Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2020 | Oct. 30, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2020 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2020 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-37769 | |
Entity Registrant Name | VBI Vaccines Inc/BC | |
Entity Central Index Key | 0000764195 | |
Entity Incorporation, State or Country Code | A1 | |
Entity Address, Address Line One | 222 Third Street | |
Entity Address, Address Line Two | Suite 2241 | |
Entity Address, City or Town | Cambridge | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02142 | |
City Area Code | 617 | |
Local Phone Number | 830-3031 | |
Title of 12(b) Security | Common Share, no par value per share | |
Trading Symbol | VBIV | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Elected Not To Use the Extended Transition Period | true | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 242,052,726 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 | |
CURRENT ASSETS | |||
Cash and cash equivalents | $ 95,158 | $ 44,213 | |
Short-term investments | 25,220 | ||
Accounts receivable, net | 27 | 201 | |
Inventory, net | 1,542 | 1,075 | |
Prepaid expenses | 2,293 | 1,024 | |
Other current assets | 2,153 | 450 | |
Total current assets | 126,393 | 46,963 | |
NON-CURRENT ASSETS | |||
Other long-term assets | 622 | 620 | |
Property and equipment, net | 9,577 | 10,195 | |
Right of use assets | 1,642 | 1,459 | |
Intangible assets, net | 59,168 | 60,756 | |
Goodwill | 2,152 | 2,208 | |
Total non-current assets | 73,161 | 75,238 | |
TOTAL ASSETS | 199,554 | 122,201 | |
CURRENT LIABILITIES | |||
Accounts payable | 3,356 | 1,127 | |
Other current liabilities | 9,338 | 12,261 | |
Current portion of deferred revenues | 408 | 882 | |
Current portion of lease liability | 848 | 642 | |
Current portion of long-term debt, net of debt discount - related party | 14,845 | ||
Total current liabilities | 13,950 | 29,757 | |
NON-CURRENT LIABILITIES | |||
Lease liability, net of current portion | 798 | 817 | |
Long-term debt, net of debt discount | 15,862 | [1] | |
Liabilities for severance pay | 485 | 463 | |
Deferred revenues, net of current portion | 2,653 | 2,909 | |
Total non-current liabilities | 19,798 | 4,189 | |
COMMITMENTS AND CONTINGENCIES (NOTE 13) | |||
STOCKHOLDERS’ EQUITY | |||
Common shares (unlimited authorized; no par value) (September 30, 2020 - issued and outstanding 242,039,480; December 31, 2019 - issued and outstanding 178,257,199) | 387,718 | 284,965 | |
Additional paid-in capital | 74,084 | 66,430 | |
Accumulated other comprehensive loss | (2,740) | (752) | |
Accumulated deficit | (293,256) | (262,388) | |
Total stockholders’ equity | 165,806 | 88,255 | |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 199,554 | $ 122,201 | |
[1] | 2019 long term debt was due to Perceptive Credit Holdings LP, a related party. |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Statement of Financial Position [Abstract] | ||
Common stock, unlimited authorized | Unlimited | Unlimited |
Common stock, no par value | $ 0 | $ 0 |
Common stock, shares issued | 242,039,480 | 178,257,199 |
Common stock, shares outstanding | 242,039,480 | 178,257,199 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Income Statement [Abstract] | ||||
Revenues | $ 298 | $ 647 | $ 897 | $ 1,647 |
Operating expenses: | ||||
Cost of revenues | 2,111 | 1,977 | 6,747 | 5,319 |
Research and development | 4,478 | 5,401 | 10,035 | 21,989 |
General and administrative | 5,562 | 9,412 | 13,520 | 16,570 |
Total operating expenses | 12,151 | 16,790 | 30,302 | 43,878 |
Loss from operations | (11,853) | (16,143) | (29,405) | (42,231) |
Interest expense, net of interest income (including related party - see Note 8) | (742) | (626) | (2,006) | (1,672) |
Foreign exchange (loss) gain | (402) | 607 | 543 | (35) |
Loss before income taxes | (12,997) | (16,162) | (30,868) | (43,938) |
Income tax expense | ||||
NET LOSS | (12,997) | (16,162) | (30,868) | (43,938) |
Other comprehensive income (loss) | 1,696 | (1,165) | (1,988) | 2,308 |
COMPREHENSIVE LOSS | $ (11,301) | $ (17,327) | $ (32,856) | $ (41,630) |
Net loss per share of common shares, basic and diluted | $ (0.06) | $ (0.15) | $ (0.15) | $ (0.44) |
Weighted-average number of common shares outstanding, basic and diluted | 234,709,403 | 105,742,073 | 210,044,126 | 99,627,345 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | AOCI Attributable to Parent [Member] | Retained Earnings [Member] | Total |
Beginning balance, value at Dec. 31, 2018 | $ 246,417 | $ 63,449 | $ (4,158) | $ (207,575) | $ 98,133 |
Balance, shares at Dec. 31, 2018 | 97,343,777 | ||||
Stock-based compensation | $ 431 | 831 | 1,262 | ||
Stock-based compensation, shares | 318,110 | ||||
Common shares issued upon exercise of warrants, shares | |||||
Net loss | (14,606) | (14,606) | |||
Warrant modification in connection with debt amendment | 179 | 179 | |||
Currency translation adjustments | 1,727 | 1,727 | |||
Ending balance, value at Mar. 31, 2019 | $ 246,848 | 64,459 | (2,431) | (222,181) | 86,695 |
Balance, shares at Mar. 31, 2019 | 97,661,887 | ||||
Stock-based compensation | $ 428 | 554 | 982 | ||
Stock-based compensation, shares | 95,312 | ||||
Net loss | (13,170) | (13,170) | |||
Currency translation adjustments | 1,746 | 1,746 | |||
Ending balance, value at Jun. 30, 2019 | $ 247,276 | 65,013 | (685) | (235,351) | 76,253 |
Balance, shares at Jun. 30, 2019 | 97,757,199 | ||||
Stock-based compensation | $ 201 | 675 | 876 | ||
Stock-based compensation, shares | |||||
Net loss | (16,162) | (16,162) | |||
Common shares issued in financing transaction | $ 37,415 | 37,415 | |||
Common shares issued in financing transaction, shares | 80,500,000 | ||||
Currency translation adjustments | (1,165) | (1,165) | |||
Ending balance, value at Sep. 30, 2019 | $ 284,892 | 65,688 | (1,850) | (251,513) | 97,217 |
Balance, shares at Sep. 30, 2019 | 178,257,199 | ||||
Beginning balance, value at Dec. 31, 2019 | $ 284,965 | 66,430 | (752) | (262,388) | 88,255 |
Balance, shares at Dec. 31, 2019 | 178,257,199 | ||||
Stock-based compensation | $ 131 | 1,056 | 1,187 | ||
Stock-based compensation, shares | 118,471 | ||||
Common shares issued in financing transaction, net of issuance costs | |||||
Common shares issued in financing transaction, net of issuance costs, shares | |||||
Warrants issued in connection with financing transactions | |||||
Warrants issued in connection with financing transactions, shares | |||||
Conversion feature issued in debt financing transaction | |||||
Common shares issued upon exercise of warrants | |||||
Common shares issued up on exercise of options | |||||
Common shares issued up on exercise of options, shares | |||||
Net loss | (8,358) | (8,358) | |||
Unrealized holding gains on short-term investments | |||||
Warrant modification in connection with debt amendment | |||||
Common shares issued in financing transaction | |||||
Common shares issued in financing transaction, shares | |||||
Currency translation adjustments | (6,653) | (6,653) | |||
Ending balance, value at Mar. 31, 2020 | $ 285,096 | 67,486 | (7,405) | (270,746) | 74,431 |
Balance, shares at Mar. 31, 2020 | 178,375,670 | ||||
Beginning balance, value at Dec. 31, 2019 | $ 284,965 | 66,430 | (752) | (262,388) | 88,255 |
Balance, shares at Dec. 31, 2019 | 178,257,199 | ||||
Ending balance, value at Sep. 30, 2020 | $ 387,718 | 74,084 | (2,740) | (293,256) | 165,806 |
Balance, shares at Sep. 30, 2020 | 242,039,480 | ||||
Beginning balance, value at Mar. 31, 2020 | $ 285,096 | 67,486 | (7,405) | (270,746) | 74,431 |
Balance, shares at Mar. 31, 2020 | 178,375,670 | ||||
Stock-based compensation | $ 91 | 983 | 1,074 | ||
Stock-based compensation, shares | |||||
Common shares issued in financing transaction, net of issuance costs | $ 53,894 | 53,894 | |||
Common shares issued in financing transaction, net of issuance costs, shares | 52,272,726 | ||||
Warrants issued in connection with financing transactions | $ (453) | 1,634 | 1,181 | ||
Warrants issued in connection with financing transactions, shares | |||||
Conversion feature issued in debt financing transaction | 2,577 | 2,577 | |||
Net loss | (9,513) | (9,513) | |||
Currency translation adjustments | 2,969 | 2,969 | |||
Ending balance, value at Jun. 30, 2020 | $ 338,628 | 72,680 | (4,436) | (280,259) | 126,613 |
Balance, shares at Jun. 30, 2020 | 230,648,396 | ||||
Stock-based compensation | $ 89 | 1,404 | 1,493 | ||
Stock-based compensation, shares | |||||
Common shares issued in financing transaction, net of issuance costs | $ 47,163 | 47,163 | |||
Common shares issued in financing transaction, net of issuance costs, shares | 10,840,334 | ||||
Common shares issued upon exercise of warrants | $ 1,837 | 1,837 | |||
Common shares issued upon exercise of warrants, shares | 550,000 | ||||
Common shares issued up on exercise of options | $ 1 | 1 | |||
Common shares issued up on exercise of options, shares | 750 | ||||
Net loss | (12,997) | (12,997) | |||
Unrealized holding gains on short-term investments | 125 | 125 | |||
Currency translation adjustments | 1,571 | 1,571 | |||
Ending balance, value at Sep. 30, 2020 | $ 387,718 | $ 74,084 | $ (2,740) | $ (293,256) | $ 165,806 |
Balance, shares at Sep. 30, 2020 | 242,039,480 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (30,868) | $ (43,938) |
Adjustments to reconcile net loss to cash and cash equivalents used in operating activities: | ||
Depreciation and amortization | 1,218 | 798 |
Stock-based compensation | 3,754 | 3,120 |
Amortization of debt discount | 1,102 | 753 |
Impairment of goodwill | 6,292 | |
Interest accrued on short-term investments | (95) | |
Net change in operating working capital items: | ||
Change in accounts receivable | 173 | (127) |
Change in inventory | (458) | (427) |
Change in prepaid expenses | (1,267) | (175) |
Change in other current assets | (1,676) | (510) |
Change in other long-term assets | (3) | 6 |
Change in operating right of use assets | 724 | 768 |
Change in accounts payable | 2,167 | (3,129) |
Change in deferred revenues | (646) | (1,300) |
Change in other current liabilities | (3,962) | (1,545) |
Payments made on operating lease liabilities | (718) | (768) |
Net cash flows used in operating activities | (30,555) | (40,182) |
INVESTING ACTIVITIES | ||
Purchase of short-term investments | (25,000) | |
Purchase of property and equipment | (468) | (3,487) |
Net cash flows used in investing activities | (25,468) | (3,487) |
FINANCING ACTIVITIES | ||
Proceeds from issuance of common shares for cash | 106,269 | 40,250 |
Share issuance costs | (4,919) | (2,756) |
Proceeds from issuance of common shares for cash, upon exercise of warrants | 1,837 | |
Proceeds from issuance of common shares for cash, upon exercise of stock options | 1 | |
Proceeds from debt financing | 20,000 | |
Debt issuance costs | (1,021) | |
Repayment of long-term debt | (15,300) | |
Net cash flows provided by financing activities | 106,867 | 37,494 |
Effect of exchange rates on cash and cash equivalents | 101 | (79) |
CHANGE IN CASH AND CASH EQUIVALENTS FOR THE PERIOD | 50,945 | (6,254) |
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | 44,213 | 59,270 |
CASH AND CASH EQUIVALENTS, END OF PERIOD | 95,158 | 53,016 |
Supplementary information: | ||
Interest paid | 1,187 | 1,539 |
Non-cash investing and financing activities: | ||
Warrant modification in connection with debt amendment | 179 | |
Warrants issued in connection with financing activities | 1,634 | |
K2 conversion feature in connection with financing activities | 2,577 | |
Capital expenditures included in accounts payable and other current liabilities | (86) | (132) |
Share issuance costs included in other current liabilities | (293) | (79) |
Unrealized holding gains on short term investment | $ (125) |
NATURE OF BUSINESS AND CONTINUA
NATURE OF BUSINESS AND CONTINUATION OF BUSINESS | 9 Months Ended |
Sep. 30, 2020 | |
