Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Jun. 30, 2023 | Aug. 11, 2023 | |
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 | 121,523,280 | |
Amendment Flag | false | |
Entity Central Index Key | 0001600847 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Document Period End Date | Jun. 30, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q2 | |
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 | Jun. 30, 2023 | Dec. 31, 2022 | |
CURRENT ASSETS: | |||
Cash and cash equivalents | $ 54,075 | $ 64,657 | |
Restricted Cash | 138 | ||
Inventory | 2,390 | ||
Prepaid expenses and other current assets | 2,262 | 1,889 | |
Total current assets | 58,865 | 66,546 | |
NON-CURRENT ASSETS: | |||
Restricted deposits | 3,150 | 3,668 | |
Property, plant and equipment, net | 43,639 | 44,319 | |
Operating lease right-of-use assets | 4,336 | 7,024 | |
Severance pay fund | 1,291 | 1,703 | |
Other long-term assets | 1,227 | 1,513 | |
Total non-current assets | 53,643 | 58,227 | |
Total assets | 112,508 | 124,773 | |
CURRENT LIABILITIES: | |||
Trade payables | 2,440 | 6,384 | |
Employees and payroll accruals | 5,545 | 5,300 | |
Operating lease liabilities | 2,176 | 2,648 | |
Accrued interest of convertible senior notes | 1,842 | 1,652 | |
Accrued expenses and other current liabilities | 8,735 | 8,891 | |
Total current liabilities | 20,738 | 24,875 | |
NON-CURRENT LIABILITIES: | |||
Convertible senior notes, net | 86,117 | 96,450 | |
Warrants liability | 25,629 | ||
Accrued severance pay | 1,403 | 1,914 | |
Long-term operating lease liabilities | 2,461 | 4,867 | |
Other long-term liabilities | 1,873 | 4,690 | |
Total non-current liabilities | 117,483 | 107,921 | |
CONTINGENT LIABILITIES AND COMMITMENTS | |||
Share capital - | |||
Ordinary shares of NIS 0.01 par value - Authorized: 225,000,000 and 150,000,000 shares at June 30, 2023 (unaudited) and December 31, 2022, respectively; Issued: 112,425,611 and 74,703,030 shares at June 30, 2023 (unaudited) and December 31, 2022, respectively; Outstanding: 112,274,165 and 74,583,026 shares at June 30, 2023 (unaudited) and December 31, 2022, respectively | 305 | 211 | |
Treasury ordinary shares of NIS 0.01 par value - 151,446 and 120,004 shares at June 30, 2023 (unaudited) and December 31, 2022, respectively | [1] | ||
Additional paid-in capital | 443,450 | 408,598 | |
Accumulated deficit | (469,468) | (416,832) | |
Total shareholders’ deficit | (25,713) | (8,023) | |
Total liabilities and shareholders’ deficit | $ 112,508 | $ 124,773 | |
[1]Represents an amount lower than $1. |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) - $ / shares | Jun. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Ordinary shares par value (in Dollars per share) | $ 0.01 | $ 0.01 |
Ordinary shares authorized | 225,000,000 | 150,000,000 |
Ordinary shares Issued | 112,425,611 | 74,703,030 |
Ordinary shares outstanding | 112,274,165 | 74,583,026 |
Treasury ordinary shares par value (in Dollars per share) | $ 0.01 | $ 0.01 |
Treasury ordinary shares | 151,446 | 120,004 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Income Statement [Abstract] | ||||
Research and development expenses, net | $ 8,687 | $ 10,563 | $ 17,527 | $ 21,868 |
Commercial expenses | 3,862 | 3,193 | 9,438 | 7,072 |
General and administrative expenses | 6,253 | 4,290 | 11,417 | 8,429 |
Total operating loss | 18,802 | 18,046 | 38,382 | 37,369 |
Financial expenses, net | 12,874 | 508 | 14,254 | 1,408 |
Loss | $ 31,676 | $ 18,554 | $ 52,636 | $ 38,777 |
Net loss per share attributable to ordinary shareholders, basic (in Dollars per share) | $ 0.31 | $ 0.31 | $ 0.59 | $ 0.65 |
Weighted average number of shares used in computing net loss per share attributable to ordinary shareholders, basic (in Shares) | 102,921,207 | 59,546,273 | 89,913,214 | 59,510,918 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations (Unaudited) (Parentheticals) - $ / shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Income Statement [Abstract] | ||||
Net loss per share attributable to ordinary shareholders, diluted (in Dollars per share) | $ 0.31 | $ 0.31 | $ 0.59 | $ 0.65 |
Weighted average number of shares used in computing net loss per share attributable to ordinary shareholders, diluted | 102,921,207 | 59,546,273 | 89,913,214 | 59,510,918 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Changes in Shareholders’ Deficit (Unaudited) - USD ($) $ in Thousands | Ordinary shares | Treasury shares | Additional paid-in capital | Accumulated deficit | Total | ||
Balance at Dec. 31, 2021 | $ 169 | $ 381,225 | $ (337,457) | $ 43,937 | |||
Balance (in Shares) at Dec. 31, 2021 | 59,970,389 | ||||||
Issuance of ordinary shares upon release of restricted share units | |||||||
Issuance of ordinary shares upon release of restricted share units (in Shares) | 3,600 | ||||||
Treasury shares | |||||||
Treasury shares (in Shares) | (82,685) | ||||||
Exercise of options | 76 | 76 | |||||
Exercise of options (in Shares) | 47,426 | ||||||
Issuance of ordinary shares, net of issuance expenses | [1] | 84 | 84 | ||||
Issuance of ordinary shares, net of issuance expenses (in Shares) | [1] | 38,458 | |||||
Share-based compensation | 2,530 | 2,530 | |||||
Loss | (38,777) | (38,777) | |||||
Balance at Jun. 30, 2022 | $ 169 | [2] | 383,915 | (376,234) | 7,850 | ||
Balance (in Shares) at Jun. 30, 2022 | 59,977,188 | ||||||
Balance at Mar. 31, 2022 | $ 169 | [2] | 382,495 | (357,680) | 24,984 | ||
Balance (in Shares) at Mar. 31, 2022 | 59,946,298 | ||||||
Treasury shares | |||||||
Treasury shares (in Shares) | (7,568) | ||||||
Issuance of ordinary shares, net of issuance expenses | [3] | 84 | 84 | ||||
Issuance of ordinary shares, net of issuance expenses (in Shares) | [3] | 38,458 | |||||
Share-based compensation | 1,336 | 1,336 | |||||
Loss | (18,554) | (18,554) | |||||
Balance at Jun. 30, 2022 | $ 169 | [2] | 383,915 | (376,234) | 7,850 | ||
Balance (in Shares) at Jun. 30, 2022 | 59,977,188 | ||||||
Balance at Dec. 31, 2022 | $ 211 | [2] | 408,598 | (416,832) | $ (8,023) | ||
Balance (in Shares) at Dec. 31, 2022 | 74,583,026 | ||||||
Issuance of ordinary shares upon release of restricted share units | |||||||
Issuance of ordinary shares upon release of restricted share units (in Shares) | 112,369 | ||||||
Treasury shares | |||||||
Treasury shares (in Shares) | (31,442) | ||||||
Exercise of options | |||||||
Exercise of options (in Shares) | 246 | 246 | |||||
Issuance of ordinary shares, net of issuance expenses | [4] | $ 77 | 15,522 | $ 15,599 | |||
