Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2023 | May 12, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2023 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2023 | |
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 | 8,608,539 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
CURRENT ASSETS | ||
Cash | $ 40,392 | $ 62,629 |
Accounts receivable, net | 281 | 94 |
Inventory, net | 6,768 | 6,599 |
Prepaid expenses | 2,419 | 2,309 |
Other current assets | 1,976 | 6,059 |
Total current assets | 51,836 | 77,690 |
NON-CURRENT ASSETS | ||
Other long-term assets | 1,311 | 1,355 |
Property and equipment, net | 11,690 | 12,253 |
Right of use assets | 2,992 | 3,316 |
Intangible assets, net | 58,500 | 58,345 |
Goodwill | 2,132 | 2,127 |
Total non-current assets | 76,625 | 77,396 |
TOTAL ASSETS | 128,461 | 155,086 |
CURRENT LIABILITIES | ||
Accounts payable | 9,837 | 12,973 |
Other current liabilities | 18,101 | 22,588 |
Current portion of deferred revenues | 649 | 409 |
Current portion of lease liability | 986 | 972 |
Total current liabilities | 29,573 | 36,942 |
NON-CURRENT LIABILITIES | ||
Deferred revenues, net of current portion | 1,961 | 2,204 |
Long-term debt, net of debt discount | 49,359 | 48,888 |
Lease liability, net of current portion | 2,026 | 2,365 |
Liabilities for severance pay | 520 | 524 |
Total non-current liabilities | 53,866 | 53,981 |
COMMITMENTS AND CONTINGENCIES (NOTE 14) | ||
STOCKHOLDERS’ EQUITY | ||
Common shares (unlimited authorized; no par value) (March 31, 2023 - issued and outstanding 8,608,539; December 31, 2022 - issued and outstanding 8,608,539) | 442,322 | 442,312 |
Additional paid-in capital | 92,021 | 90,020 |
Accumulated other comprehensive income | 28,039 | 21,440 |
Accumulated deficit | (517,360) | (489,609) |
Total stockholders’ equity | 45,022 | 64,163 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 128,461 | $ 155,086 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Statement of Financial Position [Abstract] | ||
Common stock, shares authorized | Unlimited | Unlimited |
Common stock, no par value | $ 0 | $ 0 |
Common stock, shares issued | 8,608,539 | 8,608,539 |
Common stock, shares outstanding | 8,608,539 | 8,608,539 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Income Statement [Abstract] | ||
Revenues, net | $ 485 | $ 126 |
Operating expenses: | ||
Cost of revenues | 3,559 | 2,754 |
Research and development | 3,151 | 2,362 |
Sales, general and administrative | 13,284 | 10,930 |
Total operating expenses | 19,994 | 16,046 |
Loss from operations | (19,509) | (15,920) |
Interest expense, net | (1,429) | (940) |
Foreign exchange loss | (6,813) | (4,394) |
Loss before income taxes | (27,751) | (21,254) |
Income tax expense | ||
NET LOSS | (27,751) | (21,254) |
Other comprehensive income | 6,599 | 5,103 |
COMPREHENSIVE LOSS | $ (21,152) | $ (16,151) |
Net loss per share of common shares, basic and diluted | $ (3.22) | $ (2.47) |
Weighted-average number of common shares outstanding, basic and diluted | 8,608,539 | 8,608,532 |
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 |
Balance at Dec. 31, 2021 | $ 442,235 | $ 81,583 | $ (1,565) | $ (378,371) | $ 143,882 |
Balance, shares at Dec. 31, 2021 | 8,608,298 | ||||
Stock-based compensation | $ 25 | 2,477 | 2,502 | ||
Net loss | (21,254) | (21,254) | |||
Currency translation adjustments | 5,103 | 5,103 | |||
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 upon exercise of options, shares | 241 | ||||
Balance at Mar. 31, 2022 | $ 442,272 | 81,314 | 3,538 | (397,560) | 129,564 |
Balance, shares at Mar. 31, 2022 | 8,608,539 | ||||
Balance at Dec. 31, 2022 | $ 442,312 | 90,020 | 21,440 | (489,609) | 64,163 |
Balance, shares at Dec. 31, 2022 | 8,608,539 | ||||
Stock-based compensation | $ 10 | 2,001 | 2,011 | ||
Net loss | (27,751) | (27,751) | |||
Currency translation adjustments | 6,599 | 6,599 | |||
Balance at Mar. 31, 2023 | $ 442,322 | $ 92,021 | $ 28,039 | $ (517,360) | $ 45,022 |
Balance, shares at Mar. 31, 2023 | 8,608,539 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (27,751) | $ (21,254) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 508 | 473 |
Stock-based compensation | 2,011 | 2,502 |
Amortization of debt discount | 470 | 410 |
Inventory reserve | 263 | 220 |
Change in operating right of use assets | 333 | 342 |
Unrealized foreign exchange loss | 6,895 | 4,297 |
Net change in operating working capital items: | ||
Change in accounts receivable | (185) | (94) |
Change in inventory | (599) | (1,744) |
Change in prepaid expenses | (118) | 209 |
Change in other current assets | 4,089 | (928) |
Change in other long-term assets | 28 | (197) |
Change in accounts payable | (3,204) | (459) |
Change in deferred revenues | 11 | (11) |
Change in other current liabilities | (4,073) | (3,350) |
Change in operating lease liabilities | (334) | (341) |
Net cash flows used in operating activities | (21,656) | (19,925) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Purchase of property and equipment | (534) | (515) |
Net cash flows used in investing activities | (534) | (515) |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Proceeds from issuance of common shares for cash, upon exercise of options | 12 | |
Net cash flows provided by financing activities | 12 | |
Effect of exchange rates on cash | (47) | 71 |
CHANGE IN CASH FOR THE PERIOD | (22,237) | (20,357) |
CASH, BEGINNING OF PERIOD | 62,629 | 121,694 |
CASH, END OF PERIOD | 40,392 | 101,337 |
Supplementary information: | ||
Interest paid | 1,437 | 604 |
Non-cash investing and financing activities: | ||
Adjustments for prior periods from adoption of ASU 2020-06 | 681 | |
Capital expenditures included in accounts payable and other current liabilities | 120 | 146 |
Share issuance costs included in other current liabilities | $ 67 | $ 67 |
NATURE OF BUSINESS AND CONTINUA
NATURE OF BUSINESS AND CONTINUATION OF BUSINESS | 3 Months Ended |
Mar. 31, 2023 | |