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 a wholly-owned subsidiary of VBI US (“VBI Cda”); SciVac Ltd. an Israeli company (“SciVac”), and SciVac Hong Kong Limited (“SciVac HK”) are collectively referred to as the “Company,” “we,” “us,” “our,” or “VBI”. The Company’s registered office is located at Suite 1700, Park Place, 666 Burrard Street, Vancouver, BC V6C 2X8 with its principal office located at 222 Third Street, Suite 2241, Cambridge, MA 02142. Principal Operations VBI is a commercial-stage, biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. We are advancing the prevention and treatment of hepatitis B, with: (1) the only 3-antigen hepatitis B vaccine, Sci-B-Vac, which is approved for use and commercially available in Israel, and recently completed a pivotal Phase III program in the United States, Europe, and Canada; and (2) VBI-2601 (BRII-179), an immunotherapeutic candidate in development in collaboration with Brii Biosciences Limited (“Brii Bio”) for a functional cure for chronic hepatitis B. Our enveloped virus-like particle (“eVLP”) platform technology enables the development of eVLP vaccines that closely mimic the target virus to elicit a potent immune response. Our lead eVLP program candidates include VBI-1901, a glioblastoma (“GBM”) vaccine immunotherapeutic candidate, VBI-1501, our prophylactic cytomegalovirus (“CMV”) vaccine candidate, and VBI-2900, our prophylactic coronavirus vaccine program. Our coronavirus vaccine program includes both (1) VBI-2901, a trivalent pan-coronavirus vaccine candidate expressing the SARS-CoV-2 (COVID-19), SARS-CoV (SARS), and MERS-CoV (MERS) spike proteins; and (2) VBI-2902, a monovalent vaccine candidate expressing the SARS-CoV-2 (COVID-19) spike protein. We are headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada. Our manufacturing site in Rehovot, Israel produces Sci-B-Vac and VBI-2601 while our eVLP vaccine candidates are manufactured using contract development and manufacturing organizations located in the United States and Canada. The ongoing COVID-19 pandemic has materially negatively affected and continues to affect the global economy, and there is continued severe uncertainty about the duration and intensity of the impacts of the pandemic. As a result, the Company’s business and results of operations have also been adversely affected and could continue to be adversely affected by COVID-19 which has necessitated restricting the number of personnel in the Company’s research laboratories and manufacturing facility at any given point in time, and has slowed recruitment to clinical trials. The extent to which the COVID-19 pandemic will continue to impact our business will depend on future developments, which are highly uncertain and cannot be predicted. We do not yet know the full extent of potential delays or impacts on our business, our clinical studies, our research programs, the recoverability of our assets, and our manufacturing; however, the COVID-19 pandemic may disrupt or delay our business operations, including with respect to efforts relating to potential business development transactions, and it could disrupt the marketplace which could have an adverse effect on our operations. Liquidity and Going Concern The Company faces a number of risks, including but not limited to, uncertainties regarding the success of the development and commercialization of its products, demand and market acceptance of the Company’s products, and reliance on major customers. The Company anticipates that it will continue to incur significant operating costs and losses in connection with the development of its products. The Company had an accumulated deficit of $ 293,256 as of September 30, 2020 and cash outflows from operating activities of $ 30,555 for the nine months ended September 30, 2020. The Company will require significant additional funds to conduct clinical and non-clinical trials, achieve regulatory approvals, and, subject to such approvals, commercially launch its products. The Company plans to finance near term future operations with existing cash and cash equivalents reserves. Additional financing may be obtained from the issuance of equity securities, the issuance of additional debt, structured asset financings, government grants or other subsidies, and/or revenues from potential business development transactions, if any. There is no assurance the Company will manage to obtain these sources of financing, if required. The above conditions raise substantial doubt about the Company’s ability to continue as a going concern. The consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result should the Company be unable to continue as a going concern. In April 2020, the Company closed an underwritten public offering of 52,272,726 1.10 57,500 3,606 53,894 705,000 1.50 In May 2020, the Company refinanced its existing term loan facility with Perceptive Credit Holdings, LP and entered into a Loan and Guaranty Agreement (the “Loan Agreement”) with K2 HealthVentures LLC for net proceeds of $ 4.5 million. The refinanced long-term debt has a maturity date of June 1, 2024 . See Note 8 for more details. On July 21, 2020, we issued 550,000 3.34 1,837 On July 31, 2020, the Company entered into an Open Market Sale Agreement SM 125 million from time to time through Jefferies, acting as agent or principal (the “ATM Program”). Common shares are offered pursuant to a sales agreement prospectus included in the Company’s automatic shelf registration on Form S-3 filed with the United States Securities and Exchange Commission (“SEC”) on July 31, 2020. During the third quarter of 2020, the Company issued 10,840,334 common shares under the ATM Program, for total gross proceeds of $ 48,769 4.4988 . The Company incurred $ 1,606 of shares issuance costs related to the common shares issued resulting in net proceeds of $ 47,163 . As of September 30, 2020, approximately $ 76,231 of common shares remained available for issuance under the ATM Program. On July 3, 2020, the Company and the National Research Council of Canada (“NRC”) signed a contribution agreement as represented by its Industrial Research Assistance Program (“IRAP”) whereby the NRC agrees to contribute up to CAD $ 1,000 235 On September 16, 2020, the Company and Her Majesty the Queen in Right of Canada as represented by the Minister of Industry (“ISED”) signed a contribution agreement (the “Contribution Agreement”) for a contribution from the Strategic Innovation Fund (“SIF”) whereby ISED agrees to contribute up to CAD $ 55,976 to support the development of the Company’s coronavirus vaccine program, through Phase II clinical studies, for a period commencing on April 15, 2020 and ending in or before the first quarter of 2022. Grants of CAD $ 731 are recognized in the statement of operations and comprehensive loss for the three and nine months ended September 30, 2020. In connection with execution of the Contribution Agreement, the Company obtained a consent of K2 HealthVentures LLC, as administrative agent for the lenders and a lender, pursuant to the Loan Agreement. Pursuant to the consent, certain events of default that result in contributions made under the Contribution Agreement in excess of $ 500 becoming due and payable could result in an event of default under the Loan Agreement. See Note 8 for more details on the Loan Agreement. Financial instruments recognized in the condensed consolidated balance sheet consist of cash and cash equivalents, short-term investments, accounts receivable, other current assets, accounts payable, and other current liabilities. The Company believes that the carrying value of its current financial instruments approximates their fair values due to the short-term nature of these instruments. The Company does not hold any derivative financial instruments. The carrying amounts of the Company’s long-term assets approximate their respective fair values. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | 2. SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation and Consolidation The Company’s fiscal year ends on December 31 of each calendar year. The accompanying unaudited condensed consolidated financial statements have been prepared in U.S. dollars (“USD”) and pursuant to the rules and regulations of the SEC, for interim reporting. Accordingly, certain information and footnote disclosures normally included in the financial statements prepared in accordance with United States of America generally accepted accounting principles (“U.S. GAAP”), have been condensed or omitted pursuant to such rules and regulations. The December 31, 2019 consolidated balance sheet in this document was derived from the audited consolidated financial statements. The condensed consolidated financial statements and notes included in this quarterly report on Form 10-Q (this “Form 10-Q”) does not include all of the disclosures required by U.S. GAAP and should be read in conjunction with the financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 (the “2019 10-K”), as filed with the SEC on March 5, 2020. The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries: VBI DE, VBI US, VBI Cda, SciVac, and SciVac HK. Intercompany balances and transactions between the Company and its subsidiaries are eliminated in the condensed consolidated financial statements. In the opinion of management, these condensed consolidated financial statements include all adjustments and accruals of a normal and recurring nature necessary to fairly state the results of the periods presented. The results for the periods presented are not necessarily indicative of results to be expected for the full year or for any future periods. Significant Accounting Policies The significant accounting policies used in the preparation of these condensed consolidated financial statements are disclosed in the 2019 10-K, and there have been no changes to the Company’s significant accounting policies during the nine months ended September 30, 2020, other than the polices discussed below. Cash and cash equivalents Cash and cash equivalents include cash investments in interest-bearing accounts and term deposits which can readily be redeemed for cash or are issued for terms of three months or less from the date of acquisition. Short-term investments Short-term investments consist of redeemable short-term investments held with Schedule 1 Canadian banks for maturity terms greater than 3 months but less than a year from the date of acquisition. Short-term investments were initially classified as available for sale and were measured at fair value whereby unrealized holding gains or losses on these investments are reported in other comprehensive income or loss and accrued interest income was recognized in interest expense, net of interest income in the condensed consolidated statement of operations and comprehensive loss. On September 30, 2020 we re-assessed the classification of our short-term investment and we determined that the short-term investment shall be classified as held to maturity. The transfer on September 30, 2020 occurred at fair value with the unrealized holding gains remaining in other comprehensive income or loss. The unrealized holding gains will be amortized over the remaining life of the security until April 2021. Our short-term investments are considered level 2 in the fair value hierarchy. The fair value of the short-term investment was determined using the market approach method and the inputs include comparable market interest rates at September 30, 2020. Government Grants Government grants are recognized in the 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. |
NEW ACCOUNTING PRONOUNCEMENTS
NEW ACCOUNTING PRONOUNCEMENTS | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Changes and Error Corrections [Abstract] | |
NEW ACCOUNTING PRONOUNCEMENTS | 3. NEW ACCOUNTING PRONOUNCEMENTS Recently Adopted Accounting Pronouncements Intangibles – Goodwill and Other, Internal-Use Software In August 2018, the FASB issued ASU 2018-15: Intangibles – Goodwill and Other – Internal-Use Software (Subtopic 350-40): Customers’ accounting for implementation costs incurred in a cloud computing arrangement that is a service contract. This ASU aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software. Accordingly, the amendments require an entity (customer) in a hosting arrangement that is a service contract to follow the guidance in Subtopic 350-40 to determine which implementation costs to capitalize as an asset related to the service contract and which costs to expense. Our adoption of this ASU, effective January 1, 2020, was applied prospectively and did not have a material impact on our condensed consolidated financial statements and the related footnote disclosures. Recently Issued Accounting Standards, not yet Adopted None |
INVENTORY, NET
INVENTORY, NET | 9 Months Ended |
Sep. 30, 2020 | |
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 September 30, December 31, Finished goods $ - $ 58 Work-in-process 374 237 Raw materials 1,168 780 Inventory, net $ 1,542 $ 1,075 |
INTANGIBLE ASSETS AND GOODWILL
