Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2021 | May 07, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2021 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2021 | |
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 Incorporation, State or Country Code | A1 | |
Entity Address, Address Line One | 222 Third Street | |
Entity Address, Address Line Two | Suite 2241 | |
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 Share, 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 | true | |
Elected Not To Use the Extended Transition Period | true | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 254,195,435 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
CURRENT ASSETS | ||
Cash and cash equivalents | $ 108,226 | $ 93,825 |
Short-term investments | 25,333 | 25,276 |
Accounts receivable, net | 172 | 77 |
Inventory, net | 2,165 | 2,152 |
Prepaid expenses | 1,086 | 1,569 |
Other current assets | 8,577 | 9,142 |
Total current assets | 145,559 | 132,041 |
NON-CURRENT ASSETS | ||
Other long-term assets | 782 | 639 |
Property and equipment, net | 10,199 | 10,721 |
Right of use assets | 1,337 | 1,554 |
Intangible assets, net | 62,736 | 62,156 |
Goodwill | 2,283 | 2,261 |
Total non-current assets | 77,337 | 77,331 |
TOTAL ASSETS | 222,896 | 209,372 |
CURRENT LIABILITIES | ||
Accounts payable | 1,668 | 3,734 |
Other current liabilities | 20,390 | 12,415 |
Current portion of deferred revenues | 882 | 255 |
Current portion of lease liability | 885 | 944 |
Total current liabilities | 23,825 | 17,348 |
NON-CURRENT LIABILITIES | ||
Lease liability, net of current portion | 462 | 619 |
Long-term debt, net of debt discount | 15,940 | 16,329 |
Liabilities for severance pay | 542 | 522 |
Deferred revenues, net of current portion | 2,118 | 2,849 |
Total non-current liabilities | 19,062 | 20,319 |
COMMITMENTS AND CONTINGENCIES (NOTE 14) | ||
STOCKHOLDERS’ EQUITY | ||
Common shares (unlimited authorized; no par value) (March 31, 2021 - issued and outstanding 254,195,435; December 31, 2020 - issued and outstanding 247,039,010) | 427,048 | 403,528 |
Additional paid-in capital | 77,618 | 75,530 |
Accumulated other comprehensive income | 1,608 | 1,265 |
Accumulated deficit | (326,265) | (308,618) |
Total stockholders’ equity | 180,009 | 171,705 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 222,896 | $ 209,372 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Mar. 31, 2021 | |
Statement of Financial Position [Abstract] | ||
Common Stock, Shares Authorized, Unlimited [Fixed List] | Unlimited | |
Common Stock, No Par Value | $ 0 | |
Common Stock, Shares, Outstanding | 247,039,010 | 254,195,435 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Income Statement [Abstract] | ||
Revenues | $ 301 | $ 415 |
Operating expenses: | ||
Cost of revenues | 2,412 | 2,577 |
Research and development | 6,839 | 3,193 |
General and administrative | 6,747 | 4,058 |
Total operating expenses | 15,998 | 9,828 |
Loss from operations | (15,697) | (9,413) |
Interest expense, net of interest income (including related party - see Note 9) | (1,812) | (582) |
Foreign exchange (loss) gain | (138) | 1,637 |
Loss before income taxes | (17,647) | (8,358) |
Income tax expense | ||
NET LOSS | (17,647) | (8,358) |
Other comprehensive income (loss) | 343 | (6,653) |
COMPREHENSIVE LOSS | $ (17,304) | $ (15,011) |
Net loss per share of common shares, basic and diluted | $ (0.07) | $ (0.05) |
Weighted-average number of common shares outstanding, basic and diluted | 251,292,761 | 178,289,746 |
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, 2019 | $ 284,965 | $ 66,430 | $ (752) | $ (262,388) | $ 88,255 |
Balance, shares at Dec. 31, 2019 | 178,257,199 | ||||
Stock-based compensation | $ 131 | 1,056 | 1,187 | ||
Stock-based compensation, shares | 118,471 | ||||
Net loss | (8,358) | (8,358) | |||
Currency translation adjustments | (6,653) | (6,653) | |||
Ending balance, value at Mar. 31, 2020 | $ 285,096 | 67,486 | (7,405) | (270,746) | 74,431 |
Balance, shares at Mar. 31, 2020 | 178,375,670 | ||||
Beginning balance, value at Dec. 31, 2020 | $ 403,528 | 75,530 | 1,265 | (308,618) | 171,705 |
Balance, shares at Dec. 31, 2020 | 247,039,010 | ||||
Common shares issued in financing transactions, net of share issuance costs | $ 21,417 | 21,417 | |||
Common shares issued in financing transactions, net of share 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 | ||||
Stock-based compensation | $ 51 | 2,088 | 2,139 | ||
Stock-based compensation, shares | |||||
Net loss | (17,647) | (17,647) | |||
Unrealized holding gains on short-term investments | (54) | (54) | |||
Currency translation adjustments | 397 | 397 | |||
Ending balance, value at Mar. 31, 2021 | $ 427,048 | $ 77,618 | $ 1,608 | $ (326,265) | $ 180,009 |
Balance, shares at Mar. 31, 2021 | 254,195,435 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | Mar. 31, 2021 | |
CASH FLOWS FROM OPERATING ACTIVITIES | |||
Net loss | $ (17,647) | $ (8,358) | |
Adjustments to reconcile net loss to cash and cash equivalents used in operating activities: | |||
Depreciation and amortization | 446 | 406 | |
Stock-based compensation | 2,139 | 1,187 | $ 2,139 |
Amortization of debt discount | 1,611 | 239 | |
Inventory reserve | 122 | 874 | |
Interest accrued on short-term investments | (111) | ||
Net change in operating working capital items: | |||
Change in accounts receivable | (100) | 62 | |
Change in inventory | (214) | (468) | |
Change in prepaid expenses | 486 | (30) | |
Change in other current assets | 616 | 188 | |
Change in other long-term assets | (152) | (4) | |
Change in operating right of use assets | 270 | 230 | |
Change in accounts payable | (2,114) | 227 | |
Change in deferred revenues | (103) | (211) | |
Change in other current liabilities | 8,376 | (1,761) | |
Payments made on operating lease liabilities | (269) | (229) | |
Net cash flows used in operating activities | (6,644) | (7,648) | |
CASH FLOWS FROM INVESTING ACTIVITIES | |||
Purchase of property and equipment | (556) | (133) | |
Net cash flows used in investing activities | (556) | (133) | |
CASH FLOWS FROM FINANCING ACTIVITIES | |||
Proceeds from issuance of common shares for cash | 22,113 | ||
Share issuance costs | (541) | ||
Proceeds from issuance of common shares for cash, upon exercise of warrants | 52 | ||
Repayment of long-term debt | (600) | ||
Net cash flows provided by (used in) financing activities | 21,624 | (600) | |
Effect of exchange rates on cash and cash equivalents | (23) | (29) | |
CHANGE IN CASH AND CASH EQUIVALENTS, FOR THE PERIOD | 14,401 | (8,410) | |
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | 93,825 | 44,213 | |
CASH AND CASH EQUIVALENTS, END OF PERIOD | 108,226 | 35,803 | $ 108,226 |
Supplementary information: | |||
Interest paid | 403 | 475 | |
Non-cash investing and financing activities: | |||
Common shares issued upon conversion of debt | 2,000 | ||
Capital expenditures included in accounts payable and other current liabilities | 119 | 10 | |
Share issuance costs included in other current liabilities | 155 | ||
Unrealized holding gains on short term investment | $ (54) |
NATURE OF BUSINESS AND CONTINUA
NATURE OF BUSINESS AND CONTINUATION OF BUSINESS | 3 Months Ended |
Mar. 31, 2021 | |
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 222 Third Street, Suite 2241, 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 is a biopharmaceutical company driven by immunology in the pursuit of powerful 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, coronaviruses, and cytomegalovirus (“CMV”), as well as aggressive cancers including glioblastoma (“GBM”). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel. The ongoing COVID-19 pandemic has materially negatively affected and continues to affect the global economy, and there is continued severe uncertainty about the duration and intensity of the impacts of the pandemic. As a result, the Company’s business and results of operations have also been adversely affected and could continue to be adversely affected by COVID-19 which has necessitated restricting the number of personnel in the Company’s research laboratories and manufacturing facility at any given point in time, and has slowed recruitment to clinical trials. The extent to which the COVID-19 pandemic will continue to impact our business will depend on future developments, which are highly uncertain and cannot be predicted. We do not yet know the full extent of potential delays or impacts on our business, our clinical studies, our research programs, the recoverability of our assets, and our manufacturing; however, the COVID-19 pandemic may disrupt or delay our business operations, including with respect to efforts relating to potential business development transactions, and it could disrupt the marketplace which could have an adverse effect on our operations. Liquidity and Going Concern The Company has a limited operating history and 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 of its products. The Company had an accumulated deficit of $ 326,265 as of March 31, 2021 and cash outflows from operating activities of $ 6,644 for the three months ended March 31, 2021. The Company will require significant additional funds to conduct clinical and non-clinical trials, achieve regulatory approvals, and, subject to such approvals, commercially launch its products. The Company plans to finance future operations with existing cash and cash equivalent reserves. Additional financing may be obtained from the issuance of equity securities, the issuance of additional debt, structured asset financings, 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 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 March 9, 2021, the Company and Coalition for Epidemic Preparedness Innovations (“CEPI”) announced a partnership (“CEPI Funding Agreement”) to develop eVLP vaccine candidates against SARS-COV-2 variants, including the B.1.351 variant, also known as 501Y.V2, first identified in South Africa. CEPI will 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 B.1.351 strain, through Phase I clinical development. This funding will also support preclinical expansion of additional multivalent vaccine candidates designed to evaluate the potential breadth of our eVLP technology. The preclinical expansion is intended to develop clinic-ready vaccine candidates capable of addressing emerging variants. See more information on the CEPI Funding Agreement in Note 12. On July 31, 2020, the Company entered into an Open Market Sale Agreement SM 125 5,752,068 22,113 3.84 696 21,417 38,202 Financial instruments recognized in the condensed consolidated balance sheet consist of cash and cash equivalents, short-term investments, accounts receivable, other current assets, accounts payable, and other current liabilities. The Company believes that the carrying value of its current financial instruments approximates their fair values due to the short-term nature of these instruments. The Company does not hold any derivative financial instruments. The carrying amounts of the Company’s long-term assets approximate their respective fair values. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Mar. 31, 2021 | |
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, 2020 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 Form 10-Q (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, 2020 (the “2020 10-K”), as filed with the SEC on March 2, 2021. The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries: SciVac, SciVac HK, VBI DE, VBI US, VBI Cda, 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 2020 10-K, and there have been no changes to the Company’s significant accounting policies during the three months ended March 31, 2021, other than the polices discussed below. CEPI Funding Agreement Cash received in advance from the CEPI Funding Agreement is included in cash and cash equivalents on the condensed consolidated balance sheet, however, it is restricted as to its use until the relevant expenses are incurred. The cash received is recognized as deferred funding, included in other current liabilities on the condensed consolidated balance sheet, and recognized as a reduction in the related expense when incurred. As of March 31, 2021 the amount of cash included in cash and cash equivalents on the condensed consolidated balance sheets is $ 8,107 . See more information on CEPI Funding Agreement in Note 12. |
NEW ACCOUNTING PRONOUNCEMENTS
NEW ACCOUNTING PRONOUNCEMENTS | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Changes and Error Corrections [Abstract] | |
NEW ACCOUNTING PRONOUNCEMENTS | 3. NEW ACCOUNTING PRONOUNCEMENTS Recently Adopted Accounting Pronouncements None Recently Issued Accounting Standards, not yet Adopted 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 will simplify 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 will remove the separation models required for convertible debt with cash conversion features and convertible instruments with beneficial conversion features. It will also remove certain settlement conditions that are currently required for equity contracts to qualify for the derivative scope exception and will simplify the diluted earnings per share calculation for convertible instruments. ASU 2020-06 will be effective for fiscal years beginning after December 15, 2021 and interim periods within those fiscal years. Early adoption is permitted but no earlier than fiscal periods beginning after December 15, 2020, including interim periods within those fiscal years. This ASU can be applied either through a modified retrospective method of transition or a fully retrospective method of transition. The Company is currently evaluating the impact this new guidance will have on its condensed consolidated financial statements and related disclosures. |
INVENTORY, NET
INVENTORY, NET | 3 Months Ended |
Mar. 31, 2021 | |
Inventory Disclosure [Abstract] | |
INVENTORY, NET | 4. INVENTORY, NET Inventory consists of the following: SCHEDULE OF INVENTORY March 31, December 31, Finished goods $ - $ - Work-in-process 505 390 Raw materials 1,660 1,762 Inventory, net $ 2,165 $ 2,152 |
OTHER CURRENT ASSETS
OTHER CURRENT ASSETS | 3 Months Ended |
Mar. 31, 2021 | |
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 March 31, December 31, Government receivables $ 6,096 $ 7,830 Other current assets 2,481 1,312 Total other current assets $ 8,577 $ 9,142 |
INTANGIBLE ASSETS AND GOODWILL
INTANGIBLE ASSETS AND GOODWILL | 3 Months Ended |
Mar. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
INTANGIBLE ASSETS AND GOODWILL | 6. INTANGIBLE ASSETS AND GOODWILL SCHEDULE OF INTANGIBLE ASSETS INCLUDING CUMULATIVE IMPAIRMENT AND CUMULATIVE CURRENCY TRANSLATION March 31, 2021 Gross Carrying Accumulated Cumulative Cumulative Net Book Patents $ 669 $ (606 ) $ - $ 39 $ 102 In Process Research & Development (“IPR&D”) assets 61,500 - (300 ) 1,434 62,634 $ 62,169 $ (606 ) $ (300 ) $ 1,473 $ 62,736 December 31, 2020 Gross Accumulated Cumulative Cumulative Net Book Patents $ 669 $ (590 ) $ - $ 44 $ 123 IPR&D assets 61,500 - (300 ) 833 62,033 $ 62,169 $ (590 ) $ (300 ) $ 877 $ 62,156 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, 2020 relates to currency translation adjustments which increased by $ 601 SCHEDULE OF GOODWILL March 31, 2021 Gross Carrying Amount Cumulative Impairment Cumulative Translation Net Book Goodwill $ 8,714 $ (6,292 ) $ (139 ) $ 2,283 December 31, 2020 Gross Cumulative Impairment Cumulative Translation Net Book Goodwill $ 8,714 $ (6,292 ) $ (161 ) $ 2,261 The change in carrying value for goodwill from December 31, 2020 relates to currency translation adjustments which increased by $ 22 |
OTHER CURRENT LIABILITIES
OTHER CURRENT LIABILITIES | 3 Months Ended |
Mar. 31, 2021 | |
Other Liabilities Disclosure [Abstract] | |
OTHER CURRENT LIABILITIES | 7. OTHER CURRENT LIABILITIES Other current liabilities consisted of the following: SCHEDULE OF OTHER CURRENT LIABILITIES March 31, December 31, Accrued research and development expenses (including clinical trial accrued expenses) $ 6,423 $ 5,842 Accrued professional fees 2,080 1,547 Payroll and employee-related costs 1,918 3,844 Deferred government grants 1,417 825 Deferred funding 8,107 - Other current liabilities 445 357 Total other current liabilities $ 20,390 $ 12,415 |
LOSS PER SHARE OF COMMON SHARES
LOSS PER SHARE OF COMMON SHARES | 3 Months Ended |
Mar. 31, 2021 | |
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 March 31, 2021 and 2020 have been excluded from the computation of diluted weighted average shares outstanding, as they would be antidilutive: SCHEDULE OF ANTIDILUTIVE WEIGHTED AVERAGE SHARES OUTSTANDING March 31, March 31, Warrants 3,163,172 2,618,824 Stock options and restricted stock units 18,139,335 10,894,792 K2 conversion feature 1,369,863 - 22,672,370 13,513,616 |
LONG-TERM DEBT
LONG-TERM DEBT | 3 Months Ended |
Mar. 31, 2021 | |
Debt Disclosure [Abstract] | |
