Cover
Cover - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Apr. 16, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Fiscal Period Focus | FY | ||
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 Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
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 Public Float | $ 21,950,347 | ||
Entity Common Stock, Shares Outstanding | 28,432,275 | ||
Documents Incorporated by Reference [Text Block] | Portions of the registrant’s Definitive Proxy Statement on Schedule 14A to be furnished to stockholders in connection with its 2024 Annual Meeting of Stockholders, which shall be filed with the Securities and Exchange Commission within 120 days after the end of the fiscal year to which this Annual Report on Form 10-K relates, are incorporated by reference in Part III, Items 10-14 of this Annual Report on Form 10-K | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Auditor Firm ID | 274 | ||
Auditor Name | EISNERAMPER LLP | ||
Auditor Location | Iselin, New Jersey |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
CURRENT ASSETS | ||
Cash | $ 23,685 | $ 62,629 |
Accounts receivable, net | 94 | |
Inventory, net | 8,499 | 6,599 |
Prepaid expenses | 2,284 | 2,309 |
Other current assets | 1,763 | 6,059 |
Total current assets | 36,231 | 77,690 |
NON-CURRENT ASSETS | ||
Other long-term assets | 1,178 | 1,355 |
Property and equipment, net | 9,665 | 12,253 |
Right of use assets | 2,248 | 3,316 |
Intangible assets, net | 36,499 | 58,345 |
Goodwill | 1,130 | 2,127 |
Total non-current assets | 50,720 | 77,396 |
TOTAL ASSETS | 86,951 | 155,086 |
CURRENT LIABILITIES | ||
Accounts payable | 6,431 | 12,973 |
Other current liabilities | 10,284 | 22,588 |
Current portion of deferred revenues | 7,276 | 409 |
Current portion of lease liability | 976 | 972 |
Current portion of long-term debt, net of debt discount | 50,769 | |
Total current liabilities | 75,736 | 36,942 |
NON-CURRENT LIABILITIES | ||
Deferred revenues, net of current portion | 1,832 | 2,204 |
Lease liability, net of current portion | 1,295 | 2,365 |
Long-term debt, net of debt discount | 48,888 | |
Liabilities for severance pay | 561 | 524 |
Total non-current liabilities | 3,688 | 53,981 |
COMMITMENTS AND CONTINGENCIES (NOTE 17) | ||
STOCKHOLDERS’ EQUITY | ||
Common shares (unlimited authorized; no par value) (2023 issued and outstanding – 23,918,983; 2022 issued and outstanding – 8,608,539) | 454,214 | 442,312 |
Additional paid-in capital | 107,431 | 90,020 |
Accumulated other comprehensive income | 28,327 | 21,440 |
Accumulated deficit | (582,445) | (489,609) |
Total stockholders’ equity | 7,527 | 64,163 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 86,951 | $ 155,086 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | 12 Months Ended | |
Dec. 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 | 23,918,983 | 8,608,539 |
Common stock, shares outstanding | 23,918,983 | 8,608,539 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Statement [Abstract] | ||
Revenues, net | $ 8,682 | $ 1,082 |
Operating expenses: | ||
Cost of revenues | 12,507 | 11,276 |
Research and development | 9,343 | 15,506 |
Sales, general and administrative | 42,143 | 56,120 |
Impairment charges | 24,600 | |
Total operating expenses | 88,593 | 82,902 |
Loss from operations | (79,911) | (81,820) |
Interest expense, net of interest income | (6,401) | (4,007) |
Foreign exchange loss | (6,524) | (27,476) |
Loss before income taxes | (92,836) | (113,303) |
Income tax expense | ||
NET LOSS | (92,836) | (113,303) |
Deemed dividend on certain warrants | (1,005) | |
NET LOSS AVAILABLE TO COMMON STOCKHOLDERS | (93,841) | (113,303) |
Other comprehensive income | 6,887 | 23,005 |
COMPREHENSIVE LOSS | $ (85,949) | $ (90,298) |
Net loss per share of common shares, basic | $ (6.03) | |
Net loss per share of common shares, diluted | $ (6.03) | $ (13.16) |
Weighted-average number of common shares outstanding, basic | 15,572,494 | |
Weighted-average number of common shares outstanding, diluted | 15,572,494 | 8,608,530 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - 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, 2021 | $ 442,235 | $ 81,583 | $ (1,565) | $ (378,371) | $ 143,882 |
Beginning balance, shares at Dec. 31, 2021 | 8,608,298 | ||||
Adjustments for prior periods from adoption of ASU 2020-06 | (2,746) | 2,065 | (681) | ||
Common shares issued upon exercise of options | $ 12 | 12 | |||
Common shares issued up on exercise of options, shares | 241 | ||||
Warrant issued in connection with debt amendment | 1,550 | 1,550 | |||
Stock-based compensation | 65 | 9,633 | 9,698 | ||
Net loss | (113,303) | (113,303) | |||
Currency translation adjustments | 23,005 | 23,005 | |||
Ending balance, value at Dec. 31, 2022 | $ 442,312 | 90,020 | 21,440 | (489,609) | 64,163 |
Ending balance, shares at Dec. 31, 2022 | 8,608,539 | ||||
Stock-based compensation | $ 10 | 6,651 | 6,661 | ||
Net loss | (92,836) | (92,836) | |||
Currency translation adjustments | 6,887 | 6,887 | |||
Common shares issued in financing transactions, net of issuance costs | $ 22,652 | 22,652 | |||
Common shares issued in financing transactions, net of issuance costs, shares | 15,310,444 | ||||
Warrants issued in connection with financing transactions | $ (10,760) | 10,760 | |||
Ending balance, value at Dec. 31, 2023 | $ 454,214 | $ 107,431 | $ 28,327 | $ (582,445) | $ 7,527 |
Ending balance, shares at Dec. 31, 2023 | 23,918,983 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (92,836) | $ (113,303) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Depreciation and amortization | 1,990 | 2,061 |
Stock-based compensation | 6,661 | 9,698 |
Amortization of debt discount | 1,881 | 1,707 |
Loss on extinguishment of long-term debt | 172 | |
Impairment charges | 24,600 | |
Inventory reserve | 1,668 | 1,186 |
Change in operating right of use assets | 1,408 | 1,357 |
Unrealized foreign exchange loss | 6,609 | 27,445 |
Net change in operating working capital items: | ||
Change in accounts receivable | 99 | (87) |
Change in inventory | (3,718) | (5,690) |
Change in prepaid expenses | 17 | 18 |
Change in other current assets | 4,281 | (2,738) |
Change in other long-term assets | 102 | (173) |
Change in accounts payable | (6,652) | 8,893 |
Change in deferred revenues | 6,356 | 16 |
Change in other current liabilities | (11,943) | (2,910) |
Payments made on operating lease liabilities | (1,406) | (1,347) |
Net cash flows used in operating activities | (60,883) | (73,695) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Purchase of property and equipment | (867) | (4,344) |
Net cash flows used in investing activities | (867) | (4,344) |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Proceeds from issuance of common shares for cash | 24,273 | |
Share issuance costs | (1,575) | |
Proceeds from issuance of common shares for cash, upon exercise of stock options | 12 | |
Proceeds from debt financing | 20,000 | |
Debt issuance costs | (563) | |
Net cash flows provided by financing activities | 22,698 | 19,449 |
Effect of exchange rates on cash | 108 | (475) |
CHANGE IN CASH FOR THE YEAR | (38,944) | (59,065) |
CASH, BEGINNING OF YEAR | 62,629 | 121,694 |
CASH, END OF YEAR | 23,685 | 62,629 |
Supplementary information: | ||
Interest paid | 6,130 | 3,231 |
Non-cash investing and financing: | ||
Adjustments for prior periods from adoption of ASU 2020-06 | 681 | |
Warrants issued in connection with financing transactions | 10,760 | |
Warrants issued in connection with debt amendment | 1,550 | |
Capital expenditures included in accounts payable and other current liabilities | 142 | 406 |
Share issuance costs included in other current liabilities | $ 112 | $ 67 |
NATURE OF BUSINESS AND CONTINUA
NATURE OF BUSINESS AND CONTINUATION OF BUSINESS | 12 Months Ended |
Dec. 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. Principal Operations 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 and a proprietary mRNA-launched eVLP (“MLE”) 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. 2023 Organizational Changes As announced on April 4, 2023, the Company reduced its internal workforce by 30 35 30 35 . 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 $ 582,445 23,685 60,883 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. Based on available cash at December 31, 2023, together with the net proceeds from the April 2024 Offering, in order to continue to fund our operations, we must raise additional equity or debt capital in the near term and cannot provide any assurance that we will be successful in doing so. If we are unable to obtain additional financing in the near future, we may be required to pursue a reorganization proceeding, including under applicable bankruptcy or insolvency laws. 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 from this uncertainty. On March 9, 2021, the Company and the Coalition for Epidemic Preparedness Innovations (“CEPI”) announced a partnership (“CEPI Funding Agreement”) to develop eVLP vaccine candidates against SARS-COV-2 variants, including the Beta variant, also known as the B.1.351 variant and 501Y.V2, first identified in South Africa. CEPI agreed to provide up to $ 33,018 On August 26, 2022, we 1) filed a registration statement on Form S-3 (File No. 333-267109), which included a base prospectus which covers the offering, issuance and sale of up to $ 300,000 125,000 1,046,808 738 0.7048 107 631 124,262 Upon filing of this Form 10-K, we will become subject to General Instruction I.B.6 of Form S-3, pursuant to which in no event will we sell our common shares in a registered primary offering using Form S-3 with a value exceeding more than one-third of our public float in any 12 calendar month period so long as our public float remains below $ 75,000 125,000 75,000 25,174 27,334,007 0.9210 In September 2022, the Company refinanced its existing term loan facility with K2HV to increase the amount of term loans available to $ 100,000 On July 5, 2023, the Company announced the expansion of its hepatitis B partnership with Brii Bio. Through (i) a Collaboration and License Agreement (the “Collaboration Agreement”), dated July 5, 2023, by and between the Company and Brii Bio, and (ii) the Amended and Restated Collaboration and License Agreement (the “A&R Collaboration Agreement, which amended and restated the Brii Collaboration and License Agreement, and together with the Collaboration Agreement, the “Brii Collaboration Agreements”), dated July 5, 2023, by and between the Company and Brii Bio, Brii Bio expanded its exclusive license to VBI-2601 to global rights and acquired an exclusive license for PreHevbri in Asia Pacific (“APAC”), excluding Japan. As part of this collaboration, Brii Bio paid the Company an upfront payment of $ 15,000 3,000 5,000 7,000 In July 2023, the Company closed (i) an underwritten public offering of 12,445,454 12,545,454 1,536,363 1,636,363 1.65 1,818,182 1,818,182 1.65 1.65 0.6057 20,500 3,000 As of December 31, 2023, the Company had outstanding warrants to purchase up to an aggregate of 14,363,636 0.6057 1,005 On November 1, 2023, the Company received a letter from the Listing Qualifications Department of the Nasdaq Capital Market’s (“Nasdaq”) indicating that, based upon the closing bid price of the Company’s common shares for the 30 consecutive business day period between September 19, 2023 through October 31, 2023, it did not meet the minimum bid price of $1.00 per share required for continued listing on Nasdaq pursuant to Nasdaq Listing Rule 5550(a)(2). The letter also indicated that the Company will be provided with a compliance period of 180 calendar days, or until April 29, 2024 (the “Compliance Period”), in which to regain compliance pursuant to Nasdaq Listing Rule 5810(c)(3)(A). In order to regain compliance with Nasdaq’s minimum bid price requirement, the common shares must maintain a minimum closing bid price of $1.00 for a minimum of ten consecutive business days during the Compliance Period. In the event that the Company does not regain compliance by the end of the Compliance Period, it may be eligible for additional time to regain compliance. To qualify, the Company will be required to meet the continued listing requirement for the market value of our publicly held shares and all other initial listing standards for Nasdaq, with the exception of the bid price requirement, and will need to provide written notice of our intention to cure the deficiency during the second compliance period, by effecting a reverse stock split if necessary. If we meet these requirements, the Company may be granted an additional 180 calendar days to regain compliance. The Company has not regained compliance as of the date of this Form 10-K, and if it fails to regain compliance during the Compliance Period or any subsequent grace period granted by Nasdaq, its common shares will be subject to delisting by Nasdaq, which could seriously decrease or eliminate the value of an investment in the common shares and result in significantly increased uncertainty as to the Company’s ability to raise additional capital. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | 2. SIGNIFICANT ACCOUNTING POLICIES Basis of Consolidation The consolidated financial statements include the accounts of VBI 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 consolidated financial statements. Reverse Stock Split On April 12, 2023, VBI effected a 1-for-30 reverse stock split Foreign Currency The functional and reporting currency of the Company is the United States dollar. Each of the Company’s subsidiaries determines its own respective functional currency, based on the primary economic environment that it operates in, and this currency is used to separately measure each entity’s financial position and operating results. Assets and liabilities of foreign operations with a different functional currency from that of the Company are translated at the closing rate at the end of each reporting period. Profit or loss items are translated at average exchange rates for all the relevant periods. All resulting translation differences are recognized as a component of other comprehensive loss /income. Foreign exchange gains and losses arising from transactions denominated in a currency other than the functional currency of the entity involved, are included in operating results. Use of Estimates Preparation of the consolidated financial statements in conformity with accounting principles generally accepted in the U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual amounts could differ from the estimates made. We continually evaluate estimates used in the preparation of the consolidated financial statements for reasonableness. Appropriate adjustments, if any, to the estimates used are made prospectively based upon such periodic evaluation. The significant areas of estimation include revenue recognition, determining the deferred tax valuation allowance, estimating accrued research and development expenses, the inputs in determining the fair value of the in-process research and development (“IPR&D”) and goodwill as part of the impairment analysis and the inputs in determining the fair value of equity-based awards and warrants issued. Actual results may differ from those estimates. Concentration of Credit Risk Financial instruments that potentially subject us to significant concentrations of credit risk consist principally of cash and accounts receivable. We place our cash primarily in commercial checking accounts. Commercial bank balances may from time to time exceed federal insurance limits. The Company has not experienced any losses in cash and accounts receivable for the years ended December 31, 2023 and 2022. Inventory Inventory components include all raw materials, work-in-progress and finished goods. Cost is determined on a specific item or first-in/first-out basis. The cost of inventories comprises costs to purchase, costs incurred in bringing the inventories to their present location and condition, and costs incurred in the manufacturing process including labor and overhead. Inventory is valued at the lower of cost or net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. On a quarterly basis, the Company evaluates the condition and age of inventories and makes provisions for slow moving inventories accordingly. Property and Equipment Property and equipment are recorded at cost less accumulated depreciation. The assets are depreciated by the straight-line method over the estimated useful lives of the related assets as follows: SCHEDULE OF ESTIMATED USEFUL LIVES OF PROPERTY AND EQUIPMENT Number of years Furniture and office equipment 5 14 Machinery and equipment 3 7 Computers 2 3 Leasehold improvements shorter of useful life or the term of the lease When assets are retired or otherwise disposed of, the cost and the related accumulated depreciation is removed from the accounts, and any resulting gain or loss is recognized in the consolidated statement of operations and comprehensive loss. The cost of maintenance and repairs is charged to expense as incurred; significant renewals and betterments are capitalized. Impairment of Long-Lived Assets Long-lived assets, such as property and equipment and finite-lived intangible assets, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. Recoverability of assets to be held and used is measured by comparison of the carrying amount of an asset the fair value of the asset. If the carrying amount of the asset exceeds the fair value of the asset, then an impairment charge is recognized for the amount by which the carrying amount of the asset exceeds the fair value of the asset. See Notes 6 and 7 for more details on impairment testing on property and equipment for the year ended December 31, 2023. In-Process Research and Development Assets and Goodwill The Company’s intangible assets determined to have indefinite useful lives including IPR&D and goodwill, are tested for impairment annually, or more frequently if events or circumstances indicate that the assets might be impaired. Such circumstances could include but are not limited to: (1) a significant adverse change in legal factors or in business climate, (2) unanticipated competition, or (3) an adverse action or assessment by a regulator. The Company has established August 31st as the date for its annual impairment test of IPR&D and goodwill. The costs of rights to IPR&D projects acquired in an asset acquisition are expensed in the consolidated statements of operations unless the project has an alternative future use. These costs include initial payments incurred prior to regulatory approval in connection with research and development agreements that provide rights to develop, manufacture, market and/or sell pharmaceutical products. The IPR&D assets, which consist of the CMV and GBM programs, were acquired in a business combination, capitalized as an intangible asset and are tested for impairment at least annually until commercialization, after which time the IPR&D will be amortized over its estimated useful life. The impairment test compares the carrying amount of the IPR&D asset to its fair value. If the carrying amount exceeds the fair value of the asset, such excess is recorded as an impairment loss. See Note 6 and 8 for more details on impairment testing for the year ended December 31, 2023. Goodwill represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired in a business combination. When evaluating goodwill for impairment, we may first perform an assessment qualitatively whether it is more likely than not that a reporting unit’s carrying amount exceeds its fair value, referred to as a “step zero” approach. Subsequently (if necessary, after step zero), if the carrying value of a reporting unit exceeded its fair value an impairment would be recorded. We would perform our goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. See Note 6 and 8 for more details on impairment testing for the year ended December 31, 2023. Restructuring charges Restructuring costs include charges associated with exit or disposal activities that meet the definition of restructuring under FASB ASC Topic 420, Exit or Disposal Cost Obligations (“ASC 420”). The Company’s restructuring plans are typically completed within a one-year period or less. Restructuring costs incurred under these plans may include (i) one-time termination benefits related to employee separations, (ii) contract termination costs, and (iii) other related costs associated with exit or disposal activities including, but not limited to, costs for consolidating or closing facilities. Long-Term Debt The Company accounts for long-term debt under the provisions of ASC 470-20, Debt – Debt with conversion and other options (“ASC 470”). Debt discount is charged to interest expense, net of interest income in the consolidated statement of operations and comprehensive loss using the effective interest method over the term of the debt. Research and Development All costs of research and development are expensed as incurred. When preparing our financial statements, we are required to estimate our accrued research and development expenses. This process involves reviewing contracts and communicating with our personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual cost. Payments under some of the contracts we have with third parties depend on factors such as successful enrollment of certain numbers of patients, site initiation and the completion of clinical trial milestones. When accruing research and development expenses, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If possible, we obtain information regarding unbilled services directly from our service providers. However, we may be required to estimate the cost of these services based only on information available to us. If we underestimate or overestimate the cost associated with research and development services at a given point in time, adjustments to research and development expenses may be necessary in future periods. Historically, our estimated accrued research and development expenses have approximated actual expense incurred. Government Grants Government grants are recognized in the consolidated statement of operations and comprehensive loss in the same period as the relevant expenses, in compliance with the agreement, as a reduction in the related expense or reduce the carrying value of the asset being acquired. Cash received from government grants related to deposits are recognized as deferred government grants, included in other current liabilities on the consolidated balance sheet, and recognized as the related deposit is used. CEPI Funding Agreement Cash received in advance from the CEPI Funding Agreement is included in cash on the 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 consolidated balance sheet, and recognized as a reduction in the related expense when incurred. As of December 31, 2023, the amount of cash received in advance from CEPI, not yet recognized as a reduction in expenses in the consolidated statement of operations but included in cash on the consolidated balance sheets, is $ 3,601 Revenue Recognition Product Sales, net We sell our product to a limited number of wholesalers and specialty distributors in the U.S., to Valneva, as part of our marketing and distribution agreement covering the U.K. and certain EU markets, and directly to health fund customers in Israel (collectively, our “Customers”). Revenues from product sales are recognized when we have satisfied our performance obligation, which is the transfer of control of our product upon delivery to the Customer. The timing between the recognition of revenue for product sales and the receipt of payment is not significant. Because our standard credit terms are short-term and we expect to receive payment in less than one-year, there is no significant financing component on the related receivables. Taxes collected from Customers relating to product sales and remitted to governmental authorities are excluded from revenues. Since our performance obligation is part of a contract that has an original expected duration of one year or less, we elect not to disclose the information about our remaining performance obligations. Overall, product revenue, net, reflects our best estimates of the amount of