Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 24, 2022 | Jun. 30, 2021 | |
Document Information Line Items | |||
Entity Registrant Name | GAMIDA CELL LTD. | ||
Trading Symbol | GMDA | ||
Document Type | 10-K | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Common Stock, Shares Outstanding | 60,002,190 | ||
Entity Public Float | $ 379,900,000 | ||
Amendment Flag | false | ||
Entity Central Index Key | 0001600847 | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Well-known Seasoned Issuer | No | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Shell Company | false | ||
Entity Ex Transition Period | false | ||
ICFR Auditor Attestation Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity File Number | 001-38716 | ||
Entity Incorporation, State or Country Code | L3 | ||
Entity Tax Identification Number | 00-0000000 | ||
Entity Address, Address Line One | 116 Huntington Avenue | ||
Entity Address, City or Town | Boston, | ||
Entity Address, State or Province | MA | ||
Entity Address, Postal Zip Code | 02116 | ||
City Area Code | (713) | ||
Local Phone Number | 400-6400 | ||
Title of 12(b) Security | Ordinary Shares, NIS 0.01 par value | ||
Security Exchange Name | NASDAQ | ||
Entity Interactive Data Current | Yes | ||
Auditor Firm ID | 1281 | ||
Auditor Name | KOST FORER GABBAY & KASIERER | ||
Auditor Location | Tel-Aviv, Israel |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 55,892 | $ 127,170 |
Marketable securities | 40,034 | |
Prepaid expenses and other current assets | 2,688 | 3,087 |
Total current assets | 98,614 | 130,257 |
NON-CURRENT ASSETS: | ||
Restricted deposits | 3,961 | |
Property, plant and equipment, net | 35,180 | 18,238 |
Operating lease right-of-use assets | 7,236 | 6,841 |
Severance pay fund | 2,148 | 2,191 |
Other long-term assets | 1,647 | 786 |
Total non-current assets | 50,172 | 28,056 |
Total assets | 148,786 | 158,313 |
CURRENT LIABILITIES: | ||
Trade payables | 8,272 | 6,331 |
Employees and payroll accruals | 4,957 | 4,705 |
Operating lease liabilities | 2,699 | 2,475 |
Accrued interest of convertible senior notes | 1,640 | |
Accrued expenses and current liabilities | 7,865 | 7,988 |
Total current liabilities | 25,433 | 21,499 |
NON-CURRENT LIABILITIES: | ||
Convertible senior notes, net | 71,417 | |
Accrued severance pay | 2,396 | 2,426 |
Long-term operating lease liabilities | 5,603 | 5,517 |
Total non-current liabilities | 79,416 | 7,943 |
CONTINGENT LIABILITIES AND COMMITMENTS | ||
SHAREHOLDERS’ EQUITY: | ||
Ordinary shares of NIS 0.01 par value - Authorized: 150,000,000 and 100,000,000 shares at December 31, 2021 and 2020, respectively; Issued and outstanding: 59,970,389 and 59,000,153 shares at December 31, 2021 and 2020, respectively | 169 | 166 |
Additional paid-in capital | 381,225 | 376,369 |
Accumulated deficit | (337,457) | (247,664) |
Total shareholders’ equity | 43,937 | 128,871 |
Total liabilities and shareholders’ equity | $ 148,786 | $ 158,313 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - ₪ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Ordinary shares par value (in New Shekels per share) | ₪ 0.01 | ₪ 0.01 |
Ordinary shares authorized | 150,000,000 | 100,000,000 |
Ordinary shares Issued | 59,970,389 | 59,000,153 |
Ordinary shares outstanding | 59,970,389 | 59,000,153 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Statement [Abstract] | ||
Research and development expenses, net | $ 50,177 | $ 38,873 |
Commercial expenses | 20,013 | 8,894 |
General and administrative expenses | 16,977 | 13,158 |
Total operating loss | 87,167 | 60,925 |
Financial expenses, net | 2,626 | 648 |
Loss | $ 89,793 | $ 61,573 |
Net loss per share attributable to ordinary shareholders, basic and diluted (in Dollars per share) | $ 1.52 | $ 1.41 |
Weighted average number of shares used in computing net loss per share attributable to ordinary shareholders, basic and diluted (in Shares) | 59,246,803 | 43,725,584 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Shareholders’ Equity - USD ($) $ in Thousands | Ordinary shares | Additional paid-in capital | Accumulated deficit | Total |
Balance at Dec. 31, 2019 | $ 92 | $ 239,577 | $ (186,091) | $ 53,578 |
Balance (in Shares) at Dec. 31, 2019 | 33,670,926 | |||
Loss | (61,573) | (61,573) | ||
Issuance of Ordinary shares, net of issuance expenses of $10,902 | $ 72 | 132,776 | 132,848 | |
Issuance of Ordinary shares, net of issuance expenses of $10,902 (in Shares) | 24,677,084 | |||
Exercise of options | $ 2 | 648 | 650 | |
Exercise of options (in Shares) | 652,143 | |||
Share-based compensation | 3,368 | 3,368 | ||
Balance at Dec. 31, 2020 | $ 166 | 376,369 | (247,664) | 128,871 |
Balance (in Shares) at Dec. 31, 2020 | 59,000,153 | |||
Loss | (89,793) | (89,793) | ||
Grant of restricted shares | $ 2 | (2) | ||
Grant of restricted shares (in Shares) | 531,477 | |||
Exercise of options | $ 1 | 625 | 626 | |
Exercise of options (in Shares) | 438,759 | |||
Share-based compensation | 4,233 | 4,233 | ||
Balance at Dec. 31, 2021 | $ 169 | $ 381,225 | $ (337,457) | $ 43,937 |
Balance (in Shares) at Dec. 31, 2021 | 59,970,389 |
Consolidated Statements of Ch_2
Consolidated Statements of Changes in Shareholders’ Equity (Parentheticals) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Net of issuance expenses | $ 10,902 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows from operating activities: | ||
Loss | $ (89,793) | $ (61,573) |
Adjustments to reconcile loss to net cash used in operating activities: | ||
Depreciation of property, plant and equipment | 431 | 357 |
Financing expense, net | 359 | 166 |
Share-based compensation | 4,233 | 3,368 |
Amortization of debt discount and issuance costs | 638 | |
Operating lease right-of-use assets | 2,109 | 1,891 |
Operating lease liabilities | (2,193) | (1,318) |
Accrued severance pay, net | 12 | |
Decrease (increase) in prepaid expenses and other assets | 1,008 | (1,630) |
Increase in trade payables | 1,941 | 5,066 |
Increase (decrease) in accrued expenses and current liabilities | (505) | 3,454 |
Net cash used in operating activities | (81,760) | (50,219) |
Cash flows from investing activities: | ||
Purchase of property, plant and equipment | (15,054) | (11,804) |
Purchase of marketable securities | (102,179) | |
Proceeds from maturity of marketable securities | 61,534 | 13,551 |
Investment in restricted deposits | (5,222) | (158) |
Net cash provided by (used in) investing activities | (60,921) | 1,589 |
Cash flows from financing activities: | ||
Proceeds from issuance of ordinary shares, net | 133,312 | |
Proceeds from exercise of options | 626 | 650 |
Proceeds from issuance of convertible senior notes, net | 70,777 | |
Net cash provided by financing activities | 71,403 | 133,962 |
Increase (decrease) in cash and cash equivalents | (71,278) | 85,332 |
Cash and cash equivalents at beginning of year | 127,170 | 41,838 |
Cash and cash equivalents at end of year | 55,892 | 127,170 |
Significant non-cash transactions: | ||
Lease liabilities arising from new right-of-use asset | 2,503 | 3,373 |
Issuance expenses on credit | 468 | |
Purchase of property, plant and equipment on credit | 634 | 415 |
Supplemental disclosures of cash flow information: | ||
Cash paid for interest | $ 2,572 | $ 34 |
General
General | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
GENERAL | NOTE 1: GENERAL a. Gamida Cell Ltd. (the “Company”), founded in 1998, is an advanced cell therapy company committed to finding cures for patients with blood cancers and serious blood diseases. The Company develops novel curative treatments using stem cells and Natural Killer (NK) cells. b. The Company has created a novel NAM cell expansion technology platform that is designed to enhance the number and functionality of allogenic donor cells. This proprietary therapeutic platform may enable the development of therapies with the potential to improve treatment outcomes beyond what is possible with current donor-derived therapies. The lead product candidate, omidubicel, is an advanced cell therapy in development as a potential life-saving treatment option for patients in need of a bone marrow transplant (BMT). In May 2020, the Company reported that omidubicel met its primary endpoint in an international, randomized, multi-center Phase 3 clinical study in 125 patients with high-risk hematologic malignancies undergoing bone marrow transplant and who had no available matched donor. The study evaluated the safety and efficacy of omidubicel compared to standard umbilical cord blood. BMT with a graft derived from bone marrow or peripheral blood cells of a matched donor is currently the standard of care treatment for many of these patients, but there is a significant unmet need for patients who cannot find a fully matched donor. In October 2020, the Company reported that omidubicel met all three of its secondary endpoints. In October 2021, the complete results from our pivotal Phase 3 clinical study of omidubicel in 125 patients with various hematologic malignancies were published in the peer-reviewed medical journal Blood. The trial achieved its primary endpoint of time to neutrophil engraftment as well as all three of the prespecified secondary endpoints. These secondary endpoints were the proportion of patients who achieved platelet engraftment by day 42, the proportion of patients with grade 2 or grade 3 bacterial or invasive fungal infections in the first 100 days following transplant, and the number of days alive and out of the hospital in the first 100 days following transplant. All three secondary endpoints demonstrated statistical significance in an intent-to-treat analysis. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has received orphan drug designation in the U.S. and in Europe. In addition to omidubicel, the Company is developing GDA-201, an investigational NK cell-based cancer immunotherapy to be used in combination with standard-of-care therapeutic antibodies. NK cells have potent anti-tumor properties and have the advantage over other oncology cell therapies of not requiring genetic matching, potentially enabling NK cells to serve as a universal donor-based therapy when combined with certain antibodies. GDA-201 is currently in an investigator-sponsored Phase 1/2 study for the treatment of relapsed or refractory non-Hodgkin lymphoma (NHL). In December 2020, the Company reported updated and expanded results from the Phase 1 clinical study at the Annual Meeting of the American Society of Hematology, or ASH. The data from the first 35 patients demonstrated that GDA-201 was clinically active and generally well tolerated. Among the 19 patients with NHL, 13 complete responses and one partial response were observed, with an overall response rate of 74 percent and a complete response rate of 68 percent. At the December 2021 Annual Meeting of ASH, the Company reported two-year follow-up data from this clinical trial on outcomes and cytokine biomarkers associated with survival. The data demonstrated a median duration of response of 16 months (range 5-36 months), an overall survival at two years of 78% (95% CI, 51%–91%) and a safety profile similar to that reported previously. c. The Company is devoting substantially all of its efforts toward research and development activities. In the course of such activities, the Company has sustained operating losses and expects such losses to continue in