LONG-TERM DEBT | 9. LONG-TERM DEBT As of March 31, 2021, and December 31, 2020, the long-term debt is as follows: SCHEDULE OF LONG-TERM DEBT March 31, December 31, Long-term debt, net of debt discount of $ 3,450 5,061 $ 15,940 $ 16,329 Less: current portion, net of debt discount of $ 0 0 - - Long-term debt $ 15,940 $ 16,329 On May 22, 2020, the Company (along with its subsidiary VBI Cda) entered into the Loan Agreement with K2 HealthVentures LLC and any other lender from time to time party thereto (the “Lenders”) pursuant to which we received the first tranche secured term loan of $ 20 million (the “First Tranche Term Loan”). The Lenders agreed to make available the following additional tranches subject to the following conditions and upon the submission of a loan request by the Company: (1) up to $10 million available between January 1, 2021 and April 30, 2021 upon achievement of certain milestones (the “Second Tranche Term Loan”), (2) $10 million available between the closing date and December 31, 2021, subject to achievement of a certain U.S. Food and Drug Administration approval (the “Third Tranche Term Loan”), and (3) a final tranche of up to $ 10 million that can be made available any time prior to June 30, 2022, subject to the advance of the Third Tranche Term Loan, satisfactory review by the administrative agent of our financial and operating plan, and approval by the Lenders’ investment committee (the “Fourth Tranche Term Loan” ). Pursuant to the Loan Agreement, the Lenders originally had the ability to convert, at the Lenders’ option, up to $ 4 million of the secured term loan into common shares of the Company at a conversion price of $ 1.46 per share (“K2 conversion feature”) until the maturity date of June 1, 2024 2 million of the secured term loan into 1,369,863 common shares at a conversion price of $ 1.46 . The Lenders have the ability to convert an additional $2 million at the Lenders’ option. The Administrative Agent has determined that sufficient Second Tranche Milestones have been satisfied to enable the Company to request draw down of the Second Tranche Term Loan up to the Second Tranche Maximum Amount (as such terms are defined in the Loan Agreement). The Company and the Lenders are in the process of amending the Loan Agreement to extend the Second Tranche Availability Period. 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 The number of common shares issuable pursuant to the K2 Warrant, at any given time, is determined by the aggregate original principal amount of the loans advanced at that time pursuant to the Loan Agreement multiplied by 3.5% and divided by the Warrant Price. If the full $50 million available in all K2 tranches is advanced pursuant to the Loan Agreement, up to 1,562,500 common shares will be issuable pursuant to the K2 Warrant. May 22, 2030 The total proceeds attributed to the K2 Warrant was $ 1,181 based on the relative fair value of the K2 Warrant as compared to the sum of the fair values of the K2 Warrant, K2 conversion feature and debt. The effective conversion price of the K2 conversion feature of $ 1.52 was determined to be less than the fair value of the underlying common stock at the date of commitment, resulting in a beneficial conversion feature (“BCF”) at that date. The intrinsic value of the BCF was $ 2,577 and recorded to additional paid-in capital. The K2 warrant and the K2 conversion feature resulted in the debt being issued at a discount. The Company also incurred $ 1,021 of debt issuance costs and is required to make a final payment equal to 6.95% of the aggregate original secured term loan principal on the maturity date of the term loan, or upon earlier prepayment of the term loans in accordance with the Loan Agreement, resulting in an additional discount of $ 1,390 . The total initial debt discount is $ 6,169 . Upon receipt of additional funds under the Loan Agreement, additional common shares will be issuable pursuant to the K2 Warrant as determined by the principal amount of the additional funds advanced multiplied by 3.5% and divided by the Warrant Price, and the final payment will increase by 6.95% of the funds advanced. The total principal amount of the loan under the Loan Agreement outstanding at March 31, 2021, including the $1,390 final payment discussed above, is $ 19,390 . The principal amount of the loan made under the Loan Agreement accrues interest at an annual rate equal to the greater of (a) 8.25% or (b) prime rate plus 5.00% . The interest rate as of March 31, 2021 was 8.25% . The Company is required to pay only interest until July 1, 2022. If there is no Event of Default (as defined in the Loan Agreement) and a Third Tranche Term Loan of $ 10 million is made upon the achievement of a certain milestone then the interest only period is extended to January 1, 2023 . The effective interest rate on the remaining loan of $ 18,000 18.14% . Upon the occurrence of an Event of Default, and during the continuance of an Event of Default, the applicable rate of interest, described above, will be increased by 5.00% June 1, 2024 The obligations under the Loan Agreement are secured on a senior basis by a lien on substantially all of the assets of the Company and its subsidiaries other than intellectual property. The subsidiaries of the Company, other than VBI Cda and SciVac HK, 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 initial debt discount related to the Loan Agreement with K2 HealthVentures LLC and the term loan facility with Perceptive Credit Holdings, LP is $ 6,169 and $ 4,018 , respectively. As of March 31, 2021, and December 31, 2020, the unamortized debt discount was $ 3,450 and $ 5,061 respectively. The debt discount is being charged to interest expense, net of interest income in the condensed consolidated statement of operations and comprehensive loss using the effective interest method over the term of the debt. During the three months ended March 31, 2021, as a result of the conversion of term loan to common shares, $ 1,161 of additional interest accretion was recognized in interest expense, net of interest income in the condensed consolidated statement of operations and comprehensive loss. At March 31, 2021 and December 31, 2020, the fair value of our outstanding debt, which is considered level 3 in the fair value hierarchy, is estimated to be $ 18,921 20,117 , respectively. Interest expense, net of interest income recorded in the three months ended March 31, 2021 and 2020 was as follows: SCHEDULE OF INTEREST EXPENSE 2021 2020 Three months ended March 31 2021 2020 Interest expense $ 389 $ 475 Amortization of debt discount 1,611 239 Interest income (188 ) (132 ) Total interest expense, net of interest income $ 1,812 $ 582 Interest expense and amortization of debt discount for the three months ended March 31, 2021 does not include any amounts incurred to a related party. Interest expense and amortization of debt discount for the three months ended March 31, 2020 was fully incurred to a related party. The following table summarizes the future principal payments due under long-term debt: SCHEDULE OF FUTURE PRINCIPAL OF LONG-TERM DEBT Principal Remaining 2021 $ - 2022 4,215 2023 8,980 2024 6,195 Total $ 19,390 |
STOCKHOLDERS_ EQUITY AND ADDITI
STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL | 3 Months Ended |
Mar. 31, 2021 | |
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 December 31, 2020, there were 989,813 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. No further options will be issued under the 2014 Plan. As of March 31, 2021, there were 521,242 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% 16,523,250 105,030 The aggregate number of common shares remaining available for issuance for awards under the 2016 Plan totaled 5,920,455 Activity related to stock options is as follows: SCHEDULE OF STOCK OPTIONS ACTIVITY Number of Weighted Balance outstanding at December 31, 2020 12,507,541 $ 2.38 Granted 5,540,000 $ 3.15 Forfeited (13,236 ) $ 2.25 Balance outstanding at March 31, 2021 18,034,305 $ 2.62 Exercisable at March 31, 2021 7,028,418 $ 2.66 Information relating to RSUs is as follow: SCHEDULE OF RESTRICTED STOCK UNITS Number of Weighted Unvested shares outstanding at December 31, 2020 129,356 $ 1.62 Vested (24,326 ) $ 2.03 Unvested shares outstanding at March 31, 2021 105,030 $ 1.52 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 2021 2020 Volatility 97.13 % 90.12 % Risk free interest rate 0.54 % 1.54 % Expected term in years 5.85 5.77 Expected dividend yield 0.00 % 0.00 % Weighted average fair value per option $ 2.40 $ 1.04 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 months ended March 31, 2021 and 2020 was as follows: SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE Three months ended March 31 2021 2020 Research and development $ 428 $ 244 General and administrative 1,690 933 Cost of revenues 21 10 Total stock-based compensation expense $ 2,139 $ 1,187 Warrants Activity related to the warrants is as follows: SCHEDULE OF WARRANT ACTIVITY Number of Weighted Balance outstanding at December 31, 2020 3,197,666 $ 2.23 Exercised (34,494 ) $ 1.50 Balance outstanding at March 31, 2021 3,163,172 $ 2.24 |
