Gamida Cell (GMDAQ) 10-Q 14 Nov 23 2023 Q3 Quarterly report Financial data

Document And Entity Information

Document And Entity Information - shares	9 Months Ended
	Sep. 30, 2023	Nov. 10, 2023
Document Information Line Items
Entity Registrant Name	GAMIDA CELL LTD.
Trading Symbol	GMDA
Document Type	10-Q
Current Fiscal Year End Date	--12-31
Entity Common Stock, Shares Outstanding		132,638,514
Amendment Flag	false
Entity Central Index Key	0001600847
Entity Current Reporting Status	Yes
Entity Filer Category	Non-accelerated Filer
Document Period End Date	Sep. 30, 2023
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q3
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Shell Company	false
Entity Ex Transition Period	false
Document Quarterly Report	true
Document Transition Report	false
Entity File Number	001-38716
Entity Incorporation, State or Country Code	L3
Entity Tax Identification Number	00-0000000
Entity Address, Address Line One	116 Huntington Avenue
Entity Address, Address Line Two	7th Floor
Entity Address, City or Town	Boston
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02116
City Area Code	(617)
Local Phone Number	892-9080
Title of 12(b) Security	Ordinary Shares, par value NIS 0.01 per share
Security Exchange Name	NASDAQ
Entity Interactive Data Current	Yes

Condensed Consolidated Balance

Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands		Sep. 30, 2023	Dec. 31, 2022
CURRENT ASSETS:
Cash and cash equivalents		$ 60,431	$ 64,657
Short-term restricted deposit		2,723
Inventory		2,324
Accounts receivable		676
Prepaid expenses and other current assets		2,355	1,889
Total current assets		68,509	66,546
NON-CURRENT ASSETS:
Restricted deposits		377	3,668
Property, plant and equipment, net		42,667	44,319
Operating lease right-of-use assets		3,706	7,024
Severance pay fund		1,288	1,703
Other long-term assets		1,201	1,513
Total non-current assets		49,239	58,227
Total assets		117,748	124,773
CURRENT LIABILITIES:
Trade payables		1,664	6,384
Employees and payroll accruals		6,058	5,300
Operating lease liabilities		1,497	2,648
Accrued interest of convertible senior notes		710	1,652
Accrued expenses and other current liabilities		10,725	8,891
Total current liabilities		20,654	24,875
NON-CURRENT LIABILITIES:
Convertible senior notes, net		81,419	96,450
Warrants liability		11,610
Accrued severance pay		1,381	1,914
Long-term operating lease liabilities		2,302	4,867
Other long-term liabilities			4,690
Total non-current liabilities		96,712	107,921
CONTINGENT LIABILITIES AND COMMITMENTS
Ordinary shares of NIS 0.01 par value - Authorized: 225,000,000 and 150,000,000 shares at September 30, 2023 (unaudited) and December 31, 2022; Issued: 132,083,914 and 74,703,030 at September 30, 2023 (unaudited) and December 31, 2022, respectively; Outstanding: 131,931,600 and 74,583,026 shares at September 30, 2023 (unaudited) and December 31, 2022, respectively		357	211
Treasury Ordinary shares of NIS 0.01 par value – 152,314 and 120,004 shares at September 30, 2023 (unaudited) and December 31, 2022, respectively	[1]
Additional paid-in capital		471,012	408,598
Accumulated deficit		(470,987)	(416,832)
Total shareholders’ equity (deficit)		382	(8,023)
Total liabilities and shareholders’ equity (deficit)		$ 117,748	$ 124,773
[1]Represents less than $1.

Condensed Consolidated Balanc_2

Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) - $ / shares	Sep. 30, 2023	Dec. 31, 2022
Statement of Financial Position [Abstract]
Ordinary shares par value (in Dollars per share)	$ 0.01	$ 0.01
Ordinary shares authorized	225,000,000	150,000,000
Ordinary shares Issued	112,425,611	74,703,030
Ordinary shares outstanding	112,274,165	74,583,026
Treasury ordinary shares par value (in Dollars per share)	$ 0.01	$ 0.01
Treasury ordinary shares	151,446	120,004

Condensed Consolidated Statemen

Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Income Statement [Abstract]
Net revenue	$ 673		$ 673
Cost of sales	626		626
Research and development expenses, net	4,248	9,864	21,776	31,732
Selling, general and administrative	13,837	7,197	34,691	22,698
Total operating expenses	18,085	17,061	56,467	54,430
Total operating loss	18,038	17,061	56,420	54,430
Financial (income) expenses, net	(16,519)	741	(2,265)	2,149
Net loss	$ 1,519	$ 17,802	$ 54,155	$ 56,579
Net loss per share attributable to ordinary shareholders, basic and diluted (in Dollars per share)	$ 0.01	$ 0.29	$ 0.53	$ 0.95
Weighted average number of shares used in computing net loss per share attributable to ordinary shareholders, basic and diluted (in Shares)	124,236,300	60,440,765	101,479,968	59,821,655

Condensed Consolidated Statem_2

Condensed Consolidated Statements of Operations (Unaudited) (Parentheticals) - $ / shares	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Income Statement [Abstract]
Net loss per share attributable to ordinary shareholders, diluted (in Dollars per share)	$ 0.01	$ 0.29	$ 0.53	$ 0.95
Weighted average number of shares used in computing net loss per share attributable to ordinary shareholders, diluted	124,236,300	60,440,765	101,479,968	59,821,655

Condensed Consolidated Statem_3

Condensed Consolidated Statements of Changes in Shareholders’ Deficit (Unaudited) - USD ($) $ in Thousands		Ordinary shares		Treasury shares		Additional paid-in capital		Accumulated deficit	Total
Balance at Dec. 31, 2021		$ 169				$ 381,225		$ (337,457)	$ 43,937
Balance (in Shares) at Dec. 31, 2021		59,970,389
Grant of restricted shares			[1]				[1]
Grant of restricted shares (in Shares)		3,600
Treasury shares (in Shares)		(85,770)
Exercise of options			[1]			76			76
Exercise of options (in Shares)		47,426
Issuance of ordinary shares, net of issuance expenses **	[2]	$ 41				22,257			22,298
Issuance of ordinary shares, net of issuance expenses ** (in Shares)	[2]	14,445,165
Share-based compensation						3,829			3,829
Loss								(56,579)	(56,579)
Balance at Sep. 30, 2022		$ 210			[1]	407,387		(394,036)	13,561
Balance (in Shares) at Sep. 30, 2022		74,380,810
Balance at Jun. 30, 2022		$ 169			[1]	383,915		(376,234)	7,850
Balance (in Shares) at Jun. 30, 2022		59,977,188
Treasury shares (in Shares)		(3,085)
Issuance of ordinary shares, net of issuance expenses **	[3]	$ 41				22,173			22,214
Issuance of ordinary shares, net of issuance expenses ** (in Shares)	[3]	14,406,707
Share-based compensation						1,299			1,299
Loss								(17,802)	(17,802)
Balance at Sep. 30, 2022		$ 210			[1]	407,387		(394,036)	13,561
Balance (in Shares) at Sep. 30, 2022		74,380,810
Treasury shares	[1]
Balance at Dec. 31, 2022		$ 211			[1]	408,598		(416,832)	$ (8,023)
Balance (in Shares) at Dec. 31, 2022		74,583,026							74,583,026
Grant of restricted shares (in Shares)									2,127,834
Issuance of ordinary shares upon release of restricted share units		$ 1				1			$ 2
Issuance of ordinary shares upon release of restricted share units (in Shares)		348,998
Treasury shares (in Shares)		(32,310)
Exercise of options					[1]		[1]			[1]
Exercise of options (in Shares)		1,066							1,066
Issuance of ordinary shares, net of issuance expenses **	[2]	$ 127				41,118			$ 41,245
Issuance of ordinary shares, net of issuance expenses ** (in Shares)	[2]	46,671,195
Issuance of ordinary shares for 2022 Notes		$ 18				16,953			16,971
Issuance of ordinary shares for 2022 Notes (in Shares)		10,326,355
Exercise of warrants liability			[1]			45			45
Exercise of warrants liability (in Shares)		33,270
Share-based compensation						4,297			4,297
Loss								(54,155)	(54,155)
Balance at Sep. 30, 2023		$ 357			[1]	471,012		(470,987)	$ 382
Balance (in Shares) at Sep. 30, 2023		131,931,600							112,274,165
Balance at Jun. 30, 2023		$ 305			[1]	443,450		(469,468)	$ (25,713)
Balance (in Shares) at Jun. 30, 2023		112,274,165
Issuance of ordinary shares upon release of restricted share units		$ 1				1			2
Issuance of ordinary shares upon release of restricted share units (in Shares)		236,629
Treasury shares (in Shares)		(868)
Exercise of options			[1]				[1]			[1]
Exercise of options (in Shares)		820
Issuance of ordinary shares, net of issuance expenses **		$ 51				25,596			25,647
Issuance of ordinary shares, net of issuance expenses ** (in Shares)		18,888,325
Issuance of ordinary shares for 2022 Notes	[3]		[1]			589			589
Issuance of ordinary shares for 2022 Notes (in Shares)	[3]	532,529
Share-based compensation						1,376			1,376
Loss								(1,519)	(1,519)
Balance at Sep. 30, 2023		$ 357			[1]	$ 471,012		$ (470,987)	$ 382
Balance (in Shares) at Sep. 30, 2023		131,931,600							112,274,165
Treasury shares	[1]
[1]Represents less than $1.[2]Issuance costs of approximately $2,951.[3]Issuance costs of approximately $793.

