Atara Biotherapeutics Inc
For the period ended Dec 31, 2024. Filed Mar 7, 2025.
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FY2024 · Filed Mar 7, 2025
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Notes to Consolidated Financial Statements
Description of Business
Atara Biotherapeutics, Inc. (Atara, we, our or the Company) was incorporated in August 2012 in Delaware. Atara is a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr Virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune disease.
Our most advanced T-cell immunotherapy program, tab-cel® (tabelecleucel), has received marketing authorization approval under the proprietary name Ebvallo™ by the European Commission (EC) for commercial sale and use in the European Economic Area (EEA), by the Medicines and Healthcare products Regulatory Agency (MHRA) for commercial sale and use in the United Kingdom (UK) and by Swissmedic for commercial sale and use in Switzerland. Tab-cel is currently in Phase 3 development in the US. In October 2021, we entered into a commercialization agreement (Pierre Fabre Commercialization Agreement) with Pierre Fabre Medicament (Pierre Fabre), as amended in September 2022, pursuant to which we granted to Pierre Fabre an exclusive, field-limited license to commercialize and distribute Ebvallo in Europe and select emerging markets in the Middle East, Africa, Eastern Europe and Central Asia (the Initial Territory), following regulatory approval. In October 2023, we amended and restated the Pierre Fabre Commercialization Agreement (A&R Commercialization Agreement). Pursuant to the A&R Commercialization Agreement, Pierre Fabre’s exclusive rights to research, develop, manufacture, commercialize and distribute tab-cel (Ebvallo) were expanded to include all other countries in the world (Additional Territory) in addition to the Initial Territory (Initial Territory and Additional Territory together, the Territory)), subject to our performance of certain obligations. See Note 5 for further information. In December 2022, we sold a portion of our right to receive royalties and certain milestones in Ebvallo under the Pierre Fabre Commercialization Agreement to HCR Molag Fund L.P. (HCRx) for a total investment amount of $31.0 million, subject to a repayment cap between 185% and 250% of the total investment amount by HCRx. See Note 6 for further information.
We have licensed rights to T-cell product candidates from Memorial Sloan Kettering Cancer Center (MSK), rights related to our next-generation CAR T programs from MSK, and rights to know-how and technology from the Council of the Queensland Institute of Medical Research (QIMR Berghofer). See Note 9 for further information.
In November 2023, we announced a reduction in force that reduced our workforce by approximately 30%. We recognized $6.7 million in total for severance and related benefits for employees laid off under the reduction in force. These charges are one-time termination benefits and are all cash charges. In January 2024, we announced a strategic reduction in workforce of approximately 25%. We recognized $5.1 million in total for severance and related benefits for employees laid off under the reduction in force. These charges are one-time termination benefits and are all cash charges. The majority of the associated costs are cash expenditures and primarily represent one-time termination benefits. Refer to Note 8 for further information.
Summary of Significant Accounting Policies
Principles of Consolidation
The consolidated financial statements include the accounts of Atara and our wholly owned subsidiaries. All intercompany balances and transactions are eliminated in consolidation.
Segment and Geographic Information
We operate and manage our business asone operating and reportable segment, which is the business of developing therapeutics. Our President & Chief Executive Officer, who is our chief operating decision maker (CODM), reviews financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance. The CODM assesses performance for the business and decides how to allocate resources based on net loss that also is reported on the income statement as consolidated net loss. The CODM uses net loss to monitor expenditures and budget versus actual results. The measure of segment assets is reported on the balance sheet as total consolidated assets. The following tables represent information provided to the chief operating decision maker:
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Revenue | $128,940 | $8,573 |
| Less: | ||
| Cost of commercialization revenue | 21,009 | 8,886 |
| Platform sciences, development and operations expense | 77,444 | 122,940 |
| Medical and safety expense | 44,138 | 67,445 |
| Regulatory and quality expense | 29,901 | 34,400 |
| General and administrative expense | 39,886 | 50,908 |
| Other segment items* | 1,965 | 120 |
| Net loss | (85,403) | (276,126) |
*Other segment items include Other Income (expense), net and Provision for (benefit from) income taxes
Substantially all of our assets are located in the U.S. All commercialization and collaboration revenue recognized in 2024 and 2023 related to our agreements with Pierre Fabre, a French company.
Use of Estimates
We prepare our consolidated financial statements in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP), which requires us to make estimates and assumptions that affect the amounts reported in our consolidated financial statements and accompanying notes. The level of uncertainty in estimates and assumptions increases with the length of time until the underlying transactions are completed. Significant estimates and assumptions relied upon in preparing these financial statements include those related to revenue recognition, accrued research and development expenses, stock-based compensation expense, liability related to the sale of future revenues and income taxes. Additionally, we use available market information to assess the fair value of our short-term investments. Actual results could differ materially from those estimates. If actual amounts differ from estimates, we include the updates in our consolidated results of operations in the period the actual amounts become known. Historically, the aggregate differences, if any, between our estimates and actual amounts in any year have not had a material effect on our consolidated financial statements.
June 2024 Reverse Stock Split
At our annual meeting of stockholders held on June 10, 2024, the stockholders of Atara approved a proposal to authorize our Board of Directors (the Board) to amend our Amended and Restated Certificate of Incorporation to effect a reverse stock split. The Board approved the reverse stock split on June 10, 2024 and, on June 20, 2024, we effected a 1-for-25 reverse stock split of our common stock. The par value and the authorized shares of the common stock were not adjusted as a result of the reverse stock split. All equity related information including per share amounts for all periods presented in these condensed consolidated financial statements and the notes thereto have been adjusted retroactively, where applicable, to reflect the effect of this reverse stock split.
Liquidity Risk
We have incurred significant operating losses since inception and have relied primarily on public and private equity financings and receipts from commercialization and license and collaboration agreements to fund our operations. As we continue to incur losses, our transition to profitability will depend on the successful development, approval and commercialization of product candidates and on the achievement of sufficient revenues to support our cost structure. We may never achieve sustained operating cash inflows or profitability.
Going Concern
We have incurred operating losses since inception and we expect that existing cash, cash equivalents and short-term investments as of December 31, 2024, will not be sufficient to fund our planned operations for at least 12 months after the issuance of the accompanying consolidated financial statements. Although we anticipate the receipt of certain payments from the amended and restated Pierre Fabre Commercialization Agreement, such payments are contingent upon the successful filing and approval of the tab-cel BLA, as well as the completion of specific development and regulatory activities by us and actions taken by third parties, and are, therefore, uncertain at this time.
To alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, we plan to secure additional capital, potentially through a combination of public or private security offerings; use of our ATM facility as described in Note 10; and/or strategic transactions. We may need to raise additional funding as required based on the status of our development programs and our projected cash flows. Although we have been successful in raising capital in the past, and expect to continue to raise capital as required, there is no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to fund continuing operations, if at all, or identify and enter into any strategic transactions that will provide the capital that we will require. If we are unable to obtain sufficient funding on acceptable terms, we could be forced to delay, limit, reduce or terminate preclinical studies, clinical studies or other development activities for one or more of our product candidates, which could have a material adverse effect on our business, results of operations, and financial condition. Accordingly, we have concluded that substantial doubt exists with respect to our ability to continue as a going concern for at least 12 months after the issuance of the accompanying consolidated financial statements. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Concentration of Credit Risk and Other Uncertainties
We place cash and cash equivalents in the custody of financial institutions that management believes are of high credit quality, the amount of which at times, may be in excess of the amount insured by the Federal Deposit Insurance Corporation. We also make short-term investments in money market funds; U.S. Treasury, government agency and corporate debt obligations; commercial paper; certificates of deposit; and asset-backed securities, which can be subject to certain credit risk. We strive to mitigate this credit risk by investing in high-grade instruments, limiting our exposure to any one issuer and monitoring the ongoing creditworthiness of the financial institutions and issuers.
Currency Translation
Transactions and monetary assets and liabilities that are denominated in a foreign currency are translated into U.S. dollars at the current exchange rate on the transaction date and as of each balance sheet date, respectively, with gains or losses on foreign exchange changes recognized in interest and other income (expense), net in the consolidated statements of operations and comprehensive loss. Foreign currency-denominated monetary assets and liabilities as of December 31, 2024 were not material.
Cash, Cash Equivalents and Short-Term Investments
Cash and cash equivalents are defined as highly liquid investments with original maturities of 90 days or less at the date of purchase.
Investments with original maturities of greater than 90 days are classified as short-term investments on the balance sheet.
As our entire investment portfolio is considered available for use in current operations, we classify all investments as available-for-sale and as current assets, even though the stated maturity may be more than one year from the current balance sheet date. Available-for-sale securities are carried at fair value, with unrealized gains and losses reported in accumulated other comprehensive loss, which is a separate component of stockholders’ equity in the consolidated balance sheet.
The amortized cost of securities is adjusted for amortization of premiums and accretion of discounts to maturity, which are recorded to interest income in the consolidated statements of operations and comprehensive loss.
Changesin the fair value of available-for-sale securities impact the consolidated statements of operations and comprehensive loss only when such securities are sold, if an allowance for credit losses is recognized or if an impairment is recognized. Realized gains and losses on the sale of securities are determined by specific identification of each security’s cost basis. We regularly review our investment portfolio to determine if any security is impaired, which would require us to record an allowance for credit losses or impairment charge in the period any such determination is made. In making this judgment, we evaluate, among other things, the duration and extent to which the fair value of a security is less than its cost, our intent to sell or whether it is more likely than not that wewill be required to sell the security before recovery of its amortized cost basis, the financial condition of the issuer and any changes thereto, and, as necessary, the portion of a decline in fair value that is credit-related. This assessment could change in the future due to new developments or changes in assumptions related to any particular security. Realized gains and losses, allowances for credit losses and impairments on available-for-sale securities, if any, are recorded to other income (expense), net in the statements of operations and comprehensive loss.
Fair Value Measurement
The carrying amounts of certain of our financial instruments including cash equivalents, accounts receivable, other current assets, accounts payable and accrued liabilities approximate fair value due to their short maturities. Short-term investments are comprised of available-for-sale securities, which are carried at fair value.
Financial Instruments
Our financial assets are measured at fair value on a recurring basis using the following hierarchy to prioritize valuation inputs, in accordance with applicable GAAP:
Level 1: Quoted prices in active markets for identical assets or liabilities that we have the ability to access
Level 2: Observable market-based inputs or unobservable inputs that are corroborated by market data such as quoted prices, interest rates and yield curves
Level 3: Inputs that are unobservable data points that are not corroborated by market data
We review the fair value hierarchy classification on a quarterly basis. Changes in the ability to observe valuation inputs may result in a reclassification of levels of certain securities within the fair value hierarchy. We recognize transfers into and out of levels within the fair value hierarchy in the period in which the actual event or change in circumstances that caused the transfer occurs. There have been no transfers between Level 1, Level 2, and Level 3 in any periods presented.
Financial assets and liabilities are considered Level 2 when their fair values are determined using inputs that are observable in the market or can be derived principally from or corroborated by observable market data such as pricing for similar securities, recently executed transactions, cash flow models with yield curves, and benchmark securities. In addition, Level 2 financial instruments are valued using comparisons to like-kind financial instruments and models that use readily observable market data as their basis. U.S. Treasury, government agency and corporate debt obligations, commercial paper and asset-backed securities are valued primarily using market prices of comparable securities, bid/ask quotes, interest rate yields and prepayment spreads and are included in Level 2.