INTANGIBLE ASSETS AND GOODWILL | 9 Months Ended |
Sep. 30, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
INTANGIBLE ASSETS AND GOODWILL | 5. INTANGIBLE ASSETS AND GOODWILL The Company’s intangible assets determined to have indefinite useful lives including In-Process Research and Development (“IPR&D”) and goodwill, are tested for impairment annually, or more frequently if events or circumstances indicate that the assets might be impaired. Such circumstances could include but are not limited to: (1) a significant adverse change in legal factors or in business climate, (2) unanticipated competition, or (3) an adverse action or assessment by a regulator. The Company has established August 31st as the date for its annual impairment test of IPR&D and goodwill. The costs of rights to IPR&D projects acquired in an asset acquisition are expensed in the consolidated statements of operations unless the project has an alternative future use. These costs include initial payments incurred prior to regulatory approval in connection with research and development agreements that provide rights to develop, manufacture, market and/or sell pharmaceutical products. The IPR&D assets, which consist of the CMV and GBM programs, were acquired in a business combination, capitalized as an intangible asset and are tested for impairment at least annually until commercialization, after which time the IPR&D will be amortized over its estimated useful life. The impairment test compares the carrying amount of the IPR&D asset to its fair value. If the carrying amount exceeds the fair value of the asset, such excess is recorded as an impairment loss. There was no IPR&D impairment determined as a result of the Company’s annual testing on August 31, 2020. 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 the amount and timing of costs to develop the IPR&D into viable products, the amount and timing of future cash inflows, the discount rate and the probability of technical and regulatory success applied to the cash flows. The discount rate used was 11% and the cumulative probability of technical and regulatory success to achieve approval to market the products ranged from approximately 6% to 17% . SCHEDULE OF INTANGIBLE ASSETS INCLUDING CUMULATIVE IMPAIRMENT AND CUMULATIVE CURRENCY TRANSLATION September 30, 2020 Gross Carrying Accumulated Cumulative Cumulative Net Book Patents $ 669 $ (569 ) $ - $ 31 $ 131 IPR&D assets 61,500 - (300 ) (2,163 ) 59,037 $ 62,169 $ (569 ) $ (300 ) $ (2,132 ) $ 59,168 December 31, 2019 Gross Accumulated Cumulative Cumulative Net Book Patents $ 669 $ (521 ) $ - $ 30 $ 178 IPR&D assets 61,500 - (300 ) (622 ) 60,578 $ 62,169 $ (521 ) $ (300 ) $ (592 ) $ 60,756 The Company amortizes intangible assets with finite lives on a straight-line basis over their estimated useful lives. The change in carrying value for IPR&D assets from December 31, 2019 relates to currency translation adjustments which decreased by $ 1,541 Goodwill represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired in a business combination. When evaluating goodwill for impairment, we may first perform an assessment qualitatively whether it is more likely than not that a reporting unit’s carrying amount exceeds its fair value, referred to as a “step zero” approach. Subsequently (if necessary, after step zero), if the carrying value of a reporting unit exceeded its fair value an impairment would be recorded. We would perform our goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. There was no goodwill impairment determined as a result of the Company’s annual testing on August 31, 2020. The fair value of the Company, which consists of a single reporting unit, included in the impairment test was determined using the closing market stock price of VBI as of August 31, 2020. SCHEDULE OF GOODWILL September 30, 2020 Gross Carrying Amount Cumulative Impairment Cumulative Translation Net Book Goodwill $ 8,714 $ (6,292 ) $ (270 ) $ 2,152 December 31, 2019 Gross Cumulative Impairment Cumulative Translation Net Book Goodwill $ 8,714 $ (6,292 ) $ (214 ) $ 2,208 The change in carrying value for goodwill from December 31, 2019 relates to currency translation adjustments which decreased by $ 56 |
OTHER CURRENT LIABILITIES
OTHER CURRENT LIABILITIES | 9 Months Ended |
Sep. 30, 2020 | |
Other Liabilities Disclosure [Abstract] | |
OTHER CURRENT LIABILITIES | 6. OTHER CURRENT LIABILITIES Other current liabilities consisted of the following: SCHEDULE OF OTHER CURRENT LIABILITIES September 30, December 31, Accrued research and development expenses (including clinical trial accrued expenses) $ 6,377 $ 9,247 Accrued professional fees 958 446 Payroll and employee-related costs 1,632 2,184 Other current liabilities 371 384 Total Other current liabilities $ 9,338 $ 12,261 |
LOSS PER SHARE OF COMMON SHARES
LOSS PER SHARE OF COMMON SHARES | 9 Months Ended |
Sep. 30, 2020 | |
Earnings Per Share [Abstract] | |
LOSS PER SHARE OF COMMON SHARES | 7. LOSS PER SHARE OF COMMON SHARES Basic loss per share is computed by dividing net loss applicable to common stockholders by the weighted average number of common shares outstanding during each period. Diluted loss per share includes the effect, if any, from the potential exercise or conversion of securities, such as warrants, and stock options, which would result in the issuance of incremental shares of common shares unless such effect is anti-dilutive. In computing the basic and diluted net loss per share applicable to common stockholders, the weighted average number of shares remains the same for both calculations due to the fact that when a net loss exists, dilutive shares are not included in the calculation as their effect would be anti-dilutive. These potentially dilutive securities are more fully described in Note 9, Stockholders’ Equity and Additional Paid-in Capital. The following potentially dilutive securities outstanding at September 30, 2020 and 2019 have been excluded from the computation of diluted weighted average shares outstanding, as they would be antidilutive: SCHEDULE OF ANTIDILUTIVE WEIGHTED AVERAGE SHARES OUTSTANDING September 30, September 30, Warrants 3,398,824 2,618,824 Stock options and equity awards 12,580,297 6,814,104 K2 conversion feature 2,739,726 - 18,718,847 9,432,928 |
LONG-TERM DEBT
LONG-TERM DEBT | 9 Months Ended |
Sep. 30, 2020 | |
Long-term Debt | |
LONG-TERM DEBT | 8. LONG-TERM DEBT As of September 30, 2020, and December 31, 2019, the long-term debt is as follows: SCHEDULE OF LONG-TERM DEBT September 30, December 31, Long-term debt, net of debt discount $ 15,862 $ 14,845 * Less: current portion, net of debt discount - 14,845 * Long-term debt $ 15,862 $ - * * 2019 long term debt was due to Perceptive Credit Holdings LP, a related party. On May 22, 2020, the Company (along with its subsidiary VBI Cda) entered into the Loan Agreement with K2 HealthVentures LLC and any other lender from time to time party thereto (the “Lenders”) pursuant to which we received the first tranche secured term loan of $ 20 million (the “First Tranche Term Loan”). The Lenders agreed to make available the following additional tranches subject to the following conditions and upon the submission of a loan request by the Company: (1) up to $10 million available between January 1, 2021 and April 30, 2021 upon achievement of certain milestones (the “Second Tranche Term Loan”), (2) $10 million available between the closing date and December 31, 2021, subject to achievement of a certain U.S. Food and Drug Administration approval (the “Third Tranche Term Loan”), and (3) a final tranche of up to $ 10 million that can be made available any time prior to June 30, 2022, subject to the advance of the Third Tranche Term Loan, satisfactory review by the administrative agent of our financial and operating plan, and approval by the Lenders’ investment committee (the “Fourth Tranche Term Loan”). Pursuant to the Loan Agreement, the Lenders have the ability to convert, at the Lenders’ option, up to $ 4 million of the secured term loan into common shares of the Company at a conversion price of $ 1.46 per share (“K2 conversion feature”). In connection with the Loan Agreement, on May 22, 2020, the Company issued the Lenders a warrant to purchase up to 625,000 common shares (the “K2 Warrant”) at an exercise price of $ 1.12 (the “Warrant Price”). The number of common shares issuable pursuant to the K2 Warrant, at any given time, is determined by the aggregate principal amount of the loans advanced at that time pursuant to the Loan Agreement multiplied by 3.5% and divided by the Warrant Price. If the full $50 million available in all K2 tranches is advanced pursuant to the Loan Agreement, up to 1,562,500 common shares will be issuable pursuant to the K2 Warrant. The K2 Warrant may be exercised either for cash or on a cashless “net exercise” basis and expires on May 22, 2030 . The total proceeds attributed to the K2 Warrant was $ 1,181 based on the relative fair value of the K2 Warrant as compared to the sum of the fair values of the K2 Warrant, K2 conversion feature and debt. The effective conversion price of the K2 conversion feature of $ 1.52 was determined to be less than the fair value of the underlying common stock at the date of commitment, resulting in a beneficial conversion feature (“BCF”) at that date. The intrinsic value of the BCF was $ 2,577 and recorded to additional paid-in capital. The K2 warrant and the K2 conversion feature resulted in the debt being issued at a discount. The Company also incurred $ 1,021 of debt issuance costs and is required to make a final payment equal to 6.95% of the aggregate secured term loan principal outstanding on the maturity date of the term loan, or upon earlier prepayment of the term loans in accordance with the Loan Agreement, resulting in an additional discount of $ 1,390 . The total debt discount is $ 6,169 . See Note 9 for more detail on assumptions used in the valuation of the K2 Warrant. Upon receipt of additional funds under the Loan Agreement, additional common shares will be issuable pursuant to the K2 Warrant as determined by the principal amount of the additional funds advanced multiplied by 3.5% and divided by the Warrant Price, and the final payment will increase by 6.95% of the funds advanced. The total principal amount of the loan under the Loan Agreement outstanding at September 30, 2020, including the $ 1,390 21,390 8.25% 5.00% 8.25% 10 January 1, 2023 Upon the occurrence of an Event of Default, and during the continuance of an Event of Default, the applicable rate of interest, described above, will be increased by 5.00% June 1, 2024 The obligations under the Loan Agreement are secured on a senior basis by a lien on substantially all of the assets of the Company and its subsidiaries other than intellectual property. The subsidiaries of the Company, other than VBI Cda and SciVac HK, are guarantors of the obligations of the Company and VBI Cda under the Loan Agreement. The Loan Agreement also contains customary events of default. Approximately $ 14.5 million of the proceeds received were used to repay the Company’s existing loan facility with Perceptive Credit Holdings, LP, a related party (“Perceptive”), which was due on June 30, 2020. The early repayment resulted in a loss on extinguishment of debt of $ 84 , which is included in interest expense, net of interest income on the condensed consolidated statement of operations and comprehensive loss. On May 6, 2016, the Company through VBI US assumed a term loan facility with Perceptive in the amount of $ 6,000 (the “Facility”). On December 6, 2016, the Company amended the Facility (the “Amended Credit Facility”) and raised Perceptive commitment amount to $ 13,200 , which was combined with the remaining balance from the Facility of $ 1,800 . In connection with the Amended Credit Facility, on December 6, 2016, the Company issued to Perceptive two warrants; the first warrant to purchase 363,771 shares of the Company’s common shares at an exercise price of $ 4.13 , and the second warrant to purchase 1,341,282 shares of the Company’s common shares at an exercise price of $ 3.355 . The total proceeds attributed to the warrants was $ 2,793 based on the relative fair value of the warrants as compared to the sum of the fair values of the warrants and debt. This resulted in the debt being issued at a discount. The Company incurred $ 360 of debt issuance costs and was required to pay an exit fee of $ 300 upon full repayment of the debt resulting in