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”); 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. Reverse Stock Split The Company effected a 1-for-30 reverse stock split All share and per share amounts, including common shares underlying stock options, restricted stock units, and warrants, and applicable exercise prices, have been retroactively adjusted for all periods presented herein to give effect to the Reverse Split as required in accordance with United States of America generally accepted accounting principles (“U.S. GAAP”). Per the requirements of the Business Corporations Act remaining after the completion of the Split that was less than half of a share was cancelled and each fractional share that was at least half of a share was rounded up to one whole share. No shareholders received cash in lieu of fractional shares. 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. Recent Organizational Changes As announced on April 4, 2023, VBI plans to focus the Company’s efforts on the fight against hepatitis B, concentrating on broadening access to PreHevbrio and PreHevbri, where it is available, and advancing its HBV immunotherapeutic candidate, VBI-2601, which has the potential to be part of functional cure regimen for chronic HBV patients. As part of this commitment, we also announced our plans to reduce our workforce by 30 35 30 35 COVID-19 Pandemic 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, our business and results of operations were adversely affected and, as the ongoing effects of the COVID-19 pandemic continue to impact the global economy, these effects may continue to adversely affect our business and results of operations. The extent to which these effects will continue to impact our business will depend on future developments, which are highly uncertain and cannot be predicted. Recently, the World Health Organization determined that COVID-19 no longer fit the definition of a public health emergency and the U.S. government announced its plan to let the declaration of a public health emergency associated with COVID-19 expire on May 11, 2023. COVID-19 is expected to remain a serious endemic threat for an indefinite future period and may continue to adversely affect the global economy, and we are unable to predict 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. 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 has an accumulated deficit of $ 517,360 40,392 21,656 The Company will require significant additional funds to conduct clinical and non-clinical trials, achieve and maintain regulatory approvals, and commercially launch and sell our approved products. Additional financing may be obtained from the issuance of equity securities, the issuance of additional debt, 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 from this uncertainty. 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 | 3 Months Ended |
Mar. 31, 2023 | |
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 U.S. GAAP, have been condensed or omitted pursuant to such rules and regulations. The December 31, 2022 condensed 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, 2022 (the “2022 10-K”), as filed with the SEC on March 13, 2023. 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 2022 10-K, and there have been no changes to the Company’s significant accounting policies during the three months ended March 31, 2023, other than the polices discussed below. |
NEW ACCOUNTING PRONOUNCEMENTS
NEW ACCOUNTING PRONOUNCEMENTS | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Changes and Error Corrections [Abstract] | |
NEW ACCOUNTING PRONOUNCEMENTS | 3. NEW ACCOUNTING PRONOUNCEMENTS Recently Adopted Accounting Pronouncements 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. Our adoption of this ASU, effective January 1, 2023, did not have a material impact on our condensed consolidated financial statements and the related footnote disclosures. |
INVENTORY, NET
INVENTORY, NET | 3 Months Ended |
Mar. 31, 2023 | |
Inventory Disclosure [Abstract] | |
INVENTORY, NET | 4. INVENTORY, NET Inventory consists of the following: SCHEDULE OF INVENTORY March 31, 2023 December 31, Finished goods $ 894 $ 893 Work-in-process 2,520 1,869 Raw materials 3,354 3,837 Inventory, net $ 6,768 $ 6,599 |
OTHER CURRENT ASSETS
OTHER CURRENT ASSETS | 3 Months Ended |
Mar. 31, 2023 | |
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, 2023 December 31, Government receivables $ 1,203 $ 4,033 Other current assets 773 2,026 Total other current assets $ 1,976 $ 6,059 |
INTANGIBLE ASSETS, NET, AND GOO
INTANGIBLE ASSETS, NET, AND GOODWILL | 3 Months Ended |
Mar. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
INTANGIBLE ASSETS, NET, AND GOODWILL | 6. INTANGIBLE ASSETS, NET, AND GOODWILL SCHEDULE OF INDEFINITE LIVED INTANGIBLE ASSETS INCLUDING CUMULATIVE IMPAIRMENT AND CURRENCY TRANSLATION March 31, 2023 Gross Carrying Amount Accumulated Amortization Cumulative Impairment Charge Cumulative Currency Translation Net Book Value License $ 669 $ (669 ) $ - $ - $ - IPR&D assets 61,500 - (300 ) (2,700 ) 58,500 $ 62,169 $ (669 ) $ (300 ) $ (2,700 ) $ 58,500 December 31, 2022 Gross Carrying Amount Accumulated Amortization Cumulative Impairment Charge Cumulative Currency Translation Net Book Value License $ 669 $ (669 ) $ - $ - $ - IPR&D assets 61,500 - (300 ) (2,855 ) 58,345 $ 62,169 $ (669 ) $ (300 ) $ (2,855 ) $ 58,345 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, 2022, relates to currency translation adjustments which increased by $ 155 SCHEDULE OF GOODWILL March 31, 2023 Gross Carrying Amount Cumulative Impairment Charge Cumulative Currency Translation Net Book Value Goodwill $ 8,714 $ (6,292 ) $ (290 ) $ 2,132 December 31, 2022 Gross Cumulative Cumulative Net Book Goodwill $ 8,714 $ (6,292 ) $ (295 ) $ 2,127 The change in carrying value for goodwill from December 31, 2022, relates to currency translation adjustments which increased by $ 5 |
OTHER CURRENT LIABILITIES
OTHER CURRENT LIABILITIES | 3 Months Ended |
Mar. 31, 2023 | |
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, 2023 December 31, Accrued research and development expenses (including clinical trial accrued expenses) $ 5,450 $ 6,561 Accrued professional fees 3,215 3,250 Payroll and employee-related costs 2,531 4,036 Deferred funding 6,154 6,966 Other current liabilities 751 1,775 Total other current liabilities $ 18,101 $ 22,588 |
LOSS PER SHARE OF COMMON SHARES
LOSS PER SHARE OF COMMON SHARES | 3 Months Ended |
Mar. 31, 2023 | |
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, 2023 and 2022 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 2023 2022 Three months ended March 31, 2023 2022 Warrants 118,816 46,136 Stock options and restricted stock units 803,894 779,524 K2HV conversion feature 205,396 45,662 Antidilutive weighted average shares outstanding 1,128,106 871,322 |
LONG-TERM DEBT
LONG-TERM DEBT | 3 Months Ended |
Mar. 31, 2023 | |
Debt Disclosure [Abstract] | |
