Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 03, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2023 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2023 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-12830 | |
Entity Registrant Name | Lineage Cell Therapeutics, Inc. | |
Entity Central Index Key | 0000876343 | |
Entity Tax Identification Number | 94-3127919 | |
Entity Incorporation, State or Country Code | CA | |
Entity Address, Address Line One | 2173 Salk Avenue | |
Entity Address, Address Line Two | Suite 200 | |
Entity Address, City or Town | Carlsbad | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 92008 | |
City Area Code | 442 | |
Local Phone Number | 287-8990 | |
Title of 12(b) Security | Common shares no par value | |
Trading Symbol | LCTX | |
Security Exchange Name | NYSE | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 174,986,671 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | |
CURRENT ASSETS | |||
Cash and cash equivalents | $ 31,474 | $ 11,355 | |
Marketable securities | 9,858 | 46,520 | |
Accounts receivable, net (Note 3) | 432 | 297 | |
Prepaid expenses and other current assets | 1,717 | 1,828 | |
Total current assets | 43,481 | 60,000 | |
NONCURRENT ASSETS | |||
Property and equipment, net (Notes 6 and 14) | 4,854 | 5,673 | |
Deposits and other long-term assets | 552 | 627 | |
Goodwill | [1] | 10,672 | 10,672 |
Intangible assets, net | 46,594 | 46,692 | |
TOTAL ASSETS | 106,153 | 123,664 | |
CURRENT LIABILITIES | |||
Accounts payable and accrued liabilities | 5,030 | 8,608 | |
Lease liabilities, current portion (Note 14) | 881 | 916 | |
Financing lease, current portion (Note 14) | 55 | 36 | |
Deferred revenues (Note 3) | 9,915 | 9,421 | |
Total current liabilities | 15,881 | 18,981 | |
LONG-TERM LIABILITIES | |||
Deferred tax liability | 273 | 2,076 | |
Deferred revenues, net of current portion (Note 3) | 21,195 | 27,725 | |
Lease liability, net of current portion (Note 14) | 2,047 | 2,860 | |
Financing lease, net of current portion (Note 14) | 97 | 84 | |
Other long-term liabilities | 2 | ||
TOTAL LIABILITIES | 39,493 | 51,728 | |
Commitments and contingencies (Note 14) | |||
SHAREHOLDERS’ EQUITY | |||
Preferred shares, no par value, authorized 2,000 shares; none issued and outstanding as of September 30, 2023 and December 31, 2022 | |||
Common shares, no par value, 450,000 and 250,000 shares authorized as of September 30, 2023 and December 31, 2022, respectively; 174,987 and 170,093 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively | 450,282 | 440,280 | |
Accumulated other comprehensive loss | (2,084) | (3,571) | |
Accumulated deficit | (380,081) | (363,370) | |
Lineage Cell Therapeutics, Inc. shareholders’ equity | 68,117 | 73,339 | |
Noncontrolling deficit | (1,457) | (1,403) | |
Total shareholders’ equity | 66,660 | 71,936 | |
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ 106,153 | $ 123,664 | |
[1]Goodwill represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired and liabilities assumed in the Asterias Merger, see Note 14 (Commitment and Contingencies) for further discussion on the Asterias Merger. |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, no par value | $ 0 | $ 0 |
Preferred stock, shares authorized | 2,000,000 | 2,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, no par value | $ 0 | $ 0 |
Common stock, shares authorized | 450,000,000 | 250,000,000 |
Common stock, shares issued | 174,986,671 | 170,093,114 |
Common stock, shares outstanding | 174,986,671 | 170,093,114 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
REVENUES: | ||||
Collaboration revenues | $ 957 | $ 2,592 | $ 5,949 | $ 11,605 |
Royalties and license fees | 289 | 406 | 908 | 1,183 |
Total revenues | 1,246 | 2,998 | 6,857 | 12,788 |
Cost of sales | (169) | (235) | (415) | (626) |
Gross profit | 1,077 | 2,763 | 6,442 | 12,162 |
OPERATING EXPENSES: | ||||
Research and development | 3,741 | 3,592 | 11,799 | 9,883 |
General and administrative | 4,041 | 4,422 | 13,014 | 18,160 |
Total operating expenses | 7,782 | 8,014 | 24,813 | 28,043 |
Loss from operations | (6,705) | (5,251) | (18,371) | (15,881) |
OTHER INCOME (EXPENSES): | ||||
Interest income, net | 433 | 384 | 1,225 | 435 |
Loss on marketable equity securities, net | (60) | (233) | (170) | (1,677) |
Gain on revaluation of warrant liability | 1 | 223 | ||
Other expenses, net | (826) | (475) | (1,253) | (2,550) |
Total other income (expenses), net | (453) | (324) | (197) | (3,569) |
LOSS BEFORE INCOME TAXES | (7,158) | (5,575) | (18,568) | (19,450) |
Provision for income tax benefit (expense) | (541) | 1,803 | (541) | |
NET LOSS | (7,158) | (6,116) | (16,765) | (19,991) |
Net loss attributable to noncontrolling interest | 48 | 47 | 54 | 72 |
NET LOSS ATTRIBUTABLE TO LINEAGE CELL THERAPEUTICS, INC. | $ (7,110) | $ (6,069) | $ (16,711) | $ (19,919) |
NET LOSS PER COMMON SHARE: | ||||
Basic | $ (0.04) | $ (0.04) | $ (0.10) | $ (0.12) |
Diluted | $ (0.04) | $ (0.04) | $ (0.10) | $ (0.12) |
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: | ||||
Basic | 174,868 | 169,786 | 171,880 | 169,722 |
Diluted | 174,868 | 169,786 | 171,880 | 169,722 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss (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 LOSS | $ (7,158) | $ (6,116) | $ (16,765) | $ (19,991) |
Other comprehensive loss, net of tax: | ||||
Foreign currency translation adjustment | 518 | 323 | 1,337 | 2,177 |
Unrealized gain (loss) on marketable debt securities | 9 | (150) | 150 | (150) |
COMPREHENSIVE LOSS | (6,631) | (5,943) | (15,278) | (17,964) |
Less: Comprehensive loss attributable to noncontrolling interest | 48 | 47 | 54 | 72 |
COMPREHENSIVE LOSS ATTRIBUTABLE TO LINEAGE COMMON SHAREHOLDERS | $ (6,583) | $ (5,896) | $ (15,224) | $ (17,892) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||||
Net loss attributable to Lineage Cell Therapeutics, Inc. | $ (7,110) | $ (6,069) | $ (16,711) | $ (19,919) |
Net loss allocable to noncontrolling interest | (48) | (47) | (54) | (72) |
Adjustments to reconcile net loss attributable to Lineage Cell Therapeutics, Inc. to net cash (used in) provided by operating activities: | ||||
Loss on marketable equity securities, net | 60 | 233 | 170 | 1,677 |
Accretion of income on marketable debt securities | (647) | (186) | ||
Depreciation expense, including amortization of leasehold improvements | 419 | 441 | ||
Change in right-of-use assets and liabilities | 86 | (24) | ||
Amortization of intangible assets | 98 | 113 | ||
Stock-based compensation | 1,269 | 987 | 3,580 | 3,328 |
Gain on revaluation of warrant liability | (1) | (223) | ||
Deferred income tax benefit | (1,803) | |||
Foreign currency remeasurement and other loss | 1,893 | 2,668 | ||
Changes in operating assets and liabilities: | ||||
Accounts receivable, net (Note 3) | (141) | 50,206 | ||
Prepaid expenses and other current assets | 56 | 517 | ||
Accounts payable and accrued liabilities (Note 7) | (3,456) | (17,573) | ||
Deferred revenue and other liabilities (Note 3) | (6,036) | (11,591) | ||
Net cash (used in) provided by operating activities | (22,547) | 9,362 | ||
CASH FLOWS FROM INVESTING ACTIVITIES: | ||||
Proceeds from the sale of marketable equity securities | 196 | |||
Purchases of marketable debt securities | (16,403) | (40,628) | ||
Maturities of marketable debt securities | 53,497 | |||
Purchase of equipment | (583) | (429) | ||
Net cash provided by (used in) investing activities | 36,707 | (41,057) | ||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||||
Proceeds from employee options exercised | 88 | 506 | ||
Common shares received and retired for employee taxes paid | (37) | (17) | ||
Proceeds from exercise of subsidiary warrants, net | 991 | |||
Proceeds from sale of common shares | 6,625 | 148 | ||
Payments for offering costs | (199) | (95) | ||
Repayment of financing lease liability | (41) | (23) | ||
Net cash provided by financing activities | 6,436 | 1,510 | ||
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (532) | (795) | ||
NET INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | 20,064 | (30,980) | ||
CASH, CASH EQUIVALENTS AND RESTRICTED CASH: | ||||
At beginning of the period | 11,936 | 56,277 | ||
At end of the period | 32,000 | 25,297 | 32,000 | 25,297 |
Reconciliation of cash, cash equivalents and restricted cash, end of period: | ||||
Cash and cash equivalents | 31,474 | 24,752 | 31,474 | 24,752 |
Restricted cash included in deposits and other long-term assets (see Note 14 (Commitments and Contingencies)) | 526 | 545 | 526 | 545 |
Total cash, cash equivalents, and restricted cash | $ 32,000 | $ 25,297 | $ 32,000 | $ 25,297 |
Organization and Business Overv
Organization and Business Overview | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Business Overview | 1. Organization and Business Overview We are a clinical-stage biotechnology company developing novel allogeneic, or “off-the-shelf”, cell therapies to address unmet medical needs. Our programs are based on our proprietary, cell-based technology platform, and its associated development and manufacturing capabilities. From this platform, we design, develop, manufacture, and test specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. The cells we manufacture are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages which are relevant to the underlying condition are transplanted into patients in an effort to (a) replace restore Our business strategy is to efficiently leverage our technology platform and our development, formulation, delivery, and manufacturing capabilities to advance our programs internally or in conjunction with strategic partners to further enhance their value and probability of success. A significant area of focus is a partnership we entered into with F. Hoffmann-La Roche Ltd and Genentech, Inc., a member of the Roche Group (collectively or individually, “Roche” or “Genentech”), under which we are developing our lead cell therapy program known as OpRegen ® 50.0 620.0 Our most advanced unpartnered product candidate is OPC1, an allogeneic oligodendrocyte progenitor cell therapy designed to improve recovery following a spinal cord injury (“SCI”). OPC1 has been tested in two clinical trials to date; a five patient Phase 1 clinical trial in acute thoracic SCI, where all subjects are followed for at least 10 years, and a 25 patient Phase 1/2a multicenter clinical trial in subacute cervical SCI, where all subjects were evaluated for at least two years. Results from both studies have been published in the Journal of Neurosurgery Spine. OPC1 clinical development has been supported in part by a $ 14.3 D O S E D Our pipeline of allogeneic, or “off-the-shelf”, cell therapy programs currently includes: ● OpRegen trial, being conducted by Roche, for the treatment of GA secondary to AMD, also known as atrophic or dry AMD. ● OPC1 ● ANP1 ● PNC1, ● VAC Other Programs We have additional undisclosed product candidates being considered for development and which cover a range of therapeutic areas and unmet medical needs. Generally, these product candidates are based on the same platform technology and employ a similar, guided cell differentiation and transplant approach as the product candidates described above, but in some cases may also include genetic modifications designed to enhance efficacy and/or safety profiles. Our efforts to broaden the application of our cell therapy platform and support long-term growth include a strategic collaboration we entered into with Eterna Therapeutics. This reflected a portion of our corporate strategy to capitalize on our process development capabilities by combining them with cell engineering and/or editing technologies, to create novel and potentially superior product profiles. In addition to seeking to create value for shareholders by developing product candidates and advancing those candidates through clinical development, we also may seek to create value from licensing non-core intellectual property or related technologies, through partnering and/or strategic transactions. |
Basis of Presentation, Liquidit
