Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 10, 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 | 132,638,514 | |
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, 2023 | |
Document Fiscal Year Focus | 2023 | |
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, 2023 | Dec. 31, 2022 | |
CURRENT ASSETS: | |||
Cash and cash equivalents | $ 60,431 | $ 64,657 | |
Short-term restricted deposit | 2,723 | ||
Inventory | 2,324 | ||
Accounts receivable | 676 | ||
Prepaid expenses and other current assets | 2,355 | 1,889 | |
Total current assets | 68,509 | 66,546 | |
NON-CURRENT ASSETS: | |||
Restricted deposits | 377 | 3,668 | |
Property, plant and equipment, net | 42,667 | 44,319 | |
Operating lease right-of-use assets | 3,706 | 7,024 | |
Severance pay fund | 1,288 | 1,703 | |
Other long-term assets | 1,201 | 1,513 | |
Total non-current assets | 49,239 | 58,227 | |
Total assets | 117,748 | 124,773 | |
CURRENT LIABILITIES: | |||
Trade payables | 1,664 | 6,384 | |
Employees and payroll accruals | 6,058 | 5,300 | |
Operating lease liabilities | 1,497 | 2,648 | |
Accrued interest of convertible senior notes | 710 | 1,652 | |
Accrued expenses and other current liabilities | 10,725 | 8,891 | |
Total current liabilities | 20,654 | 24,875 | |
NON-CURRENT LIABILITIES: | |||
Convertible senior notes, net | 81,419 | 96,450 | |
Warrants liability | 11,610 | ||
Accrued severance pay | 1,381 | 1,914 | |
Long-term operating lease liabilities | 2,302 | 4,867 | |
Other long-term liabilities | 4,690 | ||
Total non-current liabilities | 96,712 | 107,921 | |
CONTINGENT LIABILITIES AND COMMITMENTS | |||
Ordinary shares of NIS 0.01 par value - Authorized: 225,000,000 and 150,000,000 shares at September 30, 2023 (unaudited) and December 31, 2022; Issued: 132,083,914 and 74,703,030 at September 30, 2023 (unaudited) and December 31, 2022, respectively; Outstanding: 131,931,600 and 74,583,026 shares at September 30, 2023 (unaudited) and December 31, 2022, respectively | 357 | 211 | |
Treasury Ordinary shares of NIS 0.01 par value – 152,314 and 120,004 shares at September 30, 2023 (unaudited) and December 31, 2022, respectively | [1] | ||
Additional paid-in capital | 471,012 | 408,598 | |
Accumulated deficit | (470,987) | (416,832) | |
Total shareholders’ equity (deficit) | 382 | (8,023) | |
Total liabilities and shareholders’ equity (deficit) | $ 117,748 | $ 124,773 | |
[1]Represents less than $1. |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) - $ / shares | Sep. 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 | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Statement [Abstract] | ||||
Net revenue | $ 673 | $ 673 | ||
Cost of sales | 626 | 626 | ||
Research and development expenses, net | 4,248 | 9,864 | 21,776 | 31,732 |
Selling, general and administrative | 13,837 | 7,197 | 34,691 | 22,698 |
Total operating expenses | 18,085 | 17,061 | 56,467 | 54,430 |
Total operating loss | 18,038 | 17,061 | 56,420 | 54,430 |
Financial (income) expenses, net | (16,519) | 741 | (2,265) | 2,149 |
Net loss | $ 1,519 | $ 17,802 | $ 54,155 | $ 56,579 |
Net loss per share attributable to ordinary shareholders, basic and diluted (in Dollars per share) | $ 0.01 | $ 0.29 | $ 0.53 | $ 0.95 |
Weighted average number of shares used in computing net loss per share attributable to ordinary shareholders, basic and diluted (in Shares) | 124,236,300 | 60,440,765 | 101,479,968 | 59,821,655 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations (Unaudited) (Parentheticals) - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Statement [Abstract] | ||||
Net loss per share attributable to ordinary shareholders, diluted (in Dollars per share) | $ 0.01 | $ 0.29 | $ 0.53 | $ 0.95 |
Weighted average number of shares used in computing net loss per share attributable to ordinary shareholders, diluted | 124,236,300 | 60,440,765 | 101,479,968 | 59,821,655 |
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 | |||||||||
Grant of restricted shares | [1] | [1] | ||||||||
Grant of restricted shares (in Shares) | 3,600 | |||||||||
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 (in Shares) | (3,085) | |||||||||
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 | |||||||||
Treasury shares | [1] | |||||||||
Balance at Dec. 31, 2022 | $ 211 | [1] | 408,598 | (416,832) | $ (8,023) | |||||
Balance (in Shares) at Dec. 31, 2022 | 74,583,026 | 74,583,026 | ||||||||
Grant of restricted shares (in Shares) | 2,127,834 | |||||||||
Issuance of ordinary shares upon release of restricted share units | $ 1 | 1 | $ 2 | |||||||
Issuance of ordinary shares upon release of restricted share units (in Shares) | 348,998 | |||||||||
Treasury shares (in Shares) | (32,310) | |||||||||
Exercise of options | [1] | [1] | [1] | |||||||
Exercise of options (in Shares) | 1,066 | 1,066 | ||||||||
Issuance of ordinary shares, net of issuance expenses ** | [2] | $ 127 | 41,118 | $ 41,245 | ||||||
Issuance of ordinary shares, net of issuance expenses ** (in Shares) | [2] | 46,671,195 | ||||||||
Issuance of ordinary shares for 2022 Notes | $ 18 | 16,953 | 16,971 | |||||||
Issuance of ordinary shares for 2022 Notes (in Shares) | 10,326,355 | |||||||||
Exercise of warrants liability | [1] | 45 | 45 | |||||||
Exercise of warrants liability (in Shares) | 33,270 | |||||||||
Share-based compensation | 4,297 | 4,297 | ||||||||
Loss | (54,155) | (54,155) | ||||||||
Balance at Sep. 30, 2023 | $ 357 | [1] | 471,012 | (470,987) | $ 382 | |||||
Balance (in Shares) at Sep. 30, 2023 | 131,931,600 | 112,274,165 | ||||||||
Balance at Jun. 30, 2023 | $ 305 | [1] | 443,450 | (469,468) | $ (25,713) | |||||
Balance (in Shares) at Jun. 30, 2023 | 112,274,165 | |||||||||
Issuance of ordinary shares upon release of restricted share units | $ 1 | 1 | 2 | |||||||
Issuance of ordinary shares upon release of restricted share units (in Shares) | 236,629 | |||||||||
Treasury shares (in Shares) | (868) | |||||||||
Exercise of options | [1] | [1] | [1] | |||||||
Exercise of options (in Shares) | 820 | |||||||||
Issuance of ordinary shares, net of issuance expenses ** | $ 51 | 25,596 | 25,647 | |||||||
Issuance of ordinary shares, net of issuance expenses ** (in Shares) | 18,888,325 | |||||||||
Issuance of ordinary shares for 2022 Notes | [3] | [1] | 589 | 589 | ||||||
Issuance of ordinary shares for 2022 Notes (in Shares) | [3] | 532,529 | ||||||||
Share-based compensation | 1,376 | 1,376 | ||||||||
Loss | (1,519) | (1,519) | ||||||||
Balance at Sep. 30, 2023 | $ 357 | [1] | $ 471,012 | $ (470,987) | $ 382 | |||||
Balance (in Shares) at Sep. 30, 2023 | 131,931,600 | 112,274,165 | ||||||||
Treasury shares | [1] | |||||||||
[1]Represents less than $1.[2]Issuance costs of approximately $2,951.[3]Issuance costs of approximately $793. |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Statement of Cash Flows [Abstract] | ||
Loss | $ (54,155) | $ (56,579) |
Adjustments to reconcile loss to net cash used in operating activities: | ||
Depreciation of property, plant and equipment | 1,024 | 391 |
