Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 10, 2022 | |
Document Information Line Items | ||
Entity Registrant Name | GAMIDA CELL LTD. | |
Trading Symbol | GMDA | |
Document Type | 10-Q | |
Current Fiscal Year End Date | --12-31 | |
Entity Common Stock, Shares Outstanding | 74,380,810 | |
Amendment Flag | false | |
Entity Central Index Key | 0001600847 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Document Period End Date | Sep. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Shell Company | false | |
Entity Ex Transition Period | false | |
Document Quarterly 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, Address Line Two | 7th Floor | |
Entity Address, City or Town | Boston | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02116 | |
City Area Code | (617) | |
Local Phone Number | 892-9080 | |
Title of 12(b) Security | Ordinary Shares, par value NIS 0.01 per share | |
Security Exchange Name | NASDAQ | |
Entity Interactive Data Current | Yes |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 | |
CURRENT ASSETS: | |||
Cash and cash equivalents | $ 55,071 | $ 55,892 | |
Marketable securities | 6,224 | 40,034 | |
Prepaid expenses and other current assets | 1,408 | 2,688 | |
Total current assets | 62,703 | 98,614 | |
NON-CURRENT ASSETS: | |||
Restricted deposits | 3,556 | 3,961 | |
Property, plant and equipment, net | 39,940 | 35,180 | |
Operating lease right-of-use assets | 5,459 | 7,236 | |
Severance pay fund | 1,595 | 2,148 | |
Other long-term assets | 1,059 | 1,647 | |
Total non-current assets | 51,609 | 50,172 | |
Total assets | 114,312 | 148,786 | |
CURRENT LIABILITIES: | |||
Trade payables | 1,916 | 8,272 | |
Employees and payroll accruals | 5,689 | 4,957 | |
Operating lease liabilities | 1,880 | 2,699 | |
Accrued interest of convertible senior notes | 551 | 1,640 | |
Accrued expenses and other current liabilities | 12,677 | 7,865 | |
Total current liabilities | 22,713 | 25,433 | |
NON-CURRENT LIABILITIES: | |||
Convertible senior notes, net | 71,999 | 71,417 | |
Accrued severance pay | 1,865 | 2,396 | |
Long-term operating lease liabilities | 4,174 | 5,603 | |
Total non-current liabilities | 78,038 | 79,416 | |
CONTINGENT LIABILITIES AND COMMITMENTS | |||
Share capital - | |||
Ordinary shares of NIS 0.01 par value - Authorized: 150,000,000 shares at September 30, 2022 (unaudited) and December 31, 2021; Issued 74,466,580 and 59,970,389 at September 30, 2022 (unaudited) and December 31, 2021 respectively; Outstanding: 74,380,810 and 59,970,389 shares at September 30, 2022 (unaudited) and December 31, 2021, respectively | 210 | 169 | |
Treasury ordinary shares of NIS 0.01 par value - 85,770 and 0 shares at September 30, 2022 (unaudited) and December 31, 2021, respectively | [1] | ||
Additional paid-in capital | 407,387 | 381,225 | |
Accumulated deficit | (394,036) | (337,457) | |
Total shareholders’ equity | 13,561 | 43,937 | |
Total liabilities and shareholders’ equity | $ 114,312 | $ 148,786 | |
[1]Represents an amount lower than $1. |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) | Sep. 30, 2022 ₪ / shares shares | Sep. 30, 2022 $ / shares shares | Dec. 31, 2021 ₪ / shares shares | Dec. 31, 2021 $ / shares shares |
Statement of Financial Position [Abstract] | ||||
Ordinary shares par value (in New Shekels per share) | ₪ / shares | ₪ 0.01 | ₪ 0.01 | ||
Ordinary shares authorized | 150,000,000 | 150,000,000 | 150,000,000 | 150,000,000 |
Ordinary shares Issued | 74,466,580 | 74,466,580 | 59,970,389 | 59,970,389 |
Ordinary shares outstanding | 74,380,810 | 74,380,810 | 59,970,389 | 59,970,389 |
Treasury ordinary shares par value (in Dollars per share) | $ / shares | $ 0.01 | $ 0.01 | ||
Treasury ordinary shares | 85,770 | 85,770 | 0 | 0 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Income Statement [Abstract] | ||||
Research and development expenses, net | $ 9,864 | $ 11,725 | $ 31,732 | $ 36,435 |
Commercial expenses | 2,760 | 5,755 | 9,832 | 14,974 |
General and administrative expenses | 4,437 | 5,001 | 12,866 | 12,388 |
Total operating loss | 17,061 | 22,481 | 54,430 | 63,797 |
Financial expenses, net | 741 | 692 | 2,149 | 2,119 |
Loss | $ 17,802 | $ 23,173 | $ 56,579 | $ 65,916 |
Net loss per share attributable to ordinary shareholders, basic and diluted (in Dollars per share) | $ 0.29 | $ 0.39 | $ 0.95 | $ 1.11 |
Weighted average number of shares used in computing net loss per share attributable to ordinary shareholders, basic and diluted (in Shares) | 60,440,765 | 59,281,243 | 59,821,655 | 59,219,757 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations (Unaudited) (Parentheticals) - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Income Statement [Abstract] | ||||