Basis of Presentation, Liquidity and Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation, Liquidity and Summary of Significant Accounting Policies | 2. Basis of Presentation, Liquidity and Summary of Significant Accounting Policies The accompanying unaudited condensed consolidated interim financial statements were prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. In accordance with those rules and regulations, certain information and footnote disclosures normally included in comprehensive consolidated financial statements have been condensed or omitted. The condensed consolidated balance sheet as of December 31, 2022 was derived from the audited consolidated financial statements at that date but does not include all the information and footnotes required by GAAP. These unaudited condensed consolidated interim financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the 2022 10-K. The accompanying unaudited condensed consolidated interim financial statements, in the opinion of management, include all adjustments, consisting only of normal recurring adjustments, necessary for a fair presentation of our financial condition and results of operations. The condensed consolidated results of operations are not necessarily indicative of the results to be expected for any other interim period or for the entire year. Principles of consolidation The accompanying unaudited condensed consolidated interim financial statements include the accounts of our subsidiaries. All material intercompany accounts and transactions have been eliminated in consolidation. The following table sets out Lineage’s ownership, directly or indirectly, of the outstanding shares of its subsidiaries as of September 30, 2023. Schedule of Lineage’s Ownership of Outstanding Shares of its Subsidiaries Subsidiary Field of Business Lineage Ownership Country Cell Cure Neurosciences Ltd. Manufacturing of Lineage’s product candidates 94 % (1) Israel ES Cell International Pte. Ltd. Research and clinical grade cell lines 100 % Singapore (1) Includes shares owned by Lineage and ES Cell International Pte. Ltd. As of September 30, 2023, Lineage consolidated its direct and indirect wholly-owned or majority-owned subsidiaries because Lineage has the ability to control their operating and financial decisions and policies through its ownership, and the noncontrolling interest is reflected as a separate element of shareholders’ equity on Lineage’s condensed consolidated balance sheets. Liquidity At September 30, 2023, we had $ 41.3 Capital Resources Since inception we have incurred significant operating losses and have funded our operations primarily through the issuance of equity securities, the sale of common stock of our former subsidiaries, OncoCyte Corporation and AgeX Therapeutics, Inc., receipt of proceeds from research grants, revenues from collaborations, royalties from product sales, and sales of research products and services. As of September 30, 2023, $ 57.2 As of September 30, 2023, we had $ 9.9 Additional Capital Requirements Our financial obligations primarily consist of obligations to licensors under license agreements, obligations related to grants received from government entities, including the Israel Innovation Authority (“IIA”), obligations under contracts with vendors who provide research services and purchase commitments with suppliers. Our obligations to licensors under license agreements and our obligations related to grants received from government entities require us to make future payments, such as sublicense fees, milestone payments, redemption fees, royalties and patent maintenance costs. Sublicense fees are payable to licensors or government entities when we sublicense the applicable intellectual property to third parties; the fees are based on a percentage of the license fees we receive from sublicensees. Milestone payments, including those related to the Roche Agreement, are due to licensors or government entities upon achievement of commercial, development and regulatory milestones. Redemption fees due to the IIA under the Innovation Law are due upon receipt of milestone payments and royalties received under the Roche Agreement. See Note 14 (Commitment and Contingencies) for additional information. Royalties, including those related to royalties we may receive under the Roche Agreement, are payable to licensors or government entities based on a percentage of net sales of licensed products. Patent maintenance costs are payable to licensors as reimbursement for the cost of maintaining license patents. Due to the contingent nature of the payments, the amounts and timing of payments to licensors under our in-license agreements are uncertain and may fluctuate significantly from period to period. As of September 30, 2023, we have not included these commitments on our condensed consolidated balance sheet because the achievement of events that would trigger our payment obligations and the timing thereof are not fixed and determinable. In the normal course of business, we enter into services agreements with contract research organizations, contract manufacturing organizations and other third parties. Generally, these agreements provide for termination upon notice, with specified amounts due upon termination based on the timing of termination and the terms of the agreement. The amounts and timing of payments under these agreements are uncertain and contingent upon the initiation and completion of the services to be provided. Significant Accounting Policies We describe our significant accounting policies in Note 2 to the consolidated financial statements in Item 8 of the 2022 10-K. There have been no changes to our significant accounting policies during the nine months ended September 30, 2023. Recently Issued and Recently Adopted Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that are adopted by the Company as of the specified effective date. The Company has evaluated recently issued accounting pronouncements and does not believe any will have a material impact on the Company’s condensed consolidated financial statements or related financial statement disclosures. |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Revenue | 3. Revenue Our disaggregated revenues were as follows for the periods presented (in thousands): Schedule of Disaggregated Revenues 2023 2022 2023 2022 Three Months ended Nine Months ended 2023 2022 2023 2022 Revenues under collaborative agreements Upfront license fees $ 957 $ 2,592 $ 5,949 $ 11,605 Total revenues under collaborative agreements 957 2,592 5,949 11,605 Royalties and license fees 289 406 908 1,183 Total revenue $ 1,246 $ 2,998 $ 6,857 $ 12,788 We are recognizing the upfront payment of $ 50.0 During the three and nine months ended September 30, 2023, we recognized $ 1.2 6.9 1.0 5.9 During the three and nine months ended September 30, 2022, we recognized $ 3.0 12.8 2.6 11.6 Accounts receivable, net, and deferred revenues (contract liabilities) from contracts with customers, including collaboration partners, consisted of the following (in thousands): Schedule of Contract with Customer Contract Liability and Receivable September 30, 2023 December 31, 2022 Accounts receivable, net (1) $ 325 $ 297 Deferred revenues $ 31,110 $ 37,146 (1) Excludes government grants as Lineage has determined government grants are outside the scope of ASU 2014-09 – Revenue from Contracts with Customers As of September 30, 2023, the amounts included in the transaction price of our contracts with customers (ASU 2014-09 – Revenue from Contracts with Customers 32.8 31.1 1.6 31.1 9.9 |
Marketable Debt Securities
Marketable Debt Securities | 9 Months Ended |
Sep. 30, 2023 | |
Cash and Cash Equivalents [Abstract] | |
Marketable Debt Securities | 4. Marketable Debt Securities Marketable securities on the Company’s condensed consolidated balance sheet consists of $ 9.8 0.1 46.1 0.4 The following tables are a summary of available-for-sale debt securities included within marketable securities in the Company’s condensed consolidated balance sheet as of September 30, 2023 and December 31, 2022 (in thousands): Summary of Available for Sale Debt Securities September 30, 2023 (Unaudited) Financial Assets: Amortized Cost Unrealized Unrealized Fair Value U.S. Treasury securities $ 9,800 $ 1 $ - $ 9,801 Total $ 9,800 $ 1 $ - $ 9,801 December 31, 2022 Financial Assets: Amortized Cost Unrealized Unrealized Losses Fair Value U.S. Treasury securities $ 46,247 $ 2 $ (152 ) $ 46,097 Total $ 46,247 $ 2 $ (152 ) $ 46,097 The Company has not recognized an allowance for credit losses on any securities in an unrealized loss position as of September 30, 2023. We believe that the individual unrealized losses represent temporary declines resulting from changes in interest rates, and we intend to hold these marketable debt securities to their maturity. The Company currently does not intend to sell these securities prior to maturity and does not consider these investments to be other-than-temporarily impaired at September 30, 2023. As of September 30, 2023, the amortized cost and estimated fair value of the Company’s available-for-sale debt securities by contractual maturity are shown below (in thousands): Schedule of Amortized cost And Estimated fair Value Available-for-sale debt securities maturing: Amortized Cost Estimated Fair Value In one year or less $ 9,800 $ 9,801 Total available-for-sale debt securities $ 9,800 $ 9,801 We did not have any marketable debt securities classified as cash equivalents on the condensed consolidated balance sheets as of September 30, 2023 or December 31, 2022. |
Marketable Equity Securities
Marketable Equity Securities | 9 Months Ended |
Sep. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Equity Securities | 5. Marketable Equity Securities Lineage’s marketable equity securities includes the shares of stock of OncoCyte Corporation and Hadasit Bio-Holdings Ltd (“HBL”). All share prices are determined based on the closing price of OncoCyte and HBL common stock on the last day of the applicable quarter, or the last trading day of the applicable quarter, if the last day of a quarter fell on a day that was not a trading day. As of September 30, 2023, Lineage owned approximately 7,500 24,000 3.12 56,000 0.4 6.42 The following table represents the realized and unrealized loss on marketable equity securities (in thousands): Schedule Of Marketable Equity Securities 2023 2022 2023 2022 Three Months ended Nine Months ended 2023 2022 2023 2022 Loss on marketable equity securities, net $ (60 ) $ (233 ) $ (170 ) $ (1,677 ) Less: Loss recognized in earnings on marketable equity securities sold 23 - 23 - Unrealized loss recognized on marketable equity securities held at end of period, net $ (37 ) $ (233 ) $ (147 ) $ (1,677 ) |
Property and Equipment, Net
Property and Equipment, Net | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | 6. Property and Equipment, Net At September 30, 2023 and December 31, 2022 property and equipment, net was comprised of the following (in thousands): Schedule of Property and Equipment, Net September 30, 2023 December 31, 2022 (Unaudited) Equipment, furniture and fixtures $ 3,363 $ 3,264 Leasehold improvements 2,195 2,150 Right-of-use assets 5,890 6,109 Property and equipment, gross 5,890 6,109 Accumulated depreciation and amortization (6,594 ) (5,850 ) Property and equipment, net $ 4,854 $ 5,673 Property and equipment for financing leases was $ 193,000 121,000 Depreciation and amortization expense was $ 143,000 145,000 419,000 441,000 |
Goodwill and Intangible Assets,
Goodwill and Intangible Assets, Net | 9 Months Ended |
Sep. 30, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill and Intangible Assets, Net | 7. Goodwill and Intangible Assets, Net At September 30, 2023 and December 31, 2022 goodwill and intangible assets, net consisted of the following (in thousands): Schedule of Goodwill and Intangible Assets, Net September 30, 2023 December 31, 2022 (Unaudited) Goodwill (1) $ 10,672 $ 10,672 Intangible assets: Acquired IPR&D – OPC1 (from the Asterias Merger) (2) $ 31,700 $ 31,700 Acquired IPR&D – VAC (from the Asterias Merger) (2) 14,840 14,840 Intangible assets subject to amortization: Acquired patents 18,953 18,953 Acquired royalty contracts (3) 650 650 Total intangible assets 66,143 66,143 Accumulated amortization (4) (19,549 ) (19,451 ) Intangible assets, net $ 46,594 $ 46,692 (1) Goodwill represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired and liabilities assumed in the Asterias Merger, see Note 14 (Commitment and Contingencies) for further discussion on the Asterias Merger. (2) Asterias had two in-process research and development (“IPR&D”) intangible assets that were valued at $ 46.5 31.7 14.8 (3) Asterias had royalty cash flows under patent families it acquired from Geron Corporation (“Geron”). Such patent families are expected to continue to generate revenue, are not used in the OPC1 or the VAC platform, and are considered to be separate long-lived intangible assets under Accounting Standards Codifications (“ASC”) Topic 805, Business Combinations (4) As of September 30, 2023 acquired patents were fully amortized and the acquired royalty contracts had a remaining unamortized balance of approximately $ 54,000 Lineage amortizes its intangible assets over an estimated period of 5 10 33,000 98,000 Amortization of intangible assets for periods subsequent to September 30, 2023 is as follows (in thousands): Schedule of Intangible Assets Future Amortization Expenses Year Ending December 31, Amortization Expense 2023 $ 32 2024 22 Total $ 54 |
Accounts Payable and Accrued Li
Accounts Payable and Accrued Liabilities | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
Accounts Payable and Accrued Liabilities | 8. Accounts Payable and Accrued Liabilities At September 30, 2023 and December 31, 2022 accounts payable and accrued liabilities consisted of the following (in thousands): Schedule of Accounts Payable and Accrued Liabilities September 30, 2023 December 31, 2022 (Unaudited) Accounts payable $ 2,430 $ 2,393 Accrued compensation 2,251 2,382 Accrued liabilities (1) 349 3,833 Total $ 5,030 $ 8,608 (1) The decrease in accrued liabilities was due to a payment made in connection with the settlement of litigation in February 2023 related to the Asterias Merger. See Note 14 (Commitment and Contingencies) for additional information. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 9. Fair Value Measurements Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. To increase the comparability of fair value measures, the following hierarchy prioritizes the inputs to valuation methodologies used to measure fair value (ASC 820-10-50), Fair Value Measurements and Disclosures ● Level 1 – Inputs to the valuation methodology are quoted prices for identical assets or liabilities in active markets. ● Level 2 – Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. ● Level 3 – Inputs to the valuation methodology are unobservable; that reflect management’s own assumptions about the assumptions market participants would make and significant to the fair value. We have not transferred any instruments between the three levels of the fair value hierarchy. We measure our money market fund, marketable securities and our liability classified warrants at fair value on a recurring basis. The fair values of such assets and liabilities were as follows as of September 30, 2023 and December 31, 2022 (in thousands): Schedule of Fair Value of Assets and Liabilities Valued on Recurring Basis Fair Value Measurements Using Balance at Quoted Prices in Active Markets for Identical Assets (Level 1) Significant (Level 2) Significant Unobservable Inputs (Level 3) Assets: Money market fund (1) $ 19,782 $ 19,782 $ - $ - Marketable debt securities 9,801 9,801 - - Marketable equity securities 57 57 - - Total assets measured at fair value $ 29,640 $ 29,640 $ - $ - Fair Value Measurements Using Balance at Quoted Prices in Active Markets for Identical Assets (Level 1) Significant (Level 2) Significant Inputs (Level 3) Assets: Money market fund (1) $ 4,102 $ 4,102 $ - $ - Marketable debt securities 46,097 46,097 - - Marketable equity securities 423 423 - - Total assets measured at fair value $ 50,622 $ 50,622 $ - $ - Liabilities: Warrants to purchase Cell Cure ordinary shares (2) $ 2 $ - $ - $ 2 Total liabilities measured at fair value $ 2 $ - $ - $ 2 (1) Included in cash and cash equivalents in the accompanying condensed consolidated balance sheet. (2) Included in other long-term liabilities in the accompanying condensed consolidated balance sheet. As of September 30, 2023, the fair value of our liability classified warrants was zero. Lineage’s marketable equity securities includes the shares of stock of OncoCyte and HBL. Both securities have readily determinable fair values and are measured at fair value and reported as current assets on the accompanying condensed consolidated balance sheets based on the closing trading price of the security as of the date being presented. The carrying value of cash, restricted cash, accounts receivable, accounts payable, and accrued liabilities approximate their respective fair values due to their relative short maturities. |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 10. Related Party Transactions In connection with the putative shareholder class action lawsuits filed in February 2019 and October 2019 challenging the Asterias Merger (see Note 14), Lineage agreed to pay the expenses for the legal defense of Neal Bradsher, a member of the Lineage board of directors, Broadwood Partners, L.P., a shareholder of Lineage, and Broadwood Capital, Inc., which serves as the general partner of Broadwood Partners, L.P., all of whom were named defendants in the lawsuits, prior to being dismissed. Through September 30, 2023, Lineage has incurred approximately $ 626,000 |