REVENUES AND DEFERRED REVENUE
REVENUES AND DEFERRED REVENUE | 3 Months Ended |
Mar. 31, 2021 | |
Revenue from Contract with Customer [Abstract] | |
REVENUES AND DEFERRED REVENUE | 11. REVENUES AND DEFERRED REVENUE Revenue is comprised of the following: SCHEDULE OF REVENUE COMPRISED Three months ended March 31 2021 2020 Product revenues $ 167 $ 180 R&D service revenues 134 235 Total revenue $ 301 $ 415 The following table presents revenues expected to be recognized in the future related to performance obligations, based on current estimates, that are unsatisfied at March 31, 2021: SUMMARY OF REVENUE EXPECTED TO BE RECOGNIZED IN FUTURE RELATED TO PERFORMANCE OBLIGATIONS Total Current portion to March 31, Remaining portion thereafter Product revenues $ 469 $ - $ 469 R&D service revenues 2,531 882 1,649 Total $ 3,000 $ 882 $ 2,118 The following table presents changes in the deferred revenue balance for the three months ended March 31, 2021: SUMMARY OF CHANGES IN DEFERRED REVENUE Balance at December 31, 2020 $ 3,104 Recognition of deferred revenue (128 ) Currency translation 24 Balance at March 31, 2021 $ 3,000 Short Term $ 882 Long Term $ 2,118 Collaboration and License Agreement – Brii Bio On December 4, 2018, we entered into a Collaboration and License Agreement with Brii Biosciences Limited (“Brii Bio”) (the “Collaboration and License Agreement”), amended on April 8, 2021, whereby: ● The Company and Brii Bio agreed to collaborate on the development of a hepatitis B 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 hepatitis B, with a novel composition developed jointly with Brii Bio (either being the “Licensed Product”); and, ● The Company granted Brii Bio an exclusive royalty-bearing license to perform studies, regulatory and other activities, as may be required to obtain and maintain marketing approval of the Licensed Product in the Licensed Territory and to commercialize the Licensed Product for the diagnosis and treatment of hepatitis B in the Licensed Territory. Pursuant to the Collaboration and License Agreement, 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 initial consideration of the Collaboration and License Agreement consisted of a $ 11,000 2,295,082 3,626 7,374 4,737 2,637 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 March 31, 2021, R&D services related to Brii Bio that remain unsatisfied are $ 2,331 3,000 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 | 3 Months Ended |
Mar. 31, 2021 | |
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; costs for the three months ended March 31, 2021 are $ 256 National Research Council of Canada (“NRC”) On March 31, 2020, the Company announced a collaboration with the NRC, Canada’s largest federal research and development organization, to develop a pan-coronavirus vaccine candidate, targeting COVID-19, SARS, and MERS. The NRC and the Company are collaborating to evaluate and select promising coronavirus vaccine candidates. The collaboration combines the Company’s viral vaccine expertise, eVLP technology platform, and modified coronavirus antigens with the NRC’s proprietary SARS-CoV-2 antigens and assay development capabilities to select the most immunogenic vaccine candidate for further development. On December 21, 2020, we 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. The amendment also extended the expiry date of the agreement to March 15, 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 months ended March 31, 2021 are $ 158 0 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 B.1.351 variant, also known as 501Y.V2, first identified in South Africa. CEPI will 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 B.1.351 strain, through Phase I clinical development. This funding will also support preclinical expansion of additional multivalent vaccine candidates designed to evaluate the potential breadth of our eVLP technology. The preclinical expansion is intended to develop clinic-ready vaccine candidates capable of addressing emerging variants. Under the terms of the CEPI Funding Agreement, among other things, the Company and CEPI agreed on the importance of global equitable access to any vaccines produced pursuant to the CEPI Funding Agreement. Any such vaccines, if approved, are expected to be procured and allocated through global mechanisms under discussion as part of the Access to COVID-19 Tools (ACT) Accelerator, an international initiative launched by the World Health Organization (“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 will be expensed as incurred in Research and Development expenses; costs for the three months ended March 31, 2021 are $ 157 . As of March 31, 2021 the Company received cash of $ 8,285 and recognized $ 157 as a reduction in expenses. As of March 31, 2021, the Company had $ 8,107 recorded as deferred funding, recorded in other current liabilities on the condensed consolidated balance sheet. Brii Biosciences Limited On December 4, 2018, we entered into a License Agreement with Brii Bio, as described in Note 11. |
GOVERNMENT GRANTS
GOVERNMENT GRANTS | 3 Months Ended |
Mar. 31, 2021 | |
Government Grants | |
GOVERNMENT GRANTS | 13. GOVERNMENT GRANTS Grants recognized in research and development expenses in the consolidated statement of operations and comprehensive loss are as follows: Industrial Research Assistance Program (“IRAP”) On July 3, 2020, the Company and the NRC signed a contribution agreement as represented by its IRAP whereby the NRC agrees to contribute up to CAD $ 1,000 For the three months ended March 31, 2021 the Company recognized $ 0 396 recorded as deferred government grants, recorded in other current liabilities on the condensed consolidated balance sheet. 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 agrees to contribute up to CAD $ 55,976 For the three months ended March 31, 2021 the Company recognized $ 2,688 1,021 recorded as deferred government grants, recorded in other current liabilities on the condensed consolidated balance sheet. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 3 Months Ended |
Mar. 31, 2021 | |
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 our 3-antigen prophylactic HBV vaccine discovered in July 2015; that our 3-antigen prophylactic HBV vaccine was approved for use in children and infants in Israel without sufficient evidence establishing its safety; that SciVac failed to provide accurate information about our 3-antigen prophylactic HBV vaccine 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 our 3-antigen prophylactic HBV vaccine in Israel from April 2011 and seeking damages in a total amount of NIS 1,879,500,000 563,737 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 and December 3, 2020 to discuss document disclosure. The next preliminary hearing is scheduled to be held on September 13, 2021. 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 expires on April 30, 2023 Our manufacturing facility lease agreement expires on January 31, 2022, which includes one five-year option to extend until 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 the option to extend the term for one additional period of three years and a term ending April 30, 2023 for the additional space leased during 2020. Options to extend are not recognized as part of the lease liabilities or recognized as right to use assets. 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 March 31, 2021 $ 343 Three months ended March 31, 2020 288 Other information: Weighted average remaining lease term 1.88 Weighted average discount rate 12 % Operating lease costs are included in general and administrative (“G&A”) expenses in the statement of operation 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 Year ending December 31: 2021 Remaining 2021 $ 802 2022 523 2023 125 Total $ 1,450 Effect of discounting (103 ) Total lease liability $ 1,347 Less: current portion (885 ) Long term lease liability $ 462 |
SEGMENT INFORMATION
SEGMENT INFORMATION | 3 Months Ended |
Mar. 31, 2021 | |
Segment Reporting [Abstract] | |