Net loss per share attributable to ordinary shareholders, basic and diluted (in Dollars per share) | $ 0.29 | $ 0.39 | $ 0.95 | $ 1.11 |
Weighted average number of shares used in computing net loss per share attributable to ordinary shareholders, basic and diluted (in Shares) | 60,440,765 | 59,281,243 | 59,821,655 | 59,219,757 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Changes in Shareholders’ Equity (Unaudited) - USD ($) $ in Thousands | Ordinary shares | Treasury shares | Additional paid-in capital | Accumulated deficit | Total | ||||||
Balance at Dec. 31, 2020 | $ 166 | $ 376,369 | $ (247,664) | $ 128,871 | |||||||
Balance (in Shares) at Dec. 31, 2020 | 59,000,153 | ||||||||||
Grant of restricted shares | $ 1 | (1) | |||||||||
Grant of restricted shares (in Shares) | 220,034 | ||||||||||
Exercise of options | $ 1 | 565 | 566 | ||||||||
Exercise of options (in Shares) | 298,693 | ||||||||||
Share-based compensation | 3,122 | 3,122 | |||||||||
Loss | (65,916) | (65,916) | |||||||||
Balance at Sep. 30, 2021 | $ 168 | 380,055 | (313,580) | 66,643 | |||||||
Balance (in Shares) at Sep. 30, 2021 | 59,518,880 | ||||||||||
Balance at Jun. 30, 2021 | $ 167 | 378,949 | (290,407) | 88,709 | |||||||
Balance (in Shares) at Jun. 30, 2021 | 59,427,996 | ||||||||||
Grant of restricted shares | $ 1 | (1) | |||||||||
Grant of restricted shares (in Shares) | 63,550 | ||||||||||
Exercise of options | [1] | 10 | 10 | ||||||||
Exercise of options (in Shares) | 27,334 | ||||||||||
Share-based compensation | 1,097 | 1,097 | |||||||||
Loss | (23,173) | (23,173) | |||||||||
Balance at Sep. 30, 2021 | $ 168 | 380,055 | (313,580) | 66,643 | |||||||
Balance (in Shares) at Sep. 30, 2021 | 59,518,880 | ||||||||||
Balance at Dec. 31, 2021 | $ 169 | 381,225 | (337,457) | 43,937 | |||||||
Balance (in Shares) at Dec. 31, 2021 | 59,970,389 | ||||||||||
Grant of restricted shares | [1] | [1] | [1] | ||||||||
Grant of restricted shares (in Shares) | 3,600 | ||||||||||
Treasury shares | [1] | [1] | [1] | ||||||||
Treasury shares (in Shares) | (85,770) | ||||||||||
Exercise of options | [1] | 76 | 76 | ||||||||
Exercise of options (in Shares) | 47,426 | ||||||||||
Issuance of ordinary shares, net of issuance expenses | [2] | $ 41 | 22,257 | 22,298 | |||||||
Issuance of ordinary shares, net of issuance expenses (in Shares) | [2] | 14,445,165 | |||||||||
Share-based compensation | 3,829 | 3,829 | |||||||||
Loss | (56,579) | (56,579) | |||||||||
Balance at Sep. 30, 2022 | $ 210 | [1] | 407,387 | (394,036) | 13,561 | ||||||
Balance (in Shares) at Sep. 30, 2022 | 74,380,810 | ||||||||||
Balance at Jun. 30, 2022 | $ 169 | [1] | 383,915 | (376,234) | 7,850 | ||||||
Balance (in Shares) at Jun. 30, 2022 | 59,977,188 | ||||||||||
Treasury shares | [1] | [1] | [1] | ||||||||
Treasury shares (in Shares) | (3,085) | ||||||||||
Exercise of options | |||||||||||
Issuance of ordinary shares, net of issuance expenses | [3] | $ 41 | 22,173 | 22,214 | |||||||
Issuance of ordinary shares, net of issuance expenses (in Shares) | [3] | 14,406,707 | |||||||||
Share-based compensation | 1,299 | 1,299 | |||||||||
Loss | (17,802) | (17,802) | |||||||||
Balance at Sep. 30, 2022 | $ 210 | [1] | $ 407,387 | $ (394,036) | $ 13,561 | ||||||
Balance (in Shares) at Sep. 30, 2022 | 74,380,810 | ||||||||||
[1]Represents an amount lower than $1.[2]Issuance costs of $2,081 relating to the follow-on offering and ATM.[3]Issuance costs of approximately $2,079 million relating to the follow-on offering and ATM. |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flows from operating activities: | ||
Loss | $ (56,579) | $ (65,916) |
Adjustments to reconcile loss to net cash used in operating activities: | ||
Depreciation of property, plant and equipment | 391 | 317 |
Financing expense (income), net | (2,461) | 89 |
Share-based compensation | 3,829 | 3,122 |
Amortization of debt discount and issuance costs | 582 | 453 |
Operating lease right-of-use assets | 1,922 | 1,542 |
Operating lease liabilities | (2,395) | (1,764) |
Accrued severance pay, net | 23 | |
Increase in prepaid expenses and other assets | 1,719 | 558 |
Increase (decrease) in trade payables | (6,355) | 1,533 |
Increase (decrease) in accrued expenses and current liabilities | 5,079 | (1,361) |
Net cash used in operating activities | (54,245) | (61,427) |
Cash flows from investing activities: | ||
Purchase of property, plant and equipment | (2,865) | (9,577) |
Purchase of marketable securities | (4,557) | (97,808) |
Proceeds from maturity of marketable securities | 37,972 | 56,717 |
Proceeds (investments) from restricted deposits | 500 | (5,803) |
Net cash provided by (used in) investing activities | 31,050 | (56,471) |
Cash flows from financing activities: | ||