consideration to which we are entitled based on the terms of the contract. The amount of variable consideration is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. If we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of revenue that we report in a particular period. We evaluate our estimates of variable considerations including, but not limited to, product returns, chargebacks, rebates, and other fees, periodically or when there is an event or change in circumstances that may indicate that our estimates may change. Reserves for Variable Consideration Revenues from product sales are recorded at the net sales price, which includes estimates of variable consideration such as product returns, chargebacks, discounts, rebates, and other fees that are offered within contracts between us and our Customers, healthcare providers, pharmacies and others relating to our product sales. We estimate variable consideration using either the most likely amount method or the expected value method, depending on the type of variable consideration and what method better predicts the amount of consideration we expect to receive. We take into consideration relevant factors such as industry data, current contractual terms, available information about Customers’ inventory, resale and chargeback data and forecasted customer buying and payment patterns, in estimating each variable consideration. The variable consideration is recorded at the time product sales is recognized, resulting in a reduction in product revenue and a reduction in accounts receivable (if the Customer offsets the amount against its accounts receivable) or as an accrued liability (if we pay the amount through our accounts payable process). Variable consideration requires significant estimates, judgment and information obtained from external sources. Product Returns Consistent with industry practice, we offer our Customers a limited right of return based on the product’s expiration date for product that has been purchased from us. We estimate the amount of our product sales that may be returned by our Customers and record this estimate as a reduction of revenue in the period the related product revenue is recognized. We consider several factors in the estimation of potential product returns including expiration dates of the product shipped, the limited product return rights, available information about Customers’ inventory and other relevant factors. Chargebacks Our Customers subsequently resell our product to healthcare providers, pharmacies and others. In addition to distribution agreements with Customers, we enter into arrangements with qualified healthcare providers that provide for chargebacks and discounts with respect to the purchase of our product. Chargebacks represent the estimated obligations resulting from contractual commitments to sell product to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase the product from us. Customers charge us for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable. Chargeback amounts are determined at the time of resale to the qualified healthcare providers by Customers, and we issue credits for such amounts generally within a few weeks of the Customer’s notification to us of the resale. Reserves for chargebacks consists of credits that we expect to issue for units that remain in the distribution channel inventories at each reporting period end that we expect will be sold to the qualified healthcare providers, and chargebacks for units that our Customers have sold to the qualified healthcare providers, but for which credits have not been issued. Trade Discounts and Allowances We provide our Customers with discounts which include early payment incentives that are explicitly stated in our contracts, and are recorded as a reduction of revenue in the period the related product revenue is recognized. Distribution Fees Distribution fees include fees paid to certain Customers for sales order management, data, and distribution services. Distribution fees are recorded as a reduction of revenue in the period the related product revenue is recognized. Collaborative Arrangements The Company first evaluates license and/or collaboration arrangements to determine whether the arrangement (or part of the arrangement) represents a collaborative arrangement pursuant to Accounting Standards Codification (“ASC”) Topic 808, Collaborative Arrangements (“ASC 808”), based on the risks and rewards and activities of the parties pursuant to the contractual arrangement. The Company then determines if the collaborative arrangements are within the scope of ASC Topic 606, Revenue Recognition (“ASC 606”). Collaborative arrangements with partners which are within the scope of ASC 606 typically include payment to us of one or more of the following: (i) license fees; (ii) research and development services to be performed as part of the contract (“R&D services”) (iii) payments related to the achievement of developmental, regulatory, or commercial milestones; and (iv) royalties on net sales of licensed products. Collaborative arrangements (or elements within the contract that are deemed part of a collaborative arrangement) with partners which represent a collaborative relationship and not a customer relationship, are accounted for outside the scope of ASC Topic 606. License Fees If a license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. R&D Services The promises under the Company’s collaboration and license agreements generally include research and development services to be performed by the Company. For performance obligations that include research and development services, the Company generally recognizes revenue allocated to such performance obligations based on an appropriate measure of progress. The Company utilizes judgment to determine the appropriate method of measuring progress for purposes of recognizing revenue, which is generally an input measure such as costs incurred. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Royalties For arrangements that include sales-based royalties, including milestone payments based on a level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from any of its licensing arrangements. Employee Benefits The Company’s liability for severance pay for the employees of its subsidiary in Israel is calculated in accordance with Israeli law based on the most recent salary paid to employees and the length of employment in the Company. The Company records its obligation with respect to employee severance payments as if it were payable at each balance sheet date. Obligations for employee benefits are recognized as a component of operating expenses in the consolidated statement of operations and comprehensive loss in the periods during which services are rendered by employees. Income Taxes Deferred tax assets and liabilities are determined based on the differences between the financial reporting and tax basis of assets and liabilities using enacted tax rates which will be in effect when the differences reverse. The Company provides a valuation allowance against net deferred tax assets unless, based upon the available evidence, it is more likely than not that the deferred tax asset will be realized. The Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities based on the technical merits of the position. The benefit is measured as the largest amount that is more likely than not to be realized upon ultimate settlement. The Company does not have any uncertain tax positions or accrued penalties and interest as of December 31, 2023 and 2022. If such matters were to arise, the Company would recognize interest and penalties related to income tax matters in income tax expense. The Company’s claim for Scientific Research and Experimental Development (“SR&ED”) deductions for income tax purposes are based upon management’s interpretation of the applicable legislation in the Income Tax Act (Canada). These amounts are subject to review and acceptance by the Canada Revenue Agency and may be subject to adjustment. Fair Value Measurements of Financial Instruments Accounting guidance defines fair value as the price that would be received to sell an asset or paid to transfer a liability (the exit price) in an orderly transaction between market participants at the measurement date. The accounting guidance outlines a valuation framework and creates a fair value hierarchy in order to increase the consistency and comparability of fair value measurements and the related disclosures. The fair value hierarchy is broken down into three levels based on the source of inputs as follows: Level 1 — Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities. Level 2 — Valuations based on observable inputs and quoted prices in active markets for similar assets and liabilities. Level 3 — Valuations based on inputs that are unobservable and models that are significant to the overall fair value measurement. Financial instruments recognized in the consolidated balance sheet consist of cash, accounts receivable, other current assets, accounts payable and other current liabilities. The Company believes that the carrying value of its current financial instruments approximates their fair values due to the short-term nature of these instruments. The Company does not hold any derivative financial instruments. The carrying amounts of the Company’s long-term financial assets approximate their respective fair values. The fair value of our outstanding debt, including the current portion, is estimated to be approximately $ 48,077 56,510 Loss Per Share Basic loss per share is computed by dividing net loss by the weighted average number of shares outstanding during the period. Diluted loss per share is computed by dividing net loss by the weighted average number of shares outstanding after giving effect to the impact of all potentially dilutive potential shares. In computing the basic and diluted net loss per share applicable to common stockholders, the weighted average number of shares remained the same for both calculations due to the fact that when a net loss exists, dilutive shares are not included in the calculation. There was no dilutive effect on the earnings per share for the years ended December 31, 2023 and 2022. Leases The Company determines if an arrangement is a lease at inception. For the Company’s operating leases, the right-of-use (“ROU”) assets represents the Company’s right to use an underlying asset for the lease term and operating lease liabilities represent an obligation to make lease payments arising from the lease. ROU assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. Since the Company’s lease agreements do not provide an implicit rate, the Company estimated an incremental borrowing rate in determining the present value of its lease payments. Operating lease expense is recognized on a straight-line basis over the lease term, subject to any changes in the lease or expectations regarding the terms. Variable lease costs such as operating costs and property taxes are expensed as incurred. Stock-Based Compensation The Company accounts for share-based awards to employees and directors in accordance with the provisions of ASC 718, Compensation—Stock Compensation (“ASC 718”). Under ASC 718, share-based awards are valued at fair value on the date of grant and that fair value is recognized over the requisite service period. The Company values its stock options using the Black-Scholes option pricing model. The Company accounts for forfeitures when they occur. The Company accounts for share-based payments to non-employees issued in exchange for services based upon the fair value of the equity instruments issued. Compensation expense for stock options issued to non-employees is calculated using the Black-Scholes option pricing model and is recorded over the service performance period. |
NEW ACCOUNTING PRONOUNCEMENTS
NEW ACCOUNTING PRONOUNCEMENTS | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Changes and Error Corrections [Abstract] | |
NEW ACCOUNTING PRONOUNCEMENTS | 3. NEW ACCOUNTING PRONOUNCEMENTS Recently Adopted Accounting Standards Credit Losses In June 2016, the FASB issued Accounting Standards Update (“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 consolidated financial statements and the related footnote disclosures. Debt with Conversions and Other Options In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including certain convertible instruments and contracts on an entity’s own equity. Specifically, the new standard has removed the separation models required for convertible debt with cash conversion features and convertible instruments with beneficial conversion features. It has also removed certain settlement conditions that are currently required for equity contracts to qualify for the derivative scope exception and simplifies the diluted earnings per share calculation for convertible instruments. On January 1, 2022, the Company adopted ASU 2020-06 using the modified retrospective method and recognized a cumulative effect of initially applying the ASU as an adjustment to the January 1, 2022 opening balance of accumulated deficit. Our conversion option that was previously bifurcated and recorded as a debt discount and additional paid-in capital has now been combined as a single instrument classified as a liability. The Company eliminated the beneficial conversion feature from additional paid-in capital; eliminated the interest accretion on the beneficial conversion feature through December 31, 2021 from the opening balance of accumulated deficit; and eliminated the corresponding debt discount. Accordingly, the cumulative effect of the changes made on our January 1, 2022 consolidated balance sheet for the adoption of the ASU was as follows: SCHEDULE OF CUMULATIVE EFFECT OF CHANGES ON CONSOLIDATED BALANCE SHEETS Balance as at Adjustments Balance as at Liabilities Long-term debt, net of debt discount $ 28,441 $ 681 $ 29,122 Stockholders’ equity Additional paid-in capital $ 81,583 $ (2,746 ) $ 78,837 Accumulated deficit $ (378,371 ) $ 2,065 $ (376,306 ) Recently Issued Accounting Standards, not yet Adopted Income Taxes In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”) which enhances the transparency and decision usefulness of income tax disclosures. The amendments under ASU 2023-09 require public business entities to annually (1) disclose specific categories in the rate reconciliation and (2) provide additional information for reconciling items that meet a quantitative threshold (if the effect of those reconciling items is equal to or greater than 5 percent of the amount computed by multiplying pretax income or loss by the applicable statutory income tax rate). ASU 2023-09 will be effective for fiscal years beginning after December 15, 2024. Public business entities are permitted to early adopt the standard for annual financial statements that have not yet been issued or made available for issuance. The Company will apply this ASU for year ended December 31, 2025 and we do not anticipate that this new guidance will have a material impact on the note disclosures going forward. |
INVENTORY, NET
INVENTORY, NET | 12 Months Ended |
Dec. 31, 2023 | |
Inventory Disclosure [Abstract] | |
INVENTORY, NET | 4. INVENTORY, NET Inventory is stated at the lower of cost or market and consists of the following: SCHEDULE OF INVENTORY 2023 2022 Finished goods $ 1,661 $ 893 Work-in-process 2,734 1,869 Raw materials 4,104 3,837 Inventory, net $ 8,499 $ 6,599 The Company recorded a provision of approximately $ 1,668 1,186 |
OTHER CURRENT ASSETS
OTHER CURRENT ASSETS | 12 Months Ended |
Dec. 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 2023 2022 Government receivables $ 1,268 $ 4,033 Other current assets 495 2,026 Total other current assets $ 1,763 $ 6,059 |
IMPAIRMENT CHARGES
IMPAIRMENT CHARGES | 12 Months Ended |
Dec. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
IMPAIRMENT CHARGES | 6. IMPAIRMENT CHARGES The drop in market conditions experienced in April 2023, September 2023, and October 2023 were considered triggering events for interim impairment tests for property and equipment, In-Process Research and Development (“IPR&D”) and goodwill. The impairment test compares the carrying amount of the assets to their respective fair values. If the carrying amount exceeds the fair value of the assets, such excess is recorded as an impairment charge. Impairment charges consist of the following: SCHEDULE OF IMPAIRMENT CHARGES 2023 2022 Property and equipment (Note 7) $ 1,000 $ - IPR&D (Note 8) 22,600 - Goodwill (Note 8) 1,000 - Impairment charges $ 24,600 $ - |
PROPERTY AND EQUIPMENT
PROPERTY AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT | 7. PROPERTY AND EQUIPMENT SCHEDULE OF PROPERTY AND EQUIPMENT 2023 Cost Accumulated Net Book Machinery and equipment $ 7,328 $ (4,399 ) $ 2,929 Furniture and office equipment 596 (216 ) 380 Computer equipment and software 1,206 (885 ) 321 Leasehold improvements 10,922 (4,887 ) 6,035 20,052 $ (10,387 ) $ 9,665 2022 Cost Accumulated Net Book Machinery and equipment $ 7,836 $ (3,447 ) $ 4,389 Furniture and office equipment 585 (152 ) 433 Computer equipment and software 1,084 (694 ) 390 Leasehold improvements 10,729 (3,688 ) 7,041 $ 20,234 $ (7,981 ) $ 12,253 Related depreciation expense for the years ended December 31, 2023 and 2022 was $ 1,990 2,009 As discussed above, in April 2023, the Company performed an interim impairment test. The fair value of the property and equipment’s assets included in the impairment test was determined using a combination of the market approach and the cost approach and is considered Level 3 in the fair value hierarchy. Some of the more significant estimates and assumptions inherent in the estimate of the fair value the property and equipment include: 1) current market prices; 2) cost to replace the assets; and 3) factors to account for obsolescence. The Company recorded an impairment of property and equipment of $ 1,000 |
INTANGIBLE ASSETS AND GOODWILL
INTANGIBLE ASSETS AND GOODWILL | 12 Months Ended |
Dec. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
INTANGIBLE ASSETS AND GOODWILL | 8. INTANGIBLE ASSETS AND GOODWILL SCHEDULE OF INDEFINITE LIVED INTANGIBLE ASSETS INCLUDING CUMULATIVE IMPAIRMENT AND CURRENCY TRANSLATION 2023 Gross Carrying Amount Accumulated Cumulative Cumulative Currency Translation Net Book Value IPR&D assets $ 61,500 $ - $ (22,900 ) $ (2,101 ) $ 36,499 2022 Gross Accumulated Cumulative Cumulative Net Book IPR&D assets $ 61,500 $ - $ (300 ) $ (2,855 ) $ 58,345 The Company’s intangible assets determined to have indefinite useful lives, IPR&D and goodwill, are tested for impairment annually, or more frequently if events or circumstances indicate that the assets might be impaired. As discussed above, in April 2023, the Company performed an interim impairment test. The IPR&D assets, consisting of the CMV and GBM programs acquired in a business combination (the 2016 merger between VBI and SciVac), are capitalized as an intangible asset and are tested for impairment at least annually until commercialization, after which time the IPR&D will be amortized over its estimated useful life. The fair value of the IPR&D assets included in the impairment test was determined using the income approach method and is considered Level 3 in the fair value hierarchy. Some of the more significant estimates and assumptions inherent in the estimate of the fair value of IPR&D assets include: 1) the amount and timing of costs to develop the IPR&D into viable products; 2) the amount and timing of future cash inflows; 3) the discount rate; and 4) the probability of technical and regulatory success. The discount rate used was 15 10 17 19,000 3,600 25 During the year ended December 31, 2023, the Company recorded an impairment of IPR&D of $ 22,600 The IPR&D assets are in VBI Cda and the change in carrying value for IPR&D assets from December 31, 2022, relates to currency translation adjustments which increased by $ 754 22,600 3,690 SCHEDULE OF GOODWILL 2023 Gross Carrying Amount Cumulative Impairment Charge Cumulative Currency Translation Net Book Value Goodwill $ 8,714 $ (7,292 ) $ (292 ) $ 1,130 2022 Gross Cumulative Cumulative Net Book Goodwill $ 8,714 $ (6,292 ) $ (295 ) $ 2,127 Goodwill represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired in a business combination. When evaluating goodwill for impairment, we may first perform an assessment qualitatively whether it is more likely than not that a reporting unit’s carrying amount exceeds its fair value, referred to as a “step zero” approach. Subsequently (if necessary, after step zero), if the carrying value of a reporting unit exceeded its fair value an impairment would be recorded. We performed our goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. There was no goodwill impairment determined as a result of the Company’s interim impairment test performed as of April 30, 2023, its annual impairment test performed as of August 31, 2023, and the second interim impairment test performed as of September 30, 2023. As discussed above, the Company considered the further decline in market conditions in October 2023 to be an additional triggering event for the third interim impairment test to be performed. During the fourth quarter of 2023, the Company recorded an impairment of goodwill of $ 1,000 The goodwill is in VBI Cda and the change in carrying value from December 31, 2022 relates to currency translation adjustments which increased goodwill by $ 3 1,000 134 |
OTHER CURRENT LIABILITIES
OTHER CURRENT LIABILITIES | 12 Months Ended |
Dec. 31, 2023 | |
Other Liabilities Disclosure [Abstract] | |
OTHER CURRENT LIABILITIES | 9. OTHER CURRENT LIABILITIES Other current liabilities consisted of the following: SCHEDULE OF OTHER CURRENT LIABILITIES 2023 2022 Accrued research and development expenses (including clinical trial accrued expenses) $ 2,018 $ 6,561 Accrued professional fees 1,674 3,250 Payroll and employee-related costs 1,934 4,036 Deferred funding 3,601 6,966 Other current liabilities 1,057 1,775 Total other current liabilities $ 10,284 $ 22,588 Included in payroll and employee-related costs are one time termination benefits as a result of our organizational changes which took place mostly in the second quarter of 2023, as discussed in Note 1. The Company did not incur contract termination costs or other related costs. The Company did not incur significant charges in one-time termination benefits during the year ended December 31, 2022. The following table presents changes in one-time termination benefits during the year ended December 31, 2023. SCHEDULE OF CHANGES IN ONE-TIME TERMINATION BENEFITS Accrued balance at January 1, 2023 $ - Charges 759 Cash payments (759 ) Accrued balance at December 31, 2023 $ - The restructuring charges are included in cost of revenues, research and development and sales, general and administrative in the consolidated statements of operations and comprehensive loss. |
LOSS PER SHARE OF COMMON SHARES
LOSS PER SHARE OF COMMON SHARES | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
LOSS PER SHARE OF COMMON SHARES | 10. 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 shares 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 remained the same for both calculations due to the fact that when a net loss exists, dilutive shares are not included in the calculation. These potentially dilutive securities are more fully described in Note 13, Stockholders’ Equity and Additional Paid-in Capital. The following potentially dilutive securities outstanding at December 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 Warrants 14,467,566 118,816 Stock options and unvested stock awards 1,650,288 761,314 K2HV conversion feature 205,396 205,396 Total 16,323,250 1,085,526 |
LONG-TERM DEBT
LONG-TERM DEBT | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