LONG-TERM DEBT | 9. LONG-TERM DEBT As of March 31, 2023, and December 31, 2022, the Company’s long-term debt is as follows: SCHEDULE OF LONG-TERM DEBT March 31, December 31, Long-term debt, net of debt discount of $ 6,341 6,811 $ 49,359 $ 48,888 Less: current portion - - Long-term debt, net of current portion $ 49,359 $ 48,888 On May 22, 2020, the Company, along with its subsidiary VBI Cda (collectively, the “Borrowers”), entered into the Loan and Guaranty Agreement (the “Loan Agreement”) with K2 HealthVentures LLC (“K2HV”) 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 4,000 43.80 June 1, 2024 2,000 45,662 43.80 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 45,662 43.80 5,000 159,734 31.302 In connection with the Loan Agreement, on May 22, 2020, the Company issued the Lenders a warrant to purchase up to 20,833 33.60 10,417 31,250 33.60 50,000 72,680 24.08 50,000 72,680 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 $ 24.08 6.95 The total principal amount of the loan under the Loan Agreement as amended by the Second Amendment, outstanding at March 31, 2023, including the Original Final Payment of $ 2,224 3,475 55,699 8.00 4.00 12.00 50,000 15.66 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 initial debt discount related to the Second Amendment is $ 7,359 6,341 6,811 At March 31, 2023 and December 31, 2022, the fair value of our outstanding debt, which is considered level 3 in the fair value hierarchy, is estimated to be $ 51,290 56,510 Interest expense, net recorded in the three months ended March 31, 2023 and 2022 was as follows: SCHEDULE OF INTEREST EXPENSE Three months ended March 31 2023 2022 Interest expense $ 1,461 $ 607 Amortization of debt discount 470 410 Interest income (502 ) (77 ) Total interest expense, net of interest income $ 1,429 $ 940 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 2023 $ - 2024 2,224 2025 - 2026 53,475 Total $ 55,699 |
STOCKHOLDERS_ EQUITY AND ADDITI
STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL | 3 Months Ended |
Mar. 31, 2023 | |
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 March 31, 2023, there were 28,090 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 March 31, 2023, there were 17,368 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 10 758,436 no The aggregate number of common shares remaining available for issuance for awards under the 2016 Plan totaled 8,169 Activity related to stock options is as follows: SCHEDULE OF STOCK OPTIONS ACTIVITY Number of Stock Weighted Average Exercise Price Balance outstanding at December 31, 2022 761,243 $ 71.26 Granted 43,976 17.25 Forfeited (1,325 ) 75.58 Balance outstanding at March 31, 2023 803,894 $ 68.32 Exercisable at March 31, 2023 592,328 $ 73.33 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, 2022 82 $ 43.80 Vested (82 ) 43.80 Unvested shares outstanding at March 31, 2023 - $ - 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 Three months ended March 31 2023 2022 Volatility 94.46 % 93.17 % Risk free interest rate 3.56 % 1.71 % Expected term in years 5.76 5.83 Expected dividend yield 0.00 % 0.00 % Weighted average fair value per option $ 13.25 $ 34.50 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, 2023 and 2022 was as follows: SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE Three months ended March 31 2023 2022 Research and development $ 266 $ 510 Sales, general and administrative 1,718 1,966 Cost of revenues 27 26 $ 2,011 $ 2,502 |
REVENUES, NET AND DEFERRED REVE
REVENUES, NET AND DEFERRED REVENUE | 3 Months Ended |
Mar. 31, 2023 | |
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 March 31 2023 2022 Product revenues, net $ 478 $ 91 R&D service revenues 7 35 $ 485 $ 126 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, 2023: SUMMARY OF REVENUE EXPECTED TO BE RECOGNIZED IN FUTURE RELATED TO PERFORMANCE OBLIGATIONS Total Current portion to March 31, 2024 Remaining portion thereafter Product revenues, net $ 469 $ - $ 469 R&D service revenues 2,141 649 1,492 $ 2,610 $ 649 $ 1,961 The following table presents changes in the deferred revenue balance for the three months ended March 31, 2023: SUMMARY OF CHANGES IN DEFERRED REVENUE Balance at January 1, 2022 $ 2,803 - - Balance at December 31, 2022 2,613 Recognition of deferred revenue (7 ) Currency translation 4 Balance at March 31, 2023 $ 2,610 Short Term $ 649 Long Term $ 1,961 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 II collaboration clinical trial for the purpose of comparing VBI-2601, 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 of the Licensed Product, for the treatment of HBV in the Licensed Territory and to commercialize and 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”) whereby: ● the Company and Brii Bio agreed to conduct an additional Phase II combination clinical trial of VBI-2601, 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 76,502 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 March 31, 2023, R&D services related to Brii Bio that remain unsatisfied are $ 1,941 2,610 Upon termination of the 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, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
COLLABORATION ARRANGEMENTS | 12. COLLABORATION ARRANGEMENTS The Company has entered into, and expects to enter into from time to time in the future, license agreements, funding agreements, collaboration agreements and similar agreements related to the advancement of its product candidates and research and development efforts. Significant agreements (collectively, the “Collaboration Agreements”) are described in detail in the Company’s 2022 Form 10-K. While specific amounts will fluctuate from quarter to quarter based on clinical trials progress, advancement and completion of research studies and manufacturing projects, and other factors, the Company believes its overall activities regarding Collaboration Agreements are materially consistent with those described in the 2022 Form 10-K, other than described below. Set forth below are the approximate amounts expensed for Collaboration Agreements during the three months ended March 31, 2023 and 2022, respectively. These expensed amounts are included under Research and Development expenses in the accompanying condensed consolidated statements of operations. SCHEDULE OF RESEARCH AND DEVELOPMENT EXPENSE 2023 2022 Three months ended March 31 2023 2022 GlaxoSmithKline Biologicals S.A $ 103 $ 135 National Research Council of Canada (“NRC”) 35 280 Coalition for Epidemic Preparedness Innovations (“CEPI”) 829 1,693 Brii Biosciences Limited 69 24 Agenus Inc. 56 - Research and Development expenses $ 1,092 $ 2,132 NRC On February 28, 2023, the Company signed a seventh amendment to the collaboration agreement with the NRC to extend the expiration date of the collaboration agreement to December 31, 2023. On April 17, 2023, the Company signed an eighth amendment to the collaboration agreement with the NRC to further broaden the scope to include the development of stable cell lines for our multivalent vaccine candidate against coronaviruses. CEPI T he Company has $ 6,154 recorded as deferred funding, recorded in other current liabilities on the condensed consolidated balance sheet. |
GOVERNMENT GRANTS
GOVERNMENT GRANTS | 3 Months Ended |
Mar. 31, 2023 | |
Government Grants | |