Proceeds from exercise of options | 76 | 566 |
Proceeds from share issuance, net | 22,298 | |
Proceeds from issuance of convertible senior notes, net | 70,777 | |
Net cash provided by financing activities | 22,374 | 71,343 |
Decrease in cash and cash equivalents | (821) | (46,555) |
Cash and cash equivalents at beginning of period | 55,892 | 127,170 |
Cash and cash equivalents at end of period | 55,071 | 80,615 |
Significant non-cash transactions: | ||
Purchase of property, plant and equipment on credit | 281 | 1,561 |
Supplemental disclosures of cash flow information: | ||
Cash paid for interest | $ (4,406) | $ (2,191) |
General
General | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
GENERAL | NOTE 1:- GENERAL a. Gamida Cell Ltd. (the “Company”), founded in 1998, is an advanced cell therapy company committed to cures for blood cancers and serious hematologic diseases. The Company harnesses its cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. b. The Company has leveraged its NAM platform, or nicotinamide cell expansion technology platform, to develop a pipeline of product candidates designed to address the limitations of other cell therapies. The Company’s proprietary technology allows for the proliferation and enhancement of donor cells, which allows for maintenance of the cells’ functional therapeutic characteristics, providing a potential treatment alternative for patients. 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 2021, the complete results from the Company’s 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 (FDA) and has received orphan drug designation in the U.S. and in Europe. In June 2022, the Company announced completion of the rolling Biologics License Application (BLA) submission to the FDA for omidubicel for the treatment of patients with blood cancers in need of an allogenic hematopoietic stem cell transplant. In August 2022, the Company announced the FDA had accepted for filing the Company’s BLA for omidubicel for the treatment of patients with blood cancers in need of an allogenic hematopoietic stem cell transplant (HSCT). The FDA granted Priority Review for the BLA and has set a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2023. In addition to omidubicel, the Company is developing GDA-201, an investigational natural killer (NK) cell-based cancer immunotherapy that is intended to be used in combination with standard-of-care therapeutic antibodies, as well as other product candidates in the Company’s NK cell pipeline. 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). Data from the 35 patients in the Phase 1/2 study 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% and a complete response rate of 68%. At the December 2021 Annual Meeting of America Society of Hematology, 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. On April 26, 2022, the Company announced that the FDA cleared its investigational new drug (IND) application and removed the clinical hold for a cryopreserved formulation of GDA-201. In June, the Company announced the activation of the initial clinical sites to screen and enroll patients in the company-sponsored Phase 1/2 study evaluating a cryopreserved formulation of GDA-201, a readily available cell therapy candidate for the treatment of follicular and diffuse large B cell lymphomas. In September 2022 the Company closed a public offering of its ordinary shares and raised an additional $18.1 million, net of issuance costs. The Company currently intends to use the net proceeds of the offering, together with its existing cash and cash equivalents and trading financial assets to fund: (i) commercial readiness activities to support potential launch of Omidubicel, if approved; (ii) continued clinical development of NK product candidates, including GDA-201; and (iii) general corporate purposes, including general and administrative expenses and working capital. c. Basis of presentation of the financial statements: The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X promulgated by the U.S Securities and Exchange Commission (the “SEC”). Certain information or footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted, pursuant to the rules and regulations of the SEC for interim financial reporting. Accordingly, they do not include all the information and footnotes necessary for a complete presentation of financial position, results of operations, or cash flows. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments, consisting of a normal recurring nature, which are necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the Company’s Annual Report on Form 10-K as of December 31, 2021 filed with the SEC on March 24, 2022. The interim period results do not necessarily indicate the results that may be expected for any other interim period or for the full fiscal year. 