Shareholders_ Equity
Shareholders’ Equity | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Shareholders’ Equity | 11. Shareholders’ Equity Preferred Shares Lineage is authorized to issue 2,000,000 no no Common Shares At December 31, 2022, Lineage was authorized to issue 250,000,000 no 250,000,000 450,000,000 174,986,671 170,093,114 At-The-Market Offering Program In May 2020, Lineage entered into a Controlled Equity Offering SM In March 2021, Lineage filed a prospectus supplement with the SEC in connection with the offer and sale of $ 25.0 In December 2021, Lineage filed a prospectus supplement with the SEC in connection with the offer and sale of up to $ 64.1 14.1 As of September 30, 2023, Lineage had sold 4,882,803 1.41 6.9 57.2 4,774,603 6.6 6.4 The shares offered under the Current Prospectus Supplement are registered pursuant to Lineage’s effective shelf registration statement on Form S-3 (File No. 333-254167), which was filed with the SEC on March 5, 2021 and declared effective on March 19, 2021. Lineage agreed to pay Cantor Fitzgerald a commission of 3.0 Reconciliation of Changes in Shareholders’ Equity The following tables document the changes in shareholders’ equity for the three and nine months ended September 30, 2023 and 2022 (unaudited and in thousands): Schedule of Shareholder’s Equity Shares Amount Shares Amount Deficit Deficit Income / (Loss) Equity Accumulated Preferred Common Other Total Shares Shares Accumulated Noncontrolling Comprehensive Shareholders’ Shares Amount Shares Amount Deficit Deficit Income / (Loss) Equity BALANCE - December 31, 2022 - $ - 170,093 $ 440,280 $ (363,370 ) $ (1,403 ) $ (3,571 ) $ 71,936 Shares issued upon vesting of - - 53 (37 ) - - - (37 ) Shares issued through ATM Shares issued through ATM, shares Financing related fees Shares issued upon exercise of - - 28 25 - - - 25 Subsidiary warrant exercise Stock-based compensation - - - 1,031 - - - 1,031 Unrealized gain on marketable debt securities - - - - - - 91 91 Foreign currency translation gain - - - - - - 373 373 Net loss - - - - (4,372 ) (32 ) - (4,404 ) BALANCE - March 31, 2023 - - 170,174 441,299 (367,742 ) (1,435 ) (3,107 ) 69,015 Shares issued through ATM - - 4,237 5,841 - - - 5,841 Financing related fees - - - (193 ) - - - (193 ) Shares issued upon exercise of - - 28 22 - - - 22 Stock-based compensation - - - 1,280 - - - 1,280 Unrealized gain on marketable debt securities - - - - - - 50 50 Foreign currency translation gain - - - - - - 446 446 Net income (loss) - - - - (5,229 ) 26 - (5,203 ) BALANCE - June 30, 2023 - - 174,439 448,249 (372,971 ) (1,409 ) (2,611 ) 71,258 Shares issued through ATM - - 538 784 - - - 784 Financing related fees - - - (28 ) - - - (28 ) Shares issued upon exercise of - - 10 8 - - - 8 Stock-based compensation - - - 1,269 - - - 1,269 Unrealized gain on marketable debt securities - - - - - - 9 9 Foreign currency translation gain - - - - - - 518 518 Net income (loss) - - - - (7,110 ) (48 ) - (7,158 ) BALANCE - September 30, 2023 - $ - 174,987 $ 450,282 $ (380,081 ) $ (1,457 ) $ (2,084 ) $ 66,660 Accumulated Preferred Common Other Total Shares Shares Accumulated Noncontrolling Comprehensive Shareholders’ Shares Amount Shares Amount Deficit Deficit Income / (Loss) Equity BALANCE - December 31, 2021 - $ - 169,477 $ 434,529 $ (337,097 ) $ (1,323 ) $ (5,211 ) $ 90,898 Shares issued upon vesting of - - 10 (8 ) - - - (8 ) Shares issued upon exercise of - - 240 189 - - - 189 Subsidiary warrant exercise - - - 2 - - - 2 Stock-based compensation - - - 1,106 - - - 1,106 Foreign currency translation gain - - - - - - 124 124 Net loss - - - - (7,087 ) (6 ) - (7,093 ) BALANCE - March 31, 2022 - - 169,727 435,818 (344,184 ) (1,329 ) (5,087 ) 85,218 Shares issued upon vesting of - - 10 (9 ) - - - (9 ) Shares issued upon exercise of - - 11 10 - - - 10 Subsidiary warrant exercise, net - - - 97 - - - 97 Stock-based compensation - - - 1,235 - - - 1,235 Foreign currency translation gain - - - - - - 1,730 1,730 Net loss - - - - (6,763 ) (19 ) - (6,782 ) BALANCE - June 30, 2022 - - 169,748 437,151 (350,947 ) (1,348 ) (3,357 ) 81,499 Beginning balance - - 169,748 437,151 (350,947 ) (1,348 ) (3,357 ) 81,499 Shares issued upon exercise of - - 138 118 - - - 118 Subsidiary warrant exercise, net - - - 892 - - - 892 Stock-based compensation - - - 987 - - - 987 Unrealized loss on marketable debt securities - - - - - - (150 ) (150 ) Foreign currency translation gain - - - - - - 323 323 Net loss - - - - (6,069 ) (47 ) - (6,116 ) Net income (loss) - - - - (6,069 ) (47 ) - (6,116 ) BALANCE - September 30, 2022 - $ - 169,886 $ 439,148 $ (357,016 ) $ (1,395 ) $ (3,184 ) $ 77,553 Ending balance - $ - 169,886 $ 439,148 $ (357,016 ) $ (1,395 ) $ (3,184 ) $ 77,553 |
Stock-Based Awards
Stock-Based Awards | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Awards | 12. Stock-Based Awards Equity Incentive Plan Awards In September 2021, our shareholders approved the Lineage Cell Therapeutics, Inc. 2021 Equity Incentive Plan (the “2021 Plan”), which became effective upon such approval. The 2021 Plan provides for the grant of incentive stock options, nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock units (“RSUs”), and other stock awards. All of our employees (including those of our affiliates), non-employee directors and consultants are eligible to participate in the 2021 Plan. In September 2023, our shareholders approved an amendment to the 2021 Plan to increase the number of common shares that may be issued under the 2021 Plan by 19,500,000 Subject to adjustment for certain changes in our capitalization, the aggregate number of our common shares that may be issued under the 2021 Plan will not exceed the sum of (i) 34,500,000 25,436,929 As a result of the approval of the 2021 Plan by our shareholders, no additional awards will be granted under the 2012 Plan. A summary of activity under the 2021 Plan is as follows (in thousands, except per share amounts): Schedule of Share-based Compensation Activity Number of Options Outstanding Weighted Average Exercise Price Balance at December 31, 2022 6,001 $ 1.40 Options granted 5,720 $ 1.45 Options expired/forfeited/cancelled (239 ) $ 1.42 Balance at September 30, 2023 11,482 $ 1.42 Options exercisable at September 30, 2023 2,054 $ 1.43 Number of RSUs Outstanding Balance at December 31, 2022 939 RSUs forfeited (100 ) RSUs vested (80 ) Balance at September 30, 2023 759 A summary of activity of the 2012 Plan, and the 2018 inducement option (which was issued to a Lineage executive outside of all equity plans), is as follows (in thousands, except per share amounts): Schedule of Share-based Compensation Activity Number of Options Outstanding Weighted Average Exercise Price Balance at December 31, 2022 12,172 $ 1.83 Options exercised (66 ) $ 0.84 Options expired/forfeited/cancelled (420 ) $ 1.89 Balance at September 30, 2023 11,686 $ 1.83 Options exercisable at September 30, 2023 9,846 $ 1.69 Stock-based compensation expense The fair value of each option award is estimated on the date of grant using a Black-Scholes option pricing model applying the weighted-average assumptions noted in the following table: Schedule of Weighted Average Assumptions to Calculate Fair Value of Stock Options Nine Months ended September 30, (unaudited) 2023 2022 Expected life (in years) 6.20 6.20 Risk-free interest rates 4.1 % 2.1 % Volatility 74.7 % 73.6 % Dividend yield - - Operating expenses include stock-based compensation expense as follows (in thousands): Schedule of Stock Based Compensation Expense Three Months ended September 30, (unaudited) Nine Months ended September 30, (unaudited) 2023 2022 2023 2022 Research and development $ 260 $ 204 $ 729 $ 559 General and administrative 1,009 783 2,851 2,769 Total stock-based compensation expense $ 1,269 $ 987 $ 3,580 $ 3,328 As of September 30, 2023, total unrecognized compensation costs related to unvested stock options and unvested RSUs under all equity plans (including the 2018 inducement option), were $ 10.6 2.6 Basic and diluted net income (loss) per share attributable to common shareholders Basic earnings per share is calculated by dividing net income or loss attributable to Lineage common shareholders by the weighted average number of common shares outstanding, net of unvested restricted stock or RSUs, subject to repurchase by Lineage, if any, during the period. Diluted earnings per share is calculated by dividing the net income or loss attributable to Lineage common shareholders by the weighted average number of common shares outstanding, adjusted for the effects of potentially dilutive common shares issuable under outstanding stock options, restricted stock awards and warrants, using the treasury-stock method, convertible preferred stock, if any, using the if-converted method, and treasury stock held by subsidiaries, if any. For the three and nine months ended September 30, 2023 and 2022, respectively, Lineage reported a net loss attributable to common shareholders, and therefore, all potentially dilutive common shares were considered antidilutive for those periods. The following common share equivalents were excluded from the computation of diluted net loss per common share for the periods presented because including them would have been antidilutive (in thousands): Schedule Of Computation Of Diluted Net Loss Per Common Share Three Months ended Nine Months ended 2023 2022 2023 2022 Stock options 23,168 17,972 23,168 17,972 Restricted stock units 759 939 759 939 |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 13. Income Taxes The provision for income taxes for interim periods is generally determined using an estimated annual effective tax rate as prescribed by ASC 740-270, Income Taxes, Interim Reporting Under ASC 740, a valuation allowance is provided when it is more likely than not that some portion of the deferred tax assets will not be realized. Lineage established a full valuation allowance as of December 31, 2018 due to the uncertainty of realizing future tax benefits from its net operating loss carryforwards and other deferred tax assets, including foreign net operating losses generated by its subsidiaries. For the tax years beginning on or after January 1, 2022, the Tax Cuts and Jobs Act of 2017 (“TCJA”) eliminated the option to currently deduct research and development expenses and requires taxpayers to capitalize and amortize them over five years for research activities performed in the United States and 15 years for research activities performed outside the United States pursuant to IRC Section 174. Although Congress is considering legislation that would repeal or defer this capitalization and amortization requirement, it is not certain that this provision will be repealed or otherwise modified. If the requirement is not repealed or replaced, it will decrease our tax deduction for research and development expenses in future years. The 2017 Tax Act subjects a U.S. stockholder to Global Intangible Low-Taxed Income (“GILTI”) earned by certain foreign subsidiaries. In general, GILTI is the excess of a U.S. stockholder’s total net foreign income over a deemed return on tangible assets. The provision further allows a deduction of 50% of GILTI: however, this deduction is limited to the company’s pre-GILTI U.S. income. Lineage incurred GILTI income during the years 2021 and 2022. For the three and nine months ended September 30, 2023, no GILTI income was included in the Company’s tax provision. Lineage recorded a $ 1.8 million deferred tax benefit for the nine months ended September 30, 2023, due to the ability to offset certain deferred tax assets against the deferred tax liability associated with IPR&D, and the related release of the valuation allowance. It was determined that a portion of the deferred tax liability related to the indefinite lived assets may be realized prior to the expiration of certain pre 2018 net operating losses. Lineage did not record a