Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 10, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2022 | |
Document Fiscal Period Focus | Q3 | |
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 | Sep. 30, 2022 | Dec. 31, 2021 |
CURRENT ASSETS | ||
Cash | $ 83,550 | $ 121,694 |
Accounts receivable, net | 132 | 8 |
Inventory, net | 5,796 | 2,576 |
Prepaid expenses | 2,730 | 2,373 |
Other current assets | 4,008 | 3,633 |
Total current assets | 96,216 | 130,284 |
NON-CURRENT ASSETS | ||
Other long-term assets | 1,349 | 1,259 |
Property and equipment, net | 11,149 | 11,037 |
Right of use assets | 3,465 | 3,344 |
Intangible assets, net | 57,727 | 62,091 |
Goodwill | 2,104 | 2,261 |
Total non-current assets | 75,794 | 79,992 |
TOTAL ASSETS | 172,010 | 210,276 |
CURRENT LIABILITIES | ||
Accounts payable | 11,666 | 4,280 |
Other current liabilities | 21,504 | 26,941 |
Current portion of deferred revenues | 597 | 526 |
Current portion of lease liability | 914 | 839 |
Total current liabilities | 34,681 | 32,586 |
NON-CURRENT LIABILITIES | ||
Deferred revenues, net of current portion | 2,004 | 2,277 |
Long-term debt, net of debt discount | 48,418 | 28,441 |
Lease liability, net of current portion | 2,571 | 2,516 |
Liabilities for severance pay | 519 | 574 |
Total non-current liabilities | 53,512 | 33,808 |
COMMITMENTS AND CONTINGENCIES (NOTE 14) | ||
STOCKHOLDERS’ EQUITY | ||
Common shares (unlimited authorized; no par value) (September 30, 2022 - issued and outstanding 258,257,494; December 31, 2021 - issued and outstanding 258,250,273) | 442,300 | 442,235 |
Additional paid-in capital | 87,705 | 81,583 |
Accumulated other comprehensive income (loss) | 22,280 | (1,565) |
Accumulated deficit | (468,468) | (378,371) |
Total stockholders’ equity | 83,817 | 143,882 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 172,010 | $ 210,276 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 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 | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Income Statement [Abstract] | ||||
Revenues, net | $ 317 | $ 107 | $ 789 | $ 550 |
Operating expenses: | ||||
Cost of revenues | 2,672 | 2,466 | 7,948 | 7,511 |
Research and development | 4,983 | 2,972 | 12,988 | 14,392 |
General and administrative | 14,220 | 9,693 | 40,234 | 25,807 |
Total operating expenses | 21,875 | 15,131 | 61,170 | 47,710 |
Loss from operations | (21,558) | (15,024) | (60,381) | (47,160) |
Interest expense, net of interest income | (958) | (1,026) | (2,799) | (3,683) |
Foreign exchange (loss) gain | (2,693) | 203 | (28,982) | (127) |
Loss before income taxes | (25,209) | (15,847) | (92,162) | (50,970) |
Income tax expense | ||||
NET LOSS | (25,209) | (15,847) | (92,162) | (50,970) |
Other comprehensive (loss) income | (494) | (1,607) | 23,845 | 106 |
COMPREHENSIVE LOSS | $ (25,703) | $ (17,454) | $ (68,317) | $ (50,864) |
Net loss per share of common shares, basic and diluted | $ (0.10) | $ (0.06) | $ (0.36) | $ (0.20) |
Weighted-average number of common shares outstanding, basic and diluted | 258,257,494 | 256,360,356 | 258,257,229 | 254,055,707 |
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 | (50,970) | ||||
Common shares issued upon of conversion of long-term debt | 2,000 | ||||
Ending balance, value at Sep. 30, 2021 | $ 439,286 | 79,075 | 1,371 | (359,588) | 160,144 |
Ending balance, shares at Sep. 30, 2021 | 257,304,768 | ||||
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 | |||
Warrant modification in connection with debt amendment | 867 | 867 | |||
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 | ||||
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 | ||||
Stock-based compensation | $ 32 | 2,497 | 2,529 | ||
Net loss | (15,847) | (15,847) | |||
Currency translation adjustments | (1,607) | (1,607) | |||
Common shares issued in financing transactions, net of share issuance costs | $ 6,982 | 6,982 | |||
Common shares issued in financing transaction, net of issuance costs, shares | 2,156,597 | ||||
Common shares issued upon exercise of warrants | $ 4 | 4 | |||
Common shares issued upon exercise of warrants, shares | 3,033 | ||||
Ending balance, value at Sep. 30, 2021 | $ 439,286 | 79,075 | 1,371 | (359,588) | 160,144 |
Ending balance, shares at Sep. 30, 2021 | 257,304,768 | ||||
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 | (92,162) | ||||
Common shares issued upon of conversion of long-term debt | |||||
Ending balance, value at Sep. 30, 2022 | $ 442,300 | 87,705 | 22,280 | (468,468) | 83,817 |
Ending balance, shares at Sep. 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 | ||||
Stock-based compensation | $ 14 | 2,398 | 2,412 | ||
Net loss | (25,209) | (25,209) | |||
Currency translation adjustments | (494) | (494) | |||
Warrant modification in connection with debt amendment | 1,550 | 1,550 | |||
Ending balance, value at Sep. 30, 2022 | $ 442,300 | $ 87,705 | $ 22,280 | $ (468,468) | $ 83,817 |
Ending balance, shares at Sep. 30, 2022 | 258,257,494 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (92,162) | $ (50,970) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1,541 | 1,366 |
Stock-based compensation | 7,371 | 7,091 |
Amortization of debt discount | 1,237 | 2,499 |
Loss on extinguishment of long-term debt | 172 | |
Inventory reserve | 1,401 | 1,056 |
Unrealized foreign exchange loss | 28,410 | |
Net change in operating working capital items: | ||
Change in accounts receivable | (127) | 40 |
Change in inventory | (5,174) | (1,178) |
Change in prepaid expenses | (407) | (1,477) |
Change in other current assets | (667) | 4,182 |
Change in other long-term assets | (174) | (448) |
Change in operating right of use assets | 1,010 | 768 |
Change in accounts payable | 7,606 | 10 |
Change in deferred revenues | 30 | (244) |
Change in other current liabilities | (3,715) | 16,710 |
Payments made on operating lease liabilities | (1,001) | (797) |
Net cash flows used in operating activities | (54,649) | (21,392) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Redemption of short-term investments | 25,151 | |
Purchase of property and equipment | (2,892) | (1,385) |
Net cash flows (used in) provided by in investing activities | (2,892) | 23,766 |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Proceeds from issuance of common shares for cash | 30,275 | |
Share issuance costs | (937) | |
Proceeds from debt financing | 20,000 | 12,000 |
Debt issuance costs | (563) | (22) |
Proceeds from issuance of common shares for cash, upon exercise of warrants | 85 | |
Proceeds from issuance of common shares for cash, upon exercise of options | 12 | |
Net cash flows provided by financing activities | 19,449 | 41,401 |
Effect of exchange rates on cash | (52) | (130) |
CHANGE IN CASH FOR THE PERIOD | (38,144) | 43,645 |
CASH, BEGINNING OF PERIOD | 121,694 | 93,825 |
CASH, END OF PERIOD | 83,550 | 137,470 |
Supplementary information: | ||
Interest paid | 2,067 | 1,428 |
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 | |
