273 |
Common stock, shares outstanding | 258,257,494 | 258,250,273 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Income Statement [Abstract] | ||||
Revenues, net | $ 346 | $ 142 | $ 472 | $ 443 |
Operating expenses: | ||||
Cost of revenues | 2,522 | 2,634 | 5,276 | 5,046 |
Research and development | 5,643 | 4,582 | 8,005 | 11,421 |
General and administrative | 15,084 | 9,367 | 26,014 | 16,114 |
Total operating expenses | 23,249 | 16,583 | 39,295 | 32,581 |
Loss from operations | (22,903) | (16,441) | (38,823) | (32,138) |
Interest expense, net of interest income | (901) | (845) | (1,841) | (2,657) |
Foreign exchange loss | (21,895) | (190) | (26,289) | (328) |
Loss before income taxes | (45,699) | (17,476) | (66,953) | (35,123) |
Income tax expense | ||||
NET LOSS | (45,699) | (17,476) | (66,953) | (35,123) |
Other comprehensive income | 19,236 | 1,370 | 24,339 | 1,713 |
COMPREHENSIVE LOSS | $ (26,463) | $ (16,106) | $ (42,614) | $ (33,410) |
Net loss per share of common shares, basic and diluted | $ (0.18) | $ (0.07) | $ (0.26) | $ (0.14) |
Weighted-average number of common shares outstanding, basic and diluted | 258,257,494 | 255,142,550 | 258,257,095 | 252,884,284 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | AOCI Attributable to Parent [Member] | Retained Earnings [Member] | Total |
Beginning balance, value at Dec. 31, 2020 | $ 403,528 | $ 75,530 | $ 1,265 | $ (308,618) | $ 171,705 |
Beginning balance, shares at Dec. 31, 2020 | 247,039,010 | ||||
Stock-based compensation | $ 51 | 2,088 | 2,139 | ||
Net loss | (17,647) | (17,647) | |||
Currency translation adjustments | 397 | 397 | |||
Common shares issued in financing transactions, net of share issuance costs | $ 21,417 | 21,417 | |||
Common shares issued in financing transaction, net of issuance costs, shares | 5,752,068 | ||||
Common shares issued upon exercise of warrants | $ 52 | 52 | |||
Common shares issued upon exercise of warrants, shares | 34,494 | ||||
Common shares issued upon of conversion of long-term debt | $ 2,000 | 2,000 | |||
Common shares issued upon of conversion of long-term debt, shares | 1,369,863 | ||||
Unrealized holding gain on short-term investments | (54) | (54) | |||
Ending balance, value at Mar. 31, 2021 | $ 427,048 | 77,618 | 1,608 | (326,265) | 180,009 |
Ending balance, shares at Mar. 31, 2021 | 254,195,435 | ||||
Beginning balance, value at Dec. 31, 2020 | $ 403,528 | 75,530 | 1,265 | (308,618) | 171,705 |
Beginning balance, shares at Dec. 31, 2020 | 247,039,010 | ||||
Net loss | (35,123) | ||||
Common shares issued upon of conversion of long-term debt | 2,000 | ||||
Ending balance, value at Jun. 30, 2021 | $ 432,268 | 76,578 | 2,978 | (343,741) | 168,083 |
Ending balance, shares at Jun. 30, 2021 | 255,145,138 | ||||
Beginning balance, value at Mar. 31, 2021 | $ 427,048 | 77,618 | 1,608 | (326,265) | 180,009 |
Beginning balance, shares at Mar. 31, 2021 | 254,195,435 | ||||
Stock-based compensation | $ 32 | 2,391 | 2,423 | ||
Net loss | (17,476) | (17,476) | |||
Currency translation adjustments | 1,316 | 1,316 | |||
Common shares issued in financing transactions, net of share issuance costs | $ 861 | 861 | |||
Common shares issued in financing transaction, net of issuance costs, shares | 284,100 | ||||
Common shares issued upon exercise of warrants | $ 29 | 29 | |||
Common shares issued upon exercise of warrants, shares | 19,346 | ||||
Unrealized holding gain on short-term investments | 54 | 54 | |||
Common shares issued upon cashless exercise of warrants | $ 4,298 | (4,298) | |||
Common shares issued upon cashless exercise of warrants shares. | 646,257 | ||||
Warrant modification in connection with debt amendment | 867 | 867 | |||
Ending balance, value at Jun. 30, 2021 | $ 432,268 | 76,578 | 2,978 | (343,741) | 168,083 |
Ending balance, shares at Jun. 30, 2021 | 255,145,138 | ||||
Beginning balance, value at Dec. 31, 2021 | $ 442,235 | 81,583 | (1,565) | (378,371) | 143,882 |
Beginning balance, shares at Dec. 31, 2021 | 258,250,273 | ||||
Adjustments for prior periods from adoption of ASU 2020-06 | (2,746) | 2,065 | (681) | ||
Common shares issued upon exercise of options | $ 12 | 12 | |||
Common shares issued up on exercise of options, shares | 7,221 | ||||
Stock-based compensation | $ 25 | 2,477 | 2,502 | ||
Net loss | (21,254) | (21,254) | |||
Currency translation adjustments | 5,103 | 5,103 | |||
Ending balance, value at Mar. 31, 2022 | $ 442,272 | 81,314 | 3,538 | (397,560) | 129,564 |
Ending balance, shares at Mar. 31, 2022 | 258,257,494 | ||||
Beginning balance, value at Dec. 31, 2021 | $ 442,235 | 81,583 | (1,565) | (378,371) | 143,882 |
Beginning balance, shares at Dec. 31, 2021 | 258,250,273 | ||||
Net loss | (66,953) | ||||
Common shares issued upon of conversion of long-term debt | |||||
Ending balance, value at Jun. 30, 2022 | $ 442,286 | 83,757 | 22,774 | (443,259) | 105,558 |
Ending balance, shares at Jun. 30, 2022 | 258,257,494 | ||||
Beginning balance, value at Mar. 31, 2022 | $ 442,272 | 81,314 | 3,538 | (397,560) | 129,564 |
Beginning balance, shares at Mar. 31, 2022 | 258,257,494 | ||||
Stock-based compensation | $ 14 | 2,443 | 2,457 | ||
Net loss | (45,699) | (45,699) | |||
Currency translation adjustments | 19,236 | 19,236 | |||
Ending balance, value at Jun. 30, 2022 | $ 442,286 | $ 83,757 | $ 22,774 | $ (443,259) | $ 105,558 |
Ending balance, shares at Jun. 30, 2022 | 258,257,494 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (66,953) | $ (35,123) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Depreciation and amortization | 1,015 | 921 |
Stock-based compensation | 4,959 | 4,562 |
Amortization of debt discount | 821 | 2,012 |
Inventory reserve | 353 | 720 |
Unrealized foreign exchange loss | 26,337 | 278 |
Net change in operating working capital items: | ||
Change in accounts receivable | (134) | (15) |
Change in inventory | (2,225) | (563) |
Change in prepaid expenses | 653 | 73 |
Change in other current assets | (917) | 1,881 |
Change in other long-term assets | (215) | (298) |
Change in operating right of use assets | (668) | 543 |
Change in accounts payable | 905 | (2,097) |
Change in deferred revenues | 41 | (175) |
Change in other current liabilities | (2,021) | 10,459 |
Payments made on operating lease liabilities | 674 | (540) |
Net cash flows used in operating activities | (37,375) | (17,362) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Redemption of short-term investments | 25,151 | |
Purchase of property and equipment | (1,592) | (960) |
Net cash flows (used in) provided by in investing activities | (1,592) | 24,191 |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Proceeds from issuance of common shares for cash | 23,030 | |
Share issuance costs | (743) | |
Proceeds from debt financing | 12,000 | |
Debt issuance costs | (22) | |
Proceeds from issuance of common shares for cash, upon exercise of options | 12 | 81 |
Net cash flows provided by financing activities | 12 | 34,346 |
Effect of exchange rates on cash | (325) | 27 |
CHANGE IN CASH FOR THE PERIOD | (39,280) | 41,202 |
CASH, BEGINNING OF PERIOD | 121,694 | 93,825 |
CASH, END OF PERIOD | 82,414 | 135,027 |
Supplementary information: | ||
Interest paid | 1,248 | 811 |
Non-cash investing and financing activities: | ||
Adjustments for prior periods from adoption of ASU 2020-06 | 681 | |
Warrant modification in connection with debt amendment | 867 | |
Common shares issued in connection with cashless warrant exercise | 4,298 | |
Common shares issued upon conversion of debt | 2,000 | |
Capital expenditures included in accounts payable and other current liabilities | 757 | 122 |
Share issuance costs included in other current liabilities | $ 67 | $ 9 |
NATURE OF BUSINESS AND CONTINUA
NATURE OF BUSINESS AND CONTINUATION OF BUSINESS | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
NATURE OF BUSINESS AND CONTINUATION OF BUSINESS | 1. NATURE OF BUSINESS AND CONTINUATION OF BUSINESS Corporate Overview VBI Vaccines Inc. (the “Company” or “VBI”) was incorporated under the laws of British Columbia, Canada on April 9, 1965 The Company and its wholly-owned subsidiaries, VBI Vaccines (Delaware) Inc., a Delaware corporation (“VBI DE”); VBI DE’s wholly-owned subsidiary, Variation Biotechnologies (US), Inc., a Delaware corporation (“VBI US”); Variation Biotechnologies, Inc. a Canadian company and the wholly-owned subsidiary of VBI US (“VBI Cda”); and SciVac Ltd. an Israeli company (“SciVac”); SciVac Hong Kong Limited (“SciVac HK”) and VBI Vaccines B.V a Netherlands company (“VBI BV”), are collectively referred to as the “Company”, “we”, “us”, “our”, or “VBI”. The Company’s registered office is located at Suite 1700, Park Place, 666 Burrard Street, Vancouver, BC V6C 2X8 with its principal office located at 160 Second Street, Floor 3, Cambridge, MA 02142. In addition, the Company has manufacturing facilities located in Rehovot, Israel and research facilities located in Ottawa, Ontario, Canada. Principal Operations VBI Vaccines Inc. (“VBI”) is a commercial stage biopharmaceutical company driven by immunology in the pursuit of prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B (“HBV”), COVID-19 and coronaviruses, and cytomegalovirus (“CMV”), as well as aggressive cancers including glioblastoma (“GBM”). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel. The ongoing COVID-19 pandemic has materially negatively affected and continues to affect the global economy, and there is continued severe uncertainty about the duration and intensity of the impacts of the pandemic. As a result, the Company’s business and results of operations have also been adversely affected and could continue to be adversely affected by COVID-19 which has necessitated restricting the number of personnel in the Company’s research laboratories and manufacturing facility at any given point in time, and has slowed recruitment to clinical trials. The extent to which the COVID-19 pandemic will continue to impact our business will depend on future developments, which are highly uncertain and cannot be predicted. We do not yet know the full extent of potential delays or impacts on our business, our clinical studies, our research programs, the recoverability of our assets, and our manufacturing; however, the COVID-19 pandemic may continue to disrupt or delay our business operations, including with respect to efforts relating to potential business development transactions, and it could continue to disrupt the marketplace which could have an adverse effect on our operations. Liquidity and Going Concern The Company faces a number of risks, including but not limited to, uncertainties regarding the success of the development and commercialization of its products, demand and market acceptance of the Company’s products, and reliance on major customers. The Company anticipates that it will continue to incur significant operating costs and losses in connection with the development and commercialization of its products. The Company had an accumulated deficit of $ 443,259 37,375 The Company will require significant additional funds to conduct clinical and non-clinical trials, commercially launch our products, and achieve regulatory approvals. Additional financing may be obtained from the issuance of equity securities, the issuance of additional debt, structured asset financings, government or non-governmental organization grants or subsidies, and/or revenues from potential business development transactions, if any. There is no assurance the Company will manage to obtain these sources of financing, if required. The above conditions raise substantial doubt about the Company’s ability to continue as a going concern. The condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result should the Company be unable to continue as a going concern. On July 1, 2022, we received a letter from the Listing Qualifications Department of the Nasdaq Stock Market (“NASDAQ”) indicating that, based upon the closing bid price of our common shares for the 30 consecutive business day period between May 18, 2022 through June 30, 2022, we did not meet the minimum bid price of $ 1.00 In order to regain compliance with NASDAQ’s minimum bid price requirement, our common shares must maintain a minimum closing bid price of $ 1.00 Financial instruments recognized in the condensed consolidated balance sheet consist of cash, accounts receivable, other current assets, accounts payable, and other current liabilities. The Company believes that the carrying value of its current financial instruments approximates their fair values due to the short-term nature of these instruments. The Company does not hold any derivative financial instruments. The carrying amounts of the Company’s other long-term assets approximate their respective fair values. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | 2. SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation and Consolidation The Company’s fiscal year ends on December 31 of each calendar year. The accompanying unaudited condensed consolidated financial statements have been prepared in U.S. dollars (“USD”) and pursuant to the rules and regulations of the SEC, for interim reporting. Accordingly, certain information and footnote disclosures normally included in the financial statements prepared in accordance with United States of America generally accepted accounting principles (“U.S. GAAP”), have been condensed or omitted pursuant to such rules and regulations. The December 31, 2021 consolidated balance sheet in this document was derived from the audited consolidated financial statements. The condensed consolidated financial statements and notes included in this quarterly report on this Form 10-Q does not include all of the disclosures required by U.S. GAAP and should be read in conjunction with the financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 (the “2021 10-K”), as filed with the SEC on March 7, 2022. The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries: VBI DE, VBI US, VBI Cda, SciVac, SciVac HK, and VBI BV. Intercompany balances and transactions between the Company and its subsidiaries are eliminated in the condensed consolidated financial statements. Certain items previously reported in specific financial statement captions have been reclassified to conform to the current presentation. In the opinion of management, these condensed consolidated financial statements include all adjustments and accruals of a normal and recurring nature necessary to fairly state the results of the periods presented. The results for the periods presented are not necessarily indicative of results to be expected for the full year or for any future periods. Significant Accounting Policies The significant accounting policies used in the preparation of these condensed consolidated financial statements are disclosed in the 2021 10-K, and there have been no changes to the Company’s significant accounting policies during the six months ended June 30, 2022, other than the polices discussed below. |