deferred tax benefit for the second and third quarters of 2023, and did not record a deferred tax benefit for the three and nine months ended September 30, 2022. For the three and nine months ended September 30, 2022, Lineage recorded a withholding tax for the amount of $ 0.5 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 14. Commitments and Contingencies Real Property Leases Carlsbad Lease In May 2019, Lineage entered into a lease for approximately 8,841 March 31, 2026 24,666 25,197 17,850 In addition to base rent, Lineage pays a pro-rata portion of increases in certain expenses, including real property taxes, utilities (to the extent not separately metered to the leased space) and the landlord’s operating expenses, over the amounts of those expenses incurred by the landlord. These pro-rata charges are expensed as incurred and excluded from the calculation of the ROU assets and lease liabilities. Carlsbad Sublease In September 2022, Lineage entered into a sublease for approximately 4,500 October 1, 2022 March 31, 2024 22,500 22,500 Cell Cure Leases Cell Cure leases 728.5 7,842 December 31, 2027 option to extend the lease for five years 39,776 12,200 In January 2018, Cell Cure entered into a lease for an additional 934 10,054 December 31, 2027 option to extend the lease for five years 93,827 26,000 426,000 In November 2021, Cell Cure entered into a lease for an additional 133 1,432 December 31, 2027 option to extend the lease for five years 11,880 3,757 12,494 3,951 In August 2022, Cell Cure entered into a lease for 300 3,229 December 31, 2027 option to extend the lease for five years 16,350 4,800 Supplemental Information – Leases Supplemental cash flow information related to leases is as follows (in thousands): Schedule of Supplemental Cash Flow Information Related to Leases 2023 2022 Nine Months ended September 30, 2023 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 833 $ 727 Operating cash flows from financing leases $ 8 $ 14 Financing cash flows from financing leases $ 41 $ 23 Right-of-use assets obtained in exchange for lease obligations: Operating leases $ - $ 1,028 Finance leases $ 79 $ - Supplemental balance sheet information related to leases was as follows (in thousands, except lease term and discount rate): Schedule of Supplemental Balance Sheet Information Related to Leases September 30, December 31, (Unaudited) Operating leases Right-of-use assets, net $ 2,652 $ 3,517 Right-of-use lease liabilities, current $ 881 $ 916 Right-of-use lease liabilities, noncurrent 2,047 2,860 Total operating lease liabilities $ 2,928 $ 3,776 Financing leases Right-of-use assets, net $ 141 $ 105 Lease liabilities, current $ 55 $ 29 Lease liabilities, noncurrent 97 84 Total finance lease liabilities 152 113 Other current liabilities - 7 Total finance lease liabilities $ 152 $ 120 Weighted average remaining lease term Operating leases 3.7 4.3 Finance leases 3.2 4.1 Weighted average discount rate Operating leases 6.4 % 6.3 % Finance leases 6.8 % 6.9 % Future minimum lease commitments are as follows as of September 30, 2023 (in thousands): Schedule of Future Minimum Lease Commitments (Unaudited) Operating Finance Year Ending December 31, 2023 $ 275 $ 16 2024 921 60 2025 852 50 2026 623 26 2027 658 18 Total lease payments 3,329 170 Less imputed interest (401 ) (18 ) Total $ 2,928 $ 152 Collaborations Roche Agreement In December 2021, Lineage entered into the Roche Agreement, wherein Lineage granted to Roche exclusive worldwide rights to develop and commercialize RPE cell therapies, including Lineage’s proprietary cell therapy known as OpRegen, for the treatment of ocular disorders, including GA secondary to AMD. Under the terms of the Roche Agreement, Roche paid Lineage a $ 50.0 620.0 Unless earlier terminated by either party, the Roche Agreement will expire on a product-by-product and country-by-country basis upon the expiration of all of Roche’s payment obligations under the agreement. Roche may terminate the agreement in its entirety, or on a product-by-product or country-by-country basis, at any time with advance written notice. Either party may terminate the agreement in its entirety with written notice for the other party’s material breach if such party fails to cure the breach or upon certain insolvency events involving the other party. In January 2022, Lineage received the $ 50.0 12.1 8.9 1.9 21.5 ITI Collaboration Agreement In April 2021, Lineage entered into a collaborative agreement with Immunomic Therapeutics, Inc. (“ITI”) whereby Lineage agreed to perform up to approximately $ 2.2 1.6 0.5 0.5 Agreements with Hadasit and IIA The OpRegen program was supported in part with licenses to technology obtained from Hadasit, the technology transfer company of Hadassah Medical Center, and through a series of research grants from the IIA, an independent agency created to address the needs of global innovation ecosystems. A subset of the intellectual property underlying OpRegen was originally generated at Hadassah Medical Center and licensed to Cell Cure for further development. Under the Encouragement of Research, Development and Technological Innovation in the Industry Law 5744, and the regulations, guidelines, rules, procedures and benefit tracks thereunder (collectively, the “Innovation Law”), annual research and development programs that meet specified criteria and were approved by a committee of the IIA were eligible for grants. The grants awarded were typically up to 50 The terms of the grants under the Innovation Law generally require that the products developed as part of the programs under which the grants were given be manufactured in Israel. The know-how developed thereunder may not be transferred outside of Israel unless prior written approval is received from the IIA. Transfer of IIA-funded know-how outside of Israel is subject to approval and payment of a redemption fee to the IIA calculated according to formulas provided under the Innovation Law. In November 2021, the IIA research committee approved an application made by Cell Cure with respect to the grant of an exclusive license and transfer of the technological know-how for OpRegen to Roche. Under the provisions for the redemption fee, Lineage is obligated to pay the IIA approximately 24.1 92.7 Pursuant to the Second Amended and Restated License Agreement, dated June 15, 2017, between Cell Cure and Hadasit, and a certain letter agreement entered into on December 17, 2021, Hadasit was entitled to, and was paid, a sublicensing fee of 21.5 50.0 50 Second Amendment to Clinical Trial and Option Agreement and License Agreement with Cancer Research UK In May 2020, Lineage and Asterias entered into a Second Amendment to the Clinical Trial and Option Agreement (the “Second CTOA Amendment”) with CRUK and Cancer Research Technology (“CRT”). The Second CTOA Amendment amended the initial agreement and the first amendment to the Clinical Trial and Option Agreement, each of which is dated September 8, 2014, between Asterias, CRUK and CRT. Pursuant to the Second CTOA Amendment, Lineage assumed all obligations of Asterias and exercised early its option to acquire data generated in the Phase 1 clinical trial of VAC2 in non-small cell lung cancer being conducted by CRUK. Lineage and CRT effectuated the option by simultaneously entering into a license agreement (the “CRT License Agreement”) pursuant to which Lineage paid a signature fee of £ 1,250,000 1.6 8,000,000 22,500,000 Either party may terminate the CRT License Agreement for the uncured material breach of the other party. CRT may terminate the CRT License Agreement in the case of Lineage’s insolvency or if Lineage ceases all development and commercialization of all products under the CRT License Agreement. Other Contingent Obligations We have obligations under license agreements and grants received from government entities to make future payments to third parties, which become due and payable on the achievement of certain development, regulatory and commercial milestones or on the sublicense of our rights to another party. These commitments include sublicense fees, milestone payments, redemption fees and royalties. Sublicense fees are payable to licensors or government entities when we sublicense underlying intellectual property to third parties; the fees are based on a percentage of the license fees we receive from sublicensees. Milestone payments are due to licensors or government entities upon the future achievement of certain development and regulatory milestones. Redemption fees due to the IIA under the Innovation Law are due upon receipt of any milestone and royalties received under the Roche Agreement. Royalties are payable to licensors or government entities based on a percentage of net sales of licensed products. As of September 30, 2023, we have not included these commitments on our condensed consolidated balance sheet because the achievement and timing of these events are not fixed and determinable. Litigation – General From time to time, we are subject to legal proceedings and claims in the ordinary course of business. While management presently believes that the ultimate outcome of these proceedings, individually and in the aggregate, will not materially harm our financial position, cash flows, or overall trends in results of operations, legal proceedings are subject to inherent uncertainties, and unfavorable rulings or outcomes could occur that have individually or in aggregate, a material adverse effect on our business, financial condition or operating results. We are not currently subject to any pending material litigation, other than ordinary routine litigation incidental to our business. Asterias Merger In November 2018, Lineage, Asterias Biotherapeutics, Inc. (“Asterias”), and Patrick Merger Sub, Inc., a wholly owned subsidiary of Lineage, entered into an Agreement and Plan of Merger pursuant to which Lineage agreed to acquire all of the outstanding common stock of Asterias in a stock-for-stock transaction (the “Asterias Merger”). The Asterias Merger closed in March 2019. In October 2019, a putative class action lawsuit was filed against the company and certain other named defendants challenging the Asterias Merger. In February 2023, the court approved a Stipulation and Agreement of Compromise and Settlement pursuant to which, Lineage and certain insurers of the defendants paid $ 10.65 7.12 3.53 Lineage and all defendants have denied, and continue to deny, the claims alleged in the lawsuit and the settlement does not reflect or constitute any admission, concession, presumption, proof, evidence or finding of any liability, fault, wrongdoing or injury or damages, or of any wrongful conduct, acts or omissions on the part any defendant. Premvia Litigation Settlement In July 2019, the Company, along with other named defendants, was sued in the Superior Court of the State of California in a matter captioned Gonzalez v. Aronowitz, M.D., et al 25,000 HBL Books and Records Request On April 17, 2023, Cell Cure Neurosciences Ltd. (“Cell Cure”), Lineage’s subsidiary, received a motion for disclosure of documents pursuant to Section 198A of the Israeli Companies Law 5759-1999. The motion was filed in the district court in Tel Aviv-Yafo (the “Court”) by HBL Hadasit Bio-Holdings Ltd. (“HBL”), currently an approximately 5% shareholder of Cell Cure. According to the motion, the requested production of documents is intended to allow HBL to examine the possibility of pursuing a derivative action related to, among other things, the validity of an intercompany Collaboration and License Agreement (the “Intercompany Agreement”) entered into between Lineage and Cell Cure pursuant to which Cell Cure conveyed certain rights and other assets to Lineage, and Lineage agreed to undertake certain liabilities and obligations of Cell Cure relating to the OpRegen® program. In its motion, HBL alleges, among other things, that Lineage, in its capacity as Cell Cure’s controlling shareholder, and members of Cell Cure’s board of directors caused damage to Cell Cure because the Intercompany Agreement was an interested party transaction that was not fairly priced and exploits Cell Cure’s resources for the benefit of Lineage. The motion seeks an order to compel Cell Cure to disclose and deliver to HBL the documents described in the motion, such additional, cumulative, or alternative relief as the court deems appropriate, and reimbursement of HBL’s expenses, including attorneys’ fees. Cell Cure filed an opposition to the motion on July 9, 2023. The Court has set a hearing date for the motion of December 3, 2023. It is impossible at this time to assess whether the outcome of this proceeding will have a material adverse effect on Lineage’s consolidated results of operations, cash flows or financial position. Therefore, in accordance with ASC 450, Contingencies, Employment Contracts Lineage has employment agreements with all of its executive officers. Under the provisions of the agreements, Lineage may be required to incur severance obligations for matters relating to changes in control, as defined in the agreements, and involuntary terminations. Indemnification In the normal course of business, Lineage may agree to indemnify and reimburse other parties, typically Lineage’s clinical research organizations, investigators, clinical sites, and suppliers, for losses and expenses suffered or incurred by the indemnified parties arising from claims of third parties in connection with the use or testing of Lineage’s products and services. Indemnification could also cover third party infringement claims with respect to patent rights, copyrights, or other intellectual property pertaining to Lineage products and services. The term of these indemnification agreements generally continue in effect after the termination or expiration of the particular research, development, services, or license agreement to which they relate. The potential future payments Lineage could be required to make under these indemnification agreements will generally not be subject to any specified maximum amount. Generally, Lineage has not been subject to any material claims or demands for indemnification. Lineage maintains liability insurance policies that limit its financial exposure under the indemnification agreements. Accordingly, Lineage has not recorded any liabilities for these agreements as of September 30, 2023 or December 31, 2022. Royalty Obligations and License Fees We have licensing agreements with research institutions, universities and other parties providing us with certain rights to use intellectual property in conducting research and development activities in exchange for the payment of royalties on future product sales, if any. In addition, in order to maintain these licenses and other rights, we must comply with various conditions including the payment of patent related costs and annual minimum maintenance fees. As part of the Asterias Merger, Lineage acquired certain royalty revenues for cash flows generated under patent families that Asterias acquired from Geron Corporation. Lineage continues to make royalty payments to Geron from royalties generated from these patents. Royalty revenues and royalty payments are included withing Royalties and license fees and Cost of sales, respectively, in our condensed consolidated statements of operations. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 15. Subsequent Events Israel-Hamas War All of our manufacturing processes, including cell banking and product manufacturing for our cell therapy product candidates, are conducted by our subsidiary, Cell Cure, at its facility in Jerusalem, Israel, and more than two-thirds of our employees are Cell Cure employees who are based in the same facility. As of the date of this report, our operations have not been materially or adversely impacted as a result of the Israel-Hamas war that began in October 2023. It is currently not possible to predict the scope, duration or severity of the ongoing war or its effects on our operations, financial condition or operating results. The ongoing war is rapidly evolving, and could materially adversely impact our business and operations, including our ability to raise capital, as well as the overall economy in Israel and the value of the New Israeli Shekel. |
Basis of Presentation, Liquid_2
Basis of Presentation, Liquidity and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Principles of consolidation | Principles of consolidation The accompanying unaudited condensed consolidated interim financial statements include the accounts of our subsidiaries. All material intercompany accounts and transactions have been eliminated in consolidation. The following table sets out Lineage’s ownership, directly or indirectly, of the outstanding shares of its subsidiaries as of September 30, 2023. Schedule of Lineage’s Ownership of Outstanding Shares of its Subsidiaries Subsidiary Field of Business Lineage Ownership Country Cell Cure Neurosciences Ltd. Manufacturing of Lineage’s product candidates 94 % (1) Israel ES Cell International Pte. Ltd. Research and clinical grade cell lines 100 % Singapore (1) Includes shares owned by Lineage and ES Cell International Pte. Ltd. As of September 30, 2023, Lineage consolidated its direct and indirect wholly-owned or majority-owned subsidiaries because Lineage has the ability to control their operating and financial decisions and policies through its ownership, and the noncontrolling interest is reflected as a separate element of shareholders’ equity on Lineage’s condensed consolidated balance sheets. |
Liquidity | Liquidity At September 30, 2023, we had $ 41.3 |
Capital Resources | Capital Resources Since inception we have incurred significant operating losses and have funded our operations primarily through the issuance of equity securities, the sale of common stock of our former subsidiaries, OncoCyte Corporation and AgeX Therapeutics, Inc., receipt of proceeds from research grants, revenues from collaborations, royalties from product sales, and sales of research products and services. As of September 30, 2023, $ 57.2 As of September 30, 2023, we had $ 9.9 |
Additional Capital Requirements | Additional Capital Requirements Our financial obligations primarily consist of obligations to licensors under license agreements, obligations related to grants received from government entities, including the Israel Innovation Authority (“IIA”), obligations under contracts with vendors who provide research services and purchase commitments with suppliers. Our obligations to licensors under license agreements and our obligations related to grants received from government entities require us to make future payments, such as sublicense fees, milestone payments, redemption fees, royalties and patent maintenance costs. Sublicense fees are payable to licensors or government entities when we sublicense the applicable intellectual property to third parties; the fees are based on a percentage of the license fees we receive from sublicensees. Milestone payments, including those related to the Roche Agreement, are due to licensors or government entities upon achievement of commercial, development and regulatory milestones. Redemption fees due to the IIA under the Innovation Law are due upon receipt of milestone payments and royalties received under the Roche Agreement. See Note 14 (Commitment and Contingencies) for additional information. Royalties, including those related to royalties we may receive under the Roche Agreement, are payable to licensors or government entities based on a percentage of net sales of licensed products. Patent maintenance costs are payable to licensors as reimbursement for the cost of maintaining license patents. Due to the contingent nature of the payments, the amounts and timing of payments to licensors under our in-license agreements are uncertain and may fluctuate significantly from period to period. As of September 30, 2023, we have not included these commitments on our condensed consolidated balance sheet because the achievement of events that would trigger our payment obligations and the timing thereof are not fixed and determinable. In the normal course of business, we enter into services agreements with contract research organizations, contract manufacturing organizations and other third parties. Generally, these agreements provide for termination upon notice, with specified amounts due upon termination based on the timing of termination and the terms of the agreement. The amounts and timing of payments under these agreements are uncertain and contingent upon the initiation and completion of the services to be provided. Significant Accounting Policies We describe our significant accounting policies in Note 2 to the consolidated financial statements in Item 8 of the 2022 10-K. There have been no changes to our significant accounting policies during the nine months ended September 30, 2023. |
Recently Issued and Recently Adopted Accounting Pronouncements | Recently Issued and Recently Adopted Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that are adopted by the Company as of the specified effective date. The Company has evaluated recently issued accounting pronouncements and does not believe any will have a material impact on the Company’s condensed consolidated financial statements or related financial statement disclosures. |
Basis of Presentation, Liquid_3
Basis of Presentation, Liquidity and Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Lineage’s Ownership of Outstanding Shares of its Subsidiaries | Schedule of Lineage’s Ownership of Outstanding Shares of its Subsidiaries Subsidiary Field of Business Lineage Ownership Country Cell Cure Neurosciences Ltd. Manufacturing of Lineage’s product candidates 94 % (1) Israel ES Cell International Pte. Ltd. Research and clinical grade cell lines 100 % Singapore (1) Includes shares owned by Lineage and ES Cell International Pte. Ltd. |
Revenue (Tables)
Revenue (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Disaggregated Revenues | Our disaggregated revenues were as follows for the periods presented (in thousands): Schedule of Disaggregated Revenues 2023 2022 2023 2022 Three Months ended Nine Months ended 2023 2022 2023 2022 Revenues under collaborative agreements Upfront license fees $ 957 $ 2,592 $ 5,949 $ 11,605 Total revenues under collaborative agreements 957 2,592 5,949 11,605 Royalties and license fees 289 406 908 1,183 Total revenue $ 1,246 $ 2,998 $ 6,857 $ 12,788 |
Schedule of Contract with Customer Contract Liability and Receivable | Accounts receivable, net, and deferred revenues (contract liabilities) from contracts with customers, including collaboration partners, consisted of the following (in thousands): Schedule of Contract with Customer Contract Liability and Receivable September 30, 2023 December 31, 2022 Accounts receivable, net (1) $ 325 $ 297 Deferred revenues $ 31,110 $ 37,146 (1) Excludes government grants as Lineage has determined government grants are outside the scope of ASU 2014-09 – Revenue from Contracts with Customers |
Marketable Debt Securities (Tab
Marketable Debt Securities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Cash and Cash Equivalents [Abstract] | |
Summary of Available for Sale Debt Securities | The following tables are a summary of available-for-sale debt securities included within marketable securities in the Company’s condensed consolidated balance sheet as of September 30, 2023 and December 31, 2022 (in thousands): Summary of Available for Sale Debt Securities September 30, 2023 (Unaudited) Financial Assets: Amortized Cost Unrealized Unrealized Fair Value U.S. Treasury securities $ 9,800 $ 1 $ - $ 9,801 Total $ 9,800 $ 1 $ - $ 9,801 December 31, 2022 Financial Assets: Amortized Cost Unrealized Unrealized Losses Fair Value U.S. Treasury securities $ 46,247 $ 2 $ (152 ) $ 46,097 Total $ 46,247 $ 2 $ (152 ) $ 46,097 |
Schedule of Amortized cost And Estimated fair Value | As of September 30, 2023, the amortized cost and estimated fair value of the Company’s available-for-sale debt securities by contractual maturity are shown below (in thousands): Schedule of Amortized cost And Estimated fair Value Available-for-sale debt securities maturing: Amortized Cost Estimated Fair Value In one year or less $ 9,800 $ 9,801 Total available-for-sale debt securities $ 9,800 $ 9,801 |
Marketable Equity Securities (T
Marketable Equity Securities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule Of Marketable Equity Securities | The following table represents the realized and unrealized loss on marketable equity securities (in thousands): Schedule Of Marketable Equity Securities 2023 2022 2023 2022 Three Months ended Nine Months ended 2023 2022 2023 2022 Loss on marketable equity securities, net $ (60 ) $ (233 ) $ (170 ) $ (1,677 ) Less: Loss recognized in earnings on marketable equity securities sold 23 - 23 - Unrealized loss recognized on marketable equity securities held at end of period, net $ (37 ) $ (233 ) $ (147 ) $ (1,677 ) |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment, Net | At September 30, 2023 and December 31, 2022 property and equipment, net was comprised of the following (in thousands): Schedule of Property and Equipment, Net September 30, 2023 December 31, 2022 (Unaudited) Equipment, furniture and fixtures $ 3,363 $ 3,264 Leasehold improvements 2,195 2,150 Right-of-use assets 5,890 6,109 Property and equipment, gross 5,890 6,109 Accumulated depreciation and amortization (6,594 ) (5,850 ) Property and equipment, net $ 4,854 $ 5,673 |
Goodwill and Intangible Asset_2
Goodwill and Intangible Assets, Net (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Goodwill and Intangible Assets, Net | At September 30, 2023 and December 31, 2022 goodwill and intangible assets, net consisted of the following (in thousands): Schedule of Goodwill and Intangible Assets, Net September 30, 2023 December 31, 2022 (Unaudited) Goodwill (1) $ 10,672 $ 10,672 Intangible assets: Acquired IPR&D – OPC1 (from the Asterias Merger) (2) $ 31,700 $ 31,700 Acquired IPR&D – VAC (from the Asterias Merger) (2) 14,840 14,840 Intangible assets subject to amortization: Acquired patents 18,953 18,953 Acquired royalty contracts (3) 650 650 Total intangible assets 66,143 66,143 Accumulated amortization (4) (19,549 ) (19,451 ) Intangible assets, net $ 46,594 $ 46,692 (1) Goodwill represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired and liabilities assumed in the Asterias Merger, see Note 14 (Commitment and Contingencies) for further discussion on the Asterias Merger. (2) Asterias had two in-process research and development (“IPR&D”) intangible assets that were valued at $ 46.5 31.7 14.8 (3) Asterias had royalty cash flows under patent families it acquired from Geron Corporation (“Geron”). Such patent families are expected to continue to generate revenue, are not used in the OPC1 or the VAC platform, and are considered to be separate long-lived intangible assets under Accounting Standards Codifications (“ASC”) Topic 805, Business Combinations (4) As of September 30, 2023 acquired patents were fully amortized and the acquired royalty contracts had a remaining unamortized balance of approximately $ 54,000 |