GOVERNMENT GRANTS | 13. GOVERNMENT GRANTS 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 Costs associated with the contribution agreement are expensed as incurred in Research and Development expenses. For the three months ended March 31, 2023 and 2022, the Company recognized $ 41 0 0 44 Strategic Innovation Fund (“SIF”) On September 16, 2020, the Company signed the Contribution Agreement (as amended, the “Contribution Agreement”) with Her Majesty the Queen in Right of Canada, as represented by the Minister of Industry (the “Minister”), whereby the Minister agreed to contribute an amount not exceeding the lesser of (i) 75% of VBI Cda’s costs incurred in respect of the Project, subject to certain eligibility limitations as set forth in the Contribution Agreement and (ii) CAD $56 million from the SIF to support the development of our coronavirus vaccine program, VBI-2900, though Phase II clinical studies (the “Project”) Costs associated with the Contribution Agreement are expensed as incurred in Research and Development expenses and overhead charges are included in Sales, General and Administrative. For the three months ended March 31, 2023 and 2022, the Company recognized $ 1,707 1,453 0 753 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 3 Months Ended |
Mar. 31, 2023 | |
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 1,879,500 519,917 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, June 9, 2022, and January 12, 2023. The next preliminary hearing is scheduled to be held on July 13, 2023. On December 5, 2022, another tort claim was filed in the District Court of the central district in Israel naming our subsidiary, SciVac, as a defendant. The claim was filed by a minor and his parents against SciVac, the IMoH, and Prof. Arieh Raziel, requesting compensation due to bodily injury of the minor, who was diagnosed as suffering from an Autism Spectrum Disorder. The plaintiffs allege that the minor’s disabilities and the syndrome from which he suffers were caused due to a combination of several factors, including negligent pregnancy monitoring, negligent labor and delivery procedure, and administration of the alleged defective vaccine (Sci-B-Vac vaccine). Preliminary hearings will begin on July 13, 2023. SciVac believes these matters to be without merit and intends to defend these claims vigorously. |
LEASES
LEASES | 3 Months Ended |
Mar. 31, 2023 | |
Leases | |
LEASES | 15. 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 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 U.S. expires on October 31, 2024 with no option to extend. Our manufacturing facility lease agreement in Israel has been extended for 5 years with a term now ending January 31, 2027 A lease for additional office space in Israel has a term ending November 30, 2025 with an option to extend for two additional years and June 30, 2027 with an option to extend the term for five additional years. In September 2022, the Company extended the term of our lease for our research facility in Canada, which comprises office and laboratory space, for three additional years, which now has a term ending on December 31, 2025 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. SCHEDULE OF LEASE COST AND OTHER INFORMATION Three months ended March 31 2023 2022 Operating lease cost $ 491 $ 341 Weighted average discount rate 13 % 12 % Weighted average remaining lease term 2.74 3.39 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: SUMMARY OF FUTURE UNDISCOUNTED CASH PAYMENTS RECONCILED TO LEASE LIABILITIES Remaining 2023 $ 970 2024 1,193 2025 686 2026 594 2027 163 Total $ 3,606 Effect of discounting (594 ) Total lease liability $ 3,012 Less: current portion (986 ) Lease liability, net of current portion $ 2,026 |
SEGMENT INFORMATION
SEGMENT INFORMATION | 3 Months Ended |
Mar. 31, 2023 | |
Segment Reporting [Abstract] | |
SEGMENT INFORMATION | 16. 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 March 31 2023 2022 United States $ 322 $ - Israel - 95 China / Hong Kong 7 25 Europe 156 6 $ 485 $ 126 There was no |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 3 Months Ended |
Mar. 31, 2023 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | 17. SUBSEQUENT EVENTS On April 4, 2023, as discussed in Note 1, the Company announced its intention to reduce our operating expenses and internal workforce by 30 35 On April 12, 2023, as discussed in Note 1, the Company effected the Reverse Stock Split. On April 26, 2023, the Company received a letter from the Listing Qualifications Department of Nasdaq stating that for the last 10 consecutive business days, from April 12, 2023 to April 25, 2023, the closing bid price of the Company’s common shares had been at or greater than $ 1.00 On April 27, 2023, the Company approved the grant of options to purchase 8,000 36 April 27, 2033 . The Company has experienced a significant and sustained drop in our stock price during April 2023 that may be an indicator of a potential impairment to our property and equipment, intangible assets, and goodwill, which may result in the Company having to perform an interim impairment analysis during the three months ended June 30, 2023. |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
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 U.S. GAAP, have been condensed or omitted pursuant to such rules and regulations. The December 31, 2022 condensed 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, 2022 (the “2022 10-K”), as filed with the SEC on March 13, 2023. 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 2022 10-K, and there have been no changes to the Company’s significant accounting policies during the three months ended March 31, 2023, other than the polices discussed below. |
INVENTORY, NET (Tables)
INVENTORY, NET (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Inventory Disclosure [Abstract] | |
SCHEDULE OF INVENTORY | Inventory consists of the following: SCHEDULE OF INVENTORY March 31, 2023 December 31, Finished goods $ 894 $ 893 Work-in-process 2,520 1,869 Raw materials 3,354 3,837 Inventory, net $ 6,768 $ 6,599 |
OTHER CURRENT ASSETS (Tables)
OTHER CURRENT ASSETS (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
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, 2023 December 31, Government receivables $ 1,203 $ 4,033 Other current assets 773 2,026 Total other current assets $ 1,976 $ 6,059 |
INTANGIBLE ASSETS, NET, AND G_2
INTANGIBLE ASSETS, NET, AND GOODWILL (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
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 March 31, 2023 Gross Carrying Amount Accumulated Amortization Cumulative Impairment Charge Cumulative Currency Translation Net Book Value License $ 669 $ (669 ) $ - $ - $ - IPR&D assets 61,500 - (300 ) (2,700 ) 58,500 $ 62,169 $ (669 ) $ (300 ) $ (2,700 ) $ 58,500 December 31, 2022 Gross Carrying Amount Accumulated Amortization Cumulative Impairment Charge Cumulative Currency Translation Net Book Value License $ 669 $ (669 ) $ - $ - $ - IPR&D assets 61,500 - (300 ) (2,855 ) 58,345 $ 62,169 $ (669 ) $ (300 ) $ (2,855 ) $ 58,345 |
SCHEDULE OF GOODWILL | SCHEDULE OF GOODWILL March 31, 2023 Gross Carrying Amount Cumulative Impairment Charge Cumulative Currency Translation Net Book Value Goodwill $ 8,714 $ (6,292 ) $ (290 ) $ 2,132 December 31, 2022 Gross Cumulative Cumulative Net Book Goodwill $ 8,714 $ (6,292 ) $ (295 ) $ 2,127 |