NEW ACCOUNTING PRONOUNCEMENTS
NEW ACCOUNTING PRONOUNCEMENTS | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Changes and Error Corrections [Abstract] | |
NEW ACCOUNTING PRONOUNCEMENTS | 3. NEW ACCOUNTING PRONOUNCEMENTS Recently Adopted Accounting Pronouncements In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including certain convertible instruments and contracts on an entity’s own equity. Specifically, the new standard has removed the separation models required for convertible debt with cash conversion features and convertible instruments with beneficial conversion features. It has also removed certain settlement conditions that are currently required for equity contracts to qualify for the derivative scope exception and simplifies the diluted earnings per share calculation for convertible instruments. On January 1, 2022, the Company adopted ASU 2020-06 using the modified retrospective method and recognized a cumulative effect of initially applying the ASU as an adjustment to the January 1, 2022 opening balance of accumulated deficit. Our conversion option that was previously bifurcated and recorded as a debt discount and additional paid-in capital has now been combined as a single instrument classified as a liability. The Company eliminated the beneficial conversion feature from additional paid-in capital; eliminated the interest accretion on the beneficial conversion feature through December 31, 2021 from the opening balance of accumulated deficit; and eliminated the corresponding debt discount. The prior period consolidated financial statements have not been retrospectively adjusted and continue to be reported under the accounting standards in effect for those periods. Accordingly, the cumulative effect of the changes made on our January 1, 2022 condensed consolidated balance sheet for the adoption of the ASU was as follows: SCHEDULE OF CUMULATIVE EFFECT OF CHANGES ON CONSOLIDATED BALANCE SHEETS Balance as at December 31, 2021 Adjustments from adoption of ASU 2020-06 Balance as at January 1, 2022 Liabilities Long-term debt, net of debt discount $ 28,441 $ 681 $ 29,122 Stockholders’ equity Additional paid-in capital $ 81,583 $ (2,746 ) $ 78,837 Accumulated deficit $ (378,371 ) $ 2,065 $ (376,306 ) Recently Issued Accounting Standards, not yet Adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). The amendments in ASU 2016-13, among other things, require the measurement of all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. Financial institutions and other organizations will now use forward-looking information to better inform their credit loss estimates. Many of the loss estimation techniques applied today will still be permitted, although the inputs to those techniques will change to reflect the full amount of expected credit losses. ASU 2016-13 will be effective for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. The Company is currently evaluating the potential impact of ASU 2016-13 on its condensed consolidated financial statements. |
INVENTORY, NET
INVENTORY, NET | 6 Months Ended |
Jun. 30, 2022 | |
Inventory Disclosure [Abstract] | |
INVENTORY, NET | 4. INVENTORY, NET Inventory consists of the following: SCHEDULE OF INVENTORY June 30, 2022 December 31, 2021 Finished goods $ 180 $ - Work-in-process 911 645 Raw materials 2,959 1,931 Total $ 4,050 $ 2,576 |
OTHER CURRENT ASSETS
OTHER CURRENT ASSETS | 6 Months Ended |
Jun. 30, 2022 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
OTHER CURRENT ASSETS | 5. OTHER CURRENT ASSETS Other current assets consisted of the following: SCHEDULE OF OTHER CURRENT ASSETS June 30, 2022 December 31, 2021 Government receivables $ 2,313 $ 1,438 Other current assets 2,155 2,195 Total $ 4,468 $ 3,633 |
INTANGIBLE ASSETS, NET, AND GOO
INTANGIBLE ASSETS, NET, AND GOODWILL | 6 Months Ended |
Jun. 30, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
INTANGIBLE ASSETS, NET, AND GOODWILL | 6. INTANGIBLE ASSETS, NET, AND GOODWILL SCHEDULE OF INDEFINITE LIVED INTANGIBLE ASSETS INCLUDING CUMULATIVE IMPAIRMENT AND CURRENCY TRANSLATION June 30, 2022 Gross Carrying Amount Accumulated Amortization Cumulative Impairment Charge Cumulative Currency Translation Net Book Value Patents $ 669 $ (664 ) $ - $ 13 $ 18 IPR&D assets 61,500 - (300 ) 161 61,361 $ 62,169 $ (664 ) $ (300 ) $ 174 $ 61,379 December 31, 2021 Gross Carrying Amount Accumulated Amortization Cumulative Impairment Charge Cumulative Currency Translation Net Book Value Patents $ 669 $ (660 ) $ - $ 47 $ 56 IPR&D assets 61,500 - (300 ) 835 62,035 $ 62,169 $ (660 ) $ (300 ) $ 882 $ 62,091 The Company amortizes intangible assets with finite lives on a straight-line basis over their estimated useful lives. The change in carrying value for IPR&D assets from December 31, 2021 relates to currency translation adjustments which decreased by $ 674 SCHEDULE OF GOODWILL June 30, 2022 Gross Carrying Amount Cumulative Impairment Charge Cumulative Currency Translation Net Book Value Goodwill $ 8,714 $ (6,292 ) $ (185 ) $ 2,237 December 31, 2021 Gross Carrying Amount Cumulative Impairment Charge Cumulative Currency Translation Net Book Value Goodwill $ 8,714 $ (6,292 ) $ (161 ) $ 2,261 The change in carrying value for goodwill from December 31, 2021 relates to currency translation adjustments which increased by $ 24 |
OTHER CURRENT LIABILITIES
OTHER CURRENT LIABILITIES | 6 Months Ended |
Jun. 30, 2022 | |
Other Liabilities Disclosure [Abstract] | |
OTHER CURRENT LIABILITIES | 7. OTHER CURRENT LIABILITIES Other current liabilities consisted of the following: SCHEDULE OF OTHER CURRENT LIABILITIES June 30, 2022 December 31, 2021 Accrued research and development expenses (including clinical trial accrued expenses) $ 7,600 $ 8,196 Accrued professional fees 4,199 2,294 Payroll and employee-related costs 2,377 4,805 Deferred funding 8,639 10,183 Other current liabilities 1,565 1,463 Total $ 24,380 $ 26,941 |
LOSS PER SHARE OF COMMON SHARES
LOSS PER SHARE OF COMMON SHARES | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
LOSS PER SHARE OF COMMON SHARES | 8. LOSS PER SHARE OF COMMON SHARES Basic loss per share is computed by dividing net loss applicable to common stockholders by the weighted average number of common shares outstanding during each period. Diluted loss per share includes the effect, if any, from the potential exercise or conversion of securities, such as warrants, and stock options, which would result in the issuance of incremental shares of common shares unless such effect is anti-dilutive. In computing the basic and diluted net loss per share applicable to common stockholders, the weighted average number of shares remains the same for both calculations due to the fact that when a net loss exists, dilutive shares are not included in the calculation as their effect would be anti-dilutive. These potentially dilutive securities are more fully described in Note 10, Stockholders’ Equity and Additional Paid-in Capital. The following potentially dilutive securities outstanding at June 30, 2022 and 2021 have been excluded from the computation of diluted weighted average shares outstanding, as they would be antidilutive: SCHEDULE OF ANTI-DILUTIVE WEIGHTED AVERAGE SHARES OUTSTANDING June 30, 2022 June 30, 2021 Warrants 1,384,469 1,387,502 Stock options and restricted stock units 23,278,795 18,103,114 K2 conversion feature 1,369,863 1,369,863 Total 26,033,127 20,860,479 |
LONG-TERM DEBT
LONG-TERM DEBT | 6 Months Ended |
Jun. 30, 2022 | |
Debt Disclosure [Abstract] | |
LONG-TERM DEBT | 9. LONG-TERM DEBT As of June 30, 2022, and December 31, 2021, the long-term debt is as follows: SCHEDULE OF LONG-TERM DEBT June 30, 2022 December 31, 2021 Long-term debt, net of debt discount of $ 2,281 3,783 $ 29,943 $ 28,441 Less: current portion, net of debt discount of $ 734 0 8,780 - Long-term debt, net of current portion $ 21,163 $ 28,441 On May 22, 2020, the Company (along with its subsidiary VBI Cda) entered into the Loan and Guaranty Agreement (the “Loan Agreement”) with K2 HealthVentures LLC and any other lender from time-to-time party thereto (the “Lenders”) pursuant to which we received the first tranche secured term loan of $ 20,000 10,000 10,000 10,000 4,000 1.46 June 1, 2024 2,000 1,369,863 1.46 2,000 On May 17, 2021, the Company entered into the First Amendment with the Lenders to: (1) increase the Second Tranche Term Loan from $ 10,000 12,000 7.75 4.50 July 1, 2022 January 1, 2023 In connection with the Loan Agreement, on May 22, 2020, the Company issued the Lenders a warrant to purchase up to 625,000 1.12 312,500 937,500 1.12 May 22, 2030 The total proceeds attributed to the Original K2 Warrant was $ 1,181 1.52 2,577 1,021 6.95 1,390 6,169 The Second Tranche Term Loan, issued pursuant to the Loan Agreement as amended by the First Amendment, resulted in the Company incurring an additional $ 20 150 834 6.95 The Company accounted for the First Amendment as a debt modification and as a result the debt discount was increased by $ 1,721 867 834 20 The total principal amount of the loan under the Loan Agreement, as amended by the First Amendment, outstanding at June 30, 2022, including the $ 2,224 32,224 8.25 5.00 7.75 4.50 9.75 9.25 January 1, 2023 30,000 14.09 Upon the occurrence of an Event of Default, and during the continuance of an Event of Default, the applicable rate of interest, described above, will be increased by 5.00 June 1, 2024 The obligations under the Loan Agreement, as amended by the First Amendment, are secured on a senior basis by a lien on substantially all of the assets of the Company and its subsidiaries other than intellectual property. The subsidiaries of the Company, other than VBI Cda and SciVac HK, and VBI BV, are guarantors of the obligations of the Company and VBI Cda under the Loan Agreement. The Loan Agreement also contains customary events of default. The total debt discount related to the Loan Agreement, as amended by the First Amendment, with K2 HealthVentures LLC is $ 7,209 2,281 3,783 At June 30, 2022 and December 31, 2021, the fair value of our outstanding debt, which is considered level 3 in the fair value hierarchy, is estimated to be $ 29,977 30,406 Interest expense, net of interest income recorded in the three and six months ended June 30, 2022 and 2021 was as follows: SCHEDULE OF INTEREST EXPENSE 2022 2021 2022 2021 Three months ended June 30 Six months ended June 30 2022 2021 2022 2021 Interest expense $ 669 $ 481 $ 1,276 $ 870 Amortization of debt discount 411 401 821 2,012 Interest income (179 ) (37 ) (256 ) (225 ) Total $ 901 $ 845 $ 1,841 $ 2,657 The following table summarizes the future principal payments due under long-term debt: SCHEDULE OF FUTURE PRINCIPAL OF LONG-TERM DEBT Principal payments on Loan Agreement and final payment Remaining 2022 $ - 2023 19,492 2024 12,732 Total $ 32,224 |
STOCKHOLDERS_ EQUITY AND ADDITI
STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL | 6 Months Ended |
Jun. 30, 2022 | |
Equity [Abstract] | |
STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL | 10. STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL Stock option plans The Company’s stock option plans are approved by and administered by the Board and its Compensation Committee. The Board designates, in connection with recommendations from the Compensation Committee, eligible participants to be included under the plan, and designates the number of options, exercise price and vesting period of the new options. 2006 VBI US Stock Option Plan The 2006 VBI US Stock Option Plan (the “2006 Plan”), was approved by and was previously administered by the VBI US board of directors which designated eligible participants to be included under the 2006 Plan, and designated the number of options, exercise price and vesting period of the new options. The 2006 Plan was not approved by the stockholders of VBI US. The 2006 Plan was superseded by the 2014 Plan (as defined below) following the PLCC Merger and no further options will be issued under the 2006 Plan. As of June 30, 2022, there were 842,803 2014 Equity Incentive Plan On May 1, 2014, the VBI DE board of directors adopted the VBI Vaccines Inc. 2014 Equity Incentive Plan (the “2014 Plan”). The 2014 Plan was approved by the VBI DE’s shareholders on July 14, 2014. The 2014 Plan was superseded by the 2016 Plan (as defined below) and no further options will be issued under the 2014 Plan. As of June 30, 2022, there were 521,242 2016 VBI Equity Incentive Plan The 2016 VBI Equity Incentive Plan (the “2016 Plan”) is a rolling incentive plan that sets the number of common shares issuable under the 2016 Plan, together with any other security-based compensation arrangement of the Company, at a maximum of 10 21,895,297 19,453 The aggregate number of common shares remaining available for issuance for awards under the 2016 Plan totaled 1,100,657 Activity related to stock options is as follows: SCHEDULE OF STOCK OPTIONS ACTIVITY Number of Stock Options Weighted Average Exercise Price Balance outstanding at December 31, 2021 18,534,379 $ 2.63 Granted 4,990,000 1.53 Exercised (7,221 ) 1.65 Forfeited (257,816 ) 2.72 Balance outstanding at June 30, 2022 23,259,342 $ 2.39 Exercisable at June 30, 2022 13,376,375 $ 2.53 Information relating to RSUs is as follow: SCHEDULE OF RESTRICTED STOCK UNITS Number of Stock Awards Weighted Average Fair Value at Grant Date Unvested shares outstanding at December 31, 2021 39,329 $ 1.47 Vested (19,876 ) 1.49 Unvested shares outstanding at June 30, 2022 19,453 $ 1.46 In determining the amount of stock-based compensation the Company used the Black-Scholes option pricing model to establish the fair value of options granted by applying the following weighted average assumptions: SCHEDULE OF FAIR VALUE OF OPTIONS GRANTED BY USING BLACK-SCHOLES OPTION PRICING ASSUMPTIONS 2022 2021 Volatility 93.17 % 97.13 % Risk free interest rate 1.71 % 0.54 % Expected term in years 5.83 5.85 Expected dividend yield 0.00 % 0.00 % Weighted average fair value per option $ 1.15 $ 2.40 The fair value of the options is recognized as an expense on a straight-line basis over the vesting period and forfeitures are accounted for when they occur. The total stock-based compensation expense recorded in the three and six months ended June 30, 2022 and 2021 was as follows: SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE Three months ended June 30 Six months ended June 30 2022 2021 2022 2021 Research and development $ 510 $ 463 $ 1,020 $ 891 General and administrative 1,917 1,937 3,883 3,627 Cost of revenues 30 23 56 44 Total stock-based compensation expense $ 2,457 $ 2,423 $ 4,959 $ 4,562 |