Financial assets and liabilities are considered Level 3 when their fair values are determined using pricing models, discounted cash flow methodologies, or similar techniques, and at least one significant model assumption or input is unobservable. We have no Level 3 financial assets or liabilities.
Accounts Receivable, net
Accounts receivable are primarily amounts due from our commercialization partner.
We estimate the allowance for doubtful accounts using the current expected credit loss model, or CECL model. Under the CECL model, the allowance for doubtful accounts reflects the net amount expected to be collected from the accounts receivable. We evaluate the collectability of these cash flow based on the asset’s amortized cost, the risk of loss even when that risk is remote, losses over an asset’s contractual life, and other relevant information available to us. Accounts receivable balances are written off against the allowance when it is probable that the receivable will not be collected. Given the nature and history of our accounts receivable, we determined that an allowance for doubtful accounts was not required for the periods presented.
Inventories
Inventories are stated at the lower of cost or estimated net realizable value, on a specific identification basis. We use actual costs to determine our cost basis for inventories. Inventories consist of raw materials, work-in-process and finished goods.
We begin capitalizing costs as inventory when the product candidate receives regulatory approval and when the manufacturing facility producing such inventory is qualified by the relevant regulatory agency. Prior to regulatory approval and facility qualification, we record such production costs related to product candidates as research and development expenses. Any manufactured product that is available for commercial sale is recorded to inventory; to the extent it is later used for clinical studies, such inventory costs are then recorded within research and development expenses.
We assess the recoverability of our inventory each reporting period and reduce the carrying value of the inventory when items are determined to be obsolete, defective or in excess of forecasted production requirements. Inventory write-downs for excess, defective and obsolete inventory are recorded within cost of commercialization revenue.
Property and Equipment, net
Property and equipment are stated at cost and depreciated using the straight-line method over the estimated useful lives of the assets, ranging from three tofive years, except for leasehold improvements, which are depreciated on a straight-line basis over the lesser of the estimated useful life of the leasehold improvement or the lease term. Costs incurred to acquire, construct or install property and equipment during the construction stage of a capital project or costs incurred to purchase and develop internal use software during the application development stage are recorded as construction in progress. Maintenance and repairs are expensed as incurred.
Long-lived Assets
We evaluate the carrying amount of our long-lived assets whenever events or changes in circumstances indicate that the assets may not be recoverable. An impairment loss would be recognized when estimated future cash flows expected to result from the use of the asset and its eventual disposition are less than the carrying amount of the asset. To date, there have beenno such impairment losses.
Asset Retirement Obligation (ARO)
An ARO is a legal obligation associated with the retirement of long-lived assets pertaining to leasehold improvements. These liabilities are initially recorded at fair value and the related asset retirement costs are capitalized by increasing the carrying amount of the related assets by the same amount as the liability. Asset retirement costs are subsequently depreciated over the useful lives of the related assets. Subsequent to initial recognition, we record period-to-period changes in the ARO liability resulting from the passage of time and revisions to either the timing or the amount of the original estimate of undiscounted cash flows. We derecognize ARO liabilities when the related obligations are settled.
Leases
We determine if a contract is or contains a lease at contract inception. Operating leases are included in operating lease assets, other current liabilities, and operating lease liabilities on our consolidated balance sheets. Our policy is to not recognize right-of-use (ROU) assets and lease liabilities for short-term operating leases with terms of 12 months or less; we recognize short-term lease expense for these leases on a straight-line basis over the lease term. Operating lease ROU assets and long-term operating lease liabilities are presented separately and operating lease liabilities payable in the next twelve months are recorded in other current liabilities. Finance lease ROU assets are recorded in other assets and the related finance lease liabilities are presented in other current liabilities and other long-term liabilities.
Lease assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. The lease term includes renewal options that we are reasonably certain of exercising as of the commencement date. None of the lease terms used to calculate the future minimum lease payments at commencement date include renewal options. As most of our leases do not provide an implicit rate, we use our incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The incremental borrowing rate for our leases is determined based on lease term and currency in which lease payments are made, adjusted for impacts of collateral. Lease assets also includes any lease payments made and excludes lease incentives and initial direct costs incurred. Operating lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. Finance lease assets are amortized over the shorter of the lease term or the asset’s estimated useful life.
Our facilities and equipment operating leases have lease and non-lease components and we have made a policy election to account for the lease and non-lease components as a single lease component.
We are considered the sub-lessor for certain of our leases where we have entered into a sub-lease agreement with or have assigned our lease to another party. Rental income was not material for any period presented and we record rental income as a reduction to rent expense within operating expenses.
We analyze whether or not amendments to existing leases classify as a lease modification or a full or partial termination of the existing lease. To the extent a partial lease termination is identified, our accounting policy is to decrease the existing right-of-use asset on a basis proportionate to the reduction in lease liability resulting from the partial termination.
Accruals of Research and Development Costs
We record accruals for estimated research and development costs based on an evaluation of our vendors’ progress towards completion of specific tasks, using data such as patient enrollment, clinical site activations or information provided to us by our vendors regarding their actual costs incurred. Payments for these activities are based on the terms of individual contracts and payment timing may differ significantly from the period in which the services are performed. We determine accrual estimates through reports from and discussions with internal personnel and outside service providers as to the progress or state of completion of studies, or the services completed. Our estimates of accrued expenses as of each balance sheet date are based on the facts and circumstances known at the time. Costs that are paid in advance of performance are deferred as a prepaid asset and recognized as expense as the services are provided.
Sale of Future Revenues
To the extent that we account for the sale of future revenues as debt in accordance with ASC 470, we amortize the liability and recognize interest expense related to the sale of future revenues using the effective interest rate method over the estimated life of the underlying agreement. The liability and related interest expense are based on our current estimate of expected future payments over the life of the arrangement. We re-assess the amount and timing of expected payments each reporting period using a combination of internal projections and forecasts from external resources and record interest expense on the carrying value of the liability using the imputed effective interest rate on a prospective basis.
Revenue Recognition
For contracts that are determined to be within the scope of Accounting Standards Codification Topic 606 (Accounting Standards Update (ASU) No. 2014-09), Revenue from Contracts with Customers, and all subsequent amendments (collectively, ASC 606), revenue is recognized as we satisfy performance obligations and when a customer obtains control of the promised goods or services. The amount of revenue recognized reflects the consideration to which we expect to be entitled to receive in exchange for these goods and services. To achieve this core principle, we apply the following five steps (i) identify the contract with the customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when or as we satisfy a performance obligation. We only apply the five-step model to contracts when we determine that collection of substantially all consideration for goods and services that are transferred is probable based on the customer’s intent and ability to pay the promised consideration.
Performance obligations promised in a contract are identified based on the goods and services that will be transferred to the customer that are both capable of being distinct and are distinct in the context of the contract. To the extent a contract includes multiple promised goods and services, we apply judgment to determine whether promised goods and services are both capable of being distinct and distinct in the context of the contract. If these criteria are not met, the promised goods and services are accounted for as a combined performance obligation.
The transaction price is determined based on the consideration to which we will be entitled in exchange for transferring goods and services to the customer. To the extent the transaction price includes variable consideration, we estimate the amount of variable consideration that should be included in the transaction price utilizing either the expected value method or the most likely amount method, depending on the nature of the variable consideration. Variable consideration is included in the transaction price if, in our judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Any estimates, including the effect of the constraint on variable consideration, are evaluated at each reporting period for any changes. Determining the transaction price requires significant judgment, which is discussed in further detail for our out-license agreements in Note 5. Our out-license agreements do not contain a significant financing component.
If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price to each performance obligation on a relative standalone selling price basis unless the transaction price is variable and meets the criteria to be allocated entirely to a performance obligation or to a distinct service that forms part of a single performance obligation. The consideration to be received is allocated among the separate performance obligations based on relative standalone selling prices. We typically determine standalone selling prices using an expected cost plus margin approach model.
We satisfy performance obligations either over time or at a point in time. Revenue is recognized over time if either (i) the customer simultaneously receives and consumes the benefits provided by our performance, (ii) our performance creates or enhances an asset that the customer controls as the asset is created or enhanced or (iii) our performance does not create an asset with an alternative use to the entity and we have an enforceable right to payment for performance completed to date. We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition. If we do not satisfy a performance obligation over time, the related performance obligation is satisfied at a point in time by transferring control of a promised good or service to a customer.
As discussed in further detail in Note 5, the terms of our customer contracts include potential payments to us for some or all of the following: nonrefundable, upfront fees; development, regulatory, and commercial milestone payments; research and development funding payments; royalties on the net sales of licensed products; and transition plan cost reimbursements for certain development, safety, regulatory, and process science services. These payments relate to promised goods or services for which revenue will be recognized upon our satisfaction of the underlying performance obligations.
Licenses of intellectual property: If the license of our intellectual property is determined to be distinct from the other performance obligations identified in an arrangement, we recognize revenues from consideration allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are combined with other promises, we utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue.
Upfront payments: Upfront payments and fees are recorded as deferred revenue upon receipt or when due and may require deferral of revenue recognition to a future period until we have satisfied our obligations under these arrangements.
Milestone payments: At the inception of each arrangement that includes development milestone payments, we evaluate the probability of reaching the milestones and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur in the future, the associated milestone value is included in the transaction price. The transaction price is then allocated to each performance obligation on a relative standalone selling price basis, for which we recognize revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, we re-evaluate the probability of achievement of such development milestones and any related constraint and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license and collaboration revenues and the consolidated statements of operations and comprehensive loss in the period of adjustment.
Royalties: For arrangements that include sales-based royalties, including milestone payments based on levels of sales, if the license is deemed to be the predominant item to which the royalties relate, we recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied, or partially satisfied. To date, we have not recognized material royalty revenue resulting from our out-licensing agreements.
Transition plan cost reimbursements: Reimbursements for certain development, safety, regulatory and manufacturing services are recorded as revenue as we perform the services and related obligations identified within the transition plans for our customers.
Certain judgments affect the application of our revenue recognition policy. For example, we record short-term and long-term deferred revenue based on our best estimate of when such revenue will be recognized. Short-term deferred revenue consists of amounts that are expected to be recognized as revenue in the next 12 months, and long-term deferred revenue consists of amounts that we expect will be recognized after the next 12 months. This estimate is based on forecasted patient demand, our current operating plan and expected dates of technology transfer, and if these items should change in the future, we may recognize a different amount of deferred revenue over the next 12-month period.
Cost of commercialization revenue consists primarily of expenses associated with cell selection services performed for Pierre Fabre, in-license sales-related milestone costs, period manufacturing expenses and adjustments to reduce inventory to the lower of cost or net realizable value. The majority of tab-cel (Ebvallo) sold to Pierre Fabre to date had been produced prior to receiving regulatory approval. Costs incurred to produce tab-cel (Ebvallo) prior to regulatory approval, referred to as zero cost inventories, have been recorded as research and development expense in our consolidated statement of operations and comprehensive income (loss). As we sell Ebvallo produced after receiving regulatory approval and in a qualified manufacturing facility, and as revenue is recognized on such Ebvallo sales, cost of commercialization revenue includes direct and indirect costs related to the production of Ebvallo. Such costs include, but are not limited to, CMO costs, quality testing and validation, materials used in production, and an allocation of compensation, benefits and overhead costs associated with employees involved with production.