Condensed Consolidated Statem_4

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Statement of Cash Flows [Abstract]
Loss	$ (54,155)	$ (56,579)
Adjustments to reconcile loss to net cash used in operating activities:
Depreciation of property, plant and equipment	1,024	391
Financing expense (income), net	61	(2,461)
Share-based compensation	4,297	3,829
Change in Fair Value of warrants liability	(9,143)
Change in Fair Value in convertible notes	1,039
Warrants issuance costs	1,733
Amortization of debt discount and issuance costs	625	582
Inventory	(92)
Operating lease right-of-use assets	2,020	1,922
Operating lease liabilities	(2,417)	(2,395)
Increase in accounts receivable	(676)
Increase (decrease) accrued severance pay, net	(118)	23
(Increase) decrease in prepaid expenses and other assets	(239)	1,719
Decrease in trade payables	(4,720)	(6,355)
Increase (decrease) in accrued expenses and other liabilities	(2,096)	5,079
Net cash used in operating activities	(62,857)	(54,245)
Purchase of property, plant and equipment	(833)	(2,865)
Purchase of marketable securities		(4,557)
Proceeds from maturity of marketable securities		37,972
Proceeds from restricted deposits	294	500
Net cash provided by (used in) investing activities	(539)	31,050
Proceeds from exercise of warrants	45
Proceeds from exercise of options		76
Principal payments of convertible senior note	(1,142)
Proceeds from share issuance and warrants liability, net	60,267	22,298
Net cash provided by financing activities	59,170	22,374
Decrease in cash and cash equivalents	(4,226)	(821)
Cash and cash equivalents at beginning of period	64,657	55,892
Cash and cash equivalents at end of period	60,431	55,071
Purchase of property, plant and equipment on credit		281
Cash paid for interest	$ (5,685)	$ (4,406)

General

General	9 Months Ended
	Sep. 30, 2023
General [Abstract]
GENERAL	NOTE 1: GENERAL a. Gamida Cell Ltd. (the “Company”), founded in 1998, is a cell therapy pioneer working to turn cells into powerful therapeutics. The Company applies a proprietary expansion platform leveraging the properties of nicotinamide (“NAM”) to allogeneic cell sources including umbilical cord blood-derived cells and natural killer (NK) cells to create cell therapy candidates, with the potential to redefine standards of care. b. On April 17, 2023, the U.S. Food and Drug Administration approved the Company’s allogeneic cell therapy, Omisirge (omidubicel-onlv), for use in adult and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection. In addition, the Company has applied its NAM cell expansion technology to NK cells, to develop its initial NK product candidate, GDA-201, an investigational, NK cell-based immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. c. In March 2023, the Company announced a strategic reprioritization of its business activities to primarily focus on the commercial launch of Omisirge. d. In October 2023, the Company announced early data from 10 patients with CD20 positive non-Hodgkin lymphoma that are in the first three cohorts in an ongoing multicenter Phase 1/2 study of NK cell therapy candidate GDA-201. The study is designed to evaluate safety and determine the maximum tolerated dose. The patients were heavily pretreated with a median of six prior lines of therapy, including CAR-T cell therapy (six patients) and hematopoietic stem cell transplant (four patients). Preliminary results showed marked shrinkage of target lesions in five patients; efficacy evaluation showed two patients with complete response, two with partial response, and one with stable disease. No dose-limiting toxicities were reported in the 10 patients treated with doses up to 1x10 8 Activity appears to be dose dependent with two of the three patients in Cohort 3 responding. The fourth and final cohort of the Phase 1 portion of the study, at the target dose level of 2x10 8 e. Prior to FDA approval of Omisirge in April 2023, the Company devoted substantially all of its efforts toward research and development activities. In the course of such activities, the Company has sustained operating losses and expects such losses to continue in the foreseeable future. The Company’s accumulated deficit as of September 30, 2023 was $470,987 and negative cash flows from operating activities during the nine months ended September 30, 2023 were $62,857. The Company’s management plan is to seek a strategic partnership to support the commercialization of Omisirge or seek additional financing as required to fund its operations until achieving positive cash flows. However, there is no assurance that capital financing and/or a strategic transaction will be available to the Company, and even if available, whether it will be on terms acceptable to the Company or in amounts required. f. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The unaudited condensed consolidated financial statements do not include any adjustments to the carrying amounts and classifications of assets and liabilities that would result if the Company were unable to continue as a going concern. g. The Company has a wholly owned U.S. subsidiary, Gamida Cell Inc. (the “Subsidiary”), which was incorporated in 2000, under the laws of the State of Delaware. The Company has one operating segment and reporting unit. The subsidiary was created to assist with the commercialization of the Company’s products in the United States.

Significant Accounting Policies

Significant Accounting Policies	9 Months Ended
	Sep. 30, 2023
Significant Accounting Policies [Abstract]
SIGNIFICANT ACCOUNTING POLICIES	NOTE 2: SIGNIFICANT ACCOUNTING POLICIES a. Basis of presentation of the financial statements: The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information Certain information or footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted, pursuant to the rules and regulations of the SEC for interim financial reporting. Accordingly, they do not include all the information and footnotes necessary for a complete presentation of financial position, results of operations, or cash flows. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments, consisting of a normal recurring nature, which are necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the Company’s Annual Report on Form 10-K as of December 31, 2022 filed with the SEC on March 31, 2023. The interim period results do not necessarily indicate the results that may be expected for any other interim period or for the full fiscal year. b. Use of estimates: The preparation of the unaudited condensed financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. The Company’s management believes that the estimates, judgements and assumptions used are reasonable based upon information available at the time they are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities at the dates of the consolidated financial statements, and the reported amount of expenses during the reporting periods. Estimates may include: revenue recognition, such as returns of product sold, stock-based compensation, inventory, and impairment of long lived assets. Actual results could differ from those estimates. c. Inventories: Inventories are stated at the lower of cost or net realizable value. The Company regularly evaluates its ability to realize the value of inventory. If the inventories are deemed damaged, if actual demand of the Company’s therapies deteriorates, or if market conditions are less favorable than those projected, inventory reserves or write-offs may be required. During the three and nine months period ended September 30, 2023, a reserve for slow-moving inventory approaching expiration dates and inventory write-offs were recorded. d. Revenue recognition: Revenues are recognized in accordance with ASC 606. Revenue from contracts with customers is recognized when control of the promised goods or services is transferred to the customers, in an amount that reflects the consideration the Company expects to receive in exchange for those goods or services. The Company’s revenues are comprised of product revenue from the sales of Omisirge. Gamida Cell has a sole distributor in the United States and sells to this customer under the Flash Title model, whereby the third-party partner takes ownership but does not handle physical storage or distribution. The customer in turn resells the product to the transplant centers, while also managing the order to cash processes. To determine revenue recognition for arrangements the Company determines that are within the scope of Topic 606, the Company performs the following five steps: (i) Identify the contract(s) with a customer: The Company enters into an enforceable contract with a customer that (1) defines each party’s rights regarding delivery of and payment for a product, (2) the contract has commercial substance and (3) the Company determines that collection of substantially all consideration for such product is probable based on the payer’s intent and ability to pay the promised consideration. (ii) Identify the performance obligations in the contract: The Company’s sales contracts include the delivery of Omisirge, which represent the Company’s single performance obligation under each contract. (iii) Determine the transaction price: The transaction price is determined based on the consideration to which the Company will be entitled in exchange for providing a product to the customer. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the net realizable value utilizing either the expected value method or the most likely amount method depending on the nature of the variable consideration. Variable consideration is included in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Product revenues are recognized, net of variable consideration related to certain allowances and accruals, at the time of delivery to the transplant center. (iv) Allocate the transaction price to the performance obligations in the contract: If a contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. (v) Recognize revenue when (or as) the entity satisfies a performance obligation: Revenue is recognized when or as performance obligations are satisfied by transferring control of a promised good or service to a customer. Control either transfers over time or at a point in time, which affects when revenue is recorded. Revenues from sales of products are recognized at the point in time of transfer of control of the product, which is the time of delivery to a transplant center. e. Accounts receivable: The Company’s accounts receivable balance consists of amounts due from product sales to a single customer, which is the Company’s sole distributor of Omisirge in the United States. Under the Flash Title model, whereby the third-party partner takes ownership does not handle physical storage or distribution. Gamida Cell sells to this customer which in turn resells the product to the transplant centers, while also managing the order to cash processes. f. Cost of sales: Cost of sales in 2023 were direct costs attributable to the production of Omisirge, including raw materials, production, labor, and certain maintenance and indirect manufacturing overhead costs, quality testing directly related to each product batch, and depreciation on capital expenditure relating to the manufacturing facility that Gamida Cell has purchased to produce Omisirge. It also includes any cost of batch failure losses and royalty expenses. Cost of sales for Omisirge are recognized when incurred. g. Selling, general & administrative: Beginning July 1, 2023, the Company’s reporting of operating expenses was modified to reflect the Company’s transition to the commercial stage, with all operating costs now reported as either research and development expenses, or selling, general & administrative (SG&A) expenses. For 2022 and the first two quarters of 2023, previously reported commercial and general & administrative costs were combined into SG&A expenses. Beyond commercial and general & administrative costs, SG&A also includes certain indirect manufacturing and quality expenses, excess capacity costs and medical affairs expenditures. Excess capacity costs reflect those labor and manufacturing overhead costs incurred, but not absorbed in cost of sales in the period, given that our facility is staffed to produce the anticipated demand over the course of the coming year. h. Recently adopted accounting standards: In June 2016, FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. ASU 2016-13 amends the impairment model to utilize an expected loss methodology in place of the currently used incurred loss methodology, which will result in the more timely recognition of losses. Topic 326 is effective for the Company beginning on January 1, 2023. Effective January 1, 2023, the Company adopted the standard. Adoption of the standard did not have an impact on the financial statements.