SEGMENT INFORMATION | 15. SEGMENT INFORMATION The Company’s Chief Executive Officer (“CEO”) has been identified as the chief operating decision maker. The CEO evaluates the performance of the Company and allocates resources based on the information provided by the Company’s internal management system at a consolidated level. The Company has determined that it has only one Revenues from external customers are attributed to geographic areas based on location of the contracting customers: SCHEDULE OF REVENUES FROM EXTERNAL CUSTOMERS Three Months Ended March 31, 2021 2020 Israel $ 169 $ 132 China / Hong Kong 128 231 Europe 4 52 $ 301 $ 415 There was no |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2021 | |
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, 2020 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 Form 10-Q (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, 2020 (the “2020 10-K”), as filed with the SEC on March 2, 2021. The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries: SciVac, SciVac HK, VBI DE, VBI US, VBI Cda, 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 | Significant Accounting Policies The significant accounting policies used in the preparation of these condensed consolidated financial statements are disclosed in the 2020 10-K, and there have been no changes to the Company’s significant accounting policies during the three months ended March 31, 2021, other than the polices discussed below. |
CEPI Funding Agreement | CEPI Funding Agreement Cash received in advance from the CEPI Funding Agreement is included in cash and cash equivalents on the condensed consolidated balance sheet, however, it is restricted as to its use until the relevant expenses are incurred. The cash received is recognized as deferred funding, included in other current liabilities on the condensed consolidated balance sheet, and recognized as a reduction in the related expense when incurred. As of March 31, 2021 the amount of cash included in cash and cash equivalents on the condensed consolidated balance sheets is $ 8,107 . See more information on CEPI Funding Agreement in Note 12. |
INVENTORY, NET (Tables)
INVENTORY, NET (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Inventory Disclosure [Abstract] | |
SCHEDULE OF INVENTORY | Inventory consists of the following: SCHEDULE OF INVENTORY March 31, December 31, Finished goods $ - $ - Work-in-process 505 390 Raw materials 1,660 1,762 Inventory, net $ 2,165 $ 2,152 |
OTHER CURRENT ASSETS (Tables)
OTHER CURRENT ASSETS (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
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 March 31, December 31, Government receivables $ 6,096 $ 7,830 Other current assets 2,481 1,312 Total other current assets $ 8,577 $ 9,142 |
INTANGIBLE ASSETS AND GOODWILL
INTANGIBLE ASSETS AND GOODWILL (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
SCHEDULE OF INTANGIBLE ASSETS INCLUDING CUMULATIVE IMPAIRMENT AND CUMULATIVE CURRENCY TRANSLATION | SCHEDULE OF INTANGIBLE ASSETS INCLUDING CUMULATIVE IMPAIRMENT AND CUMULATIVE CURRENCY TRANSLATION March 31, 2021 Gross Carrying Accumulated Cumulative Cumulative Net Book Patents $ 669 $ (606 ) $ - $ 39 $ 102 In Process Research & Development (“IPR&D”) assets 61,500 - (300 ) 1,434 62,634 $ 62,169 $ (606 ) $ (300 ) $ 1,473 $ 62,736 December 31, 2020 Gross Accumulated Cumulative Cumulative Net Book Patents $ 669 $ (590 ) $ - $ 44 $ 123 IPR&D assets 61,500 - (300 ) 833 62,033 $ 62,169 $ (590 ) $ (300 ) $ 877 $ 62,156 |
SCHEDULE OF GOODWILL | SCHEDULE OF GOODWILL March 31, 2021 Gross Carrying Amount Cumulative Impairment Cumulative Translation Net Book Goodwill $ 8,714 $ (6,292 ) $ (139 ) $ 2,283 December 31, 2020 Gross Cumulative Impairment Cumulative Translation Net Book Goodwill $ 8,714 $ (6,292 ) $ (161 ) $ 2,261 |
OTHER CURRENT LIABILITIES (Tabl
OTHER CURRENT LIABILITIES (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Other Liabilities Disclosure [Abstract] | |
SCHEDULE OF OTHER CURRENT LIABILITIES | Other current liabilities consisted of the following: SCHEDULE OF OTHER CURRENT LIABILITIES March 31, December 31, Accrued research and development expenses (including clinical trial accrued expenses) $ 6,423 $ 5,842 Accrued professional fees 2,080 1,547 Payroll and employee-related costs 1,918 3,844 Deferred government grants 1,417 825 Deferred funding 8,107 - Other current liabilities 445 357 Total other current liabilities $ 20,390 $ 12,415 |
LOSS PER SHARE OF COMMON SHAR_2
LOSS PER SHARE OF COMMON SHARES (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Earnings Per Share [Abstract] | |
SCHEDULE OF ANTIDILUTIVE WEIGHTED AVERAGE SHARES OUTSTANDING | The following potentially dilutive securities outstanding at March 31, 2021 and 2020 have been excluded from the computation of diluted weighted average shares outstanding, as they would be antidilutive: SCHEDULE OF ANTIDILUTIVE WEIGHTED AVERAGE SHARES OUTSTANDING March 31, March 31, Warrants 3,163,172 2,618,824 Stock options and restricted stock units 18,139,335 10,894,792 K2 conversion feature 1,369,863 - 22,672,370 13,513,616 |
LONG-TERM DEBT (Tables)
LONG-TERM DEBT (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Debt Disclosure [Abstract] | |
SCHEDULE OF LONG-TERM DEBT | As of March 31, 2021, and December 31, 2020, the long-term debt is as follows: SCHEDULE OF LONG-TERM DEBT March 31, December 31, Long-term debt, net of debt discount of $ 3,450 5,061 $ 15,940 $ 16,329 Less: current portion, net of debt discount of $ 0 0 - - Long-term debt $ 15,940 $ 16,329 |
SCHEDULE OF INTEREST EXPENSE | Interest expense, net of interest income recorded in the three months ended March 31, 2021 and 2020 was as follows: SCHEDULE OF INTEREST EXPENSE 2021 2020 Three months ended March 31 2021 2020 Interest expense $ 389 $ 475 Amortization of debt discount 1,611 239 Interest income (188 ) (132 ) Total interest expense, net of interest income $ 1,812 $ 582 |
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 Remaining 2021 $ - 2022 4,215 2023 8,980 2024 6,195 Total $ 19,390 |
STOCKHOLDERS_ EQUITY AND ADDI_2
STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Equity [Abstract] | |
SCHEDULE OF STOCK OPTIONS ACTIVITY | Activity related to stock options is as follows: SCHEDULE OF STOCK OPTIONS ACTIVITY Number of Weighted Balance outstanding at December 31, 2020 12,507,541 $ 2.38 Granted 5,540,000 $ 3.15 Forfeited (13,236 ) $ 2.25 Balance outstanding at March 31, 2021 18,034,305 $ 2.62 Exercisable at March 31, 2021 7,028,418 $ 2.66 |
SCHEDULE OF RESTRICTED STOCK UNITS | Information relating to RSUs is as follow: SCHEDULE OF RESTRICTED STOCK UNITS Number of Weighted Unvested shares outstanding at December 31, 2020 129,356 $ 1.62 Vested (24,326 ) $ 2.03 Unvested shares outstanding at March 31, 2021 105,030 $ 1.52 |
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 2021 2020 Volatility 97.13 % 90.12 % Risk free interest rate 0.54 % 1.54 % Expected term in years 5.85 5.77 Expected dividend yield 0.00 % 0.00 % Weighted average fair value per option $ 2.40 $ 1.04 |
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 months ended March 31, 2021 and 2020 was as follows: SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE Three months ended March 31 2021 2020 Research and development $ 428 $ 244 General and administrative 1,690 933 Cost of revenues 21 10 Total stock-based compensation expense $ 2,139 $ 1,187 |
SCHEDULE OF WARRANT ACTIVITY | Activity related to the warrants is as follows: SCHEDULE OF WARRANT ACTIVITY Number of Weighted Balance outstanding at December 31, 2020 3,197,666 $ 2.23 Exercised (34,494 ) $ 1.50 Balance outstanding at March 31, 2021 3,163,172 $ 2.24 |
REVENUES AND DEFERRED REVENUE (
REVENUES AND DEFERRED REVENUE (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Revenue from Contract with Customer [Abstract] | |
SCHEDULE OF REVENUE COMPRISED | Revenue is comprised of the following: SCHEDULE OF REVENUE COMPRISED Three months ended March 31 2021 2020 Product revenues $ 167 $ 180 R&D service revenues 134 235 Total revenue $ 301 $ 415 |
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 March 31, 2021: SUMMARY OF REVENUE EXPECTED TO BE RECOGNIZED IN FUTURE RELATED TO PERFORMANCE OBLIGATIONS Total Current portion to March 31, Remaining portion thereafter Product revenues $ 469 $ - $ 469 R&D service revenues 2,531 882 1,649 Total $ 3,000 $ 882 $ 2,118 |