REVENUES, NET AND DEFERRED REVE
REVENUES, NET AND DEFERRED REVENUE | 6 Months Ended |
Jun. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
REVENUES, NET AND DEFERRED REVENUE | 11. REVENUES, NET AND DEFERRED REVENUE Revenues, net comprises the following: SCHEDULE OF REVENUE COMPRISED Three months ended June 30 Six months ended June 30 2022 2021 2022 2021 Product revenues, net $ 331 $ 71 $ 422 $ 238 R&D service revenues 15 71 50 205 Total revenues, net $ 346 $ 142 $ 472 $ 443 The following table presents revenues expected to be recognized in the future related to performance obligations, based on current estimates, that are unsatisfied at June 30, 2022: SUMMARY OF REVENUE EXPECTED TO BE RECOGNIZED IN FUTURE RELATED TO PERFORMANCE OBLIGATIONS Total Current portion to June 30, 2023 Remaining portion thereafter Product revenues, net $ 469 $ - $ 469 R&D service revenues 2,273 864 1,409 Total revenues, net $ 2,742 $ 864 $ 1,878 The following table presents changes in the deferred revenue balance for the six months ended June 30, 2022: SUMMARY OF CHANGES IN DEFERRED REVENUE Balance at January 1, 2021 $ 3,104 Currency translation - Balance at December 31, 2021 2,803 Recognition of deferred revenue (38) Currency translation (23) Balance at June 30, 2022 $ 2,742 Short Term $ 864 Long Term $ 1,878 Collaboration and License Agreement – Brii Bio On December 4, 2018, the Company entered into a Collaboration and License Agreement (the “License Agreement”) with Brii Biosciences Limited (“Brii Bio”), amended on April 8, 2021, whereby: ● the Company and Brii Bio agreed to collaborate on the development of a HBV recombinant protein-based immunotherapeutic in the licensed territory, which consists of China, Hong Kong, Taiwan and Macau (collectively, the “Licensed Territory”), and to conduct a Phase Ib/IIa collaboration clinical trial for the purpose of comparing VBI-2601 (BRII-179), which is a recombinant protein-based immunotherapeutic developed by VBI for use in treating chronic HBV, with a novel composition developed jointly with Brii Bio (either being the “Licensed Product”); ● the Company granted Brii Bio an exclusive royalty-bearing license to perform studies, and regulatory and other activities, as may be required to obtain and maintain marketing approval for the Licensed Product, for the treatment of HBV in the Licensed Territory and to commercialize and promote the Licensed Product for the diagnosis and treatment of chronic HBV in the Licensed Territory; and ● Brii Bio granted the Company an exclusive royalty-free license under Brii Bio’s technology and Brii Bio’s interest in any joint technology developed during the collaboration to develop and commercialize the Licensed Product for the diagnosis and treatment of chronic HBV in the countries of the world other than the Licensed Territory. On December 20, 2021, the Company and Brii Bio further amended the License Agreement (the “Second Amendment”) subject to the following additional terms and conditions: ● the Company and Brii Bio agreed to conduct an additional Phase II combination clinical trial of VBI-2601 (BRII-179), both with and without IFN-α, and BRII-835 (VIR-2218) (“Combo Clinical Trial”); and ● Brii Bio granted the Company a non-exclusive royalty free license under the Brii Bio technology arising from the data generated in the Combo Clinical Trial solely for use in the development, manufacture or commercialization of the Licensed Product in combination with an siRNA in the countries of the world other than the Licensed Territory. Pursuant to the License Agreement, as amended, the Company is responsible for the R&D Services and Brii Bio is responsible for costs relating to the clinical trials for the Licensed Territory. The Company and Brii Bio will jointly own all right, title and interest in the joint know-how development and the patents claiming joint inventions made pursuant to the Second Amendment. As part of the initial consideration of the License Agreement consisted of an $ 11,000 2,295,082 3,626 7,374 4,737 2,637 There was no additional consideration contemplated in the Second Amendment. In addition, the Company is also eligible to receive an additional $ 117,500 The R&D Services will be satisfied over time as services are rendered using the “cost-to-cost” input method as this method represents the most accurate depiction of the transfer of services based on the types of costs expected to be incurred. As of June 30, 2022, R&D services related to Brii Bio that remain unsatisfied are $ 2,073 2,742 Upon termination of the Collaboration and License Agreement prior to the end of the term, there is no obligation for refund and any amounts in deferred revenue related to unsatisfied performance obligations will be immediately recognized. |
COLLABORATION ARRANGEMENTS
COLLABORATION ARRANGEMENTS | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
COLLABORATION ARRANGEMENTS | 12. COLLABORATION ARRANGEMENTS GlaxoSmithKline Biologicals S.A. (“GSK”) On September 10, 2019, the Company entered into a Clinical Collaboration Agreement (“Collaboration Agreement”) pursuant to which we will investigate the use of GSK’s proprietary AS01 B B This relationship is considered a collaborative relationship and not a customer relationship and is therefore accounted for outside the scope of ASC Topic 606. Costs associated with the second study arm will be expensed as incurred in Research and Development expenses; three and six months ended June 30, 2022 are $ 4 139 70 326 National Research Council of Canada (“NRC”) On March 31, 2020, the Company announced a collaboration with the NRC, Canada’s largest federal research and development organization, to develop a pan-coronavirus vaccine candidate, targeting COVID-19, SARS, and MERS. The NRC and the Company are collaborating to evaluate and select promising coronavirus vaccine candidates. The collaboration combines the Company’s viral vaccine expertise, eVLP technology platform, and modified coronavirus antigens with the NRC’s proprietary SARS-CoV-2 antigens and assay development capabilities to select the most immunogenic vaccine candidate for further development. On December 21, 2020, the Company signed an amendment to the collaboration agreement with the NRC to broaden the scope of collaboration to include certain pre-clinical evaluations, bioprocess optimization, technology transfer, and the performance of additional scale up work. On July 8, 2021, the Company signed a second amendment to the collaboration agreement with the NRC to broaden the scope of the collaboration to include developing a vaccine against the Beta variant of SARS-CoV-2. On August 27, 2021, the Company signed a third amendment to the collaboration agreement with the NRC further broaden the scope to include certain stable cell line work for our vaccine candidate against the Beta variant of SARS-CoV-2. On November 15, 2021, we signed a fourth amendment to the collaboration agreement with the NRC to further broaden the scope to include additional animal studies and PRNT analysis for our vaccine candidate against the Beta variant of SARS-CoV-2. On February 8, 2022, we signed a fifth amendment to the collaboration agreement with the NRC to further broaden the scope to include additional assays of new variants against SARS-CoV-2. On April 28, 2022, we signed a sixth amendment to the collaboration agreement with the NRC to further broaden the scope to include generation and testing of stable pools of cells expressing SARS-CoV-2 spike protein. The expiry date of the collaboration agreement, as amended, is October 31, 2022. This relationship is considered a collaborative relationship and not a customer relationship and is therefore accounted for outside the scope of ASC Topic 606. Costs associated with the collaboration will be expensed as incurred in Research and Development expenses; costs for the three and six months ended June 30, 2022 are $ 304 584 56 229 CEPI On March 9, 2021, the Company and CEPI announced the CEPI Funding Agreement, to develop eVLP vaccine candidates against SARS-COV-2 variants, including the Beta variant, also known as the B.1.351 variant and as 501Y.V2, first identified in South Africa. CEPI agreed to provide up to $33,018 to support the advancement of VBI-2905, a monovalent eVLP candidate expressing the pre-fusion form of the spike protein from the Beta variant strain, through Phase I clinical development. This funding will also support preclinical expansion of additional multivalent vaccine candidates designed to evaluate the potential breadth of our eVLP technology. The preclinical expansion is intended to develop clinic-ready vaccine candidates capable of addressing emerging variants. Under the terms of the CEPI Funding Agreement, among other things, the Company and CEPI agreed on the importance of global equitable access to any vaccines produced pursuant to the CEPI Funding Agreement. Any such vaccines, if approved, are expected to be procured and allocated through global mechanisms as part of the Access to COVID-19 Tools (ACT) Accelerator, an international initiative launched by the WHO, Gavi the Vaccine Alliance, CEPI, and other global non-governmental organizations and governmental leaders in 2021. This relationship is considered a collaborative relationship and not a customer relationship and is therefore accounted for outside the scope of ASC Topic 606. Costs associated with the collaboration are expensed as incurred in Research and Development and General and Administrative expenses; costs for the three and six months ended June 30, 2022 are $ 713 2,406 2,048 2,207 19,327 8,639 Brii Biosciences Limited On December 4, 2018, we entered into the Collaboration and License Agreement with Brii Bio, which was amended on April 8, 2021, as described in Note 11. As described in Note 11, the Company and Brii Bio entered into the Second Amendment on December 20, 2021. The Combo Clinical Trial collaboration is considered a collaborative relationship and not a customer relationship and is therefore accounted for outside the scope of ASC Topic 606. Costs associated with the Combo Clinical Trial collaboration will be expensed as incurred in Research and Development expenses; costs for the three and six months ended June 30, 2022, were $ 111 135 |
GOVERNMENT GRANTS
GOVERNMENT GRANTS | 6 Months Ended |
Jun. 30, 2022 | |
Government Grants | |
GOVERNMENT GRANTS | 13. GOVERNMENT GRANTS Grants recognized in research and development expenses in the condensed consolidated statement of operations and comprehensive loss are as follows: Industrial Research Assistance Program (“IRAP”) On July 3, 2020, the Company and the NRC as represented by its IRAP signed a contribution agreement whereby the NRC agreed to contribute up to CAD $ 1,000 For the three and six months ended June 30, 2022 the Company recognized $ 0 0 43 For the three and six months ended June 30, 2021, the Company recognized $ 0 0 Strategic Innovation Fund (“SIF”) On September 16, 2020, the Company and Her Majesty the Queen in Right of Canada as represented by the Minister of Industry (“ISED”) signed a contribution agreement (the “Contribution Agreement”) for a contribution from SIF whereby ISED agreed to contribute up to CAD $ 55,976 For the three and six months ended June 30, 2022, the Company recognized $ 499 1,952 760 For the three and six months ended June 30, 2021, the Company recognized $ 1,324 4,012 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | 14. COMMITMENTS AND CONTINGENCIES Legal Proceedings From time to time, the Company may be involved in certain claims and litigation arising out of the ordinary course and conduct of business. Management assesses such claims and, if it considers that it is probable that an asset had been impaired or a liability had been incurred and the amount of loss can be reasonably estimated, provisions for loss are made based on management’s assessment of the most likely outcome. On September 13, 2018, two civil claims were brought in the District Court of the central district in Israel naming our subsidiary SciVac as a defendant. In one claim, two minors, through their parents, allege, among other things: defects in certain batches of Sci-B-Vac discovered in July 2015; that Sci-B-Vac was approved for use in children and infants in Israel without sufficient evidence establishing its safety; that SciVac failed to provide accurate information about Sci-B-Vac to consumers; and that each child suffered side effects from the vaccine. The claim was filed together with a motion seeking approval of a class action on behalf of 428,000 children vaccinated with Sci-B-Vac in Israel from April 2011 and seeking damages in a total amount of NIS 1,879,500 537,000 SciVac believes these matters to be without merit and intends to defend these claims vigorously. The District Court has accepted SciVac’s motion to suspend reaching a decision on the approval of the class action pending the determination of liability under the civil action. Preliminary hearings for the trial of the civil action began on January 15, 2020, with subsequent preliminary hearings held on May 13, 2020, December 3, 2020, September 30, 2021 and June 9, 2022. The next preliminary hearing is scheduled to be held on January 12, 2023. Operating leases The Company has entered into various non-cancelable lease agreements for its office, lab, and manufacturing facilities, which are classified as operating leases. The office facility lease agreement in the United States (“U.S.”) expires on October 31, 2024 Our manufacturing facility lease agreement in Israel has been extended for 5 years with a term now ending January 31, 2027 The lease agreement for our research facility in Canada, which comprises office and laboratory space, has a term ending on December 31, 2022 with an option to extend the term for one additional period of three years. A lease for additional office space at our research facility commenced on October 1, 2020 with a term ending April 30, 2023. During the three and six months ended June 30, 2022, the Company entered into new lease agreements and recognized a ROU asset of $ 0 795 There are no residual value guarantees, no variable lease payments, and no restrictions or covenants imposed by leases. The discount rate used in measuring the lease liabilities and right of use assets was determined by reviewing our incremental borrowing rate at the initial measurement date. SUMMARY OF LEASE COST AND OTHER INFORMATION Lease cost: Operating lease costs: Three months ended June 30, 2022 $ 451 Six months ended June 30, 2022 895 Three months ended June 30, 2021 340 Six months ended June 30, 2021 683 Other information: Weighted average remaining lease term 3.23 Weighted average discount rate 12 % Operating lease costs are included G&A expenses in the statement of operations and comprehensive loss. The following table summarizes future undiscounted cash payments reconciled to the lease liabilities: SCHEDULE OF FUTURE UNDISCOUNTED CASH PAYMENTS RECONCILED TO LEASE LIABILITIES Remaining 2022 $ 648 2023 1,176 2024 1,064 2025 575 2026 574 2027 169 Total $ 4,206 Effect of discounting (808 ) Total lease liability $ 3,398 Less: current portion 891 Lease liability, net of current portion $ 2,507 |