Leases

Leases	9 Months Ended
	Sep. 30, 2023
Leases
LEASES	NOTE 3: LEASES The Company entered into operating leases primarily for its production plant, and its laboratories and offices. The leases have remaining lease terms of up to five years, and the Company does not assume renewals in its determination of the lease term unless the renewals are considered as reasonably certain at lease commencement. The components of operating lease costs were as follows: Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 Unaudited Operating lease costs $ 746 $ 676 $ 1,906 $ 2,093 Short-term lease costs - 8 82 92 Total lease costs $ 746 $ 684 $ 1,988 $ 2,185 Supplemental balance sheet information related to operating leases is as follows: Nine months ended September 30, Unaudited Weighted average remaining lease term (in years) 3.16 Weighted average discount rate 2.80 % Maturities of lease liabilities were as follows: September 30, 2023 Unaudited 2023 $ 624 2024 1,203 2025 1,071 2026 710 Thereafter 541 Total undiscounted lease payments 4,149 Less - imputed interest (350 ) Present value of lease liabilities $ 3,799

Convertible Senior Notes, Net

Convertible Senior Notes, Net	9 Months Ended
	Sep. 30, 2023
Convertible Senior Notes, Net [Abstract]
CONVERTIBLE SENIOR NOTES, NET	NOTE 4: CONVERTIBLE SENIOR NOTES, NET a. On February 16, 2021, the Subsidiary issued convertible senior notes (the “2021 Notes”) due in 2026, in the aggregate principal amount of $75 million, pursuant to an Indenture between the Company, the Subsidiary, and Wilmington Savings Fund Society, FSB, dated February 16, 2021 (the “Indenture”). The 2021 Notes bear interest payable semiannually in arrears, at a rate of 5.875% per year. The 2021 Notes will mature on February 15, 2026, unless earlier converted, redeemed or repurchased in accordance with their terms. Subject to the provisions of the Indenture, the holders of the 2021 Notes have the right, prior to the close of business on the second scheduled trading day immediately preceding February 15, 2026, to convert any 2021 Notes or portion thereof that is $1,000 or an integral multiple thereof, into the Company’s Ordinary shares at an initial conversion rate of 56.3063 shares per $1,000 principal amount of 2021 Notes (equivalent to an exchange price of $17.76 per share). The conversion rate is subject to adjustment in specified events. Upon the occurrence of a fundamental change (as defined in the Indenture), holders of the 2021 Notes may require the Company to repurchase for cash all or a portion of their 2021 Notes, in multiples of $1,000 principal amount, at a repurchase price equal to 100% of the principal amount of the 2021 Notes, plus any accrued and unpaid interest, if any, to, but excluding, interest accrued after the date of such repurchase notice. If certain fundamental changes referred to as make-whole fundamental changes occur, the conversion rate for the 2021 Notes may be increased. Subject to the provisions of the Indenture, the Subsidiary may redeem for cash all or a portion of the 2021 Notes for cash, at its option, at a redemption price equal to 100% of the principal amount of the 2021 Notes to be redeemed, plus accrued and unpaid interest on the notes to be redeemed, if the last reported closing price of the Company’s Ordinary shares has been at least 130% of the exchange price then in effect for at least 20 trading days during any 30 consecutive trading day period, and in the event of certain tax law changes. The Company accounts for its 2021 Notes in accordance with ASC 470-20 “Debt with Conversion and Other Options.” The 2021 Notes are accounted for as a single liability measured at its amortized cost, as no other embedded features require bifurcation and recognition as derivatives according to ASC 815-40. September 30, December 31, 2023 2022 Unaudited Liability component: Principal amount $ 75,000 $ 75,000 Issuance costs (4,223 ) (4,223 ) Net of issuance costs 70,777 70,777 Amortized issuance costs 2,048 1,423 Net carrying amount $ 72,825 $ 72,200 The total issuance costs of the 2021 Notes amounted to $4,223 and are amortized to interest expenses at an annual effective interest rate of 7.37%, over the term of the 2021 Notes. As of September 30, 2023, and December 31, 2022, the total estimated fair value of the 2021 Notes was $75,483 and $73,331, respectively. The fair value was determined using the Company’s effective rates for September 30, 2023 and December 31, 2022. The fair value of the 2021 Notes are classified as Level 3; see Note 5 below for further details. b. In December 2022, the Company, as guarantor, and the Subsidiary entered into a Loan and Security Agreement (the “Loan Agreement”) with certain funds managed by Highbridge Capital Management, LLC (collectively, “Highbridge”), as the lenders (together with the other lenders from time to time party thereto, the “Lenders”), and Wilmington Savings Fund Society, FSB, as collateral agent and administrative agent. Pursuant to the Loan Agreement, the Subsidiary issued convertible senior notes with an aggregate principal amount of $25 million (the “2022 Notes”). The 2022 Notes bear interest of 7.5% which is paid on a quarterly basis and require monthly principal installment payments. The 2022 Notes are exchangeable, at the option of the Lenders, into Ordinary shares at an exchange rate of 0.52356 Ordinary shares per $1.00 principal amount (equivalent to an exchange price of $1.91 per share), together with a make-whole premium equal to all accrued and unpaid and remaining coupons due through the maturity date. The exchange rate is subject to adjustment in the event of ordinary share dividends, reclassifications and certain other fundamental transactions affecting the Ordinary shares. In addition, under certain circumstances, the Company can issue Ordinary shares in exchange for the discharge of the monthly principal installment payments. The Loan Agreement contains customary representations and warranties and covenants, including a $20 million minimum liquidity covenant and certain negative covenants restricting dispositions, changes in business and business locations, mergers and acquisitions, indebtedness, issuances of preferred stock, liens, collateral accounts, restricted payments, transactions with affiliates, compliance with laws, and issuances of capital stock. Most of these restrictions are subject to certain minimum thresholds and exceptions. Certain of the negative covenants will terminate when less than $5.0 million of principal amount is outstanding under the Loan Agreement. As of September 30, 2023, the Company is in compliance with such covenants. The Company has elected the fair value option to measure the 2022 Notes upon issuance, in accordance with ASC 825-10. Under the fair value option, the 2022 Notes are measured at fair value each period with changes in fair value reported in the statements of operations. According to ASC 825-10, changes in fair value that are caused by changes in the instrument-specific credit risk will be presented separately in other comprehensive income (loss). As of September 30, 2023, the Company issued 9,168,058 and 1,158,297 Ordinary shares in exchange for the discharge of $15,554 of the outstanding principal balance and the discharge of $1,418 of interest payments, respectively, in respect of the 2022 Notes.

