Cover
Cover - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 22, 2024 | Jun. 30, 2023 | |
Document Information [Line Items] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Interactive Data Current | Yes | ||
ICFR Auditor Attestation Flag | false | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Documents Incorporated by Reference [Text Block] | None | ||
Entity Information [Line Items] | |||
Entity Registrant Name | GAMIDA CELL LTD. | ||
Entity Central Index Key | 0001600847 | ||
Entity File Number | 001-38716 | ||
Entity Tax Identification Number | 00-0000000 | ||
Entity Incorporation, State or Country Code | L3 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Shell Company | false | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Public Float | $ 216.7 | ||
Entity Contact Personnel [Line Items] | |||
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 | ||
Entity Phone Fax Numbers [Line Items] | |||
City Area Code | (617) | ||
Local Phone Number | 892-9080 | ||
Entity Listings [Line Items] | |||
Title of 12(b) Security | Ordinary Shares, NIS 0.01 par value | ||
Trading Symbol | GMDA | ||
Security Exchange Name | NASDAQ | ||
Entity Common Stock, Shares Outstanding | 154,050,953 |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2023 | |
Auditor [Table] | |
Auditor Name | KOST FORER GABBAY & KASIERER |
Auditor Firm ID | 1281 |
Auditor Location | Tel-Aviv, Israel |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | |
CURRENT ASSETS: | |||
Cash and cash equivalents | $ 46,554 | $ 64,657 | |
Short-term restricted deposit | 3,056 | ||
Inventory | 1,906 | ||
Accounts receivable | 1,610 | ||
Prepaid expenses and other current assets | 1,420 | 1,889 | |
Total current assets | 54,546 | 66,546 | |
NON-CURRENT ASSETS: | |||
Restricted deposits | 377 | 3,668 | |
Property, plant and equipment, net | 41,264 | 44,319 | |
Operating lease right-of-use assets | 3,177 | 7,024 | |
Other long-term assets | 2,822 | 3,216 | |
Total non-current assets | 47,640 | 58,227 | |
Total assets | 102,186 | 124,773 | |
CURRENT LIABILITIES: | |||
Trade payables | 1,880 | 6,384 | |
Employees and payroll accruals | 5,637 | 5,300 | |
Operating lease liabilities | 1,270 | 2,648 | |
Accrued interest of convertible senior notes | 1,780 | 1,652 | |
Convertible senior notes | 6,505 | ||
Accrued expenses and current liabilities | 8,129 | 8,891 | |
Total current liabilities | 25,201 | 24,875 | |
NON-CURRENT LIABILITIES: | |||
Convertible senior notes, net | 73,041 | 96,450 | |
Warrants liability | 3,284 | ||
Long-term operating lease liabilities | 2,127 | 4,867 | |
Other long-term liabilities | 1,482 | 6,604 | |
Total non-current liabilities | 79,934 | 107,921 | |
Total liabilities | 105,135 | 132,796 | |
CONTINGENT LIABILITIES AND COMMITMENTS | |||
SHAREHOLDERS’ DEFICIT: | |||
Ordinary shares of NIS 0.01 par value - Authorized: 325,000,000 and 150,000,000 shares at December 31, 2023 and 2022; Issued: 144,596,195 and 74,703,030 shares at December 31, 2023 and 2022, respectively; Outstanding: 144,443,714 and 74,583,026 shares at December 31, 2023 and 2022, respectively | 391 | 211 | |
Treasury ordinary shares of NIS 0.01 par value; 152,481 and 120,004 shares at December 31, 2023 and 2022, respectively | [1] | ||
Additional paid-in capital | 476,488 | 408,598 | |
Accumulated deficit | (479,828) | (416,832) | |
Total shareholders’ deficit | (2,949) | (8,023) | |
Total liabilities and shareholders’ deficit | $ 102,186 | $ 124,773 | |
[1] Represents an amount lower than $1. |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - ₪ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Statement of Financial Position [Abstract] | ||
Ordinary shares par value (in New Shekels per share) | ₪ 0.01 | ₪ 0.01 |
Ordinary shares authorized | 325,000,000 | 150,000,000 |
Ordinary shares Issued | 144,596,195 | 74,703,030 |
Ordinary shares outstanding | 144,443,714 | 74,583,026 |
Treasury ordinary shares par value (in New Shekels per share) | ₪ 0.01 | ₪ 0.01 |
Treasury ordinary shares | 152,481 | 120,004 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Statement [Abstract] | ||
Net revenue | $ 1,784 | |
Cost of sales | 1,454 | |
Excess Capacity | 4,081 | |
Research and development expenses, net | 24,308 | 42,692 |
Selling, general and administrative | 44,584 | 32,301 |
Other operating expenses | 395 | |
Total operating expenses | 73,368 | 74,993 |
Total operating loss | 73,038 | 74,993 |
Financial (income) expenses | (10,042) | 4,382 |
Net loss | $ 62,996 | $ 79,375 |
Net loss per share attributable to ordinary shareholders, basic (in Dollars per share) | $ 0.57 | $ 1.24 |
Weighted average number of shares used in computing net loss per share attributable to ordinary shareholders, basic (in Shares) | 110,049,547 | 63,826,295 |
Consolidated Statements of Op_2
Consolidated Statements of Operations (Parentheticals) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Statement [Abstract] | ||
Net loss per share attributable to ordinary shareholders, diluted | $ 0.57 | $ 1.24 |
Weighted average number of shares used in computing net loss per share attributable to ordinary shareholders, diluted | 110,049,547 | 63,826,295 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Shareholders' Equity (Deficit) - USD ($) $ in Thousands | Ordinary shares | Additional paid-in capital | Accumulated deficit | Treasury shares | 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 and vested restricted share units | $ 1 | (1) | ||||||||
Grant of restricted shares and vested restricted share units (in Shares) | 240,050 | |||||||||
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 | ||||||||
Treasury shares | [1] | |||||||||
Treasury shares (in Shares) | (120,004) | |||||||||
Share-based compensation | 5,041 | 5,041 | ||||||||
Loss | (79,375) | (79,375) | ||||||||
Balance at Dec. 31, 2022 | $ 211 | 408,598 | (416,832) | [1] | $ (8,023) | |||||
Balance (in Shares) at Dec. 31, 2022 | 74,583,026 | 74,583,026 | ||||||||
Issuance of ordinary shares upon release of restricted share units | $ 2 | 1 | $ 3 | |||||||
Issuance of ordinary shares upon release of restricted share units (in Shares) | 588,612 | |||||||||
Issuance of ordinary shares for 2022 Notes | $ 21 | 17,537 | 17,558 | |||||||
Issuance of ordinary shares for 2022 Notes (in Shares) | 11,254,597 | |||||||||
Exercise of warrants liability | [1] | 45 | 45 | |||||||
Exercise of warrants liability (in Shares) | 33,270 | |||||||||
Exercise of options | [1] | [1] | [1] | |||||||
Exercise of options (in Shares) | 1,066 | 1,066 | ||||||||
Issuance of ordinary shares, net of issuance expenses | [3] | $ 157 | 44,796 | $ 44,953 | ||||||
Issuance of ordinary shares, net of issuance expenses (in Shares) | [3] | 58,015,620 | ||||||||
Treasury shares | [1] | [1] | ||||||||
Treasury shares (in Shares) | (32,477) | |||||||||
Share-based compensation | 5,511 | 5,511 | ||||||||
Loss | (62,996) | (62,996) | ||||||||
Balance at Dec. 31, 2023 | $ 391 | $ 476,488 | $ (479,828) | [1] | $ (2,949) | |||||
Balance (in Shares) at Dec. 31, 2023 | 144,443,714 | 144,443,714 | ||||||||
[1] Represents an amount lower than $1 Issuance expenses of $4,160 Issuance expenses of $3,067 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | ||
Cash flows from operating activities: | |||
Net Loss | $ (62,996) | $ (79,375) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation of property, plant and equipment | 2,024 | 440 | |
Financing expense (income), net | 829 | (375) | |
Share-based compensation | 5,511 | 5,041 | |
Change in fair value of warrants liability | (17,469) | ||
Change in fair value in convertible note | 611 | ||
Warrants liability issuance costs | 1,733 | ||
Amortization of debt discount and issuance costs | 841 | 783 | |
Loss from sale of equipment | 395 | ||
Change in assets and liabilities: | |||
Increase in inventory | 326 | ||
Operating lease right-of-use assets | 2,679 | 2,494 | |
Operating lease liabilities | (2,949) | (3,069) | |
Increase in accounts receivable | (1,610) | ||
Decrease in prepaid expenses and other assets | 1,001 | 669 | |
Decrease in trade payables | (4,504) | (1,888) | |
Decrease (increase) in accrued expenses and current liabilities | (5,542) | 4,857 | |
Net cash used in operating activities | (79,120) | (70,423) | |
Cash flows from investing activities: | |||
Purchase of property, plant and equipment | (1,081) | (6,354) | |
Purchase of marketable securities | (5,037) | ||
Proceeds from maturity of marketable securities | 45,029 | ||
Proceeds from restricted deposits | 238 | 406 | |
Proceeds from sale of equipment | 33 | ||
Net cash provided by (used in) investing activities | (810) | 34,044 | |
Cash flows from financing activities: | |||
Proceeds from exercise of warrants liability | 45 | ||
Proceeds from exercise of options | [1] | 76 | |
Principal payments of convertible senior note | (2,249) | ||
Proceeds from share issuance and warrants liability, net | 63,976 | 22,298 | |
Proceeds from issuance of convertible senior notes, net | 22,770 | ||
Net cash provided by financing activities | 61,772 | 45,144 | |
Effect of exchange rate changed on cash and cash equivalents | 55 | ||
Decrease (increase) in cash and cash equivalents | (18,103) | 8,765 | |
Cash and cash equivalents at beginning of year | 64,657 | 55,892 | |
Cash and cash equivalents at end of year | 46,554 | 64,657 | |
Significant non-cash transactions: | |||
Lease liabilities arising from new right-of-use asset | 2,282 | ||
Purchase of property, plant and equipment on credit | 720 | ||
Conversion of convertible senior note | 16,107 | ||
Reclassification from property, plant and equipment to inventory | 2,232 | ||
Cash paid for interest | $ 5,909 | $ 4,406 | |
[1] Represents an amount lower than $1 |
General
General | 12 Months Ended |
Dec. 31, 2023 | |
General [Abstract] | |
GENERAL | NOTE 1:- GENERAL a. Gamida Cell Ltd., founded in 1998, is a cell therapy pioneer working to turn cells into powerful therapeutics. 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 financial statements represents the consolidation of these two entities (the “Company”). 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 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 the first quarter of 2023, the Company completed a strategic reprioritization of Company's business activities to reduce Company's operating expenses and focus on the commercial launch of Omisirge® (omidubicel-onlv). 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 December 31, 2023 was $479,828 and negative cash flows from operating activities during the year ended December 31, 2023 were $79,120. As of December 31, 2023, the Company had approximately $46,554 in cash and cash equivalents. The Company has limited available cash resources and requires additional financing in order to continue to fund its current operations beyond the second quarter of 2024, and to pay existing and future liabilities and other obligations. On March 26, 2024, the Company entered into a Restructuring Support Agreement, or the Support Agreement, with certain funds managed by Highbridge Capital Management, LLC. These funds hold all of the Company exchangeable senior notes issued in 2021 and 2022. Pursuant to the Support Agreement, the Company and Highbridge have agreed to restructure all of our outstanding equity and debt in a voluntary restructuring proceeding in the District Court of Beersheba, Israel that is governed by Israeli law, referred to as the restructuring process. If this process is completed as contemplated by the Support Agreement, all outstanding shares of Gamida Cell Ltd. will be cancelled, after which Gamida Cell Ltd. will continue to exist as a private operating company that is owned entirely by Highbridge. Pursuant to the Support Agreement, each holder of ordinary shares of the Company as of the completion of the restructuring process will be entitled to a certain contingent value rights agreement to be executed in connection with the restructuring process. There is no assurance that the Company will complete the restructuring process as currently contemplated. If the Company is unable to complete restructuring process in the second quarter of 2024, the Company expects that it will enter into involuntary restructuring proceedings in Israeli court and the Company's shareholders would not receive any proceeds from such proceedings. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The consolidated financial statements do not include any adjustments to the carrying amounts and classifications of assets and liabilities that would result if the Company were unable to continue as a going concern. |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Significant Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES a. Basis of presentation of the financial statements: The Company’s consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles (U.S. GAAP). b. Use of estimates: The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. The Company’s management believes that the estimates, judgment and assumptions used are reasonable based upon information available at the time they are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities at the dates of the consolidated financial statements, and the reported amount of expenses during the reporting periods. Actual results could differ from those estimates. c. Principles of consolidation: The consolidated financial statements include the accounts of the Company and its subsidiary. Intercompany balances have been eliminated upon consolidation. The Company has one operating segment and reporting unit. d. Consolidated financial statements in U.S dollars: The functional currency is the currency that best reflects the economic environment in which the Company and its subsidiary operates and conducts their transactions. Most of the Company’s revenues and costs are incurred in U.S. dollar. In addition, the Company’s financing activities are incurred in U.S. dollars. The Company’s management believes that the functional currency of the Company is the U.S. dollar. Accordingly, monetary accounts maintained in currencies other than the U.S. dollar are remeasured into U.S. dollars in accordance with ASC No. 830 “Foreign Currency Matters.” All transaction gains and losses of the remeasured monetary balance sheet items are reflected in the statements of operations as financing income or expenses as appropriate. e. Cash and cash equivalents: Cash equivalents are short-term highly liquid deposits that are readily convertible to cash with original maturities of three months or less, at the date acquired. f. Short-term and long-term restricted deposits: Restricted short-term deposits are deposits with maturities of up to one year and are used as security for the rental of premises and as guarantee for the Israeli Investment Center. Restricted long-term deposits are deposits with maturities of more than one year and are used as security for the rental of premises and for the Company’s credit cards. g. Property, plant and equipment: Property, plant and equipment are measured at cost, including directly attributable costs, less accumulated depreciation, accumulated impairment losses and any related investment grants, excluding day-to-day servicing expenses. Depreciation is calculated on a straight-line basis over the useful life of the assets at annual rates as follows: % Machinery 10-15 Leasehold improvements (*) Office, furniture and equipment 6-33 Production plant 11 (*) Over the shorter of the term of the lease or its useful life. h. Impairment of long-lived assets: The Company’s long-lived assets are reviewed for impairment in accordance with ASC No. 360 “Property, Plant and Equipment,” whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If indicators of impairment exist and the undiscounted future cash flows that the assets are expected to generate are less than the carrying value of the assets, the Company reduces the carrying amount of the assets through an impairment charge, to their estimated fair values. During the years ended December 31, 2023 and 2022, no impairment indicators have been identified. i. Treasury shares: From time to time, forfeited equity grants will be transferred to the Company and the Company holds them as treasury shares. The Company presents the cost to repurchase treasury shares as a reduction of shareholders’ equity. j. Share-based compensation: The Company accounts for share-based compensation in accordance with ASC No. 718, “Compensation - Stock Compensation”, which requires companies to estimate the fair value of equity-based payment awards on the date of grant using an option-pricing model. The value of the award is recognized as an expense over the requisite service periods, which is the vesting period of the respective award, on a straight-line basis when the only condition to vesting is continued service. The Company has selected the binominal option-pricing model as the most appropriate fair value method for its option awards. The fair value of restricted shares is based on the closing market value of the underlying shares at the date of grant. The Company recognizes forfeitures of equity-based awards as they occur. k. Accounts receivable: Accounts receivable are recorded net of credit losses allowance for any potential uncollectible amounts. 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. The Company makes estimates of expected credit and collectability trends for the allowance for credit losses based upon its assessment of various factors, the age of the trade receivable balances, credit quality of its customers, current economic conditions, reasonable and supportable forecasts of future economic conditions, and other factors that may affect its ability to collect from customers. As of December 31, 2023 no allowances for credit losses of trade receivable were recorded. l. Employee benefit liabilities: 1. Severance pay The majority of the Company’s employees who are Israeli citizens have subscribed to Section 14 of Israel’s Severance Pay Law, 5723-1963 (the “Severance Pay Law”). Pursuant to Section 14 of the Severance Pay Law, employees covered by this section are entitled to monthly deposits at a rate of 8.33% of their monthly salary, made on their behalf by the Company. Payments made to employees in accordance with this section release the Company from any future severance liabilities with respect to such employees. Neither severance pay liability nor severance pay fund under Section 14 of the Severance Pay Law is recorded on the Company’s consolidated balance sheets. For the Company’s employees in Israel who are not subject to Section 14 of the Severance Pay Law, the Company has a liability for severance pay pursuant to the Severance Pay Law based on the most recent salary of these employees multiplied by the number of years of employment as of the balance sheet date. Accrued severance pay for these employees was $1,482 and $1,914 as of December 31, 2023 and 2022, respectively. The Company’s liability for these employees is fully provided for by monthly deposits with severance pay funds, insurance policies and accruals. The deposited funds include profits accumulated up to the balance sheet date. The deposited funds may be withdrawn only upon the fulfillment of the obligation pursuant to the Severance Pay Law or labor agreements. The severance pay fund amounted to $1,359 and $1,703 as of December 31, 2023 and 2022, respectively. Severance expense for the years ended December 31, 2023 and 2022, was $483 and $895, respectively The Company offers a defined contribution 401(k) plan (the “Plan”) covering all eligible US employees. Participants are permitted to make contributions up to the maximum amount allowed under the Internal Revenue Code. The Company’s contributions to the Plan for the years ended December 31, 2023 and 2022 were $515 and $424, respectively. m. Fair value of financial instruments: The accounting guidance for fair value provides a framework for measuring fair value, clarifies the definition of fair value, and expands disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows: Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. Level 2: Observable inputs that are based on inputs not quoted on active markets but corroborated by market data. Level 3: Unobservable inputs are used when little or no market data are available. n. Leases: The Company accounts for leases according to ASC 842, “Leases”. The Company determines if an arrangement is a lease and the classification of that lease at inception based on: (1) whether the contract involves the use of a distinct identified asset, (2) whether the Company obtains the right to substantially all the economic benefits from the use of the asset throughout the period, and (3) whether the Company has a right to direct the use of the asset. The Company elected the practical expedient for lease agreements with a term of twelve months or less and does not recognize right-of-use (“ROU”) assets and lease liabilities in respect of those agreements. The Company also elected the practical expedient to not separate lease and non-lease components for its leases. An ROU asset represents the right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease agreement. An ROU asset is measured based on the discounted present value of the remaining lease payments, plus any initial direct costs incurred and prepaid lease payments, excluding lease incentives. The lease liability is measured at lease commencement date based on the discounted present value of the remaining lease payments. The implicit rate within the operating leases is generally not determinable, therefore the Company uses the Incremental Borrowing Rate (“IBR”) based on the information available at commencement date in determining the present value of lease payments. The Company’s IBR is estimated to approximate the interest rate for collateralized borrowing with similar terms and payments and in economic environments where the leased asset is located. Certain leases include options to extend the lease. An option to extend the lease is considered in connection with determining the ROU asset and lease liability when it is reasonably certain that the Company will exercise that option. An option to terminate is considered unless it is reasonably certain that the Company will not exercise the option. Payments under the Company’s lease arrangements are primarily fixed however, certain lease agreements contain variable payments, which are expensed as incurred and not included in the operating lease right-of-use assets and liabilities. Variable lease payments are primarily comprised of payments affected by common area maintenance and utility charges. o. Inventories: Inventories are stated at the lower of cost or net realizable value; cost is determined using the average cost method. 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. As of December 31, 2023, a reserve for slow-moving inventory approaching expiration dates and inventory write-offs of $357 was recorded. p. 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 which represents the sales of Omisirge. The Company has a sole distributor in the United States and sells to this customer. 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 customer that defines each party’s rights regarding delivery of and payment for a Product, (ii) the contract has commercial substance and (iii) 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 contracts include the sale and 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 transaction price 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 at the time of delivery to the transplant center. (iv) Allocate the transaction price to the performance obligations in the contract: 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 a point in time based on the transfer of control of the product, which is 24 hours after delivery to a transplant center. The Company applied the practical expedient in ASC 606 and did not evaluate payment terms of one year or less for the existence of a significant financing component. For the year ended December 31, 2023 all of the company’s revenues were incurred in USA and the payment terms are typically 95 days based on customary practices. q. Research and development expenses: Research and development expenses net of grants are recognized in the consolidated statements of operations when incurred. Research and development expenses consist of personnel costs (including salaries, benefits and share-based compensation), materials, consulting fees and payments to subcontractors, costs associated with obtaining regulatory approvals, and executing preclinical and clinical studies. In addition, research and development expenses include overhead allocations consisting of various administrative and facilities related costs. The Company charges research and development expenses as incurred. Royalty-bearing grants from the Israeli Innovation Authority (the “IIA”) of the Ministry of Economy and Industry in Israel for funding of approved research and development projects are recognized at the time the Company is entitled to such grants, on the basis of the costs incurred, and are presented as a reduction from research and development expenses. In the event of failure of a project that was partly financed by the IIA, the Company will not be obligated to pay any royalties or repay the amounts received. The Company recognized the amounts of grants received in research and development as a reduction from research and development expenses in the amount of $309 and $978 for the years ended December 31, 2023 and 2022, respectively. r. Cost of Sales: Cost of sales includes direct costs attributable to the production of Omisirge. Cost of sales includes raw materials, production, labor, and certain maintenance and indirect manufacturing overheads costs, quality testing directly related to the product, and depreciation on equipment used in the manufacturing of Omisirge. It also includes any cost of batch failure losses and royalty expenses. Cost of sales for Omisirge are recognized when batch failure or revenue is recognized. s. Excess Capacity: Excess capacity costs reflect labor and manufacturing overhead costs incurred above the amount of these costs absorbed in cost of sales as part of standard costs, which are based on staffed capacity levels, given that the Kiryat Gat facility is staffed to produce the anticipated demand over the course of the coming year. t. Selling, General & Administrative (SG&A): Beginning July 1, 2023, reporting of Operating Expenses has been modified to reflect the Company’s transition to commercial stage. Costs that were previously reported as Commercial and General & Administrative costs, are currently being reported as part of Selling, General & Administrative (SG&A) expenses. SG&A Costs consist mainly of personnel costs (including salaries, benefits and share-based compensation), supply chain and quality assurance indirect