Warrant issued in connection with debt amendment | 1,550 | |
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 | 283 | 73 |
Share issuance costs included in other current liabilities | $ 67 | $ 78 |
NATURE OF BUSINESS AND CONTINUA
NATURE OF BUSINESS AND CONTINUATION OF BUSINESS | 9 Months Ended |
Sep. 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 COVID-19 pandemic has materially negatively affected the global economy, and the ongoing effects of the COVID-19 pandemic, including but not limited to, supply chain issues, global shortages of supplies, materials and products, volatile market conditions and rising global inflation, continue to do so. As a result of the COVID-19 pandemic, the Company’s business and results of operations were adversely affected and, as the ongoing effects of the COVID-19 pandemic continue to impact the global economy, may continue to adversely affect our business and results of operations. The extent to which the effects of 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 effects of 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 $ 468,468 54,649 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 September 30, 2022, we did not meet the minimum bid price of $1.00 per share required for continued listing on NASDAQ pursuant to NASDAQ Listing Rule 5550(a)(2). The letter also indicated that we will be provided with a compliance period of 180 calendar days, or until December 28, 2022 (the “Compliance Period”), in which to regain compliance pursuant to NASDAQ Listing Rule 5810(c)(3)(A). 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 On August 26, 2022, the Company 1) filed a registration statement for a base prospectus which covers the offering, issuance and sale of up to $ 300,000 125,000 125,000 27,022 125,000 In September 2022, the Company refinanced its existing term loan facility with K2 HealthVentures LLC (“K2”) to increase the amount of term loans available to $ 100,000 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. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 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 nine months ended September 30, 2022, other than the polices discussed below. |
NEW ACCOUNTING PRONOUNCEMENTS
NEW ACCOUNTING PRONOUNCEMENTS | 9 Months Ended |
Sep. 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 | 9 Months Ended |
Sep. 30, 2022 | |
Inventory Disclosure [Abstract] | |
INVENTORY, NET | 4. INVENTORY, NET Inventory consists of the following: SCHEDULE OF INVENTORY September 30, 2022 December 31, Finished goods $ 774 $ - Work-in-process 1,074 645 Raw materials 3,948 1,931 Total $ 5,796 $ 2,576 |
OTHER CURRENT ASSETS
OTHER CURRENT ASSETS | 9 Months Ended |
Sep. 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 September 30, 2022 December 31, Government receivables $ 2,350 $ 1,438 Other current assets 1,658 2,195 Total $ 4,008 $ 3,633 |
INTANGIBLE ASSETS, NET, AND GOO
INTANGIBLE ASSETS, NET, AND GOODWILL | 9 Months Ended |
Sep. 30, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
INTANGIBLE ASSETS, NET, AND GOODWILL | 6. INTANGIBLE ASSETS, NET, AND GOODWILL The Company’s intangible assets determined to have indefinite useful lives including In-Process Research and Development (“IPR&D”) and goodwill, are tested for impairment annually, or more frequently if events or circumstances indicate that the assets might be impaired. Such circumstances could include but are not limited to: (1) a significant adverse change in legal factors or in business climate, (2) unanticipated competition, or (3) an adverse action or assessment by a regulator. The Company has established August 31st as the date for its annual impairment test of IPR&D and goodwill. The costs of rights to IPR&D projects acquired in an asset acquisition are expensed in the consolidated statements of operations unless the project has an alternative future use. These costs include initial payments incurred prior to regulatory approval in connection with research and development agreements that provide rights to develop, manufacture, market and/or sell pharmaceutical products. The IPR&D assets, which consist of the CMV and GBM programs, were acquired in a business combination, capitalized as an intangible asset and are tested for impairment at least annually until commercialization, after which time the IPR&D will be amortized over its estimated useful life. The impairment test compares the carrying amount of the IPR&D asset to its fair value. If the carrying amount exceeds the fair value of the asset, such excess is recorded as an impairment loss. There was no IPR&D impairment as a result of the Company’s annual testing on August 31, 2022. The fair value of the IPR&D assets included in the impairment test was determined using the income approach method and is considered Level 3 in the fair value hierarchy. Some of the more significant estimates and assumptions inherent in the estimate of the fair value of IPR&D assets including: 1) the amount and timing of costs to develop the IPR&D into viable products; 2) the amount and timing of future cash inflows; 3) the discount rate; and 4) the probability of technical and regulatory success. The discount rate used was 12% and the cumulative probability of technical and regulatory success to achieve approval to market the products ranged from approximately 10% to 17% . The fair value of our CMV asset was in excess of its carrying value by approximately 25 SCHEDULE OF INDEFINITE LIVED INTANGIBLE ASSETS INCLUDING CUMULATIVE IMPAIRMENT AND CURRENCY TRANSLATION September 30, 2022 Gross Carrying Amount Accumulated Amortization Cumulative Impairment Charge Cumulative Currency Translation Net Book Value Patents $ 669 $ (669 ) $ - $ 3 $ 3 IPR&D assets 61,500 - (300 ) (3,476 ) 57,724 $ 62,169 $ (669 ) $ (300 ) $ (3,473 ) $ 57,727 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 $ 4,311 Goodwill represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired in a business combination. When evaluating goodwill for impairment, we may first perform an assessment qualitatively whether it is more likely than not that a reporting unit’s carrying amount exceeds its fair value, referred to as a “step zero” approach. Subsequently (if necessary, after step zero), if the carrying value of a reporting unit exceeded its fair value an impairment would be recorded. We would perform our goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. There was no goodwill impairment determined as a result of the Company’s annual testing on August 31, 2022. The fair value of the Company, which consists of a single reporting unit, included in the impairment test was determined using the closing market stock price of VBI as of August 31, 2022. SCHEDULE OF GOODWILL September 30, 2022 Gross Carrying Amount Cumulative Impairment Charge Cumulative Currency Translation Net Book Value Goodwill $ 8,714 $ (6,292 ) $ (318 ) $ 2,104 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 $ 157 |