Schedule of Intangible Assets Future Amortization Expenses | Amortization of intangible assets for periods subsequent to September 30, 2023 is as follows (in thousands): Schedule of Intangible Assets Future Amortization Expenses Year Ending December 31, Amortization Expense 2023 $ 32 2024 22 Total $ 54 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accounts Payable and Accrued Liabilities | At September 30, 2023 and December 31, 2022 accounts payable and accrued liabilities consisted of the following (in thousands): Schedule of Accounts Payable and Accrued Liabilities September 30, 2023 December 31, 2022 (Unaudited) Accounts payable $ 2,430 $ 2,393 Accrued compensation 2,251 2,382 Accrued liabilities (1) 349 3,833 Total $ 5,030 $ 8,608 (1) The decrease in accrued liabilities was due to a payment made in connection with the settlement of litigation in February 2023 related to the Asterias Merger. See Note 14 (Commitment and Contingencies) for additional information. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value of Assets and Liabilities Valued on Recurring Basis | We measure our money market fund, marketable securities and our liability classified warrants at fair value on a recurring basis. The fair values of such assets and liabilities were as follows as of September 30, 2023 and December 31, 2022 (in thousands): Schedule of Fair Value of Assets and Liabilities Valued on Recurring Basis Fair Value Measurements Using Balance at Quoted Prices in Active Markets for Identical Assets (Level 1) Significant (Level 2) Significant Unobservable Inputs (Level 3) Assets: Money market fund (1) $ 19,782 $ 19,782 $ - $ - Marketable debt securities 9,801 9,801 - - Marketable equity securities 57 57 - - Total assets measured at fair value $ 29,640 $ 29,640 $ - $ - Fair Value Measurements Using Balance at Quoted Prices in Active Markets for Identical Assets (Level 1) Significant (Level 2) Significant Inputs (Level 3) Assets: Money market fund (1) $ 4,102 $ 4,102 $ - $ - Marketable debt securities 46,097 46,097 - - Marketable equity securities 423 423 - - Total assets measured at fair value $ 50,622 $ 50,622 $ - $ - Liabilities: Warrants to purchase Cell Cure ordinary shares (2) $ 2 $ - $ - $ 2 Total liabilities measured at fair value $ 2 $ - $ - $ 2 (1) Included in cash and cash equivalents in the accompanying condensed consolidated balance sheet. (2) Included in other long-term liabilities in the accompanying condensed consolidated balance sheet. As of September 30, 2023, the fair value of our liability classified warrants was zero. |
Shareholders_ Equity (Tables)
Shareholders’ Equity (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Schedule of Shareholder’s Equity | The following tables document the changes in shareholders’ equity for the three and nine months ended September 30, 2023 and 2022 (unaudited and in thousands): Schedule of Shareholder’s Equity Shares Amount Shares Amount Deficit Deficit Income / (Loss) Equity Accumulated Preferred Common Other Total Shares Shares Accumulated Noncontrolling Comprehensive Shareholders’ Shares Amount Shares Amount Deficit Deficit Income / (Loss) Equity BALANCE - December 31, 2022 - $ - 170,093 $ 440,280 $ (363,370 ) $ (1,403 ) $ (3,571 ) $ 71,936 Shares issued upon vesting of - - 53 (37 ) - - - (37 ) Shares issued through ATM Shares issued through ATM, shares Financing related fees Shares issued upon exercise of - - 28 25 - - - 25 Subsidiary warrant exercise Stock-based compensation - - - 1,031 - - - 1,031 Unrealized gain on marketable debt securities - - - - - - 91 91 Foreign currency translation gain - - - - - - 373 373 Net loss - - - - (4,372 ) (32 ) - (4,404 ) BALANCE - March 31, 2023 - - 170,174 441,299 (367,742 ) (1,435 ) (3,107 ) 69,015 Shares issued through ATM - - 4,237 5,841 - - - 5,841 Financing related fees - - - (193 ) - - - (193 ) Shares issued upon exercise of - - 28 22 - - - 22 Stock-based compensation - - - 1,280 - - - 1,280 Unrealized gain on marketable debt securities - - - - - - 50 50 Foreign currency translation gain - - - - - - 446 446 Net income (loss) - - - - (5,229 ) 26 - (5,203 ) BALANCE - June 30, 2023 - - 174,439 448,249 (372,971 ) (1,409 ) (2,611 ) 71,258 Shares issued through ATM - - 538 784 - - - 784 Financing related fees - - - (28 ) - - - (28 ) Shares issued upon exercise of - - 10 8 - - - 8 Stock-based compensation - - - 1,269 - - - 1,269 Unrealized gain on marketable debt securities - - - - - - 9 9 Foreign currency translation gain - - - - - - 518 518 Net income (loss) - - - - (7,110 ) (48 ) - (7,158 ) BALANCE - September 30, 2023 - $ - 174,987 $ 450,282 $ (380,081 ) $ (1,457 ) $ (2,084 ) $ 66,660 Accumulated Preferred Common Other Total Shares Shares Accumulated Noncontrolling Comprehensive Shareholders’ Shares Amount Shares Amount Deficit Deficit Income / (Loss) Equity BALANCE - December 31, 2021 - $ - 169,477 $ 434,529 $ (337,097 ) $ (1,323 ) $ (5,211 ) $ 90,898 Shares issued upon vesting of - - 10 (8 ) - - - (8 ) Shares issued upon exercise of - - 240 189 - - - 189 Subsidiary warrant exercise - - - 2 - - - 2 Stock-based compensation - - - 1,106 - - - 1,106 Foreign currency translation gain - - - - - - 124 124 Net loss - - - - (7,087 ) (6 ) - (7,093 ) BALANCE - March 31, 2022 - - 169,727 435,818 (344,184 ) (1,329 ) (5,087 ) 85,218 Shares issued upon vesting of - - 10 (9 ) - - - (9 ) Shares issued upon exercise of - - 11 10 - - - 10 Subsidiary warrant exercise, net - - - 97 - - - 97 Stock-based compensation - - - 1,235 - - - 1,235 Foreign currency translation gain - - - - - - 1,730 1,730 Net loss - - - - (6,763 ) (19 ) - (6,782 ) BALANCE - June 30, 2022 - - 169,748 437,151 (350,947 ) (1,348 ) (3,357 ) 81,499 Beginning balance - - 169,748 437,151 (350,947 ) (1,348 ) (3,357 ) 81,499 Shares issued upon exercise of - - 138 118 - - - 118 Subsidiary warrant exercise, net - - - 892 - - - 892 Stock-based compensation - - - 987 - - - 987 Unrealized loss on marketable debt securities - - - - - - (150 ) (150 ) Foreign currency translation gain - - - - - - 323 323 Net loss - - - - (6,069 ) (47 ) - (6,116 ) Net income (loss) - - - - (6,069 ) (47 ) - (6,116 ) BALANCE - September 30, 2022 - $ - 169,886 $ 439,148 $ (357,016 ) $ (1,395 ) $ (3,184 ) $ 77,553 Ending balance - $ - 169,886 $ 439,148 $ (357,016 ) $ (1,395 ) $ (3,184 ) $ 77,553 |
Stock-Based Awards (Tables)
Stock-Based Awards (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Schedule of Weighted Average Assumptions to Calculate Fair Value of Stock Options | The fair value of each option award is estimated on the date of grant using a Black-Scholes option pricing model applying the weighted-average assumptions noted in the following table: Schedule of Weighted Average Assumptions to Calculate Fair Value of Stock Options Nine Months ended September 30, (unaudited) 2023 2022 Expected life (in years) 6.20 6.20 Risk-free interest rates 4.1 % 2.1 % Volatility 74.7 % 73.6 % Dividend yield - - |
Schedule of Stock Based Compensation Expense | Operating expenses include stock-based compensation expense as follows (in thousands): Schedule of Stock Based Compensation Expense Three Months ended September 30, (unaudited) Nine Months ended September 30, (unaudited) 2023 2022 2023 2022 Research and development $ 260 $ 204 $ 729 $ 559 General and administrative 1,009 783 2,851 2,769 Total stock-based compensation expense $ 1,269 $ 987 $ 3,580 $ 3,328 |
Schedule Of Computation Of Diluted Net Loss Per Common Share | The following common share equivalents were excluded from the computation of diluted net loss per common share for the periods presented because including them would have been antidilutive (in thousands): Schedule Of Computation Of Diluted Net Loss Per Common Share Three Months ended Nine Months ended 2023 2022 2023 2022 Stock options 23,168 17,972 23,168 17,972 Restricted stock units 759 939 759 939 |
2021 Equity Incentive Plan [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Schedule of Share-based Compensation Activity | A summary of activity under the 2021 Plan is as follows (in thousands, except per share amounts): Schedule of Share-based Compensation Activity Number of Options Outstanding Weighted Average Exercise Price Balance at December 31, 2022 6,001 $ 1.40 Options granted 5,720 $ 1.45 Options expired/forfeited/cancelled (239 ) $ 1.42 Balance at September 30, 2023 11,482 $ 1.42 Options exercisable at September 30, 2023 2,054 $ 1.43 Number of RSUs Outstanding Balance at December 31, 2022 939 RSUs forfeited (100 ) RSUs vested (80 ) Balance at September 30, 2023 759 |
2012 Equity Incentive Plan and 2018 Inducement Option [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Schedule of Share-based Compensation Activity | A summary of activity of the 2012 Plan, and the 2018 inducement option (which was issued to a Lineage executive outside of all equity plans), is as follows (in thousands, except per share amounts): Schedule of Share-based Compensation Activity Number of Options Outstanding Weighted Average Exercise Price Balance at December 31, 2022 12,172 $ 1.83 Options exercised (66 ) $ 0.84 Options expired/forfeited/cancelled (420 ) $ 1.89 Balance at September 30, 2023 11,686 $ 1.83 Options exercisable at September 30, 2023 9,846 $ 1.69 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Supplemental Cash Flow Information Related to Leases | Supplemental cash flow information related to leases is as follows (in thousands): Schedule of Supplemental Cash Flow Information Related to Leases 2023 2022 Nine Months ended September 30, 2023 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 833 $ 727 Operating cash flows from financing leases $ 8 $ 14 Financing cash flows from financing leases $ 41 $ 23 Right-of-use assets obtained in exchange for lease obligations: Operating leases $ - $ 1,028 Finance leases $ 79 $ - |
Schedule of Supplemental Balance Sheet Information Related to Leases | Supplemental balance sheet information related to leases was as follows (in thousands, except lease term and discount rate): Schedule of Supplemental Balance Sheet Information Related to Leases September 30, December 31, (Unaudited) Operating leases Right-of-use assets, net $ 2,652 $ 3,517 Right-of-use lease liabilities, current $ 881 $ 916 Right-of-use lease liabilities, noncurrent 2,047 2,860 Total operating lease liabilities $ 2,928 $ 3,776 Financing leases Right-of-use assets, net $ 141 $ 105 Lease liabilities, current $ 55 $ 29 Lease liabilities, noncurrent 97 84 Total finance lease liabilities 152 113 Other current liabilities - 7 Total finance lease liabilities $ 152 $ 120 Weighted average remaining lease term Operating leases 3.7 4.3 Finance leases 3.2 4.1 Weighted average discount rate Operating leases 6.4 % 6.3 % Finance leases 6.8 % 6.9 % |
Schedule of Future Minimum Lease Commitments | Future minimum lease commitments are as follows as of September 30, 2023 (in thousands): Schedule of Future Minimum Lease Commitments (Unaudited) Operating Finance Year Ending December 31, 2023 $ 275 $ 16 2024 921 60 2025 852 50 2026 623 26 2027 658 18 Total lease payments 3,329 170 Less imputed interest (401 ) (18 ) Total $ 2,928 $ 152 |
Organization and Business Ove_2
Organization and Business Overview (Details Narrative) - USD ($) $ in Millions | 1 Months Ended | 9 Months Ended | |
Jan. 31, 2022 | Dec. 31, 2021 | Sep. 30, 2023 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Amount of grants received | $ 14.3 | ||
Roche Agreement [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Upfront payment received | $ 50 | ||
Amount of grants received | $ 50 | ||
Collaboration License Agreement [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Maximum milestone payments to be received upon performance conditions | $ 620 |
Schedule of Lineage_s Ownership
Schedule of Lineage’s Ownership of Outstanding Shares of its Subsidiaries (Details) | 9 Months Ended | |
Sep. 30, 2023 | ||
Cell Cure Neurosciences Ltd [Member] | ||
Field of business description | Manufacturing of Lineage’s product candidates | [1] |
Ownership percentage by parent | 94% | [1] |
Es CellInternational Pte Ltd [Member] | ||
Field of business description | Research and clinical grade cell lines | |
Ownership percentage by parent | 100% | |
[1]Includes shares owned by Lineage and ES Cell International Pte. Ltd. |
Basis of Presentation, Liquid_4
Basis of Presentation, Liquidity and Summary of Significant Accounting Policies (Details Narrative) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Accounting Policies [Abstract] | ||
Cash, cash equivalents and marketable securities | $ 41,300 | |
Amount reserved for future issuance | 57,200 | |
Marketable securities | $ 9,858 | $ 46,520 |
Schedule of Disaggregated Reven
Schedule of Disaggregated Revenues (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Disaggregation of Revenue [Line Items] | ||||
Total revenues under collaborative agreements | $ 957 | $ 2,592 | $ 5,949 | $ 11,605 |
Royalties and license fees | 289 | 406 | 908 | 1,183 |
Total revenue | 1,246 | 2,998 | 6,857 | 12,788 |
Upfront License Fees [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues under collaborative agreements | $ 957 | $ 2,592 | $ 5,949 | $ 11,605 |
Schedule of Contract with Custo
Schedule of Contract with Customer Contract Liability and Receivable (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | |
Revenue from Contract with Customer [Abstract] | |||
Accounts receivable, net | [1] | $ 325 | $ 297 |
Deferred revenues | $ 31,110 | $ 37,146 | |
[1]Excludes government grants as Lineage has determined government grants are outside the scope of ASU 2014-09 – Revenue from Contracts with Customers |
Revenue (Details Narrative)
Revenue (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Upfront payment | $ 50,000 | ||||
Total revenue | $ 1,246 | $ 2,998 | 6,857 | $ 12,788 | |
Collaboration revenues | 957 | 2,592 | 5,949 | 11,605 | |
Transaction price for good and service | 32,800 | 32,800 | |||
Deferred revenue | 31,110 | 31,110 | $ 37,146 | ||
Unfulfilled commitments | 1,600 | 1,600 | |||
Deferred revenue to be recognized | 9,915 | 9,915 | $ 9,421 | ||
Roche and Immunomic Therapeutics Collaboration Agreement [Member] | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Collaboration revenues | $ 1,000 | $ 2,600 | $ 5,900 | $ 11,600 |
Summary of Available for Sale D
Summary of Available for Sale Debt Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Cash and Cash Equivalents [Line Items] | ||
Amortized cost | $ 9,800 | $ 46,247 |
Unrealized gains | 1 | 2 |
Unrealized losses | (152) | |
Fair value | 9,801 | 46,097 |