expenses, medical affairs expenses, marketing and selling, finance, and legal expenses. u. Income taxes: The Company accounts for income taxes in accordance with ASC 740, “Income Taxes”, which prescribes the use of the liability method whereby deferred tax asset and liability account balances are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company provides a valuation allowance, to reduce deferred tax assets to their estimated realizable value, if needed. ASC 740 offers a two-step approach for recognizing and measuring a liability for uncertain tax positions. The first step is to evaluate the tax position taken or expected to be taken in a tax return by determining if the weight of available evidence indicates that it is more likely than not that, on an evaluation of the technical merits, the tax position will be sustained on audit, including resolution of any related appeals or litigation processes. The second step is to measure the tax benefit as the largest amount that is more than 50% likely to be realized upon ultimate settlement. Any interest and penalties related to unrecognized tax benefits are recorded as income tax expense. As of December 31, 2023 and 2022, no liability for unrecognized tax benefits was recorded as a result of ASC 740. v. Basic and diluted net loss per share: The Company computes net loss per share using the two-class method required for participating securities. The two-class method requires income available to ordinary shareholders for the period to be allocated between ordinary shares and participating securities based upon their respective rights to receive dividends as if all income for the period had been distributed. The Company considers its restricted shares to be participating securities as the holders of the restricted shares would be entitled to dividends that would be distributed to the holders of ordinary shares, on a pro-rata basis. These participating securities do not contractually require the holders of such shares to participate in the Company’s losses. As such, net loss for the periods presented was not allocated to the Company’s participating securities. The Company’s basic net loss per share is calculated by dividing net loss attributable to ordinary shareholders by the weighted average number of ordinary shares outstanding for the period, without consideration of potentially dilutive securities. The diluted net loss per share is calculated by giving effect to all potentially dilutive securities outstanding for the period using the treasury share method or the if-converted method for the convertible senior notes if the assumed conversion into ordinary shares is dilutive. Diluted net loss per share is the same as basic net loss per share in periods when the effects of potentially dilutive ordinary shares are antidilutive. w. 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 material impact on the financial statements. x. Recently issued accounting pronouncements not yet adopted: In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in ASC 280 on an interim and annual basis. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-07. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. For the Company, ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-09. |
Property, Plant and Equipment,
Property, Plant and Equipment, Net | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment, Net [Abstract] | |
PROPERTY, PLANT AND EQUIPMENT, NET | NOTE 3:- PROPERTY, PLANT AND EQUIPMENT, NET The composition of property, plant and equipment is as follows: December 31, 2023 2022 Cost: Machinery $ 2,796 $ 4,383 Leasehold improvements 1,280 1,447 Office, furniture and equipment 941 1,014 Production plant 41,122 41,971 46,139 48,815 Less - accumulated depreciation (4,875 ) (4,496 ) Depreciable cost $ 41,264 $ 44,319 Depreciation expense amounted to $2,024 and $440 for the years ended December 31, 2023 and 2022, respectively. The depreciation expense relating to equipment sold during 2023 was $1,646. Loss from sale of equipment amounted to $395 for the year ended December 31, 2023 and was recognized in Other operating expenses. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2023 | |
Leases [Abstract] | |
LEASES | NOTE 4:- LEASES The Company entered into operating leases primarily for its production plant, and its laboratories, offices and automobiles. The leases have remaining lease terms of up to four years, The Company does not assume renewals in its determination of the lease term unless the renewals are considered as reasonably certain at lease commencement. The components of operating lease costs were as follows: Year ended 2023 2022 Operating lease costs $ 2,476 $ 2,833 Short-term lease costs 17 91 Total lease costs $ 2,493 $ 2,924 Supplemental balance sheet information related to operating leases is as follows: Year ended 2023 2022 Weighted average remaining lease term (in years) 3.18 3.28 Weighted average discount rate 2.63 % 3.56 % Maturities of lease liabilities were as follows: Year ended 2024 1,172 2025 1,044 2026 691 2027 525 Total undiscounted lease payments 3,432 Less - imputed interest (35 ) Present value of lease liabilities $ 3,397 |
Convertible Senior Notes, Net
Convertible Senior Notes, Net | 12 Months Ended |
Dec. 31, 2023 | |
Convertible Senior Notes, Net [Abstract] | |
CONVERTIBLE SENIOR NOTES, NET | NOTE 5:- 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 $75,000, 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 Convertible Notes are accounted for as a single liability measured at its amortized cost, as no other embedded features require bifurcation and recognition as derivatives according to ASC 815-40. Year ended 2023 2022 Liability component: Principal amount $ 75,000 $ 75,000 Issuance costs (4,223 ) (4,223 ) Principal net of issuance costs 70,777 70,777 Amortized issuance costs 2,264 1,423 Net carrying amount (including accrued interest) $ 73,041 $ 72,200 The total issuance costs of the 2021 Notes amounted to $4,223 and are amortized to interest expense at an annual effective interest rate of 7.37%, over the term of the 2021 Notes. As of December 31, 2023 and 2022, the total estimated fair value of the 2021 Notes was $74,946 and $73,331, respectively. The fair value was determined using the Company’s effective rates for December 31, 2023 and 2022. 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 $25,000 aggregate principal amount of convertible senior notes (the “2022” Notes). The 2022 Notes bear interest of 7.5% which will be paid on a quarterly basis and 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, 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 million of principal amount is outstanding under the Loan Agreement. As of December 31, 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 December 31, 2023, the Company issued 10,044,275 and 1,210,322 Ordinary shares in exchange for the discharge of $16,107 of the aggregate outstanding balance and the discharge of $1,451 interest make-whole payments, respectively, in respect of the 2022 Notes. As of December 31, 2023, the Company has paid $2,249 in principal payments and $1,503 in interest payments. The principal balance of the loan as of December 31, 2023 is $6,644. |
Accrued Expenses and Current Li
Accrued Expenses and Current Liabilties | 12 Months Ended |
Dec. 31, 2023 | |
Accrued Expenses and Current Liabilties [Abstract] | |
ACCRUED EXPENSES AND CURRENT LIABILTIES | NOTE 6:- ACCRUED EXPENSES AND CURRENT LIABILTIES December 31, 2023 2022 Subcontractors $ 126 $ 794 Third Party Settlement Agreement* 4,424 2,666 Clinical activities 2,169 2,709 Professional services 1,070 1,561 Production plant in process - 790 Other 340 371 $ 8,129 $ 8,891 * 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 $8,848 (€8,000). As of December 31, 2023, the Company had paid the first two installment payments of $1,594 (€1,500) and $2,646 (€2,500). The remaining $4,424 (€4,000) will be paid in 2024. The current liability to Lonza increased during 2023, as a portion of the termination payments were classified as long-term liabilities in 2022. |
Selling, General and Administra
Selling, General and Administrative | 12 Months Ended |
Dec. 31, 2023 | |
Selling, General and Administrative [Abstract] | |
SELLING, GENERAL AND ADMINISTRATIVE | NOTE 7:- SELLING, GENERAL AND ADMINISTRATIVE December 31, 2023 2022 Salaries & related $ 17,004 $ 12,902 Share-based compensation 4,183 3,151 Professional services* 20,262 13,099 Other 3,135 3,149 $ 44,584 $ 32,301 * Professional fees include legal, accounting and audit services, and other consulting fees. |
Financial (Income) Expenses
Financial (Income) Expenses | 12 Months Ended |
Dec. 31, 2023 | |
Financial (Income) Expenses [Abstract] | |
FINANCIAL (INCOME) EXPENSES | NOTE 8:- FINANCIAL (INCOME) EXPENSES December 31, 2023 2022 Change in Fair Value of warrant derivative liabilities $ (17,469 ) $ - Change in Fair Value of convertible loan 611 - Interest Income (2,727 ) (3,234 ) Interest Expense 7,587 5,683 Follow On Costs 1,733 2,132 Other 223 (199 ) $ (10,042 ) $ 4,382 |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Measurements [Abstract] | |
FAIR VALUE MEASUREMENTS | NOTE 9:- FAIR VALUE MEASUREMENTS Cash and cash equivalents, short-term restricted deposits, prepaid expenses and other assets, accounts receivables, 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 the Company’s assets and liabilities measured at fair value by level within the fair value hierarchy for the years ended December 31, 2023 and 2022: December 31, 2023 2022 Level 1 Level 3 Total Level 1 Level 3 Total Financial assets: Money market funds included in cash and cash equivalent $ 46,554 $ - $ 46,554 $ 58,827 $ 58,827 $ - Total assets measured at fair value $ 46,554 $ - $ 46,554 $ 58,827 $ - $ 58,827 Financial liabilities: 2022 Notes $ - $ 6,505 $ 6,505 $ - $ 24,250 $ 24,250 Warrants liability - 3,284 3,284 - - - Total liabilities measured at fair value - $ 9,789 $ 9,789 $ - $ 24,250 $ 24,250 See Note 5 “Convertible Senior Notes” for the carrying amount and estimated fair value of the Company’s 2021 Notes as of December 31, 2023 and 2022. The Company classify Money market funds 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 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 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 December 31, 2023: Warrant Initial measurement (April 21, 2023) $ 20,753 Change in fair value (17,469 ) Balance December 31, 2023 $ 3,284 The key inputs used in the valuation of the warrants liability as of December 31, 2023 and April 21, 2023, the initial measurement date, are included below: Input December 31, April, 21, Exercise price $ 1.35 $ 1.35 Share price on date $ 0.41 $ 1.60 Risk-free rate 4.0 % 3.7 % Expected volatility 90 % 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 December 31, 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 Notes liability as of December 31, 2023 and December 31, 2022: 2022 Balance as of December 31, 2022 $ 24,250 2023 principal payments and conversions (18,356 ) Change in fair value 611 Balance as of December 31, 2023 $ 6,505 The key inputs used in the valuation of the 2022 Notes liability as of December 31, 2023 and December 31, 2022 the initial measurement date: December 31, December 31, 2023 2022 Voluntary conversion price $ 1.91 $ 1.91 Share price on date $ 0.41 $ 1.29 Risk-free rate 4.8 % 4.4 % Expected volatility 109 % 75 % Implied yield 31.0 % 32.8 % |
Contingent Liabilities and Comm
Contingent Liabilities and Commitments | 12 Months Ended |
Dec. 31, 2023 | |
Contingent Liabilities and Commitments [Abstract] | |
CONTINGENT LIABILITIES AND COMMITMENTS | NOTE 10:- CONTINGENT LIABILITIES AND COMMITMENTS a. Legal proceedings: From time to time the Company or its subsidiaries may be involved in legal proceedings and/or litigation arising in the ordinary course of business. While the outcome of these matters cannot be predicted with certainty, the Company does not believe it will have a material effect on its consolidated financial position, results of operations, or cash flows. b. Bank guarantees: As of December 31, 2023, the Company obtained bank guarantees in the amount of $2,844, primarily in connection with an Investment Center grant in order to ensure the fulfillment of the grant terms. c. Governments grants: The Company has received grants from the IIA to finance its research and development programs in Israel, through which the Company received IIA participation payments in the aggregate amount of $37,082 through December 31, 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 3-3.5% of future sales of the developed products, up to 100% of the amount of grants received. Pursuant to the latest IIA regulations, grants received from the IIA before June 30, 2017 bear an annual interest LIBOR rate that applied at the time of the approval of the applicable file and such interest will apply to all the funding received under that approval. Grants received from the IIA after June 30, 2017 bear an annual interest rate based on the 12-month LIBOR< until December 31, 2023, and as of January 1, 2024, bear an annual interest rate based on the 12-month Secured Overnight Financing Rate (“SOFR”), or in an alternative publication by the Bank of Israel, with the addition of 0.72%. Grants approved after January 1, 2024 will bear the higher of (i) the 12-month SOFR interest rate, plus 1%, or (ii) a fixed annual interest rate of 4%. Through December 31, 2023, the Company has accrued $61 in royalty expenses. The Company’s contingent royalty liability to the IIA at December 31, 2023, including grants received by the Company and the associated LIBOR interest on all such grants totaled $43,745. |