OTHER CURRENT LIABILITIES
OTHER CURRENT LIABILITIES | 9 Months Ended |
Sep. 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 September 30, 2022 December 31, Accrued research and development expenses (including clinical trial accrued expenses) $ 7,224 $ 8,196 Accrued professional fees 2,970 2,294 Payroll and employee-related costs 2,392 4,805 Deferred funding 7,479 10,183 Other current liabilities 1,439 1,463 Total $ 21,504 $ 26,941 |
LOSS PER SHARE OF COMMON SHARES
LOSS PER SHARE OF COMMON SHARES | 9 Months Ended |
Sep. 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 September 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 September 30, 2022 September 30, 2021 Warrants 3,564,882 1,384,469 Stock options and restricted stock units 23,102,475 18,409,572 K2 conversion feature 6,161,889 1,369,863 Total 32,829,246 21,163,904 |
LONG-TERM DEBT
LONG-TERM DEBT | 9 Months Ended |
Sep. 30, 2022 | |
Long-term Debt | |
LONG-TERM DEBT | 9. LONG-TERM DEBT As of September 30, 2022, and December 31, 2021, the long-term debt is as follows: SCHEDULE OF LONG-TERM DEBT September 30, 2022 December 31, Long-term debt, net of debt discount of $ 7,281 3,783 $ 48,418 $ 28,441 Less: current portion - - Long-term debt, net of current portion $ 48,418 $ 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 and any other lender from time-to-time party thereto (the “Lenders”). On May 22, 2020, the Lenders advanced the first tranche of term loans of $ 20,000 . Pursuant to the Loan Agreement, the Lenders originally had the ability to convert, at the Lenders’ option, up to $ 4,000 of the secured term loan into common shares of the Company at a conversion price of $ 1.46 per share until the original maturity date of June 1, 2024 . On February 3, 2021, pursuant to the Loan Agreement, the Lenders, converted $ 2,000 of the secured term loan into 1,369,863 common shares at a conversion price of $ 1.46 per share. On May 17, 2021, the Company entered into the First Amendment to the Loan and Guaranty Agreement (“First Amendment”) with the Lenders and received additional loan advances of $ 12,000 On September 14, 2022, the Company entered into the Second Amendment to the Loan Agreement (the “Second Amendment”) with the Lenders to: (i) increase the amount of the term loans available under the Loan Agreement to $ 100,000 50,000 On September 15, 2022, the Lenders advanced to the Borrowers the Restatement First Tranche Term Loan (as defined in the Second Amendment) in an aggregate amount of $ 50,000 30,000 15,000 10,000 25,000 Pursuant to the Second Amendment, the Lenders have the ability to convert $ 7,000 2,000 1,369,863 1.46 5,000 4,792,026 1.0434 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 in connection with the Second Amendment and the advance of the first tranche of term loans of $ 50,000 2,180,413 0.8026 50,000 2,180,413 The Company is required to make a final payment equal to 6.95 30,000 2,224 Upon receipt of additional funds, issuable pursuant to the second, third and fourth tranches, under the Second Amendment, additional common shares will be issuable pursuant to the Second Amendment Warrant as determined by the principal amount of the second tranche, third tranche and fourth tranche actually funded multiplied by 3.5% and divided by the warrant exercise price of $ 0.8026 6.95 The Company accounted for the Second Amendment as a debt extinguishment and resulted in an extinguishment loss of $ 172 48,340 7,359 1,550 563 The total principal amount of the loan under the Loan Agreement as amended by the Second Amendment, outstanding at September 30, 2022, including the Original Final Payment of $ 2,224 3,475 55,699 8.00 4.00 10.25 50,000 13.63 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 September 14, 2026 The obligations under the Loan Agreement as amended by the Second 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, 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 Second Amendment is $ 7,359 7,281 3,783 At September 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 $ 47,080 30,406 Interest expense, net of interest income recorded in the three and nine months ended September 30, 2022 and 2021 was as follows: SCHEDULE OF INTEREST EXPENSE 2022 2021 2022 2021 Three months ended September 30 Nine months ended September 30 2022 2021 2022 2021 Interest expense $ 856 $ 618 $ 2,132 $ 1,488 Amortization of debt discount 416 487 1,237 2,499 Extinguishment loss 172 - 172 - Interest income (486 ) (79 ) (742 ) (304 ) Total $ 958 $ 1,026 $ 2,799 $ 3,683 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 - 2024 2,224 2025 - 2026 53,475 Total $ 55,699 |
STOCKHOLDERS_ EQUITY AND ADDITI
STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL | 9 Months Ended |
Sep. 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 September 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 September 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 21,727,860 10,570 The aggregate number of common shares remaining available for issuance for awards under the 2016 Plan totaled 1,268,789 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 5,140,000 1.51 Exercised (7,221 ) 1.65 Forfeited (575,253 ) 2.28 Balance outstanding at September 30, 2022 23,091,905 $ 2.38 Exercisable at September 30, 2022 14,536,140 $ 2.52 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 Forfeited (695 ) 1.46 Vested (28,064 ) 1.48 Unvested shares outstanding at September 30, 2022 10,570 $ 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 93.23 % 96.99 % Risk free interest rate 1.75 % 0.57 % Expected term in years 5.83 5.84 Expected dividend yield 0.00 % 0.00 % Weighted average fair value per option $ 1.13 $ 2.41 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 nine months ended September 30, 2022 and 2021 was as follows: SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE Three months ended September 30 Nine months ended September 30 2022 2021 2022 2021 Research and development $ 514 $ 476 $ 1,534 $ 1,368 General and administrative 1,868 2,029 5,751 5,656 Cost of revenues 30 24 86 67 Total stock-based compensation expense $ 2,412 $ 2,529 $ 7,371 $ 7,091 |
REVENUES, NET AND DEFERRED REVE
REVENUES, NET AND DEFERRED REVENUE | 9 Months Ended |
Sep. 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 September 30 Nine months ended September 30 2022 2021 2022 2021 Product revenues, net $ 258 $ 24 $ 680 $ 262 R&D service revenues 59 83 109 288 Total revenues, net $ 317 $ 107 $ 789 $ 550 The following table presents revenues expected to be recognized in the future related to performance obligations, based on current estimates, that are unsatisfied at September 30, 2022: SUMMARY OF REVENUE EXPECTED TO BE RECOGNIZED IN FUTURE RELATED TO PERFORMANCE OBLIGATIONS Total Current portion to September 30, 2023 Remaining portion thereafter Product revenues, net $ 469 $ - $ 469 R&D service revenues 2,132 597 1,535 Total revenues, net $ 2,601 $ 597 $ 2,004 The following table presents changes in the deferred revenue balance for the nine months ended September 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 (57) Currency translation (145) Balance at September 30, 2022 $ 2,601 Short Term $ 597 Long Term $ 2,004 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 License Agreement”) 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 License Agreement. 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 License Agreement. 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 September 30, 2022, R&D services related to Brii Bio that remain unsatisfied are $ 1,932 2,601 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 | 9 Months Ended |