Fair Value Measurements

Fair Value Measurements	9 Months Ended
	Sep. 30, 2023
Fair Value Measurements [Abstract]
FAIR VALUE MEASUREMENTS	NOTE 5: FAIR VALUE MEASUREMENTS Cash and cash equivalents, restricted deposits, prepaid expenses and other assets, trade payables and accrued expenses and other liabilities, are stated at their carrying value which approximates their fair value due to the short time to the expected receipt or payment. The Company classifies cash equivalents within Level 1, and the 2021 Notes, 2022 Notes and warrants liability are classified within Level 3, because the Company uses quoted market prices or alternative pricing sources and models utilizing market observable inputs to determine their fair value. The following tables present information about the Company’s financial assets and liabilities that are measured in fair value on a recurring basis as of September 30, 2023 and December 31, 2022: September 30, 2023 (unaudited) December 31, 2022 Level 1 Level 3 Total Level 1 Level 3 Total Financial assets: Money market funds included in cash and cash equivalent $ 56,222 $ - $ 56,222 $ 58,827 $ - $ 58,827 Total assets measured at fair value $ 56,222 $ - $ 56,222 $ 58,827 $ - $ 58,827 Financial Liabilities: 2022 Notes $ - $ 8,594 $ 8,594 $ - $ 24,250 $ 24,250 Warrants liability - 11,610 $ 11,610 - - - Total liabilities measured at fair value $ - $ 20,204 $ 20,204 $ - $ 24,250 $ 24,250 In connection with the April 19, 2023 public offering of Ordinary shares, the Company granted certain investors warrants to purchase 17,500,000 Ordinary shares at an exercise price of $1.35 per share. The warrants liability was valued using a Black Scholes Option Pricing Model, which is considered to be a Level 3 fair value measurement. The Black Scholes model’s primary unobservable input utilized in determining the fair value of the warrants is the expected volatility of the Ordinary shares. The expected volatility was implied from a blend of the Company’s own Ordinary share and public warrant pricing, and the average historical share volatilities of several unrelated public companies within the Company’s industry that the Company considers to be comparable to its own business. The following table summarizes the warrant liability activity as of September 30, 2023: Warrant liability Initial measurement (April 21, 2023) $ 20,753 Change in fair value (9,143 ) Balance at September 30, 2023 (unaudited) $ 11,610 The key inputs used in the valuation of the warrants liability as of September 30, 2023 and April 21, 2023, the initial measurement date, are included below: Input September 30, April, 21, Exercise price $ 1.35 $ 1.35 Share price on date $ 1.03 $ 1.60 Risk-free rate 4.6 % 3.7 % Expected volatility 89 % 91 % Dividend Rate 0 % 0 % The 2022 Notes were valued using the Monte Carlo simulation analysis to generate expected future cash flows based on movement in the Company’s stock price. These future cash flows were then discounted to present value. Cash flows associated with the future conversion of loan principal into shares were discounted at the risk-free rate commensurate with the remaining term of the loan. Future cash flows resulting from the contractual debt payments were discounted at a market yield. The significant inputs into the Monte Carlo simulation were the closing stock price as of September 30, 2023, a volatility analysis of the stock, and the risk-free rate using the U.S. Treasury Constant Maturity Rate for the remaining time between the valuation date and maturity date. The fair value for the 2022 Notes liability as of September 30, 2023 and December 31, 2022: 2022 Balance at December 31, 2022 $ 24,250 2023 principal payments and conversions (16,695 ) Change in fair value 1,039 Balance at September 30, 2023 (unaudited) $ 8,594 The key inputs used in the valuation of the 2022 Notes liability as of September 30, 2023 and December 31, 2022, the initial measurement date: September 30, December 31, 2023 2022 Unaudited Voluntary conversion price $ 1.91 $ 1.91 Share price on date $ 1.03 $ 1.29 Risk-free rate 5.4 % 4.4 % Expected volatility 100 % 75 % Implied yield 31.5 % 32.8 %

Contingent Liabilities and Comm

Contingent Liabilities and Commitments	9 Months Ended
	Sep. 30, 2023
Contingent Liabilities and Commitments [Abstract]
CONTINGENT LIABILITIES AND COMMITMENTS	NOTE 6: CONTINGENT LIABILITIES AND COMMITMENTS a. Legal proceedings: From time to time the Company or the Subsidiary may be involved in legal proceedings and/or litigation arising in the ordinary course of business. While the outcome of these matters cannot be predicted with certainty, the Company does not believe it will have a material effect on its consolidated financial position, results of operations, or cash flows. b. Bank guarantees: As of September 30, 2023, the Company obtained bank guarantees in the amount of $2,686, primarily in connection with an Israeli Investment Center grant which requires a bank guarantee in order to ensure the fulfillment of the grant terms. c. Governments grants: The Company has received grants from the Israeli Innovation Authority (IIA) to finance its research and development programs in Israel, through which the Company received IIA participation payments in the aggregate amount of $37,082 through September 30, 2023, of which $34,477 is royalty-bearing grants and $2,605 is non-royalty-bearing grants. In return, the Company is committed to pay IIA royalties at a rate of 3-5% of future sales of the developed products, up to 100% of the amount of grants received plus interest at the LIBOR rate. Through September 30, 2023, the Company has accrued $20 in royalty expenses. The Company’s contingent royalty liability to the IIA at September 30, 2023, including grants received by the Company and the associated LIBOR interest on all such grants totaled to $43,447. d. Lonza settlement: In December 2022, the Company signed an agreement with Lonza Netherlands B.V., or Lonza, to mutually terminate their Service Agreement, whereas the Company shall pay Lonza an aggregate amount of $8,479 (€8,000). As of September 30, 2023, the Company had paid the first payment of $1,594 (€1,500); an additional $2,646 (€2,500) will be paid in 2023 and the remaining $4,240 (€4,000) will be paid in 2024. US dollar amounts for this payment obligation were estimated using the € to US dollar exchange rate on September 30, 2023, as this payment obligation is in €.

Shareholders' Equity

Shareholders' Equity	9 Months Ended
	Sep. 30, 2023
Shareholders’ Equity [Abstract]
SHAREHOLDERS’ EQUITY	NOTE 7: SHAREHOLDERS’ EQUITY a. Ordinary shares: Subject to the Company’s Amended and Restated Articles of Association, as amended, the holders of the Company’s Ordinary shares have the right to receive notices to attend and vote in general meetings of the Company’s shareholders, and the right to participate in dividends and other distributions upon liquidation. On September 27, 2022, the Company issued and sold, in an underwritten public offering, an aggregate of 12,905,000 of its Ordinary shares at a public offering price of $1.55 per share, for gross proceeds of approximately $20,000, before deducting underwriting discounts and commissions and offering expenses. On April 19, 2023, the Company issued and sold 17,500,000 of its Ordinary shares at a public offering price of $1.30 per ordinary share and accompanying warrants to purchase 17,500,000 Ordinary shares, for gross proceeds of approximately $22.8 million, before deducting underwriting discounts and commissions and offering expenses, of $1.9 million. As of September 30, 2023, the Company had raised $39,412 in net proceeds by issuing 29,171,195 shares via an ATM offering, at an average public offering price of $1.39 per share. b. Warrants to investors: As part of its April 2023 underwritten public offering of its securities, the Company granted certain investors 17,500,000 warrants to purchase the Company’s Ordinary shares that will expire on April 21, 2028. The warrants were classified as a liability on the balance sheet initially, and subsequently measured at fair value through earnings, as the warrants are not considered indexed to the Company’s own equity pursuant to ASC 815-40. The change in fair value of the warrants liability is recognized in financial expenses, net, in the consolidated statements of operation. During the nine months ended September 30, 2023, 33,270 of such warrants were exercised in exchange for 32,270 of the Company’s Ordinary shares. c. Treasury shares: During the nine months ended September 30, 2023, the Company cancelled 32,310 outstanding restricted shares, whereby the restricted shares became treasury shares.