Financing expense (income), net | 61 | (2,461) |
Share-based compensation | 4,297 | 3,829 |
Change in Fair Value of warrants liability | (9,143) | |
Change in Fair Value in convertible notes | 1,039 | |
Warrants issuance costs | 1,733 | |
Amortization of debt discount and issuance costs | 625 | 582 |
Inventory | (92) | |
Operating lease right-of-use assets | 2,020 | 1,922 |
Operating lease liabilities | (2,417) | (2,395) |
Increase in accounts receivable | (676) | |
Increase (decrease) accrued severance pay, net | (118) | 23 |
(Increase) decrease in prepaid expenses and other assets | (239) | 1,719 |
Decrease in trade payables | (4,720) | (6,355) |
Increase (decrease) in accrued expenses and other liabilities | (2,096) | 5,079 |
Net cash used in operating activities | (62,857) | (54,245) |
Purchase of property, plant and equipment | (833) | (2,865) |
Purchase of marketable securities | (4,557) | |
Proceeds from maturity of marketable securities | 37,972 | |
Proceeds from restricted deposits | 294 | 500 |
Net cash provided by (used in) investing activities | (539) | 31,050 |
Proceeds from exercise of warrants | 45 | |
Proceeds from exercise of options | 76 | |
Principal payments of convertible senior note | (1,142) | |
Proceeds from share issuance and warrants liability, net | 60,267 | 22,298 |
Net cash provided by financing activities | 59,170 | 22,374 |
Decrease in cash and cash equivalents | (4,226) | (821) |
Cash and cash equivalents at beginning of period | 64,657 | 55,892 |
Cash and cash equivalents at end of period | 60,431 | 55,071 |
Purchase of property, plant and equipment on credit | 281 | |
Cash paid for interest | $ (5,685) | $ (4,406) |
General
General | 9 Months Ended |
Sep. 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 (“NAM”) to allogeneic cell sources including umbilical cord blood-derived cells and natural killer (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 approved the Company’s allogeneic 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. c. In March 2023, the Company announced a strategic reprioritization of its business activities to primarily focus on the commercial launch of Omisirge. d. In October 2023, the Company announced early data from 10 patients with CD20 positive non-Hodgkin lymphoma that are in the first three cohorts in an ongoing multicenter Phase 1/2 study of NK cell therapy candidate GDA-201. The study is designed to evaluate safety and determine the maximum tolerated dose. The patients were heavily pretreated with a median of six prior lines of therapy, including CAR-T cell therapy (six patients) and hematopoietic stem cell transplant (four patients). Preliminary results showed marked shrinkage of target lesions in five patients; efficacy evaluation showed two patients with complete response, two with partial response, and one with stable disease. No dose-limiting toxicities were reported in the 10 patients treated with doses up to 1x10 8 Activity appears to be dose dependent with two of the three patients in Cohort 3 responding. The fourth and final cohort of the Phase 1 portion of the study, at the target dose level of 2x10 8 e. 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 September 30, 2023 was $470,987 and negative cash flows from operating activities during the nine months ended September 30, 2023 were $62,857. 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. However, there is no assurance that capital financing and/or a strategic transaction will be available to the Company, and even if available, whether it will be on terms acceptable to the Company or in amounts required. f. 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. g. 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 | 9 Months Ended |
Sep. 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, judgements 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. Estimates may include: revenue recognition, such as returns of product sold, stock-based compensation, inventory, and impairment of long lived assets. Actual results could differ from those estimates. c. Inventories: Inventories are stated at the lower of cost or net realizable value. The Company regularly evaluates its ability to realize the value of inventory. If the inventories are deemed damaged, if actual demand of the Company’s therapies deteriorates, or if market conditions are less favorable than those projected, inventory reserves or write-offs may be required. During the three and nine months period ended September 30, 2023, a reserve for slow-moving inventory approaching expiration dates and inventory write-offs were recorded. d. Revenue recognition: Revenues are recognized in accordance with ASC 606. Revenue from contracts with customers is recognized when control of the promised goods or services is transferred to the customers, in an amount that reflects the consideration the Company expects to receive in exchange for those goods or services. The Company’s revenues are comprised of product revenue from the sales of Omisirge. Gamida Cell has a sole distributor in the United States and sells to this customer under the Flash Title model, whereby the third-party partner takes ownership but does not handle physical storage or distribution. The customer in turn resells the product to the transplant centers, while also managing the order to cash processes. To determine revenue recognition for arrangements the Company determines that are within the scope of Topic 606, the Company performs the following five steps: (i) Identify the contract(s) with a customer: The Company enters into an enforceable contract with a customer that (1) defines each party’s rights regarding delivery of and payment for a product, (2) the contract has commercial substance and (3) the Company determines that collection of substantially all consideration for such product is probable based on the payer’s intent and ability to pay the promised consideration. (ii) Identify the performance obligations in the contract: The Company’s sales contracts include the delivery of Omisirge, which represent the Company’s single performance obligation under each contract. (iii) Determine the transaction price: The transaction price is determined based on the consideration to which the Company will be entitled in exchange for providing a product to the customer. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the net realizable value utilizing either the expected value method or the most likely amount method depending on the nature of the variable consideration. Variable consideration is included in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Product revenues are recognized, net of variable consideration related to certain allowances and accruals, at the time of delivery to the transplant center. (iv) Allocate the transaction price to the performance obligations in the contract: If a contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. (v) Recognize revenue when (or as) the entity satisfies a performance obligation: Revenue is recognized when or as performance obligations are satisfied by transferring control of a promised good or service to a customer. Control either transfers over time or at a point in time, which affects when revenue is recorded. Revenues from sales of products are recognized at the point in time of transfer of control of the product, which is the time of delivery to a transplant center. e. Accounts receivable: The Company’s accounts receivable balance consists of amounts due from product sales to a single customer, which is the Company’s sole distributor of Omisirge in the United States. Under the Flash Title model, whereby the third-party partner takes ownership does not handle physical storage or distribution. Gamida Cell sells to this customer which in turn resells the product to the transplant centers, while also managing the order to cash processes. f. Cost of sales: Cost of sales in 2023 were direct costs attributable to the production of Omisirge, including raw materials, production, labor, and certain maintenance and indirect manufacturing overhead costs, quality testing directly related to each product batch, and depreciation on capital expenditure relating to the manufacturing facility that Gamida Cell has purchased to produce Omisirge. It also includes any cost of batch failure losses and royalty expenses. Cost of sales for Omisirge are recognized when incurred. g. Selling, general & administrative: Beginning July 1, 2023, the Company’s reporting of operating expenses was modified to reflect the Company’s transition to the commercial stage, with all operating costs now reported as either research and development expenses, or selling, general & administrative (SG&A) expenses. For 2022 and the first two quarters of 2023, previously reported commercial and general & administrative costs were combined into SG&A expenses. Beyond commercial and general & administrative costs, SG&A also includes certain indirect manufacturing and quality expenses, excess capacity costs and medical affairs expenditures. Excess capacity costs reflect those labor and manufacturing overhead costs incurred, but not absorbed in cost of sales in the period, given that our facility is staffed to produce the anticipated demand over the course of the coming year. h. 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 is effective for the Company beginning on January 1, 2023. Effective January 1, 2023, the Company adopted the standard. Adoption of the standard did not have an impact on the financial statements. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2023 | |
Leases | |
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 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 were as follows: Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 Unaudited Operating lease costs $ 746 $ 676 $ 1,906 $ 2,093 Short-term lease costs - 8 82 92 Total lease costs $ 746 $ 684 $ 1,988 $ 2,185 Supplemental balance sheet information related to operating leases is as follows: Nine months ended September 30, Unaudited Weighted average remaining lease term (in years) 3.16 Weighted average discount rate 2.80 % Maturities of lease liabilities were as follows: September 30, 2023 Unaudited 2023 $ 624 2024 1,203 2025 1,071 2026 710 Thereafter 541 Total undiscounted lease payments 4,149 Less - imputed interest (350 ) Present value of lease liabilities $ 3,799 |
Convertible Senior Notes, Net
Convertible Senior Notes, Net | 9 Months Ended |
Sep. 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. September 30, December 31, 2023 2022 Unaudited 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 2,048 1,423 Net carrying amount $ 72,825 $ 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 September 30, 2023, and December 31, 2022, the total estimated fair value of the 2021 Notes was $75,483 and $73,331, respectively. The fair value was determined using the Company’s effective rates for September 30, 2023 and December 31, 2022. The fair value of the 2021 Notes are 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 convertible senior notes with an aggregate principal amount of $25 million (the “2022 Notes”). The 2022 Notes bear interest of 7.5% which is paid on a quarterly basis and require monthly principal installment payments. The 2022 Notes are 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 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 September 30, 2023, the Company is in compliance with such covenants. The Company has elected the fair value option to measure the 2022 Notes upon issuance, in accordance with ASC 825-10. Under the fair value option, the 2022 Notes are 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 September 30, 2023, the Company issued 9,168,058 and 1,158,297 Ordinary shares in exchange for the discharge of $15,554 of the outstanding principal balance and the discharge of $1,418 of interest payments, respectively, in respect of the 2022 Notes. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Measurements [Abstract] | |
FAIR VALUE MEASUREMENTS | NOTE 5: FAIR VALUE MEASUREMENTS Cash and cash equivalents, 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 Company classifies cash equivalents within Level 1, and the 2021 Notes, 2022 Notes 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 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 September 30, 2023 and December 31, 2022: September 30, 2023 (unaudited) December 31, 2022 Level 1 Level 3 Total Level 1 Level 3 Total Financial assets: Money market funds included in cash and cash equivalent $ 56,222 $ - $ 56,222 $ 58,827 $ - $ 58,827 Total assets measured at fair value $ 56,222 $ - $ 56,222 $ 58,827 $ - $ 58,827 Financial Liabilities: 2022 Notes $ - $ 8,594 $ 8,594 $ - $ 24,250 $ 24,250 Warrants liability - 11,610 $ 11,610 - - - Total liabilities measured at fair value $ - $ 20,204 $ 20,204 $ - $ 24,250 $ 24,250 In connection with the April 19, 2023 public offering of Ordinary shares, the Company granted certain investors warrants to purchase 17,500,000 Ordinary shares at an exercise price of $1.35 per share. 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 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 public warrant pricing, 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 warrant liability activity as of September 30, 2023: Warrant liability Initial measurement (April 21, 2023) $ 20,753 Change in fair value (9,143 ) Balance at September 30, 2023 (unaudited) $ 11,610 The key inputs used in the valuation of the warrants liability as of September 30, 2023 and April 21, 2023, the initial measurement date, are included below: Input September 30, April, 21, Exercise price $ 1.35 $ 1.35 Share price on date $ 1.03 $ 1.60 Risk-free rate 4.6 % 3.7 % Expected volatility 89 % 91 % Dividend Rate 0 % 0 % The 2022 Notes were 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 September 30, 2023, a volatility analysis of the stock, and the risk-free rate using the U.S. Treasury Constant Maturity Rate for the remaining time between the valuation date and maturity date. The fair value for the 2022 Notes liability as of September 30, 2023 and December 31, 2022: 2022 Balance at December 31, 2022 $ 24,250 2023 principal payments and conversions (16,695 ) Change in fair value 1,039 Balance at September 30, 2023 (unaudited) $ 8,594 The key inputs used in the valuation of the 2022 Notes liability as of September 30, 2023 and December 31, 2022, the initial measurement date: September 30, December 31, 2023 2022 Unaudited Voluntary conversion price $ 1.91 $ 1.91 Share price on date $ 1.03 $ 1.29 Risk-free rate 5.4 % 4.4 % Expected volatility 100 % 75 % Implied yield 31.5 % 32.8 % |