LONG-TERM DEBT | 11. LONG-TERM DEBT SCHEDULE OF LONG-TERM DEBT 2023 2022 Long-term debt, net of debt discount of $ 4,930 6,811 $ 50,769 $ 48,888 Current portion, net of debt discount of $ 4,930 0 (50,769 ) - Long-term debt, net of current portion $ - $ 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 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 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 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 72,680 The First Amendment Warrant and the Second Amendment Warrant may be exercised either for cash or on a cashless “net exercise” basis. The First Amendment Warrant expires on May 22, 2030 and the Second Amendment Warrant expires on September 14, 2032. 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 various 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 applicable tranche actually funded multiplied by 3.5% and divided by the warrant exercise price of $ 24.08 6.95 The Company accounted for the Second Amendment as a debt extinguishment and resulted in an extinguishment loss of $ 172 48,340 7,359 1,550 563 The total principal amount of the loan under the Loan Agreement as amended by the Second Amendment, outstanding as of December 31, 2023, including the Original Final Payment of $ 2,224 3,475 55,699 8.00 4.00 12.50 50,000 16.13 The secured term loan maturity date is September 14, 2026 the Loan Agreement, was extended from October 30, 2023, to November 6, 2023, which date was extended again from November 6, 2023, to November 13, 2023, pursuant to a subsequent letter agreement dated November 3, 2023. On November 13, 2023, the Borrowers entered into a forbearance agreement with the Lenders (the “Forbearance Agreement”), pursuant to which the Lenders agreed to forbear from exercising the Secured Parties’ (as defined in the Loan Agreement) rights with respect to the failure to meet the minimum Net Revenue covenant for the measurement periods ended September 30, 2023, from November 13, 2023, through and including November 28, 2023 (the “Forbearance Period”), subject to compliance by the Borrowers with certain terms and conditions as set forth in the Forbearance Agreement. Such conditions include delivery of cash flow budget and adherence reports, and adherence with such budget and cash flow forecast. On each of November 28, 2023, December 12, 2023, December 26, 2023, January 9, 2024, January 23, 2024, and February 6, 2024, the Loan Parties entered into extensions to the Forbearance Agreement pursuant to which the Lenders agreed to extend the Forbearance Period through and including December 12, 2023, December 26, 2023, January 9, 2024, January 23, 2024, February 6, 2024, and February 20, 2024, respectively, subject to compliance by the Borrowers with the same terms and conditions as set forth in the Forbearance Agreement. The obligations under the Loan Agreement as amended by the Third Amendment (as defined below) are secured on a senior basis by a lien on substantially all of the assets of the Company and its subsidiaries. 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. On July 5, 2023, the Borrowers and K2HV entered into (i) an amendment (the “Third Amendment”) to the Loan Agreement, and (ii) an amendment to the Pledge and Security Agreement, dated May 22, 2020, by and among the Company, VBI DE, VBI Cda, K2HV, and Ankura Trust Company, LLC, as collateral trustee for the lenders, pursuant to which the parties have agreed to permit the Brii Collaboration Agreements, the Supply Agreement, and the Letter Agreement, SciVac and Brii Bio. The Company granted to K2HV a security interest in, all of its respective right, title, and interest in and to substantially all of the Company’s intellectual property. In addition, among others, any breach, default or other triggering event by the Company occurring under the Brii Collaboration Agreements resulting in Brii Bio exercising a right to terminate the Brii Collaboration Agreements, will cross default the Third Amendment. On February 13, 2024, the Loan Parties entered into an amendment (the “Fourth Amendment”) to the Loan Agreement, effective upon entry into certain transactions with Brii Bio, pursuant to which the parties have agreed to, among other things, (i) remove a financial covenant requiring us to maintain minimum net revenue of 75 The effectiveness of the Fourth Amendment was conditioned upon entry into the Brii Purchase Agreement, the Rehovot Purchase Agreement and the Side Letter (each as defined herein), each of which were entered into by us and the respective parties thereto on February 13, 2024, as described above. The total initial debt discount related to the Second Amendment is $ 7,359 4,930 7,359 6,811 The debt discount is being charged to interest expense, net of interest income in the consolidated statement of operations and comprehensive loss using the effective interest method over the term of the debt. Interest expense, net of interest income recorded for the years ended December 31, 2023 and 2022 was as follows: SCHEDULE OF INTEREST EXPENSE 2023 2022 Interest expense $ 6,183 $ 3,515 Amortization of debt discount 1,881 1,707 Extinguishment loss - 172 Interest income (1,663 ) (1,387 ) Total interest expense, net of interest income $ 6,401 $ 4,007 |
EMPLOYEE BENEFITS
EMPLOYEE BENEFITS | 12 Months Ended |
Dec. 31, 2023 | |
Retirement Benefits [Abstract] | |
EMPLOYEE BENEFITS | 12. EMPLOYEE BENEFITS Defined Contribution Plan The Company operates a defined contribution retirement benefit plan for all qualifying employees in accordance with corresponding federal and state/provincial law. For VBI DE and VBI Cda employees, the respective companies contribute up to 3 50 179 170 For qualifying employees in Israel, under Israeli law, the assets of the plan are held separately from those of the Company, in funds under the control of trustees. The total expense recognized for the years ended December 31, 2023 and 2022 was $ 393 442 Liability for Severance Pay Israel’s labor laws and the Law “severance pay, 1963” (the “Law”), require the Company to pay severance pay to employees during dismissal, disability, and retirement. Legal retirement age under Israeli labor laws is currently 64 for women and 67 for men. Thus, under the plan, an employee who was employed by the Company for at least one year (and in the circumstances defined by the law) and was involuntarily terminated by the Company after the said period is entitled to severance pay. The rate of compensation listed in the Law is the employee’s final monthly salary for each year of employment. Under the program, the Company is obligated to deposit amounts at the rate fixed by Law (since January 1, 2008), to ensure the accrual of such a severance pay due to the employee as described above. The rate required by law is 8.33 Severance payments pursuant to the aforementioned statutory or contractual obligations, included in the consolidated statement of operations and comprehensive loss for the years ended December 31, 2023 and 2022 was $ 106 5 |
STOCKHOLDERS_ EQUITY AND ADDITI
STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL | 13. STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL Authorized We have an unlimited number of common shares authorized without par value. Common Shares Issuances 2023 common share issuances were as follows: i. In July 2023, the Company closed an underwritten public offering of 12,445,454 1.65 20,500 ii. On July 5, 2023, the Company closed a registered direct offering of 1,818,182 1.65 3,000 iii. During the second half of the year ended December 31, 2023, as part of the ATM Program, the Company issued 1,046,808 738 0.7048 2022 common share issuances were as follows: i. On January 10, 2022, the Company issued 241 49.43 12 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, 2023, there were 28,038 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 December 31, 2023, there were 17,195 2016 VBI Equity Incentive Plan The 2016 Plan, as amended, 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 1,605,055 The principal features of the 2016 Plan are as follows: Eligible Participants Eligible participants include individuals employed (including services as a director) by the Company or its affiliates, including a service provider, who, by the nature of his or her position or job is, in the opinion of the Board, in a position to contribute to the success of the Company (“Eligible Persons”). Reservation of Shares The aggregate number of common shares reserved for issuance to any one participant under the 2016 Plan, together with all other security-based compensation arrangements must not exceed 5 The maximum number of common shares (a) issued to insiders within any one-year period; and (b) issuable to insiders at any time, under the 2016 Plan, when combined with all of the Company’s other security-based compensation arrangements, must not exceed 10 The aggregate number of common shares remaining available for issuance for awards under the 2016 Plan totaled 692,820 The source of common shares issued under the various stock option plans are new common shares. Options and Stock Appreciation Rights The Company may grant options to Eligible Persons on such terms and conditions consistent with the 2016 Plan. The exercise price for an option must not be less than 100% of the “market price,” as that term is defined in the 2016 Plan, based on the trading price per common share, on the date of grant of such option. With respect to SARs attached to an option, which allows the holder, upon vesting of the option and Tandem SAR, to choose to exercise the stock appreciation right or to exercise the option, the exercise price is the exercise price applicable to the option (as explained above) to which the Tandem SAR relates, subject to adjustment provisions under the 2016 Plan. For stand-alone SARs, a SAR that is granted without reference to any related Company options, the base price must not be less than 100% of the market price on the date of grant of such Stand-Alone SAR. Stock appreciation rights (and in the case of Tandem SARs, the related options) will be settled by payment in cash or common shares or a combination thereof, with an aggregate value equal to the product of (a) the excess of the market price on the date of exercise over the exercise price or base price under the applicable stock appreciation right, multiplied by (b) the number of stock appreciation rights exercised or settled. The Company has not issued any SARs under the 2016 Plan at December 31, 2023 and 2022. Under the 2016 Plan unless otherwise designated by the Board of Directors, 25 10 Upon a participant’s termination of employment due to death, or in the case of disability: (a) the outstanding options that were granted prior to the year that includes the participant’s death or disability that have not become vested prior to such date will continue to vest and, upon vesting, be exercisable during the 36-month period following such date; and (b) the outstanding options that have become vested prior to the participant’s death or disability will continue to be exercisable during the 36-month period following such date. In the case of a participant’s termination of employment or contract for services without cause: (a) the outstanding options that have not become vested prior to the participant’s termination will continue to vest and, upon vesting, be exercisable during the 120-day period following such date; and (b) the outstanding options that have become vested prior to the participant’s termination will continue to be exercisable during the 120-day period following such date. In the case of a participant’s termination due to resignation (including voluntary withdrawal of services by a non-employee participant): (a) the outstanding options that have not become vested prior to the date of notice of resignation will be forfeited and cancelled as of such date; and (b) the outstanding options that have become vested prior to the date of notice of resignation will continue to be exercisable during the 90-day period following such date. In the case of a participant’s termination of employment or contract for services for cause, any and all then outstanding unvested options granted to such participant will be immediately forfeited and cancelled, without any consideration therefore, as of the date such notice of termination is given. Share Units The Board of Directors may grant share units, which include RSUs and PSUs, to Eligible Persons on such terms and conditions consistent with the 2016 Plan. The Board will determine the grant value and the valuation date for each grant of share units. The number of share units to be covered by each grant will be determined by dividing the grant value for such grant by the market value of a common share as of the valuation date, rounded up to the next whole number. Share units subject to a grant will vest as specified in the grant agreement governing such grant, provided that the participant is employed on the relevant vesting date. RSUs and PSUs will be settled upon, or as soon as reasonably practicable following the vesting thereof, subject to the terms of the grant agreement. In all events, RSUs and PSUs will be settled on or before the earlier of the 90 th th If and when cash dividends are paid with respect to common shares to shareholders of record during the period from the grant date to the date of settlement of the RSUs or PSUs, a number of dividend equivalent RSUs or PSUs, as applicable, will be credited to the share unit account of such participant. In the event a participant’s employment is terminated due to resignation, share units that have not vested prior to the date of resignation will not vest and all such common shares will be forfeited immediately. In the case of a participant’s termination due to death, or in the case of disability, all share units granted prior to the year that includes the participant’s death or disability, that have not vested prior to the participant’s death or disability will vest at the end of the vesting period and in the case of PSUs, subject to the achievement of applicable performance conditions and the adjustment of the number of PSUs that vest to reflect the extent to which such performance conditions were achieved. In the event a participant’s employment or contract for services is terminated without cause, prior to the end of a vesting period relating to such participant’s grant, the number of RSUs or PSUs, respectively, as determined by their respective formula set out in the 2016 Plan will become vested at the end of the vesting period. In the event a participant’s employment is terminated for cause, share units that have not vested prior to the date of the termination for cause will not vest and all such share units will be forfeited immediately. Restricted Stock Restricted stock means common shares that are subject to restrictions on such participant’s free enjoyment of the common shares granted, as determined by the Board. Notwithstanding the restrictions, the participant will receive dividends paid on the restricted stock, will receive proceeds of the restricted stock in the event of any change in the common shares and will be entitled to vote the restricted stock during the restriction period. The participant will not have rights to sell, transfer or assign, or otherwise dispose of the shares of restricted stock or any interest therein while the restrictions remain in effect. Grants of restricted stock will be forfeited if the applicable restriction does not lapse prior to such date or occurrence of such event or the satisfaction of such other criteria as is specified in the grant agreement. No restricted stock has been issued through December 31, 2023. Stock-Based Compensation Expense The table below provides information, as of December 31, 2023, regarding the 2006 Plan, the 2014 Plan and the 2016 Plan under which our equity securities are authorized for issuance to officers, directors, employees, consultants, independent contractors and advisors. SCHEDULE OF STOCK OPTIONS OUTSTANDING UNDER DIFFERENT PLANS Plan Category Number of securities to be issued upon exercise/vesting of outstanding awards Weighted average exercise price 2006 Plan 28,038 $ 126.49 2014 Plan 17,195 151.53 2016 Plan 1,605,055 27.56 1,650,288 $ 30.53 Activity related to stock options is as follows: SCHEDULE OF STOCK OPTIONS ACTIVITY Number of Stock Options Weighted Average Exercise Price Balance outstanding at December 31, 2021 617,655 $ 78.90 Granted 171,292 45.24 Exercised (241 ) 49.43 Forfeited (27,474 ) 77.61 Balance outstanding at December 31, 2022 761,232 $ 71.26 Granted 993,643 2.02 Forfeited (104,587 ) 56.52 Balance outstanding at December 31, 2023 1,650,288 $ 30.53 Exercisable at December 31, 2023 718,513 $ 63.81 SCHEDULE OF EXERCISE PRICE RANGE STOCK OPTIONS OUTSTANDING AND EXERCISABLE Outstanding Exercisable Exercise Price Number Of Options Weighted Average Remaining Life (Years) Number Of Options Weighted Average Exercise Price $ 0.00 – 0.99 - - - $ - 1.00 – 1.99 932,500 9.58 94,790 1.30 2.00 – 2.99 8,000 9.33 1,777 2.49 3.00 + 709,788 6.32 621,946 73.51 1,650,288 8.17 718,513 $ 63.81 The weighted average remaining contractual life of exercisable options was years 6.50 6.54 Information relating to restricted stock units is as follow: SCHEDULE OF RESTRICTED STOCK UNITS Number of Weighted Unvested shares outstanding at December 31, 2021 1,304 $ 44.10 Vested (1,199 ) 44.40 Forfeited (23 ) 43.80 Unvested shares outstanding at December 31, 2022 82 $ 43.80 Vested (82 ) 43.80 Unvested shares outstanding at December 31, 2023 - $ - The intrinsic value of outstanding options at December 31, 2023 was $ 0 0 0 0 no 241 2 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 2023 2022 Volatility 112.44 % 93.23 % Risk free interest rate 4.17 % 1.75 % Expected term in years 5.74 5.83 Expected dividend yield 0.00 % 0.00 % Weighted average fair value per option $ 1.65 $ 33.90 The volatility was based on the Company’s recent historic volatility since May 6, 2016. The risk-free rate was based on rates provided by the United States Treasury with a term equal to the expected life of the option. The Company does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate expected term due to the limited period of time its equity shares have been publicly traded. As a result, the Company uses the simplified method to determine the expected term of stock options whereby the expected term equals the average between the vesting period and the contractual life. The fair value of the options is recognized as an expense on a straight-line basis over the vesting period, forfeitures are accounted for when they occur. The total stock-based compensation expense recorded in the years ended December 31, was as follows: SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE 2023 2022 Research and development $ 872 $ 1,998 General and administration 5,699 7,585 Cost of revenue 90 115 $ 6,661 $ 9,698 There is $ 2,684 1.52 Warrants On September 14, 2022, in connection with the Second Amendment, as described in Note 11, the Company issued a warrant to purchase an additional 2,180,413 0.8026 September 14, 2032 In July 2023, in connection with the underwritten public offering and registered direct offering, the Company issued common warrants to purchase 14,363,636 1.65 0.6057 1,005 The value attributed to the common warrants, on date of issuance, was based on the Black-Scholes option pricing model by applying the following assumptions: SCHEDULE OF FAIR VALUE OF WARRANTS GRANTED BY USING BLACK-SCHOLES OPTION PRICING ASSUMPTIONS Common warrant Volatility 118.94 % Risk free interest rate 4.25 % Expected term in years 5 Expected dividend yield 0.00 % Fair value per warrant $ 1.38 Activity related to the warrants is as follows: SCHEDULE OF WARRANT ACTIVITY Number of Warrants Weighted Average Balance outstanding at December 31, 2021 46,136 $ 37.28 Issued 72,680 24.08 Balance outstanding at December 31, 2022 118,816 $ 29.20 Expired (14,886 ) 45.00 Issued 14,363,636 0.61 Balance outstanding at December 31, 2023 14,467,566 $ 0.79 |
REVENUE, NET AND DEFERRED REVEN
REVENUE, NET AND DEFERRED REVENUE | 12 Months Ended |
Dec. 31, 2023 | |
Revenue from Contract with Customer [Abstract] | |
REVENUE, NET AND DEFERRED REVENUE | 14. REVENUE, NET AND DEFERRED REVENUE Revenue, net comprises of the following: SCHEDULE OF REVENUE COMPRISED 2023 2022 Product revenue, net $ 3,107 $ 931 License revenue 3,596 - R&D Service revenue 1,979 151 Revenues $ 8,682 $ 1,082 Cost of revenues for the year ended December 31, 2023, for product revenue and R&D services revenue was $ 12,507 and deminimus, respectively. Cost of revenues for the year ended December 31, 2022, for product revenue and R&D services revenue was $ 11,235 and $ 41 , respectively. The following table presents revenue expected to be recognized in the future related to performance obligations, based on current estimates, that are unsatisfied at December 31, 2023: SUMMARY OF REVENUE EXPECTED TO BE RECOGNIZED IN FUTURE RELATED TO PERFORMANCE OBLIGATIONS Total 2024 2025 and thereafter Product revenue, net $ 5,116 $ 5,116 $ - R&D Service revenue 3,992 2,160 1,832 $ 9,108 $ 7,276 $ 1,832 The following table presents changes in the deferred revenue balance for the year ended December 31, 2023: SUMMARY OF CHANGES IN DEFERRED REVENUE Balance at January 1, 2022 $ 2,803 - - - Balance at December 31, 2022 $ 2,613 Amounts received 8,056 Recognition of deferred revenue (1,952 ) Currency translation 391 Balance at December 31, 2023 $ 9,108 Short Term $ 7,276 Long Term $ 1,832 Brii Collaboration Agreements – VBI-2601 On December 4, 2018, the Company entered into a Collaboration and License Agreement (the “Brii Collaboration and License Agreement”) with Brii Bio, as amended on April 8, 2021, pursuant to which: ● 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 Brii Collaboration and License Agreement (the “Brii Second Amendment Collaboration and 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 Brii Collaboration and License Agreement, as amended by the Brii Second Amendment Collaboration and License Agreement, the Company was responsible for the R&D Services and Brii Bio was responsible for costs relating to the clinical trials for the Licensed Territory. The initial consideration of the Brii Collaboration and 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 Brii Second Amendment Collaboration and License Agreement. On July 5, 2023, the Company and Brii Bio entered into the A&R Collaboration Agreement, to, among other things, and subject to the terms and conditions set forth in the A&R Collaboration Agreement, expand the Licensed Territory to the entire world (the “New Licensed Territory”) for Brii Bio’s exclusive rights and licenses to make, have made, use, sell, offer for sale, and import VBI-2601 (“VBI-2601 Licensed Product”). Pursuant to the A&R Collaboration Agreement, the Company granted Brii Bio an exclusive royalty-bearing license, with the right to grant sublicenses through multiple tiers, to (i) perform studies, regulatory and other activities, as may be required to obtain and maintain marketing approval of the VBI-2601 Licensed Products in the New Licensed Territory; and (ii) research, develop, make, have made, distribute, use, sell, offer for sale, have sold, import, export or otherwise commercialize the VBI-2601 Licensed Products for the field of the diagnosis and treatment of hepatitis B in the New Licensed Territory. Except for the rights and licenses expressly granted in the A&R Collaboration Agreement, the Company and Brii Bio retained all rights under their respective intellectual property. Additionally, the A&R Collaboration Agreement constitutes the entire agreement between the VBI and Brii Bio relating to VBI-2601 and supersedes all previous agreements, including the Brii Collaboration and License Agreement and the Brii Second Amendment Collaboration and License Agreement. As a result of the A&R Collaboration Agreement, the unsatisfied performance obligation of $ 1,925 The initial consideration of the A&R Collaboration Agreement consisted of a $ 5,000 227,000 5,000 5,000 43 1,597 3,360 The A&R Collaboration Agreement will be in effect on a region-by-region basis until the last-to-expire of the latest of the following terms in each region of the New Licensed Territory: (i) expiration, invalidation or lapse of the last Company patent claiming such VBI-2601 Licensed Product, (ii) 10 years from the date of first commercial sale of such VBI-2601 Licensed Product in the applicable region, or (iii) termination or expiration of the Company’s obligation to pay third party royalties with respect to sales of such VBI-2601 Licensed Product in such