SEGMENT INFORMATION
SEGMENT INFORMATION | 6 Months Ended |
Jun. 30, 2022 | |
Segment Reporting [Abstract] | |
SEGMENT INFORMATION | 15. SEGMENT INFORMATION The Company’s Chief Executive Officer (“CEO”) has been identified as the chief operating decision maker. The CEO evaluates the performance of the Company and allocates resources based on the information provided by the Company’s internal management system at a consolidated level. The Company has determined that it has only one Revenues, net from external customers are attributed to geographic areas based on location of the contracting customers: SCHEDULE OF REVENUES FROM EXTERNAL CUSTOMERS Three Months Ended June 30 Six Months Ended June 30 2022 2021 2022 2021 United States $ 207 $ - $ 207 $ - Israel 126 87 221 256 China / Hong Kong 13 55 38 183 Europe - - 6 4 Total $ 346 $ 142 $ 472 $ 443 There was no |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 6 Months Ended |
Jun. 30, 2022 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | 16. SUBSEQUENT EVENTS Subsequent to June 30, 2022, the Company granted a total of 150,000 Options granted will vest 25% on the one-year anniversary of the grant date, with the remaining 75% vesting on a monthly basis over the subsequent 24 months. All options granted automatically expire 10 years from the date of issuance. The following discussion and analysis summarizes the significant factors affecting our operating results, financial condition, liquidity, and cash flows as of and for the periods presented below. The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the audited consolidated financial statements and related notes included elsewhere in this Form 10-Q. In addition to historical information, this discussion and analysis here and throughout this Form 10-Q contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements. Overview VBI Vaccines Inc. (“VBI”) is a commercial stage biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through our innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, we develop vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. We are committed to targeting and overcoming significant infectious diseases, including hepatitis B (“HBV”), COVID-19 and coronaviruses, and cytomegalovirus (“CMV”), as well as aggressive cancers including glioblastoma. We are headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel. Product Pipeline VBI’s pipeline is comprised of vaccine and immunotherapeutic programs developed by virus-like particle technologies to target two distinct, but often related, disease areas – infectious disease and oncology. We prioritize the development of programs for disease targets that are challenging, underserved, and where the human immune system, when powered and stimulated appropriately, can be a formidable opponent. VLP vaccines are a type of sub-unit vaccine, in which only the portions of viruses critical for eliciting an immune response are presented to the body. Because of their structural similarity to viruses presented in nature, including their particulate nature and repetitive structure, virus-like particles (VLPs) can stimulate potent immune responses. VLPs can be customized to present any protein antigen, including multiple antibody and T cell targets, making them, we believe, ideal technologies for the development of both prophylactic and therapeutic vaccines. However, only a few antigenic proteins self-assemble into VLPs, which limit the number of potential targets. Notably, HBV antigens are among those that are able to spontaneously form orderly VLP structures. Our eVLP platform technology expands the list of potentially viable target indications for VLPs by providing a stable core (Gag Protein) and lipid bilayer (the “envelope”). It is a flexible platform that enables the synthetic manufacture of an “enveloped” VLP, or “eVLP”, which looks structurally and morphologically similar to the virus, with no infectious material. Our product pipeline includes an approved vaccine and multiple late- and early-stage investigational programs. The investigational programs are in various stages of clinical development and the scientific information included about these therapeutics is preliminary and investigative. The investigational programs have not been approved by the United States Food and Drug Administration, European Medicines Agency, United Kingdom Medicines and Healthcare products Regulatory Agency, Health Canada, or any other health authority and no conclusion can or should be drawn regarding the safety or efficacy of these investigational programs. In addition to our existing pipeline programs, we may also seek to in-license clinical-stage vaccines or vaccine-related technologies that we believe complement our pipeline, as well as technologies that may supplement our efforts in both immuno-oncology and infectious disease. Key Targeted Disease Areas Hepatitis B Virus (“HBV”) HBV infection can cause liver inflammation, fibrosis, and liver injury, resulting in potentially life-threatening conditions through acute illness and chronic disease, including liver failure, cirrhosis, and cancer. HBV remains a significant public health burden with as many as 2.2 million chronically-infected people in the United States (“U.S.”) alone. Worldwide, this number is estimated to be as high as 350 million, with approximately 800,000 deaths resulting from the consequences of HBV infection each year. Despite the highly infectious nature of HBV, due to its often-asymptomatic nature, it is estimated that as many as 67% of chronically infected adults in the U.S. are unaware of their infection status. There is no cure available for HBV infection and while public health initiatives highlight immunization as the most effective strategy for the prevention of HBV infections, the U.S. adult HBV vaccination rates remain persistently low at only about 30% of all adults age 19 years and older. In April 2022, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) implemented a change to the adult HBV vaccine recommendations. As incorporated in the CDC’s 2022 Adult Immunization Schedule and as published in the April 1, 2022, CDC Morbidity and Mortality Weekly Report (MMWR), adults aged 19 to 59 years are now universally recommended to be vaccinated against HBV infection. Additionally, while adults aged 60 years and older with risk factors for HBV infection are still recommended to receive HBV vaccinations, adults aged 60 years and older without known risk factors for HBV may now also receive HBV vaccinations. In addition to our approved vaccine, PreHevbrio (Hepatitis B Vaccine [Recombinant]), there are four other vaccines approved in the U.S. for the prevention of HBV infection in adults: Engerix-B ® ® ® ® COVID-19 and Other Coronaviruses Coronaviruses are a large family of enveloped viruses that cause respiratory illness of varying severities. Only seven coronaviruses are known to cause disease in humans, four of which most frequently cause symptoms typically associated with the common cold. Three of the seven coronaviruses, however, have more serious outcomes in people. These more pathogenic coronaviruses are (1) SARS-CoV-2, a novel coronavirus identified as the cause of COVID-19; (2) MERS-CoV, identified in 2012 as the cause of Middle East Respiratory Syndrome (“MERS”); and (3) SARS-CoV, identified in 2002 as the cause of Severe Acute Respiratory Syndrome (“SARS”). The virus that causes COVID-19 continues to evolve and several SARS-CoV-2 variants have emerged and certain of these variants have been identified as having a significant public health impact. To date, notable Variants of Concern (“VOC”) include: ● Alpha (B.1.1.7) – First identified as in the United Kingdom (“UK”), VOC in December 2020 ● Beta (B.1.351) – First identified in South Africa, VOC in December 2020 ● Gamma (P.1) – First identified in Brazil, VOC in January 2021 ● Delta (B.1.617.2) – First identified in India, VOC in May 2021 ● Omicron (B.1.1.529; BA.1-BA.5) – First identified in South Africa, VOC in November 2021 Glioblastoma (“GBM”) Glioblastoma (“GBM”) is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, about 12,000 new GBM cases are diagnosed each year. The current standard of care for GBM is surgical resection, followed by radiation and chemotherapy. Even with intensive treatment, GBM progresses rapidly and has a high mortality rate, with median overall survival for primary GBM of about 14 months. Median overall survival for recurrent GBM is even lower, at about 8 months. Cytomegalovirus (“CMV”) CMV is a common virus that is a member of the herpes family. It infects one in every two people in many developed countries. Most CMV infections are “silent”, meaning the majority of people who are infected exhibit no signs or symptoms. Despite its typically asymptomatic nature in older children and adults, CMV may cause severe infections in newborn children (congenital CMV) and may also cause serious infections in people with weakened immune systems, such as solid organ or bone marrow transplant recipients. Congenital CMV infection can be treated – but not cured – and there are currently no approved vaccines available for the prevention of infection in either the congenital or the transplant setting. Zika Zika is a mosquito-borne virus that is spread primarily through the bite of an infected Aedes species mosquito, but can also be transmitted sexually, during pregnancy, or during childbirth. Acute infections are typically mild, but Zika has been associated with a number of neurological complications in newborns. The first formal description of Zika virus was published in 1952, but it was not until 2007 that the first Zika outbreak in humans was recorded. Over the past decade, Zika has begun to spread globally, and between January 2014 and February 2016, 33 countries reported circulation of the Zika virus, including in North America. There is currently no vaccine to prevent Zika infection. Pipeline Programs The table below is an overview of our commercial vaccine and our investigational programs as of August 4, 2022: Indication Program Technology Current Status Approved Vaccine ● Hepatitis B PreHevbrio 1,2,3 Hepatitis B Vaccine VLP Registration/Commercial (Recombinant) Prophylactic Candidates ● COVID-19 (Beta variant) VBI-2905 eVLP Ongoing Phase Ib ● COVID-19 (Ancestral) VBI-2902 eVLP Ongoing Phase Ia ● Cytomegalovirus VBI-1501 eVLP Phase I Completed ● Pan-coronavirus (Multivalent) VBI-2901 eVLP Pre-Clinical ● Coronaviruses (Multivalent) Undisclosed eVLP Pre-Clinical ● Zika VBI-2501 eVLP Pre-Clinical Therapeutic Candidates ● Hepatitis B VBI-2601 VLP Ongoing Phase II ● Glioblastoma VBI-1901 eVLP Ongoing Phase I/IIa ● Other CMV-Associated Cancers Undisclosed eVLP Preclinical 1 2 3 A summary of our marketed product, lead pipeline programs and recent developments follows. Marketed Product PreHevbrio (Hepatitis B Vaccine [Recombinant]) PreHevbrio (Hepatitis B Vaccine [Recombinant]) was approved by the FDA on November 30, 2021 for the prevention of infection caused by all known subtypes of HBV in adults age 18 years and older. PreHevbrio contains the S, pre-S2, and pre-S1 HBV surface antigens, and is the only approved 3-antigen HBV vaccine for adults in the U.S. On February 23, 2022, following discussion at the CDC’s ACIP meeting, PreHevbrio joined the list of recommended products for prophylactic adult vaccination against HBV infection. The inclusion of PreHevbrio in the ACIP recommendation was reflected in a CDC publication on April 1, 2022, and was a notable milestone as many insurance plans and institutions require an ACIP recommendation before a vaccine is able to be reimbursed or is made available to patients. Additionally, PreHevbrio will be included in the next annual update of the CDC Adult Immunization Schedule in 2023, which will summarize changes throughout the coming year. VBI launched PreHevbrio in the U.S. at the end of the first quarter of 2022, and revenue generation began in the second quarter of 2022. Commercial and regulatory activity for VBI’s 3-antigen HBV vaccine outside of the U.S. include: ● European Union (“EU”): ● United Kingdom (“UK”): ● Israel: ® ● Canada: Prophylactic Investigational Candidates VBI-2900: Coronavirus Vaccine Program (VBI-2901, VBI-2902, VBI-2905) In response to the ongoing SARS-CoV-2 (COVID-19) pandemic, VBI initiated development of a prophylactic coronavirus vaccine program. Coronaviruses are enveloped viruses by nature which make them a prime target for VBI’s flexible eVLP platform technology. On August 