additional debt discount. Following the Amended Credit Facility and the warrant issuance, the total debt discount was $ 3,453 . On July 17, 2018, the Company amended the Amended Credit Facility (the “Second Amendment”) to extend the period the Company was required to pay only the interest on the loan from May 31, 2018 to December 31, 2018 and to extend the expiration date of certain warrants to purchase 363,771 common shares issued to Perceptive with an original expiration date of July 25, 2019 to December 6, 2021 . The Company accounted for this as a debt modification, and as a result of the extension of the warrant expiration date in connection with the Second Amendment, the debt discount was increased by $ 386 . This amount represents the incremental fair value of the modified warrants. On January 31, 2019, the Company further amended the Amended Credit Facility (the “Third Amendment”) to i) extend the period the Company was required to pay only the interest on the loan from December 31, 2018 to January 31, 2020, ii) extend the maturity of the term loan to June 30, 2020 , and iii) reduce the exercise price on certain warrants to purchase common shares issued to Perceptive to $ 2.75 from $ 4.13 for 363,771 warrants issued on July 25, 2014, and for 363,771 warrants issued on December 6, 2016, and from $ 3.355 for 1,341,282 warrants issued on December 6, 2016. The Company has accounted for this as a debt modification, and as a result of the amendment to the exercise price in connection with the Third Amendment, the debt discount was increased by $ 179 . This amount represents the incremental fair value of the modified warrants. The total debt discount related to the Loan Agreement of $ 6,169 is being charged to interest expense using the effective interest method over the term of the debt. At September 30, 2020 and December 31, 2019, the fair value of our outstanding debt, which is considered level 3 in the fair value hierarchy, is estimated to be approximately $ 17,644 15,272 , respectively. Interest expense, net of interest income recorded in the three and nine months ended September 30, 2020 and 2019 was as follows: SCHEDULE OF INTEREST EXPENSE 2020 2019 2020 2019 Three months ended Nine months ended 2020 2019 2020 2019 Interest expense $ 422 $ 509 $ 1,330 $ 1,539 Amortization of debt discount 468 245 1,102 753 Interest income (148 ) (128 ) (426 ) (620 ) Total interest expense, net of interest income $ 742 $ 626 $ 2,006 $ 1,672 Interest expense and amortization of debt discount for the three months ended September 30, 2020 does not include any amounts incurred to a related party. Interest expense and amortization of debt discount for the nine months ended September 30, 2020 includes $ 723 461 Interest expense and amortization of debt discount for the three and nine months ended September 2019 was fully incurred to a related party. The following table summarizes the future principal payments due under long-term debt: SCHEDULE OF FUTURE PRINCIPAL OF LONG-TERM DEBT Principal Remaining 2020 $ - 2021 - 2022 4,683 2023 9,978 2024 6,729 Total $ 21,390 |
STOCKHOLDERS_ EQUITY AND ADDITI
STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL | 9 Months Ended |
Sep. 30, 2020 | |
Equity [Abstract] | |
STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL | 9. STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL Stock option plans The Company’s stock option plans are approved by and administered by the Company’s 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 No further options will be issued under the 2006 VBI US Stock Option Plan (the “2006 Plan”). As of September 30, 2020, there were 993,666 2013 Equity Incentive Plan No further options will be issued under the 2013 Equity Incentive Plan (the “2013 Plan”). As of September 30, 2020, there were no 2014 Equity Incentive Plan No further options will be issued under the 2014 Equity Incentive Plan (the “2014 Plan”). As of September 30, 2020, there were 521,242 2016 VBI Incentive Plan The 2016 VBI Equity Incentive Plan (the “2016 Plan”) is a rolling incentive plan that sets the number of common shares issuable under the 2016 Plan, together with any other security-based compensation arrangement of the Company, at a maximum of 10 10 10,896,937 168,452 The aggregate number of common shares remaining available for issuance for awards under the 2016 Plan total 10,321,347 Activity related to stock options is as follows: SCHEDULE OF STOCK OPTIONS ACTIVITY Number of Weighted Balance outstanding at December 31, 2019 6,471,708 $ 2.79 Granted 5,960,900 $ 1.93 Exercised (750 ) 1.64 Forfeited (20,013 ) $ 1.94 Balance outstanding at September 30, 2020 12,411,845 $ 2.38 Exercisable at September 30, 2020 5,567,736 $ 2.86 Information relating to RSUs is as follow: SCHEDULE OF RESTRICTED STOCK UNITS Number of Weighted Unvested shares outstanding at December 31, 2019 157,997 $ 2.77 Granted 125,000 $ 1.46 Vested (107,044 ) 2.83 Forfeited (7,501 ) $ 1.53 Unvested shares outstanding at September 30, 2020 168,452 $ 1.81 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 2020 2019 Volatility 91.47 % 118.62 % Risk free interest rate 1.20 % 2.46 % Expected term in years 5.81 5.78 Expected dividend yield 0.00 % 0.00 % Weighted average fair value per option $ 1.41 $ 1.45 The fair value of the options is recognized as an expense on a straight-line basis over the vesting period and forfeitures are accounted for when they occur. The total stock-based compensation expense recorded in the three and nine months ended September 30, 2020 and 2019 was as follows: SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE Three months ended September 30 Nine months ended September 30 2020 2019 2020 2019 Research and development $ 309 $ 184 $ 770 $ 629 General and administrative 1,170 675 2,947 2,439 Cost of revenues 14 17 37 52 Total stock-based compensation expense $ 1,493 $ 876 $ 3,754 $ 3,120 Warrants In April 2020, the Company engaged National to provide financial advisory services in connection with the offering. As consideration for such services, the Company issued to National or its designees warrants to purchase up to an aggregate of 705,000 1.50 On May 22, 2020, in connection with the Loan Agreement, as described in Note 8, the Company issued a warrant, the K2 Warrant, to purchase up to an aggregate of 625,000 common shares, subject to terms and conditions set forth in the form of warrant agreement. The K2 Warrant expires on May 22, 2030 and has an exercise price of $ 1.12 per share. On July 21, 2020, the Company issued 550,000 3.34 1,837 The value attributed to the National Warrants and the K2 Warrant were 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 National K2 Warrant Volatility 103.13 % 95.00 % Risk free interest rate 0.26 % 0.66 % Expected term in years 3 10 Expected dividend yield 0.00 % 0.00 % Fair value per warrant $ 0.64 $ 2.25 Activity related to the warrants is as follows: SCHEDULE OF WARRANT ACTIVITY Number of Weighted Balance outstanding at December 31, 2019 2,618,824 $ 2.87 Issued 1,330,000 1.32 Exercised (550,000 ) $ 3.34 Balance outstanding at September 30, 2020 3,398,824 $ 2.19 |
REVENUES AND DEFERRED REVENUE
REVENUES AND DEFERRED REVENUE | 9 Months Ended |
Sep. 30, 2020 | |
Revenue from Contract with Customer [Abstract] | |
REVENUES AND DEFERRED REVENUE | 10. REVENUES AND DEFERRED REVENUE Revenue is comprised of the following: SCHEDULE OF REVENUE COMPRISED Three months ended September 30 Nine months ended September 30 2020 2019 2020 2019 Product revenues $ 15 $ 168 $ 213 $ 365 R&D service revenues 283 479 684 1,282 Total revenue $ 298 $ 647 $ 897 $ 1,647 The following table presents revenues expected to be recognized in the future related to performance obligations, based on current estimates, that are unsatisfied at September 30, 2020: SUMMARY OF REVENUE EXPECTED TO BE RECOGNIZED IN FUTURE RELATED TO PERFORMANCE OBLIGATIONS Total Current portion to September 30, Remaining portion thereafter Product revenues $ 469 $ - $ 469 R&D service revenues 2,592 408 2,184 Total $ 3,061 $ 408 $ 2,653 The following table presents changes in the deferred revenue balance for the nine months ended September 30, 2020: SUMMARY OF CHANGES IN DEFERRED REVENUE Balance at December 31, 2019 $ 3,791 Amounts invoiced and revenue deferred 11 Recognition of deferred revenue (657 ) Currency translation (84 ) Balance at September 30, 2020 $ 3,061 Short Term $ 408 Long Term $ 2,653 Collaboration and License Agreement – Brii Bio On December 4, 2018, we entered into a Collaboration and License Agreement with Brii Bio (the “Collaboration and License Agreement”), whereby: ● The Company and Brii Bio agreed to collaborate on the development of a hepatitis B recombinant protein-based immunotherapeutic in the licensed territory, which consists of China, Hong Kong, Taiwan, and Macau (collectively, the “Licensed Territory”), and to conduct a Phase Ib/IIa collaboration clinical trial for the purpose of comparing VBI-2601 (BRII-179), which is a recombinant protein-based immunotherapeutic developed by VBI for use in treating chronic hepatitis B, with a novel composition developed jointly with Brii Bio (either being the “Licensed Product”); and, ● The Company granted Brii Bio an exclusive royalty-bearing license to perform studies, regulatory and other activities, as may be required to obtain and maintain marketing approval of the Licensed Product in the Licensed Territory and to commercialize the Licensed Product for the diagnosis and treatment of hepatitis B in the Licensed Territory. Pursuant to the Collaboration and License Agreement, the Company is responsible for the R&D services and Brii Bio is responsible for costs relating to the clinical trials for the Licensed Territory. The initial consideration of the Collaboration and License Agreement consisted of a $ 11 2,295,082 3.6 7.4 4.8 2.6 In addition, the Company is also eligible to receive an additional $ 117.5 million in potential regulatory and sales milestone payments, along with royalties on commercial sales in the Licensed Territory. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. Therefore, no variable consideration was included in the initial transaction price and no such amounts have been recognized to date. On December 4, 2018, the Company recognized the VBI-2601 (BRII-179) license when it was granted as it was determined to be distinct and Brii Bio was able to use and benefit from the license. The R&D Services will be satisfied over time as services are rendered using the “cost-to-cost” input method as this method represents the most accurate depiction of the transfer of services based on the types of costs expected to be incurred. As of September 30, 2020, R&D services related to Brii Bio that remain unsatisfied are $ 2.4 million, out of the $ 3.1 million total deferred revenue. Upon termination of the Collaboration and License Agreement prior to the end of the term, there is no obligation for refund and any amounts in deferred revenue related to unsatisfied performance obligations will be immediately recognized. |
COLLABORATON ARRANGEMENTS
COLLABORATON ARRANGEMENTS | 9 Months Ended |
Sep. 30, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
COLLABORATON ARRANGEMENTS | 11. COLLABORATON ARRANGEMENTS GlaxoSmithKline Biologicals S.A. (“GSK”) On September 10, 2019, we entered into a Clinical Collaboration and Supported Study Agreement (“Collaboration Agreement”) pursuant to which we will investigate the use of GSK’s proprietary AS01 B B This relationship is considered a collaborative relationship and not a customer relationship and is therefore accounted for outside the scope of ASC Topic 606. Costs associated with the second study arm will be expensed as incurred in Research and Development expenses; costs for the three and nine months ended September 30, 2020 are $ 149 485 National Research Council of Canada (“NRC”) On March 31, 2020, we 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. This relationship is considered a collaborative relationship and not a customer relationship and is therefore accounted for outside the scope of ASC Topic 606. Costs associated with the collaboration will be expensed as incurred in Research and Development expenses; costs for the three and nine months ended September 30, 2020 are $ 131 395 Brii Biosciences Limited On December 4, 2018, we entered into the Collaboration and License Agreement with Brii Bio, as described in Note 10. |
INCOME TAXES
INCOME TAXES | 9 Months Ended |