region. Upon expiration (but not an earlier termination) of the A&R Collaboration Agreement in each region of the New Licensed Territory, the Company will grant Brii Bio a perpetual, non-exclusive, fully paid-up, royalty free license, which such license, pursuant to the Brii Purchase Agreement (as defined herein), shall also be irrevocable under the Company’s technology related to the VBI-2601 Licensed Products in such region to make and sell VBI-2601 Licensed Products for the field of the diagnosis and treatment of hepatitis B in such region. Pursuant to the Brii Purchase Agreement, on February 13, 2024, the Company and Brii Bio agreed to amend the A&R Collaboration Agreement to, among other things, subject to the terms and conditions set forth in the A&R Collaboration Agreement, (i) amend the terms the royalty bearing license granted by the Company to Brii Bio for research studies and development of VBI-2601 to be “perpetual and irrevocable”, (ii) omit the requirement for Brii Bio to obtain marketing approval and commercialize VBI-2601 in the United States and China, (iii) revise the indemnity requirements such that Brii Bio indemnifies the Company with respect to certain transferred intellectual property after the effective date of the Brii Purchase Agreement and the Company indemnifies Brii Bio prior to such date,(iv) omit the requirement for Brii Bio to make royalty and milestone payments to the Company and (v) omit certain rights of the Company to terminate the A&R Collaboration Agreement and certain other effects of termination of the A&R Collaboration Agreement. Brii Collaboration Agreements – PreHevbri On July 5, 2023, the Company and Brii Bio also entered into the Collaboration Agreement, to, among other things, and subject to the terms and conditions set forth in the Collaboration Agreement, acquired an exclusive license for PreHevbri in APAC, excluding Japan (“PreHevbri Licensed Territory”), for Brii Bio’s exclusive rights and licenses to make, have made, use, sell, offer for sale, and import PreHevbri (“PreHevbri Licensed Product”). Pursuant to the Collaboration Agreement, the Company granted Brii Bio an exclusive royalty-bearing license, with the right to grant sublicenses through multiple tiers, to (i) perform studies, regulatory and other activities, as may be required to obtain and maintain marketing approval of the PreHevbri Licensed Products in the PreHevbri Licensed Territory; and (ii) research, develop, make, have made, distribute, use, sell, offer for sale, have sold, import, export or otherwise commercialize the PreHevbri Licensed Products for the field of the diagnosis and treatment of hepatitis B in the PreHevbri Licensed Territory. Except for the rights and licenses expressly granted in the Collaboration Agreement, the Company and Brii Bio retained all rights under their respective intellectual property. The initial consideration of the Collaboration Agreement consisted of a $ 2,000 195,000 2,000 2,000 88 1,597 315 The Collaboration Agreement will be in effect on a region-by-region basis until the last-to-expire of the latest of the following terms in each region of the New Licensed Territory: (i) 10 years from the date of first commercial sale of such PreHevbri Licensed Product in the applicable region, or (ii) termination or expiration of the Company’s obligation to pay third party royalties with respect to sales of such PreHevbri Licensed Product in such region. Upon expiration (but not an earlier termination) of the Collaboration Agreement in each region of the PreHevbri Licensed Territory, the Company will grant Brii Bio a perpetual, non-exclusive, fully paid-up, royalty free license, which such license, pursuant to the Brii Purchase Agreement, shall also be irrevocable, under the Company’s technology related to the PreHevbri Licensed Products in such region to make and sell PreHevbri Licensed Products for the field of the diagnosis and treatment of hepatitis B in such region. Pursuant to the Brii Purchase Agreement, on February 13, 2024, the Company and Brii Bio agreed to amend the Collaboration Agreement to, among other things, subject to the terms and conditions set forth in the Collaboration Agreement, (i) amend the terms of the royalty bearing license granted by the Company to Brii Bio for the global development activities of the Licensed Product to be “perpetual and irrevocable”, (ii) omit the requirement for Brii Bio to obtain marketing approval for the Licensed Product in certain territories and (iii) omit the requirement for Brii Bio to make royalty and milestone payments to the Company. The R&D services and technology transfer for the Brii Collaboration Agreements 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. Upon termination of the Brii Collaboration Agreements 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. Supply Agreement On July 5, 2023, in connection with the Brii Collaboration Agreements, the Company and Brii Bio entered into the Supply Agreement related to the clinical and commercial manufacture and supply of VBI-2601 and PreHevbri and any related manufacturing expenditures, as negotiated. Pursuant to the Supply Agreement, the Company received an advance payment of $ 5,000 from Brii Bio. The advance payment of $ 5,000 will be allocated to the following performance obligations, depending on which performance obligation is requested by Brii Bio, until the advance payment of $ 5,000 has been fully utilized: (i) units of VBI-2601 and/or PreHevbri; and (ii) manufacturing expenditures. The advance payment of $ 5,000 is included in deferred revenue as of December 31, 2023. The performance obligation of a unit of VBI-2601 and/or PreHevbri will be satisfied at a point in time using the prices set out in the Supply Agreement and revenue will be recognized upon transfer of control of the performance obligation. The manufacturing expenditures 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 December 31, 2023, performance obligations related to the Brii Collaboration Agreements and the Supply Agreements that remain unsatisfied were $ 8,433 . |
COLLABORATIVE ARRANGEMENTS
COLLABORATIVE ARRANGEMENTS | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
COLLABORATIVE ARRANGEMENTS | 15. COLLABORATIVE ARRANGEMENTS National Research Council of Canada (“NRC”) On March 31, 2020, the Company announced a collaboration with the NRC, Canada’s largest federal research and development organization, to develop a pan-coronavirus vaccine candidate, targeting COVID-19, SARS, and MERS. The NRC and the Company are collaborating to evaluate and select promising coronavirus vaccine candidates. The collaboration combines the Company’s viral vaccine expertise, eVLP technology platform, and modified coronavirus antigens with the NRC’s proprietary SARS-CoV-2 antigens and assay development capabilities to select the most immunogenic vaccine candidate for further development. On December 21, 2020, the Company signed an amendment to the collaboration agreement with the NRC to broaden the scope of collaboration to include certain pre-clinical evaluations, bioprocess optimization, technology transfer, and the performance of additional scale up work. On July 8, 2021, the Company signed a second amendment to the collaboration agreement with the NRC to broaden the scope of the collaboration to include developing a vaccine against the Beta variant of SARS-CoV-2. On August 27, 2021, the Company signed a third amendment to the collaboration agreement with the NRC further broaden the scope to include certain stable cell line work for our vaccine candidate against the Beta variant of SARS-CoV-2. On November 15, 2021, we signed a fourth amendment to the collaboration agreement with the NRC to further broaden the scope to include additional animal studies and PRNT analysis for our vaccine candidate against the Beta variant of SARS-CoV-2. On February 8, 2022, we signed a fifth amendment to the collaboration agreement with the NRC to further broaden the scope to include additional assays of new variants against SARS-CoV-2. On April 28, 2022, we signed a sixth amendment to the collaboration agreement with the NRC to further broaden the scope to include generation and testing of stable pools of cells expressing SARS-CoV-2 spike protein. On February 28, 2023, we 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. This relationship is considered a collaborative relationship and not a customer relationship and is therefore accounted for outside the scope of ASC Topic 606. CEPI On March 9, 2021, the Company and CEPI announced the CEPI Funding Agreement, to develop eVLP vaccine candidates against SARS-COV-2 variants, including the Beta variant, also known as the B.1.351 variant and as 501Y.V2, first identified in South Africa. CEPI agreed to provide up to $33,018 to support the advancement of VBI-2905, a monovalent eVLP candidate expressing the pre-fusion form of the spike protein from the Beta variant strain, through Phase I clinical development On December 6, 2022, we and CEPI entered into an amendment to the CEPI Funding Agreement (the “CEPI Amendment”) to expand the scope of the CEPI Funding Agreement. The CEPI Amendment, among others, (i) expands the definition of “Project Vaccine” to include additional multivalent vaccine constructs within the VBI-2900 program, (ii) removes certain pricing restrictions previously allocated to high-income countries in the CEPI Funding Agreement, (iii) updates the proposed volume commitment percentage contributions by us to CEPI for a Project Vaccine, and (iv) adds certain commercial benefits and related adjustments for CEPI following the endemic period, including royalties paid to CEPI, in the event that CEPI provides funding for Phase III clinical studies of the Project Vaccine. This relationship is considered a collaborative relationship and not a customer relationship and is therefore accounted for outside the scope of ASC Topic 606. Since inception of the CEPI Funding Agreement, the Company has received $ 19,327 3,601 Agenus Inc. On October 12, 2022, the Company entered into a Clinical Collaboration Agreement (“Agenus Collaboration Agreement”) with Agenus Inc. pursuant to which the Company will evaluate VBI-1901 in combination anti-PD-1 balstilimab in a Phase II study as part of the INSIGhT adaptive platform trial in patients first diagnosed with GBM. This relationship is considered a collaborative relationship and not a customer relationship and is therefore accounted for outside the scope of ASC Topic 606. The total amount of expenses for collaborative relationships recorded in the years ended December 31, was as follows: SCHEDULE OF RESEARCH AND DEVELOPMENT EXPENSE 2023 2022 NRC $ 35 $ 851 CEPI 3,486 3,648 Agenus Inc. 642 3,748 Research and Development Expenses $ 4,163 $ 8,247 Costs associated with collaborative relationships are expensed as incurred in Research and Development expenses and overhead charges are included in General and Administrative. |
GOVERNMENT GRANTS
GOVERNMENT GRANTS | 12 Months Ended |
Dec. 31, 2023 | |
Government Grants | |
GOVERNMENT GRANTS | 16. GOVERNMENT GRANTS On September 16, 2020, we 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 $55,976 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 General and Administrative. For the years ended December 31, 2023 and 2022, the Company recognized $ 5,392 6,038 55 790 |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | 17. INCOME TAXES Components of the Company’s loss from continuing operations before income taxes are as follows: SCHEDULE OF LOSS BEFORE INCOME TAX 2023 2022 Netherlands $ (738 ) $ (394 ) United States (7,560 (3,909 ) Canada (32,360 ) (46,364 ) Israel (52,178 ) (62,636 ) $ (92,836 ) $ (113,303 ) The Company operates in United States, Israel and Canadian tax jurisdictions. Its income is subject to varying rates of tax, and losses incurred in one jurisdiction cannot be used to offset income taxes payable in another. A reconciliation of the income tax rate with the Company’s effective tax rate and income tax expense are as follows: SCHEDULE OF EFFECTIVE INCOME TAX RATE RECONCILIATION 2023 2022 Loss before income taxes $ (92,836 ) $ (113,303 ) Canadian statutory tax rate 26.50 % 26.50 % Expected benefit of income tax ) (30,025 ) Research and development tax credits (319 ) (386 ) Change in tax rate 203 1,970 Change in valuation allowance * 17,707 12,562 Difference between Canadian and foreign tax rates 2,042 2,771 Stock based compensation 1,628 2,362 Foreign exchange translation 2,643 10,814 Goodwill impairment 265 - Permanent statutory to GAAP difference 141 (308 ) Other 292 240 $ - $ - * A portion of the change in valuation allowance is recognized in equity, therefore the overall change in the valuation allowance will not equal the amount recognized in tax expense. For 2023 the Canadian statutory income tax rate of approximately 26.50 15 11.50 23 24 The Deferred tax asset (liability) consisted of the following: SCHEDULE OF DEFERRED TAX ASSETS 2023 2022 Net operating losses $ 108,574 $ 98,147 Research and development tax credits 14,655 13,995 Property and equipment 830 1,072 Reserves and other 2,928 2,253 Intangible assets (9,672 ) (15,461 ) Allowable capital losses 342 56 Debt obligations (1,902 ) (2,683 ) Deferred financing costs 962 1,201 Net deferred tax assets 116,717 98,580 Less: valuation allowance (116,717 ) (98,580 ) $ - $ - As of December 31, 2023 and 2022, the Company had United States federal net operating loss carryovers (“NOLs”) of approximately $ 59,524 55,375 29,000 50 As of December 31, 2023 and 2022, the Company also had Canadian net operating loss carryovers of approximately $ 102,475 97,433 As of December 31, 2023 and 2022, the Company had $ 6,964 6,242 As of December 31, 2023 and 2022, the Company had unclaimed research and development expenses in Canada of approximately $ 28,580 24,997 As of December 31, 2023 and 2022, the Company had $ 204 213 As of December 31, 2023 and 2022, the Company also had Israel net operating loss carryovers of approximately $ 291,711 256,305 As of December 31, 2023, the Company had NOLs aggregating approximately $454,508. The NOLs are available to reduce taxable income of future years and expire as follows: SCHEDULE OF NOL’S AVAILABLE TO REDUCE TAXABLE INCOME OF FUTURE YEARS Netherlands United States Canada Israel Total 2025 - - 862 - 862 2026 - 10 3,590 - 3,600 2027 - 446 4,159 - 4,605 2028 - 718 1,610 - 2,328 2029 - 672 3,016 - 3,688 2030 - 2,556 977 - 3,533 2031 - 3,617 1,207 - 4,824 2032 - 2,962 - - 2,962 2033 - 3,126 1,411 - 4,537 2034 - 5,626 5,284 - 10,910 2035 - 4,661 1,589 - 6,250 2036 - 5,323 6,995 - 12,318 2037 - 6,017 9,473 - 15,490 2038 - - 2,353 - 2,353 2039 - - 7,488 - 7,488 2040 - - 15,896 - 15,896 2041 - - 11,682 - 11,682 2042 - - 13,434 - 13,434 2043 - - 11,449 - 11,449 No expiration 798 23,790 - 291,711 316,299 Total losses $ 798 59,524 $ 102,475 $ 291,711 $ 454,508 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | 18. COMMITMENTS AND CONTINGENCIES Licensing Ferring and SciGen License Agreements On October 18, 2022, the Company amended and restated the original Ferring License Agreement (the “Amended and Restated Ferring License Agreement”), which amends and restates certain of the terms relating to the manufacture and marketing of HBsAg products, which includes, among others, updates to the definition of net sales, and a reduction in the fixed royalty rate on net sales of HBsAg products (“Product”) from seven percent (7%) to three and a half percent (3.5%) in consideration for the grant of the license to utilize genetically engineered CHO cells encoding the hepatitis B antigen and certain information related to the manufacture of hepatitis B vaccines 5 Under the original Ferring License Agreement and the SciGen Assignment Agreement, we originally were to pay royalties on a country-by-country basis until the date 10 years after the date of commencement of the first royalty year in respect of such country. In April 2019, we exercised our option to extend the original Ferring License Agreement in respect of all the countries that still make up the territory for an additional 7 years by making a one-time payment to Ferring of $ 100 In addition, the Company is committed to pay 30 Royalty payments under the Amended and Restated Ferring License Agreement or the original Ferring License Agreement of $ 250 33 Royalty payments under the SciGen Assignment Agreement of $ 155 47 eVLP Technology Under a license agreement with UPMC and other licensors relating to eVLP technology, we have an exclusive license to a family of patents that expired in the U.S. in 2023 and expired in other countries in 2021. UPMC is also a co-owner of the patent family covering our VBI-1501 CMV vaccine and we are negotiating an agreement with UPMC to cover this patent family. During year ended December 31, 2023, we did not make any milestone payments. 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 1,879,500 518,197 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, January 12, 2023 and July 13, 2023. The next preliminary hearing is scheduled to be held on June 20, 2024. 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 have not yet been scheduled. SciVac intends to defend these claims vigorously. |
LEASES
LEASES | 12 Months Ended |
Dec. 31, 2023 | |
Leases | |
LEASES | 19. 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. The total operating lease cost recorded in the years ended December 31, 2023 and 2022 was as follows: SCHEDULE OF LEASE COST AND OTHER INFORMATION 2023 2022 Operating lease cost $ 1,866 $ 1,865 Weighted average discount rate 13 % Weighted average remaining lease term 2.36 years Operating lease costs are included in cost of revenues, research and development, and general and administrative expenses in the statement of operation 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 Year ending December 31 2024 $ 1,177 2025 686 2026 593 2027 163 Total 2,619 Effect of discounting (348 ) Total lease liability 2,271 Current portion (976 ) Long term lease liability, net of current portion $ 1,295 |
SEGMENT INFORMATION
SEGMENT INFORMATION | 12 Months Ended |
Dec. 31, 2023 | |
Segment Reporting [Abstract] | |
SEGMENT INFORMATION | 20. 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 2023 2022 United States $ 1,845 $ 695 Israel 167 315 China/Hong Kong 5,585 66 Europe 1,085 6 Revenues $ 8,682 $ 1,082 There was no For the year ended December 31, 2023, the Company had 1 customer that individually accounted for 64 For the year ended December 31, 2022, the Company had 4 customers that individually accounted for 18 15 14 10 Tangible long-lived assets (Property and equipment and Right of Use assets) attributed to geographic areas are as follows: SCHEDULE OF PROPERTY AND EQUIPMENT AND OPERATING LEASE RIGHT OF USE ASSETS 2023 2022 Israel $ 11,009 $ 13,892 United States 506 985 Canada (country of domicile) 398 692 Total $ 11,913 $ 15,569 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | 21. SUBSEQUENT EVENTS February 2024 Agreements with Brii Bio On February 13, 2024, the Company entered into a series of agreements with Brii Biosciences Limited (“Brii Bio”), pursuant to which, subject to achievement of certain activities, we would receive up to $ 33,000 Rehovot Purchase Agreement On February 13, 2024, the Company and SciVac entered into a purchase agreement (the “Rehovot Purchase Agreement”) with a wholly-owned subsidiary of Brii Bio, to be formed in Israel (“Brii Israel”) prior to the closing, and joined as a party to the agreement prior to the closing as the purchaser, and Brii Biosciences, Inc, a Delaware corporation, pursuant to which, upon achievement of certain activities and closing of the transactions contemplated by the Rehovot Purchase Agreement, subject to the terms and conditions therein, SciVac will sell to Brii Israel certain assets, including SciVac and its affiliates’ interest and rights in certain leases with respect to the vaccine manufacturing facility in Israel, for an aggregate purchase price of $ 10,000 The Rehovot Purchase Agreement contains representations and warranties of SciVac and Brii Israel that are typical for transactions of this type. The Rehovot Purchase Agreement also contains covenants on the part of the Company that are typical for transactions of this type. The closing of the transactions pursuant to the Rehovot Purchase Agreement are subject to the terms and conditions therein, including closing conditions that are typical for transactions of this type and the Company’s completion of the Essential Activities (as defined below). Closing will not occur prior to June 30, 2024. Brii Purchase Agreement On February 13, 2024, the Company and VBI Cda entered into a Purchase Agreement with Brii Bio (the “Brii Purchase Agreement”), pursuant to which the Company and VBI Cda will sell, transfer, convey and assign to Brii Bio, substantially all of the intellectual property related to VBI-2601 owned by the Company and VBI Cda, for a secured promissory note in the principal amount up to $ 10,000 2,500 7,500 2,500 Brii Side Letter On February 13, 2024, the Company and Brii Bio entered into a side letter (the “Side Letter”) setting forth certain essential and additional priority activities to transfer manufacturing responsibility for clinical supply and commercial supply of VBI-2601 and PreHevbri for the Brii Territories set forth in the Side Letter (the “Essential Activities”) the Company is required to complete as a condition to the entry into the License Agreement (as defined below) and consummation of the transactions pursuant to the Rehovot Purchase Agreement. The principal amount of the Note shall increase up to $ 18,000 Brii License Agreement On February 13, 2024, the Company entered into a series of agreements and amendments to existing agreements with Brii Bio. Upon completion of the Essential Activities pursuant to the Side Letter, VBI Cda and Brii Bio will enter into a license agreement (the “Brii License Agreement”) pursuant to which Brii Bio shall issue a secured promissory note in the amount of $ 5,000 Loan Agreement and Forbearance Agreement with K2HV On each of January 9, 2024, January 23, 2024, and February 6, 2024, as discussed in Note 11, the Loan Parties entered into extensions to the Forbearance Agreement. Additionally, on February 14, 2024, as discussed in Note 11, the Loan Parties entered into the Fourth Amendment to the Loan Agreement. ATM Program Subsequent to December 31, 2023, the Company sold and issued 2,114,314 1,435 0.6789 April 2024 Offering On April 9, 2024, the Company entered into a securities purchase agreement with certain institutional investors named therein pursuant to which the Company issued and sold 2,272,728 2,272,728 0.88 0.76 1,700 In connection with the April 2024 Offering, the Company also issued to H.C. Wainwright & Co., LLC or its designees, warrants to purchase up to 136,364 1.10 Exercise of Warrants In April 2024, warrants for the purchase of 126,250 0.6057 76 |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Consolidation | Basis of Consolidation The consolidated financial statements include the accounts of VBI 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 consolidated financial statements. |
Reverse Stock Split | Reverse Stock Split On April 12, 2023, VBI effected a 1-for-30 reverse stock split |
Foreign Currency | Foreign Currency The functional and reporting currency of the Company is the United States dollar. Each of the Company’s subsidiaries determines its own respective functional currency, based on the primary economic environment that it operates in, and this currency is used to separately measure each entity’s financial position and operating results. Assets and liabilities of foreign operations with a different functional currency from that of the Company are translated at the closing rate at the end of each reporting period. Profit or loss items are translated at average exchange rates for all the relevant periods. All resulting translation differences are recognized as a component of other comprehensive loss /income. Foreign exchange gains and losses arising from transactions denominated in a currency other than the functional currency of the entity involved, are included in operating results. |