Contingent Liabilities and Comm
Contingent Liabilities and Commitments | 9 Months Ended |
Sep. 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 the 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, 2023, the Company obtained bank guarantees in the amount of $2,686, primarily in connection with an Israeli Investment Center grant 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 Israeli Innovation Authority (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 September 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 the LIBOR rate. Through September 30, 2023, the Company has accrued $20 in royalty expenses. The Company’s contingent royalty liability to the IIA at September 30, 2023, including grants received by the Company and the associated LIBOR interest on all such grants totaled to $43,447. 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 $8,479 (€8,000). As of September 30, 2023, the Company had paid the first payment of $1,594 (€1,500); an additional $2,646 (€2,500) will be paid in 2023 and the remaining $4,240 (€4,000) will be paid in 2024. US dollar amounts for this payment obligation were estimated using the € to US dollar exchange rate on September 30, 2023, as this payment obligation is in €. |
Shareholders' Equity
Shareholders' Equity | 9 Months Ended |
Sep. 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, as amended, 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 participate 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, before deducting underwriting discounts and commissions and offering expenses. On April 19, 2023, the Company issued and sold 17,500,000 of its Ordinary shares at a public offering price of $1.30 per ordinary share and accompanying warrants to purchase 17,500,000 Ordinary shares, for gross proceeds of approximately $22.8 million, before deducting underwriting discounts and commissions and offering expenses, of $1.9 million. As of September 30, 2023, the Company had raised $39,412 in net proceeds by issuing 29,171,195 shares via an ATM offering, at an average public offering price of $1.39 per share. 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 through earnings, 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 is recognized in financial expenses, net, in the consolidated statements of operation. During the nine months ended September 30, 2023, 33,270 of such warrants were exercised in exchange for 32,270 of the Company’s Ordinary shares. c. Treasury shares: During the nine months ended September 30, 2023, the Company cancelled 32,310 outstanding restricted shares, whereby the restricted shares became treasury shares. |
Share-Based Compensation
Share-Based Compensation | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Compensation [Abstract] | |
SHARE-BASED COMPENSATION | NOTE 8: SHARE-BASED COMPENSATION a. Option plans: On January 23, 2017, the Company’s Board of Directors approved the Company’s 2017 Share Incentive Plan (the “2017 Plan”), 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 February 25, 2021 and November 17, 2021, the board of directors and shareholders, respectively, approved an amendment and restatement of the 2017 Plan. The 2017 Plan, as amended, also contains an “evergreen” provision, which provides for an automatic allotment of Ordinary shares to be added every year to the pool of Ordinary shares available for grant under the 2017 Plan. Under the evergreen provision, on January 1 of each year (beginning January 1, 2022), the number of Ordinary shares available under the 2017 Plan automatically increases by the lesser of the following: (i) 4% of our outstanding Ordinary shares on the last day of the immediately preceding year; and (ii) an amount determined in advance of January 1 by the board of directors. As of September 30, 2023, 2,025,064 shares were reserved for issuance under the 2017 Plan. 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, 2023 and 2022: Nine months ended September 30, 2023 2022 Unaudited Dividend yield 0 % 0 % Expected volatility of the share prices 73 % 66%-67 % Risk-free interest rate 4.3 % 1.8% - 3.5 % 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 as of September 30, 2023 under the Amended and Restated 2017 Plan as well as historical equity incentive plans under which no equity awards remain outstanding and related information: Number of options Weighted average exercise price Balance as of January 1, 2023 6,133,903 $ 4.62 Granted 2,127,834 1.53 Exercised (1,066 ) 0.25 Forfeited (641,406 ) 2.61 Expired (511,031 ) 5.57 Balance as of September 30, 2023 (unaudited) 7,108,234 3.85 Exercisable as of September 30, 2023 (unaudited) 3,955,093 4.75 As of September 30, 2023, there are $6,969 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 September 30, 2023 is as follows: Number of Weighted average grant date fair value (unaudited) (unaudited) Unvested as of January 1, 2023 1,126,743 $ 3.29 Granted 1,036,606 1.53 Vested (499,894 ) 2.85 Forfeited (333,173 ) 2.30 Unvested as of September 30, 2023 (unaudited) 1,330,282 2.33 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, 2023 and 2022 is comprised as follows: Three months ended Nine months ended 2023 2022 2023 2022 Unaudited Cost of sales expenses $ 3 $ - $ 3 $ - Research and development expenses, net 230 533 1,026 1,551 Selling, general and, administrative 1,143 766 3,268 2,278 Total share-based compensation $ 1,376 $ 1,299 $ 4,297 $ 3,829 |
Basic and Diluted Net Loss Per
Basic and Diluted Net Loss Per Share | 9 Months Ended |