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 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. d. The Company continues to devote 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 September 30, 2022 was $394.036 and negative cash flows from operating activities during the nine-month period ended September 30, 2022 was $54.246. The Company’s management plans to seek additional financing as required to fund its operations until achieving positive cash flows. 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 the amounts required. e. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The unaudited condensed consolidated financial statements do not include any adjustments to the carrying amounts and classifications of assets and liabilities that would result if the Company were unable to continue as a going concern. f. 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 | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES a. Use of estimates: The preparation of condensed 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. b. 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. c. 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. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2022 | |
Leases [Abstract] | |
LEASES | NOTE 3:- LEASES The Company entered into operating leases primarily for its production plant, and its laboratories and offices. The leases have remaining lease terms of up to six years, and 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: Nine months ended 2022 2021 (unaudited) (unaudited) Operating lease costs $ 2,093 $ 1,754 Short-term lease costs 92 84 Total lease costs $ 2,185 $ 1,838 Supplemental balance sheet information related to operating leases is as follows: Nine months (unaudited) Weighted average remaining lease term (in years) 3.88 Weighted average discount rate 2.61 % Maturities of lease liabilities were as follows: As of 2022 $ 654 2023 1,589 2024 1,595 2025 1,195 2026 700 Thereafter 538 Total undiscounted lease payments 6,271 Less: Imputed interest (217 ) Present value of lease liabilities $ 6,054 |
Convertible Senior Notes, Net
Convertible Senior Notes, Net | 9 Months Ended |
Sep. 30, 2022 | |
Convertible Senior Notes, Net [Abstract] | |
CONVERTIBLE SENIOR NOTES, NET | NOTE 4:- 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 Liability component: Principal amount $ 75,000 Issuance costs (4,223 ) Net of issuance costs 70,777 Amortized issuance costs 1,222 Net carrying amount $ 71,999 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. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Measurements [Abstract] | |
FAIR VALUE MEASUREMENTS | NOTE 5:- FAIR VALUE MEASUREMENTS The carrying amounts of the Company’s financial instruments, including cash and cash equivalents and marketable securities, are stated at their carrying value, which approximates their fair value due to the short time to the expected receipt or payment. The following table presents information about our financial instruments that are measured at the fair value as of September 30, 2022 and December 31, 2021: September 30, 2022 December 31, 2021 Level 1 Level 2 Total Level 1 Level 2 Total Financial assets: Money market funds included in cash and cash equivalents $ 49,395 $ - $ 49,935 $ 51,021 $ - $ 51,021 Marketable securities: Corporate debentures - 2,841 2,841 - 19,605 19,605 Government debentures - 3,383 3,383 - 20,429 20,429 Total assets measured at fair value $ 49,395 $ 6,224 $ 55,619 $ 51,021 $ 40,034 $ 91,055 We classify our cash equivalents and marketable securities within Level 1 or Level 2 because we use quoted market prices or alternative pricing sources and models utilizing market observable inputs to determine their fair value. |
Contingent Liabilities and Comm
Contingent Liabilities and Commitments | 9 Months Ended |
Sep. 30, 2022 | |
Contingent Liabilities and Commitments [Abstract] | |
CONTINGENT LIABILITIES AND COMMITMENTS | NOTE 6:- CONTINGENT LIABILITIES AND COMMITMENTS a. Legal proceedings: From time to time, the Company or its subsidiary 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 September 30, 2022, the Company obtained bank guarantees in the amount of $2,929, primarily in connection with an Investment Center grant of up to $2,786 expected to be received in 2022 which requires a bank guarantee in order to ensure the fulfillment of the grant terms. 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 $36.8 million through September 30, 2022, of which $34.2 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 September 30, 2022, no royalties have been paid or accrued. The Company’s contingent royalty liability to the IIA at September 30, 2022, including grants received by the Company and the associated LIBOR interest on all such grants totaled to $42.2 million. |