Use of Estimates | Use of Estimates Preparation of the consolidated financial statements in conformity with accounting principles generally accepted in the U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual amounts could differ from the estimates made. We continually evaluate estimates used in the preparation of the consolidated financial statements for reasonableness. Appropriate adjustments, if any, to the estimates used are made prospectively based upon such periodic evaluation. The significant areas of estimation include revenue recognition, determining the deferred tax valuation allowance, estimating accrued research and development expenses, the inputs in determining the fair value of the in-process research and development (“IPR&D”) and goodwill as part of the impairment analysis and the inputs in determining the fair value of equity-based awards and warrants issued. Actual results may differ from those estimates. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject us to significant concentrations of credit risk consist principally of cash and accounts receivable. We place our cash primarily in commercial checking accounts. Commercial bank balances may from time to time exceed federal insurance limits. The Company has not experienced any losses in cash and accounts receivable for the years ended December 31, 2023 and 2022. |
Inventory | Inventory Inventory components include all raw materials, work-in-progress and finished goods. Cost is determined on a specific item or first-in/first-out basis. The cost of inventories comprises costs to purchase, costs incurred in bringing the inventories to their present location and condition, and costs incurred in the manufacturing process including labor and overhead. Inventory is valued at the lower of cost or net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. On a quarterly basis, the Company evaluates the condition and age of inventories and makes provisions for slow moving inventories accordingly. |
Property and Equipment | Property and Equipment Property and equipment are recorded at cost less accumulated depreciation. The assets are depreciated by the straight-line method over the estimated useful lives of the related assets as follows: SCHEDULE OF ESTIMATED USEFUL LIVES OF PROPERTY AND EQUIPMENT Number of years Furniture and office equipment 5 14 Machinery and equipment 3 7 Computers 2 3 Leasehold improvements shorter of useful life or the term of the lease When assets are retired or otherwise disposed of, the cost and the related accumulated depreciation is removed from the accounts, and any resulting gain or loss is recognized in the consolidated statement of operations and comprehensive loss. The cost of maintenance and repairs is charged to expense as incurred; significant renewals and betterments are capitalized. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets Long-lived assets, such as property and equipment and finite-lived intangible assets, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. Recoverability of assets to be held and used is measured by comparison of the carrying amount of an asset the fair value of the asset. If the carrying amount of the asset exceeds the fair value of the asset, then an impairment charge is recognized for the amount by which the carrying amount of the asset exceeds the fair value of the asset. See Notes 6 and 7 for more details on impairment testing on property and equipment for the year ended December 31, 2023. |
In-Process Research and Development Assets and Goodwill | In-Process Research and Development Assets and Goodwill The Company’s intangible assets determined to have indefinite useful lives including IPR&D and goodwill, are tested for impairment annually, or more frequently if events or circumstances indicate that the assets might be impaired. Such circumstances could include but are not limited to: (1) a significant adverse change in legal factors or in business climate, (2) unanticipated competition, or (3) an adverse action or assessment by a regulator. The Company has established August 31st as the date for its annual impairment test of IPR&D and goodwill. The costs of rights to IPR&D projects acquired in an asset acquisition are expensed in the consolidated statements of operations unless the project has an alternative future use. These costs include initial payments incurred prior to regulatory approval in connection with research and development agreements that provide rights to develop, manufacture, market and/or sell pharmaceutical products. The IPR&D assets, which consist of the CMV and GBM programs, were acquired in a business combination, capitalized as an intangible asset and are tested for impairment at least annually until commercialization, after which time the IPR&D will be amortized over its estimated useful life. The impairment test compares the carrying amount of the IPR&D asset to its fair value. If the carrying amount exceeds the fair value of the asset, such excess is recorded as an impairment loss. See Note 6 and 8 for more details on impairment testing for the year ended December 31, 2023. Goodwill represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired in a business combination. When evaluating goodwill for impairment, we may first perform an assessment qualitatively whether it is more likely than not that a reporting unit’s carrying amount exceeds its fair value, referred to as a “step zero” approach. Subsequently (if necessary, after step zero), if the carrying value of a reporting unit exceeded its fair value an impairment would be recorded. We would perform our goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. See Note 6 and 8 for more details on impairment testing for the year ended December 31, 2023. |
Restructuring charges | Restructuring charges Restructuring costs include charges associated with exit or disposal activities that meet the definition of restructuring under FASB ASC Topic 420, Exit or Disposal Cost Obligations (“ASC 420”). The Company’s restructuring plans are typically completed within a one-year period or less. Restructuring costs incurred under these plans may include (i) one-time termination benefits related to employee separations, (ii) contract termination costs, and (iii) other related costs associated with exit or disposal activities including, but not limited to, costs for consolidating or closing facilities. |
Long-Term Debt | Long-Term Debt The Company accounts for long-term debt under the provisions of ASC 470-20, Debt – Debt with conversion and other options (“ASC 470”). Debt discount is charged to interest expense, net of interest income in the consolidated statement of operations and comprehensive loss using the effective interest method over the term of the debt. |
Research and Development | Research and Development All costs of research and development are expensed as incurred. When preparing our financial statements, we are required to estimate our accrued research and development expenses. This process involves reviewing contracts and communicating with our personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual cost. Payments under some of the contracts we have with third parties depend on factors such as successful enrollment of certain numbers of patients, site initiation and the completion of clinical trial milestones. When accruing research and development expenses, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If possible, we obtain information regarding unbilled services directly from our service providers. However, we may be required to estimate the cost of these services based only on information available to us. If we underestimate or overestimate the cost associated with research and development services at a given point in time, adjustments to research and development expenses may be necessary in future periods. Historically, our estimated accrued research and development expenses have approximated actual expense incurred. |
Government Grants | Government Grants Government grants are recognized in the consolidated statement of operations and comprehensive loss in the same period as the relevant expenses, in compliance with the agreement, as a reduction in the related expense or reduce the carrying value of the asset being acquired. Cash received from government grants related to deposits are recognized as deferred government grants, included in other current liabilities on the consolidated balance sheet, and recognized as the related deposit is used. |
CEPI Funding Agreement | CEPI Funding Agreement Cash received in advance from the CEPI Funding Agreement is included in cash on the 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 consolidated balance sheet, and recognized as a reduction in the related expense when incurred. As of December 31, 2023, the amount of cash received in advance from CEPI, not yet recognized as a reduction in expenses in the consolidated statement of operations but included in cash on the consolidated balance sheets, is $ 3,601 |
Revenue Recognition | Revenue Recognition Product Sales, net We sell our product to a limited number of wholesalers and specialty distributors in the U.S., to Valneva, as part of our marketing and distribution agreement covering the U.K. and certain EU markets, and directly to health fund customers in Israel (collectively, our “Customers”). Revenues from product sales are recognized when we have satisfied our performance obligation, which is the transfer of control of our product upon delivery to the Customer. The timing between the recognition of revenue for product sales and the receipt of payment is not significant. Because our standard credit terms are short-term and we expect to receive payment in less than one-year, there is no significant financing component on the related receivables. Taxes collected from Customers relating to product sales and remitted to governmental authorities are excluded from revenues. Since our performance obligation is part of a contract that has an original expected duration of one year or less, we elect not to disclose the information about our remaining performance obligations. Overall, product revenue, net, reflects our best estimates of the amount of consideration to which we are entitled based on the terms of the contract. The amount of variable consideration is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. If we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of revenue that we report in a particular period. We evaluate our estimates of variable considerations including, but not limited to, product returns, chargebacks, rebates, and other fees, periodically or when there is an event or change in circumstances that may indicate that our estimates may change. Reserves for Variable Consideration Revenues from product sales are recorded at the net sales price, which includes estimates of variable consideration such as product returns, chargebacks, discounts, rebates, and other fees that are offered within contracts between us and our Customers, healthcare providers, pharmacies and others relating to our product sales. We estimate variable consideration using either the most likely amount method or the expected value method, depending on the type of variable consideration and what method better predicts the amount of consideration we expect to receive. We take into consideration relevant factors such as industry data, current contractual terms, available information about Customers’ inventory, resale and chargeback data and forecasted customer buying and payment patterns, in estimating each variable consideration. The variable consideration is recorded at the time product sales is recognized, resulting in a reduction in product revenue and a reduction in accounts receivable (if the Customer offsets the amount against its accounts receivable) or as an accrued liability (if we pay the amount through our accounts payable process). Variable consideration requires significant estimates, judgment and information obtained from external sources. Product Returns Consistent with industry practice, we offer our Customers a limited right of return based on the product’s expiration date for product that has been purchased from us. We estimate the amount of our product sales that may be returned by our Customers and record this estimate as a reduction of revenue in the period the related product revenue is recognized. We consider several factors in the estimation of potential product returns including expiration dates of the product shipped, the limited product return rights, available information about Customers’ inventory and other relevant factors. Chargebacks Our Customers subsequently resell our product to healthcare providers, pharmacies and others. In addition to distribution agreements with Customers, we enter into arrangements with qualified healthcare providers that provide for chargebacks and discounts with respect to the purchase of our product. Chargebacks represent the estimated obligations resulting from contractual commitments to sell product to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase the product from us. Customers charge us for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable. Chargeback amounts are determined at the time of resale to the qualified healthcare providers by Customers, and we issue credits for such amounts generally within a few weeks of the Customer’s notification to us of the resale. Reserves for chargebacks consists of credits that we expect to issue for units that remain in the distribution channel inventories at each reporting period end that we expect will be sold to the qualified healthcare providers, and chargebacks for units that our Customers have sold to the qualified healthcare providers, but for which credits have not been issued. Trade Discounts and Allowances We provide our Customers with discounts which include early payment incentives that are explicitly stated in our contracts, and are recorded as a reduction of revenue in the period the related product revenue is recognized. Distribution Fees Distribution fees include fees paid to certain Customers for sales order management, data, and distribution services. Distribution fees are recorded as a reduction of revenue in the period the related product revenue is recognized. Collaborative Arrangements The Company first evaluates license and/or collaboration arrangements to determine whether the arrangement (or part of the arrangement) represents a collaborative arrangement pursuant to Accounting Standards Codification (“ASC”) Topic 808, Collaborative Arrangements (“ASC 808”), based on the risks and rewards and activities of the parties pursuant to the contractual arrangement. The Company then determines if the collaborative arrangements are within the scope of ASC Topic 606, Revenue Recognition (“ASC 606”). Collaborative arrangements with partners which are within the scope of ASC 606 typically include payment to us of one or more of the following: (i) license fees; (ii) research and development services to be performed as part of the contract (“R&D services”) (iii) payments related to the achievement of developmental, regulatory, or commercial milestones; and (iv) royalties on net sales of licensed products. Collaborative arrangements (or elements within the contract that are deemed part of a collaborative arrangement) with partners which represent a collaborative relationship and not a customer relationship, are accounted for outside the scope of ASC Topic 606. License Fees If a license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. R&D Services The promises under the Company’s collaboration and license agreements generally include research and development services to be performed by the Company. For performance obligations that include research and development services, the Company generally recognizes revenue allocated to such performance obligations based on an appropriate measure of progress. The Company utilizes judgment to determine the appropriate method of measuring progress for purposes of recognizing revenue, which is generally an input measure such as costs incurred. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Royalties For arrangements that include sales-based royalties, including milestone payments based on a level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from any of its licensing arrangements. |
Employee Benefits | Employee Benefits The Company’s liability for severance pay for the employees of its subsidiary in Israel is calculated in accordance with Israeli law based on the most recent salary paid to employees and the length of employment in the Company. The Company records its obligation with respect to employee severance payments as if it were payable at each balance sheet date. Obligations for employee benefits are recognized as a component of operating expenses in the consolidated statement of operations and comprehensive loss in the periods during which services are rendered by employees. |
Income Taxes | Income Taxes Deferred tax assets and liabilities are determined based on the differences between the financial reporting and tax basis of assets and liabilities using enacted tax rates which will be in effect when the differences reverse. The Company provides a valuation allowance against net deferred tax assets unless, based upon the available evidence, it is more likely than not that the deferred tax asset will be realized. The Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities based on the technical merits of the position. The benefit is measured as the largest amount that is more likely than not to be realized upon ultimate settlement. The Company does not have any uncertain tax positions or accrued penalties and interest as of December 31, 2023 and 2022. If such matters were to arise, the Company would recognize interest and penalties related to income tax matters in income tax expense. The Company’s claim for Scientific Research and Experimental Development (“SR&ED”) deductions for income tax purposes are based upon management’s interpretation of the applicable legislation in the Income Tax Act (Canada). These amounts are subject to review and acceptance by the Canada Revenue Agency and may be subject to adjustment. |
Fair Value Measurements of Financial Instruments | Fair Value Measurements of Financial Instruments Accounting guidance defines fair value as the price that would be received to sell an asset or paid to transfer a liability (the exit price) in an orderly transaction between market participants at the measurement date. The accounting guidance outlines a valuation framework and creates a fair value hierarchy in order to increase the consistency and comparability of fair value measurements and the related disclosures. The fair value hierarchy is broken down into three levels based on the source of inputs as follows: Level 1 — Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities. Level 2 — Valuations based on observable inputs and quoted prices in active markets for similar assets and liabilities. Level 3 — Valuations based on inputs that are unobservable and models that are significant to the overall fair value measurement. Financial instruments recognized in the consolidated balance sheet consist of cash, accounts receivable, other current assets, accounts payable and other current liabilities. The Company believes that the carrying value of its current financial instruments approximates their fair values due to the short-term nature of these instruments. The Company does not hold any derivative financial instruments. The carrying amounts of the Company’s long-term financial assets approximate their respective fair values. The fair value of our outstanding debt, including the current portion, is estimated to be approximately $ 48,077 56,510 |
Loss Per Share | Loss Per Share Basic loss per share is computed by dividing net loss by the weighted average number of shares outstanding during the period. Diluted loss per share is computed by dividing net loss by the weighted average number of shares outstanding after giving effect to the impact of all potentially dilutive potential shares. In computing the basic and diluted net loss per share applicable to common stockholders, the weighted average number of shares remained the same for both calculations due to the fact that when a net loss exists, dilutive shares are not included in the calculation. There was no dilutive effect on the earnings per share for the years ended December 31, 2023 and 2022. |
Leases | Leases The Company determines if an arrangement is a lease at inception. For the Company’s operating leases, the right-of-use (“ROU”) assets represents the Company’s right to use an underlying asset for the lease term and operating lease liabilities represent an obligation to make lease payments arising from the lease. ROU assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. Since the Company’s lease agreements do not provide an implicit rate, the Company estimated an incremental borrowing rate in determining the present value of its lease payments. Operating lease expense is recognized on a straight-line basis over the lease term, subject to any changes in the lease or expectations regarding the terms. Variable lease costs such as operating costs and property taxes are expensed as incurred. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for share-based awards to employees and directors in accordance with the provisions of ASC 718, Compensation—Stock Compensation (“ASC 718”). Under ASC 718, share-based awards are valued at fair value on the date of grant and that fair value is recognized over the requisite service period. The Company values its stock options using the Black-Scholes option pricing model. The Company accounts for forfeitures when they occur. The Company accounts for share-based payments to non-employees issued in exchange for services based upon the fair value of the equity instruments issued. Compensation expense for stock options issued to non-employees is calculated using the Black-Scholes option pricing model and is recorded over the service performance period. |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
SCHEDULE OF ESTIMATED USEFUL LIVES OF PROPERTY AND EQUIPMENT | The assets are depreciated by the straight-line method over the estimated useful lives of the related assets as follows: SCHEDULE OF ESTIMATED USEFUL LIVES OF PROPERTY AND EQUIPMENT Number of years Furniture and office equipment 5 14 Machinery and equipment 3 7 Computers 2 3 Leasehold improvements shorter of useful life or the term of the lease |
NEW ACCOUNTING PRONOUNCEMENTS (
NEW ACCOUNTING PRONOUNCEMENTS (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Changes and Error Corrections [Abstract] | |
SCHEDULE OF CUMULATIVE EFFECT OF CHANGES ON CONSOLIDATED BALANCE SHEETS | Accordingly, the cumulative effect of the changes made on our January 1, 2022 consolidated balance sheet for the adoption of the ASU was as follows: SCHEDULE OF CUMULATIVE EFFECT OF CHANGES ON CONSOLIDATED BALANCE SHEETS Balance as at Adjustments Balance as at Liabilities Long-term debt, net of debt discount $ 28,441 $ 681 $ 29,122 Stockholders’ equity Additional paid-in capital $ 81,583 $ (2,746 ) $ 78,837 Accumulated deficit $ (378,371 ) $ 2,065 $ (376,306 ) |
INVENTORY, NET (Tables)
INVENTORY, NET (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Inventory Disclosure [Abstract] | |
SCHEDULE OF INVENTORY | Inventory is stated at the lower of cost or market and consists of the following: SCHEDULE OF INVENTORY 2023 2022 Finished goods $ 1,661 $ 893 Work-in-process 2,734 1,869 Raw materials 4,104 3,837 Inventory, net $ 8,499 $ 6,599 |
OTHER CURRENT ASSETS (Tables)
OTHER CURRENT ASSETS (Tables) | 12 Months Ended |
Dec. 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 2023 2022 Government receivables $ 1,268 $ 4,033 Other current assets 495 2,026 Total other current assets $ 1,763 $ 6,059 |
IMPAIRMENT CHARGES (Tables)
IMPAIRMENT CHARGES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
SCHEDULE OF IMPAIRMENT CHARGES | Impairment charges consist of the following: SCHEDULE OF IMPAIRMENT CHARGES 2023 2022 Property and equipment (Note 7) $ 1,000 $ - IPR&D (Note 8) 22,600 - Goodwill (Note 8) 1,000 - Impairment charges $ 24,600 $ - |