US Treasury Securities [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Amortized cost | 9,800 | 46,247 |
Unrealized gains | 1 | 2 |
Unrealized losses | (152) | |
Fair value | $ 9,801 | $ 46,097 |
Schedule of Amortized cost And
Schedule of Amortized cost And Estimated fair Value (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Cash and Cash Equivalents [Abstract] | ||
Amortized cost, In one year or less | $ 9,800 | |
Estimated fair value, In one year or less | 9,801 | |
Amortized cost, Total available-for-sale debt securities | 9,800 | $ 46,247 |
Estimated fair value, Total available-for-sale debt securities | $ 9,801 | $ 46,097 |
Marketable Debt Securities (Det
Marketable Debt Securities (Details Narrative) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Cash and Cash Equivalents [Abstract] | ||
Marketable debt securities | $ 9,800,000 | $ 46,100,000 |
Marketable equity securities | $ 100,000 | $ 400,000 |
Schedule Of Marketable Equity S
Schedule Of Marketable Equity Securities (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | ||||
Loss on marketable equity securities, net | $ (60) | $ (233) | $ (170) | $ (1,677) |
Less: Loss recognized in earnings on marketable equity securities sold | 23 | 23 | ||
Unrealized loss recognized on marketable equity securities held at end of period, net | $ (37) | $ (233) | $ (147) | $ (1,677) |
Marketable Equity Securities (D
Marketable Equity Securities (Details Narrative) - OncoCyte Corporation [Member] - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Investment owned balance, shares | 7,500 | 56,000 |
Investment owned, at fair value | $ 24,000 | $ 400,000 |
Share price per share | $ 3.12 | $ 6.42 |
Schedule of Property and Equipm
Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Accumulated depreciation and amortization | $ (6,594) | $ (5,850) |
Property and equipment, net | 4,854 | 5,673 |
Equipment Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 3,363 | 3,264 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 2,195 | 2,150 |
Right of Use Assets [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 5,890 | $ 6,109 |
Property and Equipment, Net (De
Property and Equipment, Net (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |||||
Financing leases related to property and equipment | $ 193,000 | $ 193,000 | $ 121,000 | ||
Depreciation and amortization expense | $ 143,000 | $ 145,000 | $ 419,000 | $ 441,000 |
Schedule of Goodwill and Intang
Schedule of Goodwill and Intangible Assets, Net (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | |
Finite-Lived Intangible Assets [Line Items] | |||
Goodwill | [1] | $ 10,672 | $ 10,672 |
Total intangible assets | 66,143 | 66,143 | |
Accumulated amortization | [2] | (19,549) | (19,451) |
Intangible assets, net | 46,594 | 46,692 | |
IPR&D - OPC1 [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Intangible assets | [3] | 31,700 | 31,700 |
IPR&D - VAC [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Intangible assets | [3] | 14,840 | 14,840 |
Patents [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Intangible assets subject to amortization | 18,953 | 18,953 | |
Royalty Contracts [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Intangible assets subject to amortization | [4] | $ 650 | $ 650 |
[1]Goodwill represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired and liabilities assumed in the Asterias Merger, see Note 14 (Commitment and Contingencies) for further discussion on the Asterias Merger.[2]As of September 30, 2023 acquired patents were fully amortized and the acquired royalty contracts had a remaining unamortized balance of approximately $ 54,000 46.5 31.7 14.8 Business Combinations |
Schedule of Goodwill and Inta_2
Schedule of Goodwill and Intangible Assets Net (Details) (Parenthetical) $ in Thousands | Sep. 30, 2023 USD ($) |
Indefinite-Lived Intangible Assets [Line Items] | |
Unamortized balance of acquired royalty contracts | $ 54,000 |
In Process Research and Development [Member] | |
Indefinite-Lived Intangible Assets [Line Items] | |
Fair value of intangible assets | 46,500 |
IPR&D - OPC1 [Member] | |
Indefinite-Lived Intangible Assets [Line Items] | |
Fair value of intangible assets | 31,700 |
IPR&D - VAC [Member] | |
Indefinite-Lived Intangible Assets [Line Items] | |
Fair value of intangible assets | $ 14,800 |
Schedule of Intangible Assets F
Schedule of Intangible Assets Future Amortization Expenses (Details) $ in Thousands | Sep. 30, 2023 USD ($) |
Goodwill and Intangible Assets Disclosure [Abstract] | |
2023 | $ 32 |
2024 | 22 |
Total | $ 54 |
Goodwill and Intangible Asset_3
Goodwill and Intangible Assets, Net (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Finite-Lived Intangible Assets [Line Items] | ||||
Amortization of intangible assets | $ 33,000 | $ 33,000 | $ 98,000 | $ 98,000 |
Minimum [Member] | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Estimated useful life | 5 years | 5 years | ||
Maximum [Member] | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Estimated useful life | 10 years | 10 years |
Schedule of Accounts Payable an
Schedule of Accounts Payable and Accrued Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |||
Accounts payable | $ 2,430 | $ 2,393 | |
Accrued compensation | 2,251 | 2,382 | |
Accrued liabilities | [1] | 349 | 3,833 |
Total | $ 5,030 | $ 8,608 | |
[1]The decrease in accrued liabilities was due to a payment made in connection with the settlement of litigation in February 2023 related to the Asterias Merger. See Note 14 (Commitment and Contingencies) for additional information. |
Schedule of Fair Value of Asset
Schedule of Fair Value of Assets and Liabilities Valued on Recurring Basis (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Assets | $ 29,640 | $ 50,622 | |
Liabilities | 2 | ||
Cell Cure Warrants [Member] | |||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Liabilities | [1] | 2 | |
Fair Value, Inputs, Level 1 [Member] | |||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Assets | 29,640 | 50,622 | |
Liabilities | |||
Fair Value, Inputs, Level 1 [Member] | Cell Cure Warrants [Member] | |||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Liabilities | [1] | ||
Fair Value, Inputs, Level 2 [Member] | |||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Assets | |||
Liabilities | |||
Fair Value, Inputs, Level 2 [Member] | Cell Cure Warrants [Member] | |||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Liabilities | [1] | ||
Fair Value, Inputs, Level 3 [Member] | |||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Assets | |||
Liabilities | 2 | ||
Fair Value, Inputs, Level 3 [Member] | Cell Cure Warrants [Member] | |||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Liabilities | [1] | 2 | |
Money Market Funds [Member] | |||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Assets | [2] | 19,782 | 4,102 |
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | |||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Assets | [2] | 19,782 | 4,102 |
Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] | |||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Assets | [2] | ||
Money Market Funds [Member] | Fair Value, Inputs, Level 3 [Member] | |||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Assets | [2] | ||
Marketable Debt Securities [Member] | |||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Assets | 9,801 | 46,097 | |
Marketable Debt Securities [Member] | Fair Value, Inputs, Level 1 [Member] | |||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Assets | 9,801 | 46,097 | |
Marketable Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member] | |||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Assets | |||
Marketable Debt Securities [Member] | Fair Value, Inputs, Level 3 [Member] | |||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Assets | |||
Marketable Equity Securities [Member] | |||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Assets | 57 | 423 | |
Marketable Equity Securities [Member] | Fair Value, Inputs, Level 1 [Member] | |||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Assets | 57 | 423 | |
Marketable Equity Securities [Member] | Fair Value, Inputs, Level 2 [Member] | |||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Assets | |||
Marketable Equity Securities [Member] | Fair Value, Inputs, Level 3 [Member] | |||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Assets | |||
[1]Included in other long-term liabilities in the accompanying condensed consolidated balance sheet. As of September 30, 2023, the fair value of our liability classified warrants was zero.[2]Included in cash and cash equivalents in the accompanying condensed consolidated balance sheet. |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Neal Bradsher [Member] | Broadwood Partners, L.P [Member] | |
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | |
Legal expenses | $ 626,000 |
Schedule of Shareholder_s Equit
Schedule of Shareholder’s Equity (Details) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Beginning balance | $ 71,258 | $ 69,015 | $ 71,936 | $ 81,499 | $ 85,218 | $ 90,898 | $ 71,936 | $ 90,898 |
Shares issued upon vesting of restricted stock units, net of shares retired to pay employees’ taxes | (37) | (9) | (8) | |||||
Shares issued through ATM | 784 | 5,841 | ||||||
Financing related fees | (28) | (193) | ||||||
Shares issued upon exercise of stock options | 8 | 22 | 25 | 118 | 10 | 189 | ||
Subsidiary warrant exercise, net | 892 | 97 | 2 | |||||
Stock-based compensation | 1,269 | 1,280 | 1,031 | 987 | 1,235 | 1,106 | ||
Unrealized loss on marketable debt securities | 9 | 50 | 91 | (150) | 150 | (150) | ||
Foreign currency translation gain | 518 | 446 | 373 | 323 | 1,730 | 124 | 1,337 | 2,177 |
Net income (loss) | (7,158) | (5,203) | (4,404) | (6,116) | (6,782) | (7,093) | (16,765) | (19,991) |
Ending balance | 66,660 | 71,258 | 69,015 | 77,553 | 81,499 | 85,218 | 66,660 | 77,553 |
Preferred Stock [Member] | ||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Beginning balance | ||||||||
Beginning balance, shares | ||||||||
Shares issued upon vesting of restricted stock units, net of shares retired to pay employees’ taxes | ||||||||
Shares issued through ATM | ||||||||
Financing related fees | ||||||||
Shares issued upon exercise of stock options | ||||||||
Subsidiary warrant exercise, net | ||||||||
Stock-based compensation | ||||||||
Unrealized loss on marketable debt securities | ||||||||
Foreign currency translation gain | ||||||||
Net income (loss) | ||||||||
Ending balance | ||||||||
Ending balance, shares | ||||||||
Common Stock [Member] | ||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Beginning balance | $ 448,249 | $ 441,299 | $ 440,280 | $ 437,151 | $ 435,818 | $ 434,529 | $ 440,280 | $ 434,529 |
Beginning balance, shares | 174,439 | 170,174 | 170,093 | 169,748 | 169,727 | 169,477 | 170,093 | 169,477 |
Shares issued upon vesting of restricted stock units, net of shares retired to pay employees’ taxes | $ (37) | $ (9) | $ (8) | |||||
Shares issued upon vesting of restricted stock units, net of shares retired to pay employees' taxes, shares | 53 | 10 | 10 | |||||
Shares issued through ATM | $ 784 | $ 5,841 | ||||||
Shares issued through ATM, shares | 538 | 4,237 | ||||||
Financing related fees | $ (28) | $ (193) | ||||||
Shares issued upon exercise of stock options | $ 8 | $ 22 | $ 25 | $ 118 | $ 10 | $ 189 | ||
Shares issued upon exercise of stock options, shares | 10 | 28 | 28 | 138 | 11 | 240 | ||
Subsidiary warrant exercise, net | $ 892 | $ 97 | $ 2 | |||||
Stock-based compensation | $ 1,269 | $ 1,280 | $ 1,031 | 987 | 1,235 | 1,106 | ||
Unrealized loss on marketable debt securities | ||||||||
Foreign currency translation gain | ||||||||
Net income (loss) | ||||||||
Ending balance | $ 450,282 | $ 448,249 | $ 441,299 | $ 439,148 | $ 437,151 | $ 435,818 | $ 450,282 | $ 439,148 |
Ending balance, shares | 174,987 | 174,439 | 170,174 | 169,886 | 169,748 | 169,727 | 174,987 | 169,886 |
Retained Earnings [Member] | ||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Beginning balance | $ (372,971) | $ (367,742) | $ (363,370) | $ (350,947) | $ (344,184) | $ (337,097) | $ (363,370) | $ (337,097) |
Shares issued upon vesting of restricted stock units, net of shares retired to pay employees’ taxes | ||||||||
Shares issued through ATM | ||||||||
Financing related fees | ||||||||
Shares issued upon exercise of stock options | ||||||||
Subsidiary warrant exercise, net | ||||||||
Stock-based compensation | ||||||||
Unrealized loss on marketable debt securities | ||||||||
Foreign currency translation gain | ||||||||
Net income (loss) | (7,110) | (5,229) | (4,372) | (6,069) | (6,763) | (7,087) | ||
Ending balance | (380,081) | (372,971) | (367,742) | (357,016) | (350,947) | (344,184) | (380,081) | (357,016) |
Noncontrolling Interest [Member] | ||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Beginning balance | (1,409) | (1,435) | (1,403) | (1,348) | (1,329) | (1,323) | (1,403) | (1,323) |
Shares issued upon vesting of restricted stock units, net of shares retired to pay employees’ taxes | ||||||||
Shares issued through ATM | ||||||||
Financing related fees | ||||||||
Shares issued upon exercise of stock options | ||||||||
Subsidiary warrant exercise, net | ||||||||
Stock-based compensation | ||||||||
Unrealized loss on marketable debt securities | ||||||||
Foreign currency translation gain | ||||||||
Net income (loss) | (48) | 26 | (32) | (47) | (19) | (6) | ||
Ending balance | (1,457) | (1,409) | (1,435) | (1,395) | (1,348) | (1,329) | (1,457) | (1,395) |
AOCI Attributable to Parent [Member] | ||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Beginning balance | (2,611) | (3,107) | (3,571) | (3,357) | (5,087) | (5,211) | (3,571) | (5,211) |
Shares issued upon vesting of restricted stock units, net of shares retired to pay employees’ taxes | ||||||||
Shares issued through ATM | ||||||||
Financing related fees | ||||||||
Shares issued upon exercise of stock options | ||||||||