Sep. 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 nine months ended September 30, 2022 are $ 0 139 48 374 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 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 December 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 nine months ended September 30, 2022 are $ 118 and $ 702 712 and $ 942 , respectively. Coalition for Epidemic Preparedness Innovations (“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. 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 nine months ended September 30, 2022 are $ 692 3,098 2,711 $4,918 19,327 7,479 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 License Agreement 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 nine months ended September 30, 2022, were $ 56 191 |
GOVERNMENT GRANTS
GOVERNMENT GRANTS | 9 Months Ended |
Sep. 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 nine months ended September 30, 2022 the Company recognized $ 0 0 41 For the three and nine months ended September 30, 2021, the Company recognized $ 68 68 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 nine months ended September 30, 2022, the Company recognized $ 1,831 3,783 716 For the three and nine months ended September 30, 2021, the Company recognized $ 2,365 6,377 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Sep. 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 1,879,500 530,483 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. In September 2022, we decided to extend the term of our lease for our research facility in Canada for three additional years, which now has a term ending on December 31, 2025 During the three and nine months ended September 30, 2022, the Company entered into new lease agreements and recognized a ROU asset of $ 339 1,134 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 September 30, 2022 $ 489 Nine months ended September 30, 2022 1,383 Three months ended September 30, 2021 385 Nine months ended September 30, 2021 1,069 Other information: Weighted average remaining lease term 3.27 Weighted average discount rate 13 % 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 $ 321 2023 1,295 2024 1,196 2025 710 2026 614 2027 167 Total $ 4,303 Effect of discounting (818 ) Total lease liability $ 3,485 Less: current portion 914 Lease liability, net of current portion $ 2,571 |
SEGMENT INFORMATION
SEGMENT INFORMATION | 9 Months Ended |
Sep. 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 operating segment. 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 September 30 Nine Months Ended September 30 2022 2021 2022 2021 United States $ 238 $ - $ 444 $ - Israel 60 44 281 300 China / Hong Kong 19 63 58 246 Europe - - 6 4 Total $ 317 $ 107 $ 789 $ 550 There was no |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 9 Months Ended |
Sep. 30, 2022 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | 16. SUBSEQUENT EVENTS On October 18, 2022, the Company, Ferring International Center S.A., a company incorporated pursuant to the laws of Switzerland and SciVac, a wholly owned subsidiary of the Company, amended and restated that certain license agreement, dated as of June 3, 2004 and amended by the parties on each of January 24, 2005, March 15, 2005, June 15, 2005 and February 14, 2012 (the “Amended and Restated Ferring License Agreement”). The Amended and Restated Ferring License Agreement amends and restates certain of the terms relating to the manufacture and marketing of HBsAg products, which includes, among others, updates to the definition of net sales, and a reduction in the fixed royalty rate on net sales of HBsAg products from seven percent (7%) to three and a half percent (3.5%) in consideration for the grant of the license to utilize genetically engineered CHO cells encoding the hepatitis B antigen and certain information related to the manufacture of hepatitis B vaccines (collectively, the “Technology”). In October 2022, the Company received notice from the U.S. Food and Drug Administration (the “FDA”) that we qualified as a small business and that the Prescription Drug User Fee Act program application fee of $ 2,876 |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 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 nine months ended September 30, 2022, other than the polices discussed below. |
NEW ACCOUNTING PRONOUNCEMENTS (
NEW ACCOUNTING PRONOUNCEMENTS (Tables) | 9 Months Ended |
Sep. 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) | 9 Months Ended |
Sep. 30, 2022 | |
Inventory Disclosure [Abstract] | |
SCHEDULE OF INVENTORY | Inventory consists of the following: SCHEDULE OF INVENTORY September 30, 2022 December 31, Finished goods $ 774 $ - Work-in-process 1,074 645 Raw materials 3,948 1,931 Total $ 5,796 $ 2,576 |
OTHER CURRENT ASSETS (Tables)
OTHER CURRENT ASSETS (Tables) | 9 Months Ended |
Sep. 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 September 30, 2022 December 31, Government receivables $ 2,350 $ 1,438 Other current assets 1,658 2,195 Total $ 4,008 $ 3,633 |
INTANGIBLE ASSETS, NET, AND G_2
INTANGIBLE ASSETS, NET, AND GOODWILL (Tables) | 9 Months Ended |
Sep. 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 September 30, 2022 Gross Carrying Amount Accumulated Amortization Cumulative Impairment Charge Cumulative Currency Translation Net Book Value Patents $ 669 $ (669 ) $ - $ 3 $ 3 IPR&D assets 61,500 - (300 ) (3,476 ) 57,724 $ 62,169 $ (669 ) $ (300 ) $ (3,473 ) $ 57,727 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 September 30, 2022 Gross Carrying Amount Cumulative Impairment Charge Cumulative Currency Translation Net Book Value Goodwill $ 8,714 $ (6,292 ) $ (318 ) $ 2,104 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) | 9 Months Ended |
Sep. 30, 2022 | |
Other Liabilities Disclosure [Abstract] | |
SCHEDULE OF OTHER CURRENT LIABILITIES | Other current liabilities consisted of the following: SCHEDULE OF OTHER CURRENT LIABILITIES September 30, 2022 December 31, Accrued research and development expenses (including clinical trial accrued expenses) $ 7,224 $ 8,196 Accrued professional fees 2,970 2,294 Payroll and employee-related costs 2,392 4,805 Deferred funding 7,479 10,183 Other current liabilities 1,439 1,463 Total $ 21,504 $ 26,941 |
LOSS PER SHARE OF COMMON SHAR_2