Issuance of ordinary shares, net of issuance expenses (in Shares) | [4] | 27,782,870 | |||||
Issuance of ordinary shares, for 2022 Note | $ 17 | 16,364 | 16,381 | ||||
Issuance of ordinary shares, for 2022 Note (in Shares) | 9,793,826 | ||||||
Exercise of warrants liability | 45 | 45 | |||||
Exercise of warrants liability (in Shares) | 33,270 | ||||||
Share-based compensation | 2,921 | 2,921 | |||||
Loss | (52,636) | (52,636) | |||||
Balance at Jun. 30, 2023 | $ 305 | [2] | 443,450 | (469,468) | (25,713) | ||
Balance (in Shares) at Jun. 30, 2023 | 112,274,165 | ||||||
Balance at Mar. 31, 2023 | $ 222 | [2] | 422,203 | (437,792) | (15,367) | ||
Balance (in Shares) at Mar. 31, 2023 | 82,033,646 | ||||||
Issuance of ordinary shares upon release of restricted share units | |||||||
Issuance of ordinary shares upon release of restricted share units (in Shares) | 4,742 | ||||||
Treasury shares | |||||||
Treasury shares (in Shares) | (27,775) | ||||||
Exercise of options | |||||||
Exercise of options (in Shares) | 246 | ||||||
Issuance of ordinary shares, net of issuance expenses | [3] | $ 67 | 10,315 | 10,382 | |||
Issuance of ordinary shares, net of issuance expenses (in Shares) | [3] | 24,210,755 | |||||
Issuance of ordinary shares, for 2022 Note | $ 16 | 9,465 | 9,481 | ||||
Issuance of ordinary shares, for 2022 Note (in Shares) | 6,019,281 | ||||||
Exercise of warrants liability | 45 | 45 | |||||
Exercise of warrants liability (in Shares) | 33,270 | ||||||
Share-based compensation | 1,422 | 1,422 | |||||
Loss | (31,676) | (31,676) | |||||
Balance at Jun. 30, 2023 | $ 305 | [2] | $ 443,450 | $ (469,468) | $ (25,713) | ||
Balance (in Shares) at Jun. 30, 2023 | 112,274,165 | ||||||
[1]Issuance costs of approximately $3.[2]Represents an amount lower than $1[3]Issuance costs of approximately $2,163[4]Issuance costs of approximately $2,325 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Cash flows from operating activities: | ||
Loss | $ (52,636) | $ (38,777) |
Adjustments to reconcile loss to net cash used in operating activities: | ||
Depreciation of property, plant and equipment | 214 | 224 |
Financing expense (income), net | 1,363 | (273) |
Share-based compensation | 2,921 | 2,530 |
Change in Fair Value of Warrants liability | 4,876 | |
Change in Fair Value of convertible senior note | 4,254 | |
Warrants Issuance Costs | 1,733 | |
Amortization of loan issuance costs | 455 | 385 |
Change in assets and liabilities: | ||
Inventory | (295) | |
Operating lease right-of-use assets | 1,363 | 1,226 |
Operating lease liabilities | (1,553) | (1,649) |
Accrued severance pay, net | (99) | 14 |
Increase in prepaid expenses and other assets | (211) | (19) |
Decrease in trade payables | (3,944) | (5,535) |
Increase (decrease) in accrued expenses and other liabilities | (2,728) | 2,285 |
Net cash used in operating activities | (44,287) | (39,589) |
Cash flows from investing activities: | ||
Purchase of property, plant and equipment | (821) | (1,540) |
Purchase of marketable securities | (3,708) | |
Proceeds from maturity of marketable securities | 26,175 | |
Proceeds from restricted deposits | 500 | |
Net cash provided by (used in) investing activities | (821) | 21,427 |
Cash flows from financing activities: | ||
Proceeds from exercise of options | 76 | |
Proceeds from exercise of warrants liability | 45 | |
Proceeds from share issuance and warrants liability, net | 34,785 | 84 |
Warrants issuance cost | (166) | |
Net cash provided by financing activities | 34,664 | 160 |
Decrease in cash and cash equivalents and restricted cash | (10,444) | (18,002) |
Cash and cash equivalents at beginning of period | 64,657 | 55,892 |
Cash and cash equivalents and restricted cash at end of period | 54,213 | 37,890 |
Significant non-cash transactions: | ||
Purchase of property, plant and equipment on credit | 282 | |
Exercise of 2022 Note principal | 15,000 | |
Exercise of 2022 Note interest | 1,332 | |
Supplemental disclosures of cash flow information: | ||
Cash paid for interest | $ (3,228) | $ (2,203) |
General
General | 6 Months Ended |
Jun. 30, 2023 | |
General [Abstract] | |
GENERAL | NOTE 1:- GENERAL a. Gamida Cell Ltd. (the “Company”), founded in 1998, is a cell therapy pioneer working to turn cells into powerful therapeutics. The Company applies a proprietary expansion platform leveraging the properties of nicotinamide, or NAM, to allogeneic cell sources including umbilical cord blood-derived cells and natural killer, or NK, cells to create cell therapy candidates, with the potential to redefine standards of care. b. On April 17, 2023, the U.S. Food and Drug Administration (“FDA”) approved the Company’s allogenic cell therapy, Omisirge (omidubicel-onlv), for use in adult and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection. In addition, the Company has applied its NAM cell expansion technology to NK cells, to develop its initial NK product candidate, GDA-201, an investigational, NK cell-based immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. In March 2023, the Company announced a strategic reprioritization of its business activities to primarily focus on the commercial launch of Omisirge. c. Prior to FDA approval of Omisirge in April 2023, the Company devoted 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 June 30, 2023 was $469,468 and negative cash flows from operating activities during the six-month period ended June 30, 2023 were $44,287. The Company’s management plan is to seek a strategic partnership to support the commercialization of Omisirge or seek additional financing as required to fund its operations until achieving positive cash flows. d. 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. e. 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. The subsidiary was created to assist with the commercialization of the Company’s products in the United States. |
Significant Accounting Policies
Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2023 | |