Shareholders_ Deficit
Shareholders’ Deficit | 12 Months Ended |
Dec. 31, 2023 | |
Shareholders’ Deficit [Abstract] | |
SHAREHOLDERS’ DEFICIT | NOTE 11:- SHAREHOLDERS’ DEFICIT a. Ordinary shares: Subject to the Company’s amended and restated Articles of Association, the holders of the Company’s ordinary shares have the right to receive notices to attend and vote in general meetings of the Company’s shareholders, and the right to share in dividends and other distributions upon liquidation. 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 $22,750, before deducting underwriting discounts and commissions and offering expenses of $1,900. During 2023, the Company had raised $43,120 in net proceeds by issuing 40,515,620 shares via an ATM offering, at an average public offering price of $1.10 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 twelve months ended December 31, 2023, 33,270 of such warrants were exercised in exchange for 33,270 of the Company’s Ordinary shares. c. Treasury shares: During the year ended December 31, 2023, the Company cancelled 32,477 outstanding restricted shares, whereby the restricted shares became treasury shares. d. Option plans: 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 February 25, 2021 and November 17, 2021, the board of directors and shareholders, respectively, approved an amendment and restatement of the 2017 Plan. The 2017 Plan, as amended, also contains an “evergreen” provision, which provides for an automatic allotment of ordinary shares to be added every year to the pool of ordinary shares available for grant under the 2017 Plan. Under the evergreen provision, on January 1 of each year (beginning January 1, 2022), the number of ordinary shares available under the 2017 Plan automatically increases by the lesser of the following: (i) 4% of our outstanding ordinary shares on the last day of the immediately preceding year; and (ii) an amount determined in advance of January 1 by the board of directors. As of December 31, 2023, 2,455,978 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 above Options Plans for the years 2023 and 2022: December 31, 2023 2022 Dividend yield 0% 0% Expected volatility of the share prices 69%-74% 66%-67% Risk-free interest rate 3.5%-4.44% 1.8%-3.8% Expected term (in years) 8 8 Based on the above inputs, the fair value of the options was determined to be $0.24 - $1.59 per option at the grant date. The following table summarizes the number of options granted to employees under the Option Plans for the year ended December 31, 2023 and related information: Number of Weighted Weighted Aggregate Outstanding at the beginning of the year 6,133,903 4.62 7.51 8,939 Granted 2,167,234 1.51 - - Exercised (1,066 ) 0.25 - - Forfeited (657,309 ) 2.58 - - Expired (533,500 ) 5.57 - - Outstanding at the end of the year 7,109,262 3.83 7.16 2,259 Exercisable at the end of the year 4,280,279 4.62 6.25 683 The weighted average exercise price of the Company’s options granted during the years ended December 31, 2023 and 2022 was $1.51 and $2.55, respectively. The weighted-average grant date fair value of options granted during the years ended December 31, 2023 and 2022, was $0.95 and $1.58, respectively. The following table summarizes information about the Company’s outstanding and exercisable options granted to employees as of December 31, 2023: Exercise price Options Weighted Options Weighted $ 0.25- 3.80 4,213,394 8.54 1,725,760 8.43 $ 4.15- 4.95 1,782,094 4.61 1,656,858 5.06 $ 5.21- 7.56 350,934 6.33 275,479 6.05 $ 8.00-11.01 762,840 5.66 622,182 6.29 7,109,262 4,280,279 e. A summary of restricted shares and restricted share units activity for the year ended December 31, 2023 is as follows: Number of Weighted Unvested at the beginning of the year 1,126,743 $ 3.29 Granted 1,056,406 1.51 Vested (706,619 ) 2.85 Forfeited (339,727 ) 2.28 Unvested at the end of the year 1,136,803 $ 2.22 The total fair value of shares vested during the years ended December 31, 2023 and 2022, was $1,734 and $1,462, respectively. f. The total share-based compensation expense related to all of the Company’s equity-based awards, recognized for the years ended December 31, 2023 and 2022 is comprised as follows: Year ended 2023 2022 Cost of sales $ 9 $ - Excess Capacity 120 - Research and development expenses, net 1,199 1,890 Selling, general and administrative 4,183 3,151 Total share-based compensation $ 5,511 $ 5,041 As of December 31, 2023, there are $5,734 of total unrecognized costs related to share-based compensation that is expected to be recognized over a weighted average period of approximately 1.77 years. |
Taxes on Income
Taxes on Income | 12 Months Ended |
Dec. 31, 2023 | |
Taxes on Income [Abstract] | |
TAXES ON INCOME | NOTE 12:- TAXES ON INCOME a. Tax rates applicable to the income of the Company: 1. Corporate tax rates Taxable income of the Israeli parent is subject to the Israeli corporate tax at the rate of 23% in 2023 and 2022. The Subsidiary is taxed according to the tax laws in its country of residence. 2. Income tax benefits Income is subject to tax benefits under the Law for Encouragement of Capital Investments, 1959 (the “Investment Law”), which provides tax benefits for Israeli companies meeting certain requirements and criteria. The Investment Law has undergone certain amendments and reforms in recent decades. The Israeli parliament enacted a reform to the Investment Law, effective January 2011. According to the reform, a flat rate tax applies to companies eligible for the “Preferred Enterprise” status. In order to be eligible for Preferred Enterprise status, a company must meet minimum requirements to establish that it contributes to the country’s economic growth and is a competitive factor for the gross domestic product. The Company’s Israeli operations elected “Preferred Enterprise” status, starting in 2017. Benefits granted to a Preferred Enterprise include reduced tax rates. As part of the Economic Efficiency Law (Legislative Amendments for Accomplishment of Budgetary Targets for Budget Years 2017-2018), 5777-2016, the tax rate for Area A will be 7.5% in 2017 onwards. In other regions, the tax rate is 16%. Preferred Enterprises in peripheral regions will be eligible for Investment Center grants, as well as the applicable reduced tax rates. 3. Income taxes on non-Israeli subsidiary: The Company’s subsidiary are separately taxed under the domestic tax laws of the jurisdiction of incorporation. Tax rate applicable to Gamida cell Inc.: On December 22, 2017, the United States enacted the Tax Cuts and Jobs Act (the “U.S. Tax Reform”); a comprehensive tax legislation that includes significant changes to the taxation of business entities. These changes, most of which are effective for tax years beginning after December 31, 2017, include several key tax provisions that might impact the Company, among others: (i) a permanent reduction to the statutory federal corporate income tax rate from 35% (top rate) to 21% (flat rate) effective for tax years beginning after December 31, 2017 ((ii) stricter limitation on the tax deductibility of business interest expense; (iii) a shift of the U.S. taxation of multinational corporations from a tax on worldwide income to a territorial system (along with certain rules designed to prevent erosion of the U.S. income tax base) (iv) a one-time deemed repatriation tax on accumulated offshore earnings held in cash and illiquid assets, with the latter taxed at a lower rate and (v) an expansion of the U.S. controlled foreign corporation (“CFC”) anti deferral starting with the CFC’s first tax year beginning in 2018 intended to tax in the U.S. “global intangible low-taxed income” (“GILTI”). b. The Law for the Encouragement of Industry (Taxation), 1969: The Company has the status of an “industrial company”, under this law. According to this status and by virtue of regulations published thereunder, the Company is entitled to claim a deduction of accelerated depreciation on equipment used in industrial activities, as determined in the regulations issued under the law. The Company is also entitled to amortize a patent or knowhow usage right that is used in the enterprise’s development or promotion, to deduct listed share issuance expenses and to file consolidated financial statements under certain conditions. c. The components of the loss before income taxes were as follows: Year ended 2023 2022 Gamida Cell Ltd. - Israel $ 35,644 $ 66,137 Gamida Cell Inc. – United States 27,352 13,238 62,996 $ 79,375 d. Net operating losses carryforward: The Parent Company has net operating losses and capital losses for tax purposes as of December 31, 2023 totaling approximately $348,370 and $1,168, respectively, which may be carried forward and offset against taxable income in the future for an indefinite period. As of December 31, 2023, the Subsidiary has net operating losses carryforwards of $56,698 for federal tax purposes. e. Final tax assessments: The Company’s tax assessments through the 2018 tax year are considered final. f. Deferred taxes: Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. The Company’s deferred tax assets are comprised of operating loss carryforwards and other temporary differences. Significant components of the Company’s deferred tax assets are as follows: December 31, 2023 2022 Accruals and reserves 215 184 R&D expenses 2,660 3,421 Stock-based compensation 1,115 1,389 Issuance costs 140 106 Lease liability 392 763 Loss carryforward 42,094 34,029 Capital loss 88 58 Tax credit carried forward 243 234 Deferred tax assets before valuation allowance 46,947 40,184 Less - valuation allowance 46,579 39,548 ROU Asset (368 ) (726 ) Net deferred tax assets, net - - Management currently believes that since the Company has a history of losses, and there is uncertainty with respect to future taxable income of the Company, it is more likely than not that the deferred tax assets will not be utilized in the foreseeable future. Thus, a full valuation allowance was provided to reduce deferred tax assets to their realizable value. In 2022 and 2023 the main reconciling item for the Company’s tax rate is tax loss carryforwards and temporary differences, for which a full valuation allowance was provided. |
Basic and Diluted Net Loss Per
Basic and Diluted Net Loss Per Share | 12 Months Ended |
Dec. 31, 2023 | |
Basic and Diluted Net Loss Per Share [Abstract] | |
BASIC AND DILUTED NET LOSS PER SHARE | NOTE 13:- BASIC AND DILUTED NET LOSS PER SHARE Details of the number of shares and loss used in the computation of net loss per share: Year ended December 31, 2023 2022 Weighted Net loss Weighted Net loss For the computation of basic and diluted net loss 110,049,547 $ 62,996 63,826,295 $ 79,375 All outstanding convertible senior note options, warrants, outstanding share options, and restricted shares for the twelve months ended December 31, 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: Year ended 2023 2022 Convertible senior notes 9,948,582 4,904,318 Warrants 17,466,730 1,670,373 Outstanding share options 6,837,070 5,396,583 Restricted shares 1,526,758 1,289,395 Total 35,779,140 13,260,669 |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 14: SUBSEQUENT EVENTS a. From January 1, 2024 through March 27, 2024, the Company raised an additional $2,993 in net proceeds by issuing 9,362,420 additional ordinary shares via an ATM offering, at an average public offering price of $0.32. b. On March 26, 2024, the Company entered into a Restructuring Support Agreement, or the Support Agreement, with Highbridge Capital Management, LLC, or Highbridge in order to set forth the terms for the restructuring of Company outstanding debt and equity. If this restructuring process is completed as contemplated by the Support Agreement, the Company will continue to exist as a private operating Company that is owned entirely by Highbridge. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (62,996) | $ (79,375) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Significant Accounting Policies [Abstract] | |
Basis of presentation of the financial statements: | a. Basis of presentation of the financial statements: The Company’s consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles (U.S. GAAP). |
Use of estimates | b. Use of estimates: The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. The Company’s management believes that the estimates, judgment and assumptions used are reasonable based upon information available at the time they are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities at the dates of the consolidated financial statements, and the reported amount of expenses during the reporting periods. Actual results could differ from those estimates. |
Principles of consolidation | c. Principles of consolidation: The consolidated financial statements include the accounts of the Company and its subsidiary. Intercompany balances have been eliminated upon consolidation. The Company has one operating segment and reporting unit. |