In 2024 and 2023, cost of commercialization revenue included adjustments of $18.5 million and $6.6 million, respectively, to write-off of inventories and to reflect them at the lower of cost or net realizable value.
Research and Development Expense
Research and development expense consists of costs incurred in performing research and development activities, including compensation and benefits for research and development employees; expenses incurred under agreements with contract research organizations and investigative sites that conduct clinical and preclinical studies; expense incurred under agreements with contract manufacturing organizations related to acquiring and manufacturing clinical study materials and other supplies to support the manufacture of our product candidates; payments under licensing and research and development agreements; other outside services and consulting costs, and facilities, information technology and overhead expenses. Research and development costs are expensed as incurred.
Stock-Based Compensation Expense
We account for stock-based compensation expense, including the expense of restricted common stock awards, grants of restricted stock units (RSUs), and stock options that may be settled in shares of our common stock, based on the fair values of the equity instruments issued. The fair value is determined on the measurement date, which is generally the date of grant. The fair value of our RSUs is measured at the closing market price of our common stock on the measurement date. The fair value for our stock option awards is determined at the grant date using the Black-Scholes valuation model.
In determining the fair value of stock option awards granted, we use the Black-Scholes valuation model and assumptions include:
Expected term – We derived the expected term using the “simplified” method (the expected term is determined as the average of the time-to-vesting and the contractual life of the options), as we have limited historical information to develop expectations about future exercise patterns and post vesting employment termination behavior.
Expected volatility – Expected volatility is estimated based on the historical volatility of Atara’s stock price historical volatility for the same period of time as the expected term of the associated award.
Expected dividend – We have not historically declared or paid dividends to our stockholders and have no plans to pay dividends; therefore, we assumed an expected dividend yield of 0%.
Risk-free interest rate – The risk-free interest rate is based on the yield on U.S. Treasury securities with the expected term of the associated award.
For awards with performance-based vesting criteria, we assess the probability of the achievement of the performance conditions at the end of each reporting period and begin to recognize the share-based compensation costs when it becomes probable that the performance conditions will be met. For awards that are subject to both service and performance conditions, no expense is recognized until it is probable that performance conditions will be met. Stock-based compensation expense for awards with time-based vesting criteria is recognized as expense on a straight-line basis over the requisite service period. Stock-based compensation expense for awards with performance and other vesting criteria is recognized as expense under an accelerated graded vesting model. We account for forfeitures of stock-based awards as they occur.
Defined Contribution Plan
We have one qualified 401(k) plan covering all eligible employees. Under the plan, employees may contribute up to the statutory allowable amount for any calendar year. We make matching contributions, equal to 50% of each dollar contributed up to the first 6% of an individual’s eligible earnings, up to the annual IRS maximum. For the years ended December 31,2024 and 2023 we recorded matching contributions of approximately $1.2 million and $1.9 million, respectively.
Income Taxes
We use the asset and liability method to account for income taxes. We record deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the financial statement carrying amounts and the tax basis of assets and liabilities using enacted tax rates expected to be in effect when the differences are expected to reverse. Valuation allowances are provided when necessary to reduce net deferred tax assets to the amount that is more likely than not to be realized. Based on the available evidence, we are unable, at this time, to support the determination that it is more likely than not that our deferred tax assets will be utilized in the future. Accordingly, we recorded a full valuation allowance as of December 31, 2024 and 2023. We intend to maintain valuation allowances until sufficient evidence exists to support their reversal.
Tax benefits related to uncertain tax positions are recognized when it is more likely than not that a tax position will be sustained during an audit. Interest and penalties related to unrecognized tax benefits are included within the provision for income tax.
Comprehensive Income (Loss)
Comprehensive income (loss) is defined as a change in equity of a business enterprise during a period resulting from transactions from non-owner sources. Our other comprehensive income (loss) is comprised solely of unrealized gains (losses) on available-for-sale securities and is presented net of taxes. There have not been any material reclassifications from other comprehensive income (loss) to net loss recorded during any period presented.
Recent Accounting Pronouncements
We consider the applicability and impact of any Accounting Standards Updates (ASUs) issued by the Financial Accounting Standards Board (FASB). Other than the ASUs listed below, all other ASUs were assessed and determined to be either not applicable to Atara or are expected to have minimal impact on our consolidated financial statements.
In December 2023, the FASB issued ASU No. 2023-09 Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires enhancements to certain income tax disclosures, most notably the income tax rate reconciliation and income taxes paid. We will adopt the amendments effective for the fiscal year ending December 31, 2025. We do not expect the adoption of this standard will have a material impact on our disclosures.
In November 2024, the FASB issued ASU No. 2024-03 Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40), which requires disclosure of additional information about specific expense categories underlying certain income statement expense line items. This ASU is effective for our annual periods beginning October 1, 2027, and requires either prospective or retrospective application. We are currently evaluating the impact of the ASU on our disclosures.
Net Loss per Common Share
Basic net loss per common share is calculated by dividing net loss by the weighted-average number of shares of common stock and pre-funded warrants outstanding during the period, without consideration of common share equivalents. Diluted net loss per common share is computed by dividing net loss by the weighted-average number of shares of common stock, pre-funded warrants and common share equivalents outstanding for the period. The pre-funded warrants are included in the computation of basic and diluted net loss per common share as the exercise price is negligible and the pre-funded warrants are fully vested and exercisable. Common share equivalents are only included in the calculation of diluted net loss per common share when their effect is dilutive.
Potential dilutive securities, which include unvested RSUs, unvested performance-based RSUs and performance-based options to purchase common stock for which established performance criteria have been achieved as of the end of the respective periods, vested and unvested options to purchase common stock and shares to be issued under our employee stock purchase plan (ESPP), have been excluded from the computation of diluted net loss per common share as the effect is antidilutive. Therefore, the denominator used to calculate both basic and diluted net loss per common share is the same in all periods presented.
The following table represents the potential common shares issuable pursuant to outstanding securities as of the dates listed that were excluded from the computation of diluted net loss per common share, as their inclusion would have an antidilutive effect:
| As of December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Unvested RSUs | 414,470 | 250,449 |
| Vested and unvested options | 222,333 | 428,266 |
| ESPP share purchase rights | 5,971 | 7,434 |
| Total | 642,774 | 686,149 |
Financial Instruments
The following tables summarize the estimated fair value and related valuation input hierarchy of our available-for-sale securities as of each period end:
| Total · Total · Total · Total | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Amortized · Unrealized · Unrealized · Estimated | |||||||||
| As of December 31, 2024: · Input Level · Cost · Gain · Loss · Fair Value | |||||||||
| (in thousands) | |||||||||
| Money market funds | Level 1 | $13,718 | $— | $— | $13,718 | ||||
| U.S. Treasury obligations | Level 2 | 27,450 | 8 | $27,458 | |||||
| Total available-for-sale securities | 41,168 | 8 | — | 41,176 | |||||
| Less: amounts classified as cash equivalents | (23,708) | (2) | $(23,710) | ||||||
| Amounts classified as short-term investments | $17,460 | $6 | $— | $17,466 | |||||
| Total · Total · Total · Total | |||||||||
| Amortized · Unrealized · Unrealized · Estimated | |||||||||
| As of December 31, 2023: | Input Level | Cost | Gain | Loss | Fair Value | ||||
| (in thousands) | |||||||||
| Money market funds | Level 1 | $14,376 | $— | $— | $14,376 | ||||
| U.S. Treasury obligations | Level 2 | 9,928 | 1 | — | 9,929 | ||||
| Corporate debt obligations | Level 2 | 26,089 | — | (205) | 25,884 | ||||
| Total available-for-sale securities | 50,393 | 1 | (205) | 50,189 | |||||
| Less: amounts classified as cash equivalents | (24,304) | (1) | — | (24,305) | |||||
| Amounts classified as short-term investments | $26,089 | $— | $(205) | $25,884 | |||||
The amortized cost and fair value of our available-for-sale securities by contractual maturity were as follows:
| As of December 31, 2024 | As of December 31, 2023 | |||
|---|---|---|---|---|
| Amortized | Estimated | Amortized | Estimated | |
| Cost | Fair Value | Cost | Fair Value | |
| (in thousands) · (in thousands) | ||||
| Maturing within one year | $41,168 | $41,176 | $50,393 | $50,189 |
| Maturing in one to five years | — | — | — | — |
| Total available-for-sale securities | $41,168 | $41,176 | $50,393 | $50,189 |
We considered the current and expected future global economic and market conditions, including, but not limited to, the wars in Ukraine and the Middle East and increased tensions between the U.S. and China, and determined that our investments have not been significantly impacted. As of December 31, 2024, no significant facts or circumstances were present to indicate a deterioration in the creditworthiness of the issuers of the available-for-sale securities we hold, and we have no requirement or intention to sell these securities before maturity or recovery of their amortized cost basis. For all securities with a fair value less than its amortized cost basis, we determined the decline in fair value below amortized cost basis to be non-credit related and no allowance for losses has been recorded. During the years ended December 31, 2024 and 2023, we did not recognize any impairment losses on our investments.
We have elected the practical expedient to exclude the applicable accrued interest from both the fair value and the amortized cost basis of our available-for-sale securities for purposes of identifying and measuring an impairment. We present accrued interest receivable related to our available-for-sale securities in other current assets, separate from short-term investments, on our consolidated balance sheet. As of December 31, 2024 and 2023, accrued interest receivable was immaterial. Our accounting policy is to not measure an allowance for credit losses for accrued interest receivables and to write-off any uncollectible accrued interest receivable as a reversal of interest income in a timely manner, which we consider to be in the period in which we determine the accrued interest will not be collected by us. We havenot written off any accrued interest receivables for the years ended December 31,2024 and 2023.
In addition, restricted cash collateralized by a certificate of deposit is a financial asset measured at fair value and is a Level 1 financial instrument under the fair value hierarchy.
The following table provides a reconciliation of cash, cash equivalents and restricted cash within the consolidated balance sheets that sum to the total of the same such amounts in the consolidated statement of cash flows:
| December 31, | December 31, | |
|---|---|---|
| 2024 | 2023 | |
| (in thousands) | ||
| Cash and cash equivalents | $25,030 | $25,841 |
| Restricted cash – short-term | 146 | 146 |
| Total cash, cash equivalents and restricted cash | $25,176 | $25,987 |
Out-license Agreements
Pierre Fabre Agreements
In October 2021, we entered into the Pierre Fabre Commercialization Agreement, pursuant to which, we granted to Pierre Fabre an exclusive, field-limited license to commercialize and distribute Ebvallo in Europe and select emerging markets in the Initial Territory following regulatory approval. In September 2022, we entered into Amendment No. 1 to the Pierre Fabre Commercialization Agreement (the PF Amendment). Under the terms of the PF Amendment, following European Commission approval of Ebvallo for EBV+ PTLD and subsequent filing of the Marketing Authorization Application (MAA) transfer to Pierre Fabre, we received an additional $30 million milestone payment in exchange for, among other things, a reduction in: (i) royalties we are eligible to receive as a percentage of net sales of tab-cel (Ebvallo) in the Territory, and (ii) the supply price mark up on tab-cel purchased by Pierre Fabre. Additionally, we agreed to extend the time period for provision of certain services to Pierre Fabre in the Initial Territory at our cost pursuant to the Pierre Fabre Commercialization Agreement. In December 2022, we sold a portion of our right to receive royalties and certain milestone payments related to Ebvallo in the Initial Territory under the Pierre Fabre Commercialization Agreement to HCRx for a total investment amount of $31.0 million, subject to a repayment cap between 185% and 250% of the total investment amount by HCRx. See Note 6 for further information related to the agreement with HCRx.