LOSS PER SHARE OF COMMON SHARES (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
SCHEDULE OF ANTI-DILUTIVE WEIGHTED AVERAGE SHARES OUTSTANDING | The following potentially dilutive securities outstanding at September 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 September 30, 2022 September 30, 2021 Warrants 3,564,882 1,384,469 Stock options and restricted stock units 23,102,475 18,409,572 K2 conversion feature 6,161,889 1,369,863 Total 32,829,246 21,163,904 |
LONG-TERM DEBT (Tables)
LONG-TERM DEBT (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Long-term Debt | |
SCHEDULE OF LONG-TERM DEBT | As of September 30, 2022, and December 31, 2021, the long-term debt is as follows: SCHEDULE OF LONG-TERM DEBT September 30, 2022 December 31, Long-term debt, net of debt discount of $ 7,281 3,783 $ 48,418 $ 28,441 Less: current portion - - Long-term debt, net of current portion $ 48,418 $ 28,441 |
SCHEDULE OF INTEREST EXPENSE | Interest expense, net of interest income recorded in the three and nine months ended September 30, 2022 and 2021 was as follows: SCHEDULE OF INTEREST EXPENSE 2022 2021 2022 2021 Three months ended September 30 Nine months ended September 30 2022 2021 2022 2021 Interest expense $ 856 $ 618 $ 2,132 $ 1,488 Amortization of debt discount 416 487 1,237 2,499 Extinguishment loss 172 - 172 - Interest income (486 ) (79 ) (742 ) (304 ) Total $ 958 $ 1,026 $ 2,799 $ 3,683 |
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 - 2024 2,224 2025 - 2026 53,475 Total $ 55,699 |
STOCKHOLDERS_ EQUITY AND ADDI_2
STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL (Tables) | 9 Months Ended |
Sep. 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 5,140,000 1.51 Exercised (7,221 ) 1.65 Forfeited (575,253 ) 2.28 Balance outstanding at September 30, 2022 23,091,905 $ 2.38 Exercisable at September 30, 2022 14,536,140 $ 2.52 |
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 Forfeited (695 ) 1.46 Vested (28,064 ) 1.48 Unvested shares outstanding at September 30, 2022 10,570 $ 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 93.23 % 96.99 % Risk free interest rate 1.75 % 0.57 % Expected term in years 5.83 5.84 Expected dividend yield 0.00 % 0.00 % Weighted average fair value per option $ 1.13 $ 2.41 |
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 nine months ended September 30, 2022 and 2021 was as follows: SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE Three months ended September 30 Nine months ended September 30 2022 2021 2022 2021 Research and development $ 514 $ 476 $ 1,534 $ 1,368 General and administrative 1,868 2,029 5,751 5,656 Cost of revenues 30 24 86 67 Total stock-based compensation expense $ 2,412 $ 2,529 $ 7,371 $ 7,091 |
REVENUES, NET AND DEFERRED RE_2
REVENUES, NET AND DEFERRED REVENUE (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
SCHEDULE OF REVENUE COMPRISED | Revenues, net comprises the following: SCHEDULE OF REVENUE COMPRISED Three months ended September 30 Nine months ended September 30 2022 2021 2022 2021 Product revenues, net $ 258 $ 24 $ 680 $ 262 R&D service revenues 59 83 109 288 Total revenues, net $ 317 $ 107 $ 789 $ 550 |
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 September 30, 2022: SUMMARY OF REVENUE EXPECTED TO BE RECOGNIZED IN FUTURE RELATED TO PERFORMANCE OBLIGATIONS Total Current portion to September 30, 2023 Remaining portion thereafter Product revenues, net $ 469 $ - $ 469 R&D service revenues 2,132 597 1,535 Total revenues, net $ 2,601 $ 597 $ 2,004 |
SUMMARY OF CHANGES IN DEFERRED REVENUE | The following table presents changes in the deferred revenue balance for the nine months ended September 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 (57) Currency translation (145) Balance at September 30, 2022 $ 2,601 Short Term $ 597 Long Term $ 2,004 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 9 Months Ended |
Sep. 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 September 30, 2022 $ 489 Nine months ended September 30, 2022 1,383 Three months ended September 30, 2021 385 Nine months ended September 30, 2021 1,069 Other information: Weighted average remaining lease term 3.27 Weighted average discount rate 13 % |
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 $ 321 2023 1,295 2024 1,196 2025 710 2026 614 2027 167 Total $ 4,303 Effect of discounting (818 ) Total lease liability $ 3,485 Less: current portion 914 Lease liability, net of current portion $ 2,571 |
SEGMENT INFORMATION (Tables)
SEGMENT INFORMATION (Tables) | 9 Months Ended |
Sep. 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 September 30 Nine Months Ended September 30 2022 2021 2022 2021 United States $ 238 $ - $ 444 $ - Israel 60 44 281 300 China / Hong Kong 19 63 58 246 Europe - - 6 4 Total $ 317 $ 107 $ 789 $ 550 There was no |
NATURE OF BUSINESS AND CONTIN_2
NATURE OF BUSINESS AND CONTINUATION OF BUSINESS (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended | 13 Months Ended | 25 Months Ended | ||||
Aug. 26, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Aug. 26, 2022 | Sep. 03, 2021 | Aug. 26, 2022 | Jul. 02, 2022 | Dec. 31, 2021 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Entity incorporation, date of incorporation | Apr. 09, 1965 | |||||||
Accumulated deficit | $ 468,468 | $ 378,371 | ||||||
Net cash provided by (used in) operating activities | 54,649 | $ 21,392 | ||||||
K2 Healthventures LLC [Member] | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Increase amount of term loans available | $ 100,000 | |||||||
First ATM Program [Member] | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Original share value related to ATM Program | $ 125,000 | |||||||
Open Market Sale Agreement [Member] | First At The Market [Member] | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Share value remaining, available for sale | $ 27,022 | |||||||
Second ATM Program [Member] | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Share value remaining, available for sale | $ 125,000 | |||||||
Minimum [Member] | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Bid price | $ 1 | |||||||
Maximum [Member] | Base Prospectus [Member] | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Issuance and sale of common shares | $ 300,000 | |||||||
Maximum [Member] | Current ATM Program [Member] | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Share value remaining, available for sale | $ 125,000 |
SCHEDULE OF CUMULATIVE EFFECT O
SCHEDULE OF CUMULATIVE EFFECT OF CHANGES ON CONSOLIDATED BALANCE SHEETS (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Jan. 01, 2022 | Dec. 31, 2021 |
Liabilities | |||
Long-term debt, net of debt discount | $ 48,418 | $ 28,441 | |
Stockholders’ equity | |||
Additional paid-in capital | 87,705 | 81,583 | |
Accumulated deficit | $ (468,468) | (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 | Sep. 30, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Finished goods | $ 774 | |
Work-in-process | 1,074 | 645 |