Sep. 30, 2020 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | 12. INCOME TAXES The Company operates in U.S., 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. The Company determines its annual effective tax rate at the end of each interim period based on the year to date period results. Since the Company is incorporated in Canada, it is required to use Canada’s statutory tax rate of 26.50% The Company’s effective tax rate on loss before tax for the three and nine months ended September 30, 2020 of 0.0 % ( 0.0 % for the three and nine months ended September 30, 2019) differs from the Canadian statutory rate of 26.50% primarily due to recording a valuation allowance on the Canadian deferred tax assets in excess of the remaining Canadian deferred tax liability and the effect of recording a valuation allowance against deferred tax assets in all other jurisdictions. The Company maintains a valuation allowance on all of its deferred tax assets. A valuation allowance is required when, based upon an assessment of various factors, including recent operating loss history, anticipated future earnings, and prudent and reasonable tax planning strategies, it is more likely than not that some portion of the deferred tax assets will not be realized. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Sep. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | 13. COMMITMENTS AND CONTINGENCIES Legal Proceedings From time to time, the Company may be involved in certain claims and litigation arising out of the ordinary course and conduct of business. Management assesses such claims and, if it considers that it is probable that an asset had been impaired or a liability had been incurred and the amount of loss can be reasonably estimated, provisions for loss are made based on management’s assessment of the most likely outcome. On September 13, 2018, two actions 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 1,879,500,000 546,207 SciVac believes these matters to be without merit and intends to defend these claims vigorously. The District Court has accepted SciVac’s motion to suspend reaching a decision on the approval of the class action pending the determination of liability under the civil action. Preliminary hearings for the trial of the civil action began on January 15, 2020, with a second preliminary hearing held on May 13, 2020 to discuss document disclosure. The next preliminary hearing is scheduled to be held on December 3, 2020. Operating leases The Company has entered into various non-cancelable lease agreements for its office, lab, and manufacturing facilities, which are classified as operating leases. The office facility lease agreement in the United States expires on April 30, 2023 Our manufacturing facility lease agreement expires on January 31, 2022 The lease agreement for our research facility in Canada, which comprises office and laboratory space, had an initial term ending on December 31, 2019 the term of the lease was extended until December 31, 2022 Effective April 30, 2020, the Company entered into the seventh amendment to the lease agreement for the office facilities in Cambridge, Massachusetts, which extends the lease for a term of three years April 30, 2023 25 3 769 Options to extend are not recognized as part of the lease liabilities or recognized as right to use assets. There are no residual value guarantees, no variable lease payments, and no restrictions or covenants imposed by leases. The discount rate used in measuring the lease liabilities and right of use assets was determined by reviewing our incremental borrowing rate at the initial measurement date. SCHEDULE OF LEASE COST AND OTHER INFORMATION Lease cost: Operating lease costs: Three months ended September 30, 2020 $ 316 Nine months ended September 30, 2020 897 Other information: Weighted average remaining lease term 1.94 Weighted average discount rate 12% Operating lease costs are included in general and administrative (“G&A”) expenses in the statement of operation and comprehensive loss. The following table summarizes future undiscounted cash payments reconciled to the lease liabilities: SUMMARY OF FUTURE UNDISCOUNTED CASH PAYMENTS RECONCILED TO LEASE LIABILITIES Year ending December 31 Remaining 2020 $ 248 2021 1,001 2022 472 2023 104 Total $ 1,825 Effect of discounting (179 ) Total lease liability $ 1,646 Less: current portion (to September 30, 2021) (848 ) Long term lease liability $ 798 |
SEGMENT INFORMATION
SEGMENT INFORMATION | 9 Months Ended |
Sep. 30, 2020 | |
Segment Reporting [Abstract] | |
SEGMENT INFORMATION | 14. 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 from external customers are attributed to geographic areas based on location of the contracting customers: SCHEDULE OF REVENUES FROM EXTERNAL CUSTOMERS Three Months Ended September 30 Nine Months Ended September 30 2020 2019 2020 2019 Israel $ 48 $ 134 $ 198 $ 287 China / Hong Kong 250 467 646 1,245 Europe 0 46 53 115 Total $ 298 $ 647 $ 897 $ 1,647 There was no |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 9 Months Ended |
Sep. 30, 2020 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | 15. SUBSEQUENT EVENTS Effective as of September 4, 2020, the Company entered into a further lease agreement for additional office space at its research facility in Canada, the term of which will commence on October 1, 2020 until April 30, 2023. The Company will recognize a right of use asset and lease liability of approximately $ 66 On October 21, 2020, the Company incorporated VBI Vaccines B.V. in the Netherlands. On October 22, 2020, the Company issued 100,000 Twenty-five percent 75 October 22, 2030 During October 2020, the Company issued 13,246 1.50 20 |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Consolidation | Basis of Presentation and Consolidation The Company’s fiscal year ends on December 31 of each calendar year. The accompanying unaudited condensed consolidated financial statements have been prepared in U.S. dollars (“USD”) and pursuant to the rules and regulations of the SEC, for interim reporting. Accordingly, certain information and footnote disclosures normally included in the financial statements prepared in accordance with United States of America generally accepted accounting principles (“U.S. GAAP”), have been condensed or omitted pursuant to such rules and regulations. The December 31, 2019 consolidated balance sheet in this document was derived from the audited consolidated financial statements. The condensed consolidated financial statements and notes included in this quarterly report on Form 10-Q (this “Form 10-Q”) does not include all of the disclosures required by U.S. GAAP and should be read in conjunction with the financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 (the “2019 10-K”), as filed with the SEC on March 5, 2020. The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries: VBI DE, VBI US, VBI Cda, SciVac, and SciVac HK. Intercompany balances and transactions between the Company and its subsidiaries are eliminated in the condensed consolidated financial statements. In the opinion of management, these condensed consolidated financial statements include all adjustments and accruals of a normal and recurring nature necessary to fairly state the results of the periods presented. The results for the periods presented are not necessarily indicative of results to be expected for the full year or for any future periods. |
Significant Accounting Policies | Significant Accounting Policies The significant accounting policies used in the preparation of these condensed consolidated financial statements are disclosed in the 2019 10-K, and there have been no changes to the Company’s significant accounting policies during the nine months ended September 30, 2020, other than the polices discussed below. |
Cash and cash equivalents | Cash and cash equivalents Cash and cash equivalents include cash investments in interest-bearing accounts and term deposits which can readily be redeemed for cash or are issued for terms of three months or less from the date of acquisition. |
Short-term investments | Short-term investments Short-term investments consist of redeemable short-term investments held with Schedule 1 Canadian banks for maturity terms greater than 3 months but less than a year from the date of acquisition. Short-term investments were initially classified as available for sale and were measured at fair value whereby unrealized holding gains or losses on these investments are reported in other comprehensive income or loss and accrued interest income was recognized in interest expense, net of interest income in the condensed consolidated statement of operations and comprehensive loss. On September 30, 2020 we re-assessed the classification of our short-term investment and we determined that the short-term investment shall be classified as held to maturity. The transfer on September 30, 2020 occurred at fair value with the unrealized holding gains remaining in other comprehensive income or loss. The unrealized holding gains will be amortized over the remaining life of the security until April 2021. Our short-term investments are considered level 2 in the fair value hierarchy. The fair value of the short-term investment was determined using the market approach method and the inputs include comparable market interest rates at September 30, 2020. |
Government Grants | Government Grants Government grants are recognized in the 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. |
INVENTORY, NET (Tables)
INVENTORY, NET (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Inventory Disclosure [Abstract] | |
SCHEDULE OF INVENTORY | Inventory is stated at the lower of cost or market and consists of the following: SCHEDULE OF INVENTORY September 30, December 31, Finished goods $ - $ 58 Work-in-process 374 237 Raw materials 1,168 780 Inventory, net $ 1,542 $ 1,075 |
INTANGIBLE ASSETS AND GOODWILL
INTANGIBLE ASSETS AND GOODWILL (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
SCHEDULE OF INTANGIBLE ASSETS INCLUDING CUMULATIVE IMPAIRMENT AND CUMULATIVE CURRENCY TRANSLATION | SCHEDULE OF INTANGIBLE ASSETS INCLUDING CUMULATIVE IMPAIRMENT AND CUMULATIVE CURRENCY TRANSLATION September 30, 2020 Gross Carrying Accumulated Cumulative Cumulative Net Book Patents $ 669 $ (569 ) $ - $ 31 $ 131 IPR&D assets 61,500 - (300 ) (2,163 ) 59,037 $ 62,169 $ (569 ) $ (300 ) $ (2,132 ) $ 59,168 December 31, 2019 Gross Accumulated Cumulative Cumulative Net Book Patents $ 669 $ (521 ) $ - $ 30 $ 178 IPR&D assets 61,500 - (300 ) (622 ) 60,578 $ 62,169 $ (521 ) $ (300 ) $ (592 ) $ 60,756 |
SCHEDULE OF GOODWILL | SCHEDULE OF GOODWILL September 30, 2020 Gross Carrying Amount Cumulative Impairment Cumulative Translation Net Book Goodwill $ 8,714 $ (6,292 ) $ (270 ) $ 2,152 December 31, 2019 Gross Cumulative Impairment Cumulative Translation Net Book Goodwill $ 8,714 $ (6,292 ) $ (214 ) $ 2,208 |
OTHER CURRENT LIABILITIES (Tabl
OTHER CURRENT LIABILITIES (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Other Liabilities Disclosure [Abstract] | |
SCHEDULE OF OTHER CURRENT LIABILITIES | Other current liabilities consisted of the following: SCHEDULE OF OTHER CURRENT LIABILITIES September 30, December 31, Accrued research and development expenses (including clinical trial accrued expenses) $ 6,377 $ 9,247 Accrued professional fees 958 446 Payroll and employee-related costs 1,632 2,184 Other current liabilities 371 384 Total Other current liabilities $ 9,338 $ 12,261 |
LOSS PER SHARE OF COMMON SHAR_2
LOSS PER SHARE OF COMMON SHARES (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Earnings Per Share [Abstract] | |
SCHEDULE OF ANTIDILUTIVE WEIGHTED AVERAGE SHARES OUTSTANDING | The following potentially dilutive securities outstanding at September 30, 2020 and 2019 have been excluded from the computation of diluted weighted average shares outstanding, as they would be antidilutive: SCHEDULE OF ANTIDILUTIVE WEIGHTED AVERAGE SHARES OUTSTANDING September 30, September 30, Warrants 3,398,824 2,618,824 Stock options and equity awards 12,580,297 6,814,104 K2 conversion feature 2,739,726 - 18,718,847 9,432,928 |
LONG-TERM DEBT (Tables)
LONG-TERM DEBT (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Long-term Debt | |
SCHEDULE OF LONG-TERM DEBT | As of September 30, 2020, and December 31, 2019, the long-term debt is as follows: SCHEDULE OF LONG-TERM DEBT September 30, December 31, Long-term debt, net of debt discount $ 15,862 $ 14,845 * Less: current portion, net of debt discount - 14,845 * Long-term debt $ 15,862 $ - * * 2019 long term debt was due to Perceptive Credit Holdings LP, a related party. |