Share-Based Compensation

Share-Based Compensation	9 Months Ended
	Sep. 30, 2023
Share-Based Compensation [Abstract]
SHARE-BASED COMPENSATION	NOTE 8: SHARE-BASED COMPENSATION a. Option plans: On January 23, 2017, the Company’s Board of Directors approved the Company’s 2017 Share Incentive Plan (the “2017 Plan”), and the subsequent grant of options to the Company’s employees, officers and directors. Pursuant to the 2017 Plan, the Company initially reserved for issuance 312,867 Ordinary shares, nominal value NIS 0.01 each. On February 28, 2017, the Company’s shareholders approved the 2017 Plan. The 2017 Plan provides for the grant of awards, including options, restricted shares and restricted share units to the Company’s directors, employees, officers, consultants and advisors. On February 25, 2021 and November 17, 2021, the board of directors and shareholders, respectively, approved an amendment and restatement of the 2017 Plan. The 2017 Plan, as amended, also contains an “evergreen” provision, which provides for an automatic allotment of Ordinary shares to be added every year to the pool of Ordinary shares available for grant under the 2017 Plan. Under the evergreen provision, on January 1 of each year (beginning January 1, 2022), the number of Ordinary shares available under the 2017 Plan automatically increases by the lesser of the following: (i) 4% of our outstanding Ordinary shares on the last day of the immediately preceding year; and (ii) an amount determined in advance of January 1 by the board of directors. As of September 30, 2023, 2,025,064 shares were reserved for issuance under the 2017 Plan. The Company estimates the fair value of stock options granted using the binominal option-pricing model. The option-pricing model requires a number of assumptions, of which the most significant are the expected stock price volatility and the expected option term. Expected volatility was calculated based upon the Company’s historical share price and historical volatilities of similar entities in the related sector index. The expected term of the options granted is derived from output of the option valuation model and represents the period of time that options granted are expected to be outstanding. The risk-free interest rate is based on the yield from U.S. treasury bonds with an equivalent term. The Company has historically not paid dividends and has no foreseeable plans to pay dividends. The following table lists the inputs to the binomial option-pricing model used for the fair value measurement of equity-settled share options for the nine months ended September 30, 2023 and 2022: Nine months ended September 30, 2023 2022 Unaudited Dividend yield 0 % 0 % Expected volatility of the share prices 73 % 66%-67 % Risk-free interest rate 4.3 % 1.8% - 3.5 % Expected term (in years) 8 8 Based on the above inputs, the fair value of the options was determined to be $0.99 - $1.85 per option at the grant date. b. The following table summarizes the number of options granted to employees as of September 30, 2023 under the Amended and Restated 2017 Plan as well as historical equity incentive plans under which no equity awards remain outstanding and related information: Number of options Weighted average exercise price Balance as of January 1, 2023 6,133,903 $ 4.62 Granted 2,127,834 1.53 Exercised (1,066 ) 0.25 Forfeited (641,406 ) 2.61 Expired (511,031 ) 5.57 Balance as of September 30, 2023 (unaudited) 7,108,234 3.85 Exercisable as of September 30, 2023 (unaudited) 3,955,093 4.75 As of September 30, 2023, there are $6,969 of total unrecognized costs related to share-based compensation that are expected to be recognized over a period of up to four years. c. A summary of restricted shares and restricted share units activity as of September 30, 2023 is as follows: Number of Weighted average grant date fair value (unaudited) (unaudited) Unvested as of January 1, 2023 1,126,743 $ 3.29 Granted 1,036,606 1.53 Vested (499,894 ) 2.85 Forfeited (333,173 ) 2.30 Unvested as of September 30, 2023 (unaudited) 1,330,282 2.33 d. The total share-based compensation expense related to all of the Company’s equity-based awards, recognized for the three and nine months ended September 30, 2023 and 2022 is comprised as follows: Three months ended Nine months ended 2023 2022 2023 2022 Unaudited Cost of sales expenses $ 3 $ - $ 3 $ - Research and development expenses, net 230 533 1,026 1,551 Selling, general and, administrative 1,143 766 3,268 2,278 Total share-based compensation $ 1,376 $ 1,299 $ 4,297 $ 3,829

Basic and Diluted Net Loss Per

Basic and Diluted Net Loss Per Share	9 Months Ended
	Sep. 30, 2023
Basic and Diluted Net Loss Per Share [Abstract]
BASIC AND DILUTED NET LOSS PER SHARE	NOTE 9: BASIC AND DILUTED NET LOSS PER SHARE Basic net loss per ordinary share is computed by dividing net loss for each reporting period by the weighted-average number of Ordinary shares outstanding during each year. Diluted net loss per Ordinary share is computed by dividing net loss for each reporting period by the weighted average number of Ordinary shares outstanding during the period, plus dilutive potential Ordinary shares considered outstanding during the period, in accordance with ASC No. 260-10 “Earnings Per Share”. Details of the number of shares and loss used in the computation of loss per share: Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 Weighted Net loss Weighted Net loss Weighted Net loss Weighted Net loss Unaudited For the computation of basic and diluted loss 124,236,300 $ 1,519 60,440,765 $ 17,802 101,479,968 $ 54,155 59,821,655 $ 56,579 NOTE 9: BASIC AND DILUTED NET LOSS PER SHARE (Cont.) All outstanding convertible senior note options, warrants, outstanding share options, and restricted shares for the three and nine months ended September 30, 2023 and 2022 have been excluded from the calculation of the diluted net loss per share, because all such securities are anti-dilutive for all periods presented. The total numbers of potential shares excluded from the calculation of diluted net loss per share are as follows: Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 Unaudited Convertible senior notes 10,876,824 4,222,973 10,876,824 4,222,973 Warrants 17,466,730 108,049 17,466,730 2,233,283 Outstanding share options 7,083,976 5,189,188 6,774,012 4,964,826 Restricted shares 1,628,671 1,140,318 1,489,041 1,008,551 Total 37,056,201 $ 10,660,528 36,606,607 $ 12,429,633

Subsequent Events

Subsequent Events	9 Months Ended
	Sep. 30, 2023
Subsequent Events [Abstract]
SUBSEQUENT EVENTS	NOTE 10: SUBSEQUENT EVENTS From October 1, 2023 through November 10, 2023, the Company raised an additional $499 in net proceeds by issuing 706,914 Ordinary shares via an ATM offering, at an average public offering price of $0.73. From October 1, 2023 through November 14, 2023, the Company made a monthly principal installment payment of $554 on the 2022 Note. The outstanding principal amount of the 2022 Note is $7,751 following this payment. On October 2, 2023 the Company paid $2,646 to Lonza as part of the termination of their Service Agreement. See Note 6 for further details.

Accounting Policies, by Policy

Accounting Policies, by Policy (Policies)	9 Months Ended
	Sep. 30, 2023
Significant Accounting Policies [Abstract]
Basis of presentation of the financial statements	a. Basis of presentation of the financial statements: The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information Certain information or footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted, pursuant to the rules and regulations of the SEC for interim financial reporting. Accordingly, they do not include all the information and footnotes necessary for a complete presentation of financial position, results of operations, or cash flows. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments, consisting of a normal recurring nature, which are necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented.
Use of estimates	b. Use of estimates: The preparation of the unaudited condensed financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. The Company’s management believes that the estimates, judgements and assumptions used are reasonable based upon information available at the time they are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities at the dates of the consolidated financial statements, and the reported amount of expenses during the reporting periods. Estimates may include: revenue recognition, such as returns of product sold, stock-based compensation, inventory, and impairment of long lived assets. Actual results could differ from those estimates.
Inventories	c. Inventories: Inventories are stated at the lower of cost or net realizable value. The Company regularly evaluates its ability to realize the value of inventory. If the inventories are deemed damaged, if actual demand of the Company’s therapies deteriorates, or if market conditions are less favorable than those projected, inventory reserves or write-offs may be required. During the three and nine months period ended September 30, 2023, a reserve for slow-moving inventory approaching expiration dates and inventory write-offs were recorded.
Revenue recognition	d. Revenue recognition: Revenues are recognized in accordance with ASC 606. Revenue from contracts with customers is recognized when control of the promised goods or services is transferred to the customers, in an amount that reflects the consideration the Company expects to receive in exchange for those goods or services. The Company’s revenues are comprised of product revenue from the sales of Omisirge. Gamida Cell has a sole distributor in the United States and sells to this customer under the Flash Title model, whereby the third-party partner takes ownership but does not handle physical storage or distribution. The customer in turn resells the product to the transplant centers, while also managing the order to cash processes. To determine revenue recognition for arrangements the Company determines that are within the scope of Topic 606, the Company performs the following five steps: (i) Identify the contract(s) with a customer: The Company enters into an enforceable contract with a customer that (1) defines each party’s rights regarding delivery of and payment for a product, (2) the contract has commercial substance and (3) the Company determines that collection of substantially all consideration for such product is probable based on the payer’s intent and ability to pay the promised consideration. (ii) Identify the performance obligations in the contract: The Company’s sales contracts include the delivery of Omisirge, which represent the Company’s single performance obligation under each contract. (iii) Determine the transaction price: The transaction price is determined based on the consideration to which the Company will be entitled in exchange for providing a product to the customer. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the net realizable value utilizing either the expected value method or the most likely amount method depending on the nature of the variable consideration. Variable consideration is included in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Product revenues are recognized, net of variable consideration related to certain allowances and accruals, at the time of delivery to the transplant center. (iv) Allocate the transaction price to the performance obligations in the contract: If a contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. (v) Recognize revenue when (or as) the entity satisfies a performance obligation: Revenue is recognized when or as performance obligations are satisfied by transferring control of a promised good or service to a customer. Control either transfers over time or at a point in time, which affects when revenue is recorded. Revenues from sales of products are recognized at the point in time of transfer of control of the product, which is the time of delivery to a transplant center.
Accounts receivable	e. Accounts receivable: The Company’s accounts receivable balance consists of amounts due from product sales to a single customer, which is the Company’s sole distributor of Omisirge in the United States. Under the Flash Title model, whereby the third-party partner takes ownership does not handle physical storage or distribution. Gamida Cell sells to this customer which in turn resells the product to the transplant centers, while also managing the order to cash processes.
Cost of sales	f. Cost of sales: Cost of sales in 2023 were direct costs attributable to the production of Omisirge, including raw materials, production, labor, and certain maintenance and indirect manufacturing overhead costs, quality testing directly related to each product batch, and depreciation on capital expenditure relating to the manufacturing facility that Gamida Cell has purchased to produce Omisirge. It also includes any cost of batch failure losses and royalty expenses. Cost of sales for Omisirge are recognized when incurred.
Selling, general & administrative	g. Selling, general & administrative: Beginning July 1, 2023, the Company’s reporting of operating expenses was modified to reflect the Company’s transition to the commercial stage, with all operating costs now reported as either research and development expenses, or selling, general & administrative (SG&A) expenses. For 2022 and the first two quarters of 2023, previously reported commercial and general & administrative costs were combined into SG&A expenses. Beyond commercial and general & administrative costs, SG&A also includes certain indirect manufacturing and quality expenses, excess capacity costs and medical affairs expenditures. Excess capacity costs reflect those labor and manufacturing overhead costs incurred, but not absorbed in cost of sales in the period, given that our facility is staffed to produce the anticipated demand over the course of the coming year.
Recently adopted accounting standards	h. Recently adopted accounting standards: In June 2016, FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. ASU 2016-13 amends the impairment model to utilize an expected loss methodology in place of the currently used incurred loss methodology, which will result in the more timely recognition of losses. Topic 326 is effective for the Company beginning on January 1, 2023. Effective January 1, 2023, the Company adopted the standard. Adoption of the standard did not have an impact on the financial statements.