PROPERTY AND EQUIPMENT (Tables)
PROPERTY AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
SCHEDULE OF PROPERTY AND EQUIPMENT | SCHEDULE OF PROPERTY AND EQUIPMENT 2023 Cost Accumulated Net Book Machinery and equipment $ 7,328 $ (4,399 ) $ 2,929 Furniture and office equipment 596 (216 ) 380 Computer equipment and software 1,206 (885 ) 321 Leasehold improvements 10,922 (4,887 ) 6,035 20,052 $ (10,387 ) $ 9,665 2022 Cost Accumulated Net Book Machinery and equipment $ 7,836 $ (3,447 ) $ 4,389 Furniture and office equipment 585 (152 ) 433 Computer equipment and software 1,084 (694 ) 390 Leasehold improvements 10,729 (3,688 ) 7,041 $ 20,234 $ (7,981 ) $ 12,253 |
INTANGIBLE ASSETS AND GOODWILL
INTANGIBLE ASSETS AND GOODWILL (Tables) | 12 Months Ended |
Dec. 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 2023 Gross Carrying Amount Accumulated Cumulative Cumulative Currency Translation Net Book Value IPR&D assets $ 61,500 $ - $ (22,900 ) $ (2,101 ) $ 36,499 2022 Gross Accumulated Cumulative Cumulative Net Book IPR&D assets $ 61,500 $ - $ (300 ) $ (2,855 ) $ 58,345 |
SCHEDULE OF GOODWILL | SCHEDULE OF GOODWILL 2023 Gross Carrying Amount Cumulative Impairment Charge Cumulative Currency Translation Net Book Value Goodwill $ 8,714 $ (7,292 ) $ (292 ) $ 1,130 2022 Gross Cumulative Cumulative Net Book Goodwill $ 8,714 $ (6,292 ) $ (295 ) $ 2,127 |
OTHER CURRENT LIABILITIES (Tabl
OTHER CURRENT LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Other Liabilities Disclosure [Abstract] | |
SCHEDULE OF OTHER CURRENT LIABILITIES | Other current liabilities consisted of the following: SCHEDULE OF OTHER CURRENT LIABILITIES 2023 2022 Accrued research and development expenses (including clinical trial accrued expenses) $ 2,018 $ 6,561 Accrued professional fees 1,674 3,250 Payroll and employee-related costs 1,934 4,036 Deferred funding 3,601 6,966 Other current liabilities 1,057 1,775 Total other current liabilities $ 10,284 $ 22,588 |
SCHEDULE OF CHANGES IN ONE-TIME TERMINATION BENEFITS | The following table presents changes in one-time termination benefits during the year ended December 31, 2023. SCHEDULE OF CHANGES IN ONE-TIME TERMINATION BENEFITS Accrued balance at January 1, 2023 $ - Charges 759 Cash payments (759 ) Accrued balance at December 31, 2023 $ - |
LOSS PER SHARE OF COMMON SHAR_2
LOSS PER SHARE OF COMMON SHARES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
SCHEDULE OF ANTI-DILUTIVE WEIGHTED AVERAGE SHARES OUTSTANDING | The following potentially dilutive securities outstanding at December 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 Warrants 14,467,566 118,816 Stock options and unvested stock awards 1,650,288 761,314 K2HV conversion feature 205,396 205,396 Total 16,323,250 1,085,526 |
LONG-TERM DEBT (Tables)
LONG-TERM DEBT (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
SCHEDULE OF LONG-TERM DEBT | SCHEDULE OF LONG-TERM DEBT 2023 2022 Long-term debt, net of debt discount of $ 4,930 6,811 $ 50,769 $ 48,888 Current portion, net of debt discount of $ 4,930 0 (50,769 ) - Long-term debt, net of current portion $ - $ 48,888 |
SCHEDULE OF INTEREST EXPENSE | Interest expense, net of interest income recorded for the years ended December 31, 2023 and 2022 was as follows: SCHEDULE OF INTEREST EXPENSE 2023 2022 Interest expense $ 6,183 $ 3,515 Amortization of debt discount 1,881 1,707 Extinguishment loss - 172 Interest income (1,663 ) (1,387 ) Total interest expense, net of interest income $ 6,401 $ 4,007 |
STOCKHOLDERS_ EQUITY AND ADDI_2
STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
SCHEDULE OF STOCK OPTIONS OUTSTANDING UNDER DIFFERENT PLANS | The table below provides information, as of December 31, 2023, regarding the 2006 Plan, the 2014 Plan and the 2016 Plan under which our equity securities are authorized for issuance to officers, directors, employees, consultants, independent contractors and advisors. SCHEDULE OF STOCK OPTIONS OUTSTANDING UNDER DIFFERENT PLANS Plan Category Number of securities to be issued upon exercise/vesting of outstanding awards Weighted average exercise price 2006 Plan 28,038 $ 126.49 2014 Plan 17,195 151.53 2016 Plan 1,605,055 27.56 1,650,288 $ 30.53 |
SCHEDULE OF STOCK OPTIONS ACTIVITY | Activity related to stock options is as follows: SCHEDULE OF STOCK OPTIONS ACTIVITY Number of Stock Options Weighted Average Exercise Price Balance outstanding at December 31, 2021 617,655 $ 78.90 Granted 171,292 45.24 Exercised (241 ) 49.43 Forfeited (27,474 ) 77.61 Balance outstanding at December 31, 2022 761,232 $ 71.26 Granted 993,643 2.02 Forfeited (104,587 ) 56.52 Balance outstanding at December 31, 2023 1,650,288 $ 30.53 Exercisable at December 31, 2023 718,513 $ 63.81 |
SCHEDULE OF EXERCISE PRICE RANGE STOCK OPTIONS OUTSTANDING AND EXERCISABLE | SCHEDULE OF EXERCISE PRICE RANGE STOCK OPTIONS OUTSTANDING AND EXERCISABLE Outstanding Exercisable Exercise Price Number Of Options Weighted Average Remaining Life (Years) Number Of Options Weighted Average Exercise Price $ 0.00 – 0.99 - - - $ - 1.00 – 1.99 932,500 9.58 94,790 1.30 2.00 – 2.99 8,000 9.33 1,777 2.49 3.00 + 709,788 6.32 621,946 73.51 1,650,288 8.17 718,513 $ 63.81 |
SCHEDULE OF RESTRICTED STOCK UNITS | Information relating to restricted stock units is as follow: SCHEDULE OF RESTRICTED STOCK UNITS Number of Weighted Unvested shares outstanding at December 31, 2021 1,304 $ 44.10 Vested (1,199 ) 44.40 Forfeited (23 ) 43.80 Unvested shares outstanding at December 31, 2022 82 $ 43.80 Vested (82 ) 43.80 Unvested shares outstanding at December 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 2023 2022 Volatility 112.44 % 93.23 % Risk free interest rate 4.17 % 1.75 % Expected term in years 5.74 5.83 Expected dividend yield 0.00 % 0.00 % Weighted average fair value per option $ 1.65 $ 33.90 |
SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE | The total stock-based compensation expense recorded in the years ended December 31, was as follows: SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE 2023 2022 Research and development $ 872 $ 1,998 General and administration 5,699 7,585 Cost of revenue 90 115 $ 6,661 $ 9,698 |
SCHEDULE OF FAIR VALUE OF WARRANTS GRANTED BY USING BLACK-SCHOLES OPTION PRICING ASSUMPTIONS | The value attributed to the common warrants, on date of issuance, was based on the Black-Scholes option pricing model by applying the following assumptions: SCHEDULE OF FAIR VALUE OF WARRANTS GRANTED BY USING BLACK-SCHOLES OPTION PRICING ASSUMPTIONS Common warrant Volatility 118.94 % Risk free interest rate 4.25 % Expected term in years 5 Expected dividend yield 0.00 % Fair value per warrant $ 1.38 |
SCHEDULE OF WARRANT ACTIVITY | Activity related to the warrants is as follows: SCHEDULE OF WARRANT ACTIVITY Number of Warrants Weighted Average Balance outstanding at December 31, 2021 46,136 $ 37.28 Issued 72,680 24.08 Balance outstanding at December 31, 2022 118,816 $ 29.20 Expired (14,886 ) 45.00 Issued 14,363,636 0.61 Balance outstanding at December 31, 2023 14,467,566 $ 0.79 |
REVENUE, NET AND DEFERRED REV_2
REVENUE, NET AND DEFERRED REVENUE (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Revenue from Contract with Customer [Abstract] | |
SCHEDULE OF REVENUE COMPRISED | Revenue, net comprises of the following: SCHEDULE OF REVENUE COMPRISED 2023 2022 Product revenue, net $ 3,107 $ 931 License revenue 3,596 - R&D Service revenue 1,979 151 Revenues $ 8,682 $ 1,082 |
SUMMARY OF REVENUE EXPECTED TO BE RECOGNIZED IN FUTURE RELATED TO PERFORMANCE OBLIGATIONS | The following table presents revenue expected to be recognized in the future related to performance obligations, based on current estimates, that are unsatisfied at December 31, 2023: SUMMARY OF REVENUE EXPECTED TO BE RECOGNIZED IN FUTURE RELATED TO PERFORMANCE OBLIGATIONS Total 2024 2025 and thereafter Product revenue, net $ 5,116 $ 5,116 $ - R&D Service revenue 3,992 2,160 1,832 $ 9,108 $ 7,276 $ 1,832 |
SUMMARY OF CHANGES IN DEFERRED REVENUE | The following table presents changes in the deferred revenue balance for the year ended December 31, 2023: SUMMARY OF CHANGES IN DEFERRED REVENUE Balance at January 1, 2022 $ 2,803 - - - Balance at December 31, 2022 $ 2,613 Amounts received 8,056 Recognition of deferred revenue (1,952 ) Currency translation 391 Balance at December 31, 2023 $ 9,108 Short Term $ 7,276 Long Term $ 1,832 |
COLLABORATIVE ARRANGEMENTS (Tab
COLLABORATIVE ARRANGEMENTS (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
SCHEDULE OF RESEARCH AND DEVELOPMENT EXPENSE | SCHEDULE OF RESEARCH AND DEVELOPMENT EXPENSE 2023 2022 NRC $ 35 $ 851 CEPI 3,486 3,648 Agenus Inc. 642 3,748 Research and Development Expenses $ 4,163 $ 8,247 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
SCHEDULE OF LOSS BEFORE INCOME TAX | Components of the Company’s loss from continuing operations before income taxes are as follows: SCHEDULE OF LOSS BEFORE INCOME TAX 2023 2022 Netherlands $ (738 ) $ (394 ) United States (7,560 (3,909 ) Canada (32,360 ) (46,364 ) Israel (52,178 ) (62,636 ) $ (92,836 ) $ (113,303 ) |
SCHEDULE OF EFFECTIVE INCOME TAX RATE RECONCILIATION | The Company operates in United States, Israel and Canadian tax jurisdictions. Its income is subject to varying rates of tax, and losses incurred in one jurisdiction cannot be used to offset income taxes payable in another. A reconciliation of the income tax rate with the Company’s effective tax rate and income tax expense are as follows: SCHEDULE OF EFFECTIVE INCOME TAX RATE RECONCILIATION 2023 2022 Loss before income taxes $ (92,836 ) $ (113,303 ) Canadian statutory tax rate 26.50 % 26.50 % Expected benefit of income tax ) (30,025 ) Research and development tax credits (319 ) (386 ) Change in tax rate 203 1,970 Change in valuation allowance * 17,707 12,562 Difference between Canadian and foreign tax rates 2,042 2,771 Stock based compensation 1,628 2,362 Foreign exchange translation 2,643 10,814 Goodwill impairment 265 - Permanent statutory to GAAP difference 141 (308 ) Other 292 240 $ - $ - * A portion of the change in valuation allowance is recognized in equity, therefore the overall change in the valuation allowance will not equal the amount recognized in tax expense. |
SCHEDULE OF DEFERRED TAX ASSETS | The Deferred tax asset (liability) consisted of the following: SCHEDULE OF DEFERRED TAX ASSETS 2023 2022 Net operating losses $ 108,574 $ 98,147 Research and development tax credits 14,655 13,995 Property and equipment 830 1,072 Reserves and other 2,928 2,253 Intangible assets (9,672 ) (15,461 ) Allowable capital losses 342 56 Debt obligations (1,902 ) (2,683 ) Deferred financing costs 962 1,201 Net deferred tax assets 116,717 98,580 Less: valuation allowance (116,717 ) (98,580 ) $ - $ - |
SCHEDULE OF NOL’S AVAILABLE TO REDUCE TAXABLE INCOME OF FUTURE YEARS | SCHEDULE OF NOL’S AVAILABLE TO REDUCE TAXABLE INCOME OF FUTURE YEARS Netherlands United States Canada Israel Total 2025 - - 862 - 862 2026 - 10 3,590 - 3,600 2027 - 446 4,159 - 4,605 2028 - 718 1,610 - 2,328 2029 - 672 3,016 - 3,688 2030 - 2,556 977 - 3,533 2031 - 3,617 1,207 - 4,824 2032 - 2,962 - - 2,962 2033 - 3,126 1,411 - 4,537 2034 - 5,626 5,284 - 10,910 2035 - 4,661 1,589 - 6,250 2036 - 5,323 6,995 - 12,318 2037 - 6,017 9,473 - 15,490 2038 - - 2,353 - 2,353 2039 - - 7,488 - 7,488 2040 - - 15,896 - 15,896 2041 - - 11,682 - 11,682 2042 - - 13,434 - 13,434 2043 - - 11,449 - 11,449 No expiration 798 23,790 - 291,711 316,299 Total losses $ 798 59,524 $ 102,475 $ 291,711 $ 454,508 |
LEASES (Tables)
LEASES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Leases | |
SCHEDULE OF LEASE COST AND OTHER INFORMATION | The total operating lease cost recorded in the years ended December 31, 2023 and 2022 was as follows: SCHEDULE OF LEASE COST AND OTHER INFORMATION 2023 2022 Operating lease cost $ 1,866 $ 1,865 Weighted average discount rate 13 % Weighted average remaining lease term 2.36 years |
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 Year ending December 31 2024 $ 1,177 2025 686 2026 593 2027 163 Total 2,619 Effect of discounting (348 ) Total lease liability 2,271 Current portion (976 ) Long term lease liability, net of current portion $ 1,295 |
SEGMENT INFORMATION (Tables)
SEGMENT INFORMATION (Tables) | 12 Months Ended |
Dec. 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 2023 2022 United States $ 1,845 $ 695 Israel 167 315 China/Hong Kong 5,585 66 Europe 1,085 6 Revenues $ 8,682 $ 1,082 |
SCHEDULE OF PROPERTY AND EQUIPMENT AND OPERATING LEASE RIGHT OF USE ASSETS | Tangible long-lived assets (Property and equipment and Right of Use assets) attributed to geographic areas are as follows: SCHEDULE OF PROPERTY AND EQUIPMENT AND OPERATING LEASE RIGHT OF USE ASSETS 2023 2022 Israel $ 11,009 $ 13,892 United States 506 985 Canada (country of domicile) 398 692 Total $ 11,913 $ 15,569 |
NATURE OF BUSINESS AND CONTIN_2
NATURE OF BUSINESS AND CONTINUATION OF BUSINESS (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||||
Apr. 09, 2024 | Jul. 05, 2023 | Apr. 04, 2023 | Aug. 26, 2022 | Aug. 26, 2022 | Jul. 31, 2023 | Jun. 30, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Apr. 16, 2024 | Sep. 30, 2022 | Mar. 09, 2021 | |
Retained Earnings (Accumulated Deficit) | $ 582,445 | $ 489,609 | ||||||||||
Cash | 23,685 | 62,629 | ||||||||||
Net Cash Provided by (Used in) Operating Activities | 60,883 | 73,695 | ||||||||||
Proceeds from issuance of equity | 22,652 | |||||||||||
Stock issuance costs | 1,575 | |||||||||||
Net proceeds | $ 24,273 | |||||||||||
Common shares outstanding | 23,918,983 | 8,608,539 | ||||||||||
Upfront payment | $ 15,000 | |||||||||||
Equity investment | 3,000 | |||||||||||
Payment for clinical and commercial manufacture | 5,000 | |||||||||||
Non-refundable upfront payment | $ 7,000 | |||||||||||
Deemed dividend | $ 1,005 | |||||||||||
Common Stock [Member] | ||||||||||||
Common shares, issued | 15,310,444 | |||||||||||
Proceeds from issuance of equity | $ 22,652 | |||||||||||
Warrant [Member] | ||||||||||||
Warrants to purchase common stock | 14,363,636 | |||||||||||
Warrant price | $ 0.6057 | |||||||||||
Deemed dividend | $ 1,005 | |||||||||||
Underwritten Public Offering [Member] | ||||||||||||
Common shares, issued | 12,445,454 | |||||||||||
Shares issued, price | $ 1.65 | |||||||||||
Purchase of warrants | 12,545,454 | |||||||||||
Warrant price | $ 1.65 | |||||||||||
Gross proceeds | $ 20,500 | |||||||||||
Underwritten Public Offering [Member] | Common Stock [Member] | ||||||||||||
Common shares, issued | 1,536,363 | |||||||||||
Underwritten Public Offering [Member] | Warrant [Member] | ||||||||||||
Warrants to purchase common stock | 1,636,363 | |||||||||||
Direct Offering [Member] | ||||||||||||
Common shares, issued | 1,818,182 | 1,818,182 | ||||||||||
Shares issued, price | $ 1.65 | $ 1.65 | ||||||||||
Purchase of warrants | 1,818,182 | |||||||||||
Warrant price | $ 1.65 | |||||||||||
Gross proceeds | $ 3,000 | $ 3,000 | ||||||||||
K2 HealthVentures LLC [Member] | ||||||||||||
Increase amount of term loans available | $ 100,000 | |||||||||||
Subsequent Event [Member] | ||||||||||||
Public float value | $ 75,000 | |||||||||||
Subsequent Event [Member] | Direct Offering [Member] | ||||||||||||
Common shares, issued | 2,272,728 | |||||||||||
Shares issued, price | $ 0.88 | |||||||||||
Net proceeds | $ 1,700 | |||||||||||
Purchase of warrants | 2,272,728 | |||||||||||
Warrant price | $ 0.76 | |||||||||||
Subsequent Event [Member] | Non-affiliates [Member] | ||||||||||||
Public float value | $ 75,000 | |||||||||||
Subsequent Event [Member] | Non-affiliates [Member] | Calculated Based on Common Shares [Member] | ||||||||||||
Shares issued, price | $ 0.9210 | |||||||||||
Public float value | $ 25,174 | |||||||||||
Common shares outstanding | 27,334,007 | |||||||||||
CEPI Funding Agreement [Member] | ||||||||||||
Cash | $ 3,601 | |||||||||||
Maximum deferred fund agreed | $ 33,018 | |||||||||||
ATM Program [Member] | ||||||||||||
Common shares, issued | 1,046,808 | |||||||||||
Proceeds from issuance of equity | $ 738 | |||||||||||
Shares issued, price | $ 0.7048 | $ 0.7048 | ||||||||||
Stock issuance costs | $ 107 | |||||||||||
Net proceeds | 631 | |||||||||||
Share value remaining, available for sale | $ 124,262 | |||||||||||
Minimum [Member] | ||||||||||||
Operating expenses and workforce reduction percentage | 30% | 30% | ||||||||||
Warrant price | $ 0.6057 | |||||||||||
Minimum [Member] | ATM Program [Member] | Subsequent Event [Member] | ||||||||||||
Public float value | $ 125,000 | |||||||||||
Maximum [Member] | ||||||||||||
Operating expenses and workforce reduction percentage | 35% | 35% | ||||||||||
Share value remaining, available for sale | $ 300,000 | |||||||||||
Maximum [Member] | ATM Program [Member] | ||||||||||||
Share value remaining, available for sale | $ 125,000 |
SCHEDULE OF ESTIMATED USEFUL LI
SCHEDULE OF ESTIMATED USEFUL LIVES OF PROPERTY AND EQUIPMENT (Details) | Dec. 31, 2023 |
Furniture and Fixtures [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 5 years |
Furniture and Fixtures [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 14 years |
Machinery and Equipment [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 3 years |
Machinery and Equipment [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 7 years |
Computer Equipment [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 2 years |
Computer Equipment [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 3 years |
Leasehold Improvements [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant, and Equipment, Useful Life, Term, Description [Extensible Enumeration] | Useful Life, Shorter of Lease Term or Asset Utility [Member] |
SIGNIFICANT ACCOUNTING POLICI_4
SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) $ in Thousands | Apr. 12, 2023 | Dec. 31, 2023 | Dec. 31, 2022 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Reverse stock split, description | 1-for-30 reverse stock split | ||
Cash | $ 23,685 | $ 62,629 | |
Debt instrument fair value | 48,077 | $ 56,510 | |
CEPI Funding Agreement [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Cash | $ 3,601 |
SCHEDULE OF CUMULATIVE EFFECT O
SCHEDULE OF CUMULATIVE EFFECT OF CHANGES ON CONSOLIDATED BALANCE SHEETS (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | Jan. 01, 2022 | Dec. 31, 2021 |
Liabilities | ||||
Long-term debt, net of debt discount | $ 48,888 | |||
Stockholders’ equity | ||||
Accumulated deficit | $ (582,445) | $ (489,609) | ||
Accounting Standards Update 2020-06 [Member] | ||||
Liabilities | ||||
Long-term debt, net of debt discount | $ 29,122 | |||
Stockholders’ equity | ||||
Additional paid-in capital | 78,837 | |||
Accumulated deficit | (376,306) | |||
Accounting Standards Update 2020-06 [Member] | Previously Reported [Member] | ||||
Liabilities | ||||
Long-term debt, net of debt discount | $ 28,441 | |||
Stockholders’ equity | ||||
Additional paid-in capital | 81,583 | |||
Accumulated deficit | $ (378,371) | |||
Accounting Standards Update 2020-06 [Member] | Revision of Prior Period, Adjustment [Member] | ||||
Liabilities | ||||
Long-term debt, net of debt discount | 681 | |||
Stockholders’ equity | ||||
Additional paid-in capital | (2,746) | |||
Accumulated deficit | $ 2,065 |
SCHEDULE OF INVENTORY (Details)
SCHEDULE OF INVENTORY (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Finished goods | $ 1,661 | $ 893 |
Work-in-process | 2,734 | 1,869 |
Raw materials | 4,104 | 3,837 |
Inventory, net | $ 8,499 | $ 6,599 |
INVENTORY, NET (Details Narrati
INVENTORY, NET (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Inventory Disclosure [Abstract] | ||
Inventory reserve | $ 1,668 | $ 1,186 |
SCHEDULE OF OTHER CURRENT ASSET
SCHEDULE OF OTHER CURRENT ASSETS (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Government receivables | $ 1,268 | $ 4,033 |
Other current assets | 495 | 2,026 |
Total other current assets | $ 1,763 | $ 6,059 |
SCHEDULE OF IMPAIRMENT CHARGES
SCHEDULE OF IMPAIRMENT CHARGES (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Jun. 30, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Indefinite-Lived Intangible Assets [Line Items] | ||||
Impairment charges | $ 24,600 | |||
In Process Research and Development [Member] | ||||
Indefinite-Lived Intangible Assets [Line Items] | ||||
Impairment charges | $ 3,600 | $ 19,000 | 22,600 | |
Property, Plant and Equipment [Member] | ||||
Indefinite-Lived Intangible Assets [Line Items] | ||||
Impairment charges | 1,000 | |||
Goodwill [Member] | ||||
Indefinite-Lived Intangible Assets [Line Items] | ||||
Impairment charges | $ 1,000 |
SCHEDULE OF PROPERTY AND EQUIPM
SCHEDULE OF PROPERTY AND EQUIPMENT (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment cost | $ 20,052 | $ 20,234 |
Accumulated depreciation | (10,387) | (7,981) |
Net book value | 9,665 | 12,253 |
Machinery and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment cost | 7,328 | 7,836 |
Accumulated depreciation | (4,399) | (3,447) |
Net book value | 2,929 | 4,389 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment cost | 596 | 585 |
Accumulated depreciation | (216) | (152) |
Net book value | 380 | 433 |
Computer Equipment and Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment cost | 1,206 | 1,084 |
Accumulated depreciation | (885) | (694) |
Net book value | 321 | 390 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment cost | 10,922 | 10,729 |
Accumulated depreciation | (4,887) | (3,688) |
Net book value | $ 6,035 | $ 7,041 |
PROPERTY AND EQUIPMENT (Details
PROPERTY AND EQUIPMENT (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | ||
Apr. 30, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Impairment Effects on Earnings Per Share [Line Items] | |||
Depreciation | $ 1,990 | $ 2,009 | |
Property, Plant and Equipment [Member] | |||
Impairment Effects on Earnings Per Share [Line Items] | |||
Impairment charges | $ 1,000 |
SCHEDULE OF INDEFINITE LIVED IN
SCHEDULE OF INDEFINITE LIVED INTANGIBLE ASSETS INCLUDING CUMULATIVE IMPAIRMENT AND CURRENCY TRANSLATION (Details) - Inprocess Research and Development Assets [Member] - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Indefinite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | $ 61,500 | $ 61,500 |
Accumulated Amortization | ||
Cumulative Impairment Charge | (22,900) | (300) |
Cumulative Currency Translation | (2,101) | (2,855) |
Net Book value | $ 36,499 | $ 58,345 |
SCHEDULE OF GOODWILL (Details)
SCHEDULE OF GOODWILL (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Goodwill, Gross Carrying Amount | $ 8,714 | $ 8,714 |
Goodwill, Cumulative Impairment Charge | (7,292) | (6,292) |
Goodwill, Cumulative Currency Translation | (292) | (295) |
Goodwill, Net Book value | $ 1,130 | $ 2,127 |
INTANGIBLE ASSETS AND GOODWIL_2
INTANGIBLE ASSETS AND GOODWILL (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||||
Oct. 31, 2023 | Sep. 30, 2023 | Jun. 30, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Apr. 30, 2023 | |
Finite-Lived Intangible Assets [Line Items] | ||||||
Estimated fair value of assets discount rate | 15% | |||||
Impairment charges | $ 24,600 | |||||
Intangible asset foreign currency translation adjustment | 754 | 3,690 | ||||
Goodwill impairment | $ 1,000 | 1,000 | ||||
Goodwill foreign currency translation adjustment | 3 | 134 | ||||
In Process Research and Development [Member] | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Estimated fair value of assets discount rate | 25% | |||||
Impairment charges | $ 3,600 | $ 19,000 | $ 22,600 | |||
Minimum [Member] | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Percentage of cumulative probability | 10% | |||||
Maximum [Member] | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Percentage of cumulative probability | 17% |
SCHEDULE OF OTHER CURRENT LIABI
SCHEDULE OF OTHER CURRENT LIABILITIES (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Other Liabilities Disclosure [Abstract] | ||
Accrued research and development expenses (including clinical trial accrued expenses) | $ 2,018 | $ 6,561 |
Accrued professional fees | 1,674 | 3,250 |
Payroll and employee-related costs | 1,934 | 4,036 |
Deferred funding | 3,601 | 6,966 |
Other current liabilities | 1,057 | 1,775 |
Total other current liabilities | $ 10,284 | $ 22,588 |
SCHEDULE OF CHANGES IN ONE-TIME
SCHEDULE OF CHANGES IN ONE-TIME TERMINATION BENEFITS (Details) - One-time Termination Benefits [Member] $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Restructuring Cost and Reserve [Line Items] | |