Significant Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | NOTE 2: SIGNIFICANT ACCOUNTING POLICIES a. 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 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, 2022 filed with the SEC on March 31, 2023. 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. b. Use of estimates: The preparation of the unaudited 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. c. Inventories: Inventories are stated at the lower of cost or net realizable value; cost is determined using the standard cost. The Company regularly evaluates its ability to realize the value of inventory. If the inventories are deemed damaged, if actual demand for the Company’s therapies deteriorates, or if market conditions are less favorable than those projected, inventory write-offs may be required. During the three and six months period ended June 30, 2023, no write-offs were recorded. d. Recently adopted accounting standards: In June 2016, FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. ASU 2016-13 amends the impairment model to utilize an expected loss methodology in place of the currently used incurred loss methodology, which will result in the more timely recognition of losses. Topic 326 was effective for the Company beginning on January 1, 2023, and effective January 1, 2023, the Company adopted the standard. Adoption of the standard did not have an impact on the financial statements. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2023 | |
Leases [Abstract] | |
LEASES | NOTE 3:- LEASES The Company has entered into operating leases primarily for its production plant and its laboratories and offices. The leases have remaining lease terms of up to five 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 are as follows: Six months ended 2023 2022 Operating lease costs $ 1,160 $ 1,417 Short-term lease costs 82 84 Total lease costs $ 1,242 $ 1,501 Three months ended 2023 2022 Operating lease costs $ 497 $ 781 Short-term lease costs - 60 Total lease costs $ 497 $ 841 Supplemental balance sheet information related to operating leases is as follows: Six months ended Weighted average remaining lease term (in years) 3.09 Weighted average discount rate 3.35 % Maturities of lease liabilities were as follows: As of 2023 1,347 2024 1,200 2025 1,062 2026 706 Thereafter 541 Total undiscounted lease payments 4,856 Less: Imputed interest (219 ) Present value of lease liabilities $ 4,637 |
Convertible Senior Notes, Net
Convertible Senior Notes, Net | 6 Months Ended |
Jun. 30, 2023 | |
Convertible Senior Notes, Net [Abstract] | |
CONVERTIBLE SENIOR NOTES, NET | NOTE 4: CONVERTIBLE SENIOR NOTES, NET a. On February 16, 2021, the Subsidiary issued convertible senior notes (the “2021 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 2021 Notes bear interest payable semiannually in arrears, at a rate of 5.875% per year. The 2021 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 2021 Notes have the right, prior to the close of business on the second scheduled trading day immediately preceding February 15, 2026, to convert any 2021 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 2021 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 2021 Notes may require the Company to repurchase for cash all or a portion of their 2021 Notes, in multiples of $1,000 principal amount, at a repurchase price equal to 100% of the principal amount of the 2021 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 2021 Notes may be increased. Subject to the provisions of the Indenture, the Subsidiary may redeem for cash all or a portion of the 2021 Notes for cash, at its option, at a redemption price equal to 100% of the principal amount of the 2021 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 Company accounts for its 2021 Notes in accordance with ASC 470-20 “Debt with Conversion and Other Options.” The 2021 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 2023 As of Liability component: Principal amount $ 75,000 $ 75,000 Issuance costs (4,223 ) (4,223 ) Net of issuance costs 70,777 70,777 Amortized issuance costs 1,836 1,423 Net carrying amount $ 72,613 $ 72,200 The total issuance costs of the 2021 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 2021 Notes. As of June 30, 2023, and December 31, 2022, the total estimated fair value of the 2021 Notes was $74,883 and $73,331, respectively. The fair value was determined using the Company’s effective rates for June 30, 2023 and December 31, 2022. The fair value of the 2021 Notes is classified as Level 3, see Note 5 below for further details. b. In December 2022, the Company, as guarantor, and the Subsidiary entered into a Loan and Security Agreement (the “Loan Agreement”) with certain funds managed by Highbridge Capital Management, LLC (collectively, “Highbridge”), as the lenders (together with the other lenders from time to time party thereto, the “Lenders”), and Wilmington Savings Fund Society, FSB, as collateral agent and administrative agent. Pursuant to the Loan Agreement, the Subsidiary issued $25 million aggregate principal amount of convertible senior notes (the “2022 Note”). The 2022 Note bears interest of 7.5% which will be paid on a quarterly basis and monthly principal installment payments. The 2022 Note is exchangeable, at the option of the Lenders, into ordinary shares at an exchange rate of 0.52356 ordinary shares per $1.00 principal amount (equivalent to an exchange price of $1.91 per share), together with a make-whole premium equal to all accrued and unpaid and remaining coupons due through the maturity date. The exchange rate is subject to adjustment in the event of ordinary share dividends, reclassifications and certain other fundamental transactions affecting the ordinary shares. In addition, under certain circumstances, the Company can issue ordinary shares in exchange for the discharge of the monthly principal installment payments. The Loan Agreement contains customary representations and warranties and covenants, including a $20.0 million minimum liquidity covenant and certain negative covenants restricting dispositions, changes in business and business locations, mergers and acquisitions, indebtedness, issuances of preferred stock, liens, collateral accounts, restricted payments, transactions with affiliates, compliance with laws, and issuances of capital stock. Most of these restrictions are subject to certain minimum thresholds and exceptions. Certain of the negative covenants will terminate when less than $5.0 million of principal amount is outstanding under the Loan Agreement. As of June 30, 2023, the Company is in compliance with such covenants. The Company has elected the fair value option to measure the 2022 Note upon issuance, in accordance with ASC 825-10. Under the fair value option, the 2022 Note is measured at fair value each period with changes in fair value reported in the statements of operations. According to ASC 825-10, changes in fair value that are caused by changes in the instrument-specific credit risk will be presented separately in other comprehensive income (loss). As of June 30, 2023, the Company issued 8,737,870 and 1,055,956 ordinary shares in exchange for the discharge of $15,000 of the aggregate outstanding balance and the discharge of $1,331 interest make-whole payments, respectively, in respect of the 2022 Note. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Measurements [Abstract] | |