SUMMARY OF CHANGES IN DEFERRED REVENUE | The following table presents changes in the deferred revenue balance for the three months ended March 31, 2021: SUMMARY OF CHANGES IN DEFERRED REVENUE Balance at December 31, 2020 $ 3,104 Recognition of deferred revenue (128 ) Currency translation 24 Balance at March 31, 2021 $ 3,000 Short Term $ 882 Long Term $ 2,118 Collaboration and License Agreement – Brii Bio On December 4, 2018, we entered into a Collaboration and License Agreement with Brii Biosciences Limited (“Brii Bio”) (the “Collaboration and License Agreement”), amended on April 8, 2021, whereby: ● The Company and Brii Bio agreed to collaborate on the development of a hepatitis B 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 hepatitis B, with a novel composition developed jointly with Brii Bio (either being the “Licensed Product”); and, ● The Company granted Brii Bio an exclusive royalty-bearing license to perform studies, regulatory and other activities, as may be required to obtain and maintain marketing approval of the Licensed Product in the Licensed Territory and to commercialize the Licensed Product for the diagnosis and treatment of hepatitis B in the Licensed Territory. Pursuant to the Collaboration and License Agreement, 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 initial consideration of the Collaboration and License Agreement consisted of a $ 11,000 2,295,082 3,626 7,374 4,737 2,637 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 March 31, 2021, R&D services related to Brii Bio that remain unsatisfied are $ 2,331 3,000 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. |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
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 March 31, 2021 $ 343 Three months ended March 31, 2020 288 Other information: Weighted average remaining lease term 1.88 Weighted average discount rate 12 % |
SCHEDULE OF FUTURE UNDISCOUNTED CASH PAYMENTS RECONCILED TO LEASE LIABILITIES | The following table summarizes future undiscounted cash payments reconciled to the lease liabilities: SCHEDULE OF FUTURE UNDISCOUNTED CASH PAYMENTS RECONCILED TO LEASE LIABILITIES Year ending December 31: 2021 Remaining 2021 $ 802 2022 523 2023 125 Total $ 1,450 Effect of discounting (103 ) Total lease liability $ 1,347 Less: current portion (885 ) Long term lease liability $ 462 |
SEGMENT INFORMATION (Tables)
SEGMENT INFORMATION (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Segment Reporting [Abstract] | |
SCHEDULE OF REVENUES FROM EXTERNAL CUSTOMERS | Revenues from external customers are attributed to geographic areas based on location of the contracting customers: SCHEDULE OF REVENUES FROM EXTERNAL CUSTOMERS Three Months Ended March 31, 2021 2020 Israel $ 169 $ 132 China / Hong Kong 128 231 Europe 4 52 $ 301 $ 415 |
NATURE OF BUSINESS AND CONTIN_2
NATURE OF BUSINESS AND CONTINUATION OF BUSINESS (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | Jul. 31, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Retained Earnings (Accumulated Deficit) | $ 326,265 | $ 308,618 | ||
Net Cash Provided by (Used in) Operating Activities | $ 6,644 | $ 7,648 | ||
Description on vaccine development | On March 9, 2021, the Company and Coalition for Epidemic Preparedness Innovations (“CEPI”) announced a partnership (“CEPI Funding Agreement”) to develop eVLP vaccine candidates against SARS-COV-2 variants, including the B.1.351 variant, also known as 501Y.V2, first identified in South Africa. CEPI will 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 B.1.351 strain, through Phase I clinical development. | |||
Payments of Stock Issuance Costs | $ 541 | |||
Open Market Sale Agreement [Member] | Jefferies LLC [Member] | Maximum [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Open market sale agreement sales cost | $ 125,000 | |||
ATM Program [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Stock Issued During Period, Shares, New Issues | 5,752,068 | |||
Gross proceeds from Issuance of Common Stock | $ 22,113 | |||
Average price per share | $ 3.84 | |||
Payments of Stock Issuance Costs | $ 696 | |||
Proceeds from issuance of common stock, net | 21,417 | |||
Available share value | $ 38,202 |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) $ in Thousands | Mar. 31, 2021USD ($) |
CEPI Funding Agreement [Member] | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Restricted Cash, Current | $ 8,107 |
SCHEDULE OF INVENTORY (Details)
SCHEDULE OF INVENTORY (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Finished goods | ||
Work-in-process | 505 | 390 |
Raw materials | 1,660 | 1,762 |
Inventory, net | $ 2,165 | $ 2,152 |
SCHEDULE OF OTHER CURRENT ASSET
SCHEDULE OF OTHER CURRENT ASSETS (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Government receivables | $ 6,096 | $ 7,830 |
Other current assets | 2,481 | 1,312 |
Total other current assets | $ 8,577 | $ 9,142 |
SCHEDULE OF INTANGIBLE ASSETS I
SCHEDULE OF INTANGIBLE ASSETS INCLUDING CUMULATIVE IMPAIRMENT AND CUMULATIVE CURRENCY TRANSLATION (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2021 | Dec. 31, 2020 | |
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | $ 62,169 | $ 62,169 |
Accumulated Amortization | (606) | (590) |
Cumulative Impairment Charge | (300) | (300) |
Cumulative Currency Translation | 1,473 | 877 |
Net Book value | 62,736 | 62,156 |
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 | 1,434 | 833 |
Net Book value | 62,634 | 62,033 |
Patents [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | 669 | 669 |
Accumulated Amortization | (606) | (590) |
Cumulative Impairment Charge | ||
Cumulative Currency Translation | 39 | 44 |
Net Book value | $ 102 | $ 123 |
SCHEDULE OF GOODWILL (Details)
SCHEDULE OF GOODWILL (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
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 | (139) | (161) |
Goodwill, Net Book value | $ 2,283 | $ 2,261 |
INTANGIBLE ASSETS AND GOODWIL_2
INTANGIBLE ASSETS AND GOODWILL (Details Narrative) $ in Thousands | 3 Months Ended |
Mar. 31, 2021USD ($) | |
Goodwill [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Increase in foreign currency translation adjustment | $ 22 |
Inprocess Research And Development Assets [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Increase in foreign currency translation adjustment | $ 601 |
SCHEDULE OF OTHER CURRENT LIABI
SCHEDULE OF OTHER CURRENT LIABILITIES (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Other Liabilities Disclosure [Abstract] | ||
Accrued research and development expenses (including clinical trial accrued expenses) | $ 6,423 | $ 5,842 |
Accrued professional fees | 2,080 | 1,547 |
Payroll and employee-related costs | 1,918 | 3,844 |
Deferred government grants | 1,417 | 825 |
Deferred funding | 8,107 | |
Other current liabilities | 445 | 357 |
Total other current liabilities | $ 20,390 | $ 12,415 |
SCHEDULE OF ANTIDILUTIVE WEIGHT
SCHEDULE OF ANTIDILUTIVE WEIGHTED AVERAGE SHARES OUTSTANDING (Details) - shares | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive weighted average shares outstanding | 22,672,370 | 13,513,616 |
Warrant [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive weighted average shares outstanding | 3,163,172 | 2,618,824 |
Stock Options And Restricted Stock Units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive weighted average shares outstanding | 18,139,335 | 10,894,792 |
K2 Conversion Feature [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive weighted average shares outstanding | 1,369,863 |
SCHEDULE OF LONG-TERM DEBT (Det
SCHEDULE OF LONG-TERM DEBT (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Debt Disclosure [Abstract] | ||
Long-term debt, net of debt discount of $3,450 ($5,061 at December 31, 2020) | $ 15,940 | $ 16,329 |
Less: current portion, net of debt discount of $0 ($0 at December 31, 2020) | ||
Long-term debt | $ 15,940 | $ 16,329 |
SCHEDULE OF LONG-TERM DEBT (D_2
SCHEDULE OF LONG-TERM DEBT (Details) (Parenthetical) - Long-term Debt [Member] - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Extinguishment of Debt [Line Items] | ||
Debt Instrument, Unamortized Discount | $ 3,450 | $ 5,061 |
Debt Instrument, Unamortized Discount, Current | $ 0 | $ 0 |
SCHEDULE OF INTEREST EXPENSE (D
SCHEDULE OF INTEREST EXPENSE (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Debt Disclosure [Abstract] | ||
Interest expense | $ 389 | $ 475 |
Amortization of debt discount | 1,611 | 239 |
Interest income | (188) | (132) |
Total interest expense, net of interest income | $ 1,812 | $ 582 |
SCHEDULE OF FUTURE PRINCIPAL OF
SCHEDULE OF FUTURE PRINCIPAL OF LONG-TERM DEBT (Details) $ in Thousands | Mar. 31, 2021USD ($) |
Debt Disclosure [Abstract] | |
Remaining 2021 | |