Shareholders' Equity
Shareholders' Equity | 9 Months Ended |
Sep. 30, 2022 | |
Shareholders' Equity [Abstract] | |
SHAREHOLDERS’ EQUITY | NOTE 7:- 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 participated in dividends and other distributions upon liquidation. On September 27, 2022, the Company entered into an underwriting agreement with certain underwriters, pursuant to which the Company issued and sold, in an underwritten public offering, an aggregate of 12,905,000 of its ordinary shares at a public offering price of $1.55 per share. b. Warrants to investors: As part of its 2017 investment round, the Company granted certain investors 4,323,978 warrants with an expiration date in July 2022. As of July 3, 2022, 1,010,466 of such warrants had been exercised into the Company’s ordinary shares and the remaining 3,313,512 warrants expired. |
Share-Based Compensation
Share-Based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Compensation [Abstract] | |
SHARE-BASED COMPENSATION | NOTE 8:- 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. 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 nine months ended September 30, 2022 and 2021: Nine months ended 2022 2021 (unaudited) Dividend yield 0% 0% Expected volatility of the share prices 66%-67% 66% Risk-free interest rate 1.8% - 3.5% 1.3% - 1.6% Expected term (in years) 8 8 Based on the above inputs, the fair value of the options was determined to be $0.99 - $1.85 per option at the grant date. b. The following table summarizes the number of options granted to employees under the Option Plans as of September 30, 2022 and related information: Number of Weighted (unaudited) (unaudited) Balance as of December 31, 2021 4,411,424 $ 6.01 Granted 2,233,150 2.60 Exercised (47,426 ) 1.60 Forfeited (378,379 ) 6.52 Expired (144,717 ) 5.22 Balance as of September 30, 2022 6,074,052 4.78 Exercisable as of September 30, 2022 2,696,432 $ 5.93 As of September 30, 2022, there are $10,964 of total unrecognized costs related to share-based compensation that are expected to be recognized over a period of up to four years. c. A summary of restricted shares and restricted shares unit activity as of September 30, 2022 is as follows: Number of Weighted (unaudited) (unaudited) Unvested as of December 31, 2021 531,477 $ 5.48 Granted 1,203,650 2.77 Vested (121,768 ) 6.04 Forfeited (124,670 ) 5.21 Unvested as of September 30, 2022 1,488,689 $ 3.27 d. The total share-based compensation expense related to all of the Company’s equity-based awards, recognized for the three and nine months ended September 30, 2022 and 2021 is comprised as follows: Three months ended September 30, Nine months ended 2022 2021 2022 2021 (unaudited) Research and development expenses, net $ 533 $ 368 $ 1,551 $ 1,051 Commercial expenses 328 253 976 653 General and administrative expenses 438 476 1,302 1,418 Total share-based compensation $ 1,299 $ 1,097 $ 3,829 $ 3,122 |
Basic and Diluted Net Loss Per
Basic and Diluted Net Loss Per Share | 9 Months Ended |
Sep. 30, 2022 | |
Basic and Diluted Net Loss Per Share [Abstract] | |
BASIC AND DILUTED NET LOSS PER SHARE | NOTE 9:- 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 has a loss for the three and nine months ended September 30, 2022 and 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 loss per share: Three months ended September 30, Nine months ended September 30, 2022 2021 2022 2021 (unaudited) (unaudited) Weighted Net loss Weighted Net loss Weighted Net loss Weighted Net loss For the computation of basic and diluted loss 60,440,765 17,802 59,281,243 23,173 59,821,655 56,579 59,219,757 65,916 All outstanding convertible senior note options, warrants, outstanding share options, and restricted shares for the three and nine months ended September 30, 2022 and 2021 have been excluded from the calculation of the diluted net loss per share, because all such securities are anti-dilutive for all periods presented. The total number of potential shares excluded from the calculation of diluted net loss per share are as follows: Three months ended Nine months ended 2022 2021 2022 2021 (unaudited) Convertible senior notes 4,222,973 4,222,973 4,222,973 3,495,941 Warrants 108,049 3,313,512 2,233,283 3,313,512 Outstanding share options 5,189,188 4,336,907 4,964,826 4,069,491 Restricted shares 1,140,318 202,404 1,008,551 138,850 Total 10,660,528 12,075,796 12,429,633 11,017,794 |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Use of estimates | a. Use of estimates: The preparation of condensed 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. |