Raw materials | 3,948 | 1,931 |
Total | $ 5,796 | $ 2,576 |
SCHEDULE OF OTHER CURRENT ASSET
SCHEDULE OF OTHER CURRENT ASSETS (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Government receivables | $ 2,350 | $ 1,438 |
Other current assets | 1,658 | 2,195 |
Total | $ 4,008 | $ 3,633 |
SCHEDULE OF INDEFINITE LIVED IN
SCHEDULE OF INDEFINITE LIVED INTANGIBLE ASSETS INCLUDING CUMULATIVE IMPAIRMENT AND CURRENCY TRANSLATION (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | $ 62,169 | $ 62,169 |
Accumulated Amortization | (669) | (660) |
Cumulative Impairment Charge | (300) | (300) |
Cumulative Currency Translation | (3,473) | 882 |
Net Book value | 57,727 | 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 | (3,476) | 835 |
Net Book value | 57,724 | 62,035 |
Patents [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | 669 | 669 |
Accumulated Amortization | (669) | (660) |
Cumulative Impairment Charge | ||
Cumulative Currency Translation | 3 | 47 |
Net Book value | $ 3 | $ 56 |
SCHEDULE OF GOODWILL (Details)
SCHEDULE OF GOODWILL (Details) - USD ($) $ in Thousands | Sep. 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 | (318) | (161) |
Goodwill, net | $ 2,104 | $ 2,261 |
INTANGIBLE ASSETS, NET, AND G_3
INTANGIBLE ASSETS, NET, AND GOODWILL (Details Narrative) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Aug. 31, 2022 | |
Finite-Lived Intangible Assets [Line Items] | ||
Annual impairment test description | 1) the amount and timing of costs to develop the IPR&D into viable products; 2) the amount and timing of future cash inflows; 3) the discount rate; and 4) the probability of technical and regulatory success. The discount rate used was 12% and the cumulative probability of technical and regulatory success to achieve approval to market the products ranged from approximately 10% to 17% | |
Percentage of fair value in excess of carrying value | 25% | |
Increased in goodwill | $ 157 | |
Inprocess Research and Development Assets [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Decreased in intangible assets due to foreign currency translation adjustment | $ 4,311 |
SCHEDULE OF OTHER CURRENT LIABI
SCHEDULE OF OTHER CURRENT LIABILITIES (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Other Liabilities Disclosure [Abstract] | ||
Accrued research and development expenses (including clinical trial accrued expenses) | $ 7,224 | $ 8,196 |
Accrued professional fees | 2,970 | 2,294 |
Payroll and employee-related costs | 2,392 | 4,805 |
Deferred funding | 7,479 | 10,183 |
Other current liabilities | 1,439 | 1,463 |
Total | $ 21,504 | $ 26,941 |
SCHEDULE OF ANTI-DILUTIVE WEIGH
SCHEDULE OF ANTI-DILUTIVE WEIGHTED AVERAGE SHARES OUTSTANDING (Details) - shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive weighted average shares outstanding | 32,829,246 | 21,163,904 |
Warrant [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive weighted average shares outstanding | 3,564,882 | 1,384,469 |
Stock Options and Restricted Stock Units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive weighted average shares outstanding | 23,102,475 | 18,409,572 |
K 2 Conversion Feature [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive weighted average shares outstanding | 6,161,889 | 1,369,863 |
SCHEDULE OF LONG-TERM DEBT (Det
SCHEDULE OF LONG-TERM DEBT (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Long-term Debt | ||
Long-term debt, net of debt discount of $7,281 ($3,783 at December 31, 2021) | $ 48,418 | $ 28,441 |
Less: current portion | ||
Long-term debt, net of current portion | $ 48,418 | $ 28,441 |
SCHEDULE OF LONG-TERM DEBT (D_2
SCHEDULE OF LONG-TERM DEBT (Details) (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Long-Term Debt [Member] | ||
Extinguishment of Debt [Line Items] | ||
Debt instrument, unamortized discount | $ 7,281 | $ 3,783 |
SCHEDULE OF INTEREST EXPENSE (D
SCHEDULE OF INTEREST EXPENSE (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Long-term Debt | ||||
Interest expense | $ 856 | $ 618 | $ 2,132 | $ 1,488 |
Amortization of debt discount | 416 | 487 | 1,237 | 2,499 |
Extinguishment loss | 172 | 172 | ||
Interest income | (486) | (79) | (742) | (304) |
Total | $ 958 | $ 1,026 | $ 2,799 | $ 3,683 |
SCHEDULE OF FUTURE PRINCIPAL OF
SCHEDULE OF FUTURE PRINCIPAL OF LONG-TERM DEBT (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Total | $ 48,418 | $ 28,441 |
Loan Agreement [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Remaining 2022 | ||
2023 | ||
2024 | 2,224 | |
2025 | ||
2026 | 53,475 | |
Total | $ 55,699 |
LONG-TERM DEBT (Details Narrati
LONG-TERM DEBT (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | |||||||||
Sep. 14, 2022 | Feb. 03, 2021 | May 22, 2020 | Sep. 30, 2022 | Sep. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 15, 2022 | Dec. 31, 2021 | May 17, 2021 | |
Debt conversion, converted instrument, amount | $ 2,000 | $ 2,000 | |||||||||
Extinguishment of debt | $ (172) | (172) | |||||||||
Final payment | 55,699 | ||||||||||
Fair Value, Inputs, Level 3 [Member] | |||||||||||
Debt instrument, fair value disclosure | 47,080 | 47,080 | $ 30,406 | ||||||||
K2 Healthventures LLC [Member] | |||||||||||
Increase amount of term loans available | 100,000 | $ 100,000 | |||||||||
Second Amendment [Member] | K2 Healthventures LLC [Member] | |||||||||||
Increase amount of term loans available | $ 100,000 | ||||||||||
Loan and Guaranty Agreement [Member] | |||||||||||
Debt increased percentage | 5% | ||||||||||
Loan and Guaranty Agreement [Member] | K2 Healthventures LLC [Member] | |||||||||||
Debt conversion, converted instrument, amount | $ 4,000 | ||||||||||
Conversion price | $ 1.46 | ||||||||||
Debt instrument, maturity date | Jun. 01, 2024 | ||||||||||
Debt face amount | $ 30,000 | ||||||||||
Loan and Guaranty Agreement [Member] | K2 Healthventures LLC [Member] | K2 Warrant [Member] | |||||||||||
Purchase of warrants | 625,000 | ||||||||||
Warrant price | $ 1.12 | ||||||||||
Loan and Guaranty Agreement [Member] | K2 Healthventures LLC [Member] | Restated K2 Warrant [Member] | |||||||||||
Purchase of warrants | 312,500 | ||||||||||
Warrant price | $ 1.12 | ||||||||||
Total purchase of warrants | 937,500 | ||||||||||
Loan and Guaranty Agreement [Member] | K2 Healthventures LLC [Member] | Second Amendment Warrant [Member] | |||||||||||
Debt face amount | $ 50,000 | ||||||||||
Purchase of warrants | 2,180,413 | ||||||||||
Warrant price | $ 0.8026 | ||||||||||
Shares available | 50,000 | $ 50,000 | |||||||||
Loan and Guaranty Agreement [Member] | First Tranche [Member] | K2 Healthventures LLC [Member] | |||||||||||
Secured Debt | $ 20,000 | ||||||||||
Loan and Guaranty Agreement [Member] | First Amendment [Member] | |||||||||||
Additional secured debt | $ 12,000 | ||||||||||
Debt face amount | 30,000 | ||||||||||
Loan and Guaranty Agreement [Member] | First Amendment [Member] | K2 Healthventures LLC [Member] | |||||||||||
Final payment, value | $ 2,224 | ||||||||||