Consolidated financial statements in U.S dollars | d. Consolidated financial statements in U.S dollars: The functional currency is the currency that best reflects the economic environment in which the Company and its subsidiary operates and conducts their transactions. Most of the Company’s revenues and costs are incurred in U.S. dollar. In addition, the Company’s financing activities are incurred in U.S. dollars. The Company’s management believes that the functional currency of the Company is the U.S. dollar. Accordingly, monetary accounts maintained in currencies other than the U.S. dollar are remeasured into U.S. dollars in accordance with ASC No. 830 “Foreign Currency Matters.” All transaction gains and losses of the remeasured monetary balance sheet items are reflected in the statements of operations as financing income or expenses as appropriate. |
Cash and cash equivalents | e. Cash and cash equivalents: Cash equivalents are short-term highly liquid deposits that are readily convertible to cash with original maturities of three months or less, at the date acquired. |
Short-term and long-term restricted deposits | f. Short-term and long-term restricted deposits: Restricted short-term deposits are deposits with maturities of up to one year and are used as security for the rental of premises and as guarantee for the Israeli Investment Center. Restricted long-term deposits are deposits with maturities of more than one year and are used as security for the rental of premises and for the Company’s credit cards. |
Property, plant and equipment | g. Property, plant and equipment: Property, plant and equipment are measured at cost, including directly attributable costs, less accumulated depreciation, accumulated impairment losses and any related investment grants, excluding day-to-day servicing expenses. Depreciation is calculated on a straight-line basis over the useful life of the assets at annual rates as follows: % Machinery 10-15 Leasehold improvements (*) Office, furniture and equipment 6-33 Production plant 11 (*) Over the shorter of the term of the lease or its useful life. |
Impairment of long-lived assets: | h. Impairment of long-lived assets: The Company’s long-lived assets are reviewed for impairment in accordance with ASC No. 360 “Property, Plant and Equipment,” whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If indicators of impairment exist and the undiscounted future cash flows that the assets are expected to generate are less than the carrying value of the assets, the Company reduces the carrying amount of the assets through an impairment charge, to their estimated fair values. During the years ended December 31, 2023 and 2022, no impairment indicators have been identified. |
Treasury shares | i. Treasury shares: From time to time, forfeited equity grants will be transferred to the Company and the Company holds them as treasury shares. The Company presents the cost to repurchase treasury shares as a reduction of shareholders’ equity. |
Share-based compensation | j. Share-based compensation: The Company accounts for share-based compensation in accordance with ASC No. 718, “Compensation - Stock Compensation”, which requires companies to estimate the fair value of equity-based payment awards on the date of grant using an option-pricing model. The value of the award is recognized as an expense over the requisite service periods, which is the vesting period of the respective award, on a straight-line basis when the only condition to vesting is continued service. The Company has selected the binominal option-pricing model as the most appropriate fair value method for its option awards. The fair value of restricted shares is based on the closing market value of the underlying shares at the date of grant. The Company recognizes forfeitures of equity-based awards as they occur. |
Accounts receivable | k. Accounts receivable: Accounts receivable are recorded net of credit losses allowance for any potential uncollectible amounts. 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. The Company makes estimates of expected credit and collectability trends for the allowance for credit losses based upon its assessment of various factors, the age of the trade receivable balances, credit quality of its customers, current economic conditions, reasonable and supportable forecasts of future economic conditions, and other factors that may affect its ability to collect from customers. As of December 31, 2023 no allowances for credit losses of trade receivable were recorded. |
Employee benefit liabilities | l.Employee benefit liabilities: 1.Severance payThe majority of the Company’s employees who are Israeli citizens have subscribed to Section 14 of Israel’s Severance Pay Law, 5723-1963 (the “Severance Pay Law”). Pursuant to Section 14 of the Severance Pay Law, employees covered by this section are entitled to monthly deposits at a rate of 8.33% of their monthly salary, made on their behalf by the Company. Payments made to employees in accordance with this section release the Company from any future severance liabilities with respect to such employees. Neither severance pay liability nor severance pay fund under Section 14 of the Severance Pay Law is recorded on the Company’s consolidated balance sheets.For the Company’s employees in Israel who are not subject to Section 14 of the Severance Pay Law, the Company has a liability for severance pay pursuant to the Severance Pay Law based on the most recent salary of these employees multiplied by the number of years of employment as of the balance sheet date. Accrued severance pay for these employees was $1,482 and $1,914 as of December 31, 2023 and 2022, respectively. The Company’s liability for these employees is fully provided for by monthly deposits with severance pay funds, insurance policies and accruals. The deposited funds include profits accumulated up to the balance sheet date. The deposited funds may be withdrawn only upon the fulfillment of the obligation pursuant to the Severance Pay Law or labor agreements. The severance pay fund amounted to $1,359 and $1,703 as of December 31, 2023 and 2022, respectively.Severance expense for the years ended December 31, 2023 and 2022, was $483 and $895, respectivelyThe Company offers a defined contribution 401(k) plan (the “Plan”) covering all eligible US employees. Participants are permitted to make contributions up to the maximum amount allowed under the Internal Revenue Code. The Company’s contributions to the Plan for the years ended December 31, 2023 and 2022 were $515 and $424, respectively. |
Fair value of financial instruments | m. Fair value of financial instruments: The accounting guidance for fair value provides a framework for measuring fair value, clarifies the definition of fair value, and expands disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows: Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. Level 2: Observable inputs that are based on inputs not quoted on active markets but corroborated by market data. Level 3: Unobservable inputs are used when little or no market data are available. |
Leases | n. Leases: The Company accounts for leases according to ASC 842, “Leases”. The Company determines if an arrangement is a lease and the classification of that lease at inception based on: (1) whether the contract involves the use of a distinct identified asset, (2) whether the Company obtains the right to substantially all the economic benefits from the use of the asset throughout the period, and (3) whether the Company has a right to direct the use of the asset. The Company elected the practical expedient for lease agreements with a term of twelve months or less and does not recognize right-of-use (“ROU”) assets and lease liabilities in respect of those agreements. The Company also elected the practical expedient to not separate lease and non-lease components for its leases. An ROU asset represents the right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease agreement. An ROU asset is measured based on the discounted present value of the remaining lease payments, plus any initial direct costs incurred and prepaid lease payments, excluding lease incentives. The lease liability is measured at lease commencement date based on the discounted present value of the remaining lease payments. The implicit rate within the operating leases is generally not determinable, therefore the Company uses the Incremental Borrowing Rate (“IBR”) based on the information available at commencement date in determining the present value of lease payments. The Company’s IBR is estimated to approximate the interest rate for collateralized borrowing with similar terms and payments and in economic environments where the leased asset is located. Certain leases include options to extend the lease. An option to extend the lease is considered in connection with determining the ROU asset and lease liability when it is reasonably certain that the Company will exercise that option. An option to terminate is considered unless it is reasonably certain that the Company will not exercise the option. Payments under the Company’s lease arrangements are primarily fixed however, certain lease agreements contain variable payments, which are expensed as incurred and not included in the operating lease right-of-use assets and liabilities. Variable lease payments are primarily comprised of payments affected by common area maintenance and utility charges. |
Inventories | o. Inventories: Inventories are stated at the lower of cost or net realizable value; cost is determined using the average cost method. 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. As of December 31, 2023, a reserve for slow-moving inventory approaching expiration dates and inventory write-offs of $357 was recorded. |
Revenue recognition | p. 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 which represents the sales of Omisirge. The Company has a sole distributor in the United States and sells to this customer. 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 customer that defines each party’s rights regarding delivery of and payment for a Product, (ii) the contract has commercial substance and (iii) 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 contracts include the sale and 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 transaction price 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 at the time of delivery to the transplant center. (iv) Allocate the transaction price to the performance obligations in the contract: 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 a point in time based on the transfer of control of the product, which is 24 hours after delivery to a transplant center. The Company applied the practical expedient in ASC 606 and did not evaluate payment terms of one year or less for the existence of a significant financing component. For the year ended December 31, 2023 all of the company’s revenues were incurred in USA and the payment terms are typically 95 days based on customary practices. |
Research and development expenses | q. Research and development expenses: Research and development expenses net of grants are recognized in the consolidated statements of operations when incurred. Research and development expenses consist of personnel costs (including salaries, benefits and share-based compensation), materials, consulting fees and payments to subcontractors, costs associated with obtaining regulatory approvals, and executing preclinical and clinical studies. In addition, research and development expenses include overhead allocations consisting of various administrative and facilities related costs. The Company charges research and development expenses as incurred. Royalty-bearing grants from the Israeli Innovation Authority (the “IIA”) of the Ministry of Economy and Industry in Israel for funding of approved research and development projects are recognized at the time the Company is entitled to such grants, on the basis of the costs incurred, and are presented as a reduction from research and development expenses. In the event of failure of a project that was partly financed by the IIA, the Company will not be obligated to pay any royalties or repay the amounts received. The Company recognized the amounts of grants received in research and development as a reduction from research and development expenses in the amount of $309 and $978 for the years ended December 31, 2023 and 2022, respectively. |
Cost of sales | r. Cost of Sales: Cost of sales includes direct costs attributable to the production of Omisirge. Cost of sales includes raw materials, production, labor, and certain maintenance and indirect manufacturing overheads costs, quality testing directly related to the product, and depreciation on equipment used in the manufacturing of Omisirge. It also includes any cost of batch failure losses and royalty expenses. Cost of sales for Omisirge are recognized when batch failure or revenue is recognized. |
Excess Capacity | s. Excess Capacity: Excess capacity costs reflect labor and manufacturing overhead costs incurred above the amount of these costs absorbed in cost of sales as part of standard costs, which are based on staffed capacity levels, given that the Kiryat Gat facility is staffed to produce the anticipated demand over the course of the coming year. |
Selling, General & Administrative (SG&A) | t. Selling, General & Administrative (SG&A): Beginning July 1, 2023, reporting of Operating Expenses has been modified to reflect the Company’s transition to commercial stage. Costs that were previously reported as Commercial and General & Administrative costs, are currently being reported as part of Selling, General & Administrative (SG&A) expenses. SG&A Costs consist mainly of personnel costs (including salaries, benefits and share-based compensation), supply chain and quality assurance indirect expenses, medical affairs expenses, marketing and selling, finance, and legal expenses. |