Convertible senior notes | b. 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. |
Basic and diluted net loss per share | c. 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. |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Leases [Abstract] | |
Schedule of operating lease costs | Nine months ended 2022 2021 (unaudited) (unaudited) Operating lease costs $ 2,093 $ 1,754 Short-term lease costs 92 84 Total lease costs $ 2,185 $ 1,838 |
Schedule of operating leases | Nine months (unaudited) Weighted average remaining lease term (in years) 3.88 Weighted average discount rate 2.61 % |
Schedule of maturities of lease liabilities | As of 2022 $ 654 2023 1,589 2024 1,595 2025 1,195 2026 700 Thereafter 538 Total undiscounted lease payments 6,271 Less: Imputed interest (217 ) Present value of lease liabilities $ 6,054 |
Convertible Senior Notes, Net (
Convertible Senior Notes, Net (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Convertible Senior Notes, Net [Abstract] | |
Schedule of liability measured at its amortized cost | As of Liability component: Principal amount $ 75,000 Issuance costs (4,223 ) Net of issuance costs 70,777 Amortized issuance costs 1,222 Net carrying amount $ 71,999 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Measurements [Abstract] | |
Schedule of fair value | September 30, 2022 December 31, 2021 Level 1 Level 2 Total Level 1 Level 2 Total Financial assets: Money market funds included in cash and cash equivalents $ 49,395 $ - $ 49,935 $ 51,021 $ - $ 51,021 Marketable securities: Corporate debentures - 2,841 2,841 - 19,605 19,605 Government debentures - 3,383 3,383 - 20,429 20,429 Total assets measured at fair value $ 49,395 $ 6,224 $ 55,619 $ 51,021 $ 40,034 $ 91,055 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Compensation [Abstract] | |
Schedule of fair value measurement of equity-settled share options | Nine months ended 2022 2021 (unaudited) Dividend yield 0% 0% Expected volatility of the share prices 66%-67% 66% Risk-free interest rate 1.8% - 3.5% 1.3% - 1.6% Expected term (in years) 8 8 |
Schedule of number of options granted | Number of Weighted (unaudited) (unaudited) Balance as of December 31, 2021 4,411,424 $ 6.01 Granted 2,233,150 2.60 Exercised (47,426 ) 1.60 Forfeited (378,379 ) 6.52 Expired (144,717 ) 5.22 Balance as of September 30, 2022 6,074,052 4.78 Exercisable as of September 30, 2022 2,696,432 $ 5.93 |
Schedule of restricted shares and restricted shares | Number of Weighted (unaudited) (unaudited) Unvested as of December 31, 2021 531,477 $ 5.48 Granted 1,203,650 2.77 Vested (121,768 ) 6.04 Forfeited (124,670 ) 5.21 Unvested as of September 30, 2022 1,488,689 $ 3.27 |
Schedule of share-based compensation expense | Three months ended September 30, Nine months ended 2022 2021 2022 2021 (unaudited) Research and development expenses, net $ 533 $ 368 $ 1,551 $ 1,051 Commercial expenses 328 253 976 653 General and administrative expenses 438 476 1,302 1,418 Total share-based compensation $ 1,299 $ 1,097 $ 3,829 $ 3,122 |
Basic and Diluted Net Loss Pe_2
Basic and Diluted Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Basic and Diluted Net Loss Per Share [Abstract] | |
Schedule of number of shares and loss used in the computation of net loss per share | Three months ended September 30, Nine months ended September 30, 2022 2021 2022 2021 (unaudited) (unaudited) Weighted Net loss Weighted Net loss Weighted Net loss Weighted Net loss For the computation of basic and diluted loss 60,440,765 17,802 59,281,243 23,173 59,821,655 56,579 59,219,757 65,916 |
Schedule of outstanding convertible senior note options, warrants, outstanding share options, and restricted shares | Three months ended Nine months ended 2022 2021 2022 2021 (unaudited) Convertible senior notes 4,222,973 4,222,973 4,222,973 3,495,941 Warrants 108,049 3,313,512 2,233,283 3,313,512 Outstanding share options 5,189,188 4,336,907 4,964,826 4,069,491 Restricted shares 1,140,318 202,404 1,008,551 138,850 Total 10,660,528 12,075,796 12,429,633 11,017,794 |
General (Details)
General (Details) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 USD ($) | Dec. 31, 2021 | |
Accounting Policies [Abstract] | ||
Response rate percentage, description | Among the 19 patients with NHL, 13 complete responses and one partial response were observed, with an overall response rate of 74% and a complete response rate of 68%. | |
Clinical trial on outcomes description | 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. | |
Issuance costs | $ 18,100,000 | |
Accumulated deficit | 394,036 | |
Cash | $ 54,246 | |
Operating segment | 1 |
Leases (Details)
Leases (Details) | Sep. 30, 2022 |
Leases [Abstract] | |