Leases (Tables)

Leases (Tables)	9 Months Ended
	Sep. 30, 2023
Leases
Schedule of Operating Lease Costs	The components of operating lease costs were as follows: Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 Unaudited Operating lease costs $ 746 $ 676 $ 1,906 $ 2,093 Short-term lease costs - 8 82 92 Total lease costs $ 746 $ 684 $ 1,988 $ 2,185
Schedule of Supplemental Balance Sheet Information Related to Operating Leases	Supplemental balance sheet information related to operating leases is as follows: Nine months ended September 30, Unaudited Weighted average remaining lease term (in years) 3.16 Weighted average discount rate 2.80 %
Schedule of Maturities of Lease Liabilities	Maturities of lease liabilities were as follows: September 30, 2023 Unaudited 2023 $ 624 2024 1,203 2025 1,071 2026 710 Thereafter 541 Total undiscounted lease payments 4,149 Less - imputed interest (350 ) Present value of lease liabilities $ 3,799

Convertible Senior Notes, Net (

Convertible Senior Notes, Net (Tables)	9 Months Ended
	Sep. 30, 2023
Convertible Senior Notes, Net [Abstract]
Schedule of Liability Measured at its Amortized Cost	September 30, December 31, 2023 2022 Unaudited Liability component: Principal amount $ 75,000 $ 75,000 Issuance costs (4,223 ) (4,223 ) Net of issuance costs 70,777 70,777 Amortized issuance costs 2,048 1,423 Net carrying amount $ 72,825 $ 72,200

Fair Value Measurements (Tables

Fair Value Measurements (Tables)	9 Months Ended
	Sep. 30, 2023
Fair Value Measurements [Abstract]
Schedule of Financial Assets and Liabilities that are Measured in Fair Value	The following tables present information about the Company’s financial assets and liabilities that are measured in fair value on a recurring basis as of September 30, 2023 and December 31, 2022: September 30, 2023 (unaudited) December 31, 2022 Level 1 Level 3 Total Level 1 Level 3 Total Financial assets: Money market funds included in cash and cash equivalent $ 56,222 $ - $ 56,222 $ 58,827 $ - $ 58,827 Total assets measured at fair value $ 56,222 $ - $ 56,222 $ 58,827 $ - $ 58,827 Financial Liabilities: 2022 Notes $ - $ 8,594 $ 8,594 $ - $ 24,250 $ 24,250 Warrants liability - 11,610 $ 11,610 - - - Total liabilities measured at fair value $ - $ 20,204 $ 20,204 $ - $ 24,250 $ 24,250
Schedule of Warrants Liability Activity	The following table summarizes the warrant liability activity as of September 30, 2023: Warrant liability Initial measurement (April 21, 2023) $ 20,753 Change in fair value (9,143 ) Balance at September 30, 2023 (unaudited) $ 11,610
Schedule of Note Liability Initial Measurement Date	The key inputs used in the valuation of the warrants liability as of September 30, 2023 and April 21, 2023, the initial measurement date, are included below: Input September 30, April, 21, Exercise price $ 1.35 $ 1.35 Share price on date $ 1.03 $ 1.60 Risk-free rate 4.6 % 3.7 % Expected volatility 89 % 91 % Dividend Rate 0 % 0 %
Schedule of Note Liability	The fair value for the 2022 Notes liability as of September 30, 2023 and December 31, 2022: 2022 Balance at December 31, 2022 $ 24,250 2023 principal payments and conversions (16,695 ) Change in fair value 1,039 Balance at September 30, 2023 (unaudited) $ 8,594
Schedule of Note Liability Initial Measurement Date	The key inputs used in the valuation of the 2022 Notes liability as of September 30, 2023 and December 31, 2022, the initial measurement date: September 30, December 31, 2023 2022 Unaudited Voluntary conversion price $ 1.91 $ 1.91 Share price on date $ 1.03 $ 1.29 Risk-free rate 5.4 % 4.4 % Expected volatility 100 % 75 % Implied yield 31.5 % 32.8 %

Share-Based Compensation (Table

Share-Based Compensation (Tables)	9 Months Ended
	Sep. 30, 2023
Share-Based Compensation [Abstract]
Schedule of Fair Value Measurement of Equity-Settled Share Options	The following table lists the inputs to the binomial option-pricing model used for the fair value measurement of equity-settled share options for the nine months ended September 30, 2023 and 2022: Nine months ended September 30, 2023 2022 Unaudited Dividend yield 0 % 0 % Expected volatility of the share prices 73 % 66%-67 % Risk-free interest rate 4.3 % 1.8% - 3.5 % Expected term (in years) 8 8
Schedule of Stock Option Plans	The following table summarizes the number of options granted to employees as of September 30, 2023 under the Amended and Restated 2017 Plan as well as historical equity incentive plans under which no equity awards remain outstanding and related information: Number of options Weighted average exercise price Balance as of January 1, 2023 6,133,903 $ 4.62 Granted 2,127,834 1.53 Exercised (1,066 ) 0.25 Forfeited (641,406 ) 2.61 Expired (511,031 ) 5.57 Balance as of September 30, 2023 (unaudited) 7,108,234 3.85 Exercisable as of September 30, 2023 (unaudited) 3,955,093 4.75
Schedule of Restricted Shares Activity	A summary of restricted shares and restricted share units activity as of September 30, 2023 is as follows: Number of Weighted average grant date fair value (unaudited) (unaudited) Unvested as of January 1, 2023 1,126,743 $ 3.29 Granted 1,036,606 1.53 Vested (499,894 ) 2.85 Forfeited (333,173 ) 2.30 Unvested as of September 30, 2023 (unaudited) 1,330,282 2.33
Schedule of Share-Based Compensation Expense	The total share-based compensation expense related to all of the Company’s equity-based awards, recognized for the three and nine months ended September 30, 2023 and 2022 is comprised as follows: Three months ended Nine months ended 2023 2022 2023 2022 Unaudited Cost of sales expenses $ 3 $ - $ 3 $ - Research and development expenses, net 230 533 1,026 1,551 Selling, general and, administrative 1,143 766 3,268 2,278 Total share-based compensation $ 1,376 $ 1,299 $ 4,297 $ 3,829