Income taxes | u. Income taxes: The Company accounts for income taxes in accordance with ASC 740, “Income Taxes”, which prescribes the use of the liability method whereby deferred tax asset and liability account balances are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company provides a valuation allowance, to reduce deferred tax assets to their estimated realizable value, if needed. ASC 740 offers a two-step approach for recognizing and measuring a liability for uncertain tax positions. The first step is to evaluate the tax position taken or expected to be taken in a tax return by determining if the weight of available evidence indicates that it is more likely than not that, on an evaluation of the technical merits, the tax position will be sustained on audit, including resolution of any related appeals or litigation processes. The second step is to measure the tax benefit as the largest amount that is more than 50% likely to be realized upon ultimate settlement. Any interest and penalties related to unrecognized tax benefits are recorded as income tax expense. As of December 31, 2023 and 2022, no liability for unrecognized tax benefits was recorded as a result of ASC 740. |
Basic and diluted net loss per share | v. Basic and diluted net loss per share: The Company computes net loss per share using the two-class method required for participating securities. The two-class method requires income available to ordinary shareholders for the period to be allocated between ordinary shares and participating securities based upon their respective rights to receive dividends as if all income for the period had been distributed. The Company considers its restricted shares to be participating securities as the holders of the restricted shares would be entitled to dividends that would be distributed to the holders of ordinary shares, on a pro-rata basis. These participating securities do not contractually require the holders of such shares to participate in the Company’s losses. As such, net loss for the periods presented was not allocated to the Company’s participating securities. The Company’s basic net loss per share is calculated by dividing net loss attributable to ordinary shareholders by the weighted average number of ordinary shares outstanding for the period, without consideration of potentially dilutive securities. The diluted net loss per share is calculated by giving effect to all potentially dilutive securities outstanding for the period using the treasury share method or the if-converted method for the convertible senior notes if the assumed conversion into ordinary shares is dilutive. Diluted net loss per share is the same as basic net loss per share in periods when the effects of potentially dilutive ordinary shares are antidilutive. |
Recently adopted accounting standards | w. 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 material impact on the financial statements. |
Recently issued accounting pronouncements not yet adopted | x. Recently issued accounting pronouncements not yet adopted: In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in ASC 280 on an interim and annual basis. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-07. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. For the Company, ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-09. |
Significant Accounting Polici_2
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Significant Accounting Policies [Abstract] | |
Schedule of Straight-Line Basis Over the Useful Life of the Assets | Depreciation is calculated on a straight-line basis over the useful life of the assets at annual rates as follows: % Machinery 10-15 Leasehold improvements (*) Office, furniture and equipment 6-33 Production plant 11 (*) Over the shorter of the term of the lease or its useful life. |
Property, Plant and Equipment_2
Property, Plant and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment, Net [Abstract] | |
Schedule of Property, Plant and Equipment | The composition of property, plant and equipment is as follows: December 31, 2023 2022 Cost: Machinery $ 2,796 $ 4,383 Leasehold improvements 1,280 1,447 Office, furniture and equipment 941 1,014 Production plant 41,122 41,971 46,139 48,815 Less - accumulated depreciation (4,875 ) (4,496 ) Depreciable cost $ 41,264 $ 44,319 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Leases [Abstract] | |
Schedule of Operating Lease Costs | The components of operating lease costs were as follows: Year ended 2023 2022 Operating lease costs $ 2,476 $ 2,833 Short-term lease costs 17 91 Total lease costs $ 2,493 $ 2,924 |
Schedule of Supplemental Balance Sheet Information Related to Operating Leases | Supplemental balance sheet information related to operating leases is as follows: Year ended 2023 2022 Weighted average remaining lease term (in years) 3.18 3.28 Weighted average discount rate 2.63 % 3.56 % |
Schedule of Maturities of Lease Liabilities | Maturities of lease liabilities were as follows: Year ended 2024 1,172 2025 1,044 2026 691 2027 525 Total undiscounted lease payments 3,432 Less - imputed interest (35 ) Present value of lease liabilities $ 3,397 |
Convertible Senior Notes, Net (
Convertible Senior Notes, Net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Convertible Senior Notes, Net [Abstract] | |
Schedule of Liability Measured at its Amortized Cost | Year ended 2023 2022 Liability component: Principal amount $ 75,000 $ 75,000 Issuance costs (4,223 ) (4,223 ) Principal net of issuance costs 70,777 70,777 Amortized issuance costs 2,264 1,423 Net carrying amount (including accrued interest) $ 73,041 $ 72,200 |
Accrued Expenses and Current _2
Accrued Expenses and Current Liabilties (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accrued Expenses and Current Liabilties [Abstract] | |
Schedule of Accrued Expenses and Current Liabilties | December 31, 2023 2022 Subcontractors $ 126 $ 794 Third Party Settlement Agreement* 4,424 2,666 Clinical activities 2,169 2,709 Professional services 1,070 1,561 Production plant in process - 790 Other 340 371 $ 8,129 $ 8,891 * 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 $8,848 (€8,000). As of December 31, 2023, the Company had paid the first two installment payments of $1,594 (€1,500) and $2,646 (€2,500). The remaining $4,424 (€4,000) will be paid in 2024. The current liability to Lonza increased during 2023, as a portion of the termination payments were classified as long-term liabilities in 2022. |
Selling, General and Administ_2
Selling, General and Administrative (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Selling, General and Administrative [Abstract] | |
Schedule of Selling, General and Administrative | December 31, 2023 2022 Salaries & related $ 17,004 $ 12,902 Share-based compensation 4,183 3,151 Professional services* 20,262 13,099 Other 3,135 3,149 $ 44,584 $ 32,301 * Professional fees include legal, accounting and audit services, and other consulting fees. |
Financial (Income) Expenses (Ta
Financial (Income) Expenses (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Financial (Income) Expenses [Abstract] | |
Schedule of Financial (Income) Expenses | December 31, 2023 2022 Change in Fair Value of warrant derivative liabilities $ (17,469 ) $ - Change in Fair Value of convertible loan 611 - Interest Income (2,727 ) (3,234 ) Interest Expense 7,587 5,683 Follow On Costs 1,733 2,132 Other 223 (199 ) $ (10,042 ) $ 4,382 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Measurements [Abstract] | |
Schedule of Assets and Liabilities Measured at Fair Value | The following tables present the Company’s assets and liabilities measured at fair value by level within the fair value hierarchy for the years ended December 31, 2023 and 2022: December 31, 2023 2022 Level 1 Level 3 Total Level 1 Level 3 Total Financial assets: Money market funds included in cash and cash equivalent $ 46,554 $ - $ 46,554 $ 58,827 $ 58,827 $ - Total assets measured at fair value $ 46,554 $ - $ 46,554 $ 58,827 $ - $ 58,827 Financial liabilities: 2022 Notes $ - $ 6,505 $ 6,505 $ - $ 24,250 $ 24,250 Warrants liability - 3,284 3,284 - - - Total liabilities measured at fair value - $ 9,789 $ 9,789 $ - $ 24,250 $ 24,250 |
Schedule of Warrant Liability Activity | The following table summarizes the warrant liability activity as of December 31, 2023: Warrant Initial measurement (April 21, 2023) $ 20,753 Change in fair value (17,469 ) Balance December 31, 2023 $ 3,284 |
Schedule of Note Liability Initial Measurement Date | The key inputs used in the valuation of the warrants liability as of December 31, 2023 and April 21, 2023, the initial measurement date, are included below: Input December 31, April, 21, Exercise price $ 1.35 $ 1.35 Share price on date $ 0.41 $ 1.60 Risk-free rate 4.0 % 3.7 % Expected volatility 90 % 91 % Dividend Rate 0 % 0 % |
Schedule of Note Liability | The fair value for the 2022 Notes liability as of December 31, 2023 and December 31, 2022: 2022 Balance as of December 31, 2022 $ 24,250 2023 principal payments and conversions (18,356 ) Change in fair value 611 Balance as of December 31, 2023 $ 6,505 |
Schedule of Note Liability Initial Measurement Date | The key inputs used in the valuation of the 2022 Notes liability as of December 31, 2023 and December 31, 2022 the initial measurement date: December 31, December 31, 2023 2022 Voluntary conversion price $ 1.91 $ 1.91 Share price on date $ 0.41 $ 1.29 Risk-free rate 4.8 % 4.4 % Expected volatility 109 % 75 % Implied yield 31.0 % 32.8 % |
Shareholders_ Deficit (Tables)
Shareholders’ Deficit (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Shareholders’ Deficit [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 above Options Plans for the years 2023 and 2022: December 31, 2023 2022 Dividend yield 0% 0% Expected volatility of the share prices 69%-74% 66%-67% Risk-free interest rate 3.5%-4.44% 1.8%-3.8% Expected term (in years) 8 8 |
Schedule of Options Granted to Employees Under thSchedule of Company’s Outstanding and Exercisable Options Granted to Employeese Option Plans | The following table summarizes the number of options granted to employees under the Option Plans for the year ended December 31, 2023 and related information: Number of Weighted Weighted Aggregate Outstanding at the beginning of the year 6,133,903 4.62 7.51 8,939 Granted 2,167,234 1.51 - - Exercised (1,066 ) 0.25 - - Forfeited (657,309 ) 2.58 - - Expired (533,500 ) 5.57 - - Outstanding at the end of the year 7,109,262 3.83 7.16 2,259 Exercisable at the end of the year 4,280,279 4.62 6.25 683 |
Schedule of Outstanding and Exercisable Options Granted to Employees | The following table summarizes information about the Company’s outstanding and exercisable options granted to employees as of December 31, 2023: Exercise price Options Weighted Options Weighted $ 0.25- 3.80 4,213,394 8.54 1,725,760 8.43 $ 4.15- 4.95 1,782,094 4.61 1,656,858 5.06 $ 5.21- 7.56 350,934 6.33 275,479 6.05 $ 8.00-11.01 762,840 5.66 622,182 6.29 7,109,262 4,280,279 |
Schedule of Restricted Shares Activity | A summary of restricted shares and restricted share units activity for the year ended December 31, 2023 is as follows: Number of Weighted Unvested at the beginning of the year 1,126,743 $ 3.29 Granted 1,056,406 1.51 Vested (706,619 ) 2.85 Forfeited (339,727 ) 2.28 Unvested at the end of the year 1,136,803 $ 2.22 |
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 years ended December 31, 2023 and 2022 is comprised as follows: Year ended 2023 2022 Cost of sales $ 9 $ - Excess Capacity 120 - Research and development expenses, net 1,199 1,890 Selling, general and administrative 4,183 3,151 Total share-based compensation $ 5,511 $ 5,041 |
Taxes on Income (Tables)
Taxes on Income (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Taxes on Income [Abstract] | |
Schedule of components of the loss | The components of the loss before income taxes were as follows: Year ended 2023 2022 Gamida Cell Ltd. - Israel $ 35,644 $ 66,137 Gamida Cell Inc. – United States 27,352 13,238 62,996 $ 79,375 |
Schedule of Deferred Tax Assets | Significant components of the Company’s deferred tax assets are as follows: December 31, 2023 2022 Accruals and reserves 215 184 R&D expenses 2,660 3,421 Stock-based compensation 1,115 1,389 Issuance costs 140 106 Lease liability 392 763 Loss carryforward 42,094 34,029 Capital loss 88 58 Tax credit carried forward 243 234 Deferred tax assets before valuation allowance 46,947 40,184 Less - valuation allowance 46,579 39,548 ROU Asset (368 ) (726 ) Net deferred tax assets, net - - |
Basic and Diluted Net Loss Pe_2
Basic and Diluted Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 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 net loss per share: Year ended December 31, 2023 2022 Weighted Net loss Weighted Net loss For the computation of basic and diluted net loss 110,049,547 $ 62,996 63,826,295 $ 79,375 |
Schedule of Outstanding Warrants, Share Options, and Restricted Shares | All outstanding convertible senior note options, warrants, outstanding share options, and restricted shares for the twelve months ended December 31, 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: Year ended 2023 2022 Convertible senior notes 9,948,582 4,904,318 Warrants 17,466,730 1,670,373 Outstanding share options 6,837,070 5,396,583 Restricted shares 1,526,758 1,289,395 Total 35,779,140 13,260,669 |