SCHEDULE OF INTEREST EXPENSE | Interest expense, net of interest income recorded in the three and nine months ended September 30, 2020 and 2019 was as follows: SCHEDULE OF INTEREST EXPENSE 2020 2019 2020 2019 Three months ended Nine months ended 2020 2019 2020 2019 Interest expense $ 422 $ 509 $ 1,330 $ 1,539 Amortization of debt discount 468 245 1,102 753 Interest income (148 ) (128 ) (426 ) (620 ) Total interest expense, net of interest income $ 742 $ 626 $ 2,006 $ 1,672 |
SCHEDULE OF FUTURE PRINCIPAL OF LONG-TERM DEBT | The following table summarizes the future principal payments due under long-term debt: SCHEDULE OF FUTURE PRINCIPAL OF LONG-TERM DEBT Principal Remaining 2020 $ - 2021 - 2022 4,683 2023 9,978 2024 6,729 Total $ 21,390 |
STOCKHOLDERS_ EQUITY AND ADDI_2
STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Equity [Abstract] | |
SCHEDULE OF STOCK OPTIONS ACTIVITY | Activity related to stock options is as follows: SCHEDULE OF STOCK OPTIONS ACTIVITY Number of Weighted Balance outstanding at December 31, 2019 6,471,708 $ 2.79 Granted 5,960,900 $ 1.93 Exercised (750 ) 1.64 Forfeited (20,013 ) $ 1.94 Balance outstanding at September 30, 2020 12,411,845 $ 2.38 Exercisable at September 30, 2020 5,567,736 $ 2.86 |
SCHEDULE OF RESTRICTED STOCK UNITS | Information relating to RSUs is as follow: SCHEDULE OF RESTRICTED STOCK UNITS Number of Weighted Unvested shares outstanding at December 31, 2019 157,997 $ 2.77 Granted 125,000 $ 1.46 Vested (107,044 ) 2.83 Forfeited (7,501 ) $ 1.53 Unvested shares outstanding at September 30, 2020 168,452 $ 1.81 |
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 2020 2019 Volatility 91.47 % 118.62 % Risk free interest rate 1.20 % 2.46 % Expected term in years 5.81 5.78 Expected dividend yield 0.00 % 0.00 % Weighted average fair value per option $ 1.41 $ 1.45 |
SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE | The fair value of the options is recognized as an expense on a straight-line basis over the vesting period and forfeitures are accounted for when they occur. The total stock-based compensation expense recorded in the three and nine months ended September 30, 2020 and 2019 was as follows: SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE Three months ended September 30 Nine months ended September 30 2020 2019 2020 2019 Research and development $ 309 $ 184 $ 770 $ 629 General and administrative 1,170 675 2,947 2,439 Cost of revenues 14 17 37 52 Total stock-based compensation expense $ 1,493 $ 876 $ 3,754 $ 3,120 |
SCHEDULE OF FAIR VALUE OF WARRANTS GRANTED BY USING BLACK-SCHOLES OPTION PRICING ASSUMPTIONS | The value attributed to the National Warrants and the K2 Warrant were 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 National K2 Warrant Volatility 103.13 % 95.00 % Risk free interest rate 0.26 % 0.66 % Expected term in years 3 10 Expected dividend yield 0.00 % 0.00 % Fair value per warrant $ 0.64 $ 2.25 |
SCHEDULE OF WARRANT ACTIVITY | Activity related to the warrants is as follows: SCHEDULE OF WARRANT ACTIVITY Number of Weighted Balance outstanding at December 31, 2019 2,618,824 $ 2.87 Issued 1,330,000 1.32 Exercised (550,000 ) $ 3.34 Balance outstanding at September 30, 2020 3,398,824 $ 2.19 |
REVENUES AND DEFERRED REVENUE (
REVENUES AND DEFERRED REVENUE (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Revenue from Contract with Customer [Abstract] | |
SCHEDULE OF REVENUE COMPRISED | Revenue is comprised of the following: SCHEDULE OF REVENUE COMPRISED Three months ended September 30 Nine months ended September 30 2020 2019 2020 2019 Product revenues $ 15 $ 168 $ 213 $ 365 R&D service revenues 283 479 684 1,282 Total revenue $ 298 $ 647 $ 897 $ 1,647 |
SUMMARY OF REVENUE EXPECTED TO BE RECOGNIZED IN FUTURE RELATED TO PERFORMANCE OBLIGATIONS | The following table presents revenues expected to be recognized in the future related to performance obligations, based on current estimates, that are unsatisfied at September 30, 2020: SUMMARY OF REVENUE EXPECTED TO BE RECOGNIZED IN FUTURE RELATED TO PERFORMANCE OBLIGATIONS Total Current portion to September 30, Remaining portion thereafter Product revenues $ 469 $ - $ 469 R&D service revenues 2,592 408 2,184 Total $ 3,061 $ 408 $ 2,653 |
SUMMARY OF CHANGES IN DEFERRED REVENUE | The following table presents changes in the deferred revenue balance for the nine months ended September 30, 2020: SUMMARY OF CHANGES IN DEFERRED REVENUE Balance at December 31, 2019 $ 3,791 Amounts invoiced and revenue deferred 11 Recognition of deferred revenue (657 ) Currency translation (84 ) Balance at September 30, 2020 $ 3,061 Short Term $ 408 Long Term $ 2,653 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
SCHEDULE OF LEASE COST AND OTHER INFORMATION | Options to extend are not recognized as part of the lease liabilities or recognized as right to use assets. There are no residual value guarantees, no variable lease payments, and no restrictions or covenants imposed by leases. The discount rate used in measuring the lease liabilities and right of use assets was determined by reviewing our incremental borrowing rate at the initial measurement date. SCHEDULE OF LEASE COST AND OTHER INFORMATION Lease cost: Operating lease costs: Three months ended September 30, 2020 $ 316 Nine months ended September 30, 2020 897 Other information: Weighted average remaining lease term 1.94 Weighted average discount rate 12% |
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 Remaining 2020 $ 248 2021 1,001 2022 472 2023 104 Total $ 1,825 Effect of discounting (179 ) Total lease liability $ 1,646 Less: current portion (to September 30, 2021) (848 ) Long term lease liability $ 798 |
SEGMENT INFORMATION (Tables)
SEGMENT INFORMATION (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Segment Reporting [Abstract] | |
SCHEDULE OF REVENUES FROM EXTERNAL CUSTOMERS | Revenues from external customers are attributed to geographic areas based on location of the contracting customers: SCHEDULE OF REVENUES FROM EXTERNAL CUSTOMERS Three Months Ended September 30 Nine Months Ended September 30 2020 2019 2020 2019 Israel $ 48 $ 134 $ 198 $ 287 China / Hong Kong 250 467 646 1,245 Europe 0 46 53 115 Total $ 298 $ 647 $ 897 $ 1,647 |
NATURE OF BUSINESS AND CONTIN_2
NATURE OF BUSINESS AND CONTINUATION OF BUSINESS (Details Narrative) $ / shares in Units, $ in Thousands, $ in Thousands | Sep. 16, 2020USD ($) | Sep. 16, 2020CAD ($) | Jul. 31, 2020USD ($) | Jul. 21, 2020USD ($)$ / sharesshares | Jul. 03, 2020CAD ($) | May 31, 2020USD ($) | Apr. 30, 2020USD ($)$ / sharesshares | Sep. 30, 2020USD ($)$ / sharesshares | Sep. 30, 2020USD ($) | Sep. 30, 2020CAD ($) | Sep. 30, 2019USD ($) | Oct. 31, 2020$ / shares |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||
[custom:RetainedEarningAccumulatedDeficit-0] | $ 293,256 | $ 293,256 | ||||||||||
Net Cash Provided by (Used in) Operating Activities | 30,555 | $ 40,182 | ||||||||||
Common shares issued in public offering | shares | 52,272,726 | |||||||||||
Share issuance costs related to offering | 4,919 | 2,756 | ||||||||||
Warrant exercise price | $ / shares | $ 20,000 | |||||||||||
Proceeds from Issuance of Common Stock | $ 106,269 | $ 40,250 | ||||||||||
Warrant [Member] | ||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||
Warrant to purchase common stock | shares | 550,000 | |||||||||||
Warrant exercise price | $ / shares | $ 3.34 | |||||||||||
Proceeds from warrants | $ 1,837 | |||||||||||
Loan and Guaranty Agreement [Member] | ||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||
Debt Instrument, Maturity Date | Jun. 1, 2024 | Jun. 1, 2024 | ||||||||||
Open Market Sale Agreement [Member] | Jefferies LLC [Member] | ||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||
Open market sale agreement sales cost | $ 125,000 | |||||||||||
ATM Program [Member] | ||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||
Share issuance costs related to offering | 1,606 | |||||||||||
Proceeds from stock issuance cost | $ 47,163 | |||||||||||
Stock Issued During Period, Shares, New Issues | shares | 10,840,334 | |||||||||||
Proceeds from Issuance of Common Stock | $ 48,769 | |||||||||||
Average price per share | $ / shares | $ 4.4988 | |||||||||||
Available share value | $ 76,231 | $ 76,231 | ||||||||||
Industrial Research Assistance Program [Member] | CAD [Member] | ||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||
[custom:ResearchAndDevelopmentExpenses] | $ 1,000 | |||||||||||
Additional grants | $ 235 | |||||||||||
Contribution Agreement [Member] | CAD [Member] | ||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||
[custom:ResearchAndDevelopmentExpenses] | $ 55,976 | |||||||||||
Additional grants | $ 731 | |||||||||||
Loan Agreement [Member] | ||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||
Excess of contribution amount | $ 500 | |||||||||||
National Securities Inc [Member] | ||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||
Warrant to purchase common stock | shares | 705,000 | |||||||||||
Warrant exercise price | $ / shares | $ 1.50 | |||||||||||
K 2 Heathventures L L C [Member] | Loan and Guaranty Agreement [Member] | ||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||
Proceeds from Issuance of Long-term Debt | $ 4,500 | |||||||||||
Debt Instrument, Maturity Date | Jun. 1, 2024 | Jun. 1, 2024 | ||||||||||
Public Offering [Member] | ||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||
Shares issued price per share | $ / shares | $ 1.10 | |||||||||||
Gross proceeds from public offering | $ 57,500 | |||||||||||
Share issuance costs related to offering | 3,606 | |||||||||||
Proceeds from stock issuance cost | $ 53,894 |
SCHEDULE OF INVENTORY (Details)
SCHEDULE OF INVENTORY (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Inventory Disclosure [Abstract] | ||
Finished goods | $ 58 | |
Work-in-process | 374 | 237 |
Raw materials | 1,168 | 780 |
Inventory, net | $ 1,542 | $ 1,075 |
SCHEDULE OF INTANGIBLE ASSETS I
SCHEDULE OF INTANGIBLE ASSETS INCLUDING CUMULATIVE IMPAIRMENT AND CUMULATIVE CURRENCY TRANSLATION (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Finite-Lived Intangible Assets [Line Items] | ||
Intangible Assets, Gross | $ 62,169 | $ 62,169 |
Accumulated Amortization | (569) | (521) |
Cumulative Impairment Charge | (300) | (300) |
Cumulative Currency Translation | (2,132) | (592) |
Intangible assets, Net | 59,168 | 60,756 |
Patents [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible Assets, Gross | 669 | 669 |
Accumulated Amortization | (569) | (521) |
Cumulative Impairment Charge | ||
Cumulative Currency Translation | 31 | 30 |
Intangible assets, Net | 131 | 178 |
Inprocess Research And Development Assets [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible Assets, Gross | 61,500 | 61,500 |
Accumulated Amortization | ||
Cumulative Impairment Charge | (300) | (300) |
Cumulative Currency Translation | (2,163) | (622) |
Intangible assets, Net | $ 59,037 | $ 60,578 |
SCHEDULE OF GOODWILL (Details)
SCHEDULE OF GOODWILL (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Goodwill, Gross Carrying Amount | $ 8,714 | $ 8,714 |
Goodwill, Cumulative Impairment Charge | (6,292) | (6,292) |
Goodwill, Cumulative Currency Translation | (270) | (214) |
Goodwill, Net Book Value | $ 2,152 | $ 2,208 |
INTANGIBLE ASSETS AND GOODWIL_2
INTANGIBLE ASSETS AND GOODWILL (Details Narrative) $ in Thousands | 9 Months Ended |
Sep. 30, 2020USD ($) | |
Finite-Lived Intangible Assets [Line Items] | |
In process research and development fair value assumptions, description | The discount rate used was 11% and the cumulative probability of technical and regulatory success to achieve approval to market the products ranged from approximately 6% to 17% |
Goodwill [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Decrease in Foreign currency translation adjustment | $ 56 |
Inprocess Research And Development Assets [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Decrease in Foreign currency translation adjustment | $ 1,541 |
SCHEDULE OF OTHER CURRENT LIABI
SCHEDULE OF OTHER CURRENT LIABILITIES (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Other Liabilities Disclosure [Abstract] | ||
Accrued research and development expenses (including clinical trial accrued expenses) | $ 6,377 | $ 9,247 |
Accrued professional fees | 958 | 446 |
Payroll and employee-related costs | 1,632 | 2,184 |
Other current liabilities | 371 | 384 |