Lease term | 6 years |
Leases (Details) - Schedule of
Leases (Details) - Schedule of operating lease costs - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Schedule of Operating Lease Costs [Abstract] | ||
Operating lease costs | $ 2,093 | $ 1,754 |
Short-term lease costs | 92 | 84 |
Total lease costs | $ 2,185 | $ 1,838 |
Leases (Details) - Schedule o_2
Leases (Details) - Schedule of operating leases | Sep. 30, 2022 |
Schedule of Operating Leases [Abstract] | |
Weighted average remaining lease term (in years) | 3 years 10 months 17 days |
Weighted average discount rate | 2.61% |
Leases (Details) - Schedule o_3
Leases (Details) - Schedule of maturities of lease liabilities $ in Thousands | Sep. 30, 2022 USD ($) |
Schedule of Maturities of Lease Liabilities [Abstract] | |
2022 | $ 654 |
2023 | 1,589 |
2024 | 1,595 |
2025 | 1,195 |
2026 | 700 |
Thereafter | 538 |
Total undiscounted lease payments | 6,271 |
Less: Imputed interest | (217) |
Present value of lease liabilities | $ 6,054 |
Convertible Senior Notes, Net_2
Convertible Senior Notes, Net (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 9 Months Ended |
Feb. 16, 2021 | Sep. 30, 2022 | |
Convertible Senior Notes, Net (Details) [Line Items] | ||
Annual interest percentage | 5.875% | |
Maturity date | Feb. 15, 2026 | |
Convertible notes payable | $ 1,000 | |
Ordinary shares (in Shares) | 56.3063 | |
Principal amount | $ 1,000 | |
Exchange price (in Dollars per share) | $ 17.76 | |
Repurchase price | 100% | |
Exchange price percentage | 130% | |
Convertible notes | $ 4,223 | |
Effective interest rate | 7.37% | |
Convertible Notes [Member] | ||
Convertible Senior Notes, Net (Details) [Line Items] | ||
Aggregate principal amount | $ 75,000 | |
Principal amount | $ 1,000 | |
Repurchase price | 100% |
Convertible Senior Notes, Net_3
Convertible Senior Notes, Net (Details) - Schedule of liability measured at its amortized cost $ in Thousands | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Liability component: | |
Principal amount | $ 75,000 |
Issuance costs | (4,223) |
Net of issuance costs | 70,777 |
Amortized issuance costs | 1,222 |
Net carrying amount | $ 71,999 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Schedule of fair value - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Financial assets: | ||
Money market funds included in cash and cash equivalents | $ 49,935 | $ 51,021 |
Marketable securities: | ||
Corporate debentures | 2,841 | 19,605 |
Government debentures | 3,383 | 20,429 |
Total assets measured at fair value | 55,619 | 91,055 |
Level 1 [Member] | ||
Financial assets: | ||
Money market funds included in cash and cash equivalents | 49,395 | 51,021 |
Marketable securities: | ||
Corporate debentures | ||
Government debentures | ||
Total assets measured at fair value | 49,395 | 51,021 |
Level 2 [Member] | ||
Financial assets: | ||
Money market funds included in cash and cash equivalents | ||
Marketable securities: | ||
Corporate debentures | 2,841 | 19,605 |
Government debentures | 3,383 | 20,429 |
Total assets measured at fair value | $ 6,224 | $ 40,034 |
Contingent Liabilities and Co_2
Contingent Liabilities and Commitments (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Contingent Liabilities and Commitments (Details) [Line Items] | |
Bank guarantees amount | $ 2,929 |
Investment center grant amount | 2,786 |
Aggregate amount | 36,800 |
Royalty-bearing grants | 34,200 |
Non-royalty-bearing grants | $ 2,600 |
Percentage of interest rate | 100% |
Total grants | $ 42,200 |
Minimum [Member] | |
Contingent Liabilities and Commitments (Details) [Line Items] | |
Royalties rate | 3% |
Maximum [Member] | |
Contingent Liabilities and Commitments (Details) [Line Items] | |
Royalties rate | 3.50% |
Shareholders' Equity (Details)
Shareholders' Equity (Details) - $ / shares | 9 Months Ended | ||
Jul. 03, 2022 | Sep. 30, 2022 | Sep. 27, 2022 | |
Shareholders' Equity (Details) [Line Items] | |||
Underwriters description | 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 participated in dividends and other distributions upon liquidation. | ||
Ordinary shares | 12,905,000 | ||
Price per share (in Dollars per share) | $ 1.55 | ||
Expire date | July 2022 | ||
Remaining shares | 3,313,512 | ||
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 | 9 Months Ended | |||
Nov. 23, 2014 ₪ / shares shares | Sep. 30, 2022 USD ($) $ / shares shares | Dec. 28, 2017 shares | Jun. 26, 2017 shares | Jan. 23, 2017 ₪ / shares shares | |
Share-Based Compensation (Details) [Line Items] | |||||
Options vest period | 3 years | 4 years | |||
Ordinary shares outstanding percentage | 4% | ||||
Share-based compensation non-vested (in Dollars) | $ | $ 10,964 | ||||
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 | |