OTHER CURRENT LIABILITIES (Tabl
OTHER CURRENT LIABILITIES (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Other Liabilities Disclosure [Abstract] | |
SCHEDULE OF OTHER CURRENT LIABILITIES | Other current liabilities consisted of the following: SCHEDULE OF OTHER CURRENT LIABILITIES March 31, 2023 December 31, Accrued research and development expenses (including clinical trial accrued expenses) $ 5,450 $ 6,561 Accrued professional fees 3,215 3,250 Payroll and employee-related costs 2,531 4,036 Deferred funding 6,154 6,966 Other current liabilities 751 1,775 Total other current liabilities $ 18,101 $ 22,588 |
LOSS PER SHARE OF COMMON SHAR_2
LOSS PER SHARE OF COMMON SHARES (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
SCHEDULE OF ANTI-DILUTIVE WEIGHTED AVERAGE SHARES OUTSTANDING | The following potentially dilutive securities outstanding at March 31, 2023 and 2022 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 2023 2022 Three months ended March 31, 2023 2022 Warrants 118,816 46,136 Stock options and restricted stock units 803,894 779,524 K2HV conversion feature 205,396 45,662 Antidilutive weighted average shares outstanding 1,128,106 871,322 |
LONG-TERM DEBT (Tables)
LONG-TERM DEBT (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Debt Disclosure [Abstract] | |
SCHEDULE OF LONG-TERM DEBT | As of March 31, 2023, and December 31, 2022, the Company’s long-term debt is as follows: SCHEDULE OF LONG-TERM DEBT March 31, December 31, Long-term debt, net of debt discount of $ 6,341 6,811 $ 49,359 $ 48,888 Less: current portion - - Long-term debt, net of current portion $ 49,359 $ 48,888 |
SCHEDULE OF INTEREST EXPENSE | Interest expense, net recorded in the three months ended March 31, 2023 and 2022 was as follows: SCHEDULE OF INTEREST EXPENSE Three months ended March 31 2023 2022 Interest expense $ 1,461 $ 607 Amortization of debt discount 470 410 Interest income (502 ) (77 ) Total interest expense, net of interest income $ 1,429 $ 940 |
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 2023 $ - 2024 2,224 2025 - 2026 53,475 Total $ 55,699 |
STOCKHOLDERS_ EQUITY AND ADDI_2
STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
SCHEDULE OF STOCK OPTIONS ACTIVITY | Activity related to stock options is as follows: SCHEDULE OF STOCK OPTIONS ACTIVITY Number of Stock Weighted Average Exercise Price Balance outstanding at December 31, 2022 761,243 $ 71.26 Granted 43,976 17.25 Forfeited (1,325 ) 75.58 Balance outstanding at March 31, 2023 803,894 $ 68.32 Exercisable at March 31, 2023 592,328 $ 73.33 |
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, 2022 82 $ 43.80 Vested (82 ) 43.80 Unvested shares outstanding at March 31, 2023 - $ - |
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 Three months ended March 31 2023 2022 Volatility 94.46 % 93.17 % Risk free interest rate 3.56 % 1.71 % Expected term in years 5.76 5.83 Expected dividend yield 0.00 % 0.00 % Weighted average fair value per option $ 13.25 $ 34.50 |
SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE | SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE Three months ended March 31 2023 2022 Research and development $ 266 $ 510 Sales, general and administrative 1,718 1,966 Cost of revenues 27 26 $ 2,011 $ 2,502 |
REVENUES, NET AND DEFERRED RE_2
REVENUES, NET AND DEFERRED REVENUE (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Revenue from Contract with Customer [Abstract] | |
SCHEDULE OF REVENUE COMPRISED | Revenues, net comprises the following: SCHEDULE OF REVENUE COMPRISED Three months ended March 31 2023 2022 Product revenues, net $ 478 $ 91 R&D service revenues 7 35 $ 485 $ 126 |
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, 2023: SUMMARY OF REVENUE EXPECTED TO BE RECOGNIZED IN FUTURE RELATED TO PERFORMANCE OBLIGATIONS Total Current portion to March 31, 2024 Remaining portion thereafter Product revenues, net $ 469 $ - $ 469 R&D service revenues 2,141 649 1,492 $ 2,610 $ 649 $ 1,961 |
SUMMARY OF CHANGES IN DEFERRED REVENUE | The following table presents changes in the deferred revenue balance for the three months ended March 31, 2023: SUMMARY OF CHANGES IN DEFERRED REVENUE Balance at January 1, 2022 $ 2,803 - - Balance at December 31, 2022 2,613 Recognition of deferred revenue (7 ) Currency translation 4 Balance at March 31, 2023 $ 2,610 Short Term $ 649 Long Term $ 1,961 |
COLLABORATION ARRANGEMENTS (Tab
COLLABORATION ARRANGEMENTS (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
SCHEDULE OF RESEARCH AND DEVELOPMENT EXPENSE | SCHEDULE OF RESEARCH AND DEVELOPMENT EXPENSE 2023 2022 Three months ended March 31 2023 2022 GlaxoSmithKline Biologicals S.A $ 103 $ 135 National Research Council of Canada (“NRC”) 35 280 Coalition for Epidemic Preparedness Innovations (“CEPI”) 829 1,693 Brii Biosciences Limited 69 24 Agenus Inc. 56 - Research and Development expenses $ 1,092 $ 2,132 |
LEASES (Tables)
LEASES (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Leases | |
SCHEDULE OF LEASE COST AND OTHER INFORMATION | SCHEDULE OF LEASE COST AND OTHER INFORMATION Three months ended March 31 2023 2022 Operating lease cost $ 491 $ 341 Weighted average discount rate 13 % 12 % Weighted average remaining lease term 2.74 3.39 |
SUMMARY OF FUTURE UNDISCOUNTED CASH PAYMENTS RECONCILED TO LEASE LIABILITIES | The following table summarizes future undiscounted cash payments reconciled to the lease liabilities: SUMMARY OF FUTURE UNDISCOUNTED CASH PAYMENTS RECONCILED TO LEASE LIABILITIES Remaining 2023 $ 970 2024 1,193 2025 686 2026 594 2027 163 Total $ 3,606 Effect of discounting (594 ) Total lease liability $ 3,012 Less: current portion (986 ) Lease liability, net of current portion $ 2,026 |
SEGMENT INFORMATION (Tables)
SEGMENT INFORMATION (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
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 March 31 2023 2022 United States $ 322 $ - Israel - 95 China / Hong Kong 7 25 Europe 156 6 $ 485 $ 126 |
NATURE OF BUSINESS AND CONTIN_2
NATURE OF BUSINESS AND CONTINUATION OF BUSINESS (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Apr. 12, 2023 | Apr. 04, 2023 | Mar. 31, 2023 | Mar. 31, 2022 | Jun. 30, 2023 | Dec. 31, 2022 | |
Subsequent Event [Line Items] | ||||||
Entity incorporation, date of incorporation | Apr. 09, 1965 | |||||
Accumulated deficit | $ 517,360 | $ 489,609 | ||||
Cash | 40,392 | $ 62,629 | ||||
Cash outflows from operating activities | $ 21,656 | $ 19,925 | ||||
Subsequent Event [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Reverse stock split | 1-for-30 reverse stock split | |||||
Subsequent Event [Member] | Minimum [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Operating expenses and workforce reduction percentage | 30% | 30% | ||||
Subsequent Event [Member] | Maximum [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Operating expenses and workforce reduction percentage | 35% | 35% |