Total Other current liabilities | $ 9,338 | $ 12,261 |
SCHEDULE OF ANTIDILUTIVE WEIGHT
SCHEDULE OF ANTIDILUTIVE WEIGHTED AVERAGE SHARES OUTSTANDING (Details) - shares | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive weighted average shares outstanding | 18,718,847 | 9,432,928 |
Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive weighted average shares outstanding | 3,398,824 | 2,618,824 |
Stock Options and Equity Awards [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive weighted average shares outstanding | 12,580,297 | 6,814,104 |
K2 Conversion Feature [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive weighted average shares outstanding | 2,739,726 |
SCHEDULE OF LONG-TERM DEBT (Det
SCHEDULE OF LONG-TERM DEBT (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 | [1] |
Long-term Debt | |||
Long-term debt, net of debt discount | $ 15,862 | $ 14,845 | |
Less: current portion, net of debt discount | 14,845 | ||
Long-term debt | $ 15,862 | ||
[1] | 2019 long term debt was due to Perceptive Credit Holdings LP, a related party. |
SCHEDULE OF INTEREST EXPENSE (D
SCHEDULE OF INTEREST EXPENSE (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Long-term Debt | ||||
Interest expense | $ 422 | $ 509 | $ 1,330 | $ 1,539 |
Amortization of debt discount | 468 | 245 | 1,102 | 753 |
Interest income | (148) | (128) | (426) | (620) |
Total interest expense, net of interest income | $ 742 | $ 626 | $ 2,006 | $ 1,672 |
SCHEDULE OF FUTURE PRINCIPAL OF
SCHEDULE OF FUTURE PRINCIPAL OF LONG-TERM DEBT (Details) $ in Thousands | Sep. 30, 2020USD ($) |
Long-term Debt | |
Remaining 2020 | |
2021 | |
2022 | 4,683 |
2023 | 9,978 |
2024 | 6,729 |
Total | $ 21,390 |
LONG-TERM DEBT (Details Narrati
LONG-TERM DEBT (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | Jul. 21, 2020 | May 22, 2020 | Jan. 31, 2019 | Jul. 17, 2018 | Dec. 06, 2016 | Sep. 30, 2020 | Sep. 30, 2019 | Oct. 31, 2020 | Dec. 31, 2019 | May 06, 2016 | Jul. 25, 2014 |
Entity Listings [Line Items] | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 20,000 | ||||||||||
Proceeds from Warrant Exercises | $ 1,837 | ||||||||||
[custom:EffectivePriceOfWarrants-0] | $ 1.52 | ||||||||||
Intrinsic value of beneficial conversion feature recorded to additional paid in capital | $ 2,577 | ||||||||||
Interest expense | 723 | ||||||||||
Amortization of debt discount | 461 | ||||||||||
Fair Value, Inputs, Level 3 [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Debt Instrument, Fair Value Disclosure | 17,644 | $ 15,272 | |||||||||
Second Amended Credit Facility [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 363,771 | ||||||||||
Warrants to purchase common shares original issue date description | July 25, 2019 to December 6, 2021 | ||||||||||
Increase in debt discount | $ 386 | ||||||||||
Second Amended Credit Facility [Member] | Extended Maturity [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Debt Instrument, Maturity Date, Description | May 31, 2018 to December 31, 2018 | ||||||||||
Third Amended Credit Facility [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 2.75 | ||||||||||
Increase in debt discount | $ 179 | ||||||||||
Third Amended Credit Facility [Member] | Exercise Price Four Point One Three [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 4.13 | ||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 363,771 | 363,771 | |||||||||
Third Amended Credit Facility [Member] | Exercise Price Three Point Three Five Five [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 3.355 | ||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,341,282 | ||||||||||
Third Amended Credit Facility [Member] | Extended Maturity [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Debt Instrument, Maturity Date, Description | Amended Credit Facility (the “Third Amendment”) to i) extend the period the Company was required to pay only the interest on the loan from December 31, 2018 to January 31, 2020, ii) extend the maturity of the term loan to June 30, 2020 | ||||||||||
Credit Holdings L P [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Repayments of Related Party Debt | 14,500 | ||||||||||
Gain (Loss) on Extinguishment of Debt | 84 | ||||||||||
Warrant [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 3.34 | ||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 550,000 | ||||||||||
Proceeds from Issuance of Warrants | $ 1,837 | ||||||||||
Perceptive Credit Holdings, LP [Member] | Amended Credit Facility [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Debt discount related to Loan Agreement | $ 3,453 | ||||||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 6,000 | ||||||||||
Proceeds from Lines of Credit | 13,200 | ||||||||||
Line of Credit Facility, Remaining Borrowing Capacity | 1,800 | ||||||||||
Debt Issuance Costs, Gross | 360 | ||||||||||
Line of Credit Facility, Commitment Fee Amount | 300 | ||||||||||
Perceptive Credit Holdings, LP [Member] | Warrant [Member] | Amended Credit Facility [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Proceeds from Issuance of Warrants | $ 2,793 | ||||||||||
Perceptive Credit Holdings, LP [Member] | Tranche One [Member] | Amended Credit Facility [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 4.13 | ||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 363,771 | ||||||||||
Perceptive Credit Holdings, LP [Member] | Tranche Two [Member] | Amended Credit Facility [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 3.355 | ||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,341,282 | ||||||||||
Loan and Guaranty Agreement [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Debt Instrument, Periodic Payment | 1,390 | ||||||||||
Debt Instrument, Face Amount | $ 21,390 | ||||||||||
Debt annual interest rate | 8.25% | ||||||||||
Debt increased percentage | 5.00% | ||||||||||
Debt maturity date | Jun. 1, 2024 | ||||||||||
Loan and Guaranty Agreement [Member] | Prime Rate [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Debt annual interest rate | 5.00% | ||||||||||
Loan and Guaranty Agreement [Member] | K2 Warrant [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Warrant or Right, Reason for Issuance, Description | additional common shares will be issuable pursuant to the K2 Warrant as determined by the principal amount of the additional funds advanced multiplied by 3.5% and divided by the Warrant Price, and the final payment will increase by 6.95% of the funds advanced. | ||||||||||
Loan and Guaranty Agreement [Member] | Third Tranche [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Secured Debt | $ 10,000 | ||||||||||
Debt annual interest rate | 8.25% | ||||||||||
Loan interest period extended date | Jan. 1, 2023 | ||||||||||
Loan and Guaranty Agreement [Member] | K 2 Healthventures L L C [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Debt Instrument, Description | The Lenders agreed to make available the following additional tranches subject to the following conditions and upon the submission of a loan request by the Company: (1) up to $10 million available between January 1, 2021 and April 30, 2021 upon achievement of certain milestones (the “Second Tranche Term Loan”), (2) $10 million available between the closing date and December 31, 2021, subject to achievement of a certain U.S. Food and Drug Administration approval (the “Third Tranche Term Loan”), and (3) a final tranche of up to $ | ||||||||||
Debt Conversion, Converted Instrument, Amount | $ 4,000 | ||||||||||
Debt Instrument, Convertible, Conversion Price | $ 1.46 | ||||||||||
Debt Issuance Costs, Net | $ 1,021 | ||||||||||
Secured term loan final payment percentage | 6.95% | ||||||||||
Additional discount | $ 1,390 | ||||||||||
Debt discount related to Loan Agreement | $ 6,169 | ||||||||||
Loan and Guaranty Agreement [Member] | K 2 Healthventures L L C [Member] | K2 Warrant [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 625,000 | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 1.12 | ||||||||||
Warrant or Right, Reason for Issuance, Description | The number of common shares issuable pursuant to the K2 Warrant, at any given time, is determined by the aggregate principal amount of the loans advanced at that time pursuant to the Loan Agreement multiplied by 3.5% and divided by the Warrant Price. If the full $50 million available in all K2 tranches is advanced pursuant to the Loan Agreement, up to 1,562,500 common shares will be issuable pursuant to the K2 Warrant. | ||||||||||
Class of Warrant or Right, Date from which Warrants or Rights Exercisable | May 22, 2030 | ||||||||||
Proceeds from Warrant Exercises | $ 1,181 | ||||||||||
Loan and Guaranty Agreement [Member] | K 2 Healthventures L L C [Member] | First Tranche [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Secured Debt | 20,000 | ||||||||||
Loan and Guaranty Agreement [Member] | K 2 Healthventures L L C [Member] | Final Tranche [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Secured Debt | $ 10,000 |
SCHEDULE OF STOCK OPTIONS ACTIV
SCHEDULE OF STOCK OPTIONS ACTIVITY (Details) - Equity Option [Member] | 9 Months Ended |
Sep. 30, 2020$ / sharesshares | |
Summary of Investment Holdings [Line Items] | |
Number of Stock Options Outstanding, Beginning Balance | shares | 6,471,708 |
Weighted Average Exercise Price, Beginning Balance | $ / shares | $ 2.79 |
Number of Stock Options, Granted | shares | 5,960,900 |
Weighted Average Exercise Price, Granted | $ / shares | $ 1.93 |
Number of Stock Options, Exercised | shares | (750) |
Weighted Average Exercise Price, Exercised | $ / shares | $ 1.64 |
Number of Stock Options, Forfeited | shares | (20,013) |
Weighted Average Exercise Price, Forfeited | $ / shares | $ 1.94 |
Number of Stock Options Outstanding, Ending Balance | shares | 12,411,845 |
Weighted Average Exercise Price, Ending Balance | $ / shares | $ 2.38 |
Number of Stock Options, Exercisable | shares | 5,567,736 |
Weighted Average Exercise Price, Exercisable | $ / shares | $ 2.86 |
SCHEDULE OF RESTRICTED STOCK UN
SCHEDULE OF RESTRICTED STOCK UNITS (Details) - $ / shares | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Class of Stock [Line Items] | ||
Weighted Average Fair Value at Grant Date, Granted | $ 1.41 | $ 1.45 |
Restricted Stock Units (RSUs) [Member] | ||
Class of Stock [Line Items] | ||
Number of Stock Awards, Unvested shares outstanding beginning balance | 157,997 | |
Weighted Average Fair Value at Grant Date, Unvested shares outstanding beginning balance | $ 2.77 | |
Number of Stock Awards, Granted | 125,000 | |
Weighted Average Fair Value at Grant Date, Granted | $ 1.46 | |
Number of Stock Awards, Vested | (107,044) | |
Weighted Average Fair Value at Grant Date, Vested | $ 2.83 | |
Number of Stock Awards, Forfeited | (7,501) | |
Weighted Average Fair Value at Grant Date, Forfeited | $ 1.53 | |
Number of Stock Awards, Unvested shares outstanding ending balance | 168,452 | |
Weighted Average Fair Value at Grant Date, Unvested shares outstanding | $ 1.81 |
SCHEDULE OF FAIR VALUE OF OPTIO
SCHEDULE OF FAIR VALUE OF OPTIONS GRANTED BY USING BLACK-SCHOLES OPTION PRICING ASSUMPTIONS (Details) - $ / shares | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Equity [Abstract] | ||
Volatility | 91.47% | 118.62% |
Risk free interest rate | 1.20% | 2.46% |
Expected term in years | 5.81 | 5.78 |
Expected dividend yield | 0.00% | 0.00% |
Weighted average fair value per option | $ 1.41 | $ 1.45 |
SCHEDULE OF STOCK-BASED COMPENS
SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Total stock-based compensation expense | $ 1,493 | $ 876 | $ 3,754 | $ 3,120 |
Research and Development [Member] | ||||
Total stock-based compensation expense | 309 | 184 | 770 | 629 |
General and Administrative [Member] | ||||
Total stock-based compensation expense | 1,170 | 675 | 2,947 | 2,439 |
Cost of Revenues [Member] | ||||
Total stock-based compensation expense | $ 14 | $ 17 | $ 37 | $ 52 |
SCHEDULE OF FAIR VALUE OF WARRA
SCHEDULE OF FAIR VALUE OF WARRANTS GRANTED BY USING BLACK-SCHOLES OPTION PRICING ASSUMPTIONS (Details) - $ / shares | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Volatility | 91.47% | 118.62% |
Risk free interest rate | 1.20% | 2.46% |
Expected dividend yield | 0.00% | 0.00% |
National Warrants [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Volatility | 103.13% | |
Risk free interest rate | 0.26% | |
Expected term in years | 3 | |
Expected dividend yield | 0.00% | |
Fair value per warrant | $ 0.64 | |
K2 Warrant [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Volatility | 95.00% | |