Balance at January 1, 2023 | |
Charges | 759 |
Cash payments | (759) |
Balance at June 30, 2023 |
SCHEDULE OF ANTI-DILUTIVE WEIGH
SCHEDULE OF ANTI-DILUTIVE WEIGHTED AVERAGE SHARES OUTSTANDING (Details) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 16,323,250 | 1,085,526 |
Warrant [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 14,467,566 | 118,816 |
Stock Options And Restricted Stock Units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 1,650,288 | 761,314 |
K2HV Conversion Feature [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 205,396 | 205,396 |
SCHEDULE OF LONG-TERM DEBT (Det
SCHEDULE OF LONG-TERM DEBT (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Debt Disclosure [Abstract] | ||
Long-term debt, net of debt discount of $4,930 ($6,811 at December 31, 2022) | $ 50,769 | $ 48,888 |
Current portion, net of debt discount of $4,930 ($0 at December 31, 2022) | (50,769) | |
Long-term debt, net of current portion | $ 48,888 |
SCHEDULE OF LONG-TERM DEBT (D_2
SCHEDULE OF LONG-TERM DEBT (Details) (Parenthetical) - Long-Term Debt [Member] - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Extinguishment of Debt [Line Items] | ||
Debt instrument, unamortized discount | $ 4,930 | $ 6,811 |
Debt instrument, unamortized discount, current | $ 4,930 | $ 0 |
SCHEDULE OF INTEREST EXPENSE (D
SCHEDULE OF INTEREST EXPENSE (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Debt Disclosure [Abstract] | ||
Interest expense | $ 6,183 | $ 3,515 |
Amortization of debt discount | 1,881 | 1,707 |
Extinguishment loss | 172 | |
Interest income | (1,663) | (1,387) |
Total interest expense, net of interest income | $ 6,401 | $ 4,007 |
LONG-TERM DEBT (Details Narrati
LONG-TERM DEBT (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||||||
Feb. 13, 2024 | Sep. 14, 2022 | May 17, 2021 | Feb. 03, 2021 | May 22, 2020 | Dec. 31, 2023 | Dec. 31, 2022 | Sep. 15, 2022 | |
Debt Instrument [Line Items] | ||||||||
Extinguishment of debt | $ (172) | |||||||
Debt fair value | 48,077 | 56,510 | ||||||
Final payment | $ 55,699 | |||||||
Minimum [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Exercise price of warrants | $ 0.6057 | |||||||
Loan Agreement [Member] | Minimum [Member] | Subsequent Event [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Minimum net revenue percentage | 75% | |||||||
Loan and Guaranty Agreement [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt conversion, converted instrument, amount | $ 2,000 | $ 4,000 | ||||||
Conversion price | $ 43.80 | $ 43.80 | ||||||
Debt conversion, converted instrument, shares | 45,662 | |||||||
Extinguishment of debt | 172 | |||||||
Loan and Guaranty Agreement [Member] | First Amendment [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Secured debt | $ 30,000 | |||||||
Additional secured debt | 12,000 | |||||||
Refinancing amount | $ 30,000 | |||||||
Final payment amount | $ 2,224 | |||||||
Loan and Guaranty Agreement [Member] | Second Amendment [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Secured debt | $ 50,000 | $ 50,000 | 50,000 | |||||
Increase amount of term loans available | 100,000 | |||||||
Amount of term loans available | 50,000 | 10,000 | ||||||
Convertible amount | $ 7,000 | |||||||
Secured term loan final payment percentage | 6.95% | |||||||
Final payment amount | $ 3,475 | |||||||
Debt fair value | $ 48,340 | |||||||
Debt discount | 7,359 | |||||||
Debt issuance costs | $ 563 | |||||||
Debt instrument, interest rate, stated percentage | 12.50% | |||||||
Debt instrument, interest rate, effective percentage | 16.13% | |||||||
Debt instrument, maturity date | Sep. 14, 2026 | |||||||
Debt instrument discount | $ 7,359 | 7,359 | ||||||
Debt instrument, unamortized discount | $ 4,930 | $ 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] | 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 and Guaranty Agreement [Member] | Second Amendment [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 | |||||||
Loan and Guaranty Agreement [Member] | Original K2HV Warrant [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Purchase of warrants | 20,833 | |||||||
Exercise price of warrants | $ 33.60 | |||||||
Loan and Guaranty Agreement [Member] | First Amendment Warrant [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Exercise price of warrants | $ 33.60 | |||||||
Total purchase of warrants | 31,250 | |||||||
Loan and Guaranty Agreement [Member] | First Amendment Warrant [Member] | Restated Warrant [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Purchase of warrants | 10,417 | |||||||
Loan and Guaranty Agreement [Member] | Second Amendment Warrant [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Purchase of warrants | 72,680 | |||||||
Exercise price of warrants | $ 24.08 | |||||||
Fair value of warrants | $ 1,550 | |||||||
Loan and Guaranty Agreement [Member] | First Tranche [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Secured debt | $ 20,000 | |||||||
Loan and Guaranty Agreement [Member] | Final Tranche [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Amount of term loans available | $ 25,000 |
EMPLOYEE BENEFITS (Details Narr
EMPLOYEE BENEFITS (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Contribution of employer, percent | 8.33% | |
Total recognized expense | $ 393 | $ 442 |
Severance payment | $ 106 | 5 |
Defined Contribution Plan [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Contribution of employer, percent | 3% | |
Percent of match employee contributions | 50% | |
Total recognized expense | $ 179 | $ 170 |
SCHEDULE OF STOCK OPTIONS OUTST
SCHEDULE OF STOCK OPTIONS OUTSTANDING UNDER DIFFERENT PLANS (Details) | Dec. 31, 2023 $ / shares shares |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of securities to be issued upon exercise/vesting of outstanding awards | shares | 1,650,288 |
Weighted average exercise price | $ / shares | $ 30.53 |
2006 Plan [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of securities to be issued upon exercise/vesting of outstanding awards | shares | 28,038 |
Weighted average exercise price | $ / shares | $ 126.49 |
2014 Plan [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of securities to be issued upon exercise/vesting of outstanding awards | shares | 17,195 |
Weighted average exercise price | $ / shares | $ 151.53 |
2016 Plan [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of securities to be issued upon exercise/vesting of outstanding awards | shares | 1,605,055 |
Weighted average exercise price | $ / shares | $ 27.56 |
SCHEDULE OF STOCK OPTIONS ACTIV
SCHEDULE OF STOCK OPTIONS ACTIVITY (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Offsetting Assets [Line Items] | ||
Number of Stock Options Outstanding, Ending Balance | 1,650,288 | |
Weighted Average Exercise Price, Ending Balance | $ 30.53 | |
Equity Option [Member] | ||
Offsetting Assets [Line Items] | ||
Number of Stock Options Outstanding, Beginning Balance | 761,232 | 617,655 |
Weighted Average Exercise Price, Beginning Balance | $ 71.26 | $ 78.90 |
Number of Stock Options, Granted | 993,643 | 171,292 |
Weighted Average Exercise Price, Granted | $ 2.02 | $ 45.24 |
Number of Stock Options, Exercised | 0 | (241) |
Weighted Average Exercise Price, Exercised | $ 49.43 | |
Number of Stock Options, Forfeited | (104,587) | (27,474) |
Weighted Average Exercise Price, Forfeited | $ 56.52 | $ 77.61 |
Number of Stock Options Outstanding, Ending Balance | 1,650,288 | 761,232 |
Weighted Average Exercise Price, Ending Balance | $ 30.53 | $ 71.26 |
Number of Stock Options, Exercisable | 718,513 | |
Weighted Average Exercise Price, Exercisable | $ 63.81 |
SCHEDULE OF EXERCISE PRICE RANG
SCHEDULE OF EXERCISE PRICE RANGE STOCK OPTIONS OUTSTANDING AND EXERCISABLE (Details) | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Number of options, outstanding | shares | 1,650,288 |
Number of options, exercisable | shares | 718,513 |
Share-Based Payment Arrangement, Option, Exercise Price Range, Exercisable, Weighted Average Exercise Price | $ 63.81 |
Share-Based Payment Arrangement, Option, Exercise Price Range, Outstanding, Weighted Average Remaining Contractual Term | 8 years 2 months 1 day |
Exercise Price One [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Share-Based Payment Arrangement, Option, Exercise Price Range, Lower Range Limit | $ 0 |
Share-Based Payment Arrangement, Option, Exercise Price Range, Upper Range Limit | $ 0.99 |
Number of options, outstanding | shares | |
Number of options, exercisable | shares | |
Share-Based Payment Arrangement, Option, Exercise Price Range, Exercisable, Weighted Average Exercise Price | |
Exercise Price Two [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Share-Based Payment Arrangement, Option, Exercise Price Range, Lower Range Limit | 1 |
Share-Based Payment Arrangement, Option, Exercise Price Range, Upper Range Limit | $ 1.99 |
Number of options, outstanding | shares | 932,500 |
Number of options, exercisable | shares | 94,790 |
Share-Based Payment Arrangement, Option, Exercise Price Range, Exercisable, Weighted Average Exercise Price | $ 1.30 |
Share-Based Payment Arrangement, Option, Exercise Price Range, Outstanding, Weighted Average Remaining Contractual Term | 9 years 6 months 29 days |
Exercise Price Three [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Share-Based Payment Arrangement, Option, Exercise Price Range, Lower Range Limit | $ 2 |
Share-Based Payment Arrangement, Option, Exercise Price Range, Upper Range Limit | $ 2.99 |
Number of options, outstanding | shares | 8,000 |
Number of options, exercisable | shares | 1,777 |
Share-Based Payment Arrangement, Option, Exercise Price Range, Exercisable, Weighted Average Exercise Price | $ 2.49 |
Share-Based Payment Arrangement, Option, Exercise Price Range, Outstanding, Weighted Average Remaining Contractual Term | 9 years 3 months 29 days |
Exercise Price Four [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Share-Based Payment Arrangement, Option, Exercise Price Range, Upper Range Limit | $ 3 |
Number of options, outstanding | shares | 709,788 |
Number of options, exercisable | shares | 621,946 |
Share-Based Payment Arrangement, Option, Exercise Price Range, Exercisable, Weighted Average Exercise Price | $ 73.51 |
Share-Based Payment Arrangement, Option, Exercise Price Range, Outstanding, Weighted Average Remaining Contractual Term | 6 years 3 months 25 days |
SCHEDULE OF RESTRICTED STOCK UN
SCHEDULE OF RESTRICTED STOCK UNITS (Details) - Restricted Stock Units (RSUs) [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Class of Stock [Line Items] | ||
Number of Stock Awards, Unvested shares outstanding beginning balance | 82 | 1,304 |
Weighted Average Fair Value at Grant Date, Unvested shares outstanding beginning balance | $ 44.10 | |
Number of Stock Awards, Vested | (82) | (1,199) |
Weighted Average Fair Value at Grant Date, Vested | $ 43.80 | $ 44.40 |
Number of Stock Awards, Unvested shares outstanding beginning balance | (23) | |
Weighted Average Fair Value at Grant Date, Forfeited | $ 43.80 | |
Number of Stock Awards, Unvested shares outstanding beginning balance | 82 | |
Weighted Average Fair Value at Grant Date, Unvested shares outstanding ending balance |
SCHEDULE OF FAIR VALUE OF OPTIO
SCHEDULE OF FAIR VALUE OF OPTIONS GRANTED BY USING BLACK SCHOLES OPTION PRICING ASSUMPTIONS (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Equity [Abstract] | ||
Volatility | 112.44% | 93.23% |
Risk free interest rate | 4.17% | 1.75% |
Expected term in years | 5 years 8 months 26 days | 5 years 9 months 29 days |
Expected dividend yield | 0% | 0% |
Weighted average fair value per option | $ 1.65 | $ 33.90 |
SCHEDULE OF STOCK-BASED COMPENS
SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Total stock-based compensation expense | $ 6,661 | $ 9,698 |
Research and Development Expense [Member] | ||
Total stock-based compensation expense | 872 | 1,998 |
General and Administrative Expense [Member] | ||
Total stock-based compensation expense | 5,699 | 7,585 |
Cost of Sales [Member] | ||
Total stock-based compensation expense | $ 90 | $ 115 |
SCHEDULE OF FAIR VALUE OF WARRA
SCHEDULE OF FAIR VALUE OF WARRANTS GRANTED BY USING BLACK-SCHOLES OPTION PRICING ASSUMPTIONS (Details) | 12 Months Ended | |
Dec. 31, 2023 $ / shares | Dec. 31, 2022 $ / shares | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Warrants and rights outstanding measurement input | $ 1.65 | $ 33.90 |
Common Warrant [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Warrants and rights outstanding measurement input | $ 1.38 | |
Measurement Input, Price Volatility [Member] | Common Warrant [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Warrants and rights outstanding measurement input | 118.94 | |
Measurement Input, Risk Free Interest Rate [Member] | Common Warrant [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Warrants and rights outstanding measurement input | 4.25 | |
Measurement Input, Expected Term [Member] | Common Warrant [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Warrants term | 5 years | |
Measurement Input, Expected Dividend Rate [Member] | Common Warrant [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Warrants and rights outstanding measurement input | 0 |
SCHEDULE OF WARRANT ACTIVITY (D
SCHEDULE OF WARRANT ACTIVITY (Details) - Warrants [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Number of Warrants, Balance Outstanding Beginning | 118,816 | 46,136 |
Weighted Average Exercise Price, Balance Outstanding Beginning | $ 29.20 | $ 37.28 |
Number of Warrants, issued | 14,363,636 | 72,680 |
Weighted Average Exercise Price, Issued | $ 0.61 | $ 24.08 |
Number of Warrants, expired | (14,886) | |
Weighted Average Exercise Price, expired | $ 45 | |
Number of Warrants, Balance Outstanding Beginning | 14,467,566 | 118,816 |
Weighted Average Exercise Price, Ending Outstanding Ending | $ 0.79 | $ 29.20 |
STOCKHOLDERS_ EQUITY AND ADDI_3
STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||||
Jul. 05, 2023 | Jan. 10, 2022 | Jul. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Sep. 14, 2022 | Aug. 26, 2022 | Dec. 31, 2021 | |
Subsidiary, Sale of Stock [Line Items] | ||||||||
Proceeds from Stock Options Exercised | $ 12 | |||||||
Options outstanding | 1,650,288 | |||||||
Weighted average remaining contractual term | 6 years 6 months | 6 years 6 months 14 days | ||||||
Intrinsic value of outstanding options | $ 0 | |||||||
Intrinsic value of vested options | 0 | |||||||
Intrinsic value of expected to vest | 0 | |||||||
Unrecognized compensation of equity | $ 2,684 | |||||||
Unrecognized compensation weighted average period term | 1 year 6 months 7 days | |||||||
Deemed dividend on certain warrants | $ 1,005 | |||||||
Second Amendment [Member] | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Warrants to purchase common stock | 2,180,413 | |||||||
Warrants exercise price | $ 0.8026 | |||||||
Warrant expiration date | Sep. 14, 2032 | |||||||
Equity Option [Member] | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Stock options, exercises | 0 | 241 | ||||||
Exercise price per share | $ 2.02 | $ 45.24 | ||||||
Options outstanding | 1,650,288 | 761,232 | 617,655 | |||||
Intrinsic value of exercised options | $ 2 | |||||||
Restricted Stock Units (RSUs) [Member] | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Share based compensation fair value | $ 0 | |||||||
2006 Plan [Member] | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Options outstanding | 28,038 | |||||||
2014 Plan [Member] | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Options outstanding | 17,195 | |||||||
2016 Plan [Member] | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Options outstanding | 1,605,055 | |||||||
Share-based compensation arrangement by share-based, percentage | 10% | |||||||
Unvested stock | 1,605,055 | |||||||
Percentage of shares issued and outstanding on non-diluted basic | 5% | |||||||
Percentage of shares issued and outstanding common stock | 10% | |||||||
Number of common shares remaining available for issuance for awards | 692,820 | |||||||
Stock option vesting, percent | 25% | |||||||
2016 Plan [Member] | Maximum [Member] | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Contractual option term | 10 years | |||||||
Common Stock [Member] | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Shares issued during period, shares | 15,310,444 | |||||||
Stock options, exercises | 241 | 241 | ||||||
Exercise price per share | $ 49.43 | |||||||
Proceeds from Stock Options Exercised | $ 12 | |||||||
Common Warrant [Member] | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Warrants exercise price | $ 1.65 | |||||||
Deemed dividend on certain warrants | $ 1,005 | |||||||
ATM Program [Member] | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Shares issued during period, shares | 1,046,808 | |||||||
Share issued price per share | $ 0.7048 | |||||||
Proceeds from issuance of equity | $ 738 | |||||||
Average price per share | $ 0.7048 | |||||||
New Issuance Price [Member] | Common Warrant [Member] | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Warrants exercise price | $ 0.6057 | |||||||
Underwritten Public Offering [Member] | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Shares issued during period, shares | 12,445,454 | |||||||
Share issued price per share | $ 1.65 | |||||||
Gross proceeds of common shares issuances | $ 20,500 | |||||||
Warrants to purchase common stock | 12,545,454 | |||||||
Warrants exercise price | $ 1.65 | |||||||
Underwritten Public Offering [Member] | Common Stock [Member] | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Shares issued during period, shares | 1,536,363 | |||||||
Underwritten Public Offering [Member] | Common Warrant [Member] | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Warrants to purchase common stock | 14,363,636 | |||||||
Direct Offering [Member] | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Shares issued during period, shares | 1,818,182 | 1,818,182 | ||||||
Share issued price per share | $ 1.65 | $ 1.65 | ||||||
Gross proceeds of common shares issuances | $ 3,000 | $ 3,000 | ||||||
Warrants to purchase common stock | 1,818,182 | |||||||
Warrants exercise price | $ 1.65 |
SCHEDULE OF REVENUE COMPRISED (
SCHEDULE OF REVENUE COMPRISED (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 8,682 | $ 1,082 |
Product [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 3,107 | 931 |
License [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 3,596 | |
Service [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 1,979 | $ 151 |
SUMMARY OF REVENUE EXPECTED TO
SUMMARY OF REVENUE EXPECTED TO BE RECOGNIZED IN FUTURE RELATED TO PERFORMANCE OBLIGATIONS (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Disaggregation of Revenue [Line Items] | |
Revenues | $ 9,108 |
January 1, 2024 to December 31, 2024 [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | 7,276 |
Remaining Portion There After [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | 1,832 |
Product [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | 5,116 |
Product [Member] | January 1, 2024 to December 31, 2024 [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | 5,116 |
Product [Member] | Remaining Portion There After [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | |
Service [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | 3,992 |
Service [Member] | January 1, 2024 to December 31, 2024 [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | 2,160 |
Service [Member] | Remaining Portion There After [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenues | $ 1,832 |
SUMMARY OF CHANGES IN DEFERRED
SUMMARY OF CHANGES IN DEFERRED REVENUE (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Revenue from Contract with Customer [Abstract] | ||
Contract with customer liability,beginning | $ 2,613 | $ 2,803 |
Amount Received | 8,056 | |
Recognition of deferred revenue | (1,952) | |
Currency translation | 391 | |
Contract with customer liability, ending | 9,108 | 2,613 |
Contract with customer, liability, current | 7,276 | 409 |
Contract with customer, liability, non-current | $ 1,832 | $ 2,204 |
REVENUE, NET AND DEFERRED REV_3
REVENUE, NET AND DEFERRED REVENUE (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | ||||
Jul. 05, 2023 | Dec. 04, 2018 | Dec. 04, 2018 | Dec. 31, 2023 | Dec. 31, 2022 | |
Disaggregation of Revenue [Line Items] | |||||
Non-refundable upfront payment | $ 7,000 | ||||
Stock issued during period, value | $ 22,652 | ||||
Revenue, remaining performance obligation, amount | 9,108 | ||||
Revenue | 8,682 | $ 1,082 | |||
Collaboration and License Agreement [Member] | Brii Bio [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Non-refundable upfront payment | $ 11,000 | $ 11,000 | |||
Common shares issued in financing transactions, net of issuance costs, shares | 76,502 | ||||
Stock issued during period, value | $ 3,626 | ||||
Revenue, remaining performance obligation, amount | 7,374 | 7,374 | |||
Collaboration and License Agreement [Member] | Brii Bio [Member] | Pre Hevbri Licensed Territory [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Non-refundable upfront payment | 2,000 | ||||
Net sales milestone payments | 195,000 | ||||
Collaboration and License Agreement [Member] | Brii Bio [Member] | VBI-2601 [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Revenue | 2,637 | ||||
Collaboration and License Agreement [Member] | Brii Bio [Member] | VBI-2601 [Member] | New Licensed Territory [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Non-refundable upfront payment | 5,000 | ||||
Net sales milestone payments | 227,000 | ||||
Supply Agreement [Member] | Brii Bio [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
[custom:AdvancePayment-0] | 5,000 | ||||
Deferred Revenue | 5,000 | ||||
Brii Collaboration Agreements and Supply Agreement [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Revenue, remaining performance obligation, amount | 8,433 | ||||
Product [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Cost of Revenue | 12,507 | 11,235 | |||
Revenue, remaining performance obligation, amount | 5,116 | ||||
Revenue | 3,107 | 931 | |||
Service [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Cost of Revenue | 41 | ||||
Revenue, remaining performance obligation, amount | 3,992 | ||||
Revenue | 1,979 | 151 | |||
Service [Member] | Collaboration and License Agreement [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Revenue | 1,925 | ||||
Service [Member] | Collaboration and License Agreement [Member] | Brii Bio [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Revenue, remaining performance obligation, amount | $ 4,737 | $ 4,737 | |||
Service [Member] | Collaboration and License Agreement [Member] | Brii Bio [Member] | Pre Hevbri Licensed Territory [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Revenue, remaining performance obligation, amount | 88 | ||||
Service [Member] | Collaboration and License Agreement [Member] | Brii Bio [Member] | VBI-2601 [Member] | New Licensed Territory [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Revenue, remaining performance obligation, amount | 43 | ||||
Technology Transfer [Member] | Collaboration and License Agreement [Member] | Brii Bio [Member] | Pre Hevbri Licensed Territory [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Revenue, remaining performance obligation, amount | 1,597 | ||||
Technology Transfer [Member] | Collaboration and License Agreement [Member] | Brii Bio [Member] | VBI-2601 [Member] | New Licensed Territory [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Revenue, remaining performance obligation, amount | 1,597 | ||||
License [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Revenue | $ 3,596 | ||||
License [Member] | Collaboration and License Agreement [Member] | Brii Bio [Member] | Pre Hevbri Licensed Territory [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Revenue | 315 | ||||
License [Member] | Collaboration and License Agreement [Member] | Brii Bio [Member] | VBI-2601 [Member] | New Licensed Territory [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Revenue | $ 3,360 |
SCHEDULE OF RESEARCH AND DEVELO
SCHEDULE OF RESEARCH AND DEVELOPMENT EXPENSE (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Research and Development Expenses | $ 9,343 | $ 15,506 |