In October 2023, we entered into the A&R Commercialization Agreement with Pierre Fabre. Pursuant to the A&R Commercialization Agreement, Pierre Fabre’s exclusive rights to research, develop, manufacture, commercialize and distribute tab-cel were expanded to include all other countries in the world (Additional Territory) in addition to the Initial Territory (together, the Territory), subject to our performance of certain obligations as described below.
Pierre Fabre paid us an upfront cash payment of $45.0 million for the exclusive license grant for the Initial Territory in the fourth quarter of 2021. In December 2022, we met the contractual right to receive $40.0 million in milestone payments upon certain regulatory milestones, for which the cash was received in January 2023. Subject to the terms of the royalty purchase agreement with HCRx, as described in Note 6, we are entitled to receive an aggregate of up to $308.0 million in remaining milestone payments upon achieving certain regulatory and commercial milestones in addition to double-digit tiered royalties as a percentage of net sales of Ebvallo in the Initial Territory, until the later of 12 years after the first commercial sale in each such country, the expiration of specified patent rights, or the expiration of all regulatory exclusivity for Ebvallo on a country-by-country basis. In December 2023, upon the effective date of the A&R Commercialization Agreement, we met the contractual right to receive an additional upfront cash payment of $20.0 million for the expanded exclusive license grant in the Additional Territory, for which the cash was received in January 2024. In March 2024, we met the contractual right to receive $20.0 million in milestone payments upon achieving a regulatory milestone, for which the cash was received in April 2024. In July 2024, we met the contractual right to receive an additional $20.0 million in milestone payments upon achieving acceptance of our biologics license application (BLA) for tab-cel by the United States Food and Drug Administration (FDA) and we received the cash in August 2024. We will also be entitled to receive an aggregate of up to $580.0 millionin additional payments upon achieving certain regulatory and commercial milestones relating to tab-cel in the Additional Territory. We will be eligible to receive double-digit tiered royalties as a percentage of net sales of tab-cel in the Additional Territory until the later of 12 years after the first commercial sale in each such country, the expiration of specified patent rights in each such country, or the expiration of all regulatory exclusivity for tab-cel on a country-by-country basis.
We have entered into a separate manufacturing and supply agreement with Pierre Fabre for us to manufacture Ebvallo for Pierre Fabre to use in the Initial Territory based on a fixed price through December 31, 2023 and at a price equal to cost plus a margin for orders placed after December 31, 2023, subject to a maximum annual increase. Pierre Fabre will assume the responsibility and cost for the manufacture and supply of tab-cel (Ebvallo) in the Territory upon the Manufacturing Transition Date, which is defined as the earlier of: i) all activities relating to the transfer of tab-cel manufacturing, pursuant to the A&R Commercialization Agreement, from Atara to Pierre Fabre have been completed to the reasonable satisfaction of both parties, or ii) December 31, 2025, through the remainder of the term of the A&R Commercialization Agreement. Pierre Fabre and we are to use commercially reasonable efforts to achieve this prior to the earlier transfer date from Atara to Pierre Fabre of the first marketing authorization in the Additional Territory or the first BLA (PF Transfer Date). Prior to the Manufacturing Transition Date, we are responsible for manufacturing and supplying tab-cel (Ebvallo) to Pierre Fabre in the Territory. Without transfer of the manufacturing technology, no other party can manufacture tab-cel (Ebvallo).
In August 2024, we sold certain intermediates used in the manufacture of Ebvallo to Pierre Fabre for $15.5 million, transferring title and risk of loss to these intermediates in advance of the Manufacturing Transition Date, which guarantees Pierre Fabre supply and control of intermediates to be used in the production of Ebvallo. We received payment for these intermediates in September 2024.
Cell selection is the process of identifying the appropriate cell line from available tab-cel inventory to be used for a patient. We are responsible for the performance of commercial cell selection services in the Initial Territory at our cost through the earlier of the PF Transfer Date, June 30, 2025 or a date otherwise agreed to by Pierre Fabre and us. We are responsible for the performance of commercial cell selection services in the Additional Territory through the earlier of the PF Transfer Date or a date otherwise agreed to by Pierre Fabre and us, at the sole expense of Pierre Fabre. Without transfer of the cell selection technology, no other party can provide such services. In February 2025, we transferred commercial cell selection in the Initial Territory and the Additional Territory to Pierre Fabre.
As part of the Pierre Fabre Commercialization Agreement, we formed a joint steering committee (JSC) with Pierre Fabre that provides oversight, decision making and implementation guidance regarding the commercialization activities, the responsibilities of which has been expanded to cover the incremental scope of the A&R Commercialization Agreement.
During the applicable period specified in the A&R Commercialization Agreement, we are responsible for various development, safety, process science, and regulatory activities, including obtaining regulatory approval in the United States for tab-cel for EBV-associated post-transplant lymphoproliferative disease. Pierre Fabre will pay us for these services in accordance with the A&R Commercialization Agreement. Pierre Fabre will be responsible, at its cost, for obtaining and maintaining all other required regulatory approvals and for commercialization and distribution of tab-cel in the Additional Territory, including conducting any other clinical study required. We will own any intellectual property rights developed solely by us under the A&R Commercialization Agreement.
Accounting Analysis
Identification of the Contract
We assessed this arrangement in accordance with ASC 606 and concluded that the promises in the A&R Commercialization Agreement represent transactions with a customer.
Identification of the Promises and Performance Obligations
We identified four performance obligations under the A&R Commercialization Agreement, consisting of the following material promises:
(1)
the transfer of intellectual property rights in the form of a license in the Initial Territory, the obligation to participate in the JSC, the manufacture and supply of Ebvallo, a material right for purchases associated with the manufacture and supply of Ebvallo and the performance of cell-selection services. We concluded that the individual promises are not distinct because Pierre Fabre cannot benefit from the license without the other services and vice versa, since Pierre Fabre is not capable of carrying out the manufacturing and supply and cell selection services on their own, until the transfer of the related technologies occur. Consequently, these promises represent a single performance obligation, collectively referred to as the Initial Territory Obligation.
(2)
the transfer of intellectual property rights in the form of a license in the Additional Territory, the manufacture and supply of tab-cel and the performance of cell-selection services, as well as the promises to transfer the related technologies, and perform certain development, safety, regulatory and information technology transition services. We concluded that the promises are not distinct because Pierre Fabre cannot benefit from the license without the other services and vice versa. Consequently, these promises represent a single performance obligation, collectively referred to as the Additional Territory Obligation.
(3)
performance of certain process science services, referred to as the Process Sciences Obligation
(4)
the sale of certain intermediate inventory used in the production of tab-cel in existence on the Manufacturing Transition Date, referred to as the Intermediate Inventory Obligation.
Determination of the Transaction Price
Under the Pierre Fabre Commercialization Agreement, we determined that the $45.0 million upfront payment constituted the entire consideration to be included in the transaction price at the outset of the arrangement, and the $40.0 million in regulatory milestones achieved in December 2022 were added to the transaction price upon meeting the related milestone criteria. The remaining potential regulatory and commercial milestone payments that we are eligible to receive were excluded from the transaction price, as the milestone amounts were fully constrained based on the probability of achievement or have not been earned. None of the future royalty and sales-based milestone payments were included in the transaction price, as the potential payments represent sales-based consideration. We reevaluate the transaction price at the end of each reporting period and as uncertain events are resolved or other changes in circumstances occur, and, as necessary, we adjust our estimate of the transaction price.
Upon the effective date of the A&R Commercialization Agreement, the $20.0 million additional upfront payment received and estimated revenue for the development, safety, regulatory and process science services were added to the transaction price, and the $20.0 million regulatory milestone achieved in March 2024 and the $20.0 million regulatory milestone achieved in July 2024 were added to the transaction price upon meeting the related milestone criteria. The remaining potential regulatory and commercial milestone payments that we are eligible to receive were excluded from the transaction price, as the milestone amounts were fully constrained based on the probability of achievement or have not been earned. None of the future royalty and sales-based milestone payments were included in the transaction price, as the potential payments represent sales-based consideration.
Allocation of the Transaction Price to Performance Obligations
The transaction price was allocated to each performance obligation based on their relative standalone selling price. We developed the estimated standalone selling price for each of the A&R Commercialization Agreement performance obligations with the objective of determining the price at which we would sell such an item if it were to be sold regularly on a standalone basis.
Recognition of Revenue
Commercialization revenue associated with the Initial Territory Obligation is recognized over the period during which the material right exists, which would end upon the Manufacturing Transition Date. Based on these considerations and our forecast of the timing and associated costs of the purchases related to the manufacture and supply of Ebvallo and estimated timing of technology transfer, we estimate the material right in the Initial Territory will exist for approximately one year. We reassess this evaluation each reporting period. Commercialization revenue associated with sales of Ebvallo and intermediate inventory to Pierre Fabre is deferred until we have performed the associated manufacturing of finished Ebvallo product inventory and cell selection services, or once manufacturing and cell selection technology transfers to Pierre Fabre have been completed. At that point, Pierre Fabre would be able to utilize the inventory it had purchased from us on its own.
Commercialization revenue associated with the Additional Territory Obligation and the Process Sciences Obligation is recognized using a cost-based input method based on the amount of actual costs incurred relative to the total budgeted costs expected to be incurred for the respective performance obligations. A cost-based input method of revenue recognition requires us to make estimates of costs to complete our performance obligation. In making such estimates, significant judgment is required to evaluate assumptions related to cost estimates. The cumulative effect of revisions to estimated costs to complete our performance obligation will be recorded in the period in which changes are identified and amounts can be reasonably estimated. We expect to recognize the remaining deferred revenue associated with the Additional Territory Obligation and the Process Sciences Obligation over a period of approximately one year respectively. We reassess this evaluation each reporting period. The transfer of control occurs over the respective time period and, in our judgment, is the best measure of progress towards satisfying the performance obligation. A significant change in these assumptions and estimates could have a material impact on the timing and amount of revenue recognized in future periods. We expect to recognize revenue associated with the Intermediate Inventory Obligation at a point in time on the Manufacturing Transition Date, which is when title and risk of loss, and thus, control, of the intermediate inventory transfers to Pierre Fabre.
Deferred revenue activity related to commercialization revenue for the year ended December 31,2024 was as follows:
| Total | |
|---|---|
| (in thousands) | |
| Deferred revenue, December 31, 2023 | $115,395 |
| Additions | 105,235 |
| Recognized into commercialization revenue | (125,538) |
| Deferred revenue December 31, 2024 | 95,092 |
| Less: deferred revenue – current portion | (95,092) |
| Deferred revenue – long-term, December 31, 2024 | $— |
During the year ended December 31, 2024, we recognized $45.7 million of revenue that was included in the deferred revenue balance as of December 31,2023. During the year ended December 31, 2024, we recognized revenue of $0.9 million related to performance obligations partially satisfied in prior periods related to changes in the transaction price upon achievement of development milestones.