General (Details)
General (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
General [Abstract] | ||
Accumulated deficit | $ (479,828) | $ (416,832) |
Cash flows from operating activities | (79,120) | (70,423) |
Cash and cash equivalents | $ 46,554 | $ 64,657 |
Significant Accounting Polici_3
Significant Accounting Policies (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Significant Accounting Policies (Details) [Line Items] | ||
Severance pay percentage | 8.33% | |
Accrued Severance Cost | $ 1,482,000 | $ 1,914,000 |
Severance pay fund amount | 1,359,000 | 1,703,000 |
Severance costs | 483,000 | 895,000 |
Defined contribution plan cost | 515,000 | 424 |
Inventory write-offs | $ 357,000 | |
Financing component term | 1 year | |
Research and development expenses | $ 24,308,000 | 42,692,000 |
Tax benefit rate | 50% | |
Research and Development Expense [Member] | ||
Significant Accounting Policies (Details) [Line Items] | ||
Research and development expenses | $ 309,000 | $ 978,000 |
Significant Accounting Polici_4
Significant Accounting Policies (Details) - Schedule of Straight-Line Basis Over the Useful Life of the Assets | Dec. 31, 2023 | |
Machinery [Member] | Minimum [Member] | ||
Schedule of Straight-Line Basis Over the Useful Life of The Assets [Line Items] | ||
Useful life | 10 years | |
Machinery [Member] | Maximum [Member] | ||
Schedule of Straight-Line Basis Over the Useful Life of The Assets [Line Items] | ||
Useful life | 15 years | |
Leasehold improvements [Member] | ||
Schedule of Straight-Line Basis Over the Useful Life of The Assets [Line Items] | ||
Useful life | [1] | |
Office, furniture and equipment [Member] | Minimum [Member] | ||
Schedule of Straight-Line Basis Over the Useful Life of The Assets [Line Items] | ||
Useful life | 6 years | |
Office, furniture and equipment [Member] | Maximum [Member] | ||
Schedule of Straight-Line Basis Over the Useful Life of The Assets [Line Items] | ||
Useful life | 33 years | |
Production plant [Member] | ||
Schedule of Straight-Line Basis Over the Useful Life of The Assets [Line Items] | ||
Useful life | 11 years | |
[1]Over the shorter of the term of the lease or its useful life. |
Property, Plant and Equipment_3
Property, Plant and Equipment, Net (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Property, Plant and Equipment, Net [Abstract] | ||
Depreciation expense | $ 2,024 | $ 440 |
Depreciation expense relating to equipment sold | 1,646 | |
Other operating expenses | $ 395 |
Property, Plant and Equipment_4
Property, Plant and Equipment, Net (Details) - Schedule of Property, Plant and Equipment - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Schedule of Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Net | $ 46,139 | $ 48,815 |
Less - accumulated depreciation | (4,875) | (4,496) |
Depreciable cost | 41,264 | 44,319 |
Machinery [Member] | ||
Schedule of Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Net | 2,796 | 4,383 |
Leasehold Improvements [Member] | ||
Schedule of Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Net | 1,280 | 1,447 |
Office, furniture and equipment [Member] | ||
Schedule of Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Net | 941 | 1,014 |
Production plant [Member] | ||
Schedule of Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Net | $ 41,122 | $ 41,971 |
Leases (Details)
Leases (Details) | Dec. 31, 2023 |
Leases [Abstract] | |
Lease term | 4 years |
Leases (Details) - Schedule of
Leases (Details) - Schedule of Operating Lease Costs - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Schedule of Operating Lease Costs [Abstract] | ||
Operating lease costs | $ 2,476 | $ 2,833 |
Short-term lease costs | 17 | 91 |
Total lease costs | $ 2,493 | $ 2,924 |
Leases (Details) - Schedule o_2
Leases (Details) - Schedule of Supplemental Balance Sheet Information Related to Operating Leases | Dec. 31, 2023 | Dec. 31, 2022 |
Leases [Abstract] | ||
Weighted average remaining lease term (in years) | 3 years 2 months 4 days | 3 years 3 months 10 days |
Weighted average discount rate | 2.63% | 3.56% |
Leases (Details) - Schedule o_3
Leases (Details) - Schedule of Maturities of Lease Liabilities $ in Thousands | Dec. 31, 2023 USD ($) |
Schedule of Maturities of Lease Liabilities [Abstract] | |
2024 | $ 1,172 |
2025 | 1,044 |
2026 | 691 |
2027 | 525 |
Total undiscounted lease payments | 3,432 |
Less - imputed interest | (35) |
Present value of lease liabilities | $ 3,397 |
Convertible Senior Notes, Net_2
Convertible Senior Notes, Net (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Feb. 16, 2021 | |
Convertible Senior Notes, Net [Line Items] | |||
Aggregate principal amount | $ 75,000 | $ 75,000 | |
Bearing interest | 7.50% | 5.875% | |
Maturity date | Feb. 15, 2026 | ||
Convertible notes payable | $ 1,000 | ||
Exchange price percentage | 130% | ||
Total estimated fair value | $ 74,946 | $ 73,331 | |
Ordinary shares exchange rate (in Dollars per share) | $ 0.52356 | ||
Principal amount per share (in Dollars per share) | $ 1 | ||
Minimum liquidity covenant | $ 20,000 | ||
Aggregate outstanding balance | 16,107 | ||
Interest make-whole payment | 1,451 | ||
Principal payments | 2,249 | ||
interest payment | 1,503 | ||
Principal balance | $ 6,644 | ||
Ordinary Shares [Member] | |||
Convertible Senior Notes, Net [Line Items] | |||
Exchange price (in Dollars per share) | $ 17.76 | ||
Maximum [Member] | |||
Convertible Senior Notes, Net [Line Items] | |||
Ordinary shares issued (in Shares) | 10,044,275 | ||
Minimum [Member] | |||
Convertible Senior Notes, Net [Line Items] | |||
Ordinary shares issued (in Shares) | 1,210,322 | ||
Associated [Member] | |||
Convertible Senior Notes, Net [Line Items] | |||
Repurchase price | 100% | ||
Convertible Senior Notes Net [Member] | |||
Convertible Senior Notes, Net [Line Items] | |||
Trading days | 20 | ||
Consecutive trading day | 30 | ||
Total issuance costs | $ 4,223 | ||
2021 Notes [Member] | |||
Convertible Senior Notes, Net [Line Items] | |||
Effective interest rate | 7.37% | ||
Loan Agreement [Member] | |||
Convertible Senior Notes, Net [Line Items] | |||
Aggregate principal amount | $ 25,000 | ||
Ordinary Shares [Member] | |||
Convertible Senior Notes, Net [Line Items] | |||
Conversion rate (in Dollars per share) | $ 56.3063 | ||
Principal amount | $ 1,000 | ||
Convertible Notes [Member] | |||
Convertible Senior Notes, Net [Line Items] | |||
Aggregate principal amount | $ 75,000 | ||
Repurchase Amount | $ 1,000 | ||
Repurchase price | 100% | ||
Loan Agreement [Member] | |||
Convertible Senior Notes, Net [Line Items] | |||
Principal amount | $ 5,000 |
Convertible Senior Notes, Net_3
Convertible Senior Notes, Net (Details) - Schedule of Liability Measured at its Amortized Cost - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Schedule of Liability Measured at its Amortized Cost [Abstract] | ||
Principal amount | $ 75,000 | $ 75,000 |
Issuance costs | (4,223) | (4,223) |
Principal net of issuance costs | 70,777 | 70,777 |
Amortized issuance costs | 2,264 | 1,423 |
Net carrying amount (including accrued interest) | $ 73,041 | $ 72,200 |
Accrued Expenses and Current _3
Accrued Expenses and Current Liabilties (Details) - 12 months ended Dec. 31, 2023 $ in Thousands | USD ($) | EUR (€) | EUR (€) |
Accrued Expenses and Current Liabilties [Line Items] | |||
Aggregate amount | $ 8,848 | € 8,000 | |
Installment payments | 1,594 | 1,500 | |
Lonza Netherlands B.V [Member] | |||
Accrued Expenses and Current Liabilties [Line Items] | |||
Installment payments | 2,646 | € 2,500 | |
Cash paid | $ 4,424 | € 4,000 |
Accrued Expenses and Current _4
Accrued Expenses and Current Liabilties (Details) - Schedule of Accrued Expenses and Current Liabilties - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | |
Schedule of Accrued Expenses and Other Payables [Abstract] | |||
Subcontractors | $ 126 | $ 794 | |
Third Party Settlement Agreement | [1] | 4,424 | 2,666 |
Clinical activities | 2,169 | 2,709 | |
Professional services | 1,070 | 1,561 | |
Production plant in process | 790 | ||
Other | 340 | 371 | |
Accrued expenses and current liabilities total | $ 8,129 | $ 8,891 | |
[1]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 $8,848 (€8,000). As of December 31, 2023, the Company had paid the first two installment payments of $1,594 (€1,500) and $2,646 (€2,500). The remaining $4,424 (€4,000) will be paid in 2024. The current liability to Lonza increased during 2023, as a portion of the termination payments were classified as long-term liabilities in 2022. |
Selling, General and Administ_3
Selling, General and Administrative (Details) - Schedule of Selling, General and Administrative - Selling, General and Administrative Expenses [Member] - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | ||
Schedule of Selling, General and Administrative [Line Items] | |||
Salaries & related | $ 17,004 | $ 12,902 | |
Share-based compensation | 4,183 | 3,151 | |
Professional services | [1] | 20,262 | 13,099 |
Other | 3,135 | 3,149 | |
Accrued expenses and current liabilities total | $ 44,584 | $ 32,301 | |
[1]Professional fees include legal, accounting and audit services, and other consulting fees. |
Financial (Income) Expenses (De
Financial (Income) Expenses (Details) - Schedule of Financial (Income) Expenses - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Schedule of Financial (Income) Expenses [Abstract] | ||
Change in Fair Value of warrant derivative liabilities | $ (17,469) | |
Change in Fair Value of convertible loan | 611 | |
Interest Income | (2,727) | (3,234) |
Interest Expense | 7,587 | 5,683 |
Follow On Costs | 1,733 | 2,132 |
Other | 223 | (199) |
Financial (Income) Expenses | $ (10,042) | $ 4,382 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Schedule of Assets and Liabilities Measured at Fair Value - Fair Value, Recurring [Member] - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Financial assets: | ||
Total assets measured at fair value | $ 46,554 | $ 58,827 |
Financial liabilities: | ||
2022 Notes | 6,505 | 24,250 |
Warrants liability | 3,284 | |
Total liabilities measured at fair value | 9,789 | 24,250 |
Money Market Funds [Member] | ||
Financial assets: | ||
Money market funds included in cash and cash equivalent | 46,554 | 58,827 |
Level 1 [Member] | ||
Financial assets: | ||
Total assets measured at fair value | 46,554 | 58,827 |
Financial liabilities: | ||
2022 Notes | ||
Warrants liability | ||
Total liabilities measured at fair value | ||
Level 1 [Member] | Money Market Funds [Member] | ||
Financial assets: | ||
Money market funds included in cash and cash equivalent | 46,554 | 58,827 |
Level 3 [Member] | ||
Financial assets: | ||
Total assets measured at fair value | ||
Financial liabilities: | ||
2022 Notes | 6,505 | 24,250 |
Warrants liability | 3,284 | |
Total liabilities measured at fair value | 9,789 | 24,250 |
Level 3 [Member] | Money Market Funds [Member] | ||
Financial assets: | ||
Money market funds included in cash and cash equivalent |
Fair Value Measurements (Deta_2
Fair Value Measurements (Details) - Schedule of Warrant Liability Activity $ in Thousands | 8 Months Ended |
Dec. 31, 2023 USD ($) | |
Schedule of Warrants Liability Activity [Abstract] | |
Initial measurement (April 21, 2023) | $ 20,753 |
Change in fair value | (17,469) |
Balance December 31, 2023 | $ 3,284 |
Fair Value Measurements (Deta_3
Fair Value Measurements (Details) - Schedule of Warrants Liability Initial Measurement Date | Dec. 31, 2023 | Apr. 21, 2023 |
Measurement Input, Exercise Price [Member] | ||
Schedule of Warrants Liability Initial Measurement Date [Abstract] | ||
warrants liability | 1.35 | 1.35 |
Measurement Input, Share Price [Member] | ||
Schedule of Warrants Liability Initial Measurement Date [Abstract] | ||
warrants liability | 0.41 | 1.6 |
Measurement Input, Risk Free Interest Rate [Member] | ||
Schedule of Warrants Liability Initial Measurement Date [Abstract] | ||
warrants liability | 4 | 3.7 |
Measurement Input, Price Volatility [Member] | ||
Schedule of Warrants Liability Initial Measurement Date [Abstract] | ||
warrants liability | 90 | 91 |
Measurement Input, Expected Dividend Rate [Member] | ||
Schedule of Warrants Liability Initial Measurement Date [Abstract] | ||
warrants liability | 0 | 0 |
Fair Value Measurements (Deta_4
Fair Value Measurements (Details) - Schedule of Note Liability - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Schedule of Note Liability [Abstract] | ||
Balance as of December 31, 2022 | $ 24,250 | |
2023 principal payments and conversions | (18,356) | |
Change in fair value | 611 | |
Balance as of December 31, 2023 | $ 6,505 | $ 24,250 |
Fair Value Measurements (Deta_5
Fair Value Measurements (Details) - Schedule of Note Liability Initial Measurement Date | Dec. 31, 2023 | Dec. 31, 2022 |
Measurement Input, Price Volatility [Member] | ||
Schedule of Note Liability Initial Measurement Date [Abstract] | ||
Valuation of the 2022 notes liability | 1.91 | 1.91 |
Measurement Input, Exercise Price [Member] | ||
Schedule of Note Liability Initial Measurement Date [Abstract] | ||
Valuation of the 2022 notes liability | 0.41 | 1.29 |
Measurement Input, Risk Free Interest Rate [Member] | ||
Schedule of Note Liability Initial Measurement Date [Abstract] | ||
Valuation of the 2022 notes liability | 4.8 | 4.4 |
Measurement Input, Expected volatility [Member] | ||