the foreseeable future. The Company’s accumulated deficit as of December 31, 2021 was $337,457 and negative cash flows from operating activities during the year ended December 31, 2021 was $81,760. The Company is planning to finance its operations from its existing and future working capital resources and to continue to evaluate additional sources of capital and financing. However, there is no assurance that additional capital and/or financing will be available to the Company, and even if available, whether it will be on terms acceptable to the Company or in amounts required. The Company believes that its existing capital resources will be adequate to satisfy its expected liquidity requirements for at least twelve months from the issuance of the consolidated financial statements. d. The Company has a wholly-owned U.S. subsidiary, Gamida Cell Inc. (the “Subsidiary”), which was incorporated in 2000, under the laws of the State of Delaware. The Company has one operating segment and reporting unit. |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | NOTE 2: SIGNIFICANT ACCOUNTING POLICIES a. Basis of presentation of the financial statements: The Company’s consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles (U.S. GAAP) as set forth in the Financial Accounting Standards Board (the “FASB”) Accounting Standards Codification (ASC). Prior to 2021, the Company prepared its financial statements in accordance with International Financial Reporting Standards (IFRS), as issued by the International Accounting Standards Board (IASB), as permitted in the United States based on the Company’s qualification as a “foreign private issuer” under the rules and regulations of the U.S Securities and Exchange Commission (the “SEC”). In connection with the loss of the Company’s status as a foreign private issuer effective on January 1, 2022, the Company, as a domestic filer, prepared its consolidated financial statements in accordance with U.S. GAAP. b. Use of estimates: The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. The Company’s management believes that the estimates, judgment and assumptions used are reasonable based upon information available at the time they are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities at the dates of the consolidated financial statements, and the reported amount of expenses during the reporting periods. Actual results could differ from those estimates. c. Principles of consolidation: The consolidated financial statements include the accounts of the Company and its subsidiaries. Intercompany balances have been eliminated upon consolidation. d. Consolidated financial statements in U.S dollars: The functional currency is the currency that best reflects the economic environment in which the Company and its subsidiary operates and conducts their transactions. Most of the Company’s costs are incurred in U.S. dollar. In addition, the Company’s financing activities are incurred in U.S. dollars. The Company’s management believes that the functional currency of the Company is the U.S. dollar. Accordingly, monetary accounts maintained in currencies other than the U.S. dollar are remeasured into U.S. dollars in accordance with ASC No. 830 “Foreign Currency Matters.” All transaction gains and losses of the remeasured monetary balance sheet items are reflected in the statements of operations as financing income or expenses as appropriate. e. Cash and cash equivalents: Cash equivalents are short-term highly liquid deposits that are readily convertible to cash with original maturities of three months or less, at the date acquired. f. Investments in marketable securities: The Company’s investment in marketable securities consist primarily of trading bonds with a quoted market price that are classified as trading securities pursuant to ASC 320 “Investments — Debt Securities.” Marketable securities are stated at fair value as determined by the closing price of each security at balance sheet date. Unrealized gains and losses on these securities are included in financing income in the consolidated statements of operations. g. Restricted short-term and long-term deposits: Restricted short-term deposits are deposits with maturities of up to one year and are used as security for the Company’s credit cards. Restricted short-term deposits amounted to $500 and $152 as of December 31, 2021 and 2020, respectively, and are included in prepaid expenses and other current assets in the consolidated balance sheets. Restricted long-term deposits are deposits with maturities of more than one year and are used as guarantee for the Israeli Investment Center grant expected in 2022 and as security for the rental of premises and for the Company’s credit cards. Restricted long-term deposits amounted to $3,961 as of December 31, 2021, as presented in the consolidated balance sheet. h. Property, plant and equipment: Property, plant and equipment are measured at cost, including directly attributable costs, less accumulated depreciation, accumulated impairment losses and any related investment grants, excluding day-to-day servicing expenses. Depreciation is calculated on a straight-line basis over the useful life of the assets at annual rates as follows: % Machinery 10 - 15 Office, furniture and equipment 6 - 33 Leasehold improvements (*) Project in process- manufacturing plant (**) (*) Over the shorter of the term of the lease or its useful life. (**) As of December 31, 2021, the manufacturing plant is under validation process and therefore is not yet ready for production. Depreciation of the manufacturing plant will commence upon completion of the validation process. i. Impairment of long-lived assets: The Company’s long-lived assets are reviewed for impairment in accordance with ASC No. 360 “Property, Plant and Equipment,” whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If indicators of impairment exist and the undiscounted future cash flows that the assets are expected to generate are less than the carrying value of the assets, the Company reduces the carrying amount of the assets through an impairment charge, to their estimated fair values. During the years ended December 31, 2021 and 2020, no impairment indicators have been identified. j. Research and development expenses: Research and development expenses net of grants are recognized in the consolidated statements of operations when incurred. Research and development expenses consist of personnel costs (including salaries, benefits and share-based compensation), materials, consulting fees and payments to subcontractors, costs associated with obtaining regulatory approvals, and executing pre-clinical and clinical studies. In addition, research and development expenses include overhead allocations consisting of various administrative and facilities related costs. The Company charges research and development expenses as incurred. Royalty-bearing grants from the Israeli Innovation Authority (the “IIA”) of the Ministry of Economy and Industry in Israel for funding of approved research and development projects are recognized at the time the Company is entitled to such grants, on the basis of the costs incurred, and are presented as a reduction from research and development expenses. Since the payment of royalties is not probable when the grants are received, the Company does not record a liability for amounts received from IIA until the related revenues are recognized. In the event of failure of a project that was partly financed by the IIA, the Company will not be obligated to pay any royalties or repay the amounts received. The Company recognized the amounts of grants received in research and development as a reduction from research and development expenses in the amount of $2,189 and $1,204 for the years ended December 31, 2021 and 2020, respectively. k. Convertible senior notes: The Company accounts for its convertible senior notes in accordance with ASC 470-20 “Debt with Conversion and Other Options”. The Company early adopted ASU 2020-06 using the modified retrospective approach. The convertible senior notes are accounted for as a single liability measured at its amortized cost, as no other embedded features require bifurcation and recognition as derivatives according to ASC 815-40. The Company’s convertible senior notes are included in the calculation of diluted earnings per share (the “EPS”) if the assumed conversion into ordinary shares is dilutive, using the “if-converted” method. This involves adding back the periodic non-cash interest expense net of taxes associated with the convertible senior notes to the numerator and by adding the shares that would be issued in an assumed conversion (regardless of whether the conversion option is in or out of the money) to the denominator for the purposes of calculating diluted EPS. Since the effect of the convertible senior notes on the diluted EPS was antidilutive, the Company did not include them in the calculation of the diluted EPS. l. Share-based compensation: The Company accounts for share-based compensation in accordance with ASC No. 718, “Compensation - Stock Compensation”, which requires companies to estimate the fair value of equity-based payment awards on the date of grant using an option-pricing model. The value of the award is recognized as an expense over the requisite service periods, which is the vesting period of the respective award, on a straight-line basis when the only condition to vesting is continued service. The Company has selected the binominal option-pricing model as the most appropriate fair value method for its option awards. The fair value of restricted shares is based on the closing market value of the underlying shares at the date of grant. The Company recognizes forfeitures of equity-based awards as they occur. m. Employee benefit liabilities: The Company has several employee benefit plans: 1. Short-term employee benefits Short-term employee benefits are benefits that are expected to be settled entirely before twelve months after the end of the annual reporting period in which the employees render the related services. These benefits include salaries, paid annual leave, paid sick leave, recreation and social security contributions and are recognized as expenses as the services are rendered. 