Loan and Guaranty Agreement [Member] | Second Amendment [Member] | |||||||||||
Debt instrument, maturity date | Sep. 14, 2026 | ||||||||||
Debt face amount | $ 50,000 | $ 50,000 | |||||||||
Warrant price | $ 0.8026 | ||||||||||
Secured term loan final payment percentage | 6.95% | ||||||||||
Extinguishment of debt | 172 | ||||||||||
Debt instrument, fair value disclosure | $ 48,340 | ||||||||||
Debt discount | 7,359 | ||||||||||
Fair value of warrants | 1,550 | ||||||||||
Debt issuance costs | 563 | ||||||||||
Second amendment final payment amount | $ 2,224 | ||||||||||
Debt instrument, interest rate, stated percentage | 10.25% | 10.25% | |||||||||
Debt instrument, interest rate, effective percentage | 13.63% | 13.63% | |||||||||
Debt instrument discount | $ 7,359 | ||||||||||
Debt instrument, unamortized discount | $ 7,281 | $ 7,281 | $ 3,783 | ||||||||
Loan and Guaranty Agreement [Member] | Second Amendment [Member] | Prime Rate Plus [Member] | |||||||||||
Debt instrument, interest rate, stated percentage | 4% | 4% | |||||||||
Loan and Guaranty Agreement [Member] | Second Amendment [Member] | Minimum [Member] | |||||||||||
Debt instrument, interest rate, stated percentage | 8% | 8% | |||||||||
Loan and Guaranty Agreement [Member] | Second Amendment [Member] | K2 Healthventures LLC [Member] | Restated K2 Warrant [Member] | |||||||||||
Purchase of warrants | 2,180,413 | 2,180,413 | |||||||||
Loan and Guaranty Agreement [Member] | Secnd Amendment [Member] | |||||||||||
Second amendment final payment amount | $ 3,475 | ||||||||||
Loan Agreement [Member] | |||||||||||
Term loan available | $ 50,000 | ||||||||||
Loan Agreement [Member] | Second Tranche Term Loan [Member] | Maximum [Member] | |||||||||||
Debt face amount | 15,000 | ||||||||||
Loan Agreement [Member] | Third Tranche Term Loan [Member] | Maximum [Member] | |||||||||||
Debt face amount | 10,000 | ||||||||||
Loan Agreement [Member] | Fourth Tranche Term Loan [Member] | Maximum [Member] | |||||||||||
Debt face amount | 25,000 | ||||||||||
Loan Agreement [Member] | K2 Healthventures LLC [Member] | |||||||||||
Debt conversion, converted instrument, amount | $ 2,000 | ||||||||||
Conversion price | $ 1.46 | ||||||||||
Debt Conversion, Converted Instrument, Shares Issued | 1,369,863 | ||||||||||
Loan Agreement [Member] | Second Amendment [Member] | First Tranche Term Loan [Member] | |||||||||||
Debt face amount | $ 50,000 | ||||||||||
Loan Agreement [Member] | Second Amendment [Member] | K2 Healthventures LLC [Member] | |||||||||||
Convertible amount | $ 7,000 | ||||||||||
Loan Agreement [Member] | Second Amendment [Member] | K2 Healthventures LLC [Member] | Conversion Price of $1.46 Per Share [Member] | |||||||||||
Conversion price | $ 1.46 | ||||||||||
Convertible amount | $ 2,000 | ||||||||||
Shares available for conversion | 1,369,863 | ||||||||||
Loan Agreement [Member] | Second Amendment [Member] | K2 Healthventures LLC [Member] | Conversion Price of $1.0434 Per Share [Member] | |||||||||||
Conversion price | $ 1.0434 | ||||||||||
Convertible amount | $ 5,000 | ||||||||||
Shares available for conversion | 4,792,026 |
SCHEDULE OF STOCK OPTIONS ACTIV
SCHEDULE OF STOCK OPTIONS ACTIVITY (Details) - Equity Option [Member] | 9 Months Ended |
Sep. 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 | 5,140,000 |
Weighted Average Exercise Price, Granted | $ / shares | $ 1.51 |
Number of Stock Options, Exercised | shares | (7,221) |
Weighted Average Exercise Price, Exercised | $ / shares | $ 1.65 |
Number of Stock Options, Forfeited | shares | (575,253) |
Weighted Average Exercise Price, Forfeited | $ / shares | $ 2.28 |
Number of Stock Options Outstanding, Ending Balance | shares | 23,091,905 |
Weighted Average Exercise Price, Ending Balance | $ / shares | $ 2.38 |
Number of Stock Options, Exercisable | shares | 14,536,140 |
Weighted Average Exercise Price, Exercisable | $ / shares | $ 2.52 |
SCHEDULE OF RESTRICTED STOCK UN
SCHEDULE OF RESTRICTED STOCK UNITS (Details) - Restricted Stock Units (RSUs) [Member] | 9 Months Ended |
Sep. 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 | (695) |
Weighted Average Fair Value at Grant Date, Vested | $ / shares | $ 1.46 |
Number of Stock Awards, Vested | shares | (28,064) |
Weighted Average Fair Value at Grant Date, Vested | $ / shares | $ 1.48 |
Number of Stock Awards, Unvested shares outstanding ending balance | shares | 10,570 |
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 | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Equity [Abstract] | ||
Volatility | 93.23% | 96.99% |
Risk free interest rate | 1.75% | 0.57% |
Expected term in years | 5 years 9 months 29 days | 5 years 10 months 2 days |
Expected dividend yield | 0% | 0% |
Weighted average fair value per option | $ 1.13 | $ 2.41 |
SCHEDULE OF STOCK-BASED COMPENS
SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Total stock-based compensation expense | $ 2,412 | $ 2,529 | $ 7,371 | $ 7,091 |
Research and Development Expense [Member] | ||||
Total stock-based compensation expense | 514 | 476 | 1,534 | 1,368 |
General and Administrative Expense [Member] | ||||
Total stock-based compensation expense | 1,868 | 2,029 | 5,751 | 5,656 |
Cost of Sales [Member] | ||||
Total stock-based compensation expense | $ 30 | $ 24 | $ 86 | $ 67 |
STOCKHOLDERS_ EQUITY AND ADDI_3
STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL (Details Narrative) | 9 Months Ended |
Sep. 30, 2022 shares | |
2006 Plan [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Options outstanding | 842,803 |
2014 Plan [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Options outstanding | 521,242 |
2016 Plan [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Options outstanding | 21,727,860 |
Share-based compensation arrangement by share-based, percentage | 10% |
Share-based compensation arrangement by share-based payment award, number of shares available for grant | 1,268,789 |
2016 VBI Equity Incentive Plan [Member] | Restricted Stock Units (RSUs) [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Unvested stock | 10,570 |
SCHEDULE OF REVENUE COMPRISED (
SCHEDULE OF REVENUE COMPRISED (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Disaggregation of Revenue [Line Items] | ||||
Revenues | $ 317 | $ 107 | $ 789 | $ 550 |
Product [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 258 | 24 | 680 | 262 |
Service [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | $ 59 | $ 83 | $ 109 | $ 288 |
SUMMARY OF REVENUE EXPECTED TO
SUMMARY OF REVENUE EXPECTED TO BE RECOGNIZED IN FUTURE RELATED TO PERFORMANCE OBLIGATIONS (Details) $ in Thousands | Sep. 30, 2022 USD ($) |
Disaggregation of Revenue [Line Items] | |
Revenues | $ 2,601 |
Current Portion to September 30, 2023 [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | 597 |
Remaining Portion Thereafter [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | 2,004 |
Product [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | 469 |