Basic and Diluted Net Loss Pe_2

Basic and Diluted Net Loss Per Share (Tables)	9 Months Ended
	Sep. 30, 2023
Basic and Diluted Net Loss Per Share [Abstract]
Schedule of Number of Shares and Loss Used in the Computation of Net Loss Per Share	Details of the number of shares and loss used in the computation of loss per share: Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 Weighted Net loss Weighted Net loss Weighted Net loss Weighted Net loss Unaudited For the computation of basic and diluted loss 124,236,300 $ 1,519 60,440,765 $ 17,802 101,479,968 $ 54,155 59,821,655 $ 56,579
Schedule of Outstanding Warrants, Share Options, and Restricted Shares	All outstanding convertible senior note options, warrants, outstanding share options, and restricted shares for the three and nine months ended September 30, 2023 and 2022 have been excluded from the calculation of the diluted net loss per share, because all such securities are anti-dilutive for all periods presented. The total numbers of potential shares excluded from the calculation of diluted net loss per share are as follows: Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 Unaudited Convertible senior notes 10,876,824 4,222,973 10,876,824 4,222,973 Warrants 17,466,730 108,049 17,466,730 2,233,283 Outstanding share options 7,083,976 5,189,188 6,774,012 4,964,826 Restricted shares 1,628,671 1,140,318 1,489,041 1,008,551 Total 37,056,201 $ 10,660,528 36,606,607 $ 12,429,633

General (Details)

General (Details) $ in Thousands	9 Months Ended
	Sep. 30, 2023 USD ($) segment	Sep. 30, 2022 USD ($)	Dec. 31, 2022 USD ($)
General [Abstract]
Accumulated deficit	$ (470,987)		$ (416,832)
Cash flows from operating activities	$ (62,857)	$ (54,245)
Operating segment (in segment) | segment	1

Leases (Details)

Leases (Details)	Sep. 30, 2023
Leases
Lease term	5 years

Leases (Details) - Schedule of

Leases (Details) - Schedule of Operating Lease Costs - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Schedule of Operating Lease Costs [Abstract]
Operating lease costs	$ 746	$ 676	$ 1,906	$ 2,093
Short-term lease costs		8	82	92
Total lease costs	$ 746	$ 684	$ 1,988	$ 2,185

Leases (Details) - Schedule o_2

Leases (Details) - Schedule of Supplemental Balance Sheet Information Related to Operating Leases	Sep. 30, 2023
Schedule of Operating Leases [Abstract]
Weighted average remaining lease term (in years)	3 years 1 month 28 days
Weighted average discount rate	2.80%

Leases (Details) - Schedule o_3

Leases (Details) - Schedule of Maturities of Lease Liabilities $ in Thousands	Sep. 30, 2023 USD ($)
Schedule of Maturities of Lease Liabilities [Abstract]
2023	$ 624
2024	1,203
2025	1,071
2026	710
Thereafter	541
Total undiscounted lease payments	4,149
Less - imputed interest	(350)
Present value of lease liabilities	$ 3,799

Convertible Senior Notes, Net_2

Convertible Senior Notes, Net (Details) - USD ($) $ / shares in Units, $ in Thousands	1 Months Ended		9 Months Ended
	Dec. 31, 2022	Feb. 16, 2021	Sep. 30, 2023	Apr. 21, 2023	Apr. 19, 2023	Sep. 27, 2022
Convertible Senior Notes, Net (Details) [Line Items]
Principal amount	$ 25,000		$ 1,000
Annual interest percentage		5.875%	7.50%
Maturity date		Feb. 15, 2026
Convertible notes payable			$ 1,000
Conversion rate (in Dollars per share)			$ 56.3063
Exchange price (in Dollars per share)	$ 1.29		$ 1.03	$ 1.6
Exchange price percentage			130%
Interest expenses			$ 4,223
Effective interest rate			7.37%
Total estimated fair value	$ 73,331		$ 75,483
Ordinary shares exchange rate (in Dollars per share)			$ 0.52356
Principal amount per share (in Dollars per share)			1
Exchange price per share (in Dollars per share)			$ 1.91		$ 1.3	$ 1.55
Minimum liquidity covenant			$ 20,000
Principal amount			5,000
Aggregate outstanding balance			15,554
Interest make-whole payment			$ 1,418
Ordinary Shares [Member]
Convertible Senior Notes, Net (Details) [Line Items]
Exchange price (in Dollars per share)			$ 17.76
Maximum [Member]
Convertible Senior Notes, Net (Details) [Line Items]
Ordinary shares issued (in Shares)			9,168,058
Minimum [Member]
Convertible Senior Notes, Net (Details) [Line Items]
Ordinary shares issued (in Shares)			1,158,297
Associated [Member]
Convertible Senior Notes, Net (Details) [Line Items]
Repurchase price			100%
Convertible Senior Notes Net [Member]
Convertible Senior Notes, Net (Details) [Line Items]
Trading days			20
Consecutive trading day			30
Convertible Notes [Member]
Convertible Senior Notes, Net (Details) [Line Items]
Principal amount		$ 75,000	$ 1,000
Repurchase price			100%

Convertible Senior Notes, Net_3

Convertible Senior Notes, Net (Details) - Schedule of Liability Measured at its Amortized Cost - USD ($) $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2023	Dec. 31, 2022
Convertible Senior Notes, Net (Details) - Schedule of Liability Measured at its Amortized Cost [Line Items]
Principal amount	$ 75,000	$ 75,000
Issuance costs	(4,223)	(4,223)
Net of issuance costs	70,777	70,777
Amortized issuance costs	2,048	1,423
Net carrying amount	$ 72,825	$ 72,200

Fair Value Measurements (Detail

Fair Value Measurements (Details)	Apr. 19, 2023 $ / shares shares
Fair Value Measurements [Abstract]
Warrants to purchase | shares	17,500,000
Ordinary shares exercise price | $ / shares	$ 1.35

Fair Value Measurements (Deta_2

Fair Value Measurements (Details) - Schedule of Financial Assets and Liabilities that are Measured in Fair Value - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Fair Value Measurements (Details) - Schedule of Financial Assets and Liabilities that are Measured in Fair Value [Line Items]
Money market funds included in cash and cash equivalent	$ 56,222	$ 58,827
Total assets measured at fair value	56,222	58,827
2022 Notes	8,594	24,250
Warrants liability	11,610
Total liabilities measured at fair value	20,204	24,250
Level 1 [Member]
Fair Value Measurements (Details) - Schedule of Financial Assets and Liabilities that are Measured in Fair Value [Line Items]
Money market funds included in cash and cash equivalent	56,222	58,827
Total assets measured at fair value	56,222	58,827
2022 Notes
Warrants liability
Total liabilities measured at fair value
Level 3 [Member]
Fair Value Measurements (Details) - Schedule of Financial Assets and Liabilities that are Measured in Fair Value [Line Items]
Money market funds included in cash and cash equivalent
Total assets measured at fair value
2022 Notes	8,594	24,250
Warrants liability	11,610
Total liabilities measured at fair value	$ 20,204	$ 24,250

Fair Value Measurements (Deta_3

Fair Value Measurements (Details) - Schedule of Warrants Liability Activity $ in Thousands	5 Months Ended
	Sep. 30, 2023 USD ($)
Schedule of Warrants Liability Activity [Abstract]
Initial measurement (April 21, 2023)	$ 20,753
Change in fair value	(9,143)
Balance at September 30, 2023 (unaudited)	$ 11,610

Fair Value Measurements (Deta_4

Fair Value Measurements (Details) - Schedule of Warrants Liability Initial Measurement Date - $ / shares	Sep. 30, 2023	Apr. 21, 2023	Dec. 31, 2022
Schedule of Warrants Liability Initial Measurement Date [Abstract]
Exercise price (in Dollars per share)	$ 1.35	$ 1.35
Share price on date (in Dollars per share)	$ 1.03	$ 1.6	$ 1.29
Risk-free rate	4.60%	3.70%
Expected volatility	89%	91%
Dividend Rate	0%	0%

Fair Value Measurements (Deta_5

Fair Value Measurements (Details) - Schedule of Note Liability - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Schedule of Note Liability [Abstract]
Balance at December 31, 2022	$ 24,250
2023 principal payments and conversions	(16,695)
Change in fair value	1,039
Balance at September 30, 2023 (unaudited)	$ 8,594

Fair Value Measurements (Deta_6

Fair Value Measurements (Details) - Schedule of Note Liability Initial Measurement Date - $ / shares	9 Months Ended
	Sep. 30, 2023	Dec. 31, 2022	Apr. 21, 2023
Schedule of Note Liability Initial Measurement Date [Abstract]
Voluntary conversion price (in Dollars per share)	$ 1.91	$ 1.91
Share price on date (in Dollars per share)	$ 1.03	$ 1.29	$ 1.6
Risk-free rate	5.40%	4.40%
Expected volatility	100%	75%
Implied yield	31.50%	32.80%