Minimum [Member] | |||||
Share-Based Compensation (Details) [Line Items] | |||||
Grant date fair value per share (in Dollars per share) | $ / shares | $ 0.99 | ||||
Maximum [Member] | |||||
Share-Based Compensation (Details) [Line Items] | |||||
Grant date fair value per share (in Dollars per share) | $ / shares | $ 1.85 | ||||
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 | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Share-Based Compensation (Details) - Schedule of fair value measurement of equity-settled share options [Line Items] | ||
Dividend yield | 0% | 0% |
Expected volatility of the share prices | 66% | |
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 | 66% | |
Risk-free interest rate | 1.80% | 1.30% |
Maximum [Member] | ||
Share-Based Compensation (Details) - Schedule of fair value measurement of equity-settled share options [Line Items] | ||
Expected volatility of the share prices | 67% | |
Risk-free interest rate | 3.50% | 1.60% |
Share-Based Compensation (Det_3
Share-Based Compensation (Details) - Schedule of number of options granted | 9 Months Ended |
Sep. 30, 2022 $ / shares shares | |
Schedule Of Number Of Options Granted Abstract | |
Number of options, beginning balance | shares | 4,411,424 |
Weighted average exercise price, beginning balance | $ / shares | $ 6.01 |
Number of options, Granted | shares | 2,233,150 |
Weighted average exercise price, Granted | $ / shares | $ 2.6 |
Number of options, Exercised | shares | (47,426) |
Weighted average exercise price, Exercised | $ / shares | $ 1.6 |
Number of options, Forfeited | shares | (378,379) |
Weighted average exercise price, Forfeited | $ / shares | $ 6.52 |
Number of options, Expired | shares | (144,717) |
Weighted average exercise price, Expired | $ / shares | $ 5.22 |
Number of options, ending balance | shares | 6,074,052 |
Weighted average exercise price, ending balance | $ / shares | $ 4.78 |
Number of options, Exercisable | shares | 2,696,432 |
Weighted average exercise price, Exercisable | $ / shares | $ 5.93 |
Share-Based Compensation (Det_4
Share-Based Compensation (Details) - Schedule of restricted shares and restricted shares | 9 Months Ended |
Sep. 30, 2022 $ / shares shares | |
Schedule Of Restricted Shares And Restricted Shares Abstract | |
Number of restricted shares and restricted share units, Unvested beginning | shares | 531,477 |
Weighted average grant date fair value, Unvested beginning | $ / shares | $ 5.48 |
Number of restricted shares and restricted share units, Granted | shares | 1,203,650 |
Weighted average grant date fair value, Granted | $ / shares | $ 2.77 |
Number of restricted shares and restricted share units, Vested | shares | (121,768) |
Weighted average grant date fair value, Vested | $ / shares | $ 6.04 |
Number of restricted shares and restricted share units, Forfeited | shares | (124,670) |
Weighted average grant date fair value, Forfeited | $ / shares | $ 5.21 |
Number of restricted shares and restricted share units, Unvested ending | shares | 1,488,689 |
Weighted average grant date fair value, Unvested ending | $ / shares | $ 3.27 |
Share-Based Compensation (Det_5
Share-Based Compensation (Details) - Schedule of share-based compensation expense - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Schedule Of Share Based Compensation Expense Abstract | ||||
Research and development expenses, net | $ 533 | $ 368 | $ 1,551 | $ 1,051 |
Commercial expenses | 328 | 253 | 976 | 653 |
General and administrative expenses | 438 | 476 | 1,302 | 1,418 |
Total share-based compensation | $ 1,299 | $ 1,097 | $ 3,829 | $ 3,122 |
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 - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Schedule of Number of Shares and Loss Used in the Computation of Net Loss Per Share [Abstract] | ||||
Weighted number of shares | 60,440,765 | 59,281,243 | 59,821,655 | 59,219,757 |
Net loss attributable to Ordinary shares of the Company | $ 17,802 | $ 23,173 | $ 56,579 | $ 65,916 |
Basic and Diluted Net Loss Pe_4
Basic and Diluted Net Loss Per Share (Details) - Schedule of outstanding convertible senior note options, warrants, outstanding share options, and restricted shares - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Schedule of Outstanding Convertible Senior Note Options Warrants Outstanding Share Options and Restricted Shares [Abstract] | ||||
Convertible senior notes | 4,222,973 | 4,222,973 | 4,222,973 | 3,495,941 |
Warrants | 108,049 | 3,313,512 | 2,233,283 | 3,313,512 |
Outstanding share options | 5,189,188 | 4,336,907 | 4,964,826 | 4,069,491 |
Restricted shares | 1,140,318 | 202,404 | 1,008,551 | 138,850 |
Total | 10,660,528 | 12,075,796 | 12,429,633 | 11,017,794 |