Product [Member] | Current Portion to September 30, 2023 [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 | 2,132 |
Service [Member] | Current Portion to September 30, 2023 [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | 597 |
Service [Member] | Remaining Portion Thereafter [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | $ 1,535 |
SUMMARY OF CHANGES IN DEFERRED
SUMMARY OF CHANGES IN DEFERRED REVENUE (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
Revenue from Contract with Customer [Abstract] | ||
Beginning Balance | $ 2,803 | $ 3,104 |
Currency translation | (145) | |
Contract with Customer, Liability, Revenue Recognized | (57) | |
Ending Balance | 2,601 | $ 2,803 |
Short Term | 597 | |
Long Term | $ 2,004 |
REVENUES, NET AND DEFERRED RE_3
REVENUES, NET AND DEFERRED REVENUE (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | ||||
Dec. 04, 2018 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | |
Disaggregation of Revenue [Line Items] | |||||
Stock Issued During Period, Value, New Issues | $ 6,982 | $ 861 | $ 21,417 | ||
Revenue, Remaining Performance Obligation, Amount | $ 2,601 | ||||
Additional potential regulatory and sales milestone payments | $ 117,500 | ||||
License Agreement [Member] | Brii Bio [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Non-refundable upfront payment | $ 11,000 | ||||
Stock Issued During Period, Shares, New Issues | 2,295,082 | ||||
Stock Issued During Period, Value, New Issues | $ 3,626 | ||||
Revenue, Remaining Performance Obligation, Amount | 7,374 | ||||
License Agreement [Member] | Brii Bio [Member] | VBI-2601 [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Revenue, Remaining Performance Obligation, Amount | 2,637 | ||||
License Agreement [Member] | Brii Bio [Member] | Research and Development Expense [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Revenue, Remaining Performance Obligation, Amount | $ 4,737 | ||||
Collaboration and License Agreement [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Unsatisfied amount of research and development services | 1,932 | ||||
Contract with customer, liability | $ 2,601 |
COLLABORATION ARRANGEMENTS (Det
COLLABORATION ARRANGEMENTS (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 21 Months Ended | ||||
Mar. 09, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Dec. 31, 2021 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Research and development expense | $ 4,983 | $ 2,972 | $ 12,988 | $ 14,392 | |||
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. | ||||||
Funding received | $ 19,327 | ||||||
Deferred funding current | 7,479 | 7,479 | $ 7,479 | $ 10,183 | |||
Collaboration Agreement [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Research and development expense | 56 | 191 | |||||
Collaboration Agreement [Member] | Glaxo Smith Kline Biologicals S. A. [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Research and development expense | 0 | 48 | 139 | 374 | |||
Collaboration Agreement [Member] | National Research Council of Canada [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Research and development expense | 118 | 712 | 702 | 942 | |||
CEPI Funding Agreement [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Research and development expense | $ 692 | $ 2,711 | $ 3,098 | $ 4,918 |
GOVERNMENT GRANTS (Details Narr
GOVERNMENT GRANTS (Details Narrative) $ in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Sep. 16, 2020 CAD ($) | Jul. 03, 2020 CAD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | |
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 | $ 68 | $ 0 | $ 68 | ||
Deferred government grants | 41 | 41 | ||||
Strategic Innovation Fund [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Reduction expenses | 1,831 | $ 2,365 | 3,783 | $ 6,377 | ||
Deferred government grants | $ 716 | $ 716 | ||||
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 | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Operating lease costs | $ 489 | $ 385 | $ 1,383 | $ 1,069 |
Operating lease, weighted average remaining lease term | 3 years 3 months 7 days | 3 years 3 months 7 days | ||
Operating lease, weighted average discount rate, percent | 13% | 13% |
SCHEDULE OF FUTURE UNDISCOUNTED
SCHEDULE OF FUTURE UNDISCOUNTED CASH PAYMENTS RECONCILED TO LEASE LIABILITIES (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Commitments and Contingencies Disclosure [Abstract] | ||
Remaining 2022 | $ 321 | |
2023 | 1,295 | |
2024 | 1,196 | |
2025 | 710 | |
2026 | 614 | |
2027 | 167 | |
Total | 4,303 | |
Effect of discounting | (818) | |
Total lease liability | 3,485 | |
Less: current portion | 914 | $ 839 |
Lease liability, net of current portion | $ 2,571 | $ 2,516 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details Narrative) ₪ in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 13, 2018 USD ($) | Sep. 13, 2018 ILS (₪) | Sep. 30, 2022 USD ($) | Sep. 30, 2022 USD ($) | |
Lease Agreement [Member] | ||||
Product Liability Contingency [Line Items] | ||||
Recognized right of use asset | $ 339 | $ 1,134 | ||
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. In September 2022, we decided to extend the term of our lease for our research facility in Canada for three additional years, which now has a term ending on December 31, 2025 | |||
Sci B Vac [Member] | ||||
Product Liability Contingency [Line Items] | ||||
Damages total amount | $ 530,483 | ₪ 1,879,500 |
SCHEDULE OF REVENUES FROM EXTER
SCHEDULE OF REVENUES FROM EXTERNAL CUSTOMERS (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Revenues | $ 317 | $ 107 | $ 789 | $ 550 |
UNITED STATES | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Revenues | 238 | 444 | ||
ISRAEL | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Revenues | 60 | 44 | 281 | 300 |
China / Hong Kong [Member] | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Revenues | 19 | 63 | 58 | 246 |
Europe [Member] | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Revenues | $ 6 | $ 4 |
SEGMENT INFORMATION (Details Na
SEGMENT INFORMATION (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Revenue | $ 317 | $ 107 | $ 789 | $ 550 |
CANADA | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Revenue | $ 0 | $ 0 | $ 0 | $ 0 |
SUBSEQUENT EVENTS (Details Narr
SUBSEQUENT EVENTS (Details Narrative) - Subsequent Event [Member] | Oct. 18, 2022 USD ($) |
Subsequent Event [Line Items] | |
Fixed royalty description | The Amended and Restated Ferring License Agreement amends and restates certain of the terms relating to the manufacture and marketing of HBsAg products, which includes, among others, updates to the definition of net sales, and a reduction in the fixed royalty rate on net sales of HBsAg products from seven percent (7%) to three and a half percent (3.5%) in consideration for the grant of the license to utilize genetically engineered CHO cells encoding the hepatitis B antigen and certain information related to the manufacture of hepatitis B vaccines (collectively, the “Technology”). |
Application fee | $ 2,876 |