Contingent Liabilities and Co_2

Contingent Liabilities and Commitments (Details)	9 Months Ended		12 Months Ended
	Sep. 30, 2023 USD ($)	Sep. 30, 2023 EUR (€)	Dec. 31, 2022 USD ($)	Dec. 31, 2022 EUR (€)
Contingent Liabilities and Commitments (Details) [Line Items]
Bank guarantees amount	$ 2,686
Investment center remaining amount	37,082
Accrued royalties	34,477
Non-royalty-bearing grants	$ 2,605
Percentage of interest rate	100%	100%
Total grants	$ 43,447
Termination of aggregate amount			$ 8,479,000,000	€ 8,000
Service agreement remaining payment	2,646,000,000	€ 2,500
Royalty [Member]
Contingent Liabilities and Commitments (Details) [Line Items]
Accrued royalty expenses	$ 20
Minimum [Member]
Contingent Liabilities and Commitments (Details) [Line Items]
Royalties rate	3%
Service agreement first payment	$ 1,594,000,000
Maximum [Member]
Contingent Liabilities and Commitments (Details) [Line Items]
Royalties rate	5%
Service agreement first payment | €		€ 1,500,000,000
First Payment 2023 [Member]
Contingent Liabilities and Commitments (Details) [Line Items]
Service agreement remaining payment	$ 4,240
Second Payment 2024 [Member]
Contingent Liabilities and Commitments (Details) [Line Items]
Service agreement remaining payment	$ 4,000

Shareholders' Equity (Details)

Shareholders' Equity (Details) - USD ($) $ / shares in Units, $ in Thousands			9 Months Ended
	Apr. 19, 2023	Sep. 27, 2022	Sep. 30, 2023
Shareholders’ Equity [Abstract]
Ordinary shares	17,500,000	12,905,000
Price per share (in Dollars per share)	$ 1.3	$ 1.55	$ 1.91
Gross proceeds (in Dollars)	$ 22,800	$ 20,000
Purchase of ordinary shares	17,500,000
Preferred Units, Offering Costs (in Dollars)	$ 1,900
Net proceeds (in Dollars)			$ 39,412
Issuance of shares			29,171,195
Public offering price (in Dollars per share)			$ 1.39
Purchase of warrants			17,500,000
Warrants expired			will expire on April 21, 2028
Warrants exercised			33,270
Outstanding restricted shares			32,310

Share-Based Compensation (Detai

Share-Based Compensation (Details) $ / shares in Units, $ in Thousands	9 Months Ended
	Sep. 30, 2023 USD ($) $ / shares shares	Jan. 23, 2017 ₪ / shares shares
Share-Based Compensation (Details) [Line Items]
Ordinary shares outstanding percentage	4%
Unrecognized costs related to share-based compensation | $	$ 6,969
2017 Share Incentive Plan [Member]
Share-Based Compensation (Details) [Line Items]
Number of shares reserved for issuance | shares	2,025,064	312,867
Nominal per share value | ₪ / shares		₪ 0.01
Minimum [Member]
Share-Based Compensation (Details) [Line Items]
Grant date fair value per share	$ 0.99
Maximum [Member]
Share-Based Compensation (Details) [Line Items]
Grant date fair value per share	$ 1.85

Share-Based Compensation (Det_2

Share-Based Compensation (Details) - Schedule of Fair Value Measurement of Equity-Settled Share Options	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Schedule of Fair Value Measurement of Equity-Settled Share Options [Abstract]
Dividend yield	0%	0%
Expected volatility of the share prices	73%
Risk-free interest rate	4.30%
Expected term (in years)	8 years	8 years
Minimum [Member]
Schedule of Fair Value Measurement of Equity-Settled Share Options [Abstract]
Expected volatility of the share prices		66%
Risk-free interest rate		1.80%
Maximum [Member]
Schedule of Fair Value Measurement of Equity-Settled Share Options [Abstract]
Expected volatility of the share prices		67%
Risk-free interest rate		3.50%

Share-Based Compensation (Det_3

Share-Based Compensation (Details) - Schedule of Stock Option Plans - $ / shares	9 Months Ended
	Sep. 30, 2023
Schedule of Stock Option Plans [Abstract]
Number of options, beginning Balance	6,133,903
Weighted average exercise price, beginning Balance	$ 4.62
Number of options, Granted	2,127,834
Weighted average exercise price, Granted	$ 1.53
Number of options, Exercised	(1,066)
Weighted average exercise price, Exercised	$ 0.25
Number of options, Forfeited	(641,406)
Weighted average exercise price, Forfeited	$ 2.61
Number of options, Expired	(511,031)
Weighted average exercise price, Expired	$ 5.57
Number of options, ending Balance	7,108,234
Weighted average exercise price, ending Balance	$ 3.85
Number of options, Exercised	3,955,093
Weighted average exercise price, Exercised	$ 4.75

Share-Based Compensation (Det_4

Share-Based Compensation (Details) - Schedule of Restricted Shares Activity	9 Months Ended
	Sep. 30, 2023 $ / shares shares
Schedule of Restricted Shares Activity [Abstract]
Number of restricted shares and restricted share units, Unvested beginning | shares	1,126,743
Weighted average grant date fair value, Unvested beginning | $ / shares	$ 3.29
Number of restricted shares and restricted share units, Granted | shares	1,036,606
Weighted average grant date fair value, Granted | $ / shares	$ 1.53
Number of restricted shares and restricted share units, Vested | shares	(499,894)
Weighted average grant date fair value, Vested | $ / shares	$ 2.85
Number of restricted shares and restricted share units, Forfeited | shares	(333,173)
Weighted average grant date fair value, Forfeited | $ / shares	$ 2.3
Number of restricted shares and restricted share units, Unvested ending | shares	1,330,282
Weighted average grant date fair value, Unvested ending | $ / shares	$ 2.33

Share-Based Compensation (Det_5

Share-Based Compensation (Details) - Schedule of Share-Based Compensation Expense - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Schedule of Share Based Compensation Expense [Abstract]
Cost of sales expenses	$ 3		$ 3
Research and development expenses, net	230	533	1,026	1,551
Selling, general and, administrative	1,143	766	3,268	2,278
Total share-based compensation	$ 1,376	$ 1,299	$ 4,297	$ 3,829

Basic and Diluted Net Loss Pe_3

Basic and Diluted Net Loss Per Share (Details) - Schedule of Number of Shares and Loss Used in the Computation of Net Loss Per Share - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Schedule of Number of Shares and Loss Used in the Computation of Net Loss Per Share [Abstract]
Weighted number of shares, basic	124,236,300	60,440,765	101,479,968	59,821,655
Net loss attributable to equity holders of the Company	$ 1,519	$ 17,802	$ 54,155	$ 56,579

Basic and Diluted Net Loss Pe_4

Basic and Diluted Net Loss Per Share (Details) - Schedule of Number of Shares and Loss Used in the Computation of Net Loss Per Share (Parentheticals) - shares	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Schedule of Number of Shares and Loss Used in the Computation of Net Loss Per Share [Abstract]
Weighted number of shares, diluted	124,236,300	60,440,765	101,479,968	59,821,655

Basic and Diluted Net Loss Pe_5

Basic and Diluted Net Loss Per Share (Details) - Schedule of Outstanding Warrants, Share Options, and Restricted Shares - shares	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Basic and Diluted Net Loss Per Share (Details) - Schedule of Outstanding Warrants, Share Options, and Restricted Shares [Line Items]
Total diluted net loss per share	37,056,201	10,660,528	36,606,607	12,429,633
Convertible Senior Notes [Member]
Basic and Diluted Net Loss Per Share (Details) - Schedule of Outstanding Warrants, Share Options, and Restricted Shares [Line Items]
Total diluted net loss per share	10,876,824	4,222,973	10,876,824	4,222,973
Warrant [Member]
Basic and Diluted Net Loss Per Share (Details) - Schedule of Outstanding Warrants, Share Options, and Restricted Shares [Line Items]
Total diluted net loss per share	17,466,730	108,049	17,466,730	2,233,283
Outstanding Share Options [Member]
Basic and Diluted Net Loss Per Share (Details) - Schedule of Outstanding Warrants, Share Options, and Restricted Shares [Line Items]
Total diluted net loss per share	7,083,976	5,189,188	6,774,012	4,964,826
Restricted shares [Member]
Basic and Diluted Net Loss Per Share (Details) - Schedule of Outstanding Warrants, Share Options, and Restricted Shares [Line Items]
Total diluted net loss per share	1,628,671	1,140,318	1,489,041	1,008,551

Subsequent Events (Details)

Subsequent Events (Details) - Subsequent Event [Member] - USD ($)	Nov. 10, 2023	Oct. 02, 2023
Subsequent Events (Details) [Line Items]
Price per share (in Dollars per share)	$ 499
Additional capital	$ 706,914
Monthly installment payment	554
Principal amount	$ 7,751
Service agreement remaining payment		$ 2,646
IPO [Member]
Subsequent Events (Details) [Line Items]
Public offering price (in Dollars per share)	$ 0.73