26, 2020, we announced data from three pre-clinical studies conducted to enable selection of optimized clinical candidates for our coronavirus vaccine program. As a result of these studies, VBI selected two vaccine candidates, with the goal of bringing forward candidates that add meaningful clinical and medical benefit to those already approved: (1) VBI-2901, a multivalent pan-coronavirus vaccine candidate expressing the SARS-CoV-2, SARS, and MERS spike proteins; and (2) VBI-2902, a monovalent vaccine candidate expressing an optimized “prefusion” form of the SARS-CoV-2 spike protein. In March 2021, a Phase I study of VBI-2902 was initiated and on June 29, 2021 we announced initial positive data from the Phase Ia portion of this study that evaluated one- and two-dose regimens of 5µg of VBI-2902 in 61 healthy adults age 18-54 years. After two doses, VBI-2902 induced neutralization titers in 100% of participants, with 4.3x higher geometric mean titer (“GMT”) than that of the convalescent serum panel (n=25), and peak antibody binding GMT of 1:4,047. The study supports the assessment of a one-dose booster regimen in seropositive individuals and two-dose regimens in seronegative individuals. VBI-2902 was also well tolerated with no safety signals observed. In response to the increased circulation of SARS-CoV-2 variants, the Phase Ib portion of the ongoing Phase I study was initiated in September 2021 to assess VBI-2905, our eVLP vaccine candidate directed against the SARS-CoV-2 Beta variant. On April 5, 2022, we announced new data from the Phase 1b study (n=53). A single-dose booster of VBI-2905 increased the geometric mean titer (“GMT”) of neutralizing antibodies directed against the Beta variant 3.8-fold, at day 28, in participants who had previously received two-doses of an mRNA vaccine (ancestral strain) – approximately 2-fold increases were also seen at day 28 in antibody GMTs against both the ancestral and delta variant. New preclinical data announced at the same time showed that against a panel of coronavirus variants in mice, reactivity was seen with VBI-2902 against all variants including the ancestral strain, Delta, Beta, Omicron, Lambda, and RaTG13 (a bat coronavirus that is distant to circulating human strains). In this same panel, VBI-2901 was able to elicit an even stronger response against all variants tested – as the strains became more divergent from the ancestral strain, VBI-2901 elicited a greater difference in GMT from VBI-2902, ranging from 2.5-fold higher against the ancestral strain to 9.0-fold higher against the bat coronavirus. Additionally, a validated pseudoparticle neutralization assay (“PNA”) benchmarked against the WHO reference standard demonstrated that VBI-2902 elicited neutralizing antibody responses of 176 IU50/mL in its Phase 1a study – this international standard measure would predict a greater than 90% efficacy, with two internationally approved vaccines estimated to have 90% efficacy at 83 and 140 IU50/mL (Gilbert, PB, 2021). The new clinical and preclinical data for all three candidates continued to support the potential of the eVLP platform against coronaviruses. The first clinical study of VBI’s multivalent candidate, designed to increase breadth of protection against COVID-19 and related coronaviruses, is expected to begin in Q3 2022. The VBI-2900 program is supported by a partnership with CEPI (the “CEPI Funding Agreement”), with contributions of up to $33 million; a partnership with the Strategic Innovation Fund (“SIF”), established by the Government of Canada, with an award of up to CAD $56 million; contribution of up to CAD $1 million from the Industrial Research Assistance Program (“IRAP”) of the National Research Council of Canada (“NRC”); and a collaboration with the NRC. VBI-1501: Prophylactic CMV Vaccine Candidate Our prophylactic CMV vaccine candidate uses the eVLP platform to express a modified form of the CMV glycoprotein B (“gB”) antigen and is adjuvanted with alum, an adjuvant used in FDA-approved products. Following the successful completion of the Phase I study in May 2018, and positive discussions with Health Canada, we announced plans for a Phase II clinical study evaluating VBI-1501 on December 20, 2018. We received similarly positive guidance from the FDA in July 2019. The Phase II study is expected to assess the safety and immunogenicity of dosages of VBI-1501 up to 20µg with alum. We are currently evaluating the timing of the Phase II study. Therapeutic Investigational Candidates VBI-2601: HBV Immunotherapeutic Candidate VBI-2601 (BRII-179) is our novel, recombinant, protein-based immunotherapeutic candidate in development for the treatment of chronic HBV infection. VBI-2601 (BRII-179) is formulated to induce broad immunity against HBV, including T-cell immunity which plays an important role in controlling HBV infection. On April 12, 2021 and June 23, 2021, we announced data from the completed Phase Ib/IIa clinical study in patients with chronic HBV infection, which was conducted by our partner Brii Biosciences Limited (“Brii Bio”). The study was a randomized, controlled study designed to assess the safety, tolerability, antiviral and immunologic activity of VBI-2601. The study was a two-part, dose-escalation study assessing different dose levels of VBI-2601 (BRII-179) with and without an immunomodulatory adjuvant, conducted at multiple study sites in New Zealand, Australia, Thailand, South Korea, Hong Kong SAR, and China. The data from the Phase Ib/IIa for 33 evaluable patients across all study arms suggest: (1) VBI-2601 (BRII-179) is well tolerated at all dose levels with and without the adjuvant with no significant adverse events identified; (2) VBI-2601 (BRII-179) induced both B cell (antibody) and T cell responses in chronically-infected HBV patients, (3) VBI-2601 (BRII-179) induced restimulation of T cell responses to HBV surface antigens, including S, Pre-S1 and Pre-S2, in greater than 50% of the evaluable patients compared to no detectable response in the control arm; (4) the T cell responses and antibody responses were comparable across the 20µg and 40µg unadjuvanted study arms; and (5) T cell response rates between the adjuvanted and unadjuvanted cohorts were also comparable. Based on the acceptable safety profile and vaccine-induced adaptive immune responses seen in this study, VBI-2601 (BRII-179) has been advanced to Phase II studies. On April 21, 2021, we announced that the first patient had been dosed in a Phase II clinical study evaluating VBI-2601 (BRII-179) in combination with BRII-835 (VIR-2218), an investigational small interfering ribonucleic acid (siRNA) targeting HBV, for the treatment of chronic HBV infection. To the best of our knowledge, this is the first clinical trial in the field to evaluate the combination of these two HBV mechanisms of action. The multi-center, randomized, open-label study is designed to evaluate the safety and efficacy of this combination with and without interferon-alpha as a co-adjuvant. Brii Bio has led the design and implementation of this functional cure proof-of-concept study with the support of VBI and Vir Biotechnology (“VIR”). The study will be conducted at sites in Australia, China, Taiwan, Hong Kong SAR, South Korea, New Zealand, Singapore, and Thailand. Interim topline clinical data from this study is expected by the end of 2022. On January 5, 2022, we announced that the first patient was dosed in a second Phase IIa/IIb clinical study evaluating VBI-2601 (BRII-179). This newly announced Phase II study will assess VBI-2601 as an add-on therapy to the standard-of-care nucleos(t)ide reverse transcriptase inhibitor (nrtl) and pegylated interferon (PEG-IFN-α,) therapy. Interim topline clinical data from this Phase IIa/IIb clinical study is expected in the first half of 2023. VBI-1901: Glioblastoma (GBM) Our cancer vaccine immunotherapeutic program, VBI-1901, targets CMV proteins present in tumor cells. CMV is associated with a number of solid tumors including glioblastoma (“GBM”), breast cancer, and pediatric medulloblastoma. In January 2018, we initiated dosing in a two-part, multi-center, open-label Phase I/IIa clinical study of VBI-1901 in 38 patients with recurrent GBM. Phase I (Part A) of the study was a dose-escalation phase that defined the safety, tolerability, and optimal dose level of VBI-1901 adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF) in recurrent GBM patients with any number of prior recurrences. In December 2018, this phase completed enrollment of 18 patients across three dose cohorts, the highest of which (10 µg) was selected as the optimal dose level to test in the Phase IIa portion (Part B) of the study. Phase IIa of the study, which initiated enrollment in July 2019, is a subsequent extension of the 10 µg doses level cohort. This phase is a two-arm study that enrolled 20 first-recurrent GBM patients to receive 10 µg of VBI-1901 in combination with either GM-CSF or GlaxoSmithKline Biologicals S.A. (“GSK”) proprietary adjuvant system, AS01, as immunomodulatory adjuvants. AS01 is provided pursuant to a Clinical Collaboration and Support Study Agreement (“Collaboration Agreement”) we entered into with GSK on September 10, 2019. Enrollment of the 10 patients in the VBI-1901 with GM-CSF arm was completed in March 2020 and enrollment of the 10 patients in the VBI-1901 with AS01 was completed in October 2020. Data from the ongoing Phase IIa portion of the study was announced throughout 2020 and 2021, with the latest data presented in December 2021 at the World Vaccine & Immunology Congress. The data from the Phase IIa portion of this study demonstrate: (1) improvement in 6-month, 12-month, and 18-month overall survival (“OS”) data compared to historical controls; (2) 12-month OS of 60% (n=6/10) in the VBI-1901 + GM-CSF study arm and 70% (n=7/10) in the VBI-1901 + AS01 study arm, compared to historical controls of ~30%; (3) 18-month OS of 30% (3/10) in the VBI-1901 + GM-CSF study arm, 18-month OS not yet reached in the VBI-1901 + AS01 study arm; (3) 2 partial tumor responses, one of which remains on protocol past week 86 with a 93% tumor reduction relative to initiation of treatment at the start of the study, and 7 stable disease observations across both study arms; and (4) VBI-1901 continues to be safe and well tolerated at all doses tested, with no safety signals observed. On June 8, 2021, we announced that the FDA granted Fast-Track Designation for VBI-1901 formulated with GM-CSF for the treatment of recurrent GBM patients with first tumor recurrence. The designation was granted based on data from the Phase I/IIa study. On June 22, 2022, we announced that the FDA granted Orphan Drug Designation for VBI-1901 for the treatment of GBM. Based on the data seen to-date, as part of the next phase of development, we anticipate assessing VBI-1901 in randomized, controlled studies in both primary and recurrent GBM patients. In the recurrent setting, we aim to expand the number of patients in the current trial and add a control arm, with the potential to support an accelerated approval application based on tumor response rates and improvement in overall survival. Subject to discussion with the FDA, the amended protocol is expected to initiate enrollment of additional patients in the third quarter of 2022. In the primary setting, we expect to evaluate VBI-1901 as part of the INSIGhT adaptive platform trial in patients first diagnosed with GBM, which, subject to approval from regulatory bodies, is expected to begin in the fourth quarter of 2022. Third Party License and Assignment Agreements We currently are dependent on licenses from third parties for certain of our key technologies, including the license granted pursuant to an agreement between Savient Pharmaceuticals Inc. and SciGen Ltd dated June 2004, as subsequently amended (the “Ferring License Agreement”) and a license from L’Universite Pierre et Marie Curie, now Sorbonne Université (“UPMC”), Institut National de la Santé et de la Recherche Médicale (“INSERM”) and L’école Normale Supérieure de Lyon. Under the Ferring License Agreement, we are committed to pay Ferring royalties equal to 7% of net sales (as defined therein) of HBsAg “Product” (as defined therein). Under an Assignment Agreement between FDS Pharm LLP and SciGen Ltd., dated February 14, 2012 (the “SciGen Assignment Agreement”), we are required to pay royalties to SciGen Ltd. equal to 5% of net sales (as defined in the Ferring License Agreement) of Product. Under the Ferring License Agreement and the SciGen Assignment Agreement, we originally were to pay royalties on a country-by-country basis until the date 10 years after the date of commencement of the first royalty year in respect of such country. In April 2019, we exercised our option to extend the Ferring License Agreement in respect of all the countries that still make up the territory for an additional 7 years by making a one-time payment to Ferring of $0.1 million. Royalties under the Ferring License Agreement and SciGen Assignment Agreement will continue to be payable for the duration of the extended license periods. Under our license agreement with UPMC and other licensors relating to eVLP technology, we have an exclusive license to a family of patents that is expected to expire in the United States in 2022 and expired in other countries in 2021. Under this agreement, we are required to pay UPMC between 0.75% to 1.75% of net sales and certain lump-sum milestone payments. UPMC is also a co-owner of the patent family covering our VBI-1501 CMV vaccine and we are currently negotiating an agreement with UPMC to cover this patent family. During the three and six months ended June 30, 2022, we did not make any milestone payments. Financial Operations Overview At present, our operations are focused on: ● continuing our commercial launch of PreHevbrio in the United States; ● manufacturing our 3-antigen HBV vaccine at commercial scale to meet demand in the U.S., Europe, and Israel, where it is approved, and to prepare for supply in markets where we may obtain marketing authorization; ● preparing for commercialization of our 3-antigen HBV vaccine in Europe where we have received regulatory approval under the brand name PreHevbri, and in Canada, where we may obtain regulatory approval; ● supporting the ongoing review of the