Schedule of Note Liability Initial Measurement Date [Abstract] | ||
Valuation of the 2022 notes liability | 109 | 75 |
Measurement Input, Implied Yield [Member] | ||
Schedule of Note Liability Initial Measurement Date [Abstract] | ||
Valuation of the 2022 notes liability | 31 | 32.8 |
Contingent Liabilities and Co_2
Contingent Liabilities and Commitments (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Jan. 01, 2024 | |
Contingent Liabilities and Commitments [Line Items] | ||
Bank guarantees amount | $ 2,844 | |
Aggregate amount | 37,082 | |
Royalty grants | 34,477 | |
Non-royalty bearing grants | $ 2,605 | |
Percentage of grants received | 100% | |
Total grants | $ 43,745 | |
Royalty [Member] | ||
Contingent Liabilities and Commitments [Line Items] | ||
Accrued royalties | $ 61 | |
SOFR [Member] | ||
Contingent Liabilities and Commitments [Line Items] | ||
Interest rate | 1% | |
Minimum [Member] | ||
Contingent Liabilities and Commitments [Line Items] | ||
Royalties interest rate | 3% | |
Maximum [Member] | ||
Contingent Liabilities and Commitments [Line Items] | ||
Royalties rate | 3.50% | |
Subsequent Event [Member] | ||
Contingent Liabilities and Commitments [Line Items] | ||
Interest rate | 0.72% | |
Fixed interest rate | 4% |
Shareholders_ Deficit (Details)
Shareholders’ Deficit (Details) | 12 Months Ended | ||||
Apr. 19, 2023 USD ($) $ / shares shares | Sep. 27, 2022 USD ($) $ / shares shares | Dec. 31, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares | Jan. 23, 2017 ₪ / shares shares | |
Shareholders’ Deficit (Details) [Line Items] | |||||
Ordinary shares | shares | 17,500,000 | 12,905,000 | |||
Price per share (in Dollars per share) | $ 1.3 | $ 1.55 | |||
Gross proceeds (in Dollars) | $ | $ 22,750 | $ 20,000 | |||
Warrants to purchase | shares | 17,500,000 | ||||
Offering expenses (in Dollars) | $ | $ 1,900 | ||||
Net proceeds (in Dollars) | $ | $ 43,120 | ||||
Issuance of shares | shares | 40,515,620 | ||||
Public offering price (in Dollars per share) | $ 1.1 | ||||
Purchase of warrants | shares | 17,500,000 | ||||
Ordinary shares expire date | Apr. 21, 2028 | ||||
Warrants exercised | shares | 33,270 | ||||
Exercise of warrants liability | shares | 33,270 | ||||
Outstanding restricted shares | shares | 32,477 | ||||
Number of shares reserved for issuance | shares | 2,455,978 | ||||
Ordinary shares outstanding percentage | 4% | ||||
Weighted average exercise price options granted (in Dollars per share) | $ 0.25 | ||||
Fair value of options granted (in Dollars per share) | $ 1.51 | ||||
Fair value of shares vested (in Dollars) | $ | $ 1,734 | $ 1,462 | |||
Unrecognized costs (in Dollars) | $ | $ 5,734 | ||||
Weighted average period | 1 year 9 months 7 days | ||||
Two Thousand Seventeen Stock Compensation Plan [Member] | |||||
Shareholders’ Deficit (Details) [Line Items] | |||||
Number of shares reserved for issuance | shares | 312,867 | ||||
Price per share (in New Shekels per share) | ₪ / shares | ₪ 0.01 | ||||
Minimum [Member] | |||||
Shareholders’ Deficit (Details) [Line Items] | |||||
Grant date fair value per share (in Dollars per share) | $ 0.24 | ||||
Weighted average exercise price options granted (in Dollars per share) | 1.51 | ||||
Fair value of options granted (in Dollars per share) | 0.95 | ||||
Maximum [Member] | |||||
Shareholders’ Deficit (Details) [Line Items] | |||||
Grant date fair value per share (in Dollars per share) | $ 1.59 | ||||
Weighted average exercise price options granted (in Dollars per share) | $ 2.55 | ||||
Fair value of options granted (in Dollars per share) | $ 1.58 |
Shareholders_ Deficit (Detail_2
Shareholders’ Deficit (Details) - Schedule of Fair Value Measurement of Equity-Settled Share Options | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Shareholders’ Deficit (Details) - Schedule of Fair Value Measurement of Equity-Settled Share Options [Line Items] | ||
Dividend yield | 0% | 0% |
Expected term (in years) | 8 years | 8 years |
Minimum [Member] | ||
Shareholders’ Deficit (Details) - Schedule of Fair Value Measurement of Equity-Settled Share Options [Line Items] | ||
Expected volatility of the share prices | 69% | 66% |
Risk-free interest rate | 3.50% | 1.80% |
Maximum [Member] | ||
Shareholders’ Deficit (Details) - Schedule of Fair Value Measurement of Equity-Settled Share Options [Line Items] | ||
Expected volatility of the share prices | 74% | 67% |
Risk-free interest rate | 4.44% | 3.80% |
Shareholders_ Deficit (Detail_3
Shareholders’ Deficit (Details) - Schedule of Options Granted to Employees Under the Option Plans - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Schedule of Options Granted to Employees Under the Option Plans [Abstract] | ||
Number of options, Outstanding at the Ending of the year | 7,109,262 | 6,133,903 |
Weighted average exercise price, Outstanding at the Ending of the year | $ 3.83 | $ 4.62 |
Weighted average remaining contractual term, Outstanding at the Ending of the year | 7 years 1 month 28 days | 7 years 6 months 3 days |
Aggregate intrinsic value, Outstanding at the Ending of the year | $ 2,259 | $ 8,939 |
Number of options, Exercisable at the end of the year | 4,280,279 | |
Weighted average exercise price, Exercisable at the end of the year | $ 4.62 | |
Weighted average remaining contractual term, Exercisable at the end of the year | 6 years 3 months | |
Aggregate intrinsic value, Exercisable at the end of the year | $ 683 | |
Number of options, Granted | 2,167,234 | |
Weighted average exercise price, Granted | $ 1.51 | |
Aggregate intrinsic value, Granted | ||
Number of options, Exercised | (1,066) | |
Weighted average exercise price, Exercised | $ 0.25 | |
Aggregate intrinsic value, Exercised | ||
Number of options, Forfeited | (657,309) | |
Weighted average exercise price, Forfeited | $ 2.58 | |
Aggregate intrinsic value, Forfeited | ||
Number of options, Expired | (533,500) | |
Weighted average exercise price, Expired | $ 5.57 | |
Aggregate intrinsic value, Expired |
Shareholders_ Deficit (Detail_4
Shareholders’ Deficit (Details) - Schedule of Outstanding and Exercisable Options Granted to Employees | 12 Months Ended |
Dec. 31, 2023 shares | |
Schedule of Outstanding and Exercisable Options Granted to Employees [Line Items] | |
Options outstanding as of December 31, 2023 | 7,109,262 |
Options exercisable as of December 31, 2023 | 4,280,279 |
$ 0.25- 3.80 [Member] | |
Schedule of Outstanding and Exercisable Options Granted to Employees [Line Items] | |
Options outstanding as of December 31, 2023 | 4,213,394 |
Weighted average remaining contractual term (years) | 8 years 6 months 14 days |
Options exercisable as of December 31, 2023 | 1,725,760 |
Weighted average remaining contractual term (years) | 8 years 5 months 4 days |
$ 4.15- 4.95 [Member] | |
Schedule of Outstanding and Exercisable Options Granted to Employees [Line Items] | |
Options outstanding as of December 31, 2023 | 1,782,094 |
Weighted average remaining contractual term (years) | 4 years 7 months 9 days |
Options exercisable as of December 31, 2023 | 1,656,858 |
Weighted average remaining contractual term (years) | 5 years 21 days |
$ 5.21- 7.56 [Member] | |
Schedule of Outstanding and Exercisable Options Granted to Employees [Line Items] | |
Options outstanding as of December 31, 2023 | 350,934 |
Weighted average remaining contractual term (years) | 6 years 3 months 29 days |
Options exercisable as of December 31, 2023 | 275,479 |
Weighted average remaining contractual term (years) | 6 years 18 days |
$ 8.00-11.01 [Member] | |
Schedule of Outstanding and Exercisable Options Granted to Employees [Line Items] | |
Options outstanding as of December 31, 2023 | 762,840 |
Weighted average remaining contractual term (years) | 5 years 7 months 28 days |
Options exercisable as of December 31, 2023 | 622,182 |
Weighted average remaining contractual term (years) | 6 years 3 months 14 days |
Shareholders_ Deficit (Detail_5
Shareholders’ Deficit (Details) - Schedule of Restricted Shares Activity - Restricted Share Units [Member] | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Shareholders’ Deficit (Details) - Schedule of Restricted Shares Activity [Line Items] | |
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 | 1,056,406 |
Weighted average grant date fair value, Granted | $ / shares | $ 1.51 |
Number of restricted shares and restricted share units, Vested | shares | (706,619) |
Weighted average grant date fair value, Vested | $ / shares | $ 2.85 |
Number of restricted shares and restricted share units, Forfeited | shares | (339,727) |
Weighted average grant date fair value, Forfeited | $ / shares | $ 2.28 |
Number of restricted shares and restricted share units, Unvested end | shares | 1,136,803 |
Weighted average grant date fair value, Unvested end | $ / shares | $ 2.22 |
Shareholders_ Deficit (Detail_6
Shareholders’ Deficit (Details) - Schedule of Share-Based Compensation Expense - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Schedule of Share-Based Compensation Expense [Abstract] | ||
Cost of sales | $ 9 | |
Excess Capacity | 120 | |
Research and development expenses, net | 1,199 | 1,890 |
Selling, general and administrative | 4,183 | 3,151 |
Total share-based compensation | $ 5,511 | $ 5,041 |
Taxes on Income (Details)
Taxes on Income (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |
Dec. 22, 2017 | Dec. 31, 2023 | Dec. 31, 2022 | |
Tax On Income [Line Items] | |||
Corporate tax rate | 23% | 23% | |
Tax rate | 50% | ||
Net operating losses carryforwards (in Dollars) | $ 348,370 | ||
Maximum [Member] | |||
Tax On Income [Line Items] | |||
Statutory federal income tax rate | 35% | ||
Minimum [Member] | |||
Tax On Income [Line Items] | |||
Statutory federal income tax rate | 21% | ||
Federal Tax Purposes [Member] | |||
Tax On Income [Line Items] | |||
Net operating losses carryforwards (in Dollars) | 56,698 | ||
Capital Loss Carryforward [Member] | |||
Tax On Income [Line Items] | |||
Net operating losses carryforwards (in Dollars) | $ 1,168 | ||
ISRAEL | |||
Tax On Income [Line Items] | |||
Tax rate | 7.50% | ||
Other Regions [Member] | |||
Tax On Income [Line Items] | |||
Tax rate | 16% |
Taxes on Income (Details) - Sch
Taxes on Income (Details) - Schedule of Components of Loss Before Income Taxes - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Schedule of Components of the Loss [Line Items] | ||
Loss before income taxes | $ 62,996 | $ 79,375 |
Israel [Member] | ||
Schedule of Components of the Loss [Line Items] | ||
Loss before income taxes | 35,644 | 66,137 |
United States [Member] | ||
Schedule of Components of the Loss [Line Items] | ||
Loss before income taxes | $ 27,352 | $ 13,238 |
Taxes on Income (Details) - S_2
Taxes on Income (Details) - Schedule of Deferred Tax Assets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Schedule of Deferred Tax Assets [Abstract] | ||
Accruals and reserves | $ 215 | $ 184 |
R&D expenses | 2,660 | 3,421 |
Stock-based compensation | 1,115 | 1,389 |
Issuance costs | 140 | 106 |
Lease liability | 392 | 763 |
Loss carryforward | 42,094 | 34,029 |
Capital loss | 88 | 58 |
Tax credit carried forward | 243 | 234 |
Deferred tax assets before valuation allowance | 46,947 | 40,184 |
Less - valuation allowance | 46,579 | 39,548 |
ROU Asset | (368) | (726) |
Net deferred tax assets, net |
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 | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Basic and Diluted Net Loss Per Share [Abstract] | ||
Weighted number of shares, Basic | 110,049,547 | 63,826,295 |
Net loss attributable to equity holders of the Company Basic | $ 62,996 | $ 79,375 |
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) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Basic and Diluted Net Loss Per Share [Abstract] | ||
Weighted number of shares, Diluted | 110,049,547 | 63,826,295 |
Net loss attributable to equity holders of the company Diluted | $ 62,996 | $ 79,375 |
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 | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Schedule of Outstanding Convertible Senior Note Options, Warrants, Outstanding Share Options, and Restricted Shares [Line Items] | ||
Total diluted net loss per share | 35,779,140 | 13,260,669 |
Convertible Senior Notes [Member] | ||
Schedule of Outstanding Convertible Senior Note Options, Warrants, Outstanding Share Options, and Restricted Shares [Line Items] | ||
Total diluted net loss per share | 9,948,582 | 4,904,318 |
Warrant [Member] | ||
Schedule of Outstanding Convertible Senior Note Options, Warrants, Outstanding Share Options, and Restricted Shares [Line Items] | ||
Total diluted net loss per share | 17,466,730 | 1,670,373 |
Outstanding Share Options [Member] | ||
Schedule of Outstanding Convertible Senior Note Options, Warrants, Outstanding Share Options, and Restricted Shares [Line Items] | ||
Total diluted net loss per share | 6,837,070 | 5,396,583 |
Restricted shares [Member] | ||
Schedule of Outstanding Convertible Senior Note Options, Warrants, Outstanding Share Options, and Restricted Shares [Line Items] | ||
Total diluted net loss per share | 1,526,758 | 1,289,395 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent Event [Member] $ / shares in Units, $ in Thousands | 3 Months Ended |
Mar. 27, 2024 USD ($) $ / shares shares | |
Subsequent Event [Line Items] | |
Net proceeds of ordinary shares | $ | $ 2,993 |
Issued ordinary shares | shares | 9,362,420 |
IPO [Member] | |
Subsequent Event [Line Items] | |
Public offering price | $ / shares | $ 0.32 |