Costs incurred relating to performing the services within the Additional Territory Obligation and Process Sciences Obligation consist of third party expenses and for time incurred by our employees to satisfy requirements set forth by the A&R Commercialization Agreement. These costs are included in research and development expenses in the consolidated statements of operations and comprehensive income (loss) during the year ended December 31, 2024 and 2023. Such costs were $43.3 million for the year ended December 31,2024 and werenot material for the year ended December 31, 2023.
Liability Related to the Sale of Future Revenues
In December 2022, we entered into a Purchase and Sale Agreement (the HCRx Agreement) with HCR Molag Fund, L.P., a Delaware limited partnership, (HCRx). In exchange for a payment of $31.0 million (the Investment Amount) to Atara, net of certain transaction expenses, HCRx obtained the right to receive certain Ebvallo royalties and milestone payments payable by Pierre Fabre under the Pierre Fabre Commercialization Agreement up to an agreed upon multiple of the Investment Amount.
Under the HCRx Agreement, HCRx is entitled to receive tiered royalties on net sales of Ebvallo in the Initial Territory in amounts ranging from the mid-single digits to double digits based on annual net sales. HCRx is also entitled to certain milestone payments due to Atara from Pierre Fabre. The total royalties and milestones payable to HCRx are capped between 185% and 250% of the Investment Amount, depending upon the timing of such royalties and milestones. Upon meeting the cap amount, HCRx’s right to receive royalties and milestone payments will terminate and all rights will revert to Atara. To the extent a certain milestone within the Pierre Fabre Commercialization Agreement is not achieved on or prior to June 30, 2026, we will be required to make a one-time cash payment in the amount of $9.0 million to HCRx, and HCRx shall transfer all of its right, title and interest in this certain $9.0 million milestone payment to Atara. This payment, if required, would be included in the calculation of aggregate payments made to HCRx.
The gross proceeds of the Investment Amount of $31.0 million were recorded as a liability related to the sale of future revenues, net of transaction costs of $0.4 million, and is amortized using the effective interest method over the life of the arrangement.
To determine the amortization of the recorded liability, we are required to estimate the total amount of future payments to be received by HCRx. The sum of these amounts less the $31.0 million proceeds we received will be recorded as interest expense over the life of the HCRx Agreement. We estimate the effective interest rate used to record non-cash interest expense under the HCRx Agreement based on the estimate of future royalty payments to be received by HCRx. As of December 31,2024, the annual effective interest rate was approximately 10%. Over the life of the arrangement, the actual effective interest rate will be affected by the amount and timing of the actual and forecasted royalty and milestone payments to HCRx. At each reporting date, we reassess our estimate of the timing and amounts of future payments made to HCRx, and prospectively adjust the effective interest rate and amortization of the liability as necessary.
The following table presents the changes in the liability related to the sale of future revenues under the HCRx Agreement for the year ended December 31,2024:
| (in thousands) | |
|---|---|
| Liability related to sale of future revenues as of December 31, 2023 | $35,076 |
| Accretion of interest expense on liability related to sale of future revenues | 4,109 |
| Amortization of debt discount and debt issuance costs | 67 |
| Repayment of the liability | (246) |
| Liability related to sale of future revenues as of December 31, 2024 | 39,006 |
| Less: current portion classified within other accrued liabilities | (382) |
| Long-term liability related to sale of future revenues | $38,624 |
Leases
In November 2018, we entered into a lease agreement for office space in Thousand Oaks, California, that expires in February 2026 and for which we have the option to extend the lease for an additional period of five years after the initial term. In February 2025, we moved our headquarters to Atara Research Center (ARC), our existing office, lab, and warehouse space in Thousand Oaks, California. In March 2021, we entered into a lease agreement for the 33,659 square feet of office, lab and warehouse space at ARC. During the third quarter of 2021, the initial 10.5-year lease term commenced, upon substantial completion of the landlord’s work as defined under the agreement. Base rent is subject to annual increases of 3% with each annual anniversary of the rent commencement date. We have the option to extend this lease for two additional five-year periods after the initial term.
Additionally, in 2021, we entered into an amended lease agreement for our office and lab space in Aurora, Colorado, to add additional lab space and in November 2023, we further amended the lease agreement for our office and lab space in Aurora, Colorado, to extend the term of the lease agreement to April 2025.
In February 2017, we entered into a lease agreement (the ATOM Lease) for approximately 90,580 square feet of office, lab and cellular therapy manufacturing space in Thousand Oaks, California. The initial 15-year term of the headlease commenced on February 15, 2018, upon the substantial completion of landlord’s work as defined under the agreement. In April 2022, we assigned the ATOM Lease to FDB in connection with the closing of the sale of the ATOM Facility to FDB. Under ASC 842, we are considered to be the sub-lessor of the ATOM Lease. We have not received novation from the landlord and therefore have not been relieved of our primary obligations under the headlease. Therefore, the ROU asset and lease liability for the ATOM Facility remain on our balance sheet.
We evaluated our vendor contracts to identify embedded leases and determined that the Fujifilm MSA contained items that constituted a lease under ASC 842, Leases, as Atara has the right to substantially all of the economic benefits from the use of the asset and can direct the use of the asset. We concluded that the Fujifilm MSA contains an embedded operating lease for certain dedicated processing rooms for the manufacturing of Atara product and an embedded finance lease for certain freezers dedicated for our use. The Fujifilm MSA includes contractual obligations in the form of payments for the processing rooms and the freezers, each over a term of five years. As a result, we added ROU assets and lease liabilities for the processing rooms and freezers for the initial term of the lease in the amounts of $50.8 million and $4.8 million, respectively. In November 2023, we agreed to forego the use of one processing room for approximately one year in return for a reduction in contractual obligations under the Fujifilm MSA, and in November 2024, we exercised the option to release the processing room to FDB for the remainder of the initial term.
We lease office space in South San Francisco, California under a non-cancellable lease agreement. In December 2021, we entered into a second amendment with the landlord to extend the lease term through May 2025. The amended lease agreement does not include an option to extend the lease term. In connection with the amended lease, we are required to maintain a letter of credit in the amount of $0.1 million to the landlord. In October 2022, we entered into a sub-lease agreement with a third party for this office space. The sub-lease term commenced in November 2022 and expires in May 2025, with no option to extend the sub-lease term. We have not received novation from the landlord and therefore have not been relieved of our primary obligations under the headlease. Therefore, the ROU asset and lease liability for the South San Francisco office remain on our balance sheet.
The maturities of lease liabilities under our operating and finance leases as of December 31,2024 were as follows:
| Operating Leases · Finance Leases | ||
|---|---|---|
| Years Ending December 31, · (in thousands) | ||
| 2025 | $17,004 | $1,263 |
| 2026 | 15,677 | 1,285 |
| 2027 | 5,494 | 437 |
| 2028 | 3,319 | — |
| 2029 | 3,415 | — |
| Thereafter | 9,044 | — |
| Total lease payments | $53,953 | $2,985 |
| Less: amount representing interest | (11,160) | (346) |
| Present value of lease liabilities | $42,793 | $2,639 |
| Other current liabilities | $12,879 | $1,038 |
| Operating lease liabilities – long-term | 29,914 | — |
| Other long-term liabilities | — | 1,601 |
| Total | $42,793 | $2,639 |
The components of lease cost were as follows:
| Year Ended | Year Ended | |
|---|---|---|
| December 31, 2024 | December 31, 2023 | |
| (in thousands) | ||
| Operating lease cost: | ||
| Operating lease cost | $16,930 | $17,192 |
| Short-term lease cost | 193 | 201 |
| Total operating lease cost | $17,123 | $17,393 |
| Finance lease cost: | ||
| Amortization expense | $959 | $976 |
| Interest on lease liabilities | 326 | 416 |
| Total finance lease cost | $1,285 | $1,392 |
Other information related to leases was as follows:
| Year Ended | Year Ended | |
|---|---|---|
| December 31, 2024 | December 31, 2023 | |
| (in thousands, except lease term and discount rate) | ||
| Supplemental Cash Flows Information | ||
| Cash paid for amounts included in the measurement of lease liabilities: | ||
| Operating cash flows for operating leases | $16,019 | $16,660 |
| Operating cash flows for finance leases | 326 | 416 |
| Financing cash flows for finance leases | 892 | 947 |
| Operating lease assets obtained in exchange for lease obligations: | $— | $312 |
| Finance lease assets obtained in exchange for lease obligations: | — | — |
| Non-cash (decrease) increase to operating lease assets due to remeasurement of lease liabilities: | (3,002) | (1,589) |
| Weighted Average Remaining Lease Term | ||
| Operating leases | 4.7 years | 5.2 years |
| Finance leases | 2.3 years | 3.3 years |
| Weighted Average Discount Rate | ||
| Operating leases | 11.2% | 11.4% |
| Finance leases | 10.4% | 10.4% |
Asset Retirement Obligation
Our asset retirement obligation (ARO) consists of a contractual requirement to remove the tenant improvements at the ATOM Facility in Thousand Oaks, California and restore the facility to a condition specified in the lease agreement. Although we assigned the ATOM Lease to FDB in connection with the closing of the sale of the ATOM Facility to FDB in April 2022, we have not received novation from the landlord. Therefore, the ARO associated with the ATOM Facility remains on our balance sheet. We recorded an estimate of the fair value of our ARO liability in other long-term liabilities and the ARO asset as a long-term asset in the period incurred. The fair value of the ARO asset is amortized over the lease term. The fair value of our ARO was estimated by discounting projected cash flows over the estimated life of the related assets using our credit adjusted risk-free rate. As of December 31, 2024 and December 31, 2023, the ARO asset and liability were not material.
Restructuring
On August 8, 2022 we announced a strategic reduction in workforce of approximately 20% to focus our activities as an organization centered on research and development. The workforce reduction included total restructuring charges of $6.0 million, comprised primarily of severance payments, wages for the 60-day notice period in accordance with the California Worker Adjustment and Retraining Notification (WARN) Act and continuing health care coverage for a period of time after separation. In most cases, the severance payments were paid as a lump sum in October 2022. Certain of the notified employees had employment agreements which provided for separation benefits in the form of salary continuation; these benefits were paid between October 2022 and November 2023, and there are no further payments required for this reduction in workforce as of December 31,2024. All of the costs were cash expenditures and represented one-time termination benefits.
On November 1, 2023 we announced a strategic reduction in workforce of approximately 30%. The workforce reduction resulted in total restructuring charges of $6.7 million, comprised primarily of severance payments and wages for the 60-day notice period in accordance with the California WARN Act. In most cases, the severance payments were paid as a lump sum in January 2024. As of December 31, 2024, there are no remaining payments for the November 2023 reduction in workforce. All of the costs are cash expenditures and represent one-time termination benefits.