regulatory submissions for our 3-antigen HBV vaccine by Health Canada in Canada; ● conducting the Phase I/IIa clinical study of our GBM vaccine immunotherapeutic candidate, VBI-1901; ● preparing for the next phase of development for our GBM vaccine immunotherapeutic candidate, VBI-1901; ● conducting the Phase I clinical study of our prophylactic COVID-19 vaccine candidates, VBI-2902 and VBI-2905 (Beta variant); ● preparing for a Phase I/II clinical study of our pan-coronavirus candidate, VBI-2901; ● continuing our development and scaling-up production processes for our prophylactic coronavirus vaccine candidates using a Contract Development and Manufacturing Organization (“CDMO”) located in Canada; ● developing VBI-2601 (BRII-179), our protein-based immunotherapeutic candidate for treatment of chronic HBV, in collaboration with Brii Bio; ● preparation for further development of VBI-1501, our preventative CMV vaccine candidate; ● continuing the research and development (“R&D”) of our other pipeline candidates, including the exploration and development of new pipeline candidates; ● implementing operational, compliance, financial, and management information systems, including through third party partners, to support our commercialization activities; ● maintaining, expanding, and protecting our intellectual property portfolio; and ● developing our internal systems and processes for regulatory affairs, legal, and compliance. VBI’s revenue generating activities have been the sale of our 3-antigen HBV vaccine in Israel under the name Sci-B-Vac, and recently the sale of PreHevbrio in the U.S. In addition, we sell through named patient programs in countries where our 3-antigen HBV vaccine is not approved, though those markets have generated a limited number of sales to-date. We have also generated revenue from various business development transactions and R&D services generating fees. To date, we have financed our operations primarily with proceeds from sales of our common stock, our long-term debt agreements, and contribution agreements and partnerships with CEPI and the Government of Canada. VBI has incurred significant net losses and negative operating cash flows since inception and expects to continue incurring losses and negative cash flows from operations as we carry out planned clinical, regulatory, R&D, commercial, and manufacturing activities with respect to the advancement of our 3-antigen HBV vaccine and new pipeline candidates. As of June 30, 2022, VBI had an accumulated deficit of approximately $443.3 million and stockholders’ equity of approximately $105.6 million. Our ability to maintain our status as an operating company and to realize our investment in our In Process Research & Development (“IPR&D”) assets, which consist of our CMV and GBM programs, is dependent upon obtaining adequate cash to finance our clinical development, manufacturing, our administrative overhead and our research and development activities, and ultimately to profitably monetize our IPR&D. We expect that we will need to secure additional financing to finance our business plans, which may be a combination of proceeds from the issuance of equity securities, the issuance of additional debt, structured asset financings, government or non-governmental organization grants or subsidies, and revenues from potential business development transactions, if any. There is no assurance we will manage to obtain these sources of financing, if required. These factors raise substantial doubt about our ability to continue as a going concern. The accompanying financial statements have been prepared assuming that we will continue as a going concern. The financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result should we be unable to continue as a going concern. We have incurred operating losses since inception, have not generated significant product sales revenue and have not achieved profitable operations. We incurred net losses of $67.0 million for the six months ended June 30, 2022 In addition, we have incurred and will continue to incur significant expenses as a public company, which subject us to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act, the rules and regulations of the NASDAQ Capital Market, and the Canadian securities regulators. Overall Performance The Company had net losses of $45,699 and $ 17,476 35,123 Revenue, net Revenues, net consist of product sales of PreHevbrio in the U.S and Sci-B-Vac in Israel, as well as R&D services revenue recognized as part of the License Agreement with Brii Bio and other R&D services. In the U.S., in the second quarter, PreHevbrio was sold to a limited number of wholesalers and specialty distributors (collectively, our “Customers”). We expect to continue to expand this group of Customers over the coming months. Revenues from product sales are recognized when we have satisfied our performance obligations, which is the transfer of control of our product upon delivery to the Customer. The timing between the recognition of revenue for product sales and the receipt of payment is not significant. Because our standard credit terms are short-term and we expect to receive payment in less than one year, there is no significant financing component on the related receivables. Taxes collected from Customers relating to product sales and remitted to governmental authorities are excluded from revenues. In Israel, Sci-B-Vac is sold through procurement requests from four health funds (“HMOs”) (collectively, the “Sci-B-Vac Customers”). Overall, product revenues, net, reflects our best estimates of the amount of consideration to which we are entitled based on the terms of the contract. The amount of variable consideration is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. If our estimates differ significantly from actuals, we will record adjustments that would affect product revenues, net in the period |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Consolidation | Basis of Presentation and Consolidation The Company’s fiscal year ends on December 31 of each calendar year. The accompanying unaudited condensed consolidated financial statements have been prepared in U.S. dollars (“USD”) and pursuant to the rules and regulations of the SEC, for interim reporting. Accordingly, certain information and footnote disclosures normally included in the financial statements prepared in accordance with United States of America generally accepted accounting principles (“U.S. GAAP”), have been condensed or omitted pursuant to such rules and regulations. The December 31, 2021 consolidated balance sheet in this document was derived from the audited consolidated financial statements. The condensed consolidated financial statements and notes included in this quarterly report on this Form 10-Q does not include all of the disclosures required by U.S. GAAP and should be read in conjunction with the financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 (the “2021 10-K”), as filed with the SEC on March 7, 2022. The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries: VBI DE, VBI US, VBI Cda, SciVac, SciVac HK, and VBI BV. Intercompany balances and transactions between the Company and its subsidiaries are eliminated in the condensed consolidated financial statements. Certain items previously reported in specific financial statement captions have been reclassified to conform to the current presentation. In the opinion of management, these condensed consolidated financial statements include all adjustments and accruals of a normal and recurring nature necessary to fairly state the results of the periods presented. The results for the periods presented are not necessarily indicative of results to be expected for the full year or for any future periods. Significant Accounting Policies The significant accounting policies used in the preparation of these condensed consolidated financial statements are disclosed in the 2021 10-K, and there have been no changes to the Company’s significant accounting policies during the six months ended June 30, 2022, other than the polices discussed below. |
NEW ACCOUNTING PRONOUNCEMENTS (
NEW ACCOUNTING PRONOUNCEMENTS (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Changes and Error Corrections [Abstract] | |
SCHEDULE OF CUMULATIVE EFFECT OF CHANGES ON CONSOLIDATED BALANCE SHEETS | Accordingly, the cumulative effect of the changes made on our January 1, 2022 condensed consolidated balance sheet for the adoption of the ASU was as follows: SCHEDULE OF CUMULATIVE EFFECT OF CHANGES ON CONSOLIDATED BALANCE SHEETS Balance as at December 31, 2021 Adjustments from adoption of ASU 2020-06 Balance as at January 1, 2022 Liabilities Long-term debt, net of debt discount $ 28,441 $ 681 $ 29,122 Stockholders’ equity Additional paid-in capital $ 81,583 $ (2,746 ) $ 78,837 Accumulated deficit $ (378,371 ) $ 2,065 $ (376,306 ) |
INVENTORY, NET (Tables)
INVENTORY, NET (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Inventory Disclosure [Abstract] | |
SCHEDULE OF INVENTORY | Inventory consists of the following: SCHEDULE OF INVENTORY June 30, 2022 December 31, 2021 Finished goods $ 180 $ - Work-in-process 911 645 Raw materials 2,959 1,931 Total $ 4,050 $ 2,576 |
OTHER CURRENT ASSETS (Tables)
OTHER CURRENT ASSETS (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
SCHEDULE OF OTHER CURRENT ASSETS | Other current assets consisted of the following: SCHEDULE OF OTHER CURRENT ASSETS June 30, 2022 December 31, 2021 Government receivables $ 2,313 $ 1,438 Other current assets 2,155 2,195 Total $ 4,468 $ 3,633 |
INTANGIBLE ASSETS, NET, AND G_2
INTANGIBLE ASSETS, NET, AND GOODWILL (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
SCHEDULE OF INDEFINITE LIVED INTANGIBLE ASSETS INCLUDING CUMULATIVE IMPAIRMENT AND CURRENCY TRANSLATION | SCHEDULE OF INDEFINITE LIVED INTANGIBLE ASSETS INCLUDING CUMULATIVE IMPAIRMENT AND CURRENCY TRANSLATION June 30, 2022 Gross Carrying Amount Accumulated Amortization Cumulative Impairment Charge Cumulative Currency Translation Net Book Value Patents $ 669 $ (664 ) $ - $ 13 $ 18 IPR&D assets 61,500 - (300 ) 161 61,361 $ 62,169 $ (664 ) $ (300 ) $ 174 $ 61,379 December 31, 2021 Gross Carrying Amount Accumulated Amortization Cumulative Impairment Charge Cumulative Currency Translation Net Book Value Patents $ 669 $ (660 ) $ - $ 47 $ 56 IPR&D assets 61,500 - (300 ) 835 62,035 $ 62,169 $ (660 ) $ (300 ) $ 882 $ 62,091 |
SCHEDULE OF GOODWILL | SCHEDULE OF GOODWILL June 30, 2022 Gross Carrying Amount Cumulative Impairment Charge Cumulative Currency Translation Net Book Value Goodwill $ 8,714 $ (6,292 ) $ (185 ) $ 2,237 December 31, 2021 Gross Carrying Amount Cumulative Impairment Charge Cumulative Currency Translation Net Book Value Goodwill $ 8,714 $ (6,292 ) $ (161 ) $ 2,261 |
OTHER CURRENT LIABILITIES (Tabl
OTHER CURRENT LIABILITIES (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Other Liabilities Disclosure [Abstract] | |
SCHEDULE OF OTHER CURRENT LIABILITIES | Other current liabilities consisted of the following: SCHEDULE OF OTHER CURRENT LIABILITIES June 30, 2022 December 31, 2021 Accrued research and development expenses (including clinical trial accrued expenses) $ 7,600 $ 8,196 Accrued professional fees 4,199 2,294 Payroll and employee-related costs 2,377 4,805 Deferred funding 8,639 10,183 Other current liabilities 1,565 1,463 Total $ 24,380 $ 26,941 |
LOSS PER SHARE OF COMMON SHAR_2
LOSS PER SHARE OF COMMON SHARES (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
SCHEDULE OF ANTI-DILUTIVE WEIGHTED AVERAGE SHARES OUTSTANDING | The following potentially dilutive securities outstanding at June 30, 2022 and 2021 have been excluded from the computation of diluted weighted average shares outstanding, as they would be antidilutive: SCHEDULE OF ANTI-DILUTIVE WEIGHTED AVERAGE SHARES OUTSTANDING June 30, 2022 June 30, 2021 Warrants 1,384,469 1,387,502 Stock options and restricted stock units 23,278,795 18,103,114 K2 conversion feature 1,369,863 1,369,863 Total 26,033,127 20,860,479 |
LONG-TERM DEBT (Tables)
LONG-TERM DEBT (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Debt Disclosure [Abstract] | |
SCHEDULE OF LONG-TERM DEBT | As of June 30, 2022, and December 31, 2021, the long-term debt is as follows: SCHEDULE OF LONG-TERM DEBT June 30, 2022 December 31, 2021 Long-term debt, net of debt discount of $ 2,281 3,783 $ 29,943 $ 28,441 Less: current portion, net of debt discount of $ 734 0 8,780 - Long-term debt, net of current portion $ 21,163 $ 28,441 |
SCHEDULE OF INTEREST EXPENSE | Interest expense, net of interest income recorded in the three and six months ended June 30, 2022 and 2021 was as follows: SCHEDULE OF INTEREST EXPENSE 2022 2021 2022 2021 Three months ended June 30 Six months ended June 30 2022 2021 2022 2021 Interest expense $ 669 $ 481 $ 1,276 $ 870 Amortization of debt discount 411 401 821 2,012 Interest income (179 ) (37 ) (256 ) (225 ) Total $ 901 $ 845 $ 1,841 $ 2,657 |
SCHEDULE OF FUTURE PRINCIPAL OF LONG-TERM DEBT | The following table summarizes the future principal payments due under long-term debt: SCHEDULE OF FUTURE PRINCIPAL OF LONG-TERM DEBT Principal payments on Loan Agreement and final payment Remaining 2022 $ - 2023 19,492 2024 12,732 Total $ 32,224 |
STOCKHOLDERS_ EQUITY AND ADDI_2
STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Equity [Abstract] | |
SCHEDULE OF STOCK OPTIONS ACTIVITY | Activity related to stock options is as follows: SCHEDULE OF STOCK OPTIONS ACTIVITY Number of Stock Options Weighted Average Exercise Price Balance outstanding at December 31, 2021 18,534,379 $ 2.63 Granted 4,990,000 1.53 Exercised (7,221 ) 1.65 Forfeited (257,816 ) 2.72 Balance outstanding at June 30, 2022 23,259,342 $ 2.39 Exercisable at June 30, 2022 13,376,375 $ 2.53 |
SCHEDULE OF RESTRICTED STOCK UNITS | Information relating to RSUs is as follow: SCHEDULE OF RESTRICTED STOCK UNITS Number of Stock Awards Weighted Average Fair Value at Grant Date Unvested shares outstanding at December 31, 2021 39,329 $ 1.47 Vested (19,876 ) 1.49 Unvested shares outstanding at June 30, 2022 19,453 $ 1.46 |