2. Severance pay The majority of the Company’s employees who are Israeli citizens have subscribed to Section 14 of Israel’s Severance Pay Law, 5723-1963 (the “ Severance Pay Law Severance Pay Law For the Company’s employees in Israel who are not subject to Section 14 of the Severance Pay Law, the Company has a liability for severance pay pursuant to the Severance Pay Law based on the most recent salary of these employees multiplied by the number of years of employment as of the balance sheet date. The Company’s liability for these employees is fully provided for by monthly deposits with severance pay funds, insurance policies and accruals. The deposited funds include profits accumulated up to the balance sheet date. The deposited funds may be withdrawn only upon the fulfillment of the obligation pursuant to the Severance Pay Law or labor agreements. The severance pay fund amounted to $2,148 and $2,191 as of December 31, 2021 and 2020, respectively. Accrued severance pay is $2,396 and $2,426 as of December 31, 2021 and 2020, respectively. n. Fair value of financial instruments: The accounting guidance for fair value provides a framework for measuring fair value, clarifies the definition of fair value, and expands disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows: Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. Level 2: Observable inputs that are based on inputs not quoted on active markets but corroborated by market data. Level 3: Unobservable inputs are used when little or no market data are available. The carrying amounts of cash and cash equivalents, marketable securities, other receivables, short-term deposits, prepaid expenses and other current assets, trade payables, accrued expenses and other payables approximate their fair value due to the short-term maturity of such instruments. o. Leases: The Company accounts for leases according to ASC 842, “Leases”. The Company determines if an arrangement is a lease and the classification of that lease at inception based on: (1) whether the contract involves the use of a distinct identified asset, (2) whether the Company obtains the right to substantially all the economic benefits from the use of the asset throughout the period, and (3) whether the Company has a right to direct the use of the asset. The Company elected the practical expedient for lease agreements with a term of twelve months or less and does not recognize right-of-use (“ROU”) assets and lease liabilities in respect of those agreements. The Company also elected the practical expedient to not separate lease and non-lease components for its leases. An ROU asset represents the right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease agreement. An ROU asset is measured based on the discounted present value of the remaining lease payments, plus any initial direct costs incurred and prepaid lease payments, excluding lease incentives. The lease liability is measured at lease commencement date based on the discounted present value of the remaining lease payments. The implicit rate within the operating leases is generally not determinable, therefore the Company uses the Incremental Borrowing Rate (“IBR”) based on the information available at commencement date in determining the present value of lease payments. The Company’s IBR is estimated to approximate the interest rate for collateralized borrowing with similar terms and payments and in economic environments where the leased asset is located. Certain leases include options to extend the lease. An option to extend the lease is considered in connection with determining the ROU asset and lease liability when it is reasonably certain that the Company will exercise that option. An option to terminate is considered unless it is reasonably certain that the Company will not exercise the option. Payments under the Company’s lease arrangements are primarily fixed however, certain lease agreements contain variable payments, which are expensed as incurred and not included in the operating lease right-of-use assets and liabilities. Variable lease payments are primarily comprised of payments affected by common area maintenance and utility charges. p. Income taxes: The Company accounts for income taxes in accordance with ASC 740, “Income Taxes”, which prescribes the use of the liability method whereby deferred tax asset and liability account balances are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company provides a valuation allowance, to reduce deferred tax assets to their estimated realizable value, if needed. ASC 740 offers a two-step approach for recognizing and measuring a liability for uncertain tax positions. The first step is to evaluate the tax position taken or expected to be taken in a tax return by determining if the weight of available evidence indicates that it is more likely than not that, on an evaluation of the technical merits, the tax position will be sustained on audit, including resolution of any related appeals or litigation processes. The second step is to measure the tax benefit as the largest amount that is more than 50% likely to be realized upon ultimate settlement. As of December 31, 2021, and 2020 no liability for unrecognized tax benefits was recorded as a result of ASC 740. q. Basic and diluted net loss per share: The Company computes net loss per share using the two-class method required for participating securities. The two-class method requires income available to ordinary shareholders for the period to be allocated between ordinary shares and participating securities based upon their respective rights to receive dividends as if all income for the period had been distributed. The Company considers its restricted shares to be participating securities as the holders of the restricted shares would be entitled to dividends that would be distributed to the holders of ordinary shares, on a pro-rata basis. These participating securities do not contractually require the holders of such shares to participate in the Company’s losses. As such, net loss for the periods presented was not allocated to the Company’s participating securities. The Company’s basic net loss per share is calculated by dividing net loss attributable to ordinary shareholders by the weighted-average number of shares of ordinary shares outstanding for the period, without consideration of potentially dilutive securities. The diluted net loss per share is calculated by giving effect to all potentially dilutive securities outstanding for the period using the treasury share method or the if-converted method based on the nature of such securities. Diluted net loss per share is the same as basic net loss per share in periods when the effects of potentially dilutive ordinary shares are anti-dilutive. r. Recently issued accounting standards: In August 2020, the FASB issued Accounting Standards Update No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (ASU 2020-06), which simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. This guidance also eliminates the treasury stock method to calculate diluted earnings per share for convertible instruments and requires the use of the if-converted method. ASU 2020-06 will be effective for fiscal years beginning after December 15, 2021, with early adoption permitted. Effective January 1, 2021, the Company early adopted ASU 2020-06 using the modified retrospective approach. Adoption of the new standard did not have a material impact on the financial statements. |
Marketable Securities
Marketable Securities | 12 Months Ended |
Dec. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
MARKETABLE SECURITIES | NOTE 3: MARKETABLE SECURITIES The following table details the fair value of trading marketable securities as of December 31, 2021: As of Fair value Corporate debentures $ 19,605 Government debentures 20,429 Total $ 40,034 |
Property, Plant and Equipment,
Property, Plant and Equipment, Net | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY, PLANT AND EQUIPMENT, NET | NOTE 4: PROPERTY, PLANT AND EQUIPMENT, NET The composition of property, plant and equipment is as follows: Year ended 2021 2020 Cost: Machinery $ 4,345 $ 3,545 Leasehold improvements 1,447 1,542 Office, furniture and equipment 800 627 Production plant in process 32,644 16,149 39,236 21,863 Less - accumulated depreciation (4,056 ) (3,625 ) Depreciated cost $ 35,180 $ 18,238 Depreciation expense amounted to $431 and $357 for the years ended December 31, 2021 and 2020, respectively. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
LEASES | NOTE 5: LEASES The Company entered into operating leases primarily for its in-process production plant, and its laboratories and offices. The leases have remaining lease terms of up to six years, The Company does not assume renewals in its determination of the lease term unless the renewals are considered as reasonably certain at lease commencement. The components of operating lease costs were as follows: Year ended December 31, 2021 2020 Operating lease costs $ 2,391 $ 2,140 Short-term lease costs 103 43 Total lease costs $ 2,494 $ 2,183 Supplemental balance sheet information related to operating leases is as follows: Year ended December 31, 2021 2020 Weighted average remaining lease term (in years) 4.31 5.17 Weighted average discount rate 2.54 % 2.45 % Maturities of lease liabilities were as follows : As of 2022 $ 2,771 2023 1,801 2024 1,808 2025 1,316 2026 790 Thereafter 613 Total undiscounted lease payments 9,099 Less: Imputed interest (797 ) Present value of lease liabilities $ 8,302 |
Convertible Senior Notes, Net
Convertible Senior Notes, Net | 12 Months Ended |
Dec. 31, 2021 | |
Disclosure Of Notes And Other Explanatory Informations Explanatory [Abstract] | |
CONVERTIBLE SENIOR NOTES, NET | NOTE 6: CONVERTIBLE SENIOR NOTES, NET On February 16, 2021, the Subsidiary issued convertible senior notes (the “Convertible Notes”) due in 2026, in the aggregate principal amount of $75 million, pursuant to an Indenture between the Company, the Subsidiary, and Wilmington Savings Fund Society, FSB, dated February 16, 2021 (the “Indenture”). The Convertible Notes bear interest payable semiannually in arrears, at a rate of 5.875% per year. The Convertible Notes will mature on February 15, 2026, unless earlier converted, redeemed or repurchased in accordance with their terms. Subject to the provisions of the Indenture, the holders of the Convertible Notes have the right, prior to the close of business on the second scheduled trading day immediately preceding February 15, 2026, to convert any Convertible Notes or portion thereof that is $1,000 or an integral multiple thereof, into the Company’s ordinary shares at an initial conversion rate of 56.3063 shares per $1,000 principal amount of Convertible Notes (equivalent to an exchange price of $17.76 per share). The conversion rate is subject to adjustment in specified events. Upon the occurrence of a fundamental change (as defined in the Indenture), holders of the Convertible Notes may require the Company to repurchase for cash all or a portion of their Convertible Notes, in multiples of $1,000 principal amount, at a repurchase price equal to 100% of the principal amount of the Convertible Notes, plus any accrued and unpaid interest, if any, to, but excluding, interest accrued after the date of such repurchase notice. If certain fundamental changes referred to as make-whole fundamental changes occur, the conversion rate for the Convertible Notes may be increased. Subject to the provisions of the Indenture, the Subsidiary may redeem for cash all or a portion of the Convertible Notes for cash, at its option, at a redemption price equal to 100% of the principal amount of the Convertible Notes to be redeemed, plus accrued and unpaid interest on the notes to be redeemed, if the last reported closing price of the Company’s ordinary shares has been at least 130% of the exchange price then in effect for at least 20 trading days during any 30 consecutive trading day period, and in the event of certain tax law changes. The Convertible Notes are accounted for as a single liability measured at its amortized cost, as no other embedded features require bifurcation and recognition as derivatives according to ASC 815-40. As of 2021 Liability component: Principal amount $ 75,000 Issuance costs (4,223 ) Net issuance costs $ 70,777 Amortized issuance costs 640 Net carrying amount $ 71,417 The total issuance costs of the Convertible Notes amounted to $4,223 and are amortized to interest expenses at an annual effective interest rate of 7.37%, over the term of the Convertible Notes. |