On January 8, 2024, we announced a strategic reduction in workforce of approximately 25%. The workforce reduction resulted in total restructuring charges of $5.1 million, comprised primarily of severance payments and wages for the 60-day notice period in accordance with the California WARN Act. In most cases, the severance payments were paid during the first half of 2024. Certain of the notified employees had employment agreements that provided for separation benefits in the form of salary continuation, which are being paid from February 2024 through January 2025. As of December 31, 2024, $0.1 millionof further separation payments and benefitsare required for the January 2024 reduction in workforce. The majority of the associated costs are cash expenditures and primarily represent one-time termination benefits.
The following is a summary of restructuring charges associated with the reductions in force for the periods presented:
| Year Ended December 31, | Year Ended December 31, | |
|---|---|---|
| 2024 | 2023 | |
| (in thousands) | ||
| Research and development expense | $3,750 | $5,619 |
| General and administrative expense | 1,357 | 1,111 |
| Total restructuring charges | $5,107 | $6,730 |
The following restructuring liability activity was recorded in connection with the reduction in force for the year ended December 31,2024, with all of the $0.1 million liability balance as of December 31,2024 included within other current liabilities on the accompanying consolidated balance sheet:
| Year ended December 31, · Year ended December 31, | ||||
|---|---|---|---|---|
| 2024 · 2023 | ||||
| (in thousands) | ||||
| Liability balance, January 1 | $ | 4,923 | $ | 1,545 |
| Restructuring charges | 5,107 | 6,730 | ||
| Cash payments | (9,298) | (3,352) | ||
| Non-cash settlements/adjustments | (669) | — | ||
| Liability balance, December 31 | $ | 63 | $ | 4,923 |
Commitments and Contingencies
MSK In-License Agreements
In June 2015, we entered into an exclusive license agreement with MSK for three clinical stage T-cell therapies. We are required to make payments to MSK based on achievement of specified regulatory and sales-related milestones, as well as mid-single-digit percentage tiered royalty payments based on future sales of products resulting from the development of the licensed product candidates, if any. In addition, under certain circumstances, we are required to make certain minimum annual royalty payments to MSK, which are creditable against earned royalties owed for the same annual period. We are also required to pay a low double-digit percentage of any consideration we receive for sublicensing the licensed rights. The license agreement expires on a product-by-product and country-by-country basis on the latest of: (i) expiration of the last licensed patent rights related to each licensed product, (ii) expiration of any market exclusivity period granted by law with respect to each licensed product, and (iii) a specified number of years after the first commercial sale of the licensed product in each country. Upon expiration of the license agreement, we will retain non-exclusive rights to the licensed products.
In May and December 2018, we licensed additional technology from MSK. We are obligated to make additional milestone payments based on achievement of specified development, regulatory and sales-related milestones as well as mid-single-digit percentage tiered royalty payments based on future sales of products resulting from the development of the licensed product candidates, if any.
In March 2021, we amended and restated our license agreement with MSK to terminate our license to certain rights and license additional know-how rights not otherwise covered by our existing agreements.
In March 2024, we terminated our license agreements with MSK to the ATA2271 and ATA3271 programs targeting mesothelin.
QIMR Berghofer In-License Agreements
In October 2015, we entered into an exclusive license agreement and a research and development collaboration agreement with QIMR Berghofer. Under the terms of the license agreement, we obtained an exclusive, worldwide license to develop and commercialize allogeneic T-cell therapy programs utilizing technology and know-how developed by QIMR Berghofer. In September 2016, the exclusive license agreement and research and development collaboration agreement were amended and restated. Under the amended and restated agreements, we obtained an exclusive, worldwide license to develop and commercialize additional T-cell programs, as well as the option to license additional technology that we exercised in June 2018. We further amended and restated our license agreement and research and development collaboration agreements with QIMR Berghofer in August 2019, August 2020 and December 2021, in each case, to terminate our license to certain rights. Our current license agreement also provides for various milestone and royalty payments to QIMR Berghofer based on future product sales, if any. Under the terms of our current research and development collaboration agreement, we are also required to reimburse the cost of agreed-upon development activities related to programs developed under the collaboration. These payments are expensed on a straight-line basis over the related development periods. The agreement also provides for various milestone payments to QIMR Berghofer based on achievement of certain developmental and regulatory milestones. We are in discussions with QIMR Berghofer to return rights to ATA188 and the EBV vaccine to QIMR Berghofer.
Other In-license and Collaboration Agreements
From time to time, we have entered into other license and collaboration agreements with other parties. For example, we licensed rights related to our MSK-partnered next-generation CAR T programs from the National Institutes of Health in December 2018.
Milestones and royalties under each of the above agreements are contingent upon future events and will be recorded as expense when the underlying milestones are achieved or royalties are earned. Sales related milestone and royalty costs related to Ebvallo are recorded in cost of commercialization revenue, whereas regulatory milestone costs are recorded in research and development expense. As of December 31, 2024 and 2023, there wereno material outstanding obligations for milestones and royalties under our in-license and collaboration agreements.
CRL Manufacturing Agreement
In December 2019, we entered into a Commercial Manufacturing Services Agreement (the CRL MSA) with Cognate BioServices, Inc., which was acquired by Charles River Laboratories Inc. (CRL) in March 2021. The CRL MSA expired on August 31, 2024 and we are currently in negotiations with CRL for a statement of work to support an orderly wind-down of manufacturing activities at CRL, transition of manufacturing activities of certain intermediates to FDB, and an orderly transition of manufacturing responsibility to PF upon the Manufacturing Transition Date.
Fujifilm Master Services and Supply Agreement
In January 2022, we entered into the Fujifilm MSA, which became effective upon the closing of the sale of the ATOM Facility on April 4, 2022 and could extend for up toten years. Pursuant to the Fujifilm MSA, FDB will supply us with specified quantities of our cell therapy products and product candidates, manufactured in accordance with cGMP standards. We have certain non-cancellable minimum commitments to purchase products and services over the first five years of the Fujifilm MSA. The Fujifilm MSA does not obligate us to purchase products and product candidates exclusively from FDB.
Other Research, Development and Manufacturing Agreements
We may enter into other contracts in the normal course of business with clinical research organizations for clinical trials, with CMOs for product, product candidates and clinical supplies, and with other vendors for preclinical studies, supplies and other services for our operating purposes. These contracts generally provide for termination on notice. As of December 31, 2024 and December 31, 2023, there wereno material amounts accrued related to contract termination charges.
Minimum Commitments
The non-cancellable minimum commitments for products and services, subject to agreements with a term of greater than one year with clinical research organizations and CMOs, excluding those recognized on our balance sheet, as of December 31,2024 are set forth below:
| Calendar Year | Remaining Minimum Commitment as of December 31, 2024 |
|---|---|
| (in thousands) | |
| 2025 | 13,308 |
| 2026 | 9,605 |
| 2027 | 3,388 |
| Total | $26,301 |
We have incurred $14.1 million and $19.4 million against such minimum commitments for the years ended December 31,2024 and 2023, respectively.
As of December 31, 2024 and December 31, 2023, we have accrued $5.3 million and $11.2 million in research and development expenses related to minimum purchase commitments.
Indemnification Agreements
In the normal course of business, we enter into contracts and agreements that contain a variety of representations and warranties and provide for indemnification for certain liabilities. The exposure under these agreements is unknown because it involves claims that may be made against us in the future but have not yet been made. To date, we have not paid any claims or been required to defend any action related to our indemnification obligations. However, we may record charges in the future as a result of these indemnification obligations. We also have indemnification obligations to our directors and executive officers for specified events or occurrences, subject to some limits, while they are serving at our request in such capacities. There have been no claims to date and we consider the fair value of these indemnification agreements to be minimal. Accordingly, we didnot record liabilities for these agreements as of December 31,2024 and 2023.
Contingencies
From time to time, we may be involved in legal proceedings, as well as demands, claims and threatened litigation, which arise in the normal course of our business or otherwise. The ultimate outcome of any litigation is uncertain and unfavorable outcomes could have a negative impact on our results of operations and financial condition. Regardless of outcome, litigation can have an adverse impact on us because of the defense costs, diversion of management resources and other factors. We are not currently involved in any material legal proceedings.
During the third quarter of 2024, MSK sent us a notice alleging that under the terms of our license agreements with MSK, MSK is entitled to $6.0 million of sub-licensing fees as a result of the $60.0 million we received from Pierre Fabre related to the Additional Territory upfront and milestone payments in 2024 pursuant to the A&R Commercialization Agreement. We do not believe we owe the $6.0 million to MSK under the terms of our license agreements with MSK and have entered into evaluative non-binding mediation with MSK to potentially resolve this disagreement. We paid the $6.0 million to MSK under protest in the third quarter of 2024 in order to proceed with the dispute process per the terms of the license agreements. We recorded this cost in research and development expenses on the consolidated statements of operations and comprehensive income (loss) during the year ended December 31, 2024. There is no guarantee we will reach a favorable outcome in the mediation or on this matter and we may owe a portion of future milestones we receive from Pierre Fabre to MSK.
Stockholders’ Equity (Deficit)
Our authorized capital stock consists of 520,000,000 shares, all with a par value of $0.0001 per share, of which 500,000,000 shares are designated as common stock and 20,000,000 shares are designated as preferred stock. There wereno shares of preferred stock outstanding as of December 31,2024 and 2023.
Equity Offerings
As part of our July 2019 underwritten public offering, we issued and sold pre-funded warrants to purchase 117,801 shares of common stock in an underwritten public offering pursuant to a shelf registration on Form S-3.
Each pre-funded warrant entitles the holder to purchaseone share of common stock at an exercise price of $0.0025 per share and expires seven years from the date of issuance. These warrants were recorded as a component of stockholders’ equity (deficit) within additional paid-in capital. Per the terms of the warrant agreement, a holder of the outstanding warrants is not entitled to exercise any portion of any pre-funded warrant if, upon exercise of the warrant, the holder’s ownership (together with its affiliates) of our common stock or combined voting power of our securities beneficially owned by such holder (together with its affiliates) would exceed 9.99% after giving effect to the exercise (the 2019 Warrant Maximum Ownership Percentage). Upon at least 61 days’ prior notice to us by the holder, any holder may increase or decrease the 2019 Warrant Maximum Ownership Percentage to any other percentage not to exceed 19.99%. No July 2019 pre-funded warrants were exercised during the year ended December 31, 2024, and, as of December 31, 2024, pre-funded warrants to purchase 101,089 shares of our common stock from the July 2019 underwritten public offering were outstanding.
As part of the May 2020 underwritten public offering, we issued and sold pre-funded warrants to purchase 114,678 shares of common stock in an underwritten public offering pursuant to a shelf registration on Form S-3.
Additionally, as part of the December 2020 underwritten public offering, we issued and sold pre-funded warrants to purchase 81,632 shares of common stock in an underwritten public offering pursuant to a shelf registration on Form S-3. These warrants were recorded as a component of stockholders’ equity (deficit) within additional paid-in capital.
The terms of the pre-funded warrants issued and sold as part of the 2020 public offerings were similar to those issued and sold in 2019. No May 2020 or December 2020 pre-funded warrants were exercised during the year ended December 31, 2024. As of December 31, 2024,38,735 and 55,387 of the pre-funded warrants to purchase shares of our common stock issued and sold as part of the May 2020 and December 2020 underwritten public offerings, respectively, were outstanding.