SCHEDULE OF INVENTORY (Details)
SCHEDULE OF INVENTORY (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Finished goods | $ 894 | $ 893 |
Work-in-process | 2,520 | 1,869 |
Raw materials | 3,354 | 3,837 |
Inventory, net | $ 6,768 | $ 6,599 |
SCHEDULE OF OTHER CURRENT ASSET
SCHEDULE OF OTHER CURRENT ASSETS (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Government receivables | $ 1,203 | $ 4,033 |
Other current assets | 773 | 2,026 |
Total other current assets | $ 1,976 | $ 6,059 |
SCHEDULE OF INDEFINITE LIVED IN
SCHEDULE OF INDEFINITE LIVED INTANGIBLE ASSETS INCLUDING CUMULATIVE IMPAIRMENT AND CURRENCY TRANSLATION (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | $ 62,169 | $ 62,169 |
Accumulated Amortization | (669) | (669) |
Cumulative Impairment Charge | (300) | (300) |
Cumulative Currency Translation | (2,700) | (2,855) |
Net Book value | 58,500 | 58,345 |
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 | (2,700) | (2,855) |
Net Book value | 58,500 | 58,345 |
License [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | 669 | 669 |
Accumulated Amortization | (669) | (669) |
Cumulative Impairment Charge | ||
Cumulative Currency Translation | ||
Net Book value |
SCHEDULE OF GOODWILL (Details)
SCHEDULE OF GOODWILL (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
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 | (290) | (295) |
Goodwill, Net Book value | $ 2,132 | $ 2,127 |
INTANGIBLE ASSETS, NET, AND G_3
INTANGIBLE ASSETS, NET, AND GOODWILL (Details Narrative) $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible asset foreign currency translation adjustment | $ 155 |
Goodwill foreign currency translation adjustment | $ 5 |
SCHEDULE OF OTHER CURRENT LIABI
SCHEDULE OF OTHER CURRENT LIABILITIES (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Other Liabilities Disclosure [Abstract] | ||
Accrued research and development expenses (including clinical trial accrued expenses) | $ 5,450 | $ 6,561 |
Accrued professional fees | 3,215 | 3,250 |
Payroll and employee-related costs | 2,531 | 4,036 |
Deferred funding | 6,154 | 6,966 |
Other current liabilities | 751 | 1,775 |
Total other current liabilities | $ 18,101 | $ 22,588 |
SCHEDULE OF ANTI-DILUTIVE WEIGH
SCHEDULE OF ANTI-DILUTIVE WEIGHTED AVERAGE SHARES OUTSTANDING (Details) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive weighted average shares outstanding | 1,128,106 | 871,322 |
Warrant [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive weighted average shares outstanding | 118,816 | 46,136 |
Stock Options and Restricted Stock Units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive weighted average shares outstanding | 803,894 | 779,524 |
K2HV Conversion Feature [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive weighted average shares outstanding | 205,396 | 45,662 |
SCHEDULE OF LONG-TERM DEBT (Det
SCHEDULE OF LONG-TERM DEBT (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Debt Disclosure [Abstract] | ||
Long-term debt, net of debt discount of $6,341 ($6,811 at December 31, 2022) | $ 49,359 | $ 48,888 |
Less: current portion | ||
Long-term debt, net of current portion | $ 49,359 | $ 48,888 |
SCHEDULE OF LONG-TERM DEBT (D_2
SCHEDULE OF LONG-TERM DEBT (Details) (Parenthetical) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Long-Term Debt [Member] | ||
Extinguishment of Debt [Line Items] | ||
Debt instrument, unamortized discount | $ 6,341 | $ 6,811 |
SCHEDULE OF INTEREST EXPENSE (D
SCHEDULE OF INTEREST EXPENSE (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Debt Disclosure [Abstract] | ||
Interest expense | $ 1,461 | $ 607 |
Amortization of debt discount | 470 | 410 |
Interest income | (502) | (77) |
Total interest expense, net of interest income | $ 1,429 | $ 940 |
SCHEDULE OF FUTURE PRINCIPAL OF
SCHEDULE OF FUTURE PRINCIPAL OF LONG-TERM DEBT (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Total | $ 49,359 | $ 48,888 |
Loan Agreement [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Remaining 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 | ||||||
Sep. 14, 2022 | Feb. 03, 2021 | May 22, 2020 | Mar. 31, 2023 | Dec. 31, 2022 | Sep. 15, 2022 | May 17, 2021 | |
Debt Instrument [Line Items] | |||||||
Final payment | $ 55,699 | ||||||
Fair Value, Inputs, Level 3 [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, fair value disclosure | $ 51,290 | $ 56,510 | |||||
Second Amendment [Member] | K2 HealthVentures LLC [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Increase amount of term loans available | $ 100,000 | ||||||
Loan and Guaranty Agreement [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt increased percentage | 5% | ||||||
Loan and Guaranty Agreement [Member] | K2 HealthVentures LLC [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt conversion, converted instrument, amount | $ 4,000 | ||||||
Conversion price | $ 43.80 | ||||||
Debt instrument, maturity date | Jun. 01, 2024 | ||||||
Debt face amount | $ 30,000 | ||||||
Loan and Guaranty Agreement [Member] | K2 HealthVentures LLC [Member] | K2 Warrant [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Purchase of warrants | 20,833 | ||||||
Warrant price | $ 33.60 | ||||||
Loan and Guaranty Agreement [Member] | K2 HealthVentures LLC [Member] | Restated K2 Warrant [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Purchase of warrants | 10,417 | ||||||
Warrant price | $ 33.60 | ||||||
Total purchase of warrants | 31,250 | ||||||
Loan and Guaranty Agreement [Member] | K2 HealthVentures LLC [Member] | Second Amendment Warrant [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt face amount | $ 50,000 | ||||||
Purchase of warrants | 72,680 | ||||||
Warrant price | $ 24.08 | ||||||
Shares available | $ 50,000 | ||||||
Loan and Guaranty Agreement [Member] | First Tranche [Member] | K2 HealthVentures LLC [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Secured debt | $ 20,000 | ||||||
Loan and Guaranty Agreement [Member] | First Amendment [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Additional secured debt | $ 12,000 | ||||||
Debt face amount | 30,000 | ||||||
Loan and Guaranty Agreement [Member] | First Amendment [Member] | K2 HealthVentures LLC [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Final payment, value | $ 2,224 | ||||||
Loan and Guaranty Agreement [Member] | Second Amendment [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, maturity date | Sep. 14, 2026 | ||||||
Debt face amount | $ 50,000 | ||||||
Warrant price | $ 24.08 | ||||||
Secured term loan final payment percentage | 6.95% | ||||||
Final payment amount | $ 3,475 | ||||||
Debt instrument, interest rate, stated percentage | 12% | ||||||
Debt instrument, interest rate, effective percentage | 15.66% | ||||||
Debt instrument discount | $ 7,359 | ||||||
Debt instrument, unamortized discount | $ 6,341 | $ 6,811 | |||||