SCHEDULE OF FAIR VALUE OF OPTIONS GRANTED BY USING BLACK-SCHOLES OPTION PRICING ASSUMPTIONS | In determining the amount of stock-based compensation the Company used the Black-Scholes option pricing model to establish the fair value of options granted by applying the following weighted average assumptions: SCHEDULE OF FAIR VALUE OF OPTIONS GRANTED BY USING BLACK-SCHOLES OPTION PRICING ASSUMPTIONS 2022 2021 Volatility 93.17 % 97.13 % Risk free interest rate 1.71 % 0.54 % Expected term in years 5.83 5.85 Expected dividend yield 0.00 % 0.00 % Weighted average fair value per option $ 1.15 $ 2.40 |
SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE | The fair value of the options is recognized as an expense on a straight-line basis over the vesting period and forfeitures are accounted for when they occur. The total stock-based compensation expense recorded in the three and six months ended June 30, 2022 and 2021 was as follows: SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE Three months ended June 30 Six months ended June 30 2022 2021 2022 2021 Research and development $ 510 $ 463 $ 1,020 $ 891 General and administrative 1,917 1,937 3,883 3,627 Cost of revenues 30 23 56 44 Total stock-based compensation expense $ 2,457 $ 2,423 $ 4,959 $ 4,562 |
REVENUES, NET AND DEFERRED RE_2
REVENUES, NET AND DEFERRED REVENUE (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
SCHEDULE OF REVENUE COMPRISED | Revenues, net comprises the following: SCHEDULE OF REVENUE COMPRISED Three months ended June 30 Six months ended June 30 2022 2021 2022 2021 Product revenues, net $ 331 $ 71 $ 422 $ 238 R&D service revenues 15 71 50 205 Total revenues, net $ 346 $ 142 $ 472 $ 443 |
SUMMARY OF REVENUE EXPECTED TO BE RECOGNIZED IN FUTURE RELATED TO PERFORMANCE OBLIGATIONS | The following table presents revenues expected to be recognized in the future related to performance obligations, based on current estimates, that are unsatisfied at June 30, 2022: SUMMARY OF REVENUE EXPECTED TO BE RECOGNIZED IN FUTURE RELATED TO PERFORMANCE OBLIGATIONS Total Current portion to June 30, 2023 Remaining portion thereafter Product revenues, net $ 469 $ - $ 469 R&D service revenues 2,273 864 1,409 Total revenues, net $ 2,742 $ 864 $ 1,878 |
SUMMARY OF CHANGES IN DEFERRED REVENUE | The following table presents changes in the deferred revenue balance for the six months ended June 30, 2022: SUMMARY OF CHANGES IN DEFERRED REVENUE Balance at January 1, 2021 $ 3,104 Currency translation - Balance at December 31, 2021 2,803 Recognition of deferred revenue (38) Currency translation (23) Balance at June 30, 2022 $ 2,742 Short Term $ 864 Long Term $ 1,878 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
SUMMARY OF LEASE COST AND OTHER INFORMATION | SUMMARY OF LEASE COST AND OTHER INFORMATION Lease cost: Operating lease costs: Three months ended June 30, 2022 $ 451 Six months ended June 30, 2022 895 Three months ended June 30, 2021 340 Six months ended June 30, 2021 683 Other information: Weighted average remaining lease term 3.23 Weighted average discount rate 12 % |
SCHEDULE OF FUTURE UNDISCOUNTED CASH PAYMENTS RECONCILED TO LEASE LIABILITIES | The following table summarizes future undiscounted cash payments reconciled to the lease liabilities: SCHEDULE OF FUTURE UNDISCOUNTED CASH PAYMENTS RECONCILED TO LEASE LIABILITIES Remaining 2022 $ 648 2023 1,176 2024 1,064 2025 575 2026 574 2027 169 Total $ 4,206 Effect of discounting (808 ) Total lease liability $ 3,398 Less: current portion 891 Lease liability, net of current portion $ 2,507 |
SEGMENT INFORMATION (Tables)
SEGMENT INFORMATION (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Segment Reporting [Abstract] | |
SCHEDULE OF REVENUES FROM EXTERNAL CUSTOMERS | Revenues, net from external customers are attributed to geographic areas based on location of the contracting customers: SCHEDULE OF REVENUES FROM EXTERNAL CUSTOMERS Three Months Ended June 30 Six Months Ended June 30 2022 2021 2022 2021 United States $ 207 $ - $ 207 $ - Israel 126 87 221 256 China / Hong Kong 13 55 38 183 Europe - - 6 4 Total $ 346 $ 142 $ 472 $ 443 |
NATURE OF BUSINESS AND CONTIN_2
NATURE OF BUSINESS AND CONTINUATION OF BUSINESS (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | |||
Jun. 30, 2022 | Jun. 30, 2021 | Jul. 02, 2022 | Dec. 31, 2021 | |
Subsequent Event [Line Items] | ||||
Entity incorporation, date of incorporation | Apr. 09, 1965 | |||
Accumulated deficit | $ 443,259 | $ 378,371 | ||
Net cash provided by (used in) operating activities | $ 37,375 | $ 17,362 | ||
Subsequent Event [Member] | Minimum [Member] | ||||
Subsequent Event [Line Items] | ||||
Bid price | $ 1 |
SCHEDULE OF CUMULATIVE EFFECT O
SCHEDULE OF CUMULATIVE EFFECT OF CHANGES ON CONSOLIDATED BALANCE SHEETS (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Jan. 01, 2022 | Dec. 31, 2021 |
Liabilities | |||
Long-term debt, net of debt discount | $ 21,163 | $ 28,441 | |
Stockholders’ equity | |||
Additional paid-in capital | 83,757 | 81,583 | |
Accumulated deficit | $ (443,259) | (378,371) | |
Accounting Standards Update 2020-06 [Member] | |||
Liabilities | |||
Long-term debt, net of debt discount | $ 29,122 | ||
Stockholders’ equity | |||
Additional paid-in capital | 78,837 | ||
Accumulated deficit | (376,306) | ||
Accounting Standards Update 2020-06 [Member] | Previously Reported [Member] | |||
Liabilities | |||
Long-term debt, net of debt discount | 28,441 | ||
Stockholders’ equity | |||
Additional paid-in capital | 81,583 | ||
Accumulated deficit | $ (378,371) | ||
Accounting Standards Update 2020-06 [Member] | Revision of Prior Period, Adjustment [Member] | |||
Liabilities | |||
Long-term debt, net of debt discount | 681 | ||
Stockholders’ equity | |||
Additional paid-in capital | (2,746) | ||
Accumulated deficit | $ 2,065 |
SCHEDULE OF INVENTORY (Details)
SCHEDULE OF INVENTORY (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Finished goods | $ 180 | |
Work-in-process | 911 | 645 |
Raw materials | 2,959 | 1,931 |
Total | $ 4,050 | $ 2,576 |
SCHEDULE OF OTHER CURRENT ASSET
SCHEDULE OF OTHER CURRENT ASSETS (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Government receivables | $ 2,313 | $ 1,438 |
Other current assets | 2,155 | 2,195 |
Total | $ 4,468 | $ 3,633 |
SCHEDULE OF INDEFINITE LIVED IN
SCHEDULE OF INDEFINITE LIVED INTANGIBLE ASSETS INCLUDING CUMULATIVE IMPAIRMENT AND CURRENCY TRANSLATION (Details) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2022 | Dec. 31, 2021 | |
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | $ 62,169 | $ 62,169 |
Accumulated Amortization | (664) | (660) |
Cumulative Impairment Charge | (300) | (300) |
Cumulative Currency Translation | 174 | 882 |
Net Book value | 61,379 | 62,091 |
Inprocess Research and Development Assets [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | 61,500 | 61,500 |
Accumulated Amortization | ||
Cumulative Impairment Charge | (300) | (300) |
Cumulative Currency Translation | 161 | 835 |
Net Book value | 61,361 | 62,035 |
Patents [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | 669 | 669 |
Accumulated Amortization | (664) | (660) |
Cumulative Impairment Charge | ||
Cumulative Currency Translation | 13 | 47 |
Net Book value | $ 18 | $ 56 |
SCHEDULE OF GOODWILL (Details)
SCHEDULE OF GOODWILL (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Goodwill, Gross Carrying Amount | $ 8,714 | $ 8,714 |
Goodwill, Cumulative Impairment Charge | (6,292) | (6,292) |
Goodwill, Cumulative Currency Translation | (185) | (161) |
Goodwill, net | $ 2,237 | $ 2,261 |
INTANGIBLE ASSETS, NET, AND G_3
INTANGIBLE ASSETS, NET, AND GOODWILL (Details Narrative) - Inprocess Research and Development Assets [Member] $ in Thousands | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Finite-Lived Intangible Assets [Line Items] | |
Decreased in intangible assets due to foreign currency translation adjustment | $ 674 |
Decreased in goodwill due to foreign currency translation adjustment | $ 24 |
SCHEDULE OF OTHER CURRENT LIABI
SCHEDULE OF OTHER CURRENT LIABILITIES (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Other Liabilities Disclosure [Abstract] | ||
Accrued research and development expenses (including clinical trial accrued expenses) | $ 7,600 | $ 8,196 |
Accrued professional fees | 4,199 | 2,294 |
Payroll and employee-related costs | 2,377 | 4,805 |
Deferred funding | 8,639 | 10,183 |
Other current liabilities | 1,565 | 1,463 |
Total | $ 24,380 | $ 26,941 |
SCHEDULE OF ANTI-DILUTIVE WEIGH
SCHEDULE OF ANTI-DILUTIVE WEIGHTED AVERAGE SHARES OUTSTANDING (Details) - shares | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive weighted average shares outstanding | 26,033,127 | 20,860,479 |
Warrant [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive weighted average shares outstanding | 1,384,469 | 1,387,502 |
Stock Options and Restricted Stock Units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive weighted average shares outstanding | 23,278,795 | 18,103,114 |
K2 Conversion Feature [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive weighted average shares outstanding | 1,369,863 | 1,369,863 |
SCHEDULE OF LONG-TERM DEBT (Det
SCHEDULE OF LONG-TERM DEBT (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Debt Disclosure [Abstract] | ||
Long-term debt, net of debt discount of $2,281 ($3,783 at December 31, 2021) | $ 29,943 | $ 28,441 |
Less: current portion, net of debt discount of $734 ($0 at December 31, 2021) | 8,780 | |
Long-term debt, net of current portion | $ 21,163 | $ 28,441 |
SCHEDULE OF LONG-TERM DEBT (D_2
SCHEDULE OF LONG-TERM DEBT (Details) (Parenthetical) - Long-Term Debt [Member] - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Extinguishment of Debt [Line Items] | ||
Debt instrument, unamortized discount | $ 2,281 | $ 3,783 |
Debt instrument, unamortized discount, current | $ 734 | $ 0 |
SCHEDULE OF INTEREST EXPENSE (D
SCHEDULE OF INTEREST EXPENSE (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Debt Disclosure [Abstract] | ||||
Interest expense | $ 669 | $ 481 | $ 1,276 | $ 870 |
Amortization of debt discount | 411 | 401 | 821 | 2,012 |
Interest income | (179) | (37) | (256) | (225) |
Total | $ 901 | $ 845 | $ 1,841 | $ 2,657 |
SCHEDULE OF FUTURE PRINCIPAL OF
SCHEDULE OF FUTURE PRINCIPAL OF LONG-TERM DEBT (Details) $ in Thousands | Jun. 30, 2022 USD ($) |
Debt Disclosure [Abstract] | |
Remaining 2022 | |
2023 | 19,492 |
2024 | 12,732 |
Total | $ 32,224 |
LONG-TERM DEBT (Details Narrati
LONG-TERM DEBT (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | |||||
May 17, 2021 | Feb. 03, 2021 | May 22, 2020 | Mar. 31, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Debt Instrument [Line Items] | |||||||
Debt conversion, converted instrument, amount | $ 2,000 | $ 2,000 | |||||
Effective conversion price of the conversion feature | $ 1.52 | ||||||
Intrinsic value of beneficial conversion feature recorded to additional paid in capital | $ 2,577 | ||||||
Final payment | 32,224 | ||||||
Fair Value, Inputs, Level 3 [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, fair value disclosure | $ 29,977 | $ 30,406 | |||||
Restated K2 Warrant [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, unamortized discount | $ 1,721 | ||||||
Fair value adjustment of warrants | 867 | ||||||
Second Tranche [Member] | Fair Value, Inputs, Level 3 [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Final payment | 834 | ||||||
Second Tranche [Member] | Restated K2 Warrant [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt issuance costs | $ 20 | ||||||
Loan and Guaranty Agreement [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, maturity date | Jun. 01, 2024 | ||||||
Debt instrument, interest rate, stated percentage | 8.25% | ||||||
Final payment | $ 2,224 | ||||||
Loans payable | $ 30,000 | ||||||
Debt increased percentage | 5% | ||||||
Loan and Guaranty Agreement [Member] | Final Payment [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, interest rate, effective percentage | 14.09% | ||||||
Loan and Guaranty Agreement [Member] | Prime Rate [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, interest rate, stated percentage | 5% | ||||||
Loan and Guaranty Agreement [Member] | K 2 Healthventures L L C [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt conversion, converted instrument, amount | $ 4,000 | ||||||
Effective conversion price of the conversion feature | $ 1.46 | ||||||
Debt instrument, maturity date | Jun. 01, 2024 | ||||||
Purchase of warrants | 937,500 | ||||||
Debt issuance costs | $ 1,021 | ||||||
Final payment | 1,390 | ||||||
Debt instrument, unamortized discount | $ 6,169 | $ 2,281 | $ 3,783 | ||||
Loan and Guaranty Agreement [Member] | K 2 Healthventures L L C [Member] | K2 Warrant [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Purchase of warrants | 625,000 | ||||||
Exercise price of warrants | $ 1.12 | ||||||
Warrant maturity date | May 22, 2030 | ||||||
Proceeds from Warrant Exercises | $ 1,181 | ||||||
Loan and Guaranty Agreement [Member] | K 2 Healthventures L L C [Member] | Restated K2 Warrant [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Purchase of warrants | 312,500 | ||||||
Loan and Guaranty Agreement [Member] | First Tranche [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, interest rate, stated percentage | 9.75% | ||||||
Secured term loan final payment percentage | 6.95% | ||||||
Loan and Guaranty Agreement [Member] | First Tranche [Member] | K 2 Healthventures L L C [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Secured debt | $ 20,000 | ||||||
Loan and Guaranty Agreement [Member] | Second Tranche [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Secured debt | 10,000 | ||||||
Debt instrument, interest rate, stated percentage | 9.25% | ||||||
Debt issuance costs | $ 20 | ||||||
Secured term loan final payment percentage | 6.95% | ||||||
Third party cost | $ 150 | ||||||
Final payment | $ 834 | ||||||
Loan and Guaranty Agreement [Member] | Second Tranche [Member] | Prime Rate [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, interest rate, stated percentage | 4.50% | 4.50% | |||||
Loan and Guaranty Agreement [Member] | Second Tranche [Member] | Minimum [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Secured debt | $ 10,000 | ||||||
Debt instrument, date of first required payment | Jul. 01, 2022 | ||||||
Loan and Guaranty Agreement [Member] | Second Tranche [Member] | Maximum [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Secured debt | $ 12,000 | ||||||
Debt instrument, interest rate, stated percentage | 7.75% | 7.75% | |||||
Debt instrument, date of first required payment | Jan. 01, 2023 | ||||||
