Company Overview - Atara Biotherapeutics (ATRA) shares increased by 10% to close at $14.26, with notable trading volume compared to typical sessions, and a 2.6% gain over the past four weeks [1][2] Product Development - The rise in stock price is linked to growing investor optimism regarding Atara's lead product candidate, tabelecleucel (tab-cel), a T-cell immunotherapy for Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) [2] - Atara has resubmitted its biologics license application for tab-cel, which is currently under priority review by the FDA, with a decision expected on January 10, 2026 [2] Financial Performance - Atara is projected to report a quarterly loss of $0.83 per share, reflecting a year-over-year increase of 71.7%, while revenues are expected to be $1.29 million, down 96.8% from the same quarter last year [3] - The consensus EPS estimate for Atara has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Context - Atara Biotherapeutics is part of the Zacks Medical - Biomedical and Genetics industry, which includes Amicus Therapeutics (FOLD), another stock in the same sector that closed 2.3% higher at $8.35 and has returned 8.5% over the past month [5] - Amicus Therapeutics has a consensus EPS estimate of $0.12 for its upcoming report, representing a year-over-year change of 20%, and also holds a Zacks Rank of 3 (Hold) [6]

Core Insights - Atara Biotherapeutics, Inc. is a biotechnology company focused on immunotherapy for serious diseases, distinguishing itself with innovative approaches and strong financial metrics [1] Financial Performance - Atara's Return on Invested Capital (ROIC) is 36.19%, significantly higher than its Weighted Average Cost of Capital (WACC) of 6.53%, resulting in a ROIC to WACC ratio of 5.54, indicating effective capital utilization and strong potential for value creation [2][6] - In contrast, G1 Therapeutics, Inc. has a negative ROIC of -17.42% and a WACC of 12.24%, leading to a ROIC to WACC ratio of -1.42, highlighting inefficiencies in capital use [3] - Allogene Therapeutics, Inc. shows a ROIC of -57.03% against a WACC of 4.85%, resulting in a ROIC to WACC ratio of -11.77, further emphasizing capital inefficiency [3] - MacroGenics, Inc. and AnaptysBio, Inc. exhibit negative ROIC to WACC ratios of -3.98 and -2.27, respectively, indicating challenges in capital management [4] - CytomX Therapeutics, Inc. has a ROIC of 30.37% and a WACC of 13.35%, resulting in a ROIC to WACC ratio of 2.27, which, while positive, is less efficient than Atara [5][6] Competitive Landscape - Atara Biotherapeutics leads its peers in capital efficiency within the biotechnology sector, showcasing a strong position compared to competitors with negative or lower ROIC to WACC ratios [5][6]

[Forward-Looking Statements](index=3&type=section&id=NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section outlines the scope of forward-looking statements, covering strategic alternatives, program expectations, regulatory approvals, commercialization, market opportunities, financing, intellectual property, financial performance, workforce reductions, and manufacturing - Forward-looking statements cover strategic alternatives, program expectations, regulatory approvals (tab-cel BLA), commercialization (Ebvallo/Pierre Fabre), market opportunities, financing needs, intellectual property, financial performance, workforce reductions, and manufacturing[10](index=10&type=chunk) - These statements involve risks and uncertainties, with many discussed in detail under "1A. Risk Factors"[11](index=11&type=chunk) [Summary Risk Factors](index=4&type=section&id=Summary%20Risk%20Factors) This section highlights key risks including the uncertainty of strategic alternatives, substantial losses, product development challenges, regulatory scrutiny, and potential disruptions from workforce reductions - Strategic alternatives review may not yield expected benefits or enhance stockholder value, potentially leading to **liquidation**[13](index=13&type=chunk) - The company has incurred **substantial losses since inception** and may never achieve sustained profitability, requiring substantial near-term financing[13](index=13&type=chunk) - **Ebvallo is the only approved product** (EEA, UK, Switzerland); allogeneic CAR T programs have been paused[13](index=13&type=chunk) - T-cell immunotherapy product candidates face heightened regulatory scrutiny, and clinical trial results are not necessarily predictive of future success[13](index=13&type=chunk) - **Workforce reductions** may not result in anticipated savings and could disrupt business operations[15](index=15&type=chunk) PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements, including the balance sheets, statements of operations and comprehensive income (loss), statements of changes in stockholders' equity (deficit), statements of cash flows, and accompanying notes, providing a detailed financial overview for the periods ended June 30, 2025, and December 31, 2024 [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This statement provides a snapshot of the company's assets, liabilities, and equity at specific points in time, reflecting its financial position Condensed Consolidated Balance Sheets (Selected Items, in thousands) | Item | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :-------------- | :---------------- | | Cash and cash equivalents | $16,903 | $25,030 | | Short-term investments | $5,420 | $17,466 | | Inventories | $— | $10,655 | | Total current assets | $24,772 | $64,894 | | Total assets | $36,902 | $109,098 | | Deferred revenue | $1,607 | $95,092 | | Total current liabilities | $14,563 | $134,574 | | Total liabilities | $71,943 | $206,381 | | Total stockholders' equity (deficit) | $(35,041) | $(97,283) | - **Total assets decreased significantly from $109.1 million** at December 31, 2024, to **$36.9 million** at June 30, 2025, primarily due to reductions in current assets like cash, short-term investments, and inventories[17](index=17&type=chunk) - **Total liabilities decreased from $206.4 million to $71.9 million**, largely due to a substantial reduction in deferred revenue[17](index=17&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20(Loss)) This statement details the company's revenues, expenses, and net income or loss over specific reporting periods, indicating operational performance Condensed Consolidated Statements of Operations (Selected Items, in thousands, except per share amounts) | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Commercialization revenue | $17,575 | $28,640 | $115,724 | $55,997 | | Total costs and operating expenses | $14,378 | $46,871 | $73,725 | $105,475 | | Income (loss) from operations | $3,197 | $(18,231) | $41,999 | $(49,478) | | Net income (loss) | $2,387 | $(19,049) | $40,397 | $ (50,801) | | Basic earnings (loss) per common share | $0.20 | $(3.10) | $3.52 | $(8.64) | | Diluted earnings (loss) per common share | $0.19 | $(3.10) | $3.49 | $(8.64) | - For the six months ended June 30, 2025, the company reported a **net income of $40.4 million**, a significant improvement from a **net loss of $(50.8) million** in the prior year period[19](index=19&type=chunk) - This turnaround was driven by a substantial increase in **commercialization revenue ($115.7 million vs. $56.0 million)** and a considerable reduction in **total costs and operating expenses ($73.7 million vs. $105.5 million)**[19](index=19&type=chunk) [Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20(Deficit)) This statement tracks changes in the equity section of the balance sheet, including net income, stock issuances, and other comprehensive income or loss Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit) (Selected Items, in thousands) | Item | January 1, 2025 | June 30, 2025 | | :--------------------------------- | :-------------- | :-------------- | | Balance as of January 1, 2025 | $(97,283) | N/A | | Issuance of pre-funded warrants to purchase common stock | N/A | $14,843 | | Stock-based compensation expense | N/A | $7,010 | | Net (loss) income | N/A | $40,397 | | Balance as of June 30, 2025 | N/A | $(35,041) | - The **total stockholders' deficit improved from $(97.3) million** at January 1, 2025, to **$(35.0) million** at June 30, 2025[21](index=21&type=chunk) - This improvement was primarily due to **net income of $40.4 million** and additional paid-in capital from equity offerings and stock-based compensation[21](index=21&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This statement summarizes the cash inflows and outflows from operating, investing, and financing activities, illustrating liquidity and solvency Condensed Consolidated Statements of Cash Flows (Selected Items, in thousands) | Item | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | | Net cash used in operating activities | $(35,456) | $(40,257) | | Net cash provided by investing activities | $12,129 | $21,913 | | Net cash provided by financing activities | $15,054 | $23,817 | | Net increase (decrease) in cash, cash equivalents and restricted cash | $(8,273) | $5,473 | | Cash, cash equivalents and restricted cash at end of period | $16,903 | $31,460 | - **Net cash used in operating activities decreased to $35.5 million** for the six months ended June 30, 2025, from **$40.3 million** in the prior year, primarily due to changes in net working capital following the transfer of manufacturing responsibilities[201](index=201&type=chunk) - **Financing activities provided $15.1 million**, primarily from **$15.3 million in proceeds** from the issuance of prefunded warrants and shares in an underwritten registered direct offering[203](index=203&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes provide additional detail and context to the financial statements, explaining accounting policies, significant transactions, and other relevant information [Note 1. Description of Business](index=10&type=section&id=1.%20Description%20of%20Business) This note describes the company's core business, key products, strategic partnerships, and significant operational changes including workforce reductions - Atara Biotherapeutics is a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr Virus (EBV) T-cell platform[27](index=27&type=chunk) - **Tab-cel (Ebvallo™) has received marketing authorization** in the EEA, UK, and Switzerland, and is currently in Phase 3 development in the US[28](index=28&type=chunk) - In March 2025, **all manufacturing responsibility for tab-cel was transferred to Pierre Fabre**, and in July 2025, all clinical and development responsibility was also transferred[29](index=29&type=chunk) - The company executed multiple **workforce reductions** in November 2023 (~30%), January 2024 (~25%), January 2025 (~50%), March 2025 (~50%), and May 2025 (~30%), retaining approximately **23 employees**[31](index=31&type=chunk)[32](index=32&type=chunk)[33](index=33&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=11&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the critical accounting principles and methods used in preparing the financial statements, including details on a reverse stock split and going concern considerations - A **1-for-25 reverse stock split** was effected on June 20, 2024, with all equity-related information retroactively adjusted[36](index=36&type=chunk) - The company has incurred substantial operating losses since inception and expects existing capital to be insufficient for at least 12 months, raising **substantial doubt about its ability to continue as a going concern**[38](index=38&type=chunk)[39](index=39&type=chunk) - The business operates as one operating and reportable segment, focused on developing therapeutics, with substantially all assets located in the U.S. and commercialization revenue from Pierre Fabre (a French company)[41](index=41&type=chunk) [Note 3. Net Income (Loss) per Common Share](index=12&type=section&id=3.%20Net%20Income%20(Loss)%20per%20Common%20Share) This note details the calculation of basic and diluted earnings per share, including the treatment of potential dilutive securities Weighted-Average Shares Outstanding (in thousands) | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Weighted average shares outstanding – Basic | 12,197 | 6,143 | 11,484 | 5,883 | | Weighted average shares outstanding – Diluted | 12,310 | 6,143 | 11,576 | 5,883 | - Potential dilutive securities (unvested RSUs, options, ESPP rights) were excluded from diluted EPS calculation when their effect was antidilutive, resulting in the same denominator for basic and diluted net earnings (loss) per common share during net loss periods[46](index=46&type=chunk) [Note 4. Financial Instruments](index=13&type=section&id=4.%20Financial%20Instruments) This note provides information on the company's financial assets and liabilities, including available-for-sale securities and fair value measurements Total Available-for-Sale Securities (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :-------------- | :---------------- | | Money market funds (Level 1) | $14,444 | $13,718 | | U.S. Treasury obligations (Level 2) | $6,415 | $27,458 | | Total available-for-sale securities | $20,859 | $41,176 | - **Total available-for-sale securities decreased from $41.2 million** at December 31, 2024, to **$20.9 million** at June 30, 2025[52](index=52&type=chunk) - **No impairment losses were recognized** on investments, and no transfers between Level 1, Level 2, and Level 3 within the fair value hierarchy occurred during the periods presented[49](index=49&type=chunk)[52](index=52&type=chunk) [Note 5. Out-license Agreements](index=15&type=section&id=5.%20Out-license%20Agreements) This note details the company's licensing agreements, particularly with Pierre Fabre for tab-cel, including milestone payments, royalties, and deferred revenue - Pierre Fabre's exclusive rights to research, develop, manufacture, commercialize, and distribute tab-cel (Ebvallo) were **expanded worldwide in October 2023**[58](index=58&type=chunk) - **All manufacturing responsibility for tab-cel was transferred to Pierre Fabre** by March 2025, and all clinical and development responsibility by July 2025[60](index=60&type=chunk)[64](index=64&type=chunk) - Atara is eligible to receive up to **$308.0 million in remaining milestone payments** for the Initial Territory and up to **$550.0 million for the Additional Territory**, plus double-digit tiered royalties[62](index=62&type=chunk) Deferred Revenue Activity (in thousands) | Item | Amount | | :--------------------------------------- | :------- | | Deferred revenue, January 1, 2025 | $95,092 | | Additions | $21,914 | | Recognized into commercialization revenue | $(115,399) | | Deferred revenue June 30, 2025 | $1,607 | [Note 6. Liability Related to the Sale of Future Revenues](index=18&type=section&id=6.%20Liability%20Related%20to%20the%20Sale%20of%20Future%20Revenues) This note explains the liability arising from the sale of future Ebvallo royalties and milestone payments to HCRx, including its amortization and interest accretion - Atara sold a portion of future Ebvallo royalties and milestone payments to HCRx for **$31.0 million**, subject to a repayment cap between **185% and 250%** of the investment amount[78](index=78&type=chunk)[79](index=79&type=chunk) - The liability is amortized using the effective interest method, with an annual **effective interest rate of approximately 9%** as of June 30, 2025[81](index=81&type=chunk) Liability Related to Sale of Future Revenues (in thousands) | Item | Amount | | :--------------------------------------- | :------- | | Liability balance, January 1, 2025 | $39,006 | | Accretion of interest expense on liability related to sale of future revenues | $1,809 | | Repayment of the liability | $(51) | | Liability balance, June 30, 2025 | $40,793 | [Note 7. Leases](index=19&type=section&id=7.%20Leases) This note provides details on the company's lease arrangements, including right-of-use assets, lease liabilities, and the impact of lease terminations and assignments - The company vacated its Thousand Oaks office in February 2025, resulting in a **$1.0 million acceleration of amortization expense** on the abandoned right-of-use asset[83](index=83&type=chunk) - A non-cash **impairment of $4.1 million** was recorded for the Atara Research Center (ARC) lab's right-of-use asset due to pausing CAR-T research and development activities[84](index=84&type=chunk) - The Fujifilm MSA, containing embedded operating and finance leases, was novated to Pierre Fabre in March 2025, leading to **derecognition gains of $0.7 million (operating) and $0.5 million (finance)**[86](index=86&type=chunk) Present Value of Lease Liabilities (in thousands) | Item | June 30, 2025 | | :--------------------------------------- | :-------------- | | Total lease payments | $24,409 | | Less: amount representing interest | $(6,741) | | Present value of lease liabilities | $17,668 | [Note 8. Restructuring](index=21&type=section&id=8.%20Restructuring) This note outlines the restructuring activities, primarily workforce reductions, and the associated charges and liabilities incurred by the company - The company announced significant **workforce reductions** in January 2025 (~50%), March 2025 (~50%), and May 2025 (~30%), incurring total **restructuring charges of $11.3 million** for the six months ended June 30, 2025[93](index=93&type=chunk)[94](index=94&type=chunk)[96](index=96&type=chunk)[97](index=97&type=chunk) Total Restructuring Charges (in thousands) | Item | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :--------------------------------------- | :------------------------------- | :------------------------------- | | Research and development expense | $944 | $9,293 | | General and administrative expense | $579 | $2,043 | | Total restructuring charges | $1,523 | $11,336 | Restructuring Liability Activity (in thousands) | Item | Amount | | :--------------------------------------- | :------- | | Liability balance, January 1, 2025 | $63 | | Restructuring charges | $11,336 | | Cash payments | $(7,450) | | Non-cash settlements/adjustments | $(1,105) | | Liability balance, June 30, 2025 | $2,844 | [Note 9. Commitments and Contingencies](index=22&type=section&id=9.%20Commitments%20and%20Contingencies) This note describes the company's contractual obligations, in-license agreements, legal disputes, and manufacturing commitments - Atara has in-license agreements with Memorial Sloan Kettering Cancer Center (MSK) and QIMR Berghofer, involving milestone and tiered royalty payments[99](index=99&type=chunk)[105](index=105&type=chunk) - A dispute with MSK regarding **$6.0 million in sub-licensing fees was settled** in March 2025, with MSK returning **$3.0 million**[103](index=103&type=chunk)[104](index=104&type=chunk) - Rights to the ATA188 and EBV Vaccine programs were **returned to QIMR** in May 2025[105](index=105&type=chunk) - Manufacturing agreements with Charles River Laboratories (CRL) and FUJIFILM Diosynth Biotechnologies California, Inc. (Fujifilm) were **assigned to Pierre Fabre** by March 2025, relieving Atara of related obligations and minimum commitments[108](index=108&type=chunk)[109](index=109&type=chunk)[111](index=111&type=chunk) [Note 10. Stockholders' Equity (Deficit)](index=24&type=section&id=10.%20Stockholders'%20Equity%20(Deficit)) This note details changes in stockholders' equity, including pre-funded warrants, stock-based compensation, and activity under the at-the-market facility - **Pre-funded warrants were issued** in July 2019, May 2020, December 2020, January 2024, and May 2025, contributing to additional paid-in capital[116](index=116&type=chunk)[118](index=118&type=chunk)[120](index=120&type=chunk)[122](index=122&type=chunk)[124](index=124&type=chunk) - No shares of common stock were sold under the 2023 ATM Facility during the six months ended June 30, 2025, with **$88.7 million remaining available**[128](index=128&type=chunk)[129](index=129&type=chunk) RSU Activity (Shares) | Item | Shares | | :--------------------------------------- | :------- | | Balance as of December 31, 2024 | 414,470 | | Granted | 386,068 | | Forfeited | (13,910) | | Vested | (282,988) | | Balance as of June 30, 2025 | 503,640 | Stock-based Compensation Expense (in thousands) | Item | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | | Research and development | $2,340 | $8,027 | | General and administrative | $4,670 | $6,706 | | Total stock-based compensation expense | $7,010 | $14,733 | [Note 11. Supplemental Balance Sheet Information](index=28&type=section&id=11.%20Supplemental%20Balance%20Sheet%20Information) This note provides additional breakdown for specific balance sheet items such as inventories, property and equipment, and other current liabilities Inventories (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :--------------------------------------- | :-------------- | :---------------- | | Raw Materials | $— | $964 | | Work-in-process | $— | $9,691 | | Total inventories | $— | $10,655 | Property and Equipment, Net (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :--------------------------------------- | :-------------- | :---------------- | | Property and equipment, net | $176 | $1,294 | Other Current Liabilities (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :--------------------------------------- | :-------------- | :---------------- | | Accrued operating expenses | $4,783 | $6,027 | | Current portion of operating lease liabilities | $2,242 | $12,879 | | Current portion of finance lease liabilities | $— | $1,038 | | Other accrued liabilities | $646 | $598 | | Total other current liabilities | $7,671 | $20,542 | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, highlighting key business developments, financial performance, liquidity, and capital resources [Overview](index=30&type=section&id=Overview) This overview summarizes the company's strategic focus, product pipeline status, key partnerships, and recent regulatory developments for its lead product - Atara is a T-cell immunotherapy leader with **tab-cel (Ebvallo) approved in EEA, UK, and Switzerland**, and in Phase 3 development in the U.S. for EBV+ PTLD[146](index=146&type=chunk) - Development of allogeneic CAR T cell programs (ATA3219, ATA3431) and ATA188 for MS has been **paused or discontinued**[146](index=146&type=chunk) - All manufacturing, clinical, and development responsibility for tab-cel was **transferred to Pierre Fabre by July 2025**[149](index=149&type=chunk) - The FDA issued a **Complete Response Letter for tab-cel BLA** in January 2025 due to GMP issues, but clