13 unchanged sentences
We have audited the accompanying consolidated balance sheets of Allogene Therapeutics, Inc.
−Removed: (the Company) as of December 31, 2023 and 2022, the related consolidated statements of operations and comprehensive loss, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2023 and the related notes (collectively referred to as the “consolidated financial statements”).
−Removed: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2023, in conformity with U.S.
+Added: (the Company) as of December 31, 2024 and 2023, the related consolidated statements of operations and comprehensive loss, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2024, and the related notes (collectively referred to as the “consolidated financial statements”).
+Added: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2024, in conformity with U.S.
generally accepted accounting principles.
−Removed: Restatement of Financial Statements
−Removed: As discussed in Note 1 to the consolidated financial statements, the 2022 and 2021 consolidated financial statements have been restated to correct misstatements.
Basis for Opinion
13 unchanged sentences
Critical Audit Matter
−Removed: Critical audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that:
−Removed: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.
−Removed: We determined that there are no critical audit matters.
+Added: The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that:
+Added: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments.
+Added: The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
+Added: Impairment of Long-Lived Assets
+Added: Description of the Matter As discussed in Note 5 to the consolidated financial statements, the Company’s long-lived assets are assessed for recoverability whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable.
+Added: When indicators of impairment exist, the Company compares the estimated future undiscounted net cash flows to the carrying amount of the asset group.
+Added: If the carrying amount of the asset group exceeds the future undiscounted cash flows, an impairment is measured based on the difference between the carrying amount of the asset group and its fair value.
+Added: Indicators of impairment were identified for the year ended December 31, 2024.
+Added: As a result the Company recorded an impairment charge of $15.7 million for its right-of-use asset and related leasehold improvements.
+Added: Auditing the Company’s impairment model was challenging due to the subjective assumption of market rental rates used as an input in determining the fair value of the right-of-use asset and related leasehold improvements.
+Added: How We Addressed the Matter in Our Audit To test the Company’s accounting for the impairment over the right-of-use asset and related leasehold improvements, our audit procedures included, among others, utilizing our valuation specialists to assist in evaluating the reasonableness of the Company’s valuation methodology and the market rental rate assumption, performing an evaluation of market rental rates by benchmarking to other properties of similar type and within the geographic area, and testing the completeness and accuracy of the significant inputs within the model.
/s/ Ernst & Young LLP
6 unchanged sentences
2024 December 31,
−Removed: (As Restated)
Current assets:
6 unchanged sentences
Property and equipment, net 86,056 99,478
+Added: Deposit placed in escrow 20,773 —
Restricted cash 10,292 10,292
6 unchanged sentences
Accrued and other current liabilities 30,129 31,182
−Removed: Deferred revenue 86 95
Total current liabilities 35,523 37,079
9 unchanged sentences
400,000,000 shares authorized as of December 31, 2024 and December 31, 2023;
−Removed: 168,642,238 and 144,438,304 shares issued and outstanding as of December 31, 2023 and December 31, 2022, respectively
+Added: and 212,210,597 and 168,642,238 shares issued and outstanding as of December 31, 2024 and December 31, 2023, respectively
Additional paid-in capital 2,241,879 2,075,252
8 unchanged sentences
Year Ended December 31,
−Removed: 2023 2022 2021
−Removed: (As restated) (As restated)
Collaboration revenue - related party $ 22 $ 95
7 unchanged sentences
Interest and other income, net 20,153 18,307
−Removed: Other expenses ( 17,835 ) ( 9,444 ) ( 3,573 )
+Added: Interest expense ( 181 ) —
+Added: Other expenses, net
+Added: ( 3,920 ) ( 17,835 )
Total other income (expense), net 16,052 472
+Added: Loss before income taxes
+Added: ( 257,147 ) ( 327,265 )
+Added: Income tax expense ( 443 ) —
Net loss ( 257,590 ) ( 327,265 )
−Removed: Other comprehensive income:
−Removed: Net unrealized gain (loss) on available-for-sale investments 8,971 ( 7,359 ) ( 2,835 )
+Added: Other comprehensive loss:
+Added: Net unrealized gain on available-for-sale investments 866 8,971
Net comprehensive loss $ ( 256,724 ) $ ( 318,294 )
14 unchanged sentences
Balance — December 31, 2022 (As Restated) 144,438,304 $ 144 $ 1,911,632 $ ( 1,234,968 ) $ ( 9,926 ) $ 666,882
−Removed: Issuance of common stock upon exercise of stock options and vesting of RSUs 1,961,554 2 8,344 — — 8,346
−Removed: Vesting of early exercised common stock — — 3,848 — — 3,848
−Removed: Stock-based compensation — — 80,818 — — 80,818
−Removed: Employee stock purchase plan 187,206 — 3,617 — — 3,617
−Removed: Net loss (As Restated) — — — ( 182,051 ) — ( 182,051 )
−Removed: Net unrealized loss on available-for-sale investments — — — — ( 2,835 ) ( 2,835 )
−Removed: Balance — December 31, 2021 (As Restated) 142,623,065 142 1,822,179 ( 894,554 ) ( 2,567 ) 925,200
+Added: Issuance of common stock from ATM offering, net of commissions and offering costs of $ 1.7 million
+Added: 20,894,565 21 91,091 — — 91,112
Issuance of common stock upon exercise of stock options and vesting of RSUs 2,718,410 3 2,084 — — 2,087
4 unchanged sentences
— — — ( 327,265 ) — ( 327,265 )
−Removed: Net unrealized loss on available-for-sale investments — — — — ( 7,359 ) ( 7,359 )
−Removed: Balance — December 31, 2022 (As Restated) 144,438,304 144 1,911,632 ( 1,234,968 ) ( 9,926 ) 666,882
+Added: Net unrealized gain on available-for-sale investments — — — — 8,971 8,971
+Added: Balance — December 31, 2023 168,642,238 169 2,075,252 ( 1,562,233 ) ( 955 ) 512,233
Issuance of common stock from ATM offering, net of commissions and offering costs of $ 0.1 million
2,539,134 2 6,762 — — 6,764
+Added: Issuance of common stock from registered offering, net of commissions and offering costs of $ 4.7 million
+Added: 37,931,035 38 105,245 — — 105,283
Issuance of common stock upon exercise of stock options and vesting of RSUs 2,569,680 2 811 — — 813
14 unchanged sentences
Year Ended December 31,
−Removed: 2023 2022 2021
−Removed: (As Restated) (As Restated)
Cash flows from operating activities:
7 unchanged sentences
Non-cash rent expense 5,264 6,644
+Added: Income tax expense 443 —
Non-cash collaboration revenue - related party ( 14 ) ( 63 )
1 unchanged sentence
Changes in operating assets and liabilities:
+Added: Deposit placed in escrow ( 20,773 ) —
Prepaid expenses and other current assets ( 492 ) 1,086
2 unchanged sentences
Accrued and other current liabilities ( 1,262 ) ( 6,823 )
−Removed: Deferred revenue ( 3 ) ( 21 ) ( 38,297 )
+Added: Operating lease liabilities ( 6,307 ) ( 6,002 )
Other long-term liabilities 259 ( 611 )
2 unchanged sentences
Purchases of property and equipment ( 694 ) ( 1,516 )
−Removed: Purchase of stock in equity method investment — — ( 17,710 )
Proceeds from sales of investments 5,398 5,623
1 unchanged sentence
Purchase of investments ( 361,475 ) ( 438,629 )
−Removed: Net cash provided by (used in) investing activities 163,289 106,159 163,655
+Added: Net cash provided by investing activities 75,688 163,289
Cash flows from financing activities:
Proceeds from issuance of common stock from ATM offering, net of commissions and issuance costs 6,764 91,112
+Added: Proceeds from issuance of common stock from public offering, net of commissions and issuance costs 105,283 —
Proceeds from issuance of common stock and upon exercise of stock options 813 2,087
Proceeds from issuance of common stock under the employee stock purchase plan 1,535 2,496
+Added: Proceeds from CIRM award 2,280 —
Net cash provided by financing activities 116,675 95,695
5 unchanged sentences
Property and equipment purchases in accounts payable and accrued and other current liabilities $ 64 $ —
−Removed: Capitalized cloud computing costs included in accounts payable and accrued and other current liabilities $ — $ 415 $ —
Non-cash deferred revenue and other long-term liabilities $ 3,079 $ 3,094
1 unchanged sentence
Cash paid for amounts included in the measurement of lease liabilities $ ( 12,505 ) $ ( 12,049 )
−Removed: Cash received for amounts related to tenant improvement allowances from lessors $ — $ 325 $ 1,111
The accompanying notes are an integral part of these consolidated financial statements.
4 unchanged sentences
(the Company or Allogene) was incorporated on November 30, 2017 in the State of Delaware and is headquartered in South San Francisco, California.
−Removed: Allogene is a clinical-stage immuno-oncology company pioneering the development of genetically engineered allogeneic T cell product candidates for the treatment of cancer.
−Removed: The Company is developing a pipeline of off-the-shelf T cell product candidates that are designed to target and kill cancer cells.
+Added: Allogene is a clinical stage immuno-oncology company pioneering the development of genetically engineered allogeneic T cell product candidates for the treatment of cancer and autoimmune diseases.
+Added: The Company is developing a pipeline of “off-the-shelf” T cell product candidates that are designed to target and kill cancer cells in patients or eliminate pathogenic autoreactive cells in patients with autoimmune disorders.
+Added: The Company’s engineered T cells are allogeneic, meaning they are derived from healthy donors for intended use in any patient, rather than from an individual patient for that patient’s use, as in the case of autologous T cells.
+Added: The Company believes this key difference will enable it to deliver readily available treatments faster, more reliably, at greater scale, and to more patients.
Public Offerings
2 unchanged sentences
During the year ended December 31, 2023, the Company sold an aggregate of 20,894,565 shares of common stock in ATM offerings resulting in net proceeds of $ 91.1 million.
−Removed: During the year ended December 31, 2023, the Company sold an aggregate of 20,894,565 shares of common stock in ATM offerings resulting in net proceeds of $ 91.1 million.
The specified dollar limit on the amount of common stock that may be sold under the sales agreement was removed pursuant to the November 2, 2023 amendment to the sales agreement.
−Removed: In June 2020, the Company sold 13,457,447 shares of its common stock, which included 1,755,319 shares sold pursuant to the full exercise of the underwriters' option to purchase additional shares, in an underwritten public offering at a price of $ 47.00 per share, which resulted in gross proceeds of approximately $ 632.5 million.
−Removed: Net proceeds to the Company after deducting the underwriting discounts and commissions and other expenses were approximately $ 595.7 million.
+Added: During the year ended December 31, 2024, the Company sold an aggregate of 2,539,134 shares of common stock in ATM offerings resulting in net proceeds of $ 6.8 million.
+Added: Registered Offering
+Added: On May 13, 2024, the Company entered into (i) an underwriting agreement (Underwriting Agreement) with Goldman Sachs & Co.
+Added: LLC (Underwriter) and (ii) a Securities Purchase Agreement (Securities Purchase Agreement) with certain members of the Company’s Board of Directors and executive officers or their respective affiliates (Purchasers), pursuant to which the Company sold and issued to the Underwriter and the Purchasers an aggregate of 37,931,035 shares of common stock of the Company at a purchase price of $ 2.90 per share, in a registered offering transaction (Registered Offering) for aggregate gross proceeds of $ 110.0 million, before deducting the underwriting discount and commissions and estimated offering expenses payable by the Company.
+Added: The Registered Offering closed on May 16, 2024.
+Added: The aggregate fee payable by the Company to the Underwriter was $ 4.7 million, plus the reimbursement of certain expenses.
+Added: The Purchasers purchased an aggregate of 1,034,484 shares of common stock of the Company in the Registered Offering.
Need for Additional Capital
10 unchanged sentences
In June 2020, the Company formed a wholly-owned, Netherlands-based subsidiary, Allogene Therapeutics, B.V., to help prepare for and assist with the Company's activities in Europe.
−Removed: The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary.
+Added: The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Allogene Therapeutics, B.V.
All material intercompany balances and transactions have been eliminated during consolidation.
−Removed: Restatement of financial statements
−Removed: As described further in Note 6 and Note 8, on December 14, 2020, the Company entered into an Exclusive License Agreement (License Agreement) with Allogene Overland Biopharm (CY) Limited (Allogene Overland), a joint venture established by the Company and Overland Pharmaceuticals (CY) Inc.
−Removed: (Overland) pursuant to a Share Purchase Agreement
−Removed: (Share Purchase Agreement), dated December 14, 2020, for the purpose of developing, manufacturing and commercializing certain allogeneic CAR T cell therapies for patients in greater China, Taiwan, South Korea and Singapore, which resulted in the Company acquiring shares of Allogene Overland’s Seed Preferred Stock (Seed Preferred Shares) representing a 49 % ownership interest in exchange for entering into a License Agreement.
−Removed: In 2023, the Company re-evaluated its application of ASC Topic 606, Revenue from Contracts with Customers (ASC 606) and ASC Topic 323, Investments - Equity Method and Joint ventures (ASC 323) to its License Agreement and Share Purchase Agreement with Allogene Overland.
−Removed: Upon reassessment, the Company has determined the 49 % of Allogene Overland's outstanding Seed Preferred Shares received as a partial consideration for the License Agreement should be initially measured at fair value of $ 79.0 million rather than the zero carryover basis originally attributed to the Seed Preferred Shares.
−Removed: The initial transaction price to determine revenue related to the License Agreement was revised to include the fair value of the Seed Preferred Shares of $ 79.0 million and was allocated to the identified performance obligations based on their estimated standalone selling price.
−Removed: Additional revisions were made in the year ended December 31, 2020 whereby, on the date when the Seed Preferred Shares were received, the Company recorded as "Other expenses" in its consolidated statements of operations and comprehensive loss the basis difference of $ 67.5 million between the fair value of the Seed Preferred Shares of $ 79.0 million and the amount of the Company's underlying equity in net assets of Allogene Overland of $ 11.5 million and reduced the carrying value of the Seed Preferred Shares to $ 11.5 million.
−Removed: In the year ended December 31, 2021, the collaboration revenue increased by $ 75.6 million and the remaining transaction price of $ 3.4 million will impact subsequent future periods when related performance obligations are satisfied.
−Removed: Further, the Company recorded its share of net losses of Allogene Overland in each reporting period and reduced the carrying value of the Seed Preferred Shares.
−Removed: Refer to the Impact of restatement section below which describes detailed impact of the restatement for all the periods presented.
−Removed: The error resulted in an understatement of collaboration revenue and other expenses in the consolidated statements of operations and comprehensive loss for the years ended December 31, 2022, 2021 and 2020, and an understatement of deferred revenue and equity method investment in the consolidated balance sheets as of December 31, 2022 and 2021.
−Removed: These annual periods were restated in the Amendment No.
−Removed: 1 to the Annual Report on Form 10-K/A for the year ended December 31, 2022 filed with the Securities and Exchange Commission (the SEC) on March 14, 2024.
−Removed: The consolidated financial statements (as restated) also include adjustments to correct certain other previously identified misstatements relating to prior periods that the Company had determined to be immaterial, both individually and in aggregate, with a decrease in other expenses of $ 0.7 million for the year ended December 31, 2021 and an increase in other expenses of $ 2.0 million for the year ended December 31, 2022 in the consolidated statements of operations and comprehensive loss.
−Removed: Impact of restatement
−Removed: See below for reconciliation from the previously reported to the restated amounts in the consolidated statements of operations and comprehensive loss for the years ended December 31, 2022 and 2021, and in the consolidated balance sheets as of December 31, 2022.
−Removed: The previously reported amounts were derived from the Company's Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on February 28, 2023 (Original Report).
−Removed: These amounts are labeled as "As Previously Reported" in the tables below.
−Removed: The amounts labeled "Restatement Adjustment" represent the effects of this restatement described above.
−Removed: The following presents a reconciliation of the impacted financial statement line items as previously reported to the restated amounts as of December 31, 2022, and for the years ended December 31, 2022 and 2021 (in thousands, except share and per share data):
−Removed: December 31, 2022
−Removed: Consolidated Balance Sheets As previously Reported Restatement Adjustment As Restated
−Removed: Equity method investment $ 12,817 $ 4,500 $ 17,317
−Removed: Total assets 817,079 4,500 821,579
−Removed: Deferred revenue 885 ( 790 ) 95
−Removed: Total current liabilities 54,518 ( 790 ) 53,728
−Removed: Other long-term liabilities 1,569 4,278 5,847
−Removed: Total liabilities 151,209 3,488 154,697
−Removed: Accumulated deficit ( 1,235,980 ) 1,012 ( 1,234,968 )
−Removed: Total stockholders' equity 665,870 1,012 666,882
−Removed: Total liabilities and stockholders' equity 817,079 4,500 821,579
−Removed: Year ended December 31, 2022 Year ended December 31, 2021
−Removed: Consolidated Statements of Operations and Comprehensive Loss As Previously Reported Restatement Adjustment As Restated As Previously Reported Restatement Adjustment As Restated
−Removed: Collaboration revenue - related party $ 243 $ ( 87 ) $ 156 $ 38,489 $ 75,600 $ 114,089
−Removed: Operating expenses:
−Removed: Research and development 256,387 — 256,387 220,176 — 220,176
−Removed: General and administrative 79,305 — 79,305 74,105 — 74,105
−Removed: Total operating expenses 335,692 — 335,692 294,281 — 294,281
−Removed: Loss from operations ( 335,449 ) ( 87 ) ( 335,536 ) ( 255,792 ) 75,600 ( 180,192 )
−Removed: Other income (expense), net:
−Removed: Interest and other income, net 4,566 — 4,566 1,714 — 1,714
−Removed: Other expenses ( 1,749 ) ( 7,695 ) ( 9,444 ) ( 2,927 ) ( 646 ) ( 3,573 )
−Removed: Total other income (expense), net 2,817 ( 7,695 ) ( 4,878 ) ( 1,213 ) ( 646 ) ( 1,859 )
−Removed: Net loss ( 332,632 ) ( 7,782 ) ( 340,414 ) ( 257,005 ) 74,954 ( 182,051 )
−Removed: Other comprehensive income:
−Removed: Net unrealized (loss) gain on available-for-sale investments, net of tax ( 7,359 ) — ( 7,359 ) ( 2,835 ) — ( 2,835 )
−Removed: Net comprehensive loss ( 339,991 ) ( 7,782 ) ( 347,773 ) ( 259,840 ) 74,954 ( 184,886 )
−Removed: Net loss per share, basic and diluted ( 2.32 ) ( 2.38 ) ( 1.89 ) ( 1.34 )
−Removed: Weighted-average number of shares used in computing net loss per share, basic and diluted 143,147,165 143,147,165 135,820,386 135,820,386
−Removed: Year ended December 31, 2022 Year ended December 31, 2021
−Removed: Consolidated Statements of Stockholders' Equity As Previously Reported Restatement Adjustment As Restated As Previously Reported Restatement Adjustment As Restated
−Removed: Net Loss $ ( 332,632 ) $ ( 7,782 ) $ ( 340,414 ) $ ( 257,005 ) $ 74,954 $ ( 182,051 )
−Removed: Accumulated Deficit ( 1,235,980 ) 1,012 ( 1,234,968 ) ( 903,348 ) 8,794 ( 894,554 )
−Removed: Total stockholders' equity 665,870 1,012 666,882 916,406 8,794 925,200
−Removed: Year ended December 31, 2022 Year ended December 31, 2021
−Removed: Consolidated Statements of Cash Flow As Previously Reported Restatement Adjustment As Restated As Previously Reported Restatement Adjustment As Restated
−Removed: Net Loss $ ( 332,632 ) $ ( 7,782 ) $ ( 340,414 ) $ ( 257,005 ) $ 74,954 $ ( 182,051 )
−Removed: Non-cash collaboration revenue - related party — ( 104 ) ( 104 ) — ( 75,740 ) ( 75,740 )
−Removed: Share of losses from equity method investments 5,188 7,695 12,883 3,444 646 4,090
−Removed: Changes in operating assets and liabilities:
−Removed: Deferred revenue 462 ( 483 ) ( 21 ) ( 38,569 ) 272 ( 38,297 )
−Removed: Other long-term liabilities ( 2,556 ) 674 ( 1,882 ) 1,042 ( 132 ) 910
−Removed: Net cash used in operating activities ( 220,519 ) — ( 220,519 ) ( 184,812 ) — ( 184,812 )
−Removed: The remainder of the notes to the Company's consolidated financial statements have been updated and restated, as applicable, to reflect the impacts from the restatement discussed above.
−Removed: Included in Note 15 of these consolidated financial statements is the impact of restatement on previously issued (i) unaudited condensed balance sheets as of March 31, 2023 and 2022, June 30, 2023 and 2022 and September 30, 2023 and 2022, (ii) unaudited condensed statements of operations and comprehensive loss for the three months ended March 31, 2023 and 2022, three and six months ended June 30, 2023 and 2022, and three and nine months ended September 30, 2023 and 2022, (iii) unaudited condensed statements of cash flows for the three months ended March 31, 2023 and 2022, six months ended June 30, 2023 and 2022 and nine months ended September 30, 2023 and 2022, in each of the Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2023, June 30, 2023 and September 30, 2023.
+Added: The subsidiary was dissolved on January 3, 2024.
+Added: Reclassification of Prior Period Balances
+Added: The deferred revenue was reclassified to be included in the accrued and other current liabilities in the balance sheet as of December 31, 2023 to conform to the consolidated balance sheet presentation at December 31, 2024.
+Added: The presentation of non-cash rent expense and operating lease liabilities in the consolidated statement of cash flow for the year ended December 31, 2023 were reclassified to conform with the consolidated statement of cash flow presentation for the year ended December 31, 2024.
+Added: These reclassifications have no effect on the reported net income for the years ended December 31, 2024 and 2023.
Use of Estimates
The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the consolidated financial statements and the reported amounts of expenses during the reporting period.
−Removed: Significant estimates and assumptions made in the accompanying consolidated financial statements include but are not
−Removed: limited to the fair value of common stock, the fair value of stock options, the fair value of investments, income tax uncertainties, and certain accruals.
+Added: Significant estimates and assumptions made in the accompanying consolidated financial statements include but are not limited to the fair value of common stock, the fair value of stock options, the fair value of investments, income tax uncertainties, the CIRM award liability and certain accruals.
The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances change.
4 unchanged sentences
The Company does not enter into any investment transaction for trading or speculative purposes.
−Removed: The Company’s investment policy limits investments to certain types of instruments such as certificates of deposit, commercial paper, money market instruments, obligations issued by the U.S.
+Added: The Company’s investment policy limits investments to certain types of instruments such as certificates of deposit, commercial paper, money market instruments, asset-backed securities, obligations issued by the U.S.
government and U.S.
7 unchanged sentences
The Company has determined it operates in a single operating segment and has one reportable segment.
+Added: The Company’s method for measuring profitability on a reportable segment basis is net profit or loss.
+Added: The Company's CODM does not evaluate operating segments using asset or liability information.
+Added: Additional significant segment expenses are provided on a quarterly basis to the CODM to support the CODM’s decision making process.
+Added: Refer to Note 15 for additional information.
Cash, Cash Equivalents and Restricted Cash
11 unchanged sentences
This evaluation consists of several qualitative and quantitative factors regarding the severity and duration of the unrealized loss as well as the Company’s ability and intent to hold the available-for-sale security until a forecasted recovery occurs.
−Removed: Additionally, the Company assesses whether it has plans to sell the security or it is more likely than
−Removed: not it will be required to sell any available-for-sale securities before recovery of its amortized cost basis.
−Removed: Realized gains and losses and declines in fair value judged to be other than temporary, if any, on available-for-sale securities are included in interest and other income, net.
+Added: Additionally, the Company assesses whether it has plans to sell the security or it is more likely than not it will be required to sell any available-for-sale securities before recovery of its amortized cost basis.
+Added: Realized gains and losses and declines in fair value considered to be other than temporary, if any, on available-for-sale securities are included in interest and other income, net.
The cost of investments sold is based on the specific-identification method.
13 unchanged sentences
Maintenance and repairs are charged to operations as incurred.
−Removed: Upon sale or retirement of assets, the cost and related accumulated depreciation are removed from the consolidated balance sheet and the resulting gain or loss is reflected in other expense.
+Added: Upon sale or retirement of assets, the cost and related accumulated depreciation are removed from the consolidated balance sheets and the resulting gain or loss is reflected in other expense.
The Company has determined the estimated life of assets to be as follows:
3 unchanged sentences
Leasehold improvements Shorter of lease term or useful life
−Removed: The Company adopted Accounting Standards Update ("ASU") No.
−Removed: 2018-15, Intangibles – Goodwill and other – Internal-Use Software (Subtopic 350-40) on January 1, 2020 on a prospective basis.
The Company capitalizes implementation costs associated with internal use cloud computing arrangements in alignment with ASC 350-40 internal-use software.
Costs incurred in preliminary project stage and post implementation stage are expensed as incurred.
−Removed: Costs incurred during the application development stage of implementation are capitalized in other long-term assets on the consolidated balance sheet.
+Added: Costs incurred during the application development stage of implementation are capitalized in other long-term assets on the consolidated balance sheets.
Capitalized implementation costs from cloud computing arrangements are amortized over the term of the cloud-based service arrangement.
−Removed: The Company early adopted ASU No.
−Removed: 2016-2, Leases on January 1, 2018.
+Added: California Institute for Regenerative Medicine (CIRM) Award
+Added: Accounting for the CIRM award does not fall under ASC 606, Revenue from Contracts and Customers, as CIRM does not meet the definition of a customer.
+Added: No income associated with the CIRM award will be recognized until it is confirmed with CIRM that the award does not require repayment.
+Added: Until then such award will be recognized, along with any interest, as a long-term liability upon cash receipt.
+Added: Any estimated interest accrued for the CIRM award received is recognized as interest expense in the consolidated statements of operations.
+Added: The Company will not recognize a receivable of future awards until it is approved by CIRM.
+Added: See Note 5 below for more details.
For its long-term operating leases, the Company recognizes a right-of-use asset and a lease liability on its consolidated balance sheets.
7 unchanged sentences
The Company uses the equity method of accounting for equity investments in companies if the investment provides the ability to exercise significant influence, but not control, over operating and financial policies of the investee.
−Removed: The Company's proportionate share of the net income or loss of these companies is included in other expenses in the consolidated statement of operations.
+Added: The Company's proportionate share of the net income or loss of these companies is included in other expenses, net in the consolidated statement of operations.
Judgment regarding the level of influence over each equity method investment includes considering key factors such as our ownership interest, representation on the board of directors, participation in policy-making decisions and material purchase and sale transactions.
3 unchanged sentences
Variable Interest Entities
−Removed: For entities in which the Company has variable interests, the Company focuses on identifying if one of the entities is the primary beneficiary through having the power to direct the activities that most significantly impact the variable interest entity’s economic performance and having the obligation to absorb losses or the right to receive benefits from the variable interest entity.
+Added: For entities in which the Company has variable interests, the Company focuses on identifying if one of the entities is the primary beneficiary through having the power to direct the activities that most significantly impact the variable interest
+Added: entity’s economic performance and having the obligation to absorb losses or the right to receive benefits from the variable interest entity.
If the Company is the primary beneficiary of a variable interest entity, the assets, liabilities, and results of operations of the variable interest entity will be included in the Company’s consolidated financial statements.
6 unchanged sentences
As actual costs become known, the Company adjusts its accrued liabilities.
−Removed: The Company has not experienced any material differences between accrued costs and actual costs incurred since its inception.
Income taxes are accounted for under the asset and liability method.
26 unchanged sentences
Any impairment loss is allocated to the long-lived assets of the group on a pro rata basis using the relative carrying amounts of those assets, except that the carrying amount of an individual asset shall not be reduced below its fair value.
−Removed: The Company recorded long-lived assets impairment loss of $ 13.2 million for the year ended December 31, 2023 (see Note 5).
−Removed: There were no long-lived assets impairment losses recorded for the years ended December 31, 2022 and December 31, 2021.
+Added: The Company recorded long-lived assets impairment losses of $ 15.7 million and $ 13.2 million for the years ended December 31, 2024 and 2023, respectively (see Note 5).
Revenue Recognition
4 unchanged sentences
This assessment is performed throughout the life of the arrangement based on changes in the responsibilities of all parties in the arrangement.
−Removed: For collaboration arrangements within the scope of ASC 808 that contain multiple elements, the Company first determines which elements of the collaboration are deemed to be within the scope of ASC 808 and those that are more reflective of a vendor-customer relationship and, therefore, within the scope of Topic 606, Revenue
−Removed: from Contracts with Customers (ASC 606).
+Added: For collaboration arrangements within the scope of ASC 808 that contain multiple elements, the Company first determines which elements of the collaboration are deemed to be within the scope of ASC 808 and those that are more reflective of a vendor-customer relationship and, therefore, within the scope of Topic 606, Revenue from Contracts with Customers (ASC 606).
For elements of collaboration arrangements that are accounted for pursuant to ASC 808, an appropriate recognition method is determined and applied consistently, generally by analogy to Topic 606.
17 unchanged sentences
Recently Adopted Accounting Pronouncements
−Removed: There have been no new accounting pronouncements issued or effective that are expected to have a material impact on the Company's consolidated financial statements.
+Added: In November 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standard Update (ASU) 2023-07, Segment Reporting (Topic 280):
+Added: Improvements to Reportable Segment Disclosures (ASU 2023-07), which requires all public entities, including public entities with a single reportable segment, to provide in interim and annual periods one or more measures of segment profit or loss used by the chief operating decision maker to allocate resources and assess performance.
+Added: Additionally, the standard requires disclosures of significant segment expenses and other segment items as well as incremental qualitative disclosures.
+Added: The Company adopted this standard effective January 1, 2024 and applied the disclosure requirements retrospectively to all prior periods presented in the consolidated financial statements.
+Added: Adoption of the new guidance had no significant impact on the Company's consolidated financial statements.
Recent Accounting Pronouncements Not Yet Adopted
−Removed: In September 2023, the FASB issued Accounting Standard Update No.
−Removed: 2023-09, Income taxes (Topic 740), Improvement to income tax disclosures, which requires to disclose some additional information in the consolidated financial statements.
+Added: In December 2023, the FASB issued ASU 2023-09, Income taxes (Topic 740), Improvement to income tax disclosures , which enhances the disclosures required for income taxes in the Company’s annual financial statements.
This standard is effective for fiscal years beginning after December 15, 2024, with early adoption permitted.
−Removed: The Company is currently evaluating the impact of the new guidance on its consolidated financial statements.
+Added: The Company does not plan to adopt this standard early.
+Added: The adoption of this standard is not expected to have a material impact on the Company’s financial statements.
+Added: In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40) , which requires new disclosures to disaggregate prescribed natural expenses underlying any income statement caption.
+Added: ASU 2024-03 is effective for annual periods in fiscal years beginning after December 15, 2026, and interim periods thereafter.
+Added: Early adoption is permitted.
+Added: ASU 2024-03 applies on a prospective basis for periods beginning after the effective date.
+Added: However, retrospective application to any or all prior periods presented is permitted.
+Added: The Company is currently assessing the impact ASU 2024-03 will have on the consolidated financial statements and disclosures.
Fair Value Measurements
6 unchanged sentences
treasury securities which are classified as Level 1.
−Removed: There were no Level 3 assets or liabilities at December 31, 2023 or 2022.
+Added: There were no Level 3 assets or liabilities as of December 31, 2024 or 2023.
Financial assets subject to fair value measurements on a recurring basis and the level of inputs used in such measurements by major security type as of December 31, 2024 are presented in the following table:
4 unchanged sentences
Money market funds ¹ $ 65,780 $ — $ — $ 65,780
+Added: Commercial Paper — 66,255 — 66,255
Corporate bonds — 82,725 — 82,725
1 unchanged sentence
agency securities — 58,514 — 58,514
+Added: Asset-backed securities — 9,700 — 9,700
Total financial assets $ 151,508 $ 217,194 $ — $ 368,702
−Removed: ¹ Included within cash and cash equivalents on the Company’s consolidated balance sheet
+Added: ¹ Included within cash and cash equivalents on the Company’s consolidated balance sheets
Financial assets subject to fair value measurements on a recurring basis and the level of inputs used in such measurements by major security type as of December 31, 2023 are presented in the following table:
4 unchanged sentences
Money market funds ¹ $ 78,536 $ — $ — $ 78,536
−Removed: Commercial paper — 4,954 — 4,954
Corporate bonds — 97,166 — 97,166
2 unchanged sentences
Total financial assets $ 308,052 $ 136,026 $ — $ 444,078
−Removed: ¹ Included within cash and cash equivalents on the Company’s consolidated balance sheet
+Added: ¹ Included within cash and cash equivalents on the Company’s consolidated balance sheets
The carrying amounts of accounts payable and accrued liabilities approximate their fair values due to their short-term maturities.
2 unchanged sentences
There were no transfers of assets between the fair value measurement levels during the years ended December 31, 2024 or 2023.
−Removed: The fair value and amortized cost of cash equivalents and available-for-sale securities by major security type as of December 31, 2023 are presented in the following table:
+Added: The fair value and amortized cost of cash equivalents and available-for-sale securities by major security type as of December 31, 2024 are presented in the following tables:
December 31, 2024
2 unchanged sentences
Money market funds $ 65,780 $ — $ — $ 65,780
+Added: Commercial paper 66,269 19 ( 34 ) 66,254
Corporate bonds 82,716 53 ( 45 ) 82,724
1 unchanged sentence
agency securities 58,566 20 ( 70 ) 58,516
+Added: Asset-backed securities 9,695 5 — 9,700
Total cash equivalents and investments $ 368,791 $ 151 $ ( 240 ) $ 368,702
4 unchanged sentences
Total cash equivalents, and investments $ 368,702
−Removed: The fair value and amortized cost of cash equivalents and available-for-sale securities by major security type as of December 31, 2022 are presented in the following table:
+Added: The fair value and amortized cost of cash equivalents and available-for-sale securities by major security type as of December 31, 2023 are presented in the following tables:
December 31, 2023
2 unchanged sentences
Money market funds $ 78,536 $ — $ — $ 78,536
−Removed: Commercial paper 4,956 — ( 2 ) 4,954
Corporate bonds 97,265 113 ( 212 ) 97,166
7 unchanged sentences
Total cash equivalents, and investments $ 444,078
−Removed: The Company believes that it is more likely than not that investments in an unrealized loss position will be held until maturity and all interest and principal will be received.
−Removed: The Company does not intend to sell these investments and it is more likely than not that the Company will not be required to sell the investment before recovery of its amortized cost basis.
The fair values of available-for-sale debt investments by contractual maturity as of December 31, 2024 and 2023 were as follows:
5 unchanged sentences
Total cash equivalents and investments $ 368,702 $ 444,078
−Removed: As of December 31, 2023 and 2022, the remaining contractual maturities of available-for-sale securities were one year and less.
+Added: There were no significant realized losses on available-for-sale securities for the year ended December 31, 2024.
Realized losses on available-for-sale securities for the year ended December 31, 2023 were $ 1.0 million.
−Removed: There were no significant realized losses on available-for-sale securities for the years ended December 31, 2022 and 2021.
As of December 31, 2024 and 2023, unrealized losses on available-for-sale securities are not attributed to credit risk.
The Company believes that it is more likely than not that investments in an unrealized loss position will be held until maturity and all interest and principal will be received.
+Added: The Company does not intend to sell these investments and it is more likely than not that the Company will not be required to sell the investment before recovery of its amortized cost basis.
The Company believes that an allowance for credit losses is unnecessary because the unrealized losses on certain of the Company’s available-for-sale securities are due to market factors.
−Removed: As of December 31, 2023 and 2022, securities with a fair value of $ 48.4 million and $ 329.4 million, respectively, were in a continuous net unrealized loss position for more than 12 months.
+Added: As of December 31, 2024 and 2023, securities with a fair value of zero and $ 48.4 million, respectively, were in a continuous net unrealized loss position for more than 12 months.
To date, the Company has not recorded any impairment charges on available-for-sale securities.
+Added: The Company has made an accounting policy election not to recognize an allowance for credit losses for accrued interest receivable on available-for-sale securities.
As of December 31, 2024 and 2023, the Company recognized $ 1.9 million and $ 1.7 million, respectively, of accrued interest receivable from available-for-sale securities within prepaid expenses and other current assets on the consolidated balance sheets.
6 unchanged sentences
Furniture and fixtures 4,214 4,121
−Removed: Construction in progress — 28
Total 148,594 150,562
1 unchanged sentence
Total property and equipment, net $ 86,056 $ 99,478
−Removed: Depreciation expense for the years ended December 31, 2023, 2022 and 2021 was $ 14.2 million, $ 14.3 million and $ 10.5 million, respectively.
−Removed: Disposals of property and equipment were less than $ 0.1 million for the years ended December 31, 2023 and 2022.
−Removed: Disposals of property and equipment were zero for the year ended December 31, 2021.
−Removed: To date, the Company has not recorded any impairment loss on its Property and Equipment.
−Removed: The Company continues to monitor its long-lived assets, including Property and Equipment, for events or changes in circumstances which indicate that the carrying amount of its long-lived assets may not be recoverable.
−Removed: In December 2023, the Company made a decision to sublease one of its leased buildings in South San Francisco.
−Removed: The Company vacated and ceased occupancy of this building in December 2023 and currently the Company is actively marketing the leased building for sublease.
−Removed: The Company determined that the change in how this property is being used could indicate impairment.
−Removed: The Company has determined it operates in a single operating segment and has one reportable segment.
−Removed: The Company identified two asset groups for purposes of long-lived asset impairment assessment:
−Removed: to be sublet property and
−Removed: remaining operating segment.
−Removed: The Company concluded that the carrying value of the sublet property asset group was not recoverable and the estimated fair value of this asset group was below its carrying value.
−Removed: The lower fair value of the sublet property asset group was mainly due to the lower estimated sublease income compared to the lease payments in accordance with the initial operating lease agreement and higher discount rate.
−Removed: The Company applied a discounted cash flow method to estimate fair value of its right-of-use asset.
−Removed: It represents level 3 non-recurring fair value measurement.
−Removed: Based on this analysis, the Company concluded the fair value of the right-of-use asset of $ 13.8 million was lower than its net book value of $ 27.0 million.
+Added: Depreciation expense for the years ended December 31, 2024, and 2023 was $ 13.6 million, and $ 14.2 million, respectively.
+Added: Disposals of property and equipment were $ 0.3 million and less than $ 0.1 million for the years ended December 31, 2024 and 2023, respectively.
+Added: The Company reviews for indicators of impairment on a quarterly basis which includes the change in how its property is being used.
+Added: During the year ended December 31, 2024, the Company made a decision to sublease one of its leased buildings in South San Francisco.
+Added: The Company vacated and ceased occupancy of this building and currently the Company is actively marketing the leased building for sublease.
+Added: The Company determined that the change in how this building is being used was an indicator of impairment.
+Added: The Company identified this to-be-sublet property as a separate asset group.
+Added: The Company concluded that the carrying value of this to-be-sublet property asset group was not recoverable and the estimated fair value of this asset group was below its carrying value.
+Added: The decrease in the fair value of this asset group was mainly due to the lower estimated sublease income based on current commercial rental market conditions compared to the lease payments in accordance with the initial operating lease agreement.
+Added: The Company performed discounted cash flow analysis to estimate the fair value of its right-of-use asset and leasehold improvements.
+Added: The key inputs to this valuation were expected sublease rental income of $ 1.9 million through March 2032 and the risk-adjusted annual discount rate of 9.5 %.
+Added: Based on this analysis, the Company concluded the fair value of the right-of-use asset and leasehold improvements of $ 1.2 million was lower than its net book value of $ 7.5 million.
+Added: The Company recognized an aggregate long-lived asset impairment charge of $ 6.2 million on the right-of-use asset and leasehold improvements for the year ended December 31, 2024.
+Added: Previously, in December 2023, the Company made a decision to sublease one of its other leased buildings in South San Francisco.
+Added: The Company had vacated and ceased occupancy of this building in December 2023 and in January 2025, the Company executed two subleases for the majority of the leased building.
+Added: During the year ended December 31, 2023, the Company recognized long-lived asset impairment charge of $ 13.2 million on the right-of-use asset by applying a discounted cash flow method to estimate fair value of its right-of-use asset.
The key inputs to this valuation were expected sublease rental income of $ 22.7 million through March 31, 2032 and annual discount rate of 9.0 %.
−Removed: The Company recognized pre-tax long-lived asset impairment charge of $ 13.2 million on the right-of-use asset.
+Added: During the year ended December 31, 2024, the Company revised its valuation based on terms with a subtenant for a portion of the building and new market data.
+Added: The expected sublease rental income based on the revised valuation was $ 4.7 million through March 31, 2032 and the annual
+Added: discount rate did not change.
+Added: The Company concluded the fair value of the right-of-use asset of $ 3.1 million was lower than its book value of $ 12.6 million and recognized an additional long-lived asset impairment charge of $ 9.5 million on the right-of-use asset for the year ended December 31, 2024.
Accrued Liabilities
7 unchanged sentences
Total accrued and other current liabilities $ 30,129 $ 31,096
+Added: Accrued and Other Current Liabilities
+Added: On January 4, 2024, the Company’s Board of Directors approved a reduction in the Company’s workforce of approximately 22 % of the Company’s employees in connection with the Company’s pipeline prioritization and clinical development strategy.
+Added: The reduction in workforce was completed by June 30, 2024.
+Added: During the year ended December 31, 2024, the Company paid approximately $ 3.0 million for severance and other employee benefits.
+Added: As of December 31, 2024, less than $ 0.1 million of the severance and other employee benefits accrual was included in accrued and other current liabilities on the consolidated balance sheets.
+Added: On April 26, 2024, the Company was awarded up to $ 15.0 million from CIRM to support the clinical development of ALLO-316, an AlloCAR TTM investigational product targeting CD70 in development for the treatment of advanced or metastatic renal cell carcinoma (RCC).
+Added: Pursuant to terms of the award, the disbursements are tied to the achievement of specified operational milestones.
+Added: In addition, the terms of the award include a co-funding requirement pursuant to which the Company is required to spend up to approximately $ 25.9 million of its own capital to fund the CIRM funded research project.
+Added: The award was made in accordance with the CIRM Grants Administration Policy for Clinical Stage Projects which may require the award to be repaid by the Company.
+Added: Under the terms of the CIRM award, the Company is obligated to pay royalties based on a low single digit royalty percentage on net sales of CIRM-funded product candidate.
+Added: The maximum royalty that the Company may be required to pay to CIRM is equal to nine times the total amount awarded and paid to the Company.
+Added: After completing the CIRM funded research project and at any time after the award period end date (but no later than the ten-year anniversary of the date of the award), the Company has the right, upon its election, to convert the award into a loan.
+Added: The terms of conversion into a loan will be determined based on various factors and could result in 80 % to 100 % plus interest at 10 % per annum plus the Secured Overnight Financing Rate of the total award dependent upon the phase of clinical development of the product candidate at the time of the Company's election to be repaid to CIRM.
+Added: No income associated with the CIRM award will be recognized until it is confirmed with CIRM that the award does not require repayment.
+Added: Upon cash receipt, the CIRM award and accrued interest will be recognized as other long-term liabilities on the consolidated balance sheets.
+Added: The Company will not recognize a receivable of future awards until it is approved by CIRM.
+Added: The Company received $ 2.3 million from CIRM through December 31, 2024 and accounted for the proceeds as a liability within other long-term liabilities on the consolidated balance sheets.
+Added: During the year ended December 31, 2024, the Company recorded interest expense of $ 0.2 million.
+Added: As of December 31, 2024, $ 0.2 million of accrued interest was included in other long-term liabilities.
+Added: In February 2025, the Company met an additional operational milestone and received an additional award of $ 3.4 million from CIRM.
License and Collaboration Agreements
2 unchanged sentences
The Company is required to make milestone payments upon successful completion of regulatory and sales milestones on a target-by-target basis for the targets including CD19 and B-cell maturation antigen (BCMA), covered by the Pfizer Agreement.
−Removed: The aggregate potential milestone payments upon successful completion of various regulatory milestones in the United States and the European Union are $ 30.0 million or $ 60.0 million, depending on the target, with aggregate potential regulatory and development milestones of up to $ 840.0 million, provided that the Company is not obligated to pay a milestone for regulatory approval in the European Union for an anti-CD19 allogeneic CAR T cell product, to the extent Servier has commercial rights to such territory.
+Added: The aggregate potential milestone payments upon successful completion of various regulatory milestones in the United States and the European Union are $ 30.0 million or $ 60.0 million, depending on the target, with aggregate potential regulatory and development milestones of up to $ 840.0 million.
The aggregate potential milestone payments upon reaching certain annual net sales thresholds in North America, Europe, Asia, Australia and Oceania (the Territory) for a certain number of targets covered by the Pfizer Agreement are $ 325.0 million per target.
8 unchanged sentences
In connection with the execution of the Cellectis Agreement, on March 8, 2019, the Company and Cellectis also entered into a letter agreement (the Letter Agreement), pursuant to which the Company and Cellectis agreed to terminate the Original Cellectis Agreement.
−Removed: The Original Cellectis Agreement included a research
−Removed: collaboration to conduct discovery and pre-clinical development activities to generate CAR T cells directed at targets selected by each party, which was completed in June 2018.
−Removed: Pursuant to the Cellectis Agreement, Cellectis granted to the Company an exclusive, worldwide, royalty-bearing license, on a target-by-target basis, with sublicensing rights under certain conditions, under certain of Cellectis’ intellectual property, including its TALEN and electroporation technology, to make, use, sell, import, and otherwise exploit and commercialize CAR T products directed at certain targets, including BCMA, CD70, Claudin 18.2, DLL3 and FLT3 (the Allogene Targets), for human oncologic therapeutic, diagnostic, prophylactic and prognostic purposes.
+Added: The Original Cellectis Agreement included a research collaboration to conduct discovery and pre-clinical development activities to generate CAR T cells directed at targets selected by each party, which was completed in June 2018.
+Added: Pursuant to the Cellectis Agreement, Cellectis granted to the Company an exclusive, worldwide, royalty-bearing license, on a target-by-target basis, with sublicensing rights under certain conditions, under certain of Cellectis’s intellectual property, including its TALEN and electroporation technology, to make, use, sell, import, and otherwise exploit and commercialize CAR T products directed at certain targets, including BCMA, CD70, Claudin 18.2, DLL3 and FLT3 (the Allogene Targets), for human oncologic therapeutic, diagnostic, prophylactic and prognostic purposes.
In addition, certain Cellectis intellectual property rights granted by Cellectis to the Company and to Servier pursuant to the Exclusive License and Collaboration Agreement by and between Servier and Pfizer, dated October 30, 2016, which Pfizer assigned to the Company in April 2018, will survive the termination of the Original Cellectis Agreement.
3 unchanged sentences
Such royalties may be reduced, on a licensed product-by-licensed product and country-by-country basis, for generic entry and for payments due under licenses of third-party patents.
−Removed: Pursuant to the Cellectis Agreement, and subject to certain exceptions, the Company is required to indemnify Cellectis against all thirdparty claims related to the development, manufacturing, commercialization or use of any Allogene Product or arising out of the Company’s material breach of the representations, warranties or covenants set forth in the Cellectis Agreement, and Cellectis is required, subject to certain exceptions, to indemnify the Company against all third party claims related to the development, manufacturing, commercialization or use of CAR T products directed at Cellectis Targets or arising out of Cellectis’ material breach of the representations, warranties or covenants set forth in the Cellectis Agreement.
+Added: Pursuant to the Cellectis Agreement, and subject to certain exceptions, the Company is required to indemnify Cellectis against all third-party claims related to the development, manufacturing, commercialization or use of any Allogene Product or arising out of the Company’s material breach of the representations, warranties or covenants set forth in the Cellectis Agreement, and Cellectis is required, subject to certain exceptions, to indemnify the Company against all third party claims related to the development, manufacturing, commercialization or use of CAR T products directed at Cellectis Targets or arising out of Cellectis’ material breach of the representations, warranties or covenants set forth in the Cellectis Agreement.
The royalties are payable, on a licensed product-by-licensed product and country-by-country basis, until the later of (i) the expiration of the last to expire of the licensed patents covering such product;
9 unchanged sentences
All costs the Company incurred in connection with this agreement were recognized as research and development expenses in the consolidated statement of operations.
−Removed: For the years ended December 31, 2023 and 2022, zero clinical development milestones were achieved.
−Removed: For the year ended December 31, 2021, $ 10.0 million of costs were incurred related to the achievement of clinical development milestones under this agreement.
−Removed: License and Collaboration Agreement with Servier
−Removed: As part of the Pfizer Agreement, Pfizer assigned to the Company an Exclusive License and Collaboration Agreement (the Servier Agreement), with Les Laboratoires Servier SAS and Institut de Recherches Internationales Servier SAS (collectively, Servier) to develop, manufacture and commercialize certain allogeneic anti-CD19 CAR T cell product candidates, including UCART19, in the United States with the option to obtain the rights over additional anti-CD19 product candidates and for allogeneic CAR T cell product candidates directed against one additional target.
+Added: For the years ended December 31, 2024 and 2023, no clinical development milestones were achieved.
+Added: Exclusive License Agreement with Servier
+Added: As part of the Pfizer Agreement, Pfizer assigned to the Company an Exclusive License Agreement (the Original Servier Agreement), with Les Laboratoires Servier SAS and Institut de Recherches Internationales Servier SAS (collectively, Servier) to develop, manufacture and commercialize certain allogeneic anti-CD19 CAR T cell product candidates, including UCART19, in the United States with the option to obtain the rights over additional anti-CD19 product candidates and for allogeneic CAR T cell product candidates directed against one additional target.
In October 2019, the Company agreed to waive its rights to the one additional target.
−Removed: Under the Servier Agreement, the Company has an exclusive license to develop, manufacture and commercialize UCART19, ALLO-501 and ALLO-501A in the field of anti-tumor adoptive immunotherapy in the United States, with an exclusive option to obtain the same rights for additional product candidates in the United States and, if Servier does not elect to pursue development or commercialization of those product candidates in certain markets outside of the United States pursuant to its license, outside of the United States as well.
+Added: Under the Original Servier Agreement, the Company has an exclusive license to develop, manufacture and commercialize licensed products directed against CD19, including UCART19, ALLO-501 and cemacabtagene ansegedleucel (cema-cel, previously ALLO-501A) (collectively, CD19 Products) in the field of anti-tumor adoptive immunotherapy in the United States, with an exclusive option to obtain the same rights for additional product candidates in the United States and, if Servier does not elect to pursue development or commercialization of those product candidates in certain markets outside of the United States pursuant to its license, outside of the United States as well.
The Company is not required to make any additional payments to Servier to exercise an option.
If the Company opts-in to another product candidate, Servier has the right to obtain rights to such product candidate outside the United States and to share development costs for such product candidate.
−Removed: Under the Servier Agreement, the Company is required to use commercially reasonable efforts to develop and obtain marketing approval in the United States in the field of anti-tumor adoptive immunotherapy for at least one product directed against CD19, and Servier is required to use commercially reasonable efforts to develop and obtain marketing approval in the European Union, and one other country in a group of specified countries outside of the European Union and the United States, in the field of anti-tumor adoptive immunotherapy for at least one allogeneic adaptive T cell product directed against a certain Company-selected target.
−Removed: For product candidates that the Company is co-developing with Servier, including UCART19, ALLO-501 and ALLO-501A, the Company is responsible for 60 % of the specified development costs and Servier is responsible for the remaining 40 % of the specified development costs under the applicable global research and development plan.
−Removed: Subject to certain restrictions, each party has the right to conduct activities that are specific to its territory outside the global research and development plan at such party’s sole expense.
−Removed: In addition, each party is solely responsible for commercialization activities in its territory at such party’s sole expense.
−Removed: The Company is required to make milestone payments to Servier upon successful completion of regulatory and sales milestones.
−Removed: The Servier Agreement provides for aggregate potential payments by the Company to Servier of up to $ 137.5 million upon successful completion of various regulatory milestones, and aggregate potential payments by the Company to Servier of up to $ 78.0 million upon successful completion of various sales milestones.
−Removed: Similarly, Servier is required to make milestone payments upon successful completion of regulatory and sales milestones for products directed at the Allogene-target covered by the Servier Agreement that achieves such milestones.
−Removed: The total potential payments that Servier is obligated to make to the Company under the Servier Agreement upon successful completion of regulatory and sales milestones are $ 42.0 million and € 70.5 million ($ 77.8 million), respectively.
−Removed: The foregoing milestones are subject to certain adjustments if the Company obtains rights for certain products outside of the United States upon Servier’s election not to pursue such rights.
−Removed: Each party is also eligible to receive tiered royalties on annual net sales in countries within the paying party’s respective territory of any licensed products that are commercialized by such party that are directed at the targets licensed by such party under the Servier Agreement.
−Removed: The royalty rates are in a range from the low tens to the high teen percentages.
+Added: On May 10, 2024, the Company and Servier entered into an Amendment and Settlement Agreement (the Servier Amendment) which restructured the parties’ relationship under the Original Servier Agreement (as amended, the Servier Agreement).
+Added: The Company’s licensed territory was expanded to include the European Union and the United Kingdom.
+Added: The Company was also granted an option to further extend its licensed territory to include China and Japan upon the objective showing of sufficient resources to develop licensed products in those countries, which could be met through the Company entering into a strategic partnership covering those countries.
+Added: Additionally, the Company agreed to waive certain of its rights under the Original Servier Agreement to elect a conversion of its license to the CD19 Products to a worldwide license.
+Added: Under the Servier Agreement, the Company is required to use commercially reasonable efforts to develop, manufacture and commercialize a CD19 Product.
+Added: Under the Servier Agreement, Servier sublicenses to the Company certain rights which Servier licenses from Cellectis pursuant to a License, Development and Commercialization Agreement by and between Cellectis and Servier, dated February 7, 2014, as amended by Amendment No.
+Added: 1 to the License, Development and Commercialization Agreement, dated March 4, 2020
+Added: (as amended, the Servier-Cellectis Agreement).
+Added: As amended by the Servier Amendment, all of the Company’s future milestone payments (regulatory and sales) under the Original Servier Agreement were modified to be the same as, and to coincide with, Servier’s milestone payments to Cellectis that are required under the Servier-Cellectis Agreement.
+Added: The Servier Agreement provides for aggregate potential milestone payments by the Company to Servier of up to € 75.0 million upon successful completion of various regulatory milestones and first commercial sale milestones in the United States, European Union and the United Kingdom for the initial indication of each licensed product, of which € 60.0 million remains for the initial indication for cema-cel, with additional payments of € 55.0 million, due for each subsequent indication, of which € 50.0 million remains for the first subsequent indication for cema-cel, and aggregate potential payments by the Company to Servier of up to € 80.0 million upon achievement of certain net sales milestones for each licensed product.
+Added: Should Servier’s rights and obligations under the Servier-Cellectis Agreement be assigned to the Company, these milestone payments would terminate, and the Company would assume Servier’s milestone payment obligations to Cellectis.
+Added: In the absence of any such assignment, Servier will remain responsible for making milestone payments that may be due to Cellectis under the Servier-Cellectis Agreement.
+Added: The Company transferred € 20.0 million into an escrow account in connection with a potential future milestone payment, which is included in the remaining € 60.0 million in milestone payments referenced above for the initial indication for cema-cel.
+Added: Such milestone payment will be triggered, if at all, upon the occurrence of one of these events:
+Added: (1) the Company doses the first subject in its first phase 3 clinical study for a CD19 CAR T product that is a licensed product under the Servier Agreement, (2) the Company submits a phase 2 clinical study for a licensed product to the U.S.
+Added: Food and Drug Administration or the European Medicines Agency, and such phase 2 clinical study is accepted for regulatory approval as a pivotal study, or (3) a final and definitive decision of a tribunal or court finding that under the Servier-Cellectis Agreement the milestone has occurred and the € 20.0 million payment is due to Cellectis.
+Added: As of December 31, 2024, the Company recorded € 20.0 million as deposit placed in escrow in the consolidated balance sheets.
+Added: The Company is obligated to pay to Servier royalties on annual net sales of any licensed products that are commercialized by the Company that are directed at CD19.
+Added: Such royalties include tiered royalties on annual net sales in the United States and a flat royalty on annual net sales in territories outside the United States.
+Added: The United States royalty rates are in a range from the low tens to the mid teen percentages, and the ex-U.S.
+Added: royalty rate is 10 %.
Such royalties may be reduced for interchangeable drug entry, expiration of patent rights and amounts paid pursuant to licenses of third-party patents.
−Removed: The royalty obligation for each party with respect to a given licensed product in a given country in each party’s respective territory (the Servier Royalty Term) begins upon the first commercial sale of such product in such country and ends after a defined number of years.
−Removed: Unless earlier terminated in accordance with the Servier Agreement, the Servier Agreement will continue, on a licensed product-by-licensed product and country-by-country basis, until the Servier Royalty Term with respect to the sale of such licensed product in such country expires.
−Removed: On September 15, 2022, Servier sent a notice of discontinuation (Discontinuation) of its involvement in the development of all licensed products directed against CD19, including UCART19, ALLO-501 and ALLO-501A (collectively, CD19 Products), pursuant to the Servier Agreement.
−Removed: Servier’s Discontinuation provides the Company with the right to elect a license to the CD19 Products outside of the United States (Ex-US Option) and does not otherwise affect the Company's current exclusive license for the development and commercialization of CD19 Products in the United States.
−Removed: However, Servier has
−Removed: disputed the implications of the Discontinuation, namely whether development cost contributions continue and the timeframe during which the Company has the right to elect a license to CD19 Products outside of the United States.
−Removed: In December 2022, Servier sent the Company a notice for material breach due to the Company's purported refusal to allow an audit of certain manufacturing costs under the cost share arrangement.
−Removed: While the Company does not believe Servier has such an audit right, the Company submitted to a review of the Company's manufacturing costs of CD19 Products to recover outstanding manufacturing costs owed by Servier to the Company.
−Removed: In July 2023, Servier sent the Company a second notice for material breach alleging that the Company overcharged Servier based on Servier and its accounting firm’s review of costs eligible for cost-sharing under the Servier Agreement.
−Removed: The Company disagrees with the material breach allegations and the Company is disputing such allegations.
−Removed: Absent a resolution between the parties, disputed matters may be resolved in arbitration as specified in the Servier Agreement.
−Removed: For the years ended December 31, 2023, 2022 and 2021, the Company recorded zero , $ 19.9 million, and $ 17.1 million, respectively, of net cost recoveries under the cost-sharing terms of the Servier Agreement as a reduction to research and development expenses.
−Removed: As of December 31, 2023 and 2022, amounts due from Servier of zero and $ 1.5 million, respectively, were recorded in other current assets in the accompanying consolidated balance sheets.
−Removed: For the year ended December 31, 2022, $ 8.0 million in costs were incurred related to the achievement of a clinical development milestone under the Servier Agreement.
−Removed: Zero clinical development milestones were achieved for the years ended December 31, 2023 and 2021.
+Added: This royalty obligation begins upon the first commercial sale of such product in a given country and ends after the later of a defined number of years or the expiration of the last to expire licensed patent covering the product in such country.
+Added: The net effect of the Servier Amendment is that the Company’s royalty rate in the United States for the first half of the first tier of net sales was increased by a low single digit percentage as compared to the Original Servier Agreement.
+Added: Should Servier’s rights and obligations under the Servier-Cellectis Agreement be assigned to the Company, each tier of royalty rates in the United States to Servier would be reduced by 10 %, the ex-U.S.
+Added: royalties to Servier would terminate, and the Company would assume Servier’s royalty obligations to Cellectis.
+Added: In the absence of any such assignment, Servier will remain responsible for making royalty payments that may be due to Cellectis under the Servier-Cellectis Agreement.
+Added: The parties agreed that co-development performed by the Company and Servier under the Servier Agreement, including all development performed by Servier and for product candidates that the Company was co-developing with Servier (for which specified development costs were split under the Original Servier Agreement with the Company responsible for 60 % and Servier responsible for 40 %), including the CD19 Products, ceased as of December 15, 2022, and that all development costs incurred by either party after that date shall be borne solely by such party.
+Added: The parties agreed to waive any and all outstanding claims that were asserted relating to alleged violations of the Original Servier Agreement, including all claims that such party was entitled to various payments or refunds from the other party under the Original Servier Agreement, and any and all claims that either party now has or may have in the future related to such outstanding claims, and mutual releases with respect to such claims were granted.
+Added: The Company will recognize expense related to the revised milestones and royalties when payments become probable.
+Added: There was no gain or loss related to the expanded license territories and ceased Servier co-development.
+Added: For the year ended December 31, 2024 and 2023, the Company recorded $ 5.4 million and zero in research and development expenses upon achievement of a regulatory milestone, respectively.
Research Collaboration and License Agreement with Notch Therapeutics
On November 1, 2019, the Company entered into a Collaboration and License Agreement (the Notch Agreement) with Notch Therapeutics Inc.
−Removed: (Notch), pursuant to which Notch granted to Allogene an exclusive, worldwide, royalty-bearing, sublicensable license under certain of Notch’s intellectual property to develop, make, use, sell, import, and otherwise commercialize therapeutic gene-edited T cell and/or natural killer (NK) cell products from induced pluripotent stem cells directed at certain CAR targets for initial application in non-Hodgkin lymphoma, acute lymphoblastic leukemia and multiple myeloma.
+Added: (Notch), pursuant to which Notch granted to Allogene an exclusive, worldwide, royalty-bearing, sublicensable license under certain of Notch’s intellectual property to develop, make, use, sell, import, and otherwise commercialize therapeutic gene-edited T cell and/or natural killer (NK) cell products from induced pluripotent stem cells
+Added: directed at certain CAR targets for initial application in non-Hodgkin lymphoma, acute lymphoblastic leukemia and multiple myeloma.
In addition, Notch has granted Allogene an option to add certain specified targets to its exclusive license in exchange for an agreed per-target option fee.
1 unchanged sentence
Allogene will reimburse Notch’s costs incurred in accordance with such plan and budget.
+Added: Currently, there is no outstanding research plan or budget under the Notch Agreement.
The term of the research collaboration will expire upon the earlier of (i) the fifth anniversary of the date of the Notch Agreement, (ii) at Allogene’s election, following the joint development committee’s determination that for each exclusive target, Notch has met certain success criteria, or (iii) the joint development committee’s determination that the research collaboration cannot be reasonably pursued against any exclusive target due to technical infeasibility or safety issues.
In connection with the execution of the Notch Agreement, Allogene made an upfront payment to Notch of $ 10.0 million in return for a license to access Notch's technology in order to conduct research pursuant to the Notch Agreement.
−Removed: The Company recognized a research and development expense of $ 10 million during the year ended December 31, 2019 as the license had no foreseeable alternative future use.
In addition, Allogene made a $ 5.0 million investment in Notch’s series seed convertible preferred stock, resulting in Allogene having a 25 % ownership interest in Notch’s outstanding capital stock on a fully diluted basis immediately following the investment.
−Removed: In connection with this investment, an Allogene representative serves on the Notch Board of Directors.
+Added: In connection with this investment, an Allogene representative served on the Notch Board of Directors.
In February 2021, the Company made an additional $ 15.9 million investment in Notch's Series A preferred stock.
1 unchanged sentence
Immediately following this transaction, the Company's share in Notch was 23 % on a voting interest basis.
−Removed: The Company did not have a controlling interest in Notch as of December 31, 2023, and continued to account for its investment in Notch as an equity method investment.
+Added: On May 17, 2024, Notch closed a Series B preferred stock financing with a combination of new and existing investors (Notch Series B Financing).
+Added: The Company did not participate in the Notch Series B Financing but received Series B preferred stock as part of its anti-dilution rights.
+Added: Immediately following this transaction, the Company’s share in Notch was 13 %.
+Added: In connection with the Notch Series B Financing, the Company waived its right to appoint one member of the Notch board of directors, but retained board observation rights.
+Added: The Company no longer has any significant influence over Notch and as a result of the decrease in ownership and influence, accounted for its investment in Notch as an equity investment measured at cost less any impairment effective May 17, 2024.
Under the Notch Agreement, Notch will be eligible to receive up to $ 7.3 million upon achieving certain agreed research milestones, up to $ 4.0 million per exclusive target upon achieving certain pre-clinical development milestones, and up to $ 283.0 million per exclusive target and cell type (i.e., T cell or NK cell) upon achieving certain clinical, regulatory and commercial milestones.
4 unchanged sentences
Either party may also terminate the Collaboration Agreement with written notice upon material breach by the other party, if such breach has not been cured within a defined period of receiving such notice, or in the event of the other party’s insolvency.
−Removed: For the years ended December 31, 2023, 2022, and 2021, the Company recorded $ 1.8 million, $ 3.8 million, and $ 4.3 million, respectively, in collaboration costs as research and development expenses.
−Removed: For the year ended December 31, 2021, $ 0.3 million in costs were incurred related to the achievement of a research milestone under this agreement.
−Removed: Zero milestones were achieved for the years ended December 31, 2023 and 2022.
−Removed: For the year ended December 31, 2023, the Company recorded $ 3.0 million in other expenses as impairment loss on its equity method investment in Notch.
−Removed: Zero impairment loss was recorded for the years ended December 31, 2022 and 2021.
+Added: On January 25, 2024, the Company entered into an Amended and Restated Collaboration and License Agreement (the Amended Notch Agreement) with Notch.
+Added: The Amended Notch Agreement amends and restates the Notch Agreement.
+Added: Under the Amended Notch Agreement, the Company has relinquished its exclusive rights to all original CAR targets (the Released Targets) except for one CAR target, and has agreed to limit its option right to only one additional CAR target.
+Added: If the option is exercised, the Company will have a minimum funding commitment for the overall development program.
+Added: If Notch subsequently out-licenses any of the Released Targets (whether through an out-license, partnership, sale, or other transaction), the Company will be entitled to receive a percentage of upfront and/or milestone payments associated therewith up to a set cap of $ 30.0 million, and will be entitled to a low, single-digit royalty on net sales of products containing a Released Target.
+Added: In addition, with respect to the Company’s previous equity investment in Notch, the Amended Notch Agreement grants the Company certain anti-dilution protections up to certain limits for certain pre-IPO equity financings.
+Added: As of December 31, 2024, no Released Targets were out-licensed by Notch.
+Added: On May 17, 2024, in connection with the Notch Series B Financing the Company waived certain of its anti-dilution rights in exchange for a low single digit percentage reduction in the royalty rate for
+Added: the royalties the Company is obliged to pay to Notch under our Notch intellectual property license should the Company commercialize a licensed product.
+Added: In January 2025, Notch announced that securing additional investment and/or additional partners to take their research forward remains challenging, and therefore they significantly reduced their workforce to preserve cash and provide the time to explore alternate paths forward.
+Added: For the years ended December 31, 2024 and 2023, the Company recorded zero and $ 1.8 million, respectively, in collaboration costs as research and development expenses.
+Added: No milestones were achieved for the years ended December 31, 2024 and 2023.
+Added: For the year ended December 31, 2024, the Company recorded $ 2.0 million in other expenses, net as impairment loss on its equity investment in Notch.
+Added: For the year ended December 31, 2023, the Company recorded $ 3.0 million in other expenses, net as impairment loss on its equity method investment in Notch.
Strategic Alliance with The University of Texas MD Anderson Cancer Center
4 unchanged sentences
The Company made an upfront payment of $ 3.0 million to MD Anderson in the year ended December 31, 2020 and made an additional upfront payment of $ 3.0 million to MD Anderson in the year ended December 31, 2023.
−Removed: The Company is obligated to make further payments to MD Anderson each year upon the anniversary of the agreement effective date through the duration of the agreement term.
+Added: The Company is committed to make further payments to MD Anderson each year upon the anniversary of the agreement effective date through the duration of the agreement term, however, if MD Anderson has sufficient funds to continue the agreed-upon research projects, the Company may defer the additional payment to a later date.
These costs are expensed to research and development as MD Anderson renders the services under the strategic alliance.
2 unchanged sentences
Where any legal or regulatory authorization is finally withdrawn or terminated, the relevant study will also terminate automatically.
−Removed: For the years ended December 31, 2023, 2022, and 2021, the Company recorded $ 0.9 million, $ 1.4 million, and $ 1.0 million, respectively, in collaboration costs under this agreement as research and development expenses.
−Removed: Joint Venture and License Agreement with Allogene Overland Biopharm (CY) Limited (As Restated)
−Removed: On December 14, 2020, the Company entered into the License Agreement with Allogene Overland, a joint venture established by the Company and Overland, pursuant to the Share Purchase Agreement, for the purpose of developing, manufacturing and commercializing certain allogeneic CAR T cell therapies for patients in greater China, Taiwan, South Korea and Singapore (the JV Territory).
+Added: For the years ended December 31, 2024 and 2023, the Company recorded $ 1.6 million and $ 0.9 million, respectively, in collaboration costs under this agreement as research and development expenses.
+Added: Investment in and License Agreement with Overland Therapeutics, Inc.
+Added: Allogene Overland, later renamed Overland Therapeutics Inc.
+Added: (Overland Therapeutics), was initially established as a joint venture by the Company and Overland Pharmaceuticals (CY) Inc.
+Added: (Overland) pursuant to a Share Purchase Agreement (Share Purchase Agreement), dated December 14, 2020.
+Added: Concurrently, on December 14, 2020, the Company entered into a License Agreement (License Agreement) with Allogene Overland for the purpose of developing, manufacturing and commercializing certain allogeneic CAR T cell therapies for patients in greater China, Taiwan, South Korea and Singapore (the JV Territory).
Pursuant to the Share Purchase Agreement, the Company acquired Seed Preferred Shares in Allogene Overland representing 49 % of Allogene Overland's outstanding stock as partial consideration for the License Agreement, and Overland acquired Seed Preferred Shares representing 51 % of Allogene Overland's outstanding stock for $ 117.0 million in upfront and certain quarterly cash payments, to support operations of Allogene Overland.
−Removed: As of December 31, 2023, the Company and Overland are the sole equity holders in Allogene Overland.
The Company received $ 40.0 million from Allogene Overland as partial consideration for the License Agreement.
−Removed: Pursuant to the License Agreement, the Company granted Allogene Overland an exclusive license to develop, manufacture and commercialize certain allogeneic CAR T cell candidates directed at four targets, BCMA, CD70, FLT3, and DLL3, in the JV Territory.
+Added: Until the Organizational Restructuring (as defined below), the Company and Overland were the sole equity holders in Allogene Overland.
+Added: Pursuant to the License Agreement, the Company granted Allogene Overland an exclusive license to develop, manufacture and commercialize certain allogeneic CAR T cell candidates directed at four targets, BCMA, CD70, FLT3, and DLL3 (Overland Licensed Products), in the JV Territory.
As consideration, the Company would also be entitled to additional regulatory milestone payments of up to $ 40.0 million and, subject to certain conditions, tiered low-to-mid single-digit sales royalties.
−Removed: Subsequent to entering into the License Agreement, Allogene Overland assigned the License Agreement to a wholly-owned subsidiary, Allogene Overland Biopharm (HK) Limited (Allogene Overland HK).
−Removed: On April 1, 2022, Allogene Overland HK assigned the License Agreement to Allogene Overland Biopharm (PRC) Co., Limited.
−Removed: Promises that the Company concluded were distinct performance obligations in the License Agreement included:
+Added: Subsequent to entering into the License Agreement, Allogene Overland assigned the License Agreement to a wholly-
+Added: owned subsidiary, Allogene Overland BioPharm (HK) Limited (Allogene Overland HK).
+Added: On April 1, 2022, Allogene Overland HK assigned the License Agreement to Allogene Overland Biopharm (PRC) Co., Limited (Allogene Overland PRC).
+Added: On May 24, 2024, the Company, Overland, and Allogene Overland entered into a Share Exchange Agreement (Share Exchange Agreement) pursuant to which Overland’s cell therapy business merged into Allogene Overland (the Organizational Restructuring).
+Added: Under the Share Exchange Agreement, Allogene Overland acquired from Overland a 100 % equity interest in Overland Pharmaceuticals (US) Inc.
+Added: (Overland US).
+Added: Overland US includes certain research and development, clinical, and general and administrative staff, as well as select cell therapy assets, including its lead program, OL-101, an autologous GPRC5D-BCMA bispecific dual targeting CAR T for refractory multiple myeloma.
+Added: Upon completion of the closing of the share exchange, Overland US became a wholly owned subsidiary of Allogene Overland, Overland’s ownership increased to 82 % and the Company’s ownership decreased to 18 %.
+Added: Under a separate agreement between Overland and HH BioPharma Holdings Ltd.
+Added: (HBP) executed on May 24, 2024, Overland distributed all Series Seed Preferred Shares of Allogene Overland held by Overland to HBP and HBP has assumed all rights and obligations attached to such shares and all rights and obligations of Overland under the Share Exchange Agreement.
+Added: In connection with the Organizational Restructuring, on May 24, 2024, the Company and Allogene Overland PRC, entered into a First Amendment to the License Agreement (the License Amendment) to amend and supplement certain provisions of the License Agreement.
+Added: Under the License Amendment, the Company continues to grant Allogene Overland PRC an exclusive license to develop, manufacture, and commercialize the Licensed Products in the JV Territory, with the Company retaining exclusive rights to the Licensed Products outside the JV Territory, and the royalty obligations to the Company were amended to a flat mid single-digit royalty on net sales in the JV Territory that are no longer subject to reductions.
+Added: The License Amendment also provides the Company with additional rights to terminate the License Agreement in its entirety or with respect to the relevant Overland Licensed Products if Allogene Overland PRC fails to initiate manufacturing technology transfer with respect to an Overland Licensed Product as agreed in the License Amendment, or if HBP commits a funding default or a material breach of its representations, warranties, or covenants under the Share Exchange Agreement.
+Added: The License Amendment also provides that the License Agreement will terminate automatically if the Company’s ownership in Allogene Overland falls below 7.5 % (other than due to the Company’s sale of the shares of Allogene Overland), unless at that time Allogene Overland PRC and the Company have mutually agreed on the manufacturing technology transfer plan for the Overland Licensed Products and Allogene Overland PRC elects to continue the license for such Overland Licensed Products with increased milestones and royalties.
+Added: Under the License Amendment terms such increased milestones and royalties consist of up to $ 115.0 million in milestone payments for each Overland Licensed Product and tiered mid single-digit to low double-digit royalties on net sales in the JV Territory.
+Added: As part of the Organizational Restructuring, Allogene Overland was renamed Overland Therapeutics Inc.
+Added: (Overland Therapeutics).
+Added: Based on the License Agreement, promises that the Company concluded were distinct performance obligations included:
(1) the license of intellectual property and delivery of know-how, (2) the manufacturing license, related know-how and support, (3) know-how developed in future periods, and (4) participation in the joint steering committee.
In order to determine the transaction price, the Company evaluated all the consideration to be received over the duration of the contract.
−Removed: Fixed consideration exists in the form of the upfront payment and Seed Preferred Shares in Allogene Overland.
+Added: Fixed consideration exists in the form of the upfront payment and Seed Preferred Shares in Overland Therapeutics.
Regulatory milestones and royalties were considered variable consideration.
13 unchanged sentences
Funds received in advance are recorded as deferred revenue and will be recognized as the performance obligations are satisfied.
−Removed: The Company has determined that Allogene Overland is a variable interest entity as of December 31, 2023 and 2022, respectively.
−Removed: The Company does not have the power to direct the activities which most significantly affect Allogene Overland's economic performance.
−Removed: Accordingly, for the years ended December 31, 2023 and 2022, the Company did not consolidate Allogene Overland because the Company determined that it was not the primary beneficiary.
−Removed: The Company's total equity investment in Allogene Overland as of December 31, 2023 and 2022 was zero and $ 4.5 million, respectively (see Note 8).
−Removed: For the years ended December 31, 2023, 2022 and 2021, the Company recognized $ 0.1 million, $ 0.2 million and $ 114.1 million, respectively, of collaboration revenue, primarily related to support services and the delivery of a performance obligation consisting of a license of intellectual property and related know-how which was delivered in the first quarter of 2021.
−Removed: For the year ended December 31, 2022, the Company recorded $ 0.7 million of net cost recoveries under the terms of the license agreement as a reduction to research and development expenses.
−Removed: For the years ended December 31, 2023 and 2021, the Company recorded zero net cost recoveries.
+Added: Based on the License Amendment, the Company determined that the remaining transaction price was $ 4.6 million and it was allocated as follows:
+Added: (i) $ 1.9 million to the manufacturing license, related know-how and support, which will be recognized as services are delivered and (ii) $ 2.7 million to the know-how developed in future periods, which will be recognized as services are delivered.
+Added: As of December 31, 2024, $ 4.6 million of deferred revenue was recorded in other long-term liabilities.
+Added: The Company determined that Overland Therapeutics is a variable interest entity as of December 31, 2024 and 2023.
+Added: The Company does not have the power to direct the activities which most significantly affect Overland Therapeutics’ economic performance.
+Added: Accordingly, the Company did not consolidate Overland Therapeutics because the Company determined that it was not the primary beneficiary.
+Added: After the Organizational Restructuring, the Company has 20 % voting rights of Overland Therapeutics’ board of directors.
+Added: The Company concluded that it has significant influence over Overland Therapeutics and continued to account for its investment in Overland Therapeutics as an equity method investment.
+Added: In connection with the Organizational Restructuring, the Company recorded an increase in its equity method investment in Overland Therapeutics and corresponding gain of $ 1.1 million.
+Added: The Company’s total equity investment in Overland Therapeutics was zero as of December 31, 2024 and 2023 (see Note 8).
+Added: For the years ended December 31, 2024 and 2023, the Company recognized less than $ 0.1 million of collaboration revenue.
Collaboration and License Agreement with Antion
13 unchanged sentences
Also, in lieu of the Company's prior obligation to make a $ 3.0 million investment in Antion following the completion of certain milestones, the Company agreed to make a $ 2.0 million investment in Antion's preferred stock and acquired warrants to purchase an additional $ 3.0 million of Antion's preferred stock.
−Removed: The Company accounts for the fair value of the new investment of $ 1.0 million as an equity investment and the remaining $ 1.0 million was recorded as research and development expense.
Under the Antion Collaboration and License Agreement, Antion will be eligible to receive up to $ 35.3 million for four products upon achievement of certain development and regulatory milestones.
−Removed: For each additional product, Antion will be eligible to receive $ 2.0 million upon achievement of a regulatory milestone.
+Added: For each additional product, Antion will be
+Added: eligible to receive $ 2.0 million upon achievement of a regulatory milestone.
Antion is also entitled to receive a low single-digit royalty on the Company’s sales of licensed products, subject to certain reductions.
−Removed: For the years ended December 31, 2023 and 2022, the Company recorded $ 1.8 million and $ 5.0 million, respectively, in research and development expenses related to the upfront payment and collaboration costs.
−Removed: For the years ended December 31, 2023 and 2022, the Company recorded $ 0.4 million and zero , respectively, in research and development expenses related to the achievement of a milestone under the Antion Collaboration and License Agreement.
−Removed: For the year ended December 31, 2023 and 2022, the Company recorded $ 4.0 million and zero , respectively, in other expenses as impairment loss on its equity investment in Antion.
−Removed: As of December 31, 2023 and 2022, research and development expenses recorded in accrued and other liabilities relating to Antion were zero and $ 0.5 million, respectively.
−Removed: As of December 31, 2023 and 2022, the Company's total equity investment in Antion was zero and $ 3.0 million, respectively, and is recognized in other long-term assets in the consolidated balance sheets.
+Added: For the years ended December 31, 2024 and 2023, the Company recorded zero and $ 1.8 million, respectively, in research and development expenses related to the upfront payment and collaboration costs.
+Added: For the years ended December 31, 2024 and 2023, the Company recorded zero and $ 0.4 million, respectively, in research and development expenses related to the achievement of a milestone under the Antion Collaboration and License Agreement.
+Added: For the years ended December 31, 2024 and 2023, the Company recorded zero and $ 4.0 million, respectively, in other expenses, net as impairment loss on its equity investment in Antion.
+Added: Strategic Collaboration Agreement with Foresight Diagnostics
+Added: On January 3, 2024, the Company entered into a Strategic Collaboration Agreement with Foresight Diagnostics, Inc.
+Added: (Foresight Diagnostics) (the Foresight Agreement).
+Added: Pursuant to the Foresight Agreement, the parties have agreed to collaborate on a non-exclusive basis in the development of Foresight Diagnostics’ minimal residual disease (MRD) assay based on their PhasED-Seq Circulating Tumor DNA Platform as an in vitro diagnostic to identify the MRD+ patient population to be enrolled in the Company’s ALPHA3 trial of cema-cel, for treatment of large B cell lymphoma.
+Added: Under the Foresight Agreement, the Company has agreed to use its commercially reasonable efforts to obtain regulatory approval of cema-cel, and Foresight Diagnostics has agreed to use its commercially reasonable efforts to obtain regulatory approval of its MRD assay for use as an in vitro diagnostic with cema-cel.
+Added: Under the Foresight Agreement, the Company has agreed to fund approximately $ 26.2 million in MRD assay development costs, milestone payments for regulatory submissions and assay utilization to process clinical samples.
+Added: On February 19, 2025, the Company entered into an Amended and Restated Strategic Collaboration Agreement with Foresight Diagnostics which expands our collaboration to include the development of Foresight Diagnostics’ MRD assay as a companion diagnostic for use with cema-cel as part of a possible EU and/or UK clinical development program, and as part of an expansion of ALPHA3 to Canadian and Australian clinical trial sites in support of our US clinical development program.
+Added: In total, we have agreed to fund approximately $ 37.3 million in MRD assay development costs, milestone payments for U.S., and certain international regulatory submissions and assay utilization costs to process clinical samples, all in addition to the financial commitments under the Foresight Agreement.
+Added: For the year ended December 31, 2024, the Company recorded $ 3.5 million of research and development expenses related to clinical trials start readiness milestones.
Commitments and Contingencies
−Removed: In August 2018, the Company entered into an operating lease agreement (HQ Lease) for new office and laboratory space which consists of approximately 68,000 square feet located in South San Francisco, California.
−Removed: The lease term was 127 months beginning August 2018 through February 2029 with an option to extend the term for 7 years which was not reasonably assured of exercise.
−Removed: The Company has made certain tenant improvements, including the addition of laboratory space, and has received $ 5.0 million of tenant improvement allowances up to December 31, 2023.
+Added: In August 2018, the Company entered into an operating lease agreement (HQ Lease) for office and laboratory space which consists of approximately 68,000 square feet located in South San Francisco, California.
+Added: The lease term was 127 months beginning August 2018 through February 2029 with an option to extend the term for seven years which was not reasonably assured of exercise.
+Added: The Company has made certain tenant improvements, including the addition of laboratory space, and has received $ 5.0 million of tenant improvement allowances through December 31, 2020.
The rent payments began on March 1, 2019 after an abatement period.
2 unchanged sentences
The rent payments for the expansion premises began in August 2022 after an abatement period.
−Removed: The lease term for the existing premises was also extended and the lease for both the existing and expansion premises will expire on March 31, 2032 with an option to extend the term for 8 years which is not reasonably assured of exercise.
+Added: The lease term for the existing premises was also extended and the lease for both the existing and expansion premises will expire on March 31, 2032 with an option to extend the term for eight years which is not reasonably assured of exercise.
In October 2018, the Company entered into an operating lease agreement for office and laboratory space which consists of 14,943 square feet located in South San Francisco, California.
−Removed: The lease term was 124 months beginning November 2018 through February 2029, with an option to extend the term for another 7 years which was not reasonably assured of exercise.
+Added: The lease term was 124 months beginning November 2018 through February 2029, with an option to extend the term for another seven years which was not reasonably assured of exercise.
The Company has made certain tenant improvements, including the upgrading of current office and laboratory space with a lease incentive allowance of $ 0.8 million.
1 unchanged sentence
In December 2021, the Company amended its lease agreement to extend the term of the lease to be co-terminus with the HQ Lease.
−Removed: The lease term will expire March 31, 2032 with an option to extend the term for 8 years which is not reasonably assured of exercise.
+Added: The lease term will expire on March 31, 2032 with an option to extend the term for eight years which is not reasonably assured of exercise.
In February 2019, the Company entered into a lease agreement for approximately 118,000 square feet of space to develop a cell therapy manufacturing facility in Newark, California.
The lease term is 188 months and began in November 2020.
−Removed: Upon certain conditions, the Company has two ten-year options to extend the lease, both of which are not reasonably
−Removed: assured of exercise.
+Added: Upon certain conditions, the Company has two ten-year options to extend the lease, both of which are not reasonably assured of exercise.
The Company has received $ 3.0 million of tenant improvement allowances for costs related to the design and construction of certain Company improvements.
−Removed: The Company maintains letters of credit for the benefit of landlords which is disclosed as restricted cash in the consolidated balance sheet.
+Added: In February 2023, the Company entered into a sublease with Bellco Capital Advisors Inc.
+Added: (Bellco) for 2,218 square feet of office space in Los Angeles, California.
+Added: The sublease term is 115 months, subject to certain early termination rights.
+Added: The sublease commenced on January 1, 2024.
+Added: The Company maintains letters of credit for the benefit of landlords which is disclosed as restricted cash in the consolidated balance sheets.
Restricted cash related to letters of credit due to landlords was $ 6.0 million as of December 31, 2024 and 2023.
7 unchanged sentences
Year Ended December 31,
−Removed: 2023 2022 2021
Operating lease cost $ 11,468 $ 12,711
16 unchanged sentences
Certain lease agreements require the Company to return designated areas of leased space to its original condition upon termination of the lease agreement.
−Removed: At the inception of such leases, the Company records an asset retirement obligation and a corresponding capital asset in an amount equal to the estimated fair value of the obligation.
+Added: At the inception of such leases, the Company records an asset retirement obligation and a
+Added: corresponding capital asset in an amount equal to the estimated fair value of the obligation.
To determine the fair value of the obligation, the Company estimates the cost for a third-party to perform the restoration work.
In subsequent periods, for each asset retirement obligation, the Company records interest expense to accrete the asset retirement obligation liability to full value and depreciate each capitalized asset retirement obligation asset, both over the term of the associated lease agreement.
−Removed: Asset retirement obligations were $ 0.6 million as of December 31, 2023 and 2022.
+Added: Asset retirement obligations were $ 0.7 million and $ 0.6 million as of December 31, 2024 and 2023, respectively.
Other Commitments
10 unchanged sentences
The timing and likelihood of any significant conditional milestone payments or royalty payments becoming due was not probable as of December 31, 2024.
−Removed: Purchase Commitments
−Removed: In the normal course of business, the Company enters into various purchase commitments with third-party contract manufacturers for the manufacture and processing of our product candidates and related raw materials, and the Company has entered into other contracts in the normal course of business with contract research organizations for clinical trials and other vendors for other services and products for operating purposes.
−Removed: These agreements generally provide for termination or cancellation, other than for costs already incurred.
−Removed: As of December 31, 2023, the Company had non-cancellable purchase commitments of $ 2.1 million.
Contingencies
5 unchanged sentences
There have been no claims to date, and the Company has a directors and officers liability insurance policy that may enable it to recover a portion of any amounts paid for future claims.
−Removed: Equity Method Investments (As Restated)
+Added: Equity Investments and Equity Method Investments
Notch Therapeutics
4 unchanged sentences
Immediately following this transaction, the Company's share in Notch was 23.0 % on a voting interest basis.
−Removed: The Company’s total equity investment in Notch as of December 31, 2023 and 2022 was $ 3.6 million and $ 12.8 million, respectively, and the Company accounted for the investment using the equity method of accounting.
−Removed: During the years ended December 31, 2023, 2022 and 2021, the Company recognized its share of Notch's net loss of $ 6.2 million, $ 7.2 million
−Removed: and $ 2.7 million, respectively, under the other expenses caption within the consolidated statement of operations.
−Removed: For the year ended December 31, 2023, the Company recorded $ 3.0 million in other expenses as impairment loss on its equity method investment in Notch.
−Removed: Zero impairment loss was recorded for the years ended December 31, 2022 and 2021.
−Removed: Allogene Overland Biopharm (CY) Limited
−Removed: In conjunction with the execution of the License Agreement with Allogene Overland (see Note 6), the Company also entered into the Share Purchase Agreement and a Shareholders' Agreement with the joint venture company acquiring shares of Allogene Overland’s Seed Preferred Stock representing a 49 % ownership interest in exchange for entering into a License Agreement.
−Removed: The Company's total equity investment in Allogene Overland as of December 31, 2023 and 2022 was zero and $ 4.5 million, respectively, and the Company accounted for the investment using the equity method of accounting.
−Removed: During the years ended December 31, 2023, 2022 and 2021, the Company recognized its share of Allogene Overland's net loss of $ 4.5 million, $ 5.7 million, and $ 1.3 million, respectively, under the other expenses caption within the consolidated statement of operations.
+Added: On May 17, 2024, Notch closed the Notch Series B Financing which caused the Company’s share in Notch to decrease to 13 % immediately following this transaction.
+Added: Accordingly, effective May 17, 2024, the Company started to account for its investment in Notch as an equity investment measured at cost less impairment.
+Added: The Company’s total equity investment in Notch as of December 31, 2024 was zero .
+Added: The Company’s total equity investment in Notch as of December 31, 2023 was $ 3.6 million and the Company accounted for the investment using the equity method of accounting.
+Added: For the year to date period through May 17, 2024, the Company
+Added: recognized its share of Notch’s net loss of $ 1.7 million under the other expenses, net caption within the consolidated statements of operations.
+Added: For the year ended December 31, 2023, the Company recognized its share of Notch’s net loss of $ 6.2 million under the other expenses, net caption within the consolidated statements of operations.
+Added: As of December 31, 2024, the Company's equity investment in Notch was categorized as Level 3 within the fair value hierarchy.
+Added: During the years ended December 31, 2024 and 2023, the Company recognized $ 2.0 million and $ 3.0 million, respectively, of impairment loss under the other expenses, net caption within the consolidated statements of operations.
+Added: Overland Therapeutics, Inc.
+Added: In conjunction with the execution of the License Agreement with Allogene Overland (see Note 6), the Company also entered into the Share Purchase Agreement and a Shareholders’ Agreement with the joint venture company acquiring shares of Allogene Overland’s Seed Preferred Shares representing a 49 % ownership interest in exchange for entering into a License Agreement.
+Added: Upon completion of the Organizational Restructuring, Overland’s ownership in Allogene Overland increased to 82 % and the Company’s ownership decreased to 18 %.
+Added: As part of the Organizational Restructuring, Overland distributed all Series Seed Preferred Shares of Allogene Overland held by Overland to HBP and Allogene Overland was renamed to Overland Therapeutics.
+Added: The Company's total equity investment in Overland Therapeutics as of December 31, 2024 and 2023 was zero and the Company accounted for the investment using the equity method of accounting.
+Added: For the year ended December 31, 2024, the Company recognized its gain from the Organizational Restructuring of $ 1.1 million which was offset by its share of Overland Therapeutics' net loss of $ 1.1 million under the other expenses, net caption within the consolidated statement of operations.
+Added: During the year ended December 31, 2023, the Company recognized its share of Overland Therapeutics' net loss of $ 4.5 million under the other expenses, net caption within the consolidated statement of operations.
Stockholders’ Equity
14 unchanged sentences
Options shall not have an exercise price less than 100 % of the fair market value of the Company’s common stock on the grant date.
−Removed: If the individual possesses more than 10 % of the combined voting power of all classes of stock of the Company, the exercise price shall not be less than 110 % of the fair market value of a common share of stock on the date of grant.
+Added: If the individual possesses more than 10 % of the combined voting power of all classes of stock of the Company, the exercise price
+Added: shall not be less than 110 % of the fair market value of a common share of stock on the date of grant.
This requirement is applicable to incentive stock options only.
24 unchanged sentences
The aggregate intrinsic values of options exercised, outstanding, exercisable, vested and expected to vest were calculated as the difference between the exercise price of the options and the closing price of the Company’s common stock on the Nasdaq Global Select Market on December 31, 2024.
−Removed: The aggregate intrinsic value of options exercised during the years ended December 31, 2023, 2022 and 2021 was $ 2.3 million, $ 1.9 million and $ 21.9 million, respectively.
−Removed: During the years ended December 31, 2023, 2022 and 2021, the estimated weighted-average grant-date fair value of employee options granted was $ 3.33 per share, $ 9.97 per share and $ 18.79 per share, respectively.
+Added: The aggregate intrinsic value of options exercised during the years ended December 31, 2024 and 2023 was $ 0.6 million and $ 2.3 million, respectively.
+Added: During the years ended December 31, 2024 and 2023, the estimated weighted-average grant-date fair value of employee options granted was $ 2.05 per share and $ 3.33 per share, respectively.
As of December 31, 2024 and 2023, there was $ 35.5 million and $ 58.1 million, respectively, of unrecognized stock-based compensation related to unvested stock options, which is expected to be recognized over a weighted-average period of 1.85 years and 2.42 years, respectively.
9 unchanged sentences
Expected dividend 0 % 0 %
−Removed: The fair value of the new options granted under the Option Exchange program was estimated at the date of grant using a lattice option pricing model with the following assumptions:
−Removed: expected volatility of 73.74 %, expected risk-free rate of 3.06 %, expected dividends of 0 % and expected exercise barrier of 2.57 .
The Black-Scholes option-pricing model and the lattice option pricing model require the use of subjective assumptions which determine the fair value of stock-based awards.
These assumptions include:
−Removed: Fair value of common stock —For grants before October 2018 when the Company was private and there was no public market for the Company’s common stock, the fair value of the Company’s common stock underlying share-based awards was estimated on each grant date by the Company’s Board of Directors.
−Removed: In order to determine the fair value of the Company’s common stock underlying option grants, the Company’s Board of Directors considered, among other things, valuations of the Company’s common stock prepared by an unrelated third-party valuation firm in accordance with the guidance provided by the American Institute of Certified Public Accountants Practice Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation .
−Removed: For all grants subsequent to the Company’s IPO in October 2018, the fair value of common stock was determined by taking the closing price per share of common stock per Nasdaq.
+Added: Fair value of common stock — For all grants subsequent to the Company’s IPO in October 2018, the fair value of common stock was determined by taking the closing price per share of common stock per Nasdaq.
Expected term — The expected term represents the period that stock-based awards are expected to be outstanding.
1 unchanged sentence
The simplified method deems the term to be the average of the time-to-vesting and the contractual life of the stock-based awards.
−Removed: Expected volatility — The Company uses an average historical stock price volatility of comparable public companies within the biotechnology and pharmaceutical industry that were deemed to be representative of future stock price trends as the Company does not have sufficient trading history for its common stock.
−Removed: The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available.
+Added: Expected volatility — Prior to November 2024, the Company used an average historical stock price volatility of comparable public companies within the biotechnology and pharmaceutical industry that were deemed to be representative of future stock price trends as the Company does not have sufficient trading history for its common stock.
+Added: For grants subsequent to October 2024, the Company uses an average historical stock price volatility of its common stock as it accumulated sufficient historical stock price data.
Risk-free interest rate —The risk-free interest rate is based on the U.S.
3 unchanged sentences
Expected exercise barrier - The modified options are assumed to be exercised upon vesting and when the ratio of stock market price to exercise price reaches 2.57 , or expiration, whichever is earlier.
−Removed: For the years ended December 31, 2023, 2022 and 2021, total stock-based compensation expense related to stock options was $ 34.4 million, $ 42.2 million and $ 38.2 million, respectively.
Restricted Stock Unit Activity
9 unchanged sentences
Vested and expected to vest, December 31, 2024 13,343,793 $ 4.87 1.58 $ 28,422
−Removed: For the year ended December 31, 2023, the Company granted 3,264,750 performance-based restricted stock units and 2,189,125 restricted stock units with a market condition to certain executive officers and other employees pursuant to the 2018
−Removed: These awards are subject to the holders' continuous service to the Company through each applicable vesting event.
+Added: For the year ended December 31, 2024, the Company granted 35,000 performance-based restricted stock units to certain executive officers and other employees pursuant to the 2018 Plan.
+Added: These awards are subject to the holders' continuous
+Added: service to the Company through each applicable vesting event.
Through December 31, 2024, the Company believes that the achievement of the requisite performance conditions for these awards are not probable.
As a result, no compensation expense has been recognized related to the performance-based restricted stock units in the year ended December 31, 2024.
−Removed: The Company recognized $ 2.2 million in stock-based compensation expense related to the restricted units with a market condition for the year ended December 31, 2023.
−Removed: For the years ended December 31, 2023, 2022 and 2021, total stock-based compensation expense related to restricted stock units, performance based restricted stock units and restricted stock units with a market condition was $ 28.5 million, $ 34.3 million and $ 26.6 million, respectively .
−Removed: For the years ended December 31, 2023, 2022 and 2021, total fair value of vested restricted stock units, performance based restricted stock units and restricted stock units with a market condition as of their grant dates was $ 33.3 million, $ 32.8 million and $ 18.5 million, respectively.
+Added: The Company recognized $ 2.4 million and $ 2.2 million in stock-based compensation expense related to the restricted units with a market condition for the years ended December 31, 2024 and 2023, respectively.
+Added: For the years ended December 31, 2024 and 2023, total fair value of vested restricted stock units, performance based restricted stock units and restricted stock units with a market condition as of their grant dates was $ 20.6 million, and $ 33.3 million, respectively.
As of December 31, 2024 and 2023, there was $ 33.7 million and $ 50.7 million, respectively, of unrecognized stock-based compensation which is expected to be recognized over a weighted average period of 2.10 years and 2.36 years, respectively.
17 unchanged sentences
Dividend yield 0 % 0 %
−Removed: For the years ended December 31, 2023, 2022 and 2021, total stock-based compensation expense related to ESPP was $ 3.1 million, $ 3.6 million and $ 2.3 million, respectively.
−Removed: Founders’ Stock
−Removed: In 2018, the Company’s founders agreed to modify their common shares outstanding to include vesting provisions that require continued service to the Company in order to vest in those shares.
−Removed: Stock-based compensation expense is recognized for shares of founders’ stock as vesting conditions are met.
−Removed: In relation to the modification, 24,230,750 shares of founders’ stock remained unvested at the modification date in April 2018.
−Removed: For the years ended December 31, 2022, and 2021, $ 3.4 million and $ 13.7 million of stock-based compensation expense was recognized related to the vesting of 1,514,424 , and 6,057,695 shares, respectively, of founders' stock.
−Removed: At December 31, 2022, there was no unrecognized stock-based compensation expense.
−Removed: The weighted-average fair value at grant date for founders’ stock was $ 2.27 per share.
Stock-based compensation expense
−Removed: For the years ended December 31, 2023, 2022 and 2021, the Company recorded $ 66.0 million, $ 83.6 million and $ 80.8 million, respectively, of stock-based compensation expense related to stock options, restricted stock units, employee stock purchase plans and vesting of the founders’ common stock as research and development and general and administrative expense in its consolidated statements of operations and comprehensive loss.
−Removed: Early Exercised Options
−Removed: The Company allows certain of its employees and its directors to exercise options granted under the Prior 2018 Plan and the 2018 Plan prior to vesting.
−Removed: The shares related to early exercised stock options are subject to the Company’s lapsing repurchase right upon termination of employment or service on the Company’s Board of Directors at the lesser of the original purchase price or fair market value at the time of repurchase.
−Removed: In order to vest, the holders are required to provide continued service to the Company.
−Removed: The proceeds are initially recorded in accrued and other liabilities and other long-term liabilities for the noncurrent portion.
−Removed: The proceeds are reclassified to paid-in capital as the repurchase right lapses.
−Removed: During the years ended December 31, 2023 and 2022, no options were early exercised.
−Removed: As of December 31, 2023 and 2022, there was $ 0.5 million and $ 1.9 million, respectively, recorded in accrued and other liabilities and zero and $ 0.6 million, respectively, recorded in other long-term liabilities related to shares held by employees and directors that were subject to repurchase.
−Removed: The underlying shares are shown as outstanding in the consolidated financial statements since the exercise date but the shares which are subject to future vesting conditions are not included in the calculation of earnings per share.
+Added: The following table presents stock-based compensation expense by award type that was recorded as research development and general and administrative expense in its consolidated statements of operations and comprehensive loss:
+Added: Year Ended December 31,
+Added: Stock options $ 27,817 $ 34,350
+Added: Restricted stock units, performance based restricted stock units and restricted stock units with a market condition 21,997 28,497
+Added: Employee stock purchase plan 1,929 3,104
+Added: Total stock-based compensation expense $ 51,743 $ 65,951
Related Party Transactions
−Removed: PF Equity Holdings 2 B.V.
−Removed: held 22,032,040 shares of Common Stock based on the Schedule 13D/A filed on September 17, 2021 with the SEC.
−Removed: According to the Schedule 13D/A filing, PF Equity Holdings 2 B.V.
−Removed: is a wholly-owned subsidiary of Pfizer formed for the purpose of holding certain assets owned or controlled by Pfizer or its direct or indirect subsidiaries.
−Removed: Based on a Form 4 filed on April 4, 2022 by PF Equity Holdings 2 B.V., Pfizer held the 22,032,040 shares as of March 31, 2022.
−Removed: Collaboration Revenue and Equity Method Investment (As Restated)
−Removed: In December 2020, the Company entered into the License Agreement with Allogene Overland, a corporate joint venture entity and related party (see Note 6).
+Added: Collaboration Revenue and Equity Method Investment
+Added: In December 2020, the Company entered into the License Agreement with Overland Therapeutics, a corporate joint venture entity and related party (see Note 6).
The License Agreement was subsequently assigned to a wholly owned subsidiary of Allogene Overland, Allogene Overland HK.
On April 1, 2022, Allogene Overland HK assigned the License Agreement to Allogene Overland Biopharm (PRC) Co., Limited.
−Removed: During the years ended December 31, 2023, 2022 and 2021, the Company recognized $ 0.1 million, $ 0.2 million and $ 114.1 million, respectively, of collaboration revenue under this arrangement.
−Removed: For the year ended December 31, 2023, 2022 and 2021, the Company recorded zero , $ 0.7 million and $ 0.2 million, respectively, of net cost recoveries under the terms of the license agreement as a reduction to research and development expenses.
−Removed: For the years ended December 31, 2023, 2022 and 2021, the Company recorded $ 4.5 million, $ 5.7 million and $ 1.3 million, respectively, of its share of Allogene Overland's net loss as other expenses (see Note 8).
+Added: On May 24, 2024, the License Agreement was amended.
Consulting Agreements
In June 2018, the Company entered into a services agreement with Two River Consulting LLC (Two River) a firm affiliated with the Company’s President and Chief Executive Officer, the Company’s Executive Chair of the board of directors, and a director of the Company to provide various managerial, clinical development, administrative, accounting and financial services to the Company.
−Removed: The costs incurred for services provided under this agreement were $ 0.3 million, $ 0.7 million and $ 0.6 million for the years ended December 31, 2023, 2022 and 2021, respectively.
In December 2023, the service agreement between the Company and Two River was terminated.
+Added: The cost incurred for services provided under this agreement was $ 0.3 million for the year ended December 31, 2023.
In August 2018, the Company entered into a consulting agreement with Bellco Capital LLC (Bellco).
3 unchanged sentences
The Company may also, at its discretion, pay Bellco an annual performance award in an amount up to 60 % of the aggregate compensation payable to Bellco in a calendar year.
−Removed: The Company also reimburses Bellco for out of pocket expenses incurred in performing
−Removed: the services.
−Removed: The costs incurred for services provided, bonus and out-of-pocket expenses incurred under this consulting agreement were $ 0.9 million, $ 0.8 million and $ 0.7 million for the years ended December 31, 2023, 2022 and 2021, respectively.
−Removed: As of December 31, 2023 and 2022, amounts due to Bellco of $ 0.2 million and $ 0.3 million, respectively, were recorded in accrued and other current liabilities in the accompanying consolidated balance sheets.
+Added: The Company also reimburses Bellco for out of pocket expenses incurred in performing the services.
+Added: The costs incurred for services provided, bonus and out-of-pocket expenses incurred under this consulting agreement were $ 0.7 million and $ 0.9 million for the years ended December 31, 2024 and 2023, respectively.
+Added: As of both December 31, 2024 and 2023, amount due to Bellco of $ 0.2 million was recorded in accrued and other current liabilities in the accompanying consolidated balance sheets.
Sublease Agreements
−Removed: In December 2018, the Company entered into a sublease with Bellco for 1,293 square feet of office space in Los Angeles, California for a three year term.
−Removed: On April 1, 2020, Bellco Capital Advisors Inc.
−Removed: assumed all rights, title, interests and obligations under the sublease from Bellco Capital LLC.
+Added: In December 2018, the Company entered into a sublease with Bellco Capital LLC for 1,293 square feet of office space in Los Angeles, California for a three year term.
+Added: On April 1, 2020, Bellco assumed all rights, title, interests and obligations under the sublease from Bellco Capital LLC.
In November 2021, the sublease was extended to June 30, 2025.
The sublease was amended, effective in July 2022, to move to a nearby location, with office space of 737 square feet.
−Removed: The Company’s executive chair, Arie Belldegrun, M.D., FACS, is a trustee of the Belldegrun Family Trust, which controls Bellco Capital Advisors Inc.
−Removed: The total right of use asset and associated liability recorded related to this related party lease was $ 0.1 million and $ 0.2 million at December 31, 2023 and 2022, respectively.
−Removed: In February 2023, the Company subleased an additional 2,030 square feet of office space in Los Angeles, California, from Bellco.
+Added: The Company’s executive chairman, Arie Belldegrun, M.D., is a trustee of the Belldegrun Family Trust, which controls Bellco.
+Added: In 2023, the Company exercised its early termination right under the sublease agreement and the sublease was terminated effective December 31, 2023.
+Added: In February 2023, the Company entered into a new subleased agreement with Bellco for 2,218 square feet of office space in Los Angeles, California, from Bellco.
The sublease term is 115 months, subject to certain early termination rights.
−Removed: The sublease is expected to commence January 1, 2024.
−Removed: The Company paid approximately $ 0.2 million towards the monthly base rent due for the first month of the sublease term and its share of the security deposit.
−Removed: The total estimated amount of base rent is $ 2.9 million, subject to rent abatement.
−Removed: The Company also expects to contribute to certain tenant improvements to the space totaling to its share of the total tenant contribution.
+Added: The sublease commenced on January 1, 2024.
+Added: The total right of use asset and associated liability recorded related to this related party lease was $ 2.2 million and $ 2.5 million, respectively, as of December 31, 2024.
+Added: The Company paid approximately $ 0.2 million towards its share of the security deposit.
+Added: For the year ended December 31, 2024, the Company recorded $ 0.3 million of rent expense related to this lease.
In April 2018, the Company began to sponsor a 401(k) retirement savings plan for the benefit of its employees.
All employees are eligible to participate, provided they meet the requirements of the plan.
−Removed: The Company made contributions to the plan for eligible participants, and recorded contribution expenses of $ 2.5 million, $ 2.3 million and $ 1.8 million for the years ended December 31, 2023, 2022 and 2021, respectively.
+Added: The Company made contributions to the plan for eligible participants, and recorded contribution expenses of $ 1.9 million and $ 2.5 million for the years ended December 31, 2024 and 2023, respectively.
The Company has incurred net operating losses for all the periods presented.
1 unchanged sentence
The Company has established a full valuation allowance against its deferred tax assets due to the uncertainty surrounding the realization of such assets.
+Added: The Company's income tax expense consists of the following:
+Added: Year Ended December 31,
+Added: (in thousands)
+Added: Federal 443 —
+Added: Provision (benefit) for income taxes $ 443 $ —
Reconciliation of the benefit for income taxes calculated at the statutory rate to our benefit for income taxes is as follows:
Year Ended December 31,
−Removed: 2023 2022 2021
−Removed: (As Restated) (As Restated)
(in thousands)
9 unchanged sentences
Year Ended December 31,
−Removed: 2023 2022 2021
−Removed: (As Restated) (As Restated)
(in thousands)
11 unchanged sentences
Deferred tax liabilities:
−Removed: Fixed assets — — ( 250 )
Right of use leased assets ( 11,000 ) ( 17,652 )
6 unchanged sentences
Due to the lack of earnings history, the net deferred tax assets have been fully offset by a valuation allowance.
−Removed: The valuation allowance increased by approximately $ 80.1 million, $ 108.2 million and $ 28.5 million during the years ended December 31, 2023, 2022 and 2021, respectively.
+Added: The valuation allowance increased by approximately $ 45.2 million and $ 80.1 million during the years ended December 31, 2024 and 2023, respectively.
The following table sets forth the Company's federal and state NOL carryforwards and federal research and development tax credits as of December 31, 2024:
10 unchanged sentences
Such a limitation could result in the expiration of carryforwards before they are utilized.
−Removed: In December 2019, the FASB issued Accounting Standards Update No.
−Removed: 2019-12, Income Taxes (Topic 740):
−Removed: Simplifying the Accounting for Income Taxes (ASU 2019-12), which simplifies the accounting for income taxes, eliminates certain exceptions within ASC 740, Income Taxes, and clarifies certain aspects of the current guidance to promote consistency among reporting entities.
−Removed: This guidance was effective for the Company in the first quarter of 2021 on a prospective basis, and early adoption was permitted.
−Removed: The Company early adopted this standard as of January 1, 2020 on a prospective basis in
−Removed: accordance with ASC 250, Accounting Changes and Error Corrections.
−Removed: The adoption resulted in the Company no longer needing to determine the tax effect from unrealized gains on available for sale securities, which previously had been disclosed in the consolidated statement of operations as a benefit from income taxes.
−Removed: The impact of the adoption is that the benefit from income taxes in the consolidated statement of operations and comprehensive loss is zero .
−Removed: For the years ended December 31, 2023 , 2022 and 2021 , the Company recorded a tax benefit of zero .
+Added: Effective June 27, 2024 California's Senate Bill 167 (SB 167) introduced pivotal tax changes, including the suspension of NOLs for businesses earning over $1 million and a cap on business tax credits at $5 million.
+Added: In addition, on June 29, 2024 Senate Bill 175 (SB 175) introduced an allowance for refunds on a range of tax credits—including, for the first time, the R&D credit.
+Added: SB 167, which contains several tax measures, includes provisions that retroactively suspend California net operating losses (NOL) and limit the use of business tax credits for tax years beginning on and after January 1, 2024, and before January 1, 2027.
+Added: SB 175 states that for taxable years beginning on or after January 1, 2024, and before January 1, 2027, taxpayers can
+Added: receive a refundable credit equal to 20% of the qualified credits that could have been taken if the $5 million limitation under SB 167 had not been imposed.
+Added: The Company evaluated the impact of SB 167 and determined that the legislation did not materially impact the Company’s income tax provision for the year ended December 31, 2024.
We apply the provisions of ASC Topic 740 to account for uncertain income tax positions .
A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows:
−Removed: 2023 2022 2021
(in thousands)
15 unchanged sentences
Year Ended December 31,
−Removed: 2023 2022 2021
−Removed: (As Restated) (As Restated)
Net loss $ ( 257,590 ) $ ( 327,265 )
4 unchanged sentences
Year Ended December 31,
−Removed: 2023 2022 2021
Stock options to purchase common stock 24,184,884 21,812,946
1 unchanged sentence
Expected shares purchased under Employee Stock Purchase Plan 1,913,748 2,168,264
−Removed: Founder shares subject to future vesting — — 1,514,424
Early exercised stock options subject to future vesting — 29,180
Total 39,442,425 36,190,861
−Removed: Selected Quarterly Financial Data (Unaudited)
−Removed: The following tables present selected quarterly financial data for 2023 and 2022 (in thousands, except share and per share data):
−Removed: March 31, 2023 March 31, 2022
−Removed: Condensed Consolidated Balance Sheets As Previously Reported Restatement Adjustment As Restated As Previously Reported Restatement Adjustment As Restated
−Removed: Current assets:
−Removed: Cash and cash equivalents $ 109,931 $ — $ 109,931 $ 84,514 $ — $ 84,514
−Removed: Short-term investments 361,293 — 361,293 364,536 — 364,536
−Removed: Prepaid expenses and other current assets 10,241 — 10,241 20,694 — 20,694
−Removed: Total current assets 481,465 — 481,465 469,744 — 469,744
−Removed: Long-term investments 42,788 — 42,788 284,093 — 284,093
−Removed: Operating lease right-of-use asset 81,964 — 81,964 57,057 — 57,057
−Removed: Property and equipment, net 109,849 — 109,849 120,200 — 120,200
−Removed: Restricted cash 10,292 — 10,292 10,292 — 10,292
−Removed: Other long-term assets 9,389 — 9,389 9,042 — 9,042
−Removed: Equity method investments 11,124 3,257 14,381 14,204 13,459 27,663
−Removed: Total assets 746,871 3,257 750,128 964,632 13,459 978,091
−Removed: Liabilities and stockholders’ equity
−Removed: Current liabilities:
−Removed: Accounts payable 14,688 — 14,688 8,708 — 8,708
−Removed: Accrued and other current liabilities 44,624 — 44,624 27,763 — 27,763
−Removed: Deferred revenue 273 ( 187 ) 86 406 ( 259 ) 147
−Removed: Total current liabilities 59,585 ( 187 ) 59,398 36,877 ( 259 ) 36,618
−Removed: Lease liability, noncurrent 93,514 — 93,514 69,035 — 69,035
−Removed: Other long-term liabilities 1,510 3,695 5,205 3,490 3,681 7,171
−Removed: Total liabilities 154,609 3,509 158,118 109,402 3,421 112,823
−Removed: Stockholders’ equity:
−Removed: Preferred stock, $ 0.001 par value:
−Removed: 10,000,000 authorized as of March 31, 2023 and March 31, 2022;
−Removed: no shares were issued and outstanding as of March 31, 2023 and March 31, 2022
−Removed: Common stock, $ 0.001 par value:
−Removed: 400,000,000 and 200,000,000 shares authorized as of March 31, 2023 and March 31, 2022, respectively;
−Removed: 145,740,333 and 143,569,902 shares issued and outstanding as of March 31, 2023 and March 31, 2022, respectively
−Removed: 146 — 146 143 — 143
−Removed: Additional paid-in capital 1,932,734 — 1,932,734 1,847,534 — 1,847,534
−Removed: Accumulated deficit ( 1,334,684 ) ( 252 ) ( 1,334,936 ) ( 983,198 ) 10,037 ( 973,161 )
−Removed: Accumulated other comprehensive loss ( 5,934 ) — ( 5,934 ) ( 9,249 ) — ( 9,249 )
−Removed: Total stockholders’ equity (deficit) 592,262 ( 252 ) 592,010 855,230 10,037 865,267
−Removed: Total liabilities and stockholders’ equity 746,871 3,257 750,128 964,632 13,459 978,091
−Removed: Three Months ended March 31, 2023 Three Months ended March 31, 2022
−Removed: Condensed Consolidated Statements of Operations and Comprehensive Loss As Previously Reported Restatement Adjustment As Restated As Previously Reported Restatement Adjustment As Restated
−Removed: Collaboration revenue - related party $ 52 $ ( 22 ) $ 30 $ 61 $ ( 22 ) $ 39
−Removed: Operating expenses:
−Removed: Research and development 80,238 — 80,238 60,156 — 60,156
−Removed: General and administrative 18,884 — 18,884 19,897 — 19,897
−Removed: Total operating expenses 99,122 — 99,122 80,053 — 80,053
−Removed: Loss from operations ( 99,070 ) ( 22 ) ( 99,092 ) ( 79,992 ) ( 22 ) ( 80,014 )
−Removed: Other income (expense), net:
−Removed: Interest and other income, net 2,059 — 2,059 492 — 492
−Removed: Other expenses ( 1,693 ) ( 1,242 ) ( 2,935 ) ( 350 ) 1,265 915
−Removed: Total other income (expense), net 366 ( 1,242 ) ( 876 ) 142 1,265 1,407
−Removed: Net loss ( 98,704 ) ( 1,264 ) ( 99,968 ) ( 79,850 ) 1,243 ( 78,607 )
−Removed: Other comprehensive income:
−Removed: Net unrealized (loss) gain on available-for-sale investments, net of tax 3,992 — 3,992 ( 6,682 ) — ( 6,682 )
−Removed: Net comprehensive loss ( 94,712 ) ( 1,264 ) ( 95,976 ) ( 86,532 ) 1,243 ( 85,289 )
−Removed: Net loss per share, basic and diluted ( 0.68 ) ( 0.69 ) ( 0.56 ) ( 0.56 )
−Removed: Weighted-average number of shares used in computing net loss per share, basic and diluted 144,563,829 144,563,829 141,356,306 141,356,306
−Removed: Three Months ended March 31, 2023 Three Months ended March 31, 2022
−Removed: Condensed Consolidated Statements of Cash Flow As Previously Reported Restatement Adjustment As Restated As Previously Reported Restatement Adjustment As Restated
−Removed: Net Loss $ ( 98,704 ) $ ( 1,264 ) $ ( 99,968 ) $ ( 79,850 ) $ 1,243 $ ( 78,607 )
−Removed: Non-cash collaboration revenue - related party — ( 20 ) ( 20 ) — ( 26 ) ( 26 )
−Removed: Share of losses from equity method investments 1,693 1,242 2,935 3,800 ( 1,265 ) 2,535
−Removed: Changes in operating assets and liabilities:
−Removed: Deferred revenue ( 612 ) 609 ( 3 ) ( 17 ) 14 ( 3 )
−Removed: Other long-term liabilities ( 59 ) ( 567 ) ( 626 ) ( 635 ) 34 ( 601 )
−Removed: Net cash used in operating activities ( 66,639 ) — ( 66,639 ) ( 68,237 ) — ( 68,237 )
−Removed: June 30, 2023 June 30, 2022
−Removed: Condensed Consolidated Balance Sheets As Previously Reported Restatement Adjustment As Restated As Previously Reported Restatement Adjustment As Restated
−Removed: Current assets:
−Removed: Cash and cash equivalents $ 154,758 $ — $ 154,758 $ 96,041 $ — $ 96,041
−Removed: Short-term investments 337,204 — 337,204 394,451 — 394,451
−Removed: Prepaid expenses and other current assets 10,139 — 10,139 22,536 — 22,536
−Removed: Total current assets 502,101 — 502,101 513,028 — 513,028
−Removed: Long-term investments 52,586 — 52,586 195,637 — 195,637
−Removed: Operating lease right-of-use asset 80,314 — 80,314 86,837 — 86,837
−Removed: Property and equipment, net 106,386 — 106,386 117,216 — 117,216
−Removed: Restricted cash 10,292 — 10,292 10,292 — 10,292
−Removed: Other long-term assets 9,382 — 9,382 8,938 — 8,938
−Removed: Equity method investments 9,910 2,036 11,946 15,696 7,977 23,673
−Removed: Total assets 770,971 2,036 773,007 947,644 7,977 955,621
−Removed: Liabilities and stockholders’ equity
−Removed: Current liabilities:
−Removed: Accounts payable 10,229 — 10,229 9,713 — 9,713
−Removed: Accrued and other current liabilities 44,263 — 44,263 34,360 — 34,360
−Removed: Deferred revenue 229 ( 143 ) 86 836 ( 732 ) 104
−Removed: Total current liabilities 54,721 ( 143 ) 54,578 44,909 ( 732 ) 44,177
−Removed: Lease liability, noncurrent 91,821 — 91,821 98,232 — 98,232
−Removed: Other long-term liabilities 1,523 3,674 5,197 2,554 4,175 6,729
−Removed: Total liabilities 148,065 3,531 151,596 145,695 3,443 149,138
−Removed: Stockholders’ equity:
−Removed: Preferred stock, $ 0.001 par value:
−Removed: 10,000,000 authorized as of June 30, 2023 and June 30, 2022;
−Removed: no shares were issued and outstanding as of June 30, 2023 and June 30, 2022
−Removed: Common stock, $ 0.001 par value:
−Removed: 400,000,000 shares authorized as of June 30, 2023 and June 30, 2022;
−Removed: 167,133,664 and 143,723,171 shares issued and outstanding as of June 30, 2023 and June 30, 2022, respectively
−Removed: 167 — 167 144 — 144
−Removed: Additional paid-in capital 2,039,263 — 2,039,263 1,871,262 — 1,871,262
−Removed: Accumulated deficit ( 1,412,673 ) ( 1,495 ) ( 1,414,168 ) ( 1,057,985 ) 4,534 ( 1,053,451 )
−Removed: Accumulated other comprehensive loss ( 3,851 ) — ( 3,851 ) ( 11,472 ) — ( 11,472 )
−Removed: Total stockholders’ equity (deficit) 622,906 ( 1,495 ) 621,411 801,949 4,534 806,483
−Removed: Total liabilities and stockholders’ equity 770,971 2,036 773,007 947,644 7,977 955,621
−Removed: Three Months ended June 30, 2023 Three Months ended June 30, 2022
−Removed: Condensed Consolidated Statements of Operations and Comprehensive Loss As Previously Reported Restatement Adjustment As Restated As Previously Reported Restatement Adjustment As Restated
−Removed: Collaboration revenue - related party $ 44 $ ( 22 ) $ 22 $ 86 $ ( 22 ) $ 64
−Removed: Operating expenses:
−Removed: Research and development 62,038 — 62,038 57,171 — 57,171
−Removed: General and administrative 18,524 — 18,524 19,509 — 19,509
−Removed: Total operating expenses 80,562 — 80,562 76,680 — 76,680
−Removed: Loss from operations ( 80,518 ) ( 22 ) ( 80,540 ) ( 76,594 ) ( 22 ) ( 76,616 )
−Removed: Other income (expense), net:
−Removed: Interest and other income, net 3,778 — 3,778 315 — 315
−Removed: Other expenses ( 1,249 ) ( 1,221 ) ( 2,470 ) 1,492 ( 5,481 ) ( 3,989 )
−Removed: Total other income (expense), net 2,529 ( 1,221 ) 1,308 1,807 ( 5,481 ) ( 3,674 )
−Removed: Net loss ( 77,989 ) ( 1,243 ) ( 79,232 ) ( 74,787 ) ( 5,503 ) ( 80,290 )
−Removed: Other comprehensive income:
−Removed: Net unrealized (loss) gain on available-for-sale investments, net of tax 2,083 — 2,083 ( 2,223 ) — ( 2,223 )
−Removed: Net comprehensive loss ( 75,906 ) ( 1,243 ) ( 77,149 ) ( 77,010 ) ( 5,503 ) ( 82,513 )
−Removed: Net loss per share, basic and diluted ( 0.53 ) ( 0.54 ) ( 0.52 ) ( 0.56 )
−Removed: Weighted-average number of shares used in computing net loss per share, basic and diluted 146,795,826 146,795,826 143,385,045 143,385,045
−Removed: Six Months ended June 30, 2023 Six Months ended June 30, 2022
−Removed: Condensed Consolidated Statements of Operations and Comprehensive Loss As Previously Reported Restatement Adjustment As Restated As Previously Reported Restatement Adjustment As Restated
−Removed: Collaboration revenue - related party $ 96 $ ( 44 ) $ 52 $ 147 $ ( 44 ) $ 103
−Removed: Operating expenses:
−Removed: Research and development 142,276 — 142,276 117,327 — 117,327
−Removed: General and administrative 37,408 — 37,408 39,406 — 39,406
−Removed: Total operating expenses 179,684 — 179,684 156,733 — 156,733
−Removed: Loss from operations ( 179,588 ) ( 44 ) ( 179,632 ) ( 156,586 ) ( 44 ) ( 156,630 )
−Removed: Other income (expense), net:
−Removed: Interest and other income, net 5,837 — 5,837 807 — 807
−Removed: Other expenses ( 2,942 ) ( 2,463 ) ( 5,405 ) 1,142 ( 4,216 ) ( 3,074 )
−Removed: Total other income (expense), net 2,895 ( 2,463 ) 432 1,949 ( 4,216 ) ( 2,267 )
−Removed: Net loss ( 176,693 ) ( 2,507 ) ( 179,200 ) ( 154,637 ) ( 4,260 ) ( 158,897 )
−Removed: Other comprehensive income:
−Removed: Net unrealized (loss) gain on available-for-sale investments, net of tax 6,075 — 6,075 ( 8,905 ) — ( 8,905 )
−Removed: Net comprehensive loss ( 170,618 ) ( 2,507 ) ( 173,125 ) ( 163,542 ) ( 4,260 ) ( 167,802 )
−Removed: Net loss per share, basic and diluted ( 1.21 ) ( 1.23 ) ( 1.09 ) ( 1.12 )
−Removed: Weighted-average number of shares used in computing net loss per share, basic and diluted 145,685,993 145,685,993 142,376,280 142,376,280
−Removed: Six Months ended June 30, 2023 Six Months ended June 30, 2022
−Removed: Condensed Consolidated Statements of Cash Flow As Previously Reported Restatement Adjustment As Restated As Previously Reported Restatement Adjustment As Restated
−Removed: Net Loss $ ( 176,693 ) $ ( 2,507 ) $ ( 179,200 ) $ ( 154,637 ) $ ( 4,260 ) $ ( 158,897 )
−Removed: Non-cash collaboration revenue - related party — ( 34 ) ( 34 ) — ( 69 ) ( 69 )
−Removed: Share of losses from equity method investments 2,907 2,463 5,370 2,309 4,216 6,525
−Removed: Changes in operating assets and liabilities:
−Removed: Deferred revenue ( 656 ) 653 ( 3 ) 413 ( 430 ) ( 17 )
−Removed: Other long-term liabilities ( 46 ) ( 575 ) ( 621 ) ( 1,571 ) 543 ( 1,028 )
−Removed: Net cash used in operating activities ( 128,496 ) — ( 128,496 ) ( 110,768 ) — ( 110,768 )
−Removed: September 30, 2023 September 30, 2022
−Removed: Condensed Consolidated Balance Sheets As Previously Reported Restatement Adjustment As Restated As Previously Reported Restatement Adjustment As Restated
−Removed: Current assets:
−Removed: Cash and cash equivalents $ 69,246 $ — $ 69,246 $ 74,357 $ — $ 74,357
−Removed: Short-term investments 396,259 — 396,259 477,872 — 477,872
−Removed: Prepaid expenses and other current assets 7,949 — 7,949 16,832 — 16,832
−Removed: Total current assets 473,454 — 473,454 569,061 — 569,061
−Removed: Long-term investments 32,170 — 32,170 85,108 — 85,108
−Removed: Operating lease right-of-use asset 78,643 — 78,643 85,245 — 85,245
−Removed: Property and equipment, net 102,826 — 102,826 114,442 — 114,442
−Removed: Restricted cash 10,292 — 10,292 10,292 — 10,292
−Removed: Other long-term assets 9,576 — 9,576 9,378 — 9,378
−Removed: Equity method investments 5,365 1,085 6,450 14,046 6,905 20,951
−Removed: Total assets 712,326 1,085 713,411 887,572 6,905 894,477
−Removed: Liabilities and stockholders’ equity
−Removed: Current liabilities:
−Removed: Accounts payable 6,205 — 6,205 11,045 — 11,045
−Removed: Accrued and other current liabilities 31,195 — 31,195 36,938 — 36,938
−Removed: Deferred revenue 236 ( 150 ) 86 889 ( 790 ) 99
−Removed: Total current liabilities 37,636 ( 150 ) 37,486 48,872 ( 790 ) 48,082
−Removed: Lease liability, noncurrent 90,102 — 90,102 96,706 — 96,706
−Removed: Other long-term liabilities 1,486 3,702 5,188 2,033 4,255 6,288
−Removed: Total liabilities 129,224 3,552 132,776 147,611 3,465 151,076
−Removed: Stockholders’ equity:
−Removed: Preferred stock, $ 0.001 par value:
−Removed: 10,000,000 authorized as of September 30, 2023 and September 30, 2022;
−Removed: no shares were issued and outstanding as of September 30, 2023 and September 30, 2022
−Removed: Common stock, $ 0.001 par value:
−Removed: 400,000,000 shares authorized as of September 30, 2023 and September 30, 2022;
−Removed: 168,175,221 and 144,031,588 shares issued and outstanding as of September 30, 2023 and September 30, 2022, respectively
−Removed: 168 — 168 144 — 144
−Removed: Additional paid-in capital 2,059,333 — 2,059,333 1,893,908 — 1,893,908
−Removed: Accumulated deficit ( 1,473,988 ) ( 2,467 ) ( 1,476,455 ) ( 1,141,133 ) 3,440 ( 1,137,693 )
−Removed: Accumulated other comprehensive loss ( 2,411 ) — ( 2,411 ) ( 12,958 ) — ( 12,958 )
−Removed: Total stockholders’ equity (deficit) 583,102 ( 2,467 ) 580,635 739,961 3,440 743,401
−Removed: Total liabilities and stockholders’ equity 712,326 1,085 713,411 887,572 6,905 894,477
−Removed: Three Months ended September 30, 2023 Three Months ended September 30, 2022
−Removed: Condensed Consolidated Statements of Operations and Comprehensive Loss As Previously Reported Restatement Adjustment As Restated As Previously Reported Restatement Adjustment As Restated
−Removed: Collaboration revenue - related party $ 43 $ ( 21 ) $ 22 $ 49 $ ( 22 ) $ 27
−Removed: Operating expenses:
−Removed: Research and development 45,977 — 45,977 63,641 — 63,641
−Removed: General and administrative 17,041 — 17,041 18,897 — 18,897
−Removed: Total operating expenses 63,018 — 63,018 82,538 — 82,538
−Removed: Loss from operations ( 62,975 ) ( 21 ) ( 62,996 ) ( 82,489 ) ( 22 ) ( 82,511 )
−Removed: Other income (expense), net:
−Removed: Interest and other income, net 6,205 — 6,205 1,002 — 1,002
−Removed: Other expenses ( 4,545 ) ( 951 ) ( 5,496 ) ( 1,661 ) ( 1,072 ) ( 2,733 )
−Removed: Total other income (expense), net 1,660 ( 951 ) 709 ( 659 ) ( 1,072 ) ( 1,731 )
−Removed: Net loss ( 61,315 ) ( 972 ) ( 62,287 ) ( 83,148 ) ( 1,094 ) ( 84,242 )
−Removed: Other comprehensive income:
−Removed: Net unrealized (loss) gain on available-for-sale investments, net of tax 1,440 — 1,440 ( 1,486 ) — ( 1,486 )
−Removed: Net comprehensive loss ( 59,875 ) ( 972 ) ( 60,847 ) ( 84,634 ) ( 1,094 ) ( 85,728 )
−Removed: Net loss per share, basic and diluted ( 0.37 ) ( 0.37 ) ( 0.58 ) ( 0.59 )
−Removed: Weighted-average number of shares used in computing net loss per share, basic and diluted 167,649,010 167,649,010 143,661,721 143,661,721
−Removed: Nine Months ended September 30, 2023 Nine Months ended September 30, 2022
−Removed: Condensed Consolidated Statements of Operations and Comprehensive Loss As Previously Reported Restatement Adjustment As Restated As Previously Reported Restatement Adjustment As Restated
+Added: Segment Reporting
+Added: The Company has one reportable segment related to developing and commercializing genetically engineered allogeneic T cell product candidates for the treatment of cancer and autoimmune diseases.
+Added: The segment derives its current revenues from research and development collaborations.
+Added: The CEO, as the CODM, manages and allocates resources for the Company's operations at a consolidated company basis by assessing how to best deploy available resources across functions and research and development projects.
+Added: The CEO uses consolidated, single-segment financial information for purposes of evaluating performance, planning and forecasting future period financial results, and allocating resources.
+Added: The table below is the summary of the segment profit or loss information, including the significant segment expenses (in thousands):
+Added: Years Ended December 31,
Collaboration revenue - related party $ 22 $ 95
−Removed: Operating expenses:
−Removed: Research and development 188,253 — 188,253 180,968 — 180,968
−Removed: General and administrative 54,449 — 54,449 58,303 — 58,303
+Added: Significant operating expenses:
+Added: Cema-cel 36,369 43,225
+Added: All other development costs 23,937 24,463
+Added: Payroll 70,862 87,854
+Added: Facilities & IT-related spend 31,727 33,674
+Added: Supporting external spend 27,337 43,248
+Added: Other operating expenses 82,989 95,368
Total operating expenses 273,221 327,832
−Removed: Loss from operations ( 242,563 ) ( 65 ) ( 242,628 ) ( 239,075 ) ( 66 ) ( 239,141 )
Other income (Expense), net 16,052 472
−Removed: Interest and other income, net 12,042 — 12,042 1,809 — 1,809
−Removed: Other expenses ( 7,487 ) ( 3,414 ) ( 10,901 ) ( 519 ) ( 5,288 ) ( 5,807 )
−Removed: Total other income (expense), net 4,555 ( 3,414 ) 1,141 1,290 ( 5,288 ) ( 3,998 )
−Removed: Net loss ( 238,008 ) ( 3,479 ) ( 241,487 ) ( 237,785 ) ( 5,354 ) ( 243,139 )
−Removed: Other comprehensive income:
−Removed: Net unrealized (loss) gain on available-for-sale investments, net of tax 7,515 — 7,515 ( 10,391 ) — ( 10,391 )
−Removed: Net comprehensive loss ( 230,493 ) ( 3,479 ) ( 233,972 ) ( 248,176 ) ( 5,354 ) ( 253,530 )
−Removed: Net loss per share, basic and diluted ( 1.55 ) ( 1.58 ) ( 1.67 ) ( 1.70 )
−Removed: Weighted-average number of shares used in computing net loss per share, basic and diluted 153,087,449 153,087,449 142,809,469 142,809,469
−Removed: Nine Months ended September 30, 2023 Nine Months ended September 30, 2022
−Removed: Condensed Consolidated Statements of Cash Flow As Previously Reported Restatement Adjustment As Restated As Previously Reported Restatement Adjustment As Restated
+Added: Loss before income taxes ( 257,147 ) ( 327,265 )
+Added: Benefit (expense) from income taxes ( 443 ) —
Net loss ( 257,590 ) ( 327,265 )
−Removed: Non-cash collaboration revenue - related party — ( 49 ) ( 49 ) — ( 87 ) ( 87 )
−Removed: Share of losses from equity method investments 7,452 3,414 10,866 3,959 5,288 9,247
−Removed: Changes in operating assets and liabilities:
−Removed: Deferred revenue ( 649 ) 646 ( 3 ) 466 ( 485 ) ( 19 )
−Removed: Other long-term liabilities ( 83 ) ( 532 ) ( 615 ) ( 2,092 ) 638 ( 1,454 )
−Removed: Net cash used in operating activities ( 184,026 ) — ( 184,026 ) ( 158,423 ) — ( 158,423 )
+Added: Cema-Cel includes external development and clinical trial costs related to ALPHA3, ALPHA2, CLL, and ALLO-501 programs.
+Added: All other development costs include external development and clinical trial costs related to ALLO-329, ALLO-316, ALLO-647, BCMA, and other programs.
+Added: Supporting external spend includes professional services, research and development lab supplies and other supporting activities related to the research and development and other business operations.
+Added: Other operating expenses is primarily related to non-cash expenses such as stock-based compensation, impairment, and depreciation and amortization.
+Added: The measure of segment assets is reported on the consolidated balance sheets as total assets.
+Added: Primarily, all revenue generated and all long-lived assets are maintained in the United States.
Subsequent Events
−Removed: On January 3, 2024, the Company entered into a Strategic Collaboration Agreement (the Foresight Agreement) with Foresight Diagnostics, Inc.
−Removed: (Foresight Diagnostics).
−Removed: Pursuant to the Foresight Agreement, the parties have agreed to collaborate on a non-exclusive basis in the development of Foresight Diagnostics' minimal residual disease (MRD) assay as an in vitro diagnostic to identify the MRD+ patient population to be enrolled in the Company's planned ALPHA3 trial of cemacabtagene ansegedleucel (known as ALLO-501A), or cema-cel, for treatment of large B cell lymphoma.
−Removed: Under the Foresight Agreement, the Company has agreed to use its commercially reasonable efforts to obtain regulatory approval of cema-cel, and Foresight Diagnostics has agreed to use its commercially reasonable efforts to obtain regulatory approval of an MRD assay for use as an in vitro diagnostic with cema-cel.
−Removed: The Company has agreed to fund approximately $ 26.0 million in MRD assay development costs, milestone payments for regulatory submissions and assay utilization to process clinical samples.
−Removed: On January 25, 2024, the Company entered into an Amended and Restated Collaboration and License Agreement (the Amended Notch Agreement) with Notch.
−Removed: The Amended Notch Agreement amends and restates the Notch Agreement, dated as of November 1, 2019.
−Removed: Under the Amended Notch Agreement, the Company has relinquished its exclusive rights to all original CAR targets (the Released Targets) except for one CAR target, and has agreed to limit its option right to only one additional CAR target.
−Removed: If the option is exercised, the Company will have a minimum funding commitment for the overall development program.
−Removed: If Notch subsequently out-licenses any of the Released Targets, the Company will be entitled to receive a percentage of upfront and/or milestone payments associated therewith up to a set cap, and will be entitled to a low, single-digit royalty on net sales of products containing a Released Target.
−Removed: In addition, with respect to the Company’s previous equity investments in Notch, the Amended Notch Agreement grants the Company certain anti-dilution protections up to certain limits for certain pre-IPO equity financings.
−Removed: On January 4, 2024, the Company’s Board of Directors approved a reduction in the Company’s workforce of approximately 22 % of the Company’s employees in connection with the Company’s pipeline prioritization and clinical development strategy.
−Removed: The reduction in workforce was substantially completed by the end of January 2024.
−Removed: The Company estimates that it will incur charges of approximately $ 2.9 million for severance payments and employee benefits, primarily in the first quarter of 2024.
+Added: On December 13, 2024, the Company entered into a sublease agreement for approximately 21,793 square feet of office space in one of its leased buildings in South San Francisco.
+Added: The sublease commenced on January 1, 2025, and the sublease term is 24 months, which will expire on December 31, 2026.
+Added: The Company will receive approximately $ 0.7 million in base rent payments over the sublease term.
+Added: On January 1, 2025, the Company entered into an additional sublease agreement for approximately 24,218 square feet of office and laboratory space in one of its leased buildings in South San Francisco.
+Added: The sublease commenced on February 1, 2025, and the sublease term is 24 months, which will expire on January 31, 2027.
+Added: The Company will receive approximately $ 1.6 million in base rent payments over the sublease term.
+Added: On February 19, 2025, the Company entered into an Amended and Restated Strategic Collaboration Agreement with Foresight Diagnostics which expands our collaboration to include the development of Foresight Diagnostics’ MRD assay as a companion diagnostic for use with cema-cel as part of a possible EU and/or UK clinical development program, and as part of an expansion of ALPHA3 to Canadian and Australian clinical trial sites in support of our US clinical development program.
+Added: As part of this amendment, we have agreed to fund approximately $ 37.3 million in MRD assay development costs, milestone payments for U.S., and certain international regulatory submissions and assay utilization costs to process clinical samples, all in addition to the financial commitments under the Foresight Agreement.
+Added: On February 3, 2025, the Company received an additional award of $ 3.4 million from CIRM for achieving a specified operational milestone related to the clinical development of ALLO-316.
+Added: Subsequent to the year ended December 31, 2024, the Company sold an aggregate of 3,842,282 shares of common stock in ATM offerings resulting in net proceeds of $ 10.0 million.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.