Accrued Expenses and Other Paya
Accrued Expenses and Other Payables | 12 Months Ended |
Dec. 31, 2021 | |
Disclosure Supplement [Abstract] | |
ACCRUED EXPENSES AND OTHER PAYABLES | NOTE 7: ACCRUED EXPENSES AND OTHER PAYABLES Year ended 2021 2020 Subcontractors $ 517 $ 609 Clinical activities 5,445 4,841 Professional services 740 1,943 Production plant in process 983 415 Other 180 180 $ 7,865 $ 7,988 |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | NOTE 8: FAIR VALUE MEASUREMENTS The following tables present the fair value of money market funds and marketable securities for the years ended December 31, 2021 and 2020: December 31, 2021 2020 Level 1 Level 2 Total Level 1 Level 2 Total Cash equivalents: Money market funds $ 51,021 $ - $ 51,021 $ 123 $ - $ 123 Marketable securities: Corporate debentures - 19,605 19,605 - - - Government debentures - 20,429 20,429 - - - Total assets measured at fair value $ 51,021 $ 40,034 $ 91,055 $ 123 $ - $ 123 |
Contingent Liabilities and Comm
Contingent Liabilities and Commitments | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
CONTINGENT LIABILITIES AND COMMITMENTS | NOTE 9: CONTINGENT LIABILITIES AND COMMITMENTS a. Legal proceedings: From time to time the Company or its subsidiaries may be involved in legal proceedings and/or litigation arising in the ordinary course of business. While the outcome of these matters cannot be predicted with certainty, the Company does not believe it will have a material effect on its consolidated financial position, results of operations, or cash flows. b. Bank guarantees: As of December 31, 2021, the Company obtained bank guarantees in the amount of $3,334, primarily in connection with an Investment Center grant of up to $3,171 expected to be received in 2022 which requires a bank guarantee in order to ensure the fulfillment of the grant terms. NOTE 9: CONTINGENT LIABILITIES AND COMMITMENTS (Cont.) c. Governments grants The Company has received grants from the IIA to finance its research and development programs in Israel, through which the Company received IIA participation payments in the aggregate amount of $37.3 million through December 31, 2021, of which $34.7 million is royalty-bearing grants and $2.6 million is non-royalty-bearing grants. In return, the Company is committed to pay IIA royalties at a rate of 3-3.5% of future sales of the developed products, up to 100% of the amount of grants received plus interest at LIBOR rate. Through December 31, 2021, no royalties have been paid or accrued. The Company’s contingent royalty liability to the IIA at December 31, 2021, including grants received by the Company and the associated LIBOR interest on all such grants totaled to $44.7 million. |
Shareholders' Equity
Shareholders' Equity | 12 Months Ended |
Dec. 31, 2021 | |
Stockholders' Equity Note [Abstract] | |
SHAREHOLDERS' EQUITY | NOTE 10: SHAREHOLDERS’ EQUITY a. Ordinary shares: Subject to the Company’s amended and restated Articles of Association, the holders of the Company’s ordinary shares have the right to receive notices to attend and vote in general meetings of the Company’s shareholders, and the right to share in dividends and other distributions upon liquidation. In May 2020, the Company closed a second follow-on offering of its ordinary shares on Nasdaq, which resulted in the sale of a total of 15,333,334 ordinary shares at a public offering price of $4.50 per share, before underwriting discounts and inclusive of the underwriters’ exercise in full of their option to purchase additional shares in the offering. The Company received proceeds in the amount of $63,860 from the offering (net of issuance costs and underwriting discounts of $5,140). In December 2020, the Company closed a third follow-on offering of its ordinary shares on Nasdaq, which resulted in the sale of 9,343,750 ordinary shares at a public offering price of $8.00 per share, before underwriting discounts and inclusive of the underwriters’ exercise in full of their option to purchase additional shares in the offering. The Company received proceeds in the amount of $68,988 from the offering (net of issuance costs and underwriting discounts of $5,762). b. Warrants to investors: As part of its 2017 investment round, the Company granted certain investors 4,323,978 warrants that will expire in July 2022. As of December 31, 2021, 1,010,466 of the warrants have been exercised into the Company’s ordinary shares. |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
SHARE-BASED COMPENSATION | NOTE 11: SHARE-BASED COMPENSATION a. Option plans: On November 23, 2014, the Company’s Board of Directors approved, subject to the approval of the shareholders, creation of the Company’s ordinary C share class, with nominal value NIS 0.01 per share and classification of 1,500,000 ordinary shares for such class of shares, whereby 1,152,044 of such shares were allocated to the Company’s employees under the amended 2014 Israel Share Option Plan (the “2014 Plan”). The exercise price of the options granted under the 2014 Plan may not be less than the nominal value of the shares into which the options are exercised. The options vest primarily over three years. There are no cash settlement alternatives. On December 29, 2014, the Company’s shareholders ratified and approved the aforesaid actions. On January 23, 2017, the Company’s Board of Directors approved the Company’s 2017 Share Incentive Plan (the “2017 Plan” and together with the 2014 Plan, the “Option Plans”), and the subsequent grant of options to the Company’s employees, officers and directors. Pursuant to the 2017 Plan, the Company initially reserved for issuance 312,867 ordinary shares, nominal value NIS 0.01 each. On February 28, 2017, the Company’s shareholders approved the 2017 Plan. The 2017 Plan provides for the grant of awards, including options, restricted shares and restricted share units to the Company’s directors, employees, officers, consultants and advisors. On June 26, 2017 and on December 28, 2017, the Company’s Board of Directors approved the reservation of 463,384 and 559,764 additional ordinary shares, respectively, for issuance under the 2017 Plan (totaling, including previous plans, an aggregate of 1,338,015 ordinary Shares). On February 25, 2021 and November 17, 2021, the board of directors and shareholders, respectively, approved an amendment and restatement of the 2017 Plan. The 2017 Plan, as amended, also contains an “evergreen” provision, which provides for an automatic allotment of ordinary shares to be added every year to the pool of ordinary shares available for grant under the 2017 Plan. Under the evergreen provision, on January 1 of each year (beginning January 1, 2022), the number of ordinary shares available under the 2017 Plan automatically increases by the lesser of the following: (i) 4% of our outstanding ordinary shares on the last day of the immediately preceding year; and (ii) an amount determined in advance of January 1 by the board of directors. As of December 31, 2021, our 2017 Plan, as amended, has up to 1,520,066 ordinary shares available for issuance. The Company estimates the fair value of stock options granted using the binominal option-pricing model. The option-pricing model requires a number of assumptions, of which the most significant are the expected stock price volatility and the expected option term. Expected volatility was calculated based upon the Company’s historical share price and historical volatilities of similar entities in the related sector index. The expected term of the options granted is derived from output of the option valuation model and represents the period of time that options granted are expected to be outstanding. The risk-free interest rate is based on the yield from U.S. treasury bonds with an equivalent term. The Company has historically not paid dividends and has no foreseeable plans to pay dividends. The following table lists the inputs to the binomial option-pricing model used for the fair value measurement of equity-settled share options for the above Options Plans for the years 2021 and 2020: Year ended 2021 2020 Dividend yield 0% 0% Expected volatility of the share prices 65% 74%-79% Risk-free interest rate 1.4%-1.5% 0.6%-1.38 Expected term (in years) 8 8 Based on the above inputs, the fair value of the options was determined to be $1.52 - $5.64 per option at the grant date. b. The following table summarizes the number of options granted to employees under the Option Plans for the years ended December 31, 2021 and related information: Amount of options Weighted average exercise price Weighted average remaining contractual term (in years) Aggregate intrinsic value Balance as of December 31, 2020 3,892,714 $ 5.15 6.65 $ 608,179 Granted 1,318,351 7.33 - - Exercised (438,759 ) 1.43 - - Forfeited (217,325 ) 7.20 - - Expired (143,557 ) 7.08 - - Balance as of December 31, 2021 4,411,424 6.01 8.19 92,507 Exercisable as of December 31, 2021 2,171,616 $ 5.57 7.11 $ 92,507 As of December 31, 2021, there are $9,739 of total unrecognized costs related to share-based compensation that is expected to be recognized over a period of up to four years. c. The following table summarizes information about the Company’s outstanding and exercisable options granted to employees as of December 31, 2021: Exercise price Options outstanding as of December 31, Weighted average remaining contractual term (years) Options exercisable as of December 31, 2021 Weighted average remaining contractual term $ 0.25-3.80 435,346 9.18 123,494 5.82 $ 4.15- 4.95 2,331,999 7.67 1,578,326 7.09 $ 5.21-7.56 546,150 8.62 210,074 7.41 $ 8.00-11.01 1,097,929 8.70 259,722 7.58 4,411,424 2,171,616 d. A summary of restricted shares activity for the year ended December 31, 2021 is as follows: Amount of restricted shares Weighted average grant date fair value Unvested as of December 31, 2020 - $ - Granted 549,427 5.61 Vested - Forfeited (17,950 ) 9.51 Unvested as of December 31, 2021 531,477 $ 5.48 e. The total share-based compensation expense related to all of the Company's equity-based awards, recognized for the years ended December 31, 2021 and 2020 is comprised as follows: Year ended 2021 2020 (in thousands) Research and development expenses, net $ 1,384 $ 1,099 Commercial expenses 947 376 General and administrative expenses 1,902 1,893 Total share-based compensation $ 4,233 $ 3,368 |
Taxes on Income
Taxes on Income | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