In January 2024, we issued and sold pre-funded warrants to purchase 1,090,907 shares of common stock at a price of $13.7475 per warrant in a registered direct offering pursuant to a shelf registration on Form S-3. The gross proceeds from this sale were $15.0 million, resulting in net proceeds of $14.8 million after deducting offering expenses payable by us.
Each of the January 2024 pre-funded warrants issued entitles the holder to purchaseone share of common stock at an exercise price of $0.0025 per share, with no expiration date. These warrants were recorded as a component of stockholders’ equity (deficit) within additional paid-in capital. Per the terms of the warrant agreement, a holder of the outstanding warrants is not entitled to exercise any portion of any pre-funded warrant if, upon exercise of the warrant, the holder’s ownership (together with its affiliates) of our common stock or combined voting power of our securities beneficially owned by such holder (together with its affiliates) would exceed 9.99% after giving effect to the exercise (the January 2024 Maximum Ownership Percentage). Upon at least 61 days’ prior notice to us by the holder, any holder may increase or decrease the January 2024 Maximum Ownership Percentage to any other percentage not to exceed 19.99%. No January 2024 pre-funded warrants were exercised during the year ended December 31, 2024 and all 1,090,907 of the January 2024 pre-funded warrants remain outstanding as of December 31, 2024.
In September 2024, we issued and sold 758,900 shares of common stock at an offering price of $8.25 per share and pre-funded warrants to purchase 3,604,780 shares of common stock at an offering price of $8.2499 per warrant in a registered direct offering pursuant to a shelf registration on Form S-3. The gross proceeds from this sale were $36.0 million, resulting in net proceeds of $35.8 million after deducting offering expenses payable by us.
Each of the September 2024 pre-funded warrants issued entitles the holder to purchaseone share of common stock at an exercise price of $0.0001 per share, with no expiration date. These warrants were recorded as a component of stockholders’ equity (deficit) within additional paid-in capital. Per the terms of the warrant agreement, a holder of the outstanding warrants is not entitled to exercise any portion of any pre-funded warrant if, upon exercise of the warrant, the holder’s ownership (together with its affiliates) of our common stock or combined voting power of our securities beneficially owned by such holder (together with its affiliates) would exceed, at the holder's election,4.99%,9.99% or 19.99% after giving effect to the exercise (the September 2024 Warrant Maximum Ownership Percentage). Upon at least 61 days’ prior notice to us by the holder, any holder may increase or decrease the September 2024 Warrant Maximum Ownership Percentage to any other percentage not to exceed 19.99%.
During the year ended December 31, 2024,8,634 of the September 2024 pre-funded warrants were exercised, and as of December 31, 2024, pre-funded warrants to purchase 3,596,146 shares of our common stock from the September 2024 direct offering were outstanding.
ATM Facilities
In the past three years, we have entered into two separate sales agreements with Cowen and Company, LLC (Cowen): in November 2021 (the 2021 ATM Facility) and in November 2023 (the 2023 ATM Facility). Each ATM facility provides or provided for the sale, in our sole discretion, of shares of our common stock having an aggregate offering price of up to $100.0 million, through Cowen, as our sales agent. We filed a registration statement on Form S-3 registering the offer and sale of these shares under the Securities Act (the 2023 Registration Statement). Upon the effectiveness of the 2023 Registration Statement, the 2021 ATM Facility was terminated, and no further sales can be made under the 2021 ATM Facility. The issuance and sale of these shares by us pursuant to the ATM facilities are deemed “at the market” offerings defined in Rule 415 under the Securities Act of 1933, as amended (the Securities Act), and were registered under the Securities Act. Commissions of up to 3.0% are due on the gross sales proceeds of the common stock sold under each ATM facility.
During the year ended December 31, 2023, we sold an aggregate of 3,038,432 shares of common stock under the 2021 ATM Facility, at an average price of $0.83 per share, for gross proceeds of $2.5 million and net proceeds of $2.2 million, after deducting commissions and other offering expenses payable by us. Approximately $0.1 million of the $2.2 million net proceeds were received on January 2, 2024.
During the year ended December 31, 2024, we sold an aggregate of 492,855 shares of common stock under the 2023 ATM Facility, at an average price of $19.23 per share, for gross proceeds of $9.5 million and net proceeds of $9.3 million, after deducting commissions and other offering expenses payable by us.
As of December 31, 2024, we had $88.7 million of common stock remaining and available to be sold under the 2023 ATM Facility.
Equity Incentive Plans
In June 2024, we adopted the 2024 Equity Incentive Plan (the 2024 EIP), under which we may grant stock options, restricted stock awards (RSAs) and RSUs to employees, directors, consultants and other service providers. RSUs generally vest over two to four years. The 2014 Equity Incentive Plan, as amended (the 2014 EIP), expired March 31, 2024, after which no new awards can be granted from it. All awards granted prior to the 2014 EIP expiration continue to remain outstanding and governed in accordance with the rules set forth in the 2014 EIP and the terms of the associated grant notice. To the extent forfeited, cancelled or expired, certain awards granted under the 2014 EIP will become available for grant under the 2024 EIP.
RSUs generally vest over two tofour years. We have granted performance-based RSUs to certain of our employees that provide for the issuance of common stock if specified Company performance criteria related to tab-cel regulatory milestones are achieved. The number of performance-based RSUs that ultimately vests depends upon if and which performance criteria are achieved, as well as the employee’s continuous service, as defined in the 2014 EIP and 2024 EIP, through the date of vesting. The fair value of performance-based RSUs is determined as the closing stock price on the date of grant.
Stock options are granted at prices no less than 100% of the estimated fair value of the shares on the date of grant as determined by the board of directors, provided, however, thatthe exercise price of an option granted to a 10% shareholder cannot be less than 110% of the estimated fair value of the shares on the date of grant. Options granted generally vest over three tofour years and expire inseven toten years.
We have granted performance-based stock options to certain of our employees that provide for the issuance of a right to purchase a share of common stock if specified Company performance criteria related to tab-cel regulatory milestones are achieved. The vesting of performance-based stock options depends upon if and when the performance criteria are achieved, as well as the employee’s continuous service, as defined in the 2014 EIP and 2024 EIP, through the date of vesting.
As of December 31, 2024, a total of 554,974 shares of common stock were reserved for issuance under the 2014 EIP, of which all were subject to outstanding options and RSUs, including performance-based awards.
As of December 31, 2024, a total of 392,571 shares of common stock were reserved for issuance under the 2024 EIP, of which 347,571 shares were available for future grant and 45,000 shares were subject to outstanding options and RSUs. .
In February 2018, we adopted the 2018 Inducement Plan (Inducement Plan), under which we may grant options, stock appreciation rights, RSAs and RSUs to new employees. In November 2020, September 2021 and June 2022, we amended the Inducement Plan to reserve an additional 60,000 shares of the Company’s common stock for issuance under the Inducement Plan in each case.
As of December 31, 2024,170,873 shares of common stock were reserved for issuance under the Inducement Plan, of which 122,234 shares were available for future grant and 48,639 shares were subject to outstanding options and RSUs.
Restricted Stock Units
The following is a summary of RSU activity under our 2014 EIP, 2024 EIP and Inducement Plan:
| RSUs | ||
|---|---|---|
| Shares | WeightedAverageGrant DateFair Value | |
| Balance as of December 31, 2023 | 250,709 | $158.00 |
| Granted | 548,990 | $13.76 |
| Forfeited | (70,120) | $86.29 |
| Vested | (315,109) | $79.06 |
| Balance as of December 31, 2024 | 414,470 | $39.09 |
The weighted average grant date fair value of RSUs granted during the years ended December 31, 2024 and 2023 was $13.76 and $89.25, respectively. The estimated fair value of RSUs that vested in the years ended December 31,2024 and 2023 was $24.9 million and $32.8 million, respectively. As of December 31,2024, there was $14.0 million of unrecognized stock-based compensation expense related to RSUs that is expected to be recognized over a weighted average period of 1.4 years. The aggregate intrinsic value of the RSUs outstanding as of December 31,2024 was $5.5 million.
Under our RSU settlement procedures, for some of the RSUs granted to our employees, we withhold shares at settlement to cover the estimated payroll withholding tax obligations. During 2024, we settled 315,109 shares underlying RSUs, of which 987 shares underlying RSUs were net settled by withholding 366 shares. The value of the shares underlying RSUs withheld was not material, based on the closing price of our common stock on the settlement date. During 2023, we settled 147,520 shares underlying RSUs, of which 2,050 shares underlying RSUs were net settled by withholding 728 shares. The value of the shares underlying RSUs withheld was $0.1 million, based on the closing price of our common stock on the settlement date. The value of RSUs withheld in each period was remitted to the appropriate taxing authorities and has been reflected as a financing activity in our consolidated statements of cash flows.
Stock Options
The following is a summary of stock option activity under our 2014 EIP, 2024 EIP and Inducement Plan:
| Shares | Weighted Average Exercise Price | Weighted AverageRemainingContractualTerm (Years) | AggregateIntrinsic Value (in thousands) | |
|---|---|---|---|---|
| Balance as of December 31, 2023 | 428,786 | $290.75 | 6.5 | $— |
| Granted | 16,500 | 11.00 | ||
| Exercised | — | — | ||
| Forfeited or expired | (211,143) | 349.66 | ||
| Balance as of December 31, 2024 | 234,143 | $217.91 | 7.0 | $27 |
| Vested and expected to vest as of December 31, 2024 | 234,143 | $217.91 | 7.0 | $27 |
| Exercisable as of December 31, 2024 | 172,546 | $252.41 | 6.7 | $9 |
Aggregate intrinsic value represents the difference between the closing stock price of our common stock on December 31, 2024 and the exercise price of outstanding, in-the-money options. As of December 31, 2024, there was $4.7 million of unrecognized stock-based compensation expense related to stock options that is expected to be recognized over a weighted average period of 1.0 years. This excludes unrecognized stock-based compensation expense for performance-based stock options that were deemed not probable of vesting in accordance with U.S. GAAP.
No options for shares of our common stock were exercised during the years ended December 31, 2024 and 2023. As we believe it is more likely than not that no stock option related tax benefits will be realized, we donot record any net tax benefits related to exercised options.
The fair value of each option issued was estimated at the date of grant using the Black-Scholes valuation model. The following table summarizes the weighted-average assumptions used as inputs to the Black-Scholes model and resulting weighted-average grant date fair values of stock options granted during the periods indicated:
| Year ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Assumptions: | ||
| Expected term (years) | 5.5 | 5.8 |
| Expected volatility | 114.2% | 83.9% |
| Risk-free interest rate | 4.0% | 4.2% |
| Expected dividend yield | 0.0% | 0.0% |
| Fair Value: | ||
| Weighted-average estimated grant date fair value per share | $9.20 | $65.50 |
| Options granted | 16,500 | 187,756 |
| Total estimated grant date fair value | $151,800 | $12,298,010 |
The estimated fair value of stock options that vested in the years ended December 31, 2024 and 2023 was $9.0 million and $17.0 million, respectively.