Risk free interest rate | 0.66% | |
Expected term in years | 10 | |
Expected dividend yield | 0.00% | |
Fair value per warrant | $ 2.25 |
SCHEDULE OF WARRANT ACTIVITY (D
SCHEDULE OF WARRANT ACTIVITY (Details) - Warrants [Member] | 9 Months Ended |
Sep. 30, 2020$ / sharesshares | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | |
Number of Warrants, Balance Outstanding Beginning | shares | 2,618,824 |
Weighted Average Exercise Price, Balance Outstanding Beginning | $ / shares | $ 2.87 |
Number of Warrants, Issued | shares | 1,330,000 |
Weighted Average Exercise Price, Issued | $ / shares | $ 1.32 |
Number of Warrants, Exercised | shares | (550,000) |
Weighted Average Exercise Price, Exercised | $ / shares | $ 3.34 |
Number of Warrants, Balance Outstanding Ending | shares | 3,398,824 |
Weighted Average Exercise Price, Balance Outstanding Ending | $ / shares | $ 2.19 |
STOCKHOLDERS_ EQUITY AND ADDI_3
STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | Jul. 21, 2020 | Apr. 30, 2020 | Sep. 30, 2020 | Oct. 31, 2020 | May 22, 2020 |
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||
Warrant exercise price | $ 20,000 | ||||
Number of common shares issued, shares | 52,272,726 | ||||
Warrants [Member] | |||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||
Class of warrant or right, number of securities called by each warrant or right | 705,000 | ||||
Warrant exercise price | $ 1.50 | ||||
K2 Warrant [Member] | Loan and Guaranty Agreement [Member] | K 2 Healthventures L L C [Member] | |||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||
Class of warrant or right, number of securities called by each warrant or right | 625,000 | ||||
Warrant exercise price | $ 1.12 | ||||
Warrants and rights outstanding, maturity date | May 22, 2030 | ||||
Warrant [Member] | |||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||
Warrant exercise price | $ 3.34 | ||||
Proceeds from warrants | $ 1,837 | ||||
Warrant [Member] | Common Shares Exercise of Warrants [Member] | |||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||
Warrant exercise price | $ 3.34 | ||||
Number of common shares issued, shares | 550,000 | ||||
Proceeds from warrants | $ 1,837 | ||||
2006 Plan [Member] | |||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 993,666 | ||||
2013 Plan [Member] | |||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 0 | ||||
2014 Plan [Member] | |||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 521,242 | ||||
2016 Plan [Member] | |||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 10,896,937 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Percentage of Outstanding Stock Maximum | 10.00% | ||||
Maximum percentage of options granted | 10.00% | ||||
Number of common shares available for issuance | 10,321,347 | ||||
2016 VBI Equity Incentive Plan [Member] | Restricted Stock Units (RSUs) [Member] | |||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number | 168,452 |
SCHEDULE OF REVENUE COMPRISED (
SCHEDULE OF REVENUE COMPRISED (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Disaggregation of Revenue [Line Items] | ||||
Revenues | $ 298 | $ 647 | $ 897 | $ 1,647 |
Product [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 15 | 168 | 213 | 365 |
Service [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | $ 283 | $ 479 | $ 684 | $ 1,282 |
SUMMARY OF REVENUE EXPECTED TO
SUMMARY OF REVENUE EXPECTED TO BE RECOGNIZED IN FUTURE RELATED TO PERFORMANCE OBLIGATIONS (Details) $ in Thousands | Sep. 30, 2020USD ($) |
Disaggregation of Revenue [Line Items] | |
Revenue remaining performance obligations | $ 3,061 |
Current Portion To September Thirty Two Thousand Twenty One [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenue remaining performance obligations | 408 |
Remaining Portion Thereafter [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenue remaining performance obligations | 2,653 |
Product [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenue remaining performance obligations | 469 |
Product [Member] | Current Portion To September Thirty Two Thousand Twenty One [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenue remaining performance obligations | |
Product [Member] | Remaining Portion Thereafter [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenue remaining performance obligations | 469 |
Service [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenue remaining performance obligations | 2,592 |
Service [Member] | Current Portion To September Thirty Two Thousand Twenty One [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenue remaining performance obligations | 408 |
Service [Member] | Remaining Portion Thereafter [Member] | |
Disaggregation of Revenue [Line Items] | |
Revenue remaining performance obligations | $ 2,184 |
SUMMARY OF CHANGES IN DEFERRED
SUMMARY OF CHANGES IN DEFERRED REVENUE (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Dec. 31, 2019 | |
Revenue from Contract with Customer [Abstract] | ||
Balance at December 31, 2019 | $ 3,791 | |
Amounts invoiced and revenue deferred | 11 | |
Recognition of deferred revenue | (657) | |
Currency translation | (84) | |
Balance at September 30, 2020 | 3,061 | |
Short Term | 408 | $ 882 |
Long Term | $ 2,653 | $ 2,909 |
REVENUES AND DEFERRED REVENUE_2
REVENUES AND DEFERRED REVENUE (Details Narrative) - USD ($) $ in Thousands | Dec. 04, 2018 | Sep. 30, 2020 | Dec. 31, 2019 |
Disaggregation of Revenue [Line Items] | |||
Remaining performance obligation, deemed to be initial transaction price | $ 3,061 | ||
Additional potential regulatory and sales milestone payments | $ 117,500 | ||
Contract with Customer, Liability | 3,061 | $ 3,791 | |
License Agreement [Member] | Brii Bio [Member] | |||
Disaggregation of Revenue [Line Items] | |||
Non-refundable upfront payment | $ 11,000 | ||
Stock issued for the agreement, shares | 2,295,082 | ||
Stock issued for the agreement | $ 3,600 | ||
Remaining performance obligation, deemed to be initial transaction price | 7,400 | ||
License Agreement [Member] | Brii Bio [Member] | R&D Services [Member] | |||
Disaggregation of Revenue [Line Items] | |||
Remaining performance obligation, deemed to be initial transaction price | 4,800 | ||
License Agreement [Member] | Brii Bio [Member] | VBI-2601 [Member] | |||
Disaggregation of Revenue [Line Items] | |||
Remaining performance obligation, deemed to be initial transaction price | $ 2,600 | ||
Collaboration and License Agreement [Member] | |||
Disaggregation of Revenue [Line Items] | |||
Unsatisfied amount of research and development services | 2,400 | ||
Contract with Customer, Liability | $ 3,100 |
COLLABORATON ARRANGEMENTS (Deta
COLLABORATON ARRANGEMENTS (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Research and development expenses | $ 4,478 | $ 5,401 | $ 10,035 | $ 21,989 |
Collaboration Agreement [Member] | Glaxo Smith Kline Biologicals S. A. [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Research and development expenses | 149 | 485 | ||
Collaboration Agreement [Member] | National Research Council Of Canada [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Research and development expenses | $ 131 | $ 395 |
INCOME TAXES (Details Narrative
INCOME TAXES (Details Narrative) | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Income Tax Disclosure [Abstract] | ||
Statutory income tax rate | 26.50% | |
Effective Income Tax Rate Reconciliation, Percent | 0.00% | 0.00% |
SCHEDULE OF LEASE COST AND OTHE
SCHEDULE OF LEASE COST AND OTHER INFORMATION (Details) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2020USD ($) | Sep. 30, 2020USD ($) | |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease costs | $ 316 | $ 897 |
Operating Lease, Weighted Average Remaining Lease Term | 1 year 11 months 8 days | 1 year 11 months 8 days |
Weighted average discount rate | 12.00% | 12.00% |
SUMMARY OF FUTURE UNDISCOUNTED
SUMMARY OF FUTURE UNDISCOUNTED CASH PAYMENTS RECONCILED TO LEASE LIABILITIES (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Commitments and Contingencies Disclosure [Abstract] | ||
Remaining 2020 | $ 248 | |
2021 | 1,001 | |
2022 | 472 | |
2023 | 104 | |
Total | 1,825 | |
Effect of discounting | (179) | |
Total lease liability | 1,646 | |
Less: current portion | (848) | $ (642) |
Long term lease liability | $ 798 | $ 817 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details Narrative) | Apr. 30, 2020USD ($) | Sep. 05, 2019 | Sep. 13, 2018USD ($)Integer | Sep. 30, 2020USD ($) | Dec. 31, 2019USD ($) |
Product Liability Contingency [Line Items] | |||||
Lease expires date | Dec. 31, 2022 | ||||
Operating lease option to extend | the term of the lease was extended until December 31, 2022, with an option to extend the lease for one additional period of three years. | ||||
Operating Lease, Expense | $ 25,000 | ||||
Operating Lease, Right-of-Use Asset | $ 1,642,000 | $ 1,459,000 | |||
Office Facility Lease Agreement [Member] | UNITED STATES | |||||
Product Liability Contingency [Line Items] | |||||
Lease expires date | Apr. 30, 2023 | ||||
Office Facility Lease Agreement [Member] | Massachusetts [Member] | |||||
Product Liability Contingency [Line Items] | |||||
Lease expires date | Apr. 30, 2023 | ||||
Operating lease option to extend | the Company entered into the seventh amendment to the lease agreement for the office facilities in Cambridge, Massachusetts, which extends the lease for a term of three years | ||||
Percentage of annual increase for base rent | 3.00% | ||||
Operating Lease, Right-of-Use Asset | $ 769,000 | ||||
Manufacturing Facility Lease Agreement [Member] | UNITED STATES | |||||
Product Liability Contingency [Line Items] | |||||
Lease expires date | Jan. 31, 2022 | ||||
Operating lease option to extend | Our manufacturing facility lease agreement expires on January 31, 2022, which includes one five-year option to extend until January 31, 2027. | ||||
Lease Agreement [Member] | |||||
Product Liability Contingency [Line Items] | |||||
Lease expires date | Dec. 31, 2019 | ||||
Operating lease option to extend | The lease agreement for our research facility in Canada, which comprises office and laboratory space, had an initial term ending on December 31, 2019 with the option to extend the term for two periods of three years. | ||||
Sci B Vac [Member] | |||||
Product Liability Contingency [Line Items] | |||||
Number of children vaccinated | Integer | 428,000 | ||||
Seeking damages | $ 546,207,000 | ||||
Sci B Vac [Member] | NIS Currency [Member] | |||||
Product Liability Contingency [Line Items] | |||||
Seeking damages | $ 1,879,500,000 |
SCHEDULE OF REVENUES FROM EXTER
SCHEDULE OF REVENUES FROM EXTERNAL CUSTOMERS (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Revenue | $ 298 | $ 647 | $ 897 | $ 1,647 |
ISRAEL | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Revenue | 48 | 134 | 198 | 287 |
China / Hong Kong [Member] | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Revenue | 250 | 467 | 646 | 1,245 |
Europe [Member] | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Revenue | $ 0 | $ 46 | $ 53 | $ 115 |
SEGMENT INFORMATION (Details Na
SEGMENT INFORMATION (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Revenue | $ 298 | $ 647 | $ 897 | $ 1,647 |
CANADA | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Revenue | $ 0 | $ 0 | $ 0 | $ 0 |
SUBSEQUENT EVENTS (Details Narr
SUBSEQUENT EVENTS (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | Oct. 22, 2020 | Oct. 01, 2020 | Sep. 04, 2020 | Oct. 31, 2020 |
Subsequent Event [Line Items] | ||||
Gross proceeds | $ 20,000 | |||
Subsequent Event [Member] | ||||
Subsequent Event [Line Items] | ||||
Right of use asset and lease liability | $ 66 | |||
Percentage of options vest and exercisable, description | Twenty-five percent | |||
Percent of options vesting and exercisable | 75.00% | |||
Options granted expiration date | Oct. 22, 2030 | |||
Number of shares issued | 13,246 | |||
Warrant, Exercise Price, Increase | $ 1.50 | |||
Subsequent Event [Member] | Two Thousand Sixteen Plan [Member] | ||||
Subsequent Event [Line Items] | ||||
Shares Held in Employee Stock Option Plan, Allocated | 100,000 | |||
Lease Agreement [Member] | ||||
Subsequent Event [Line Items] | ||||
Lease agreement, description | the Company entered into a further lease agreement for additional office space at its research facility in Canada, the term of which will commence on October 1, 2020 until April 30, 2023. The Company will recognize a right of use asset and lease liability of approximately $ |