TAXES ON INCOME | NOTE 12: TAXES ON INCOME a. Tax rates applicable to the income of the Company: 1. Corporate tax rates Taxable income of the Israeli parent is subject to the Israeli corporate tax at the rate of 23% in 2021 and 2020. The Subsidiary is taxed according to the tax laws in its country of residence. 2. Income tax benefits Income is subject to tax benefits under the Law for Encouragement of Capital Investments, 1959 (the “Investment Law”), which provides tax benefits for Israeli companies meeting certain requirements and criteria. The Investment Law has undergone certain amendments and reforms in recent decades. The Israeli parliament enacted a reform to the Investment Law, effective January 2011. According to the reform, a flat rate tax applies to companies eligible for the “Preferred Enterprise” status. In order to be eligible for Preferred Enterprise status, a company must meet minimum requirements to establish that it contributes to the country’s economic growth and is a competitive factor for the gross domestic product. The Company’s Israeli operations elected “Preferred Enterprise” status, starting in 2017. Benefits granted to a Preferred Enterprise include reduced tax rates. As part of the Economic Efficiency Law (Legislative Amendments for Accomplishment of Budgetary Targets for Budget Years 2017-2018), 5777-2016, the tax rate for Area A will be 7.5% in 2017 onwards. In other regions, the tax rate is 16%. Preferred Enterprises in peripheral regions will be eligible for Investment Center grants, as well as the applicable reduced tax rates. b. The Law for the Encouragement of Industry (Taxation), 1969: The Company has the status of an “industrial company”, under this law. According to this status and by virtue of regulations published thereunder, the Company is entitled to claim a deduction of accelerated depreciation on equipment used in industrial activities, as determined in the regulations issued under the law. The Company is also entitled to amortize a patent or knowhow usage right that is used in the enterprise’s development or promotion, to deduct listed share issuance expenses and to file consolidated financial statements under certain conditions. c. The components of the loss were as follows: Year ended 2021 2020 Domestic $ 55,853 $ 45,871 Foreign 33,940 15,702 $ 89,793 $ 61,573 d. Net operating losses carryforward: The Company has net operating losses and capital losses for tax purposes as of December 31, 2021 totaling approximately $236,875 and $507, respectively, which may be carried forward and offset against taxable income in the future for an indefinite period. As of December 31, 2021, the Subsidiary has net operating losses carryforwards of $33,100 for federal tax purposes. e. Final tax assessments: The Company’s tax assessments through the 2016 tax year are considered final. f. Deferred taxes: The Company provided a full valuation allowance, to reduce deferred tax assets to their estimated realizable value, since it is more likely than not that all of the deferred tax assets will not be realized. |
Basic and Diluted Net Loss Per
Basic and Diluted Net Loss Per Share | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
BASIC AND DILUTED NET LOSS PER SHARE | NOTE 13: BASIC AND DILUTED NET LOSS PER SHARE Basic net loss per ordinary share is computed by dividing net loss for each reporting period by the weighted-average number of ordinary shares outstanding during each year. Diluted net loss per ordinary share is computed by dividing net loss for each reporting period by the weighted average number of ordinary shares outstanding during the period, plus dilutive potential ordinary shares considered outstanding during the period, in accordance with ASC No. 260-10 “Earnings Per Share”. The Company experienced a loss in the year ended December 31, 2021; hence all potentially dilutive ordinary shares were excluded due to their anti-dilutive effect. Details of the number of shares and loss used in the computation of net loss per share: Year ended December 31, 2021 2020 Weighted number of shares Net loss attributable to equity holders of the Company Weighted number of shares Net loss attributable to equity holders of the Company For the computation of basic and diluted loss 59,246,803 $ 89,793 43,725,584 $ 61,573 |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of presentation of the financial statements | a. Basis of presentation of the financial statements: The Company’s consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles (U.S. GAAP) as set forth in the Financial Accounting Standards Board (the “FASB”) Accounting Standards Codification (ASC). Prior to 2021, the Company prepared its financial statements in accordance with International Financial Reporting Standards (IFRS), as issued by the International Accounting Standards Board (IASB), as permitted in the United States based on the Company’s qualification as a “foreign private issuer” under the rules and regulations of the U.S Securities and Exchange Commission (the “SEC”). In connection with the loss of the Company’s status as a foreign private issuer effective on January 1, 2022, the Company, as a domestic filer, prepared its consolidated financial statements in accordance with U.S. GAAP. |
Use of estimates | b. Use of estimates: The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. The Company’s management believes that the estimates, judgment and assumptions used are reasonable based upon information available at the time they are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities at the dates of the consolidated financial statements, and the reported amount of expenses during the reporting periods. Actual results could differ from those estimates. |
Principles of consolidation | c. Principles of consolidation: The consolidated financial statements include the accounts of the Company and its subsidiaries. Intercompany balances have been eliminated upon consolidation. |
Consolidated financial statements in U.S dollars | d. Consolidated financial statements in U.S dollars: The functional currency is the currency that best reflects the economic environment in which the Company and its subsidiary operates and conducts their transactions. Most of the Company’s costs are incurred in U.S. dollar. In addition, the Company’s financing activities are incurred in U.S. dollars. The Company’s management believes that the functional currency of the Company is the U.S. dollar. Accordingly, monetary accounts maintained in currencies other than the U.S. dollar are remeasured into U.S. dollars in accordance with ASC No. 830 “Foreign Currency Matters.” All transaction gains and losses of the remeasured monetary balance sheet items are reflected in the statements of operations as financing income or expenses as appropriate. |
Cash and cash equivalents | e. Cash and cash equivalents: Cash equivalents are short-term highly liquid deposits that are readily convertible to cash with original maturities of three months or less, at the date acquired. |
Investments in marketable securities | f. Investments in marketable securities: The Company’s investment in marketable securities consist primarily of trading bonds with a quoted market price that are classified as trading securities pursuant to ASC 320 “Investments — Debt Securities.” Marketable securities are stated at fair value as determined by the closing price of each security at balance sheet date. Unrealized gains and losses on these securities are included in financing income in the consolidated statements of operations. |
Restricted short-term and long-term deposits | g. Restricted short-term and long-term deposits: Restricted short-term deposits are deposits with maturities of up to one year and are used as security for the Company’s credit cards. Restricted short-term deposits amounted to $500 and $152 as of December 31, 2021 and 2020, respectively, and are included in prepaid expenses and other current assets in the consolidated balance sheets. |
Property, plant and equipment | h. Property, plant and equipment: Property, plant and equipment are measured at cost, including directly attributable costs, less accumulated depreciation, accumulated impairment losses and any related investment grants, excluding day-to-day servicing expenses. Depreciation is calculated on a straight-line basis over the useful life of the assets at annual rates as follows: % Machinery 10 - 15 Office, furniture and equipment 6 - 33 Leasehold improvements (*) Project in process- manufacturing plant (**) (*) Over the shorter of the term of the lease or its useful life. (**) As of December 31, 2021, the manufacturing plant is under validation process and therefore is not yet ready for production. Depreciation of the manufacturing plant will commence upon completion of the validation process. |
Impairment of long-lived assets | i. Impairment of long-lived assets: The Company’s long-lived assets are reviewed for impairment in accordance with ASC No. 360 “Property, Plant and Equipment,” whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If indicators of impairment exist and the undiscounted future cash flows that the assets are expected to generate are less than the carrying value of the assets, the Company reduces the carrying amount of the assets through an impairment charge, to their estimated fair values. During the years ended December 31, 2021 and 2020, no impairment indicators have been identified. |
Research and development expenses | j. Research and development expenses: Research and development expenses net of grants are recognized in the consolidated statements of operations when incurred. Research and development expenses consist of personnel costs (including salaries, benefits and share-based compensation), materials, consulting fees and payments to subcontractors, costs associated with obtaining regulatory approvals, and executing pre-clinical and clinical studies. In addition, research and development expenses include overhead allocations consisting of various administrative and facilities related costs. The Company charges research and development expenses as incurred. Royalty-bearing grants from the Israeli Innovation Authority (the “IIA”) of the Ministry of Economy and Industry in Israel for funding of approved research and development projects are recognized at the time the Company is entitled to such grants, on the basis of the costs incurred, and are presented as a reduction from research and development expenses. Since the payment of royalties is not probable when the grants are received, the Company does not record a liability for amounts received from IIA until the related revenues are recognized. In the event of failure of a project that was partly financed by the IIA, the Company will not be obligated to pay any royalties or repay the amounts received. The Company recognized the amounts of grants received in research and development as a reduction from research and development expenses in the amount of $2,189 and $1,204 for the years ended December 31, 2021 and 2020, respectively. |
Convertible senior notes | k. Convertible senior notes: The Company accounts for its convertible senior notes in accordance with ASC 470-20 “Debt with Conversion and Other Options”. The Company early adopted ASU 2020-06 using the modified retrospective approach. The convertible senior notes are accounted for as a single liability measured at its amortized cost, as no other embedded features require bifurcation and recognition as derivatives according to ASC 815-40. The Company’s convertible senior notes are included in the calculation of diluted earnings per share (the “EPS”) if the assumed conversion into ordinary shares is dilutive, using the “if-converted” method. This involves adding back the periodic non-cash interest expense net of taxes associated with the convertible senior notes to the numerator and by adding the shares that would be issued in an assumed conversion (regardless of whether the conversion option is in or out of the money) to the denominator for the purposes of calculating diluted EPS. Since the effect of the convertible senior notes on the diluted EPS was antidilutive, the Company did not include them in the calculation of the diluted EPS. |