2022 | 4,215 |
2023 | 8,980 |
2024 | 6,195 |
Total | $ 19,390 |
LONG-TERM DEBT (Details Narrati
LONG-TERM DEBT (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | Feb. 03, 2021 | May 22, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | Sep. 30, 2020 | Dec. 31, 2020 |
Debt Instrument [Line Items] | ||||||
Debt Conversion, Converted Instrument, Amount | $ 2,000 | |||||
Proceeds from Warrant Exercises | 52 | |||||
Effective price of warrants | $ 1.52 | |||||
Intrinsic value of beneficial conversion feature recorded to additional paid in capital | $ 2,577 | |||||
Amortization of debt discount | 1,611 | $ 239 | ||||
Fair Value, Inputs, Level 3 [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt Instrument, Fair Value Disclosure | 18,921 | $ 20,117 | ||||
Loan and Guaranty Agreement [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt maturity date | Jun. 1, 2024 | |||||
Unamortized debt discount | 3,450 | $ 5,061 | ||||
Debt Instrument, Face Amount | $ 19,390 | |||||
Debt Instrument, Interest Rate, Stated Percentage | 8.25% | |||||
Remaining loan | $ 18,000 | |||||
Debt Instrument, Interest Rate, Effective Percentage | 18.14% | |||||
Debt increased percentage | 5.00% | |||||
Amortization of debt discount | $ 1,161 | |||||
Loan and Guaranty Agreement [Member] | Prime Rate [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt Instrument, Interest Rate, Stated Percentage | 5.00% | |||||
Loan and Guaranty Agreement [Member] | K2 Warrant [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Warrant or right, reason for issuance, description | additional common shares will be issuable pursuant to the K2 Warrant as determined by the principal amount of the additional funds advanced multiplied by 3.5% and divided by the Warrant Price, and the final payment will increase by 6.95% of the funds advanced. | |||||
Loan and Guaranty Agreement [Member] | Third Tranche [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Secured Debt | $ 10,000 | |||||
Debt Instrument, Interest Rate, Stated Percentage | 8.25% | |||||
Debt interest period extended date | Jan. 1, 2023 | |||||
Loan and Guaranty Agreement [Member] | K 2 Healthventures L L C [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt Instrument, Description | The Lenders agreed to make available the following additional tranches subject to the following conditions and upon the submission of a loan request by the Company: (1) up to $10 million available between January 1, 2021 and April 30, 2021 upon achievement of certain milestones (the “Second Tranche Term Loan”), (2) $10 million available between the closing date and December 31, 2021, subject to achievement of a certain U.S. Food and Drug Administration approval (the “Third Tranche Term Loan”), and (3) a final tranche of up to $ | |||||
Debt Conversion, Converted Instrument, Amount | $ 4,000 | |||||
Debt Instrument, Convertible, Conversion Price | $ 1.46 | |||||
Debt maturity date | Jun. 1, 2024 | |||||
Debt Issuance Costs, Net | $ 1,021 | |||||
Secured term loan final payment percentage | 6.95% | |||||
Additional discount | $ 1,390 | |||||
Unamortized debt discount | $ 6,169 | |||||
Loan and Guaranty Agreement [Member] | K 2 Healthventures L L C [Member] | K2 Warrant [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Class of warrant or right, number of securities called by each warrant or right | 625,000 | |||||
Exercise price of warrants | $ 1.12 | |||||
Warrant or right, reason for issuance, description | The number of common shares issuable pursuant to the K2 Warrant, at any given time, is determined by the aggregate original principal amount of the loans advanced at that time pursuant to the Loan Agreement multiplied by 3.5% and divided by the Warrant Price. If the full $50 million available in all K2 tranches is advanced pursuant to the Loan Agreement, up to 1,562,500 common shares will be issuable pursuant to the K2 Warrant. | |||||
Class of warrant or right, date from which warrants or rights exercisable | May 22, 2030 | |||||
Proceeds from Warrant Exercises | $ 1,181 | |||||
Loan and Guaranty Agreement [Member] | K 2 Healthventures L L C [Member] | First Tranche [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Secured Debt | 20,000 | |||||
Loan and Guaranty Agreement [Member] | K 2 Healthventures L L C [Member] | Final Tranche [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Secured Debt | 10,000 | |||||
Loan and Guaranty Agreement [Member] | Perceptive Credit Holdings L P [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Unamortized debt discount | $ 4,018 | |||||
Loan Agreement [Member] | K 2 Healthventures L L C [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt Conversion, Converted Instrument, Amount | $ 2,000 | |||||
Debt Instrument, Convertible, Conversion Price | $ 1.46 | |||||
Debt Conversion, Converted Instrument, Shares Issued | 1,369,863 | |||||
Debt Instrument, Call Feature | The Lenders have the ability to convert an additional $2 million at the Lenders’ option. |
SCHEDULE OF STOCK OPTIONS ACTIV
SCHEDULE OF STOCK OPTIONS ACTIVITY (Details) - Equity Option [Member] | 3 Months Ended |
Mar. 31, 2021$ / sharesshares | |
Summary of Investment Holdings [Line Items] | |
Number of Stock Options Outstanding, Beginning Balance | shares | 12,507,541 |
Weighted Average Exercise Price, Beginning Balance | $ / shares | $ 2.38 |
Number of Stock Options, Granted | shares | 5,540,000 |
Weighted Average Exercise Price, Granted | $ / shares | $ 3.15 |
Number of Stock Options, Forfeited | shares | (13,236) |
Weighted Average Exercise Price, Forfeited | $ / shares | $ 2.25 |
Number of Stock Options Outstanding, Ending Balance | shares | 18,034,305 |
Weighted Average Exercise Price, Ending Balance | $ / shares | $ 2.62 |
Number of Stock Options, Exercisable | shares | 7,028,418 |
Weighted Average Exercise Price, Exercisable | $ / shares | $ 2.66 |
SCHEDULE OF RESTRICTED STOCK UN
SCHEDULE OF RESTRICTED STOCK UNITS (Details) - Restricted Stock Units (RSUs) [Member] | 3 Months Ended |
Mar. 31, 2021$ / sharesshares | |
Class of Stock [Line Items] | |
Number of Stock Awards, Unvested shares outstanding beginning balance | shares | 129,356 |
Weighted Average Fair Value at Grant Date, Unvested shares outstanding beginning balance | $ / shares | $ 1.62 |
Number of Stock Awards, Vested | shares | (24,326) |
Weighted Average Fair Value at Grant Date, Vested | $ / shares | $ 2.03 |
Number of Stock Awards, Unvested shares outstanding ending balance | shares | 105,030 |
Weighted Average Fair Value at Grant Date, Unvested shares outstanding ending balance | $ / shares | $ 1.52 |
SCHEDULE OF FAIR VALUE OF OPTIO
SCHEDULE OF FAIR VALUE OF OPTIONS GRANTED BY USING BLACK-SCHOLES OPTION PRICING ASSUMPTIONS (Details) - $ / shares | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Equity [Abstract] | ||
Volatility | 97.13% | 90.12% |
Risk free interest rate | 0.54% | 1.54% |
Expected term in years | 5 years 10 months 6 days | 5 years 9 months 7 days |
Expected dividend yield | 0.00% | 0.00% |
Weighted average fair value per option | $ 2.40 | $ 1.04 |
SCHEDULE OF STOCK-BASED COMPENS
SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | Mar. 31, 2021 | |
Total stock-based compensation expense | $ 2,139 | $ 1,187 | $ 2,139 |
Research and Development [Member] | |||
Total stock-based compensation expense | 428 | 244 | |
General and Administrative [Member] | |||
Total stock-based compensation expense | 1,690 | 933 | |
Cost of Revenues [Member] | |||
Total stock-based compensation expense | $ 21 | $ 10 |
SCHEDULE OF WARRANT ACTIVITY (D
SCHEDULE OF WARRANT ACTIVITY (Details) - Warrants [Member] | 3 Months Ended |
Mar. 31, 2021$ / sharesshares | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | |
Number of Warrants, Balance Outstanding Beginning | shares | 3,197,666 |
Number of Warrants, Balance Outstanding Ending | $ / shares | $ 2.23 |
Number of Warrants, Exercised | shares | (34,494) |
Weighted Average Exercise Price, Exercised | $ / shares | $ 1.50 |
Number of Warrants, Balance Outstanding Ending | shares | 3,163,172 |
Weighted Average Exercise Price, Balance Outstanding Ending | $ / shares | $ 2.24 |
STOCKHOLDERS_ EQUITY AND ADDI_3
STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL (Details Narrative) - shares | 9 Months Ended | ||
Sep. 30, 2020 | Mar. 31, 2021 | Dec. 31, 2020 | |
2006 Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 989,813 | ||
2014 Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 521,242 | ||