Loan and Guaranty Agreement [Member] | Second Amendment [Member] | Prime Rate Plus [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, interest rate, stated percentage | 4% | ||||||
Loan and Guaranty Agreement [Member] | Second Amendment [Member] | Minimum [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, interest rate, stated percentage | 8% | ||||||
Loan and Guaranty Agreement [Member] | Second Amendment [Member] | K2 HealthVentures LLC [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Purchase of warrants | 72,680 | ||||||
Loan Agreement [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Term loan available | $ 50,000 | ||||||
Loan Agreement [Member] | Second Tranche Term Loan [Member] | Maximum [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt face amount | 15,000 | ||||||
Loan Agreement [Member] | Third Tranche Term Loan [Member] | Maximum [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt face amount | 10,000 | ||||||
Loan Agreement [Member] | Fourth Tranche Term Loan [Member] | Maximum [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt face amount | 25,000 | ||||||
Loan Agreement [Member] | K2 HealthVentures LLC [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt conversion, converted instrument, amount | $ 2,000 | ||||||
Conversion price | $ 43.80 | ||||||
Conversion price | 45,662 | ||||||
Loan Agreement [Member] | Second Amendment [Member] | First Tranche Term Loan [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt face amount | $ 50,000 | ||||||
Loan Agreement [Member] | Second Amendment [Member] | K2 HealthVentures LLC [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Convertible amount | $ 7,000 | ||||||
Loan Agreement [Member] | Second Amendment [Member] | K2 HealthVentures LLC [Member] | Conversion Price of $43.80 Per Share [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Conversion price | $ 43.80 | ||||||
Convertible amount | $ 2,000 | ||||||
Shares available for conversion | 45,662 | ||||||
Loan Agreement [Member] | Second Amendment [Member] | K2 HealthVentures LLC [Member] | Conversion Price of $31.302 Per Share [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Conversion price | $ 31.302 | ||||||
Convertible amount | $ 5,000 | ||||||
Shares available for conversion | 159,734 |
SCHEDULE OF STOCK OPTIONS ACTIV
SCHEDULE OF STOCK OPTIONS ACTIVITY (Details) - Equity Option [Member] | 3 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Offsetting Assets [Line Items] | |
Number of Stock Options Outstanding, Beginning Balance | shares | 761,243 |
Weighted Average Exercise Price, Beginning Balance | $ / shares | $ 71.26 |
Number of Stock Options, Granted | shares | 43,976 |
Weighted Average Exercise Price, Granted | $ / shares | $ 17.25 |
Number of Stock Options, Forfeited | shares | (1,325) |
Weighted Average Exercise Price, Forfeited | $ / shares | $ 75.58 |
Number of Stock Options Outstanding, Ending Balance | shares | 803,894 |
Weighted Average Exercise Price, Ending Balance | $ / shares | $ 68.32 |
Number of Stock Options, Exercisable | shares | 592,328 |
Weighted Average Exercise Price, Exercisable | $ / shares | $ 73.33 |
SCHEDULE OF RESTRICTED STOCK UN
SCHEDULE OF RESTRICTED STOCK UNITS (Details) - Restricted Stock Units (RSUs) [Member] | 3 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Class of Stock [Line Items] | |
Number of Stock Awards, Unvested shares outstanding beginning balance | shares | 82 |
Weighted Average Fair Value at Grant Date, Unvested shares outstanding beginning balance | $ / shares | $ 43.80 |
Number of Stock Awards, Vested | shares | (82) |
Weighted Average Fair Value at Grant Date, Vested | $ / shares | $ 43.80 |
Number of Stock Awards, Unvested shares outstanding beginning balance | shares | |
Weighted Average Fair Value at Grant Date, Unvested shares outstanding ending balance | $ / shares |
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, 2023 | Mar. 31, 2022 | |
Equity [Abstract] | ||
Volatility | 94.46% | 93.17% |
Risk free interest rate | 3.56% | 1.71% |
Expected term in years | 5 years 9 months 3 days | 5 years 9 months 29 days |
Expected dividend yield | 0% | 0% |
Weighted average fair value per option | $ 13.25 | $ 34.50 |
SCHEDULE OF STOCK-BASED COMPENS
SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Total stock-based compensation expense | $ 2,011 | $ 2,502 |
Research and Development Expense [Member] | ||
Total stock-based compensation expense | 266 | 510 |
General and Administrative Expense [Member] | ||
Total stock-based compensation expense | 1,718 | 1,966 |
Cost of Sales [Member] | ||
Total stock-based compensation expense | $ 27 | $ 26 |
STOCKHOLDERS_ EQUITY AND ADDI_3
STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL (Details Narrative) | 3 Months Ended |
Mar. 31, 2023 shares | |
2006 Plan [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Options outstanding | 28,090 |
2014 Plan [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Options outstanding | 17,368 |
2016 Plan [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Share-based compensation arrangement by share-based, percentage | 10% |
Number of common shares remaining available for issuance for awards | 8,169 |
2016 Plan [Member] | Share-Based Payment Arrangement, Option [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Options outstanding | 758,436 |
2016 Plan [Member] | Restricted Stock Units (RSUs) [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Unvested stock | 0 |
SCHEDULE OF REVENUE COMPRISED (
SCHEDULE OF REVENUE COMPRISED (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 485 | $ 126 |
Product [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 478 | 91 |
Service [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 7 | $ 35 |
SUMMARY OF REVENUE EXPECTED TO
SUMMARY OF REVENUE EXPECTED TO BE RECOGNIZED IN FUTURE RELATED TO PERFORMANCE OBLIGATIONS (Details) $ in Thousands | Mar. 31, 2023 USD ($) |
Disaggregation of Revenue [Line Items] | |
Revenues | $ 2,610 |
Current Portion to March 31, 2024 [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | 649 |
Remaining Portion Thereafter [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | 1,961 |
Product [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | 469 |
Product [Member] | Current Portion to March 31, 2024 [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 | 2,141 |
Service [Member] | Current Portion to March 31, 2024 [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | 649 |
Service [Member] | Remaining Portion Thereafter [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | $ 1,492 |
SUMMARY OF CHANGES IN DEFERRED
SUMMARY OF CHANGES IN DEFERRED REVENUE (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Revenue from Contract with Customer [Abstract] | ||
Contract with customer liability,beginning | $ 2,613 | $ 2,803 |
Recognition of deferred revenue | (7) | |