Share-based compensation | l. Share-based compensation: The Company accounts for share-based compensation in accordance with ASC No. 718, “Compensation - Stock Compensation”, which requires companies to estimate the fair value of equity-based payment awards on the date of grant using an option-pricing model. The value of the award is recognized as an expense over the requisite service periods, which is the vesting period of the respective award, on a straight-line basis when the only condition to vesting is continued service. The Company has selected the binominal option-pricing model as the most appropriate fair value method for its option awards. The fair value of restricted shares is based on the closing market value of the underlying shares at the date of grant. The Company recognizes forfeitures of equity-based awards as they occur. |
Employee benefit liabilities | m. Employee benefit liabilities: The Company has several employee benefit plans: 1. Short-term employee benefits Short-term employee benefits are benefits that are expected to be settled entirely before twelve months after the end of the annual reporting period in which the employees render the related services. These benefits include salaries, paid annual leave, paid sick leave, recreation and social security contributions and are recognized as expenses as the services are rendered. 2. Severance pay The majority of the Company’s employees who are Israeli citizens have subscribed to Section 14 of Israel’s Severance Pay Law, 5723-1963 (the “ Severance Pay Law Severance Pay Law For the Company’s employees in Israel who are not subject to Section 14 of the Severance Pay Law, the Company has a liability for severance pay pursuant to the Severance Pay Law based on the most recent salary of these employees multiplied by the number of years of employment as of the balance sheet date. The Company’s liability for these employees is fully provided for by monthly deposits with severance pay funds, insurance policies and accruals. The deposited funds include profits accumulated up to the balance sheet date. The deposited funds may be withdrawn only upon the fulfillment of the obligation pursuant to the Severance Pay Law or labor agreements. The severance pay fund amounted to $2,148 and $2,191 as of December 31, 2021 and 2020, respectively. Accrued severance pay is $2,396 and $2,426 as of December 31, 2021 and 2020, respectively. |
Fair value of financial instruments | n. Fair value of financial instruments: The accounting guidance for fair value provides a framework for measuring fair value, clarifies the definition of fair value, and expands disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows: Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. Level 2: Observable inputs that are based on inputs not quoted on active markets but corroborated by market data. Level 3: Unobservable inputs are used when little or no market data are available. The carrying amounts of cash and cash equivalents, marketable securities, other receivables, short-term deposits, prepaid expenses and other current assets, trade payables, accrued expenses and other payables approximate their fair value due to the short-term maturity of such instruments. |
Leases | o. Leases: The Company accounts for leases according to ASC 842, “Leases”. The Company determines if an arrangement is a lease and the classification of that lease at inception based on: (1) whether the contract involves the use of a distinct identified asset, (2) whether the Company obtains the right to substantially all the economic benefits from the use of the asset throughout the period, and (3) whether the Company has a right to direct the use of the asset. The Company elected the practical expedient for lease agreements with a term of twelve months or less and does not recognize right-of-use (“ROU”) assets and lease liabilities in respect of those agreements. The Company also elected the practical expedient to not separate lease and non-lease components for its leases. An ROU asset represents the right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease agreement. An ROU asset is measured based on the discounted present value of the remaining lease payments, plus any initial direct costs incurred and prepaid lease payments, excluding lease incentives. The lease liability is measured at lease commencement date based on the discounted present value of the remaining lease payments. The implicit rate within the operating leases is generally not determinable, therefore the Company uses the Incremental Borrowing Rate (“IBR”) based on the information available at commencement date in determining the present value of lease payments. The Company’s IBR is estimated to approximate the interest rate for collateralized borrowing with similar terms and payments and in economic environments where the leased asset is located. Certain leases include options to extend the lease. An option to extend the lease is considered in connection with determining the ROU asset and lease liability when it is reasonably certain that the Company will exercise that option. An option to terminate is considered unless it is reasonably certain that the Company will not exercise the option. Payments under the Company’s lease arrangements are primarily fixed however, certain lease agreements contain variable payments, which are expensed as incurred and not included in the operating lease right-of-use assets and liabilities. Variable lease payments are primarily comprised of payments affected by common area maintenance and utility charges. |
Income taxes | p. Income taxes: The Company accounts for income taxes in accordance with ASC 740, “Income Taxes”, which prescribes the use of the liability method whereby deferred tax asset and liability account balances are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company provides a valuation allowance, to reduce deferred tax assets to their estimated realizable value, if needed. ASC 740 offers a two-step approach for recognizing and measuring a liability for uncertain tax positions. The first step is to evaluate the tax position taken or expected to be taken in a tax return by determining if the weight of available evidence indicates that it is more likely than not that, on an evaluation of the technical merits, the tax position will be sustained on audit, including resolution of any related appeals or litigation processes. The second step is to measure the tax benefit as the largest amount that is more than 50% likely to be realized upon ultimate settlement. As of December 31, 2021, and 2020 no liability for unrecognized tax benefits was recorded as a result of ASC 740. |
Basic and diluted net loss per share | q. Basic and diluted net loss per share: The Company computes net loss per share using the two-class method required for participating securities. The two-class method requires income available to ordinary shareholders for the period to be allocated between ordinary shares and participating securities based upon their respective rights to receive dividends as if all income for the period had been distributed. The Company considers its restricted shares to be participating securities as the holders of the restricted shares would be entitled to dividends that would be distributed to the holders of ordinary shares, on a pro-rata basis. These participating securities do not contractually require the holders of such shares to participate in the Company’s losses. As such, net loss for the periods presented was not allocated to the Company’s participating securities. The Company’s basic net loss per share is calculated by dividing net loss attributable to ordinary shareholders by the weighted-average number of shares of ordinary shares outstanding for the period, without consideration of potentially dilutive securities. The diluted net loss per share is calculated by giving effect to all potentially dilutive securities outstanding for the period using the treasury share method or the if-converted method based on the nature of such securities. Diluted net loss per share is the same as basic net loss per share in periods when the effects of potentially dilutive ordinary shares are anti-dilutive. |
Recently issued accounting standards | r. Recently issued accounting standards: In August 2020, the FASB issued Accounting Standards Update No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (ASU 2020-06), which simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. This guidance also eliminates the treasury stock method to calculate diluted earnings per share for convertible instruments and requires the use of the if-converted method. ASU 2020-06 will be effective for fiscal years beginning after December 15, 2021, with early adoption permitted. Effective January 1, 2021, the Company early adopted ASU 2020-06 using the modified retrospective approach. Adoption of the new standard did not have a material impact on the financial statements. |
Significant Accounting Polici_2
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Schedule of useful life of the assets at annual rate | % Machinery 10 - 15 Office, furniture and equipment 6 - 33 Leasehold improvements (*) Project in process- manufacturing plant (**) |
Marketable Securities (Tables)
Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of the fair value of trading marketable securities | As of Fair value Corporate debentures $ 19,605 Government debentures 20,429 Total $ 40,034 |
Property, Plant and Equipment_2
Property, Plant and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Schedule of property, plant and equipment | Year ended 2021 2020 Cost: Machinery $ 4,345 $ 3,545 Leasehold improvements 1,447 1,542 Office, furniture and equipment 800 627 Production plant in process 32,644 16,149 39,236 21,863 Less - accumulated depreciation (4,056 ) (3,625 ) Depreciated cost $ 35,180 $ 18,238 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Schedule of operating lease costs | Year ended December 31, 2021 2020 Operating lease costs $ 2,391 $ 2,140 Short-term lease costs 103 43 Total lease costs $ 2,494 $ 2,183 |
Schedule of operating leases | Year ended December 31, 2021 2020 Weighted average remaining lease term (in years) 4.31 5.17 Weighted average discount rate 2.54 % 2.45 % |
Schedule of maturities of lease liabilities | As of 2022 $ 2,771 2023 1,801 2024 1,808 2025 1,316 2026 790 Thereafter 613 Total undiscounted lease payments 9,099 Less: Imputed interest (797 ) Present value of lease liabilities $ 8,302 |
Convertible Senior Notes, Net (
Convertible Senior Notes, Net (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Disclosure Of Notes And Other Explanatory Informations Explanatory [Abstract] | |
Schedule of liability and equity components of the convertible notes | As of 2021 Liability component: Principal amount $ 75,000 Issuance costs (4,223 ) Net issuance costs $ 70,777 Amortized issuance costs 640 Net carrying amount $ 71,417 |
Accrued Expenses and Other Pa_2
Accrued Expenses and Other Payables (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Disclosure Text Block Supplement [Abstract] | |