Collaboration Agreement [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Research and Development Expenses | 4,163 | 8,247 |
Collaboration Agreement [Member] | National Research Council [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Research and Development Expenses | 35 | 851 |
Collaboration Agreement [Member] | Coalition For Epidemic Preparedness Innovations [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Research and Development Expenses | 3,486 | 3,648 |
Collaboration Agreement [Member] | Agenus Inc [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Research and Development Expenses | $ 642 | $ 3,748 |
COLLABORATIVE ARRANGEMENTS (Det
COLLABORATIVE ARRANGEMENTS (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Description of vaccine development | On March 9, 2021, the Company and CEPI announced the CEPI Funding Agreement, to develop eVLP vaccine candidates against SARS-COV-2 variants, including the Beta variant, also known as the B.1.351 variant and as 501Y.V2, first identified in South Africa. CEPI agreed to provide up to $33,018 to support the advancement of VBI-2905, a monovalent eVLP candidate expressing the pre-fusion form of the spike protein from the Beta variant strain, through Phase I clinical development | |
Deferred funding | $ 3,601 | $ 6,966 |
CEPI Funding Agreement [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Deferred funding | 19,327 | |
CEPI Funding Agreement [Member] | Other Current Liabilities [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Deferred funding | $ 3,601 |
GOVERNMENT GRANTS (Details Narr
GOVERNMENT GRANTS (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | ||
Sep. 16, 2020 | Dec. 31, 2023 | Dec. 31, 2022 | |
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 $55,976 from the SIF to support the development of our coronavirus vaccine program, VBI-2900, though Phase II clinical studies (the “Project”) | ||
Contribution Agreement [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Reduction expenses | $ 5,392 | $ 6,038 | |
Deferred government grants | $ 55 | $ 790 |
SCHEDULE OF LOSS BEFORE INCOME
SCHEDULE OF LOSS BEFORE INCOME TAX (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Loss from continuing operations before income taxes | $ (92,836) | $ (113,303) |
NETHERLANDS | ||
Loss from continuing operations before income taxes | (738) | (394) |
UNITED STATES | ||
Loss from continuing operations before income taxes | (7,560) | (3,909) |
CANADA | ||
Loss from continuing operations before income taxes | (32,360) | (46,364) |
ISRAEL | ||
Loss from continuing operations before income taxes | $ (52,178) | $ (62,636) |
SCHEDULE OF EFFECTIVE INCOME TA
SCHEDULE OF EFFECTIVE INCOME TAX RATE RECONCILIATION (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | ||
Operating Loss Carryforwards [Line Items] | |||
Loss before income taxes | $ (92,836) | $ (113,303) | |
Expected benefit of income tax | (24,602) | (30,025) | |
Research and development tax credits | (319) | (386) | |
Change in tax rate | 203 | 1,970 | |
Change in valuation allowance* | [1] | 17,707 | 12,562 |
Difference between Canadian and foreign tax rates | 2,042 | 2,771 | |
Stock based compensation | 1,628 | 2,362 | |
Foreign exchange translation | 2,643 | 10,814 | |
Goodwill impairment | 265 | ||
Permanent statutory to GAAP difference | 141 | (308) | |
Other | 292 | 240 | |
Income tax expense | |||
Canada Revenue Agency [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Canadian statutory tax rate | 26.50% | 26.50% | |
[1]A portion of the change in valuation allowance is recognized in equity, therefore the overall change in the valuation allowance will not equal the amount recognized in tax expense. |
SCHEDULE OF DEFERRED TAX ASSETS
SCHEDULE OF DEFERRED TAX ASSETS (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Income Tax Disclosure [Abstract] | ||
Net operating losses | $ 108,574 | $ 98,147 |
Research and development tax credits | 14,655 | 13,995 |
Property and equipment | 830 | 1,072 |
Reserves and other | 2,928 | 2,253 |
Intangible assets | (9,672) | (15,461) |
Allowable capital losses | 342 | 56 |
Debt obligations | (1,902) | (2,683) |
Deferred financing costs | 962 | 1,201 |
Net deferred tax assets | 116,717 | 98,580 |
Less: valuation allowance | (116,717) | (98,580) |
Net deferred tax assets (liabilities) |
SCHEDULE OF NOL_S AVAILABLE TO
SCHEDULE OF NOL’S AVAILABLE TO REDUCE TAXABLE INCOME OF FUTURE YEARS (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Operating Loss Carryforwards [Line Items] | ||
Total losses | $ 454,508 | |
NETHERLANDS | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 798 | |
UNITED STATES | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 59,524 | $ 55,375 |
CANADA | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 102,475 | 97,433 |
ISRAEL | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 291,711 | $ 256,305 |
2025 [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 862 | |
2025 [Member] | NETHERLANDS | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
2025 [Member] | UNITED STATES | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
2025 [Member] | CANADA | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 862 | |
2025 [Member] | ISRAEL | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Twenty Six [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 3,600 | |
Two Thousand Twenty Six [Member] | NETHERLANDS | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Twenty Six [Member] | UNITED STATES | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 10 | |
Two Thousand Twenty Six [Member] | CANADA | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 3,590 | |
Two Thousand Twenty Six [Member] | ISRAEL | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Twenty Seven [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 4,605 | |
Two Thousand Twenty Seven [Member] | NETHERLANDS | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Twenty Seven [Member] | UNITED STATES | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 446 | |
Two Thousand Twenty Seven [Member] | CANADA | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 4,159 | |
Two Thousand Twenty Seven [Member] | ISRAEL | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Twenty Eight [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 2,328 | |
Two Thousand Twenty Eight [Member] | NETHERLANDS | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Twenty Eight [Member] | UNITED STATES | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 718 | |
Two Thousand Twenty Eight [Member] | CANADA | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 1,610 | |
Two Thousand Twenty Eight [Member] | ISRAEL | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Twenty Nine [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 3,688 | |
Two Thousand Twenty Nine [Member] | NETHERLANDS | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Twenty Nine [Member] | UNITED STATES | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 672 | |
Two Thousand Twenty Nine [Member] | CANADA | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 3,016 | |
Two Thousand Twenty Nine [Member] | ISRAEL | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Thirty [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 3,533 | |
Two Thousand Thirty [Member] | NETHERLANDS | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Thirty [Member] | UNITED STATES | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 2,556 | |
Two Thousand Thirty [Member] | CANADA | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 977 | |
Two Thousand Thirty [Member] | ISRAEL | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Thirty One [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 4,824 | |
Two Thousand Thirty One [Member] | NETHERLANDS | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Thirty One [Member] | UNITED STATES | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 3,617 | |
Two Thousand Thirty One [Member] | CANADA | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 1,207 | |
Two Thousand Thirty One [Member] | ISRAEL | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Thirty Two [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 2,962 | |
Two Thousand Thirty Two [Member] | NETHERLANDS | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Thirty Two [Member] | UNITED STATES | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 2,962 | |
Two Thousand Thirty Two [Member] | CANADA | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Thirty Two [Member] | ISRAEL | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Thirty Three [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 4,537 | |
Two Thousand Thirty Three [Member] | NETHERLANDS | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Thirty Three [Member] | UNITED STATES | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 3,126 | |
Two Thousand Thirty Three [Member] | CANADA | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 1,411 | |
Two Thousand Thirty Three [Member] | ISRAEL | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Thirty Four [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 10,910 | |
Two Thousand Thirty Four [Member] | NETHERLANDS | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Thirty Four [Member] | UNITED STATES | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 5,626 | |
Two Thousand Thirty Four [Member] | CANADA | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 5,284 | |
Two Thousand Thirty Four [Member] | ISRAEL | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Thirty Five [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 6,250 | |
Two Thousand Thirty Five [Member] | NETHERLANDS | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Thirty Five [Member] | UNITED STATES | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 4,661 | |
Two Thousand Thirty Five [Member] | CANADA | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 1,589 | |
Two Thousand Thirty Five [Member] | ISRAEL | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Thirty Six [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 12,318 | |
Two Thousand Thirty Six [Member] | NETHERLANDS | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Thirty Six [Member] | UNITED STATES | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 5,323 | |
Two Thousand Thirty Six [Member] | CANADA | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 6,995 | |
Two Thousand Thirty Six [Member] | ISRAEL | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Thirty Seven [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 15,490 | |
Two Thousand Thirty Seven [Member] | NETHERLANDS | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Thirty Seven [Member] | UNITED STATES | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 6,017 | |
Two Thousand Thirty Seven [Member] | CANADA | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 9,473 | |
Two Thousand Thirty Seven [Member] | ISRAEL | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Thirty Eight [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 2,353 | |
Two Thousand Thirty Eight [Member] | NETHERLANDS | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Thirty Eight [Member] | UNITED STATES | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Thirty Eight [Member] | CANADA | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 2,353 | |
Two Thousand Thirty Eight [Member] | ISRAEL | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Thirty Nine [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 7,488 | |
Two Thousand Thirty Nine [Member] | NETHERLANDS | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Thirty Nine [Member] | UNITED STATES | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Thirty Nine [Member] | CANADA | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 7,488 | |
Two Thousand Thirty Nine [Member] | ISRAEL | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Forty [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 15,896 | |
Two Thousand Forty [Member] | NETHERLANDS | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Forty [Member] | UNITED STATES | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Forty [Member] | CANADA | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 15,896 | |
Two Thousand Forty [Member] | ISRAEL | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Thirty Forty One [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 11,682 | |
Two Thousand Thirty Forty One [Member] | NETHERLANDS | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Thirty Forty One [Member] | UNITED STATES | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Thirty Forty One [Member] | CANADA | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 11,682 | |
Two Thousand Thirty Forty One [Member] | ISRAEL | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Forty Two [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 13,434 | |
Two Thousand Forty Two [Member] | NETHERLANDS | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Forty Two [Member] | UNITED STATES | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Forty Two [Member] | CANADA | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 13,434 | |
Two Thousand Forty Two [Member] | ISRAEL | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Forty Three [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 11,449 | |
Two Thousand Forty Three [Member] | NETHERLANDS | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Forty Three [Member] | UNITED STATES | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
Two Thousand Forty Three [Member] | CANADA | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 11,449 | |
Two Thousand Forty Three [Member] | ISRAEL | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
No Expiration [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 316,299 | |
No Expiration [Member] | NETHERLANDS | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 798 | |
No Expiration [Member] | UNITED STATES | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | 23,790 | |
No Expiration [Member] | CANADA | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | ||
No Expiration [Member] | ISRAEL | ||
Operating Loss Carryforwards [Line Items] | ||
Total losses | $ 291,711 |
INCOME TAXES (Details Narrative
INCOME TAXES (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 454,508 | |
Research and Development Expense | 9,343 | $ 15,506 |
Allowable capital losses | $ 342 | $ 56 |
Minimum [Member] | VbiDe [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Ownership percentage | 50% | |
UNITED STATES | ||
Operating Loss Carryforwards [Line Items] | ||
Provincial income tax rate | 24% | |
Operating loss carryforwards | $ 59,524 | $ 55,375 |
Tax credit carryforward, amount | 29,000 | |
CANADA | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | 102,475 | 97,433 |
Investment Tax Credit | 6,964 | 6,242 |
Research and Development Expense | 28,580 | 24,997 |
Allowable capital losses | 204 | 213 |
ISRAEL | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 291,711 | $ 256,305 |
Canada Revenue Agency [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Statutory income tax rate | 26.50% | 26.50% |
Federal income tax rate | 15% | |
Provincial income tax rate | 11.50% | |
Israel Tax Authority [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Statutory income tax rate | 23% |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details Narrative) ₪ in Thousands, $ in Thousands | 1 Months Ended | 12 Months Ended | |||||
Oct. 18, 2022 | Sep. 13, 2018 USD ($) Integer | Sep. 13, 2018 ILS (₪) Integer | Feb. 14, 2012 | Apr. 30, 2019 USD ($) | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | |
Sci B Vac [Member] | |||||||
Recorded Unconditional Purchase Obligation [Line Items] | |||||||
Children vaccinated | Integer | 428,000 | 428,000 | |||||
Loss contingency, damages seeking, value | $ 518,197 | ₪ 1,879,500 | |||||
Ferring And SciGen License Agreements [Member] | |||||||
Recorded Unconditional Purchase Obligation [Line Items] | |||||||
Ferring license agreement description | On October 18, 2022, the Company amended and restated the original Ferring License Agreement (the “Amended and Restated Ferring License Agreement”), which amends and restates certain of the terms relating to the manufacture and marketing of HBsAg products, which includes, among others, updates to the definition of net sales, and a reduction in the fixed royalty rate on net sales of HBsAg products (“Product”) from seven percent (7%) to three and a half percent (3.5%) in consideration for the grant of the license to utilize genetically engineered CHO cells encoding the hepatitis B antigen and certain information related to the manufacture of hepatitis B vaccines | ||||||
License period | Under the original Ferring License Agreement and the SciGen Assignment Agreement, we originally were to pay royalties on a country-by-country basis until the date 10 years after the date of commencement of the first royalty year in respect of such country. In April 2019, we exercised our option to extend the original Ferring License Agreement in respect of all the countries that still make up the territory for an additional 7 years by making a one-time payment to Ferring of $100. Royalties under the Amended and Restated Ferring License Agreement and SciGen Assignment Agreement will continue to be payable for the duration of the extended license periods | ||||||
Non-royalty consideration percentage | 30% | ||||||
Ferring And SciGen License Agreements [Member] | Onetime Payment [Member] | |||||||
Recorded Unconditional Purchase Obligation [Line Items] | |||||||
Royalty expense | $ 100 | ||||||
License Agreement [Member] | |||||||
Recorded Unconditional Purchase Obligation [Line Items] | |||||||
Royalty fess percentage | 5% | ||||||
Ferring License Agreement [Member] | |||||||
Recorded Unconditional Purchase Obligation [Line Items] | |||||||
Royalty expense | $ 250 | $ 33 | |||||
SciGen Assignment Agreement [Member] | |||||||
Recorded Unconditional Purchase Obligation [Line Items] | |||||||
Royalty expense | $ 155 | $ 47 |
SCHEDULE OF LEASE COST AND OTHE
SCHEDULE OF LEASE COST AND OTHER INFORMATION (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Leases | ||
Operating lease cost | $ 1,866 | $ 1,865 |
Operating Lease, Weighted Average Discount Rate, Percent | 13% | |
Operating Lease, Weighted Average Remaining Lease Term | 2 years 4 months 9 days |
SUMMARY OF FUTURE UNDISCOUNTED
SUMMARY OF FUTURE UNDISCOUNTED CASH PAYMENTS RECONCILED TO LEASE LIABILITIES (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Leases | ||
2024 | $ 1,177 | |
2025 | 686 | |
2026 | 593 | |
2027 | 163 | |
Total | 2,619 | |
Effect of discounting | (348) | |
Total lease liability | 2,271 | |
Current portion | (976) | $ (972) |
Long term lease liability, net of current portion | $ 1,295 | $ 2,365 |
LEASES (Details Narrative)
LEASES (Details Narrative) | 12 Months Ended |
Dec. 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 | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | $ 8,682 | $ 1,082 |
UNITED STATES | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | 1,845 | 695 |
ISRAEL | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | 167 | 315 |
China Hong Kong [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | 5,585 | 66 |
Europe [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | $ 1,085 | $ 6 |
SCHEDULE OF PROPERTY AND EQUI_2
SCHEDULE OF PROPERTY AND EQUIPMENT AND OPERATING LEASE RIGHT OF USE ASSETS (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Tangible long-lived assets | $ 11,913 | $ 15,569 |
ISRAEL | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Tangible long-lived assets | 11,009 | 13,892 |
UNITED STATES | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Tangible long-lived assets | 506 | 985 |
CANADA | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Tangible long-lived assets | $ 398 | $ 692 |
SEGMENT INFORMATION (Details Na
SEGMENT INFORMATION (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Revenue, Major Customer [Line Items] | ||
Revenue | $ 8,682 | $ 1,082 |
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Customer One [Member] | ||
Revenue, Major Customer [Line Items] | ||
Concentration Risk, Percentage | 64% | 18% |
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Customer Two [Member] | ||
Revenue, Major Customer [Line Items] | ||
Concentration Risk, Percentage | 15% | |
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Customer Three [Member] | ||
Revenue, Major Customer [Line Items] | ||
Concentration Risk, Percentage | 14% | |
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Customer Four [Member] | ||
Revenue, Major Customer [Line Items] | ||
Concentration Risk, Percentage | 10% | |
CANADA | ||
Revenue, Major Customer [Line Items] | ||
Revenue | $ 0 | $ 0 |
SUBSEQUENT EVENTS (Details Narr
SUBSEQUENT EVENTS (Details Narrative) - USD ($) | 1 Months Ended | 4 Months Ended | 12 Months Ended | ||||||
Apr. 09, 2024 | Feb. 13, 2024 | Jul. 05, 2023 | Apr. 15, 2024 | Jul. 31, 2023 | Apr. 15, 2024 | Dec. 31, 2023 | Dec. 31, 2022 | Aug. 26, 2022 | |
Subsequent Event [Line Items] | |||||||||
Proceeds from issuance of shares | $ 24,273,000 | ||||||||
Direct Offering [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Common shares issued in financing transactions, net of issuance costs, shares | 1,818,182 | 1,818,182 | |||||||
Warrants to purchase shares | 1,818,182 | ||||||||
Shares issued price | $ 1.65 | $ 1.65 | |||||||
Warrants exercise price | $ 1.65 | ||||||||
ATM Program [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Weighted average price | $ 0.7048 | ||||||||
Common shares issued in financing transactions, net of issuance costs, shares | 1,046,808 | ||||||||
Shares issued price | $ 0.7048 | ||||||||
Proceeds from issuance of shares | $ 631,000 | ||||||||
Subsequent Event [Member] | Direct Offering [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Common shares issued in financing transactions, net of issuance costs, shares | 2,272,728 | ||||||||
Warrants to purchase shares | 2,272,728 | ||||||||
Shares issued price | $ 0.88 | ||||||||
Warrants exercise price | $ 0.76 | ||||||||
Proceeds from issuance of shares | $ 1,700,000 | ||||||||
Subsequent Event [Member] | Placement Warrants [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Warrants to purchase shares | 136,364 | ||||||||
Warrants exercise price | $ 1.10 | ||||||||
Subsequent Event [Member] | Exercise of Warrants [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Warrants to purchase shares | 126,250 | 126,250 | |||||||
Warrants exercise price | $ 0.6057 | $ 0.6057 | |||||||
Proceeds from exercise of warrants | $ 76,000 | ||||||||
Subsequent Event [Member] | Loan Agreement [Member] | Brii Biosciences Inc [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Asset acquisition, consideration expected | $ 33,000 | ||||||||
Subsequent Event [Member] | Rehovot Purchase Agreement [Member] | Brii Biosciences Inc [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Asset acquisition, consideration expected | 10,000 | ||||||||
Subsequent Event [Member] | Brii Purchase Agreement [Member] | Secured Promissory Note [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Notes receivable | 2,500,000 | ||||||||
Maximum amount of notes expected to increase | 7,500,000 | ||||||||
Aggregate amount of notes expected to decrease | 2,500,000 | ||||||||
Subsequent Event [Member] | Brii Purchase Agreement [Member] | Secured Promissory Note [Member] | Maximum [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Notes receivable | 10,000,000 | ||||||||
Subsequent Event [Member] | Brii Side Letter [Member] | Secured Promissory Note [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Principal amount of note | 18,000,000 | ||||||||
Subsequent Event [Member] | Brii License Agreement [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Secured promissory note | $ 5,000 | ||||||||
Subsequent Event [Member] | ATM Program [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Number of shares sold | 2,114,314 | ||||||||
Gross proceeds for sale of stock | $ 1,435,000 | ||||||||
Weighted average price | $ 0.6789 | $ 0.6789 |