Subsidiary warrant exercise, net | ||||||||
Stock-based compensation | ||||||||
Unrealized loss on marketable debt securities | 9 | 50 | 91 | (150) | ||||
Foreign currency translation gain | 518 | 446 | 373 | 323 | 1,730 | 124 | ||
Net income (loss) | ||||||||
Ending balance | $ (2,084) | $ (2,611) | $ (3,107) | $ (3,184) | $ (3,357) | $ (5,087) | $ (2,084) | $ (3,184) |
Shareholders_ Equity (Details N
Shareholders’ Equity (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Dec. 31, 2021 | Mar. 31, 2021 | Mar. 31, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Subsidiary or Equity Method Investee [Line Items] | ||||||
Preferred stock, shares authorized | 2,000,000 | 2,000,000 | ||||
Preferred stock, no par value | $ 0 | $ 0 | ||||
Preferred stock, shares issued | 0 | 0 | ||||
Preferred stock, shares outstanding | 0 | 0 | ||||
Common stock, shares authorized | 450,000,000 | 250,000,000 | ||||
Common stock, no par value | $ 0 | $ 0 | ||||
Common stock, shares issued | 174,986,671 | 170,093,114 | ||||
Common stock, shares outstanding | 174,986,671 | 170,093,114 | ||||
Net proceeds | $ 6,400,000 | |||||
Proceeds from issuance of common stock | 6,625,000 | $ 148,000 | ||||
Equity securities available for sale | $ 100,000 | $ 400,000 | ||||
December Twenty Twenty Two Prospectus Supplement [Member] | ||||||
Subsidiary or Equity Method Investee [Line Items] | ||||||
Sale of stock | 4,774,603 | |||||
2017 Sales Agreement [Member] | Cantor Fitzgerald and Co Member [Member] | ||||||
Subsidiary or Equity Method Investee [Line Items] | ||||||
Percentage of commission payable | 3% | |||||
Parent Company [Member] | Sales Agreement [Member] | ||||||
Subsidiary or Equity Method Investee [Line Items] | ||||||
Net proceeds | $ 64,100,000 | $ 25,000,000 | ||||
Common stock unsold | $ 14,100,000 | |||||
Sale of stock | 4,882,803 | |||||
Sale of Stock, Price Per Share | $ 1.41 | |||||
Proceeds from issuance of common stock | $ 6,900,000 | |||||
Equity securities available for sale | $ 57,200,000 |
Schedule of Share-based Compens
Schedule of Share-based Compensation Activity (Details) shares in Thousands | 9 Months Ended |
Sep. 30, 2023 $ / shares shares | |
2021 Equity Incentive Plan [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of Options Outstanding, Beginning balance | 6,001 |
Weighted Average Exercise Price of Options Outstanding, beginning balance | $ / shares | $ 1.40 |
Number of Options Outstanding, Options granted | 5,720 |
Weighted Average Exercise Price of Options Outstanding, Options granted | $ / shares | $ 1.45 |
Number of Options Outstanding, Options expired/forfeited/cancelled | (239) |
Weighted Average Exercise Price of Options Outstanding, Options expired/forfeited/cancelled | $ / shares | $ 1.42 |
Number of Options Outstanding, Ending balance | 11,482 |
Weighted Average Exercise Price of Options Outstanding, Ending | $ / shares | $ 1.42 |
Number of Options exercisable | 2,054 |
Weighted Average Exercise Price of Options exercisable | $ / shares | $ 1.43 |
Number of RSUs Outstanding, Beginning balance | 939 |
Number of RSUs Outstanding, RSUs forfeited | (100) |
Number of RSUs Outstanding, Rsu vested | (80) |
Number of RSUs Outstanding, Ending balance | 759 |
2012 Equity Incentive Plan and 2018 Inducement Option [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of Options Outstanding, Beginning balance | 12,172 |
Weighted Average Exercise Price of Options Outstanding, beginning balance | $ / shares | $ 1.83 |
Number of Options Outstanding, Options expired/forfeited/cancelled | (420) |
Weighted Average Exercise Price of Options Outstanding, Options expired/forfeited/cancelled | $ / shares | $ 1.89 |
Number of Options Outstanding, Ending balance | 11,686 |
Weighted Average Exercise Price of Options Outstanding, Ending | $ / shares | $ 1.83 |
Number of Options exercisable | 9,846 |
Weighted Average Exercise Price of Options exercisable | $ / shares | $ 1.69 |
Number of Options Outstanding, Options exercised | (66) |
Weighted Average Exercise Price of Options, Options exercised | $ / shares | $ 0.84 |
Schedule of Weighted Average As
Schedule of Weighted Average Assumptions to Calculate Fair Value of Stock Options (Details) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | ||
Expected life (in years) | 6 years 2 months 12 days | 6 years 2 months 12 days |
Risk-free interest rates | 4.10% | 2.10% |
Volatility | 74.70% | 73.60% |
Dividend yield | (0.00%) | (0.00%) |
Schedule of Stock Based Compens
Schedule of Stock Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 1,269 | $ 987 | $ 3,580 | $ 3,328 |
Research and Development Expense [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | 260 | 204 | 729 | 559 |
General and Administrative Expense [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 1,009 | $ 783 | $ 2,851 | $ 2,769 |
Schedule Of Computation Of Dilu
Schedule Of Computation Of Diluted Net Loss Per Common Share (Details) - shares shares in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-Based Payment Arrangement, Option [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Antidilutive securities, shares | 23,168 | 17,972 | 23,168 | 17,972 |
Restricted Stock Units (RSUs) [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Antidilutive securities, shares | 759 | 939 | 759 | 939 |
Stock-Based Awards (Details Nar
Stock-Based Awards (Details Narrative) $ in Millions | 1 Months Ended | 9 Months Ended |
Sep. 30, 2023 USD ($) shares | Sep. 30, 2023 USD ($) shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
unrecognized compensation costs | $ | $ 10.6 | $ 10.6 |
Weighted average period for recognition | 2 years 7 months 6 days | |
2021 Equity Incentive Plan [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Increase in shares authorized for issuance | 19,500,000 | |
Number of shares available for grant | 25,436,929 | 25,436,929 |
2021 Equity Incentive Plan [Member] | Maximum [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Number of shares authorized for issuance | 34,500,000 | 34,500,000 |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | ||||
Deferred Income Tax Expense (Benefit) | $ 1,803 | |||
Income tax expense | $ 541 | $ (1,803) | $ 541 |
Schedule of Supplemental Cash F
Schedule of Supplemental Cash Flow Information Related to Leases (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating cash flows from operating leases | $ 833 | $ 727 |
Operating cash flows from financing leases | 8 | 14 |
Financing cash flows from financing leases | 41 | 23 |
Operating leases | 1,028 | |
Finance leases | $ 79 |
Schedule of Supplemental Balanc
Schedule of Supplemental Balance Sheet Information Related to Leases (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Lessee, Lease, Description [Line Items] | ||
Right-of-use lease liabilities, current | $ 881 | $ 916 |
Right-of-use lease liabilities, noncurrent | 2,047 | 2,860 |
Lease liabilities, current | 55 | 36 |
Lease liabilities, noncurrent | 97 | 84 |
Operating Lease [Member] | ||
Lessee, Lease, Description [Line Items] | ||
Right-of-use assets, net | 2,652 | 3,517 |
Right-of-use lease liabilities, current | 881 | 916 |
Right-of-use lease liabilities, noncurrent | 2,047 | 2,860 |
Total operating lease liabilities | $ 2,928 | $ 3,776 |
Weighted average remaining lease term | 3 years 8 months 12 days | 4 years 3 months 18 days |
Weighted average discount rate | 6.40% | 6.30% |
Financing Leases [Member] | ||
Lessee, Lease, Description [Line Items] | ||
Financing leases, Right-of-use assets, net | $ 141 | $ 105 |
Lease liabilities, current | 55 | 29 |
Lease liabilities, noncurrent | 97 | 84 |
Total finance lease liabilities | 152 | 113 |
Other current liabilities | 7 | |
Total finance lease liabilities | $ 152 | $ 120 |
Weighted average remaining lease term | 3 years 2 months 12 days | 4 years 1 month 6 days |
Weighted average discount rate | 6.80% | 6.90% |
Schedule of Future Minimum Leas
Schedule of Future Minimum Lease Commitments (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Operating Lease [Member] | ||
Lessee, Operating Lease, Liability, to be Paid, Fiscal Year Maturity [Abstract] | ||
2023 | $ 275 | |
2024 | 921 | |
2025 | 852 | |
2026 | 623 | |
2027 | 658 | |
Total lease payments | 3,329 | |
Less imputed interest | (401) | |
Total | 2,928 | $ 3,776 |
Financing Leases [Member] | ||
Finance Lease, Liability, to be Paid, Fiscal Year Maturity [Abstract] | ||
2023 | 16 | |
2024 | 60 | |
2025 | 50 | |
2026 | 26 | |
2027 | 18 | |
Total lease payments | 170 | |
Less imputed interest | (18) | |
Total | $ 152 | $ 113 |
Commitments and Contingencies_2
Commitments and Contingencies (Details Narrative) | 1 Months Ended | 9 Months Ended | ||||||||||||||||||||
Nov. 01, 2022 USD ($) | Nov. 01, 2022 ILS (₪) | Dec. 17, 2021 USD ($) | Nov. 30, 2021 USD ($) ft² m² | Feb. 28, 2023 USD ($) | Sep. 30, 2022 ft² | Aug. 31, 2022 USD ($) ft² m² | Jan. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Nov. 30, 2021 USD ($) ft² m² | Aug. 31, 2021 USD ($) | Apr. 30, 2021 USD ($) | May 31, 2020 USD ($) | May 31, 2020 GBP (£) | May 31, 2019 USD ($) ft² | Jan. 31, 2018 USD ($) ft² m² | Jan. 31, 2018 ILS (₪) ft² m² | Sep. 30, 2023 USD ($) ft² m² | Sep. 30, 2023 ILS (₪) ft² m² | Aug. 31, 2022 ILS (₪) ft² m² | Nov. 30, 2021 ILS (₪) ft² m² | Dec. 17, 2017 | |
Loss Contingencies [Line Items] | ||||||||||||||||||||||
Upfront payment | $ 14,300,000 | |||||||||||||||||||||
Insurance deductable | $ 25,000 | |||||||||||||||||||||
Roche Agreement [Member] | ||||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||||
Upfront payment received | 50,000,000 | |||||||||||||||||||||
Upfront payment | $ 50,000,000 | |||||||||||||||||||||
Roche Agreement [Member] | Israel Innovation Authority [Member] | ||||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||||
Loss contingency accrual, payments | 12,100,000 | |||||||||||||||||||||
Roche Agreement [Member] | Hadasit Medical Research Services and Development Ltd [Member] | ||||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||||
Loss contingency accrual, payments | 8,900,000 | |||||||||||||||||||||
Contingency withheld amount | $ 1,900,000 | |||||||||||||||||||||
Pay costs percentage | 21.50% | |||||||||||||||||||||
Collaboration License Agreement [Member] | ||||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||||
Maximum milestone payments to be received upon performance conditions | $ 620,000,000 | |||||||||||||||||||||
ITI Collaboration Agreement [Member] | ||||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||||
Upfront payment | $ 500,000 | $ 500,000 | ||||||||||||||||||||
Budgetary commitment amount | $ 2,200,000 | |||||||||||||||||||||
Purchase obligation | $ 1,600,000 | |||||||||||||||||||||
Agreements With Hadasit and IIA [Member] | ||||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||||
Grants awarded percentage | 50% | 50% | ||||||||||||||||||||
Royalty payment percentage | 24.10% | 24.10% | 24.10% | 50% | ||||||||||||||||||
Aggregate cap amount | $ 92,700,000 | |||||||||||||||||||||
Sublicensing fee percentage | 21.50% | |||||||||||||||||||||
Payments for Advance to Affiliate | $ 50,000,000 | |||||||||||||||||||||
License Agreement [Member] | ||||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||||
Agreed signature fee amount | $ 1,600,000 | £ 1,250,000 | ||||||||||||||||||||
License Agreement [Member] | Maximum [Member] | ||||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||||
Clinical regulatory milestone | £ | 8,000,000 | |||||||||||||||||||||
Sales related milestones | £ | £ 22,500,000 | |||||||||||||||||||||
Settlement Agreement [Member] | ||||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||||
Litigation settlement amount | 10,650,000 | |||||||||||||||||||||
Settlement Agreement [Member] | Insurers [Member] | ||||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||||
Litigation settlement amount | 7,120,000 | |||||||||||||||||||||
Settlement Agreement [Member] | Parent Company [Member] | ||||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||||
Litigation settlement amount | $ 3,530,000 | |||||||||||||||||||||
Carlsbad Lease [Member] | ||||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||||
Rentable area | ft² | 8,841 | |||||||||||||||||||||
Lease expiration date | Mar. 31, 2026 | |||||||||||||||||||||
Base monthly rent | $ 24,666 | |||||||||||||||||||||
Increased rent amount | $ 25,197 | |||||||||||||||||||||
Security deposit | 17,850 | |||||||||||||||||||||
Carlsbad SubLease [Member] | ||||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||||
Rentable area | ft² | 4,500 | |||||||||||||||||||||
Lease expiration date | Mar. 31, 2024 | |||||||||||||||||||||
Base monthly rent | 22,500 | |||||||||||||||||||||
Lease commencement date | Oct. 01, 2022 | |||||||||||||||||||||
Carlsbad SubLease [Member] | Prepaid Expenses and Other Current Assets [Member] | ||||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||||
Security deposit | $ 22,500 | |||||||||||||||||||||
Cell Cure Leases [Member] | ||||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||||
Rentable area | ft² | 1,432 | 3,229 | 1,432 | 10,054 | 10,054 | 7,842 | 7,842 | 3,229 | 1,432 | |||||||||||||
Lease expiration date | Dec. 31, 2027 | Dec. 31, 2027 | Dec. 31, 2027 | Dec. 31, 2027 | Dec. 31, 2027 | |||||||||||||||||
Base monthly rent | $ 3,757 | $ 4,800 | $ 3,757 | $ 12,200 | ₪ 39,776 | ₪ 16,350 | ₪ 11,880 | |||||||||||||||
Security deposit | $ 426,000 | |||||||||||||||||||||
Land subject to ground leases | m² | 133 | 300 | 133 | 934 | 934 | 728.5 | 728.5 | 300 | 133 | |||||||||||||
Lessee operating lease renewal term description | option to extend the lease for five years | option to extend the lease for five years | option to extend the lease for five years | option to extend the lease for five years | option to extend the lease for five years | |||||||||||||||||
Base rent and construction allowance per month | $ 26,000 | ₪ 93,827 | ||||||||||||||||||||
Payments for rent | $ 3,951 | ₪ 12,494 |