Schedule of accrued expenses and other payables | Year ended 2021 2020 Subcontractors $ 517 $ 609 Clinical activities 5,445 4,841 Professional services 740 1,943 Production plant in process 983 415 Other 180 180 $ 7,865 $ 7,988 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Schedule of fair value of money market funds and marketable securities | December 31, 2021 2020 Level 1 Level 2 Total Level 1 Level 2 Total Cash equivalents: Money market funds $ 51,021 $ - $ 51,021 $ 123 $ - $ 123 Marketable securities: Corporate debentures - 19,605 19,605 - - - Government debentures - 20,429 20,429 - - - Total assets measured at fair value $ 51,021 $ 40,034 $ 91,055 $ 123 $ - $ 123 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of fair value measurement of equity-settled share options | Year ended 2021 2020 Dividend yield 0% 0% Expected volatility of the share prices 65% 74%-79% Risk-free interest rate 1.4%-1.5% 0.6%-1.38 Expected term (in years) 8 8 |
Schedule of stock option plans | Amount of options Weighted average exercise price Weighted average remaining contractual term (in years) Aggregate intrinsic value Balance as of December 31, 2020 3,892,714 $ 5.15 6.65 $ 608,179 Granted 1,318,351 7.33 - - Exercised (438,759 ) 1.43 - - Forfeited (217,325 ) 7.20 - - Expired (143,557 ) 7.08 - - Balance as of December 31, 2021 4,411,424 6.01 8.19 92,507 Exercisable as of December 31, 2021 2,171,616 $ 5.57 7.11 $ 92,507 |
Schedule of outstanding and exercisable option granted | Exercise price Options outstanding as of December 31, Weighted average remaining contractual term (years) Options exercisable as of December 31, 2021 Weighted average remaining contractual term $ 0.25-3.80 435,346 9.18 123,494 5.82 $ 4.15- 4.95 2,331,999 7.67 1,578,326 7.09 $ 5.21-7.56 546,150 8.62 210,074 7.41 $ 8.00-11.01 1,097,929 8.70 259,722 7.58 4,411,424 2,171,616 |
Schedule of of restricted shares activity | Amount of restricted shares Weighted average grant date fair value Unvested as of December 31, 2020 - $ - Granted 549,427 5.61 Vested - Forfeited (17,950 ) 9.51 Unvested as of December 31, 2021 531,477 $ 5.48 |
Schedule of share-based compensation expense | Year ended 2021 2020 (in thousands) Research and development expenses, net $ 1,384 $ 1,099 Commercial expenses 947 376 General and administrative expenses 1,902 1,893 Total share-based compensation $ 4,233 $ 3,368 |
Taxes on Income (Tables)
Taxes on Income (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule components of the loss | Year ended 2021 2020 Domestic $ 55,853 $ 45,871 Foreign 33,940 15,702 $ 89,793 $ 61,573 |
Basic and Diluted Net Loss Pe_2
Basic and Diluted Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of number of shares and loss used in the computation of net loss per share | Year ended December 31, 2021 2020 Weighted number of shares Net loss attributable to equity holders of the Company Weighted number of shares Net loss attributable to equity holders of the Company For the computation of basic and diluted loss 59,246,803 $ 89,793 43,725,584 $ 61,573 |
General (Details)
General (Details) | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Accounting Policies [Abstract] | |
Clinical trial on outcomes | The data demonstrated a median duration of response of 16 months (range 5-36 months), an overall survival at two years of 78% (95% CI, 51%–91%) and a safety profile similar to that reported previously. |
Accumulated deficit | $ 337,457 |
Cash | $ 81,760 |
Operating segment | 1 |
Significant Accounting Polici_3
Significant Accounting Policies (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Accounting Policies [Abstract] | ||
Short-term investments | $ 500,000 | $ 152,000 |
Restricted long-term amount | 3,961,000 | |
Research and development expenses | $ 2,189 | 1,204 |
Severance pay percentage | 8.33% | |
Severance costs | $ 2,148 | 2,191 |
Accrued severance pay | 2,396 | 2,426 |
Severance expense | $ 427 | $ 12 |
Tax benefit | 50.00% |
Significant Accounting Polici_4
Significant Accounting Policies (Details) - Schedule of useful life of the assets at annual rate | 12 Months Ended | |
Dec. 31, 2021 | ||
Leasehold improvements[Member] | ||
Significant Accounting Policies (Details) - Schedule of useful life of the assets at annual rate [Line Items] | ||
Annual depreciation rate | [1] | |
Project in process- manufacturing plant [Member] | ||
Significant Accounting Policies (Details) - Schedule of useful life of the assets at annual rate [Line Items] | ||
Annual depreciation rate | [2] | |
Minimum [Member] | Machinery [Member] | ||
Significant Accounting Policies (Details) - Schedule of useful life of the assets at annual rate [Line Items] | ||
Annual depreciation rate | 10.00% | |
Minimum [Member] | Office, furniture and equipment [Member] | ||
Significant Accounting Policies (Details) - Schedule of useful life of the assets at annual rate [Line Items] | ||
Annual depreciation rate | 6.00% | |
Maximum [Member] | Machinery [Member] | ||
Significant Accounting Policies (Details) - Schedule of useful life of the assets at annual rate [Line Items] | ||
Annual depreciation rate | 15.00% | |
Maximum [Member] | Office, furniture and equipment [Member] | ||
Significant Accounting Policies (Details) - Schedule of useful life of the assets at annual rate [Line Items] | ||
Annual depreciation rate | 33.00% | |
[1] | Over the shorter of the term of the lease or its useful life. | |
[2] | As of December 31, 2021, the manufacturing plant is under validation process and therefore is not yet ready for production. Depreciation of the manufacturing plant will commence upon completion of the validation process. |
Marketable Securities (Details)
Marketable Securities (Details) - Schedule of the fair value of trading marketable securities - Marketable Securities [Member] $ in Thousands | Dec. 31, 2021USD ($) |
Marketable Securities [Line Items] | |
Corporate debentures | $ 19,605 |
Government debentures | 20,429 |
Total | $ 40,034 |
Property, Plant and Equipment_3
Property, Plant and Equipment, Net (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 431 | $ 357 |
Property, Plant and Equipment_4
Property, Plant and Equipment, Net (Details) - Schedule of property, plant and equipment - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Cost: | ||
Less - accumulated depreciation | $ (4,056) | $ (3,625) |
Depreciated cost | 35,180 | 18,238 |
Machinery [Member] | ||
Cost: | ||
Machinery | 4,345 | 3,545 |
Leasehold Improvements [Member] | ||
Cost: | ||
Leasehold improvements | 1,447 | 1,542 |
Office, Furniture and Equipment [Member] | ||
Cost: | ||
Office, furniture and equipment | 800 | 627 |
Production Plant in Process [Member] | ||
Cost: | ||
Production plant in process | 32,644 | 16,149 |
Property, Plant and Equipment, Other Types [Member] | ||
Cost: | ||
property, plant and equipment | $ 39,236 | $ 21,863 |
Leases (Details)
Leases (Details) | Dec. 31, 2021 |
Leases [Abstract] | |
Lease term | 6 years |
Leases (Details) - Schedule of
Leases (Details) - Schedule of operating lease costs - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule of operating lease costs [Abstract] | ||
Operating lease costs | $ 2,391 | $ 2,140 |
Short-term lease costs | 103 | 43 |
Total lease costs | $ 2,494 | $ 2,183 |
Leases (Details) - Schedule o_2
Leases (Details) - Schedule of operating leases | Dec. 31, 2021 | Dec. 31, 2020 |
Schedule of operating leases [Abstract] | ||
Weighted average remaining lease term (in years) | 4 years 3 months 21 days | 5 years 2 months 1 day |
Weighted average discount rate | 2.54% | 2.45% |
Leases (Details) - Schedule o_3
Leases (Details) - Schedule of maturities of lease liabilities $ in Thousands | Dec. 31, 2021USD ($) |
Schedule of maturities of lease liabilities [Abstract] | |
2022 | $ 2,771 |
2023 | 1,801 |
2024 | 1,808 |
2025 | 1,316 |
2026 | 790 |
Thereafter | 613 |
Total undiscounted lease payments | 9,099 |
Less: Imputed interest | (797) |
Present value of lease liabilities | $ 8,302 |
Convertible Senior Notes, Net_2
Convertible Senior Notes, Net (Details) | 12 Months Ended |
Dec. 31, 2021USD ($)$ / sharesshares | |
Convertible Senior Notes, Net (Details) [Line Items] | |
Principal amount | $ 75,000,000 |
Annual Interest Percentage | 5.875% |
Convertible notes payable | $ 1,000,000 |
Ordinary shares (in Shares) | shares | 56.3063 |
Principal amount | $ 1,000,000 |
Exchange price (in Dollars per share) | $ / shares | $ 17.76 |
Repurchase price | 100.00% |
Exchange price Percentage | 130.00% |
Convertible notes | $ 4,223 |
Effective interest rate | 7.37% |
Convertible Notes [Member] | |
Convertible Senior Notes, Net (Details) [Line Items] | |
Principal amount | $ 1,000,000 |
Repurchase price | 100.00% |
Convertible Senior Notes, Net_3
Convertible Senior Notes, Net (Details) - Schedule of liability and equity components of the convertible notes $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Schedule of liability and equity components of the convertible notes [Abstract] | |
Principal amount | $ 75,000 |
Issuance costs | (4,223) |
Net issuance costs | 70,777 |
Amortized issuance costs | 640 |
Net carrying amount | $ 71,417 |
Accrued Expenses and Other Pa_3
Accrued Expenses and Other Payables (Details) - Schedule of accrued expenses and other payables - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule of accrued expenses and other payables [Abstract] | ||
Subcontractors | $ 517 | $ 609 |
Clinical activities | 5,445 | 4,841 |
Professional services | 740 | 1,943 |
Production plant in process | 983 | 415 |
Other | 180 | 180 |
Total | $ 7,865 | $ 7,988 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Schedule of fair value of money market funds and marketable securities - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Cash equivalents: | ||
Money market funds | $ 51,021 | $ 123 |
Marketable securities: | ||
Corporate debentures | 19,605 | |
Government debentures | 20,429 | |
Total assets measured at fair value | 91,055 | 123 |
Fair Value, Inputs, Level 1 [Member] | ||
Cash equivalents: | ||
Money market funds | 51,021 | 123 |
Marketable securities: | ||
Corporate debentures | ||
Government debentures | ||
Total assets measured at fair value | 51,021 | 123 |
Fair Value, Inputs, Level 2 [Member] | ||
Cash equivalents: | ||
Money market funds | ||
Marketable securities: | ||
Corporate debentures | 19,605 | |
Government debentures | 20,429 | |
Total assets measured at fair value | $ 40,034 |
Contingent Liabilities and Co_2
Contingent Liabilities and Commitments (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Contingent Liabilities and Commitments (Details) [Line Items] | |
Bank guarantees amount | $ 3,334 |
Investment Center grant amount | 3,171 |
Aggregate amount | 37,300 |
Royalty-bearing grants | 34,700 |
Non-royalty-bearing grants | $ 2,600 |
Percentage of interest rate | 100.00% |
Total grants | $ 44,700 |
Maximum [Member] | |
Contingent Liabilities and Commitments (Details) [Line Items] | |
Royalties rate | 3.50% |
Minimum [Member] | |
Contingent Liabilities and Commitments (Details) [Line Items] | |
Royalties rate | 3.00% |
Shareholders' Equity (Details)
Shareholders' Equity (Details) - shares | 1 Months Ended | 12 Months Ended | |
Dec. 31, 2020 | May 31, 2020 | Dec. 31, 2021 | |
Shareholders' Equity (Details) [Line Items] | |||