Loan and Guaranty Agreement [Member] | Third Tranche [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Secured debt | 10,000 | ||||||
Debt instrument interest period extended date | Jan. 01, 2023 | ||||||
Loan and Guaranty Agreement [Member] | Final Tranche [Member] | K 2 Healthventures L L C [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Secured debt | $ 10,000 | ||||||
Loan Agreement [Member] | K 2 Healthventures L L C [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt conversion, converted instrument, amount | $ 2,000 | ||||||
Effective conversion price of the conversion feature | $ 1.46 | ||||||
Debt conversion, converted instrument, shares issued | 1,369,863 | ||||||
Debt conversion, converted instrument, additional amount | $ 2,000 | ||||||
Debt instrument discount | $ 7,209 |
SCHEDULE OF STOCK OPTIONS ACTIV
SCHEDULE OF STOCK OPTIONS ACTIVITY (Details) - Equity Option [Member] | 6 Months Ended |
Jun. 30, 2022 $ / shares shares | |
Offsetting Assets [Line Items] | |
Number of Stock Options Outstanding, Beginning Balance | shares | 18,534,379 |
Weighted Average Exercise Price, Beginning Balance | $ / shares | $ 2.63 |
Number of Stock Options, Granted | shares | 4,990,000 |
Weighted Average Exercise Price, Granted | $ / shares | $ 1.53 |
Number of Stock Options, Exercised | shares | (7,221) |
Weighted Average Exercise Price, Exercised | $ / shares | $ 1.65 |
Number of Stock Options, Forfeited | shares | (257,816) |
Weighted Average Exercise Price, Forfeited | $ / shares | $ 2.72 |
Number of Stock Options Outstanding, Ending Balance | shares | 23,259,342 |
Weighted Average Exercise Price, Ending Balance | $ / shares | $ 2.39 |
Number of Stock Options, Exercisable | shares | 13,376,375 |
Weighted Average Exercise Price, Exercisable | $ / shares | $ 2.53 |
SCHEDULE OF RESTRICTED STOCK UN
SCHEDULE OF RESTRICTED STOCK UNITS (Details) - Restricted Stock Units (RSUs) [Member] | 6 Months Ended |
Jun. 30, 2022 $ / shares shares | |
Class of Stock [Line Items] | |
Number of Stock Awards, Unvested shares outstanding beginning balance | shares | 39,329 |
Weighted Average Fair Value at Grant Date, Unvested shares outstanding beginning balance | $ / shares | $ 1.47 |
Number of Stock Awards, Vested | shares | (19,876) |
Weighted Average Fair Value at Grant Date, Vested | $ / shares | $ 1.49 |
Number of Stock Awards, Unvested shares outstanding ending balance | shares | 19,453 |
Weighted Average Fair Value at Grant Date, Unvested shares outstanding ending balance | $ / shares | $ 1.46 |
SCHEDULE OF FAIR VALUE OF OPTIO
SCHEDULE OF FAIR VALUE OF OPTIONS GRANTED BY USING BLACK-SCHOLES OPTION PRICING ASSUMPTIONS (Details) - $ / shares | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Equity [Abstract] | ||
Volatility | 93.17% | 97.13% |
Risk free interest rate | 1.71% | 0.54% |
Expected term in years | 5 years 9 months 29 days | 5 years 10 months 6 days |
Expected dividend yield | 0% | 0% |
Weighted average fair value per option | $ 1.15 | $ 2.40 |
SCHEDULE OF STOCK-BASED COMPENS
SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Total stock-based compensation expense | $ 2,457 | $ 2,423 | $ 4,959 | $ 4,562 |
Research and Development [Member] | ||||
Total stock-based compensation expense | 510 | 463 | 1,020 | 891 |
General and Administrative [Member] | ||||
Total stock-based compensation expense | 1,917 | 1,937 | 3,883 | 3,627 |
Cost of Revenues [Member] | ||||
Total stock-based compensation expense | $ 30 | $ 23 | $ 56 | $ 44 |
STOCKHOLDERS_ EQUITY AND ADDI_3
STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL (Details Narrative) | 6 Months Ended |
Jun. 30, 2022 shares | |
2006 Plan [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Share-based compensation arrangement by share-based payment award, options, outstanding, number | 842,803 |
2014 Plan [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Share-based compensation arrangement by share-based payment award, options, outstanding, number | 521,242 |
2016 Plan [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Share-based compensation arrangement by share-based payment award, options, outstanding, number | 21,895,297 |
Share-based compensation arrangement by share-based, percentage | 10% |
Share-based compensation arrangement by share-based payment award, number of shares available for grant | 1,100,657 |
2016 VBI Equity Incentive Plan [Member] | Restricted Stock Units (RSUs) [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Share-based compensation arrangement by share-based payment equity options, non vested, number | 19,453 |
SCHEDULE OF REVENUE COMPRISED (
SCHEDULE OF REVENUE COMPRISED (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Disaggregation of Revenue [Line Items] | ||||
Revenues | $ 346 | $ 142 | $ 472 | $ 443 |
Product [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 331 | 71 | 422 | 238 |
Service [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | $ 15 | $ 71 | $ 50 | $ 205 |
SUMMARY OF REVENUE EXPECTED TO
SUMMARY OF REVENUE EXPECTED TO BE RECOGNIZED IN FUTURE RELATED TO PERFORMANCE OBLIGATIONS (Details) $ in Thousands | Jun. 30, 2022 USD ($) |
Disaggregation of Revenue [Line Items] | |
Revenues | $ 2,742 |
Current Portion To June Thirty Thousand Twenty Three [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | 864 |
Remaining Portion Thereafter [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | 1,878 |
Product [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | 469 |
Product [Member] | Current Portion To June Thirty Thousand Twenty Three [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | |
Product [Member] | Remaining Portion Thereafter [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | 469 |
Service [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | 2,273 |
Service [Member] | Current Portion To June Thirty Thousand Twenty Three [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | 864 |
Service [Member] | Remaining Portion Thereafter [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | $ 1,409 |
SUMMARY OF CHANGES IN DEFERRED
SUMMARY OF CHANGES IN DEFERRED REVENUE (Details) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2022 | Dec. 31, 2021 | |
Revenue from Contract with Customer [Abstract] | ||
Contract with Customer, Liability | $ 2,803 | $ 3,104 |
Currency translation | (23) | |
Contract with Customer, Liability, Revenue Recognized | (38) | |
Contract with Customer, Liability | 2,742 | 2,803 |
Contract with Customer, Liability, Current | 864 | 526 |
Contract with Customer, Liability, Noncurrent | $ 1,878 | $ 2,277 |
REVENUES, NET AND DEFERRED RE_3
REVENUES, NET AND DEFERRED REVENUE (Details Narrative) - USD ($) $ in Thousands | Dec. 04, 2018 | Jun. 30, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Disaggregation of Revenue [Line Items] | ||||
Revenue, remaining performance obligation, amount | $ 2,742 | |||
Additional potential regulatory and sales milestone payments | $ 117,500 | |||
Contract with customer, liability | 2,742 | $ 2,803 | $ 3,104 | |
License Agreement [Member] | Brii Bio [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Non-refundable upfront payment | $ 11,000 | |||
Stock issued during period, shares | 2,295,082 | |||
Stock issued during period, value | $ 3,626 | |||
Revenue, remaining performance obligation, amount | 7,374 | |||
License Agreement [Member] | Brii Bio [Member] | Research and Services [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue, remaining performance obligation, amount | 4,737 | |||
License Agreement [Member] | Brii Bio [Member] | VBI-2601 [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue, remaining performance obligation, amount | $ 2,637 | |||
Collaboration and License Agreement [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Unsatisfied amount of research and development services | 2,073 | |||
Contract with customer, liability | $ 2,742 |
COLLABORATION ARRANGEMENTS (Det
COLLABORATION ARRANGEMENTS (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 18 Months Ended | |||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Dec. 31, 2021 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Research and development expense | $ 5,643 | $ 4,582 | $ 8,005 | $ 11,421 | ||
Description of vaccine development | On March 9, 2021, the Company and CEPI announced the CEPI Funding Agreement, to develop eVLP vaccine candidates against SARS-COV-2 variants, including the Beta variant, also known as the B.1.351 variant and as 501Y.V2, first identified in South Africa. CEPI agreed to provide up to $33,018 to support the advancement of VBI-2905, a monovalent eVLP candidate expressing the pre-fusion form of the spike protein from the Beta variant strain, through Phase I clinical development. This funding will also support preclinical expansion of additional multivalent vaccine candidates designed to evaluate the potential breadth of our eVLP technology. The preclinical expansion is intended to develop clinic-ready vaccine candidates capable of addressing emerging variants. | |||||
Funding received | $ 19,327 | |||||
Deferred funding current | 8,639 | $ 8,639 | $ 8,639 | $ 10,183 | ||
Collaboration Agreement [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Research and development expense | 111 | 135 | ||||
Collaboration Agreement [Member] | Glaxo Smith Kline Biologicals S. A. [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Research and development expense | 4 | 70 | 139 | 326 | ||
Collaboration Agreement [Member] | National Research Council of Canada [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Research and development expense | 304 | 56 | 584 | 229 | ||
CEPI Funding Agreement [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Research and development expense | $ 713 | $ 2,048 | $ 2,406 | $ 2,207 |
GOVERNMENT GRANTS (Details Narr
GOVERNMENT GRANTS (Details Narrative) $ in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Sep. 16, 2020 CAD ($) | Jul. 03, 2020 CAD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | |
Industrial Research Assistance Program [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Estimated contribution on transfer and scaleup of technical production process | $ 1,000 | |||||
Reduction expenses | $ 0 | $ 0 | ||||
Deferred government grants | 43 | 43 | ||||
Strategic Innovation Fund [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Reduction expenses | 499 | $ 1,324 | 1,952 | $ 4,012 | ||
Deferred government grants | $ 760 | $ 760 | ||||
Estimated contribution on development of uncertain event program | $ 55,976 |
SUMMARY OF LEASE COST AND OTHER
SUMMARY OF LEASE COST AND OTHER INFORMATION (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Operating lease costs | $ 451 | $ 340 | $ 895 | $ 683 |
Operating lease, weighted average remaining lease term | 3 years 2 months 23 days | 3 years 2 months 23 days | ||
Operating lease, weighted average discount rate, percent | 12% | 12% |
SCHEDULE OF FUTURE UNDISCOUNTED
SCHEDULE OF FUTURE UNDISCOUNTED CASH PAYMENTS RECONCILED TO LEASE LIABILITIES (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Commitments and Contingencies Disclosure [Abstract] | ||
Remaining 2022 | $ 648 | |
2023 | 1,176 | |
2024 | 1,064 | |
2025 | 575 | |
2026 | 574 | |
2027 | 169 | |
Total | 4,206 | |
Effect of discounting | (808) | |
Total lease liability | 3,398 | |
Less: current portion | 891 | $ 839 |
Lease liability, net of current portion | $ 2,507 | $ 2,516 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details Narrative) ₪ in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Sep. 13, 2018 USD ($) | Sep. 13, 2018 ILS (₪) | Jun. 30, 2022 USD ($) | Jun. 30, 2022 USD ($) | |
Lease Agreement [Member] | ||||
Product Liability Contingency [Line Items] | ||||
Recognized right of use asset | $ 0 | $ 795 | ||
UNITED STATES | Office Facility Lease Agreement [Member] | ||||
Product Liability Contingency [Line Items] | ||||
Lease expiration date | Oct. 31, 2024 | |||
ISRAEL | Manufacturing Facility Lease Agreement [Member] | ||||
Product Liability Contingency [Line Items] | ||||
Lessee, operating lease, option to extend | Our manufacturing facility lease agreement in Israel has been extended for 5 years with a term now ending January 31, 2027 | |||
CANADA | Lease Agreement [Member] | ||||
Product Liability Contingency [Line Items] | ||||
Lessee, operating lease, option to extend | The lease agreement for our research facility in Canada, which comprises office and laboratory space, has a term ending on December 31, 2022 with an option to extend the term for one additional period of three years. A lease for additional office space at our research facility commenced on October 1, 2020 with a term ending April 30, 2023. | |||
Sci B Vac [Member] | ||||
Product Liability Contingency [Line Items] | ||||
Damages total amount | $ 537,000 | ₪ 1,879,500 |
SCHEDULE OF REVENUES FROM EXTER
SCHEDULE OF REVENUES FROM EXTERNAL CUSTOMERS (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Revenues | $ 346 | $ 142 | $ 472 | $ 443 |
UNITED STATES | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Revenues | 207 | 207 | ||
ISRAEL | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Revenues | 126 | 87 | 221 | 256 |
China / Hong Kong [Member] | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Revenues | 13 | 55 | 38 | 183 |
Europe [Member] | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Revenues | $ 6 | $ 4 |
SEGMENT INFORMATION (Details Na
SEGMENT INFORMATION (Details Narrative) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Jun. 30, 2022 USD ($) Segment | Jun. 30, 2021 USD ($) | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Number of operating segments | Segment | 1 | |||
Revenue | $ 346 | $ 142 | $ 472 | $ 443 |
CANADA | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Revenue | $ 0 | $ 0 |
SUBSEQUENT EVENTS (Details Narr
SUBSEQUENT EVENTS (Details Narrative) - Subsequent Event [Member] - New Employees [Member] - 2016 Plan [Member] - shares | 1 Months Ended | |
Aug. 08, 2022 | Aug. 08, 2022 | |
Subsequent Event [Line Items] | ||
Options granted | 150,000 | |
Options, description and terms | Options granted will vest 25% on the one-year anniversary of the grant date, with the remaining 75% vesting on a monthly basis over the subsequent 24 months. All options granted automatically expire 10 years from the date of issuance. |