2016 Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 16,523,250 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Percentage of Outstanding Stock Maximum | 10.00% | ||
Number of common shares available for issuance | 5,920,455 | ||
2016 VBI Equity Incentive Plan [Member] | Restricted Stock Units (RSUs) [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number | 105,030 |
SCHEDULE OF REVENUE COMPRISED (
SCHEDULE OF REVENUE COMPRISED (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 301 | $ 415 |
Product [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 167 | 180 |
Service [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 134 | $ 235 |
SUMMARY OF REVENUE EXPECTED TO
SUMMARY OF REVENUE EXPECTED TO BE RECOGNIZED IN FUTURE RELATED TO PERFORMANCE OBLIGATIONS (Details) $ in Thousands | Mar. 31, 2021USD ($) |
Disaggregation of Revenue [Line Items] | |
Revenues | $ 3,000 |
Current Portion To September Thirty Two Thousand Twenty One [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | 882 |
Remaining Portion Thereafter [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | 2,118 |
Product [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | 469 |
Product [Member] | Current Portion To September Thirty Two Thousand Twenty One [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | 0 |
Product [Member] | Remaining Portion Thereafter [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | 469 |
Service [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | 2,531 |
Service [Member] | Current Portion To September Thirty Two Thousand Twenty One [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | 882 |
Service [Member] | Remaining Portion Thereafter [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | $ 1,649 |
SUMMARY OF CHANGES IN DEFERRED
SUMMARY OF CHANGES IN DEFERRED REVENUE (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Dec. 31, 2020 | |
Revenue from Contract with Customer [Abstract] | ||
Contract with Customer, Liability | $ 3,104 | |
Contract with Customer, Liability, Revenue Recognized | (128) | |
Currency translation | 24 | |
Contract with Customer, Liability | 3,000 | |
Contract with Customer, Liability, Current | 882 | $ 255 |
Contract with Customer, Liability, Noncurrent | $ 2,118 | $ 2,849 |
REVENUES AND DEFERRED REVENUE_2
REVENUES AND DEFERRED REVENUE (Details Narrative) - USD ($) $ in Thousands | Dec. 04, 2018 | Mar. 31, 2021 | Dec. 31, 2020 |
Disaggregation of Revenue [Line Items] | |||
Remaining performance obligation, deemed to be initial transaction price | $ 3,000 | ||
Additional potential regulatory and sales milestone payments | $ 117,500 | ||
Contract with customer liability | 3,000 | $ 3,104 | |
License Agreement [Member] | Brii Bio [Member] | |||
Disaggregation of Revenue [Line Items] | |||
Non-refundable upfront payment | $ 11,000 | ||
Stock issued for the agreement, shares | 2,295,082 | ||
Stock issued for the agreement | $ 3,626 | ||
Remaining performance obligation, deemed to be initial transaction price | 7,374 | ||
License Agreement [Member] | Brii Bio [Member] | R&D Services [Member] | |||
Disaggregation of Revenue [Line Items] | |||
Remaining performance obligation, deemed to be initial transaction price | 4,737 | ||
License Agreement [Member] | Brii Bio [Member] | VBI-2601 [Member] | |||
Disaggregation of Revenue [Line Items] | |||
Remaining performance obligation, deemed to be initial transaction price | $ 2,637 | ||
Collaboration and License Agreement [Member] | |||
Disaggregation of Revenue [Line Items] | |||
Unsatisfied amount of research and development services | 2,331 | ||
Contract with customer liability | $ 3,000 |
COLLABORATION ARRANGEMENTS (Det
COLLABORATION ARRANGEMENTS (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Research and development expenses | $ 6,839 | $ 3,193 | |
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 B.1.351 variant, also known as 501Y.V2, first identified in South Africa. CEPI will 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 B.1.351 strain, through Phase I clinical development. This funding will also support preclinical expansion of additional multivalent vaccine candidates designed to evaluate the potential breadth of our eVLP technology. | ||
Proceeds from collaborations | $ 8,285 | ||
Reduction in expense | 157 | ||
Deferred funding | 8,107 | ||
Collaboration Agreement [Member] | Glaxo Smith Kline Biologicals S. A. [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Research and development expenses | 256 | $ 0 | |
Collaboration Agreement [Member] | National Research Council of Canada [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Research and development expenses | 158 | ||
CEPI Funding Agreement [Member] | National Research Council of Canada [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Research and development expenses | 157 | ||
Collaborative Relationship [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Deferred funding | $ 8,107 |
GOVERNMENT GRANTS (Details Narr
GOVERNMENT GRANTS (Details Narrative) $ in Thousands, $ in Thousands | Sep. 16, 2020CAD ($) | Jul. 03, 2020CAD ($) | Mar. 31, 2021USD ($) | Dec. 31, 2020USD ($) |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Deferred government grants | $ 1,417 | $ 825 | ||
Industrial Research Assistance Program [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Reduction in expense | 0 | |||
Deferred government grants | 396 | |||
Industrial Research Assistance Program [Member] | Cannadian Dollar [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Estimated contribution on transfer and scaleup of technical production process | $ 1,000 | |||
Strategic Innovation Fund [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Reduction in expense | 2,688 | |||
Deferred government grants | $ 1,021 | |||
Strategic Innovation Fund [Member] | Cannadian Dollar [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
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 | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease costs | $ 343 | $ 288 |
Weighted average remaining lease term | 1 year 10 months 17 days | |
Weighted average discount rate | 12.00% |
SCHEDULE OF FUTURE UNDISCOUNTED
SCHEDULE OF FUTURE UNDISCOUNTED CASH PAYMENTS RECONCILED TO LEASE LIABILITIES (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Commitments and Contingencies Disclosure [Abstract] | ||
Remaining 2021 | $ 802 | |
2022 | 523 | |
2023 | 125 | |
Total | 1,450 | |
Effect of discounting | (103) | |
Total lease liability | 1,347 | |
Less: current portion | (885) | $ (944) |
Long term lease liability | $ 462 | $ 619 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details Narrative) $ in Thousands | Sep. 13, 2018USD ($) | Sep. 13, 2018ILS (₪) | Mar. 31, 2021 |
UNITED STATES | Office Facility Lease Agreement [Member] | |||
Product Liability Contingency [Line Items] | |||
Lease expiration date | Apr. 30, 2023 | ||
ISRAEL | Manufacturing Facility Lease Agreement [Member] | |||
Product Liability Contingency [Line Items] | |||
Options to extend, description | Our manufacturing facility lease agreement expires on January 31, 2022, which includes one five-year option to extend until January 31, 2027. | ||
CANADA | Lease Agreement [Member] | |||
Product Liability Contingency [Line Items] | |||
Options to extend, description | The lease agreement for our research facility in Canada, which comprises office and laboratory space, has a term ending on December 31, 2022 with the option to extend the term for one additional period of three years and a term ending April 30, 2023 for the additional space leased during 2020. | ||
Sci B Vac [Member] | |||
Product Liability Contingency [Line Items] | |||
Damage amount | $ | $ 563,737 | ||
Sci B Vac [Member] | NIS Currency [Member] | |||
Product Liability Contingency [Line Items] | |||
Damage amount | ₪ | ₪ 1,879,500,000 |
SCHEDULE OF REVENUES FROM EXTER
SCHEDULE OF REVENUES FROM EXTERNAL CUSTOMERS (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | $ 301 | $ 415 |
ISRAEL | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | 169 | 132 |
China / Hong Kong [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | 128 | 231 |
Europe [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | $ 4 | $ 52 |
SEGMENT INFORMATION (Details Na
SEGMENT INFORMATION (Details Narrative) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021USD ($)Segment | Mar. 31, 2020USD ($) | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Number of operating segments | Segment | 1 | |
Revenues | $ 301 | $ 415 |
CANADA | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | $ 0 | $ 0 |