Currency translation | 4 | |
Contract with customer liability,ending | 2,610 | 2,613 |
Contract with customer, liability, current | 649 | 409 |
Contract with customer, liability, non-current | $ 1,961 | $ 2,204 |
REVENUES, NET AND DEFERRED RE_3
REVENUES, NET AND DEFERRED REVENUE (Details Narrative) - USD ($) $ in Thousands | Dec. 04, 2018 | Mar. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Disaggregation of Revenue [Line Items] | ||||
Revenue, remaining performance obligation, amount | $ 2,610 | |||
Additional potential regulatory and sales milestone payments | $ 117,500 | |||
Contract with customer, liability | 2,610 | $ 2,613 | $ 2,803 | |
Service [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue, remaining performance obligation, amount | 2,141 | |||
License Agreement [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
License Agreement | $ 1,941 | |||
License Agreement [Member] | Brii Bio [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Non-refundable upfront payment | $ 11,000 | |||
Stock issued during period, shares | 76,502 | |||
Stock issued during period, value | $ 3,626 | |||
Revenue, remaining performance obligation, amount | 7,374 | |||
License Agreement [Member] | Brii Bio [Member] | Service [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue, remaining performance obligation, amount | 4,737 | |||
License Agreement [Member] | Brii Bio [Member] | VBI-2601 [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue, remaining performance obligation, amount | $ 2,637 |
SCHEDULE OF RESEARCH AND DEVELO
SCHEDULE OF RESEARCH AND DEVELOPMENT EXPENSE (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Research and Development expenses | $ 3,151 | $ 2,362 |
Collaboration Agreement [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Research and Development expenses | 1,092 | 2,132 |
Collaboration Agreement [Member] | Glaxo Smith Kline Biologicals S. A. [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Research and Development expenses | 103 | 135 |
Collaboration Agreement [Member] | National Research Council of Canada [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Research and Development expenses | 35 | 280 |
Collaboration Agreement [Member] | Coalition for Epidemic Preparedness Innovations [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Research and Development expenses | 829 | 1,693 |
Collaboration Agreement [Member] | Brii Bio [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Research and Development expenses | 69 | 24 |
Collaboration Agreement [Member] | Agenus Inc [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Research and Development expenses | $ 56 |
COLLABORATION ARRANGEMENTS (Det
COLLABORATION ARRANGEMENTS (Details Narrative) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Deferred funding | $ 6,154 | $ 6,966 |
GOVERNMENT GRANTS (Details Narr
GOVERNMENT GRANTS (Details Narrative) $ in Thousands, $ in Thousands | 3 Months Ended | |||
Sep. 16, 2020 | Jul. 03, 2020 CAD ($) | Mar. 31, 2023 USD ($) | Mar. 31, 2022 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Contribution agreement description | 75% of VBI Cda’s costs incurred in respect of the Project, subject to certain eligibility limitations as set forth in the Contribution Agreement and (ii) CAD $56 million from the SIF to support the development of our coronavirus vaccine program, VBI-2900, though Phase II clinical studies (the “Project”) | |||
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 | $ 41 | $ 0 | ||
Deferred government grants | 0 | 44 | ||
Strategic Innovation Fund [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Reduction expenses | 1,707 | 1,453 | ||
Deferred government grants | $ 0 | $ 753 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details Narrative) - Sci B Vac [Member] ₪ in Thousands, $ in Thousands | Sep. 13, 2018 USD ($) Integer | Sep. 13, 2018 ILS (₪) Integer |
Product Liability Contingency [Line Items] | ||
children vaccinated | 428,000 | 428,000 |
Loss contingency, damages seeking, value | $ 519,917 | ₪ 1,879,500 |
SCHEDULE OF LEASE COST AND OTHE
SCHEDULE OF LEASE COST AND OTHER INFORMATION (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Leases | ||
Operating lease cost | $ 491 | $ 341 |
Weighted average discount rate | 13% | 12% |
Weighted average remaining lease term | 2 years 8 months 26 days | 3 years 4 months 20 days |
SUMMARY OF FUTURE UNDISCOUNTED
SUMMARY OF FUTURE UNDISCOUNTED CASH PAYMENTS RECONCILED TO LEASE LIABILITIES (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Leases | ||
Remaining 2023 | $ 970 | |
2024 | 1,193 | |
2025 | 686 | |
2026 | 594 | |
2027 | 163 | |
Total | 3,606 | |
Effect of discounting | (594) | |
Total lease liability | 3,012 | |
Less: current portion | (986) | $ (972) |
Lease liability, net of current portion | $ 2,026 | $ 2,365 |
LEASES (Details Narrative)
LEASES (Details Narrative) | 3 Months Ended |
Mar. 31, 2023 | |
ISRAEL | Manufacturing Facility Lease Agreement [Member] | |
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] | |
Lessee, operating lease, option to extend | A lease for additional office space in Israel has a term ending November 30, 2025 with an option to extend for two additional years and June 30, 2027 with an option to extend the term for five additional years. In September 2022, the Company extended the term of our lease for our research facility in Canada, which comprises office and laboratory space, for three additional years, which now has a term ending on December 31, 2025 |
SCHEDULE OF REVENUES FROM EXTER
SCHEDULE OF REVENUES FROM EXTERNAL CUSTOMERS (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | $ 485 | $ 126 |
UNITED STATES | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | 322 | |
ISRAEL | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | 95 | |
China / Hong Kong [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | 7 | 25 |
Europe [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | $ 156 | $ 6 |
SEGMENT INFORMATION (Details Na
SEGMENT INFORMATION (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenue | $ 485 | $ 126 |
CANADA | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenue | $ 0 | $ 0 |
SUBSEQUENT EVENTS (Details Narr
SUBSEQUENT EVENTS (Details Narrative) - Subsequent Event [Member] - $ / shares | 6 Months Ended | |||
Apr. 27, 2023 | Apr. 04, 2023 | Jun. 30, 2023 | Apr. 26, 2023 | |
Subsequent Event [Line Items] | ||||
Bid price | $ 1 | |||
2016 Plan [Member] | ||||
Subsequent Event [Line Items] | ||||
Options to purchase common shares | 8,000 | |||
Option vesting term | 36 months | |||
Expiration date | Apr. 27, 2033 | |||
Minimum [Member] | ||||
Subsequent Event [Line Items] | ||||
Operating expenses and workforce reduction percentage | 30% | 30% | ||
Maximum [Member] | ||||
Subsequent Event [Line Items] | ||||
Operating expenses and workforce reduction percentage | 35% | 35% |