Employee Stock Purchase Plan
In May 2014, we adopted the 2014 Employee Stock Purchase Plan (“2014 ESPP”), which became effective on October 15, 2014 upon the pricing of our IPO. Following stockholder approval, in June 2024, we amended the 2014 ESPP to increase the number of shares of our common stock available for issuance under the 2014 ESPP by 40,000 shares. The 2014 ESPP permits eligible employees to purchase common stock at a discount through payroll deductions during defined offering periods. Eligible employees can purchase shares of the Company’s common stock at 85% of the lower of the fair market value of the common stock at (i) the beginning of the offering period or (ii) at the end of the purchase period. We recorded $0.2 million and $0.7 million of expense related to the 2014 ESPP in the years ended December 31,2024 and 2023, respectively. A total of 25,897 and 35,850 shares were purchased under the ESPP during the years ended December 31,2024 and 2023, respectively.
As of December 31, 2024, there was $0.1 million of unrecognized stock-based compensation expense related to the ESPP that is expected to be recognized by the end of second quarter of 2025. As of December 31, 2024, there were 23,731 shares authorized under the 2014 ESPP.
Reserved Shares
The following shares of common stock were reserved for future issuance under our equity incentive plans as of December 31,2024:
| Total Shares Reserved | |
|---|---|
| 2014 Equity Incentive Plan | 554,974 |
| 2018 Inducement Plan | 170,873 |
| 2024 Equity Incentive Plan | 392,571 |
| 2014 Employee Stock Purchase Plan | 23,731 |
| Total reserved shares of common stock | 1,142,149 |
Stock-based Compensation Expense
The following is a summary of stock-based compensation expense for the periods presented:
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| (in thousands) | ||
| Research and development | $13,465 | $26,529 |
| General and administrative | 13,536 | 18,857 |
| Total stock-based compensation expense | $27,001 | $45,386 |
Income Taxes
Losses before provision for income taxes were as follows in each period presented:
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| (in thousands) | ||
| United States | $(85,311) | $(276,360) |
| Foreign | (104) | 249 |
| Total loss before provision for income taxes | $(85,415) | $(276,111) |
The components of provision for income taxes were as follows in each period presented:
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| (in thousands) | ||
| Current provision for income taxes: | ||
| State | $— | $1 |
| Foreign | (12) | 14 |
| Total current provision for income taxes | $(12) | $15 |
A reconciliation of statutory tax rates to effective tax rates were as follows in each of the periods presented:
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Federal income taxes at statutory rate | 21.0% | 21.0% |
| Research tax credits | (26.8%) | 4.3% |
| Stock-based compensation | (16.2%) | (4.5%) |
| Other | (1.3%) | (0.4%) |
| Change in valuation allowance | 23.3% | (20.4%) |
| Effective tax rate | 0.0% | 0.0% |
Deferred tax assets and liabilities reflect the net tax effects of (a) temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes and (b) operating loss and tax credit carryforwards. Significant components of our deferred tax assets and liabilities were as follows for each of the dates presented:
| As of December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| (in thousands) | ||
| Deferred tax assets: | ||
| Net operating loss carryforwards | $259,376 | $323,581 |
| Capitalized research expenses | 61,113 | 72,229 |
| Tax credit carryforwards | 8,216 | 30,580 |
| Stock-based compensation | 5,789 | 14,033 |
| Deferred revenue | 14,709 | 17,018 |
| Operating lease liabilities | 9,403 | 12,035 |
| License fees | 4,794 | 5,926 |
| Other | 13,748 | 11,187 |
| Total deferred tax assets | 377,148 | 486,589 |
| Valuation allowance | (368,401) | (474,982) |
| Total deferred tax assets | 8,747 | 11,607 |
| Deferred tax liabilities: | ||
| Operating lease assets | (8,747) | (11,607) |
| Total deferred tax liabilities | (8,747) | (11,607) |
| Net deferred tax assets (liabilities) | $— | $— |
Under IRC Section 382, as amended, substantial restrictions exist on the utilization of net operating loss and tax credit carryforwards in the event a corporation experienced an “ownership change.” Generally, a Section 382 “ownership change” occurs if one or more stockholders or groups of stockholders who owns at least 5% of a corporation’s stock increases its ownership by more than 50 percentage points over its lowest ownership percentage within a specified testing period. Similar rules may apply under state tax laws. Accordingly, our ability to utilize net operating loss and tax credit carryforwards may be limited as a result of such ownership changes, and such a limitation could result in the expiration of carryforwards before they are utilized.
We have completed a Section 382 study of transactions in our stock through December 31, 2024. The study concluded that we have experienced ownership changes since inception with the most recent being on September 5, 2024. As a result of the ownership changes and imposed annual limitations on the amount of our tax attributes that may be utilized in a given period, should we generate taxable income, we have determined that we will have net operating losses and tax credits that will expire unutilized. We have reduced our net operating loss carryforwards and tax credit carryforwards in the above table as a result.
Beginning January 1, 2022, the Tax Cuts and Jobs Act (the Tax Act) eliminated the option to deduct research and development expenditures in the current year and requires taxpayers to capitalize such expenses pursuant to Internal Revenue Code (IRC) Section 174. The capitalized expenses are amortized over a 5-year period for domestic expenses and a 15-year period for foreign expenses. As a result of this provision of the Tax Act, deferred tax assets related to capitalized research expenses pursuant to IRC Section 174 decreased by $11.1 millionfor the year ended December 31, 2024 and increased by $21.7 million for the year ended December 31,2023, respectively. The current year decrease is a result of more amortization than the amount capitalized in the current year whereas the prior year increase was partially offset by amortization on research expenses capitalized in prior years.
Our tax credit carryforwards decreased by $22.4 million, as compared to 2023, due the Section 382 study limiting our ability to utilize attributes as a result of our ownership changes.
We regularly evaluate the positive and negative evidence in determining the realizability of our deferred tax assets. Based upon the weight of available evidence, which includes our historical operating performance and reported cumulative net losses since inception, we maintained a full valuation allowance on the net deferred tax assets as of December 31, 2024 and 2023. We intend to maintain a full valuation allowance on our deferred tax assets until sufficient positive evidence exists to support reversal of the valuation allowance. The valuation allowance decreased by $106.6 million for the year ended December 31,2024 due to the decrease in our net deferred tax assets.
The American Rescue Plan Act (ARA) was signed into law on March 11, 2021. We do not expect the ARA to have a material impact on our financial statements, however, given the potential changes to IRC Section 162(m) effective in 2027 as a result of the ARA, we will continue to monitor and assess. No changes have been made to our financial statements as of December 31, 2024.
Under the Tax Act, federal NOLs generated in tax years beginning on or after January 1, 2018 may be carried forward indefinitely, but the utilization of such federal NOLs is limited to 80% of taxable income in future years. Since enactment, the IRS and Treasury have issued final and proposed regulations including clarifying guidance on several topics addressed by the Tax Act. Not all states conform to the Tax Act or and other states have varying conformity to the Tax Act.
As of December 31, 2024, for federal income tax purposes, we had net operating loss carryforwards of approximately $1.2 billion of which $15.4 million begin to expire in 2036 and the remaining may be carried forward indefinitely, and research & development tax credits of $1.1 million which begin to expire in 2044. For state income tax purposes, we had net operating loss carryforwards of approximately $53.9 million which begin to expire in 2030, and research & development tax credits of $45.8 million which may be carried forward indefinitely.
The changes in the balance of gross unrecognized tax benefits, which excludes interest and penalties, for the years ended December 31,2023 and 2024 are as follows:
| (In thousands) | |
|---|---|
| Balance as of January 1, 2023 | 150,965 |
| Gross increases for tax positions related to current year | 5,538 |
| Gross increases for tax positions related to prior year | 3,843 |
| Gross decreases for tax positions related to prior year | — |
| Balance as of December 31, 2023 | 160,346 |
| Gross increases for tax positions related to current year | 1,011 |
| Gross increases for tax positions related to prior year | 647 |
| Gross decreases for tax positions related to prior year | (124,071) |
| Balance as of December 31, 2024 | $37,933 |
We currently have a full valuation allowance against our U.S. net deferred tax assets, which would impact the timing of the effective tax rate benefit should any uncertain tax position be favorably settled in the future. The reversal of unrecognized tax benefits would not affect our effective tax rate to the extent we continue to maintain a full valuation allowance against our deferred tax assets.
Our policy is to account for interest and penalties related to uncertain tax positions as a component of the income tax provision. We haveno accrued interest and penalties as of December 31,2024 and 2023 due to available tax losses.
Our significant jurisdictions are the U.S. federal jurisdiction and the California state jurisdiction. All of our tax years remain open to examination by the U.S. federal and California tax authorities. We also file in other state, local and foreign jurisdictions in which we operate, and such tax years remain open to examination.
As of December 31, 2024, we are not permanently reinvested with respect to its foreign earnings and have not recorded deferred income taxes and withholding taxes as these taxes are immaterial to the financial statements.
Supplemental Balance Sheet Information
Inventories
Inventories consist of the following as of each period:
| December 31, | December 31, | |
|---|---|---|
| 2024 | 2023 | |
| (in thousands) | ||
| Raw Materials | $964 | $2,335 |
| Work-in-process | 9,691 | 7,371 |
| Total inventories | $10,655 | $9,706 |
Property and equipment, net
Property and equipment consisted of the following as of each period end:
| December 31, | December 31, | |
|---|---|---|
| 2024 | 2023 | |
| (in thousands) | ||
| Leasehold improvements | $930 | $904 |
| Lab equipment | 14,446 | 15,540 |
| Machinery and equipment | 572 | 572 |
| Computer equipment and software | 1,381 | 1,279 |
| Furniture and fixtures | 1,272 | 1,272 |
| Construction in progress | — | 158 |
| Property and equipment, gross | 18,601 | 19,725 |
| Less: accumulated depreciation | (17,307) | (15,869) |
| Property and equipment, net | $1,294 | $3,856 |
Depreciation expense was $2.7 million and $3.7 million for the years ended December 31,2024 and 2023, respectively.
Other current liabilities
Other current liabilities consisted of the following as of each period end:
| December 31, | December 31, | |
|---|---|---|
| 2024 | 2023 | |
| (in thousands) | ||
| Accrued operating expenses | $6,027 | $19,007 |
| Current portion of operating lease liabilities | 12,879 | 11,264 |
| Current portion of finance lease liabilities | 1,038 | 915 |
| Other accrued liabilities | 598 | 640 |
| Total other current liabilities | $20,542 | $31,826 |
Subsequent Events
In January 2025, we announced a reduction in force of approximately 50% of total workforce. We expect to recognize approximately $7.5 million in total severance and related benefits as a result of this reduction in force, consisting primarily of severance payments and wages for the 60-day notice period in accordance with the California WARN Act. In most cases, the severance will be paid in the first half of 2025. Certain of the notified employees had employment agreements which provided for separation benefits in the form of salary continuation; these benefits will be paid from April 2025 to May 2026. The majority of the associated costs represent cash expenditures.
In March 2025, we announced a further reduction in force of approximately 50% of total workforce, retaining approximately 35 employees essential to executing on our strategic priorities. We expect to recognize approximately $3.0 million in total severance and related benefits as a result of this reduction in force, consisting primarily of severance payments and wages for the 60-day notice period in accordance with the California WARN Act. In most cases, the severance will be paid in the first half of 2025. Certain of the notified employees had employment agreements which provided for separation benefits in the form of salary continuation; these benefits will be paid from May 2025 to May 2026. The majority of the associated costs represent cash expenditures.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.