Sep. 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 September 30, Nine months ended September 30, 2023 2022 2023 2022 Weighted Net loss Weighted Net loss Weighted Net loss Weighted Net loss Unaudited For the computation of basic and diluted loss 124,236,300 $ 1,519 60,440,765 $ 17,802 101,479,968 $ 54,155 59,821,655 $ 56,579 NOTE 9: BASIC AND DILUTED NET LOSS PER SHARE (Cont.) All outstanding convertible senior note options, warrants, outstanding share options, and restricted shares for the three and nine months ended September 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 numbers of potential shares excluded from the calculation of diluted net loss per share are as follows: Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 Unaudited Convertible senior notes 10,876,824 4,222,973 10,876,824 4,222,973 Warrants 17,466,730 108,049 17,466,730 2,233,283 Outstanding share options 7,083,976 5,189,188 6,774,012 4,964,826 Restricted shares 1,628,671 1,140,318 1,489,041 1,008,551 Total 37,056,201 $ 10,660,528 36,606,607 $ 12,429,633 |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2023 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 10: SUBSEQUENT EVENTS From October 1, 2023 through November 10, 2023, the Company raised an additional $499 in net proceeds by issuing 706,914 Ordinary shares via an ATM offering, at an average public offering price of $0.73. From October 1, 2023 through November 14, 2023, the Company made a monthly principal installment payment of $554 on the 2022 Note. The outstanding principal amount of the 2022 Note is $7,751 following this payment. On October 2, 2023 the Company paid $2,646 to Lonza as part of the termination of their Service Agreement. See Note 6 for further details. |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 9 Months Ended |
Sep. 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, judgements 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. Estimates may include: revenue recognition, such as returns of product sold, stock-based compensation, inventory, and impairment of long lived assets. Actual results could differ from those estimates. |
Inventories | c. Inventories: Inventories are stated at the lower of cost or net realizable value. The Company regularly evaluates its ability to realize the value of inventory. If the inventories are deemed damaged, if actual demand of the Company’s therapies deteriorates, or if market conditions are less favorable than those projected, inventory reserves or write-offs may be required. During the three and nine months period ended September 30, 2023, a reserve for slow-moving inventory approaching expiration dates and inventory write-offs were recorded. |
Revenue recognition | d. Revenue recognition: Revenues are recognized in accordance with ASC 606. Revenue from contracts with customers is recognized when control of the promised goods or services is transferred to the customers, in an amount that reflects the consideration the Company expects to receive in exchange for those goods or services. The Company’s revenues are comprised of product revenue from the sales of Omisirge. Gamida Cell has a sole distributor in the United States and sells to this customer under the Flash Title model, whereby the third-party partner takes ownership but does not handle physical storage or distribution. The customer in turn resells the product to the transplant centers, while also managing the order to cash processes. To determine revenue recognition for arrangements the Company determines that are within the scope of Topic 606, the Company performs the following five steps: (i) Identify the contract(s) with a customer: The Company enters into an enforceable contract with a customer that (1) defines each party’s rights regarding delivery of and payment for a product, (2) the contract has commercial substance and (3) the Company determines that collection of substantially all consideration for such product is probable based on the payer’s intent and ability to pay the promised consideration. (ii) Identify the performance obligations in the contract: The Company’s sales contracts include the delivery of Omisirge, which represent the Company’s single performance obligation under each contract. (iii) Determine the transaction price: The transaction price is determined based on the consideration to which the Company will be entitled in exchange for providing a product to the customer. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the net realizable value utilizing either the expected value method or the most likely amount method depending on the nature of the variable consideration. Variable consideration is included in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Product revenues are recognized, net of variable consideration related to certain allowances and accruals, at the time of delivery to the transplant center. (iv) Allocate the transaction price to the performance obligations in the contract: If a contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. (v) Recognize revenue when (or as) the entity satisfies a performance obligation: Revenue is recognized when or as performance obligations are satisfied by transferring control of a promised good or service to a customer. Control either transfers over time or at a point in time, which affects when revenue is recorded. Revenues from sales of products are recognized at the point in time of transfer of control of the product, which is the time of delivery to a transplant center. |
Accounts receivable | e. Accounts receivable: The Company’s accounts receivable balance consists of amounts due from product sales to a single customer, which is the Company’s sole distributor of Omisirge in the United States. Under the Flash Title model, whereby the third-party partner takes ownership does not handle physical storage or distribution. Gamida Cell sells to this customer which in turn resells the product to the transplant centers, while also managing the order to cash processes. |
Cost of sales | f. Cost of sales: Cost of sales in 2023 were direct costs attributable to the production of Omisirge, including raw materials, production, labor, and certain maintenance and indirect manufacturing overhead costs, quality testing directly related to each product batch, and depreciation on capital expenditure relating to the manufacturing facility that Gamida Cell has purchased to produce Omisirge. It also includes any cost of batch failure losses and royalty expenses. Cost of sales for Omisirge are recognized when incurred. |
Selling, general & administrative | g. Selling, general & administrative: Beginning July 1, 2023, the Company’s reporting of operating expenses was modified to reflect the Company’s transition to the commercial stage, with all operating costs now reported as either research and development expenses, or selling, general & administrative (SG&A) expenses. For 2022 and the first two quarters of 2023, previously reported commercial and general & administrative costs were combined into SG&A expenses. Beyond commercial and general & administrative costs, SG&A also includes certain indirect manufacturing and quality expenses, excess capacity costs and medical affairs expenditures. Excess capacity costs reflect those labor and manufacturing overhead costs incurred, but not absorbed in cost of sales in the period, given that our facility is staffed to produce the anticipated demand over the course of the coming year. |
Recently adopted accounting standards | h. 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 is effective for the Company beginning on January 1, 2023. 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) | 9 Months Ended |
Sep. 30, 2023 | |
Leases | |
Schedule of Operating Lease Costs | The components of operating lease costs were as follows: Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 Unaudited Operating lease costs $ 746 $ 676 $ 1,906 $ 2,093 Short-term lease costs - 8 82 92 Total lease costs $ 746 $ 684 $ 1,988 $ 2,185 |
Schedule of Supplemental Balance Sheet Information Related to Operating Leases | Supplemental balance sheet information related to operating leases is as follows: Nine months ended September 30, Unaudited Weighted average remaining lease term (in years) 3.16 Weighted average discount rate 2.80 % |
Schedule of Maturities of Lease Liabilities | Maturities of lease liabilities were as follows: September 30, 2023 Unaudited 2023 $ 624 2024 1,203 2025 1,071 2026 710 Thereafter 541 Total undiscounted lease payments 4,149 Less - imputed interest (350 ) Present value of lease liabilities $ 3,799 |
Convertible Senior Notes, Net (
Convertible Senior Notes, Net (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Convertible Senior Notes, Net [Abstract] | |
Schedule of Liability Measured at its Amortized Cost | September 30, December 31, 2023 2022 Unaudited 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 2,048 1,423 Net carrying amount $ 72,825 $ 72,200 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 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 September 30, 2023 and December 31, 2022: September 30, 2023 (unaudited) December 31, 2022 Level 1 Level 3 Total Level 1 Level 3 Total Financial assets: Money market funds included in cash and cash equivalent $ 56,222 $ - $ 56,222 $ 58,827 $ - $ 58,827 Total assets measured at fair value $ 56,222 $ - $ 56,222 $ 58,827 $ - $ 58,827 Financial Liabilities: 2022 Notes $ - $ 8,594 $ 8,594 $ - $ 24,250 $ 24,250 Warrants liability - 11,610 $ 11,610 - - - Total liabilities measured at fair value $ - $ 20,204 $ 20,204 $ - $ 24,250 $ 24,250 |
Schedule of Warrants Liability Activity | The following table summarizes the warrant liability activity as of September 30, 2023: Warrant liability Initial measurement (April 21, 2023) $ 20,753 Change in fair value (9,143 ) Balance at September 30, 2023 (unaudited) $ 11,610 |
Schedule of Note Liability Initial Measurement Date | The key inputs used in the valuation of the warrants liability as of September 30, 2023 and April 21, 2023, the initial measurement date, are included below: Input September 30, April, 21, Exercise price $ 1.35 $ 1.35 Share price on date $ 1.03 $ 1.60 Risk-free rate 4.6 % 3.7 % Expected volatility 89 % 91 % Dividend Rate 0 % 0 % |
Schedule of Note Liability | The fair value for the 2022 Notes liability as of September 30, 2023 and December 31, 2022: 2022 Balance at December 31, 2022 $ 24,250 2023 principal payments and conversions (16,695 ) Change in fair value 1,039 Balance at September 30, 2023 (unaudited) $ 8,594 |
Schedule of Note Liability Initial Measurement Date | The key inputs used in the valuation of the 2022 Notes liability as of September 30, 2023 and December 31, 2022, the initial measurement date: September 30, December 31, 2023 2022 Unaudited Voluntary conversion price $ 1.91 $ 1.91 Share price on date $ 1.03 $ 1.29 Risk-free rate 5.4 % 4.4 % Expected volatility 100 % 75 % Implied yield 31.5 % 32.8 % |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 9 Months Ended |
Sep. 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 nine months ended September 30, 2023 and 2022: Nine months ended September 30, 2023 2022 Unaudited Dividend yield 0 % 0 % Expected volatility of the share prices 73 % 66%-67 % Risk-free interest rate 4.3 % 1.8% - 3.5 % Expected term (in years) 8 8 |
Schedule of Stock Option Plans | The following table summarizes the number of options granted to employees as of September 30, 2023 under the Amended and Restated 2017 Plan as well as historical equity incentive plans under which no equity awards remain outstanding and related information: Number of options Weighted average exercise price Balance as of January 1, 2023 6,133,903 $ 4.62 Granted 2,127,834 1.53 Exercised (1,066 ) 0.25 Forfeited (641,406 ) 2.61 Expired (511,031 ) 5.57 Balance as of September 30, 2023 (unaudited) 7,108,234 3.85 Exercisable as of September 30, 2023 (unaudited) 3,955,093 4.75 |
Schedule of Restricted Shares Activity | A summary of restricted shares and restricted share units activity as of September 30, 2023 is as follows: Number of Weighted average grant date fair value (unaudited) (unaudited) Unvested as of January 1, 2023 1,126,743 $ 3.29 Granted 1,036,606 1.53 Vested (499,894 ) 2.85 Forfeited (333,173 ) 2.30 Unvested as of September 30, 2023 (unaudited) 1,330,282 2.33 |
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 nine months ended September 30, 2023 and 2022 is comprised as follows: Three months ended Nine months ended 2023 2022 2023 2022 Unaudited Cost of sales expenses $ 3 $ - $ 3 $ - Research and development expenses, net 230 533 1,026 1,551 Selling, general and, administrative 1,143 766 3,268 2,278 Total share-based compensation $ 1,376 $ 1,299 $ 4,297 $ 3,829 |
Basic and Diluted Net Loss Pe_2
Basic and Diluted Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 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 September 30, Nine months ended September 30, 2023 2022 2023 2022 Weighted Net loss Weighted Net loss Weighted Net loss Weighted Net loss Unaudited For the computation of basic and diluted loss 124,236,300 $ 1,519 60,440,765 $ 17,802 101,479,968 $ 54,155 59,821,655 $ 56,579 |
Schedule of Outstanding Warrants, Share Options, and Restricted Shares | All outstanding convertible senior note options, warrants, outstanding share options, and restricted shares for the three and nine months ended September 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 numbers of potential shares excluded from the calculation of diluted net loss per share are as follows: Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 Unaudited Convertible senior notes 10,876,824 4,222,973 10,876,824 4,222,973 Warrants 17,466,730 108,049 17,466,730 2,233,283 Outstanding share options 7,083,976 5,189,188 6,774,012 4,964,826 Restricted shares 1,628,671 1,140,318 1,489,041 1,008,551 Total 37,056,201 $ 10,660,528 36,606,607 $ 12,429,633 |
General (Details)
General (Details) $ in Thousands | 9 Months Ended | ||
Sep. 30, 2023 USD ($) segment | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
General [Abstract] | |||
Accumulated deficit | $ (470,987) | $ (416,832) | |
Cash flows from operating activities | $ (62,857) | $ (54,245) | |
Operating segment (in segment) | segment | 1 |
Leases (Details)
Leases (Details) | Sep. 30, 2023 |
Leases | |
Lease term | 5 years |
Leases (Details) - Schedule of
Leases (Details) - Schedule of Operating Lease Costs - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Schedule of Operating Lease Costs [Abstract] | ||||
Operating lease costs | $ 746 | $ 676 | $ 1,906 | $ 2,093 |
Short-term lease costs | 8 | 82 | 92 | |
Total lease costs | $ 746 | $ 684 | $ 1,988 | $ 2,185 |
Leases (Details) - Schedule o_2
Leases (Details) - Schedule of Supplemental Balance Sheet Information Related to Operating Leases | Sep. 30, 2023 |
Schedule of Operating Leases [Abstract] | |
Weighted average remaining lease term (in years) | 3 years 1 month 28 days |
Weighted average discount rate | 2.80% |
Leases (Details) - Schedule o_3
Leases (Details) - Schedule of Maturities of Lease Liabilities $ in Thousands | Sep. 30, 2023 USD ($) |
Schedule of Maturities of Lease Liabilities [Abstract] | |
2023 | $ 624 |
2024 | 1,203 |
2025 | 1,071 |
2026 | 710 |
Thereafter | 541 |
Total undiscounted lease payments | 4,149 |
Less - imputed interest | (350) |
Present value of lease liabilities | $ 3,799 |
Convertible Senior Notes, Net_2
Convertible Senior Notes, Net (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 9 Months Ended | ||||
Dec. 31, 2022 | Feb. 16, 2021 | Sep. 30, 2023 | Apr. 21, 2023 | Apr. 19, 2023 | Sep. 27, 2022 | |
Convertible Senior Notes, Net (Details) [Line Items] | ||||||
Principal amount | $ 25,000 | $ 1,000 | ||||
Annual interest percentage | 5.875% | 7.50% | ||||
Maturity date | Feb. 15, 2026 | |||||
Convertible notes payable | $ 1,000 | |||||
Conversion rate (in Dollars per share) | $ 56.3063 | |||||
Exchange price (in Dollars per share) | $ 1.29 | $ 1.03 | $ 1.6 | |||
Exchange price percentage | 130% | |||||
Interest expenses | $ 4,223 | |||||
Effective interest rate | 7.37% | |||||
Total estimated fair value | $ 73,331 | $ 75,483 | ||||
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 | |||
Minimum liquidity covenant | $ 20,000 | |||||
Principal amount | 5,000 | |||||
Aggregate outstanding balance | 15,554 | |||||
Interest make-whole payment | $ 1,418 | |||||
Ordinary Shares [Member] | ||||||
Convertible Senior Notes, Net (Details) [Line Items] | ||||||
Exchange price (in Dollars per share) | $ 17.76 | |||||
Maximum [Member] | ||||||
Convertible Senior Notes, Net (Details) [Line Items] | ||||||
Ordinary shares issued (in Shares) | 9,168,058 | |||||
Minimum [Member] | ||||||
Convertible Senior Notes, Net (Details) [Line Items] | ||||||
Ordinary shares issued (in Shares) | 1,158,297 | |||||
Associated [Member] | ||||||
Convertible Senior Notes, Net (Details) [Line Items] | ||||||
Repurchase price | 100% | |||||
Convertible Senior Notes Net [Member] | ||||||
Convertible Senior Notes, Net (Details) [Line Items] | ||||||
Trading days | 20 | |||||
Consecutive trading day | 30 | |||||
Convertible Notes [Member] | ||||||
Convertible Senior Notes, Net (Details) [Line Items] | ||||||
Principal amount | $ 75,000 | $ 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 | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Convertible Senior Notes, Net (Details) - Schedule of Liability Measured at its Amortized Cost [Line Items] | ||
Principal amount | $ 75,000 | $ 75,000 |
Issuance costs | (4,223) | (4,223) |
Net of issuance costs | 70,777 | 70,777 |
Amortized issuance costs | 2,048 | 1,423 |
Net carrying amount | $ 72,825 | $ 72,200 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) | Apr. 19, 2023 $ / shares shares |
Fair Value Measurements [Abstract] | |
Warrants to purchase | shares | 17,500,000 |
Ordinary shares exercise price | $ / shares | $ 1.35 |
Fair Value Measurements (Deta_2
Fair Value Measurements (Details) - Schedule of Financial Assets and Liabilities that are Measured in Fair Value - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Fair Value Measurements (Details) - Schedule of Financial Assets and Liabilities that are Measured in Fair Value [Line Items] | ||
Money market funds included in cash and cash equivalent | $ 56,222 | $ 58,827 |
Total assets measured at fair value | 56,222 | 58,827 |
2022 Notes | 8,594 | 24,250 |
Warrants liability | 11,610 | |
Total liabilities measured at fair value | 20,204 | 24,250 |
Level 1 [Member] | ||
Fair Value Measurements (Details) - Schedule of Financial Assets and Liabilities that are Measured in Fair Value [Line Items] | ||
Money market funds included in cash and cash equivalent | 56,222 | 58,827 |
Total assets measured at fair value | 56,222 | 58,827 |
2022 Notes | ||
Warrants liability | ||
Total liabilities measured at fair value | ||
Level 3 [Member] | ||
Fair Value Measurements (Details) - Schedule of Financial Assets and Liabilities that are Measured in Fair Value [Line Items] | ||
Money market funds included in cash and cash equivalent | ||
Total assets measured at fair value | ||
2022 Notes | 8,594 | 24,250 |
Warrants liability | 11,610 | |
Total liabilities measured at fair value | $ 20,204 | $ 24,250 |
Fair Value Measurements (Deta_3
Fair Value Measurements (Details) - Schedule of Warrants Liability Activity $ in Thousands | 5 Months Ended |
Sep. 30, 2023 USD ($) | |
Schedule of Warrants Liability Activity [Abstract] | |
Initial measurement (April 21, 2023) | $ 20,753 |
Change in fair value | (9,143) |
Balance at September 30, 2023 (unaudited) | $ 11,610 |
Fair Value Measurements (Deta_4
Fair Value Measurements (Details) - Schedule of Warrants Liability Initial Measurement Date - $ / shares | Sep. 30, 2023 | Apr. 21, 2023 | Dec. 31, 2022 |
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) | $ 1.03 | $ 1.6 | $ 1.29 |
Risk-free rate | 4.60% | 3.70% | |
Expected volatility | 89% | 91% | |
Dividend Rate | 0% | 0% |
Fair Value Measurements (Deta_5
Fair Value Measurements (Details) - Schedule of Note Liability - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Schedule of Note Liability [Abstract] | ||
Balance at December 31, 2022 | $ 24,250 | |
2023 principal payments and conversions | (16,695) | |
Change in fair value | 1,039 | |
Balance at September 30, 2023 (unaudited) | $ 8,594 |
Fair Value Measurements (Deta_6
Fair Value Measurements (Details) - Schedule of Note Liability Initial Measurement Date - $ / shares | 9 Months Ended | ||
Sep. 30, 2023 | Dec. 31, 2022 | Apr. 21, 2023 | |
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) | $ 1.03 | $ 1.29 | $ 1.6 |
Risk-free rate | 5.40% | 4.40% | |
Expected volatility | 100% | 75% | |
Implied yield | 31.50% | 32.80% |
Contingent Liabilities and Co_2
Contingent Liabilities and Commitments (Details) | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 USD ($) | Sep. 30, 2023 EUR (€) | Dec. 31, 2022 USD ($) | Dec. 31, 2022 EUR (€) | |
Contingent Liabilities and Commitments (Details) [Line Items] | ||||
Bank guarantees amount | $ 2,686 | |||
Investment center remaining amount | 37,082 | |||
Accrued royalties | 34,477 | |||
Non-royalty-bearing grants | $ 2,605 | |||
Percentage of interest rate | 100% | 100% | ||
Total grants | $ 43,447 | |||
Termination of aggregate amount | $ 8,479,000,000 | € 8,000 | ||
Service agreement remaining payment | 2,646,000,000 | € 2,500 | ||
Royalty [Member] | ||||
Contingent Liabilities and Commitments (Details) [Line Items] | ||||
Accrued royalty expenses | $ 20 | |||
Minimum [Member] | ||||
Contingent Liabilities and Commitments (Details) [Line Items] | ||||
Royalties rate | 3% | |||
Service agreement first payment | $ 1,594,000,000 | |||
Maximum [Member] | ||||
Contingent Liabilities and Commitments (Details) [Line Items] | ||||
Royalties rate | 5% | |||
Service agreement first payment | € | € 1,500,000,000 | |||
First Payment 2023 [Member] | ||||
Contingent Liabilities and Commitments (Details) [Line Items] | ||||
Service agreement remaining payment | $ 4,240 | |||
Second Payment 2024 [Member] | ||||
Contingent Liabilities and Commitments (Details) [Line Items] | ||||
Service agreement remaining payment | $ 4,000 |
Shareholders' Equity (Details)
Shareholders' Equity (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | ||
Apr. 19, 2023 | Sep. 27, 2022 | Sep. 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 | |
Purchase of ordinary shares | 17,500,000 | ||
Preferred Units, Offering Costs (in Dollars) | $ 1,900 | ||
Net proceeds (in Dollars) | $ 39,412 | ||
Issuance of shares | 29,171,195 | ||
Public offering price (in Dollars per share) | $ 1.39 | ||
Purchase of warrants | 17,500,000 | ||
Warrants expired | will expire on April 21, 2028 | ||
Warrants exercised | 33,270 | ||
Outstanding restricted shares | 32,310 |
Share-Based Compensation (Detai
Share-Based Compensation (Details) $ / shares in Units, $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 USD ($) $ / shares shares | Jan. 23, 2017 ₪ / shares shares | |
Share-Based Compensation (Details) [Line Items] | ||
Ordinary shares outstanding percentage | 4% | |
Unrecognized costs related to share-based compensation | $ | $ 6,969 | |
2017 Share Incentive Plan [Member] | ||
Share-Based Compensation (Details) [Line Items] | ||
Number of shares reserved for issuance | shares | 2,025,064 | 312,867 |
Nominal per share value | ₪ / shares | ₪ 0.01 | |
Minimum [Member] | ||
Share-Based Compensation (Details) [Line Items] | ||
Grant date fair value per share | $ 0.99 | |
Maximum [Member] | ||
Share-Based Compensation (Details) [Line Items] | ||
Grant date fair value per share | $ 1.85 |
Share-Based Compensation (Det_2
Share-Based Compensation (Details) - Schedule of Fair Value Measurement of Equity-Settled Share Options | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Schedule of Fair Value Measurement of Equity-Settled Share Options [Abstract] | ||
Dividend yield | 0% | 0% |
Expected volatility of the share prices | 73% | |
Risk-free interest rate | 4.30% | |
Expected term (in years) | 8 years | 8 years |
Minimum [Member] | ||
Schedule of Fair Value Measurement of Equity-Settled Share Options [Abstract] | ||
Expected volatility of the share prices | 66% | |
Risk-free interest rate | 1.80% | |
Maximum [Member] | ||
Schedule of Fair Value Measurement of Equity-Settled Share Options [Abstract] | ||
Expected volatility of the share prices | 67% | |
Risk-free interest rate | 3.50% |
Share-Based Compensation (Det_3
Share-Based Compensation (Details) - Schedule of Stock Option Plans - $ / shares | 9 Months Ended |
Sep. 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 | 2,127,834 |
Weighted average exercise price, Granted | $ 1.53 |
Number of options, Exercised | (1,066) |
Weighted average exercise price, Exercised | $ 0.25 |
Number of options, Forfeited | (641,406) |
Weighted average exercise price, Forfeited | $ 2.61 |
Number of options, Expired | (511,031) |
Weighted average exercise price, Expired | $ 5.57 |
Number of options, ending Balance | 7,108,234 |
Weighted average exercise price, ending Balance | $ 3.85 |
Number of options, Exercised | 3,955,093 |
Weighted average exercise price, Exercised | $ 4.75 |
Share-Based Compensation (Det_4
Share-Based Compensation (Details) - Schedule of Restricted Shares Activity | 9 Months Ended |
Sep. 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 | 1,036,606 |
Weighted average grant date fair value, Granted | $ / shares | $ 1.53 |
Number of restricted shares and restricted share units, Vested | shares | (499,894) |
Weighted average grant date fair value, Vested | $ / shares | $ 2.85 |
Number of restricted shares and restricted share units, Forfeited | shares | (333,173) |
Weighted average grant date fair value, Forfeited | $ / shares | $ 2.3 |
Number of restricted shares and restricted share units, Unvested ending | shares | 1,330,282 |
Weighted average grant date fair value, Unvested ending | $ / shares | $ 2.33 |
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, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Schedule of Share Based Compensation Expense [Abstract] | ||||
Cost of sales expenses | $ 3 | $ 3 | ||
Research and development expenses, net | 230 | 533 | 1,026 | 1,551 |
Selling, general and, administrative | 1,143 | 766 | 3,268 | 2,278 |
Total share-based compensation | $ 1,376 | $ 1,299 | $ 4,297 | $ 3,829 |
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, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Schedule of Number of Shares and Loss Used in the Computation of Net Loss Per Share [Abstract] | ||||
Weighted number of shares, basic | 124,236,300 | 60,440,765 | 101,479,968 | 59,821,655 |
Net loss attributable to equity holders of the Company | $ 1,519 | $ 17,802 | $ 54,155 | $ 56,579 |
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 | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Schedule of Number of Shares and Loss Used in the Computation of Net Loss Per Share [Abstract] | ||||
Weighted number of shares, diluted | 124,236,300 | 60,440,765 | 101,479,968 | 59,821,655 |
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 | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Basic and Diluted Net Loss Per Share (Details) - Schedule of Outstanding Warrants, Share Options, and Restricted Shares [Line Items] | ||||
Total diluted net loss per share | 37,056,201 | 10,660,528 | 36,606,607 | 12,429,633 |
Convertible Senior Notes [Member] | ||||
Basic and Diluted Net Loss Per Share (Details) - Schedule of Outstanding Warrants, Share Options, and Restricted Shares [Line Items] | ||||
Total diluted net loss per share | 10,876,824 | 4,222,973 | 10,876,824 | 4,222,973 |
Warrant [Member] | ||||
Basic and Diluted Net Loss Per Share (Details) - Schedule of Outstanding Warrants, Share Options, and Restricted Shares [Line Items] | ||||
Total diluted net loss per share | 17,466,730 | 108,049 | 17,466,730 | 2,233,283 |
Outstanding Share Options [Member] | ||||
Basic and Diluted Net Loss Per Share (Details) - Schedule of Outstanding Warrants, Share Options, and Restricted Shares [Line Items] | ||||
Total diluted net loss per share | 7,083,976 | 5,189,188 | 6,774,012 | 4,964,826 |
Restricted shares [Member] | ||||
Basic and Diluted Net Loss Per Share (Details) - Schedule of Outstanding Warrants, Share Options, and Restricted Shares [Line Items] | ||||
Total diluted net loss per share | 1,628,671 | 1,140,318 | 1,489,041 | 1,008,551 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent Event [Member] - USD ($) | Nov. 10, 2023 | Oct. 02, 2023 |
Subsequent Events (Details) [Line Items] | ||
Price per share (in Dollars per share) | $ 499 | |
Additional capital | $ 706,914 | |
Monthly installment payment | 554 | |
Principal amount | $ 7,751 | |
Service agreement remaining payment | $ 2,646 | |
IPO [Member] | ||
Subsequent Events (Details) [Line Items] | ||
Public offering price (in Dollars per share) | $ 0.73 |