Underwriters description | In December 2020, the Company closed a third follow-on offering of its ordinary shares on Nasdaq, which resulted in the sale of 9,343,750 ordinary shares at a public offering price of $8.00 per share, before underwriting discounts and inclusive of the underwriters’ exercise in full of their option to purchase additional shares in the offering. The Company received proceeds in the amount of $68,988 from the offering (net of issuance costs and underwriting discounts of $5,762). | In May 2020, the Company closed a second follow-on offering of its ordinary shares on Nasdaq, which resulted in the sale of a total of 15,333,334 ordinary shares at a public offering price of $4.50 per share, before underwriting discounts and inclusive of the underwriters’ exercise in full of their option to purchase additional shares in the offering. The Company received proceeds in the amount of $63,860 from the offering (net of issuance costs and underwriting discounts of $5,140). | |
Expire date | As part of its 2017 investment round, the Company granted certain investors 4,323,978 warrants that will expire in July 2022. | ||
2017 Investor Member | |||
Shareholders' Equity (Details) [Line Items] | |||
Granted Warrants | 4,323,978 | ||
Warrant [Member] | |||
Shareholders' Equity (Details) [Line Items] | |||
Granted Warrants | 1,010,466 |
Share-Based Compensation (Detai
Share-Based Compensation (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Nov. 23, 2014₪ / sharesshares | Dec. 31, 2021USD ($)$ / sharesshares | Dec. 28, 2017shares | Jun. 26, 2017shares | Jan. 23, 2017₪ / sharesshares | |
Share-Based Compensation (Details) [Line Items] | |||||
Options vest period | 3 years | 4 years | |||
Ordinary shares outstanding percentage | 4.00% | ||||
Ordinary shares issuance | 1,520,066 | ||||
Share-based compensation non-vested (in Dollars) | $ | $ 9,739 | ||||
Minimum [Member] | |||||
Share-Based Compensation (Details) [Line Items] | |||||
Grant date fair value per share (in Dollars per share) | $ / shares | $ 1.52 | ||||
Maximum [Member] | |||||
Share-Based Compensation (Details) [Line Items] | |||||
Grant date fair value per share (in Dollars per share) | $ / shares | $ 5.64 | ||||
2017 Share Incentive Plan [Member] | |||||
Share-Based Compensation (Details) [Line Items] | |||||
Nominal per share value (in New Shekels per share) | ₪ / shares | ₪ 0.01 | ||||
Number of shares reserved for issuance | 1,338,015 | 559,764 | 463,384 | 312,867 | |
Ordinary C Share [Member] | |||||
Share-Based Compensation (Details) [Line Items] | |||||
Nominal per share value (in New Shekels per share) | ₪ / shares | ₪ 0.01 | ||||
Ordinary shares | 1,500,000 | ||||
Ordinary C Share [Member] | 2014 Israel Share Option Plan [Member] | |||||
Share-Based Compensation (Details) [Line Items] | |||||
Ordinary shares issued | 1,152,044 |
Share-Based Compensation (Det_2
Share-Based Compensation (Details) - Schedule of fair value measurement of equity-settled share options | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-Based Compensation (Details) - Schedule of fair value measurement of equity-settled share options [Line Items] | ||
Dividend yield | 0.00% | 0.00% |
Expected volatility of the share prices | 65.00% | |
Expected term (in years) | 8 years | 8 years |
Minimum [Member] | ||
Share-Based Compensation (Details) - Schedule of fair value measurement of equity-settled share options [Line Items] | ||
Expected volatility of the share prices | 74.00% | |
Risk-free interest rate | 1.40% | 0.60% |
Maximum [Member] | ||
Share-Based Compensation (Details) - Schedule of fair value measurement of equity-settled share options [Line Items] | ||
Expected volatility of the share prices | 79.00% | |
Risk-free interest rate | 1.50% | 1.38% |
Share-Based Compensation (Det_3
Share-Based Compensation (Details) - Schedule of stock option plans $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($)$ / sharesshares | |
Schedule of stock option plans [Abstract] | |
Amount of options, beginning Balance | shares | 3,892,714 |
Weighted average exercise price, beginning Balance | $ / shares | $ 5.15 |
Weighted average remaining contractual term (in years), beginning Balance | 6 years 7 months 24 days |
Aggregate intrinsic value, beginning Balance | $ | $ 608,179 |
Amount of options, Granted | shares | 1,318,351 |
Weighted average exercise price, Granted | $ / shares | $ 7.33 |
Weighted average remaining contractual term (in years), Granted | |
Aggregate intrinsic value, Granted | $ | |
Amount of options, Exercised | shares | (438,759) |
Weighted average exercise price, Exercised | $ / shares | $ 1.43 |
Weighted average remaining contractual term (in years), Exercised | |
Aggregate intrinsic value, Exercised | $ | |
Amount of options, Forfeited | shares | (217,325) |
Weighted average exercise price, Forfeited | $ / shares | $ 7.2 |
Weighted average remaining contractual term (in years), Forfeited | |
Aggregate intrinsic value, Forfeited | $ | |
Amount of options, Expired | shares | (143,557) |
Weighted average exercise price, Expired | $ / shares | $ 7.08 |
Weighted average remaining contractual term (in years), Expired | |
Aggregate intrinsic value, Expired | $ | |
Amount of options, ending Balance | shares | 4,411,424 |
Weighted average exercise price, ending Balance | $ / shares | $ 6.01 |
Weighted average remaining contractual term (in years), ending Balance | 8 years 2 months 8 days |
Aggregate intrinsic value, ending Balance | $ | $ 92,507 |
Amount of options, Exercisable | shares | 2,171,616 |
Weighted average exercise price, Exercisable | $ / shares | $ 5.57 |
Weighted average remaining contractual term (in years), Exercisable | 7 years 1 month 9 days |
Aggregate intrinsic value, Exercisable | $ | $ 92,507 |
Share-Based Compensation (Det_4
Share-Based Compensation (Details) - Schedule of outstanding and exercisable option granted | 12 Months Ended |
Dec. 31, 2021shares | |
Options Outstanding [Member] | |
Share-Based Compensation (Details) - Schedule of outstanding and exercisable option granted [Line Items] | |
Options outstanding | 4,411,424 |
Options Exercisable [Member] | |
Share-Based Compensation (Details) - Schedule of outstanding and exercisable option granted [Line Items] | |
Options exercisable | 2,171,616 |
0.25-3.8 [Member] | Options Outstanding [Member] | |
Share-Based Compensation (Details) - Schedule of outstanding and exercisable option granted [Line Items] | |
Options outstanding | 435,346 |
Weighted average remaining contractual term (Years) | 9 years 2 months 4 days |
0.25-3.8 [Member] | Options Exercisable [Member] | |
Share-Based Compensation (Details) - Schedule of outstanding and exercisable option granted [Line Items] | |
Weighted average remaining contractual term (Years) | 5 years 9 months 25 days |
Options exercisable | 123,494 |
4.15- 4.95 [Member] | Options Outstanding [Member] | |
Share-Based Compensation (Details) - Schedule of outstanding and exercisable option granted [Line Items] | |
Options outstanding | 2,331,999 |
Weighted average remaining contractual term (Years) | 7 years 8 months 1 day |
4.15- 4.95 [Member] | Options Exercisable [Member] | |
Share-Based Compensation (Details) - Schedule of outstanding and exercisable option granted [Line Items] | |
Weighted average remaining contractual term (Years) | 7 years 1 month 2 days |
Options exercisable | 1,578,326 |
5.21-7.56 [Member] | Options Outstanding [Member] | |
Share-Based Compensation (Details) - Schedule of outstanding and exercisable option granted [Line Items] | |
Options outstanding | 546,150 |
Weighted average remaining contractual term (Years) | 8 years 7 months 13 days |
5.21-7.56 [Member] | Options Exercisable [Member] | |
Share-Based Compensation (Details) - Schedule of outstanding and exercisable option granted [Line Items] | |
Weighted average remaining contractual term (Years) | 7 years 4 months 28 days |
Options exercisable | 210,074 |
8.00-11.01 [Member] | Options Outstanding [Member] | |
Share-Based Compensation (Details) - Schedule of outstanding and exercisable option granted [Line Items] | |
Options outstanding | 1,097,929 |
Weighted average remaining contractual term (Years) | 8 years 8 months 12 days |
8.00-11.01 [Member] | Options Exercisable [Member] | |
Share-Based Compensation (Details) - Schedule of outstanding and exercisable option granted [Line Items] | |
Weighted average remaining contractual term (Years) | 7 years 6 months 29 days |
Options exercisable | 259,722 |
Share-Based Compensation (Det_5
Share-Based Compensation (Details) - Schedule of of restricted shares activity | 12 Months Ended |
Dec. 31, 2021$ / sharesshares | |
Schedule of of restricted shares activity [Abstract] | |
Amount of restricted shares, Unvested beginning | |
Weighted average grant date fair value, Unvested beginning (in Dollars per share) | $ / shares | |
Amount of restricted shares, Granted | 549,427 |
Weighted average grant date fair value, Granted (in Dollars per share) | $ / shares | $ 5.61 |
Amount of restricted shares, Vested | |
Amount of restricted shares, Forfeited | (17,950) |
Weighted average grant date fair value, Forfeited (in Dollars per share) | $ / shares | $ 9.51 |
Amount of restricted shares, Unvested ending | 531,477 |
Weighted average grant date fair value, Unvested ending (in Dollars per share) | $ / shares | $ 5.48 |
Share-Based Compensation (Det_6
Share-Based Compensation (Details) - Schedule of share-based compensation expense - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule of share-based compensation expense [Abstract] | ||
Research and development expenses, net | $ 1,384 | $ 1,099 |
Commercial expenses | 947 | 376 |
General and administrative expenses | 1,902 | 1,893 |
Total share-based compensation | $ 4,233 | $ 3,368 |
Taxes on Income (Details)
Taxes on Income (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Israeli corporate income tax | 23.00% | 23.00% |
Description of corporate tax rate | Benefits granted to a Preferred Enterprise include reduced tax rates. As part of the Economic Efficiency Law (Legislative Amendments for Accomplishment of Budgetary Targets for Budget Years 2017-2018), 5777-2016, the tax rate for Area A will be 7.5% in 2017 onwards. In other regions, the tax rate is 16%. Preferred Enterprises in peripheral regions will be eligible for Investment Center grants, as well as the applicable reduced tax rates. | |
Description of net carryforward tax losses | The Company has net operating losses and capital losses for tax purposes as of December 31, 2021 totaling approximately $236,875 and $507, respectively, which may be carried forward and offset against taxable income in the future for an indefinite period. | |
Net operating losses carryforwards | $ 33,100 |
Taxes on Income (Details) - Sch
Taxes on Income (Details) - Schedule components of the loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule components of the loss [Abstract] | ||
Domestic | $ 55,853 | $ 45,871 |
Foreign | 33,940 | 15,702 |
Total net loss (income) before income taxes | $ 89,793 | $ 61,573 |
Basic and Diluted Net Loss Pe_3
Basic and Diluted Net Loss Per Share (Details) - Schedule of number of shares and loss used in the computation of net loss per share - For the computation of diluted loss [Member] - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Basic and Diluted Net Loss Per Share (Details) - Schedule of number of shares and loss used in the computation of net loss per share [Line Items] | ||
Weighted number of shares | 59,246,803 | 43,725,584 |
Net loss attributable to equity holders of the Company | $ 89,793 | $ 61,573 |