FAIR VALUE MEASUREMENTS | NOTE 5: FAIR VALUE MEASUREMENTS Cash and cash equivalents, restricted cash, restricted deposits, prepaid expenses and other assets, trade payables and accrued expenses and other liabilities, are stated at their carrying value which approximates their fair value due to the short time to the expected receipt or payment. The following tables present information about the Company’s financial assets and liabilities that are measured in fair value on a recurring basis as of June 30, 2023 and December 31, 2022: June 30, 2023 December 31, 2022 Level 1 Level 3 Total Level 1 Level 3 Total Financial assets: Money market funds included in cash and cash equivalent $ 47,559 $ 47,559 $ 58,827 $ - $ 58,827 Total Assets Measured at Fair Value 47,559 47,559 58,827 - 58,827 Financial Liabilities: 2022 Note - 13,504 13,504 - 24,250 24,250 Warrants liability - 25,629 25,629 - - - Total liabilities measured at fair value $ - $ 39,133 $ 39,133 $ - $ 24,250 $ 24,250 The Company classifies cash equivalents within Level 1, and the 2021 Notes, 2022 Note and warrants liability are classified within Level 3, because the Company uses quoted market prices or alternative pricing sources and models utilizing market observable inputs to determine their fair values. The warrants liability was valued using a Black Scholes Option Pricing Model, which is considered to be a Level 3 fair value measurement. The Black Scholes model’s primary unobservable input utilized in determining the fair value of the Private warrants is the expected volatility of the ordinary shares. The expected volatility was implied from a blend of the Company’s own ordinary share and the average historical share volatilities of several unrelated public companies within the Company’s industry that the Company considers to be comparable to its own business. The following table summarizes the warrants liability activity as of June 30, 2023: Warrant Initial Measurement (April 21, 2023) $ 20,753 Change in fair value 4,876 Balance June 30, 2023 $ 25,629 The key inputs used in the valuation of the warrants liability as of June 30, 2023 and April 21, 2023, the initial measurement date, are included below: Input June 30, April, 21, Exercise Price $ 1.35 $ 1.35 Share price on date $ 1.93 $ 1.60 Risk-free rate 4.1 % 3.7 % Expected Volatility 90 % 91 % Time to liquidation (years) 4.7 5.0 Dividend Rate 0 % 0 % The 2022 Note was valued using the Monte Carlo simulation analysis to generate expected future cash flows based on movement in the Company’s stock price. These future cash flows were then discounted to present value. Cash flows associated with the future conversion of loan principal into shares were discounted at the risk-free rate commensurate with the remaining term of the loan. Future cash flows resulting from the contractual debt payments were discounted at a market yield. The significant inputs into the Monte Carlo simulation were the closing stock price as of June 30, 2023, volatility analysis of the stock, and the risk-free rate using U.S. Treasury Constant Maturity Rate for the remaining time between the valuation date and maturity date. The fair value for the 2022 Note liability as of June 30, 2023 and December 31, 2022: 2022 Notes Balance December 31, 2022 $ 24,250 2023 Principal Reduction (15,000 ) Change in fair value 4,254 Balance June 30, 2023 $ 13,504 The key inputs used in the valuation of the 2022 Note liability as of June 30, 2023 and December 31, 2022 the initial measurement date: Input June 30, December 31, Voluntary Conversion Price $ 1.91 $ 1.91 Share price on date $ 1.93 $ 1.29 Risk-free rate 5.2 % 4.4 % Expected Volatility 100 % 75 % Implied Yield 31.0 % 32.8 % |
Contingent Liabilities and Comm
Contingent Liabilities and Commitments | 6 Months Ended |
Jun. 30, 2023 | |
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 June 30, 2023, the Company obtained bank guarantees in the amount of $2,773, primarily in connection with an Investment Center grant which requires a bank guarantee in order to ensure the fulfillment of the grant terms. c. Government grants: The Company has received grants from the Israeli Innovation Authority (the “IIA”) to finance its research and development programs in Israel, through which the Company received IIA participation payments in the aggregate amount of $37,082 through June 30, 2023, of which $34,477 is royalty-bearing grants and $2,605 is non-royalty-bearing grants. In return, the Company is committed to pay IIA royalties at a rate of 3-5% of future sales of the developed products, up to 100% of the amount of grants received plus interest at LIBOR rate. Through June 30, 2023, no royalties have been paid or accrued. The Company’s contingent royalty liability to the IIA at June 30, 2023, including grants received by the Company and the associated LIBOR interest on all such grants totaled to $43,187. d. Lonza Settlement: In December 2022, the Company signed an agreement with Lonza Netherlands B.V., or Lonza, to mutually terminate their Service Agreement, whereas the Company shall pay Lonza an aggregate amount of 8.0 million Euros. As of June 30, 2023, the Company paid the first payment of 1.5 million Euro, 2.5 million Euro will be paid in 2023 and the remaining 4 million Euro will be paid in 2024. |
Shareholders' Equity
Shareholders' Equity | 6 Months Ended |
Jun. 30, 2023 | |
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 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 for gross proceeds of approximately $20,000,000, before deducting underwriting discounts and commissions and estimated offering expenses. On April 19, 2023, the Company issued and sold, in an underwritten public offering, 17,500,000 of its ordinary shares and accompanying warrants to purchase 17,500,000 ordinary shares at a public offering price of $1.30 per ordinary share and accompanying warrants, for gross proceeds of approximately $22.8 million, before deducting underwriting discounts and commissions, and estimated offering expenses of $1.9 million. As of June 30, 2023, the Company raised $13,765 in net proceeds in 2023 by issuing 10,282,870 shares via an ATM facility, at an average public offering price of $1.38. b. Warrants to investors: As part of its April 2023 underwritten public offering of its securities, the Company granted certain investors 17,500,000 warrants to purchase the Company’s ordinary shares that will expire on April 21, 2028. The warrants were classified as a liability on the balance sheet initially, and subsequently measured at fair value on the consolidated statement of operations, as the warrants are not considered indexed to the Company’s own equity pursuant to ASC 815-40. The change in fair value of the warrants liability was recognized in financial expenses, net, in the consolidated statements of operation. As of June 30, 2023, 33,270 of such warrants have been exercised into the Company’s ordinary shares. c. Treasury Shares: During the three months ended June 30, 2023, the Company cancelled 27,775 outstanding restricted shares. |
Share-Based Compensation
Share-Based Compensation | 6 Months Ended |
Jun. 30, 2023 | |
Share-Based Compensation [Abstract] | |
SHARE-BASED COMPENSATION | NOTE 8: SHARE-BASED COMPENSATION a. Option plans: Under the Company’s amended 2014 Israel Share Option Plan (the “2014 Plan”), 1,152,044 ordinary shares were allocated to the Company’s employees. No equity grants under the 2014 Plan remain outstanding. 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 six months ended June 30, 2023 and 2022: Six months ended 2023 2022 (unaudited) Dividend yield 0 % 0 % Expected volatility of the share prices 74 % 66 % Risk-free interest rate 3.7 % 2.8 % Expected term (in years) 8 8 Based on the above inputs, the fair value of the options was determined to be $1.06 - $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 June 30, 2023 and related information: Number of Weighted average Balance as of December 31, 2022 6,133,903 $ 4.62 Granted 2,018,234 1.53 Exercised (246 ) 0.25 Forfeited (410,901 ) 3.01 Expired (292,628 ) 6.00 Balance as of June 30, 2023 (unaudited) 7,448,362 3.86 Exercisable as of June 30, 2023 (unaudited) 3,343,425 5.36 As of June 30, 2023, there are $8,570 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 share units activity as of June 30, 2023 is as follows: Number of Weighted (unaudited) (unaudited) Unvested as of December 31, 2022 1,126,743 $ 3.29 Granted 986,706 1.54 Vested (212,843 ) 4.22 Forfeited (222,191 ) 2.60 Unvested as of June 30, 2023 (unaudited) 1,678,415 2.23 d. The total share-based compensation expense related to all of the Company’s equity-based awards, recognized for the three and six months ended June 30, 2023 and 2022 is comprised as follows: Three months ended Six months ended 2023 2022 2023 2022 (unaudited) Research and development expenses, net $ 382 $ 553 $ 796 $ 1,018 Commercial expenses 357 358 691 648 General and administrative expenses 683 425 1,434 864 Total share-based compensation $ 1,422 $ 1,336 $ 2,921 $ 2,530 |
Basic and Diluted Net Loss Per
Basic and Diluted Net Loss Per Share | 6 Months Ended |
Jun. 30, 2023 | |
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.” Details of the number of shares and loss used in the computation of loss per share: Three months ended June 30, Six months ended June 30, 2023 2022 2023 2022 Unaudited Weighted Net loss Weighted Net loss Weighted Net loss Weighted Net loss For the computation of basic and diluted loss 102,921,207 31,676 59,546,273 18,554 89,913,214 52,636 59,510,918 38,788 All outstanding warrants, share options, and restricted shares, as well as any shares issuable upon exchange of the convertible senior notes, for the three and six months ended June 30, 2023 and 2022 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 Six months ended 2023 2022 2023 2022 (unaudited) Convertible senior notes 11,832,124 4,222,973 11,832,124 4,222,973 Warrants 17,466,730 3,313,512 17,466,730 3,313,512 Share options 7,406,981 5,132,921 7,014,715 4,946,420 Restricted shares 1,696,224 1,322,782 1,503,128 1,178,583 Total 38,402,059 13,992,188 37,816,697 13,661,488 |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2023 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 10: SUBSEQUENT EVENTS From July 1, 2023 through August 9, 2023, the Company raised an additional $14.0 million in net proceeds by issuing 9,249,115 ordinary shares via an ATM facility, at an average public offering price of $1.56. From July 1, 2023 through August 9, 2023, we made a monthly installment payment of $0.6 million on the 2022 Note. As of August 9, 2023, the outstanding principal amount of the 2022 Note is $9.4 million. |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
Significant Accounting Policies [Abstract] | |
Basis of presentation of the financial statements: | a. 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 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. |
Use of estimates: | b. Use of estimates: The preparation of the unaudited 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. |
Inventories: | c. Inventories: Inventories are stated at the lower of cost or net realizable value; cost is determined using the standard cost. The Company regularly evaluates its ability to realize the value of inventory. If the inventories are deemed damaged, if actual demand for the Company’s therapies deteriorates, or if market conditions are less favorable than those projected, inventory write-offs may be required. During the three and six months period ended June 30, 2023, no write-offs were recorded. |
Recently adopted accounting standards: | d. Recently adopted accounting standards: In June 2016, FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. ASU 2016-13 amends the impairment model to utilize an expected loss methodology in place of the currently used incurred loss methodology, which will result in the more timely recognition of losses. Topic 326 was effective for the Company beginning on January 1, 2023, and effective January 1, 2023, the Company adopted the standard. Adoption of the standard did not have an impact on the financial statements. |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Leases [Abstract] | |
Schedule of Operating Lease Costs | The components of operating lease costs are as follows: Six months ended 2023 2022 Operating lease costs $ 1,160 $ 1,417 Short-term lease costs 82 84 Total lease costs $ 1,242 $ 1,501 Three months ended 2023 2022 Operating lease costs $ 497 $ 781 Short-term lease costs - 60 Total lease costs $ 497 $ 841 |
Schedule of Supplemental Balance Sheet Information Related to Operating Leases | Supplemental balance sheet information related to operating leases is as follows: Six months ended Weighted average remaining lease term (in years) 3.09 Weighted average discount rate 3.35 % |
Schedule of Maturities of Lease Liabilities | Maturities of lease liabilities were as follows: As of 2023 1,347 2024 1,200 2025 1,062 2026 706 Thereafter 541 Total undiscounted lease payments 4,856 Less: Imputed interest (219 ) Present value of lease liabilities $ 4,637 |
Convertible Senior Notes, Net (
Convertible Senior Notes, Net (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Convertible Senior Notes, Net [Abstract] | |
Schedule of Liability Measured at its Amortized Cost | As of 2023 As of Liability component: Principal amount $ 75,000 $ 75,000 Issuance costs (4,223 ) (4,223 ) Net of issuance costs 70,777 70,777 Amortized issuance costs 1,836 1,423 Net carrying amount $ 72,613 $ 72,200 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Measurements [Abstract] | |
Schedule of Financial Assets and Liabilities that are Measured in Fair Value | The following tables present information about the Company’s financial assets and liabilities that are measured in fair value on a recurring basis as of June 30, 2023 and December 31, 2022: June 30, 2023 December 31, 2022 Level 1 Level 3 Total Level 1 Level 3 Total Financial assets: Money market funds included in cash and cash equivalent $ 47,559 $ 47,559 $ 58,827 $ - $ 58,827 Total Assets Measured at Fair Value 47,559 47,559 58,827 - 58,827 Financial Liabilities: 2022 Note - 13,504 13,504 - 24,250 24,250 Warrants liability - 25,629 25,629 - - - Total liabilities measured at fair value $ - $ 39,133 $ 39,133 $ - $ 24,250 $ 24,250 |
Schedule of Warrants Liability Activity | The following table summarizes the warrants liability activity as of June 30, 2023: Warrant Initial Measurement (April 21, 2023) $ 20,753 Change in fair value 4,876 Balance June 30, 2023 $ 25,629 |
Schedule of Note Liability Initial Measurement Date | The key inputs used in the valuation of the warrants liability as of June 30, 2023 and April 21, 2023, the initial measurement date, are included below: Input June 30, April, 21, Exercise Price $ 1.35 $ 1.35 Share price on date $ 1.93 $ 1.60 Risk-free rate 4.1 % 3.7 % Expected Volatility 90 % 91 % Time to liquidation (years) 4.7 5.0 Dividend Rate 0 % 0 % |
Schedule of Note Liability | The fair value for the 2022 Note liability as of June 30, 2023 and December 31, 2022: 2022 Notes Balance December 31, 2022 $ 24,250 2023 Principal Reduction (15,000 ) Change in fair value 4,254 Balance June 30, 2023 $ 13,504 |
Schedule of Note Liability Initial Measurement Date | The key inputs used in the valuation of the 2022 Note liability as of June 30, 2023 and December 31, 2022 the initial measurement date: Input June 30, December 31, Voluntary Conversion Price $ 1.91 $ 1.91 Share price on date $ 1.93 $ 1.29 Risk-free rate 5.2 % 4.4 % Expected Volatility 100 % 75 % Implied Yield 31.0 % 32.8 % |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Share-Based Compensation [Abstract] | |
Schedule of Fair Value Measurement of Equity-Settled Share Options | 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 six months ended June 30, 2023 and 2022: Six months ended 2023 2022 (unaudited) Dividend yield 0 % 0 % Expected volatility of the share prices 74 % 66 % Risk-free interest rate 3.7 % 2.8 % Expected term (in years) 8 8 |
Schedule of Stock Option Plans | The following table summarizes the number of options granted to employees under the Option Plans as of June 30, 2023 and related information: Number of Weighted average Balance as of December 31, 2022 6,133,903 $ 4.62 Granted 2,018,234 1.53 Exercised (246 ) 0.25 Forfeited (410,901 ) 3.01 Expired (292,628 ) 6.00 Balance as of June 30, 2023 (unaudited) 7,448,362 3.86 Exercisable as of June 30, 2023 (unaudited) 3,343,425 5.36 |
Schedule of Restricted Shares Activity | A summary of restricted shares and restricted share units activity as of June 30, 2023 is as follows: Number of Weighted (unaudited) (unaudited) Unvested as of December 31, 2022 1,126,743 $ 3.29 Granted 986,706 1.54 Vested (212,843 ) 4.22 Forfeited (222,191 ) 2.60 Unvested as of June 30, 2023 (unaudited) 1,678,415 2.23 |
Schedule of Share-Based Compensation Expense | The total share-based compensation expense related to all of the Company’s equity-based awards, recognized for the three and six months ended June 30, 2023 and 2022 is comprised as follows: Three months ended Six months ended 2023 2022 2023 2022 (unaudited) Research and development expenses, net $ 382 $ 553 $ 796 $ 1,018 Commercial expenses 357 358 691 648 General and administrative expenses 683 425 1,434 864 Total share-based compensation $ 1,422 $ 1,336 $ 2,921 $ 2,530 |
Basic and Diluted Net Loss Pe_2
Basic and Diluted Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Basic and Diluted Net Loss Per Share [Abstract] | |
Schedule of Number of Shares and Loss Used in the Computation of Net Loss Per Share | Details of the number of shares and loss used in the computation of loss per share: Three months ended June 30, Six months ended June 30, 2023 2022 2023 2022 Unaudited Weighted Net loss Weighted Net loss Weighted Net loss Weighted Net loss For the computation of basic and diluted loss 102,921,207 31,676 59,546,273 18,554 89,913,214 52,636 59,510,918 38,788 |
Schedule of Outstanding Warrants, Share Options, and Restricted Shares | All outstanding warrants, share options, and restricted shares, as well as any shares issuable upon exchange of the convertible senior notes, for the three and six months ended June 30, 2023 and 2022 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 Six months ended 2023 2022 2023 2022 (unaudited) Convertible senior notes 11,832,124 4,222,973 11,832,124 4,222,973 Warrants 17,466,730 3,313,512 17,466,730 3,313,512 Share options 7,406,981 5,132,921 7,014,715 4,946,420 Restricted shares 1,696,224 1,322,782 1,503,128 1,178,583 Total 38,402,059 13,992,188 37,816,697 13,661,488 |
General (Details)
General (Details) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 USD ($) | Dec. 31, 2022 USD ($) | |
General [Abstract] | ||
Accumulated deficit | $ (469,468) | $ (416,832) |
Cash flows from operating activities | $ 44,287 | |
Operating segment | 1 |
Leases (Details)
Leases (Details) | Jun. 30, 2023 |
Leases [Abstract] | |
Lease term | 5 years |
Leases (Details) - Schedule of
Leases (Details) - Schedule of Operating Lease Costs - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Schedule of Operating Lease Costs [Abstract] | ||||
Operating lease costs | $ 497 | $ 781 | $ 1,160 | $ 1,417 |
Short-term lease costs | 60 | 82 | 84 | |
Total lease costs | $ 497 | $ 841 | $ 1,242 | $ 1,501 |
Leases (Details) - Schedule o_2
Leases (Details) - Schedule of Supplemental Balance Sheet Information Related to Operating Leases | Jun. 30, 2023 |
Schedule of Operating Leases [Abstract] | |
Weighted average remaining lease term (in years) | 3 years 1 month 2 days |
Weighted average discount rate | 3.35% |
Leases (Details) - Schedule o_3
Leases (Details) - Schedule of Maturities of Lease Liabilities $ in Thousands | Jun. 30, 2023 USD ($) |
Schedule of Maturities of Lease Liabilities [Abstract] | |
2023 | $ 1,347 |
2024 | 1,200 |
2025 | 1,062 |
2026 | 706 |
Thereafter | 541 |
Total undiscounted lease payments | 4,856 |
Less: Imputed interest | (219) |
Present value of lease liabilities | $ 4,637 |
Convertible Senior Notes, Net_2
Convertible Senior Notes, Net (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 6 Months Ended | |||
Dec. 31, 2022 | Feb. 16, 2021 | Jun. 30, 2023 | Apr. 19, 2023 | Sep. 27, 2022 | |
Convertible Senior Notes, Net (Details) [Line Items] | |||||
Aggregate principal amount | $ 25,000 | ||||
Annual interest percentage | 5.875% | 7.50% | |||
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) | $ 1.29 | $ 1.93 | |||
Repurchase price | 100% | ||||
Exchange price percentage | 130% | ||||
Convertible notes | $ 4,223 | ||||
Effective interest rate | 7.37% | ||||
Total estimated fair value | $ 73,331 | $ 74,883 | |||
Ordinary shares exchange rate (in Dollars per share) | $ 0.52356 | ||||
Principal amount per share (in Dollars per share) | 1 | ||||
Exchange price per share (in Dollars per share) | $ 1.91 | $ 1.3 | $ 1.55 | ||
Principal amount | $ 5,000 | ||||
Aggregate outstanding balance | 15,000 | ||||
Interest make-whole payment | $ 1,331 | ||||
Ordinary Shares [Member] | |||||
Convertible Senior Notes, Net (Details) [Line Items] | |||||
Exchange price (in Dollars per share) | $ 17.76 | ||||
Warrant [Member] | |||||
Convertible Senior Notes, Net (Details) [Line Items] | |||||
Minimum liquidity covenant | $ 20,000 | ||||
Maximum [Member] | |||||
Convertible Senior Notes, Net (Details) [Line Items] | |||||
Ordinary shares issued (in Shares) | 8,737,870 | ||||
Minimum [Member] | |||||
Convertible Senior Notes, Net (Details) [Line Items] | |||||
Ordinary shares issued (in Shares) | 1,055,956 | ||||
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 - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2023 | Dec. 31, 2022 | |
Liability component: | ||
Principal amount | $ 75,000 | $ 75,000 |
Issuance costs | (4,223) | (4,223) |
Net of issuance costs | 70,777 | 70,777 |
Amortized issuance costs | 1,836 | 1,423 |
Net carrying amount | $ 72,613 | $ 72,200 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Schedule of Financial Assets and Liabilities that are Measured in Fair Value - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2023 | Dec. 31, 2022 | |
Financial assets: | ||
Money market funds included in cash and cash equivalent | $ 47,559 | $ 58,827 |
Total Assets Measured at Fair Value | 47,559 | 58,827 |
Financial Liabilities: | ||
2022 Note | 13,504 | 24,250 |
Warrants liability | 25,629 | |
Total liabilities measured at fair value | 39,133 | 24,250 |
Level 1 [Member] | ||
Financial assets: | ||
Money market funds included in cash and cash equivalent | 47,559 | 58,827 |
Total Assets Measured at Fair Value | 47,559 | 58,827 |
Financial Liabilities: | ||
2022 Note | ||
Warrants liability | ||
Total liabilities measured at fair value | ||
Level 3 [Member] | ||
Financial assets: | ||
Money market funds included in cash and cash equivalent | ||
Total Assets Measured at Fair Value | ||
Financial Liabilities: | ||
2022 Note | 13,504 | 24,250 |
Warrants liability | 25,629 | |
Total liabilities measured at fair value | $ 39,133 | $ 24,250 |
Fair Value Measurements (Deta_2
Fair Value Measurements (Details) - Schedule of Warrants Liability Activity - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2023 | Dec. 31, 2023 | |
Schedule of Warrants Liability Activity [Abstract] | ||
Initial Measurement (April 21, 2023) | $ 20,753 | |
Change in fair value | $ (4,254) | 4,876 |
Balance June 30, 2023 | $ 25,629 | $ 25,629 |
Fair Value Measurements (Deta_3
Fair Value Measurements (Details) - Schedule of Warrants Liability Initial Measurement Date - $ / shares | 2 Months Ended | |
Jun. 30, 2023 | Apr. 21, 2023 | |
Schedule of Warrants Liability Initial Measurement Date [Abstract] | ||
Exercise Price (in Dollars per share) | $ 1.35 | $ 1.35 |
Share price on date (in Dollars per share) | $ 1.93 | $ 1.6 |
Risk-free rate | 4.10% | 3.70% |
Expected Volatility | 90% | 91% |
Time to liquidation (years) | 4 years 8 months 12 days | 5 years |
Dividend Rate | 0% | 0% |
Fair Value Measurements (Deta_4
Fair Value Measurements (Details) - Schedule of Note Liability - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2023 | |
Schedule of Note Liability [Abstract] | |||
Balance December 31, 2022 | $ 24,250 | $ 24,250 | |
2023 Principal Reduction | (15,000) | ||
Change in fair value | 4,254 | $ (4,876) | |
Balance June 30, 2023 | $ 13,504 |
Fair Value Measurements (Deta_5
Fair Value Measurements (Details) - Schedule of Note Liability Initial Measurement Date - $ / shares | 6 Months Ended | |
Jun. 30, 2023 | Dec. 31, 2022 | |
Schedule of Note Liability Initial Measurement Date [Abstract] | ||
Voluntary Conversion Price (in Dollars per share) | $ 1.91 | $ 1.91 |
Share price on date (in Dollars per share) | $ 1.93 | $ 1.29 |
Risk-free rate | 5.20% | 4.40% |
Expected Volatility | 100% | 75% |
Implied Yield | 31% | 32.80% |
Contingent Liabilities and Co_2
Contingent Liabilities and Commitments (Details) € in Millions | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2023 USD ($) | Jun. 30, 2023 EUR (€) | Dec. 31, 2022 EUR (€) | |
Contingent Liabilities and Commitments (Details) [Line Items] | |||
Bank guarantees amount | $ 2,773 | ||
Investment center remaining amount | 37,082 | ||
Royalty-bearing grants | 34,477 | ||
Non-royalty-bearing grants | $ 2,605 | ||
Percentage of interest rate | 100% | 100% | |
Total grants | $ 43,187 | ||
Termination of aggregate amount (in Euro) | € | € 8 | ||
Service agreement remaining payment (in Euro) | € | € 4 | ||
Minimum [Member] | |||
Contingent Liabilities and Commitments (Details) [Line Items] | |||
Royalties rate | 3% | ||
Service agreement first payment (in Euro) | € | 1.5 | ||
Maximum [Member] | |||
Contingent Liabilities and Commitments (Details) [Line Items] | |||
Royalties rate | 5% | ||
Service agreement first payment (in Euro) | € | € 2.5 |
Shareholders' Equity (Details)
Shareholders' Equity (Details) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | ||
Apr. 19, 2023 | Sep. 27, 2022 | Jun. 30, 2023 | |
Shareholders’ Equity [Abstract] | |||
Ordinary shares | 17,500,000 | 12,905,000 | |
Price per share (in Dollars per share) | $ 1.3 | $ 1.55 | $ 1.91 |
Gross proceeds (in Dollars) | $ 22,800 | $ 20,000,000 | |
Purchase of ordinary shares | 17,500,000 | ||
Preferred Units, Offering Costs (in Dollars) | $ 1,900 | ||
Net proceeds (in Dollars) | $ 13,765 | ||
Issuance of shares | 10,282,870 | ||
Public offering price (in Dollars per share) | $ 1.38 | ||
Purchase of warrants | 17,500,000 | ||
Warrants expired | will expire on April 21, 2028 | ||
Warrants exercised | 33,270 | ||
Outstanding restricted shares | 27,775 |
Share-Based Compensation (Detai
Share-Based Compensation (Details) $ / shares in Units, $ in Thousands | 6 Months Ended | |||
Jun. 30, 2023 USD ($) $ / shares shares | Dec. 28, 2017 shares | Jun. 26, 2017 shares | Jan. 23, 2017 ₪ / shares shares | |
Share-Based Compensation (Details) [Line Items] | ||||
Ordinary shares | shares | 1,152,044 | |||
Ordinary shares outstanding percentage | 4% | |||
Share-based compensation non-vested (in Dollars) | $ | $ 8,570 | |||
2017 Share Incentive Plan [Member] | ||||
Share-Based Compensation (Details) [Line Items] | ||||
Number of shares reserved for issuance | shares | 1,338,015 | 559,764 | 463,384 | 312,867 |
Nominal per share value (in New Shekels per share) | ₪ / shares | ₪ 0.01 | |||
Minimum [Member] | ||||
Share-Based Compensation (Details) [Line Items] | ||||
Grant date fair value per share (in Dollars per share) | $ / shares | $ 1.06 | |||
Maximum [Member] | ||||
Share-Based Compensation (Details) [Line Items] | ||||
Grant date fair value per share (in Dollars per share) | $ / shares | $ 1.85 |
Share-Based Compensation (Det_2
Share-Based Compensation (Details) - Schedule of Fair Value Measurement of Equity-Settled Share Options | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Schedule of Fair Value Measurement of Equity-Settled Share Options [Abstract] | ||
Dividend yield | 0% | 0% |
Expected volatility of the share prices | 74% | 66% |
Risk-free interest rate | 3.70% | 2.80% |
Expected term (in years) | 8 years | 8 years |
Share-Based Compensation (Det_3
Share-Based Compensation (Details) - Schedule of Stock Option Plans - $ / shares | 6 Months Ended |
Jun. 30, 2023 | |
Schedule of Stock Option Plans [Abstract] | |
Number of options, beginning Balance | 6,133,903 |
Weighted average exercise price, beginning Balance | $ 4.62 |
Number of options, Granted | 2,018,234 |
Weighted average exercise price, Granted | $ 1.53 |
Number of options, Exercised | (246) |
Weighted average exercise price, Exercised | $ 0.25 |
Number of options, Forfeited | (410,901) |
Weighted average exercise price, Forfeited | $ 3.01 |
Number of options, Expired | (292,628) |
Weighted average exercise price, Expired | $ 6 |
Number of options, ending Balance | 7,448,362 |
Weighted average exercise price, ending Balance | $ 3.86 |
Number of options, Exercised | 3,343,425 |
Weighted average exercise price, Exercised | $ 5.36 |
Share-Based Compensation (Det_4
Share-Based Compensation (Details) - Schedule of Restricted Shares Activity | 6 Months Ended |
Jun. 30, 2023 $ / shares shares | |
Schedule of Restricted Shares Activity [Abstract] | |
Number of restricted shares and restricted share units, Unvested beginning | shares | 1,126,743 |
Weighted average grant date fair value, Unvested beginning | $ / shares | $ 3.29 |
Number of restricted shares and restricted share units, Granted | shares | 986,706 |
Weighted average grant date fair value, Granted | $ / shares | $ 1.54 |
Number of restricted shares and restricted share units, Vested | shares | (212,843) |
Weighted average grant date fair value, Vested | $ / shares | $ 4.22 |
Number of restricted shares and restricted share units, Forfeited | shares | (222,191) |
Weighted average grant date fair value, Forfeited | $ / shares | $ 2.6 |
Number of restricted shares and restricted share units, Unvested ending | shares | 1,678,415 |
Weighted average grant date fair value, Unvested ending | $ / shares | $ 2.23 |
Share-Based Compensation (Det_5
Share-Based Compensation (Details) - Schedule of Share-Based Compensation Expense - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Schedule of Share Based Compensation Expense [Abstract] | ||||
Research and development expenses, net | $ 382 | $ 553 | $ 796 | $ 1,018 |
Commercial expenses | 357 | 358 | 691 | 648 |
General and administrative expenses | 683 | 425 | 1,434 | 864 |
Total share-based compensation | $ 1,422 | $ 1,336 | $ 2,921 | $ 2,530 |
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 | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Schedule of Number of Shares and Loss Used in the Computation of Net Loss Per Share [Abstract] | ||||
Weighted number of shares, basic | 102,921,207 | 59,546,273 | 89,913,214 | 59,510,918 |
Net loss attributable to equity holders of the Company | $ 31,676 | $ 18,554 | $ 52,636 | $ 38,788 |
Basic and Diluted Net Loss Pe_4
Basic and Diluted Net Loss Per Share (Details) - Schedule of Number of Shares and Loss Used in the Computation of Net Loss Per Share (Parentheticals) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Schedule of Number of Shares and Loss Used in the Computation of Net Loss Per Share [Abstract] | ||||
Weighted number of shares, diluted | 102,921,207 | 59,546,273 | 89,913,214 | 59,510,918 |
Basic and Diluted Net Loss Pe_5
Basic and Diluted Net Loss Per Share (Details) - Schedule of Outstanding Warrants, Share Options, and Restricted Shares - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Schedule of Outstanding Convertible Senior Note Options, Warrants, Outstanding Share Options, and Restricted Shares [Abstract] | ||||
Convertible senior notes | 11,832,124 | 4,222,973 | 11,832,124 | 4,222,973 |
Warrants | 17,466,730 | 3,313,512 | 17,466,730 | 3,313,512 |
Outstanding share options | 7,406,981 | 5,132,921 | 7,014,715 | 4,946,420 |
Restricted shares | 1,696,224 | 1,322,782 | 1,503,128 | 1,178,583 |
Total | 38,402,059 | 13,992,188 | 37,816,697 | 13,661,488 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent Event [Member] $ / shares in Units, $ in Millions | Aug. 09, 2023 USD ($) $ / shares shares |
Subsequent Events (Details) [Line Items] | |
Additional capital | $ 14 |
Ordinary shares (in Shares) | shares | 9,249,115 |
Price per share (in Dollars per share) | $ / shares | $ 1.56 |
Sale of stock value | $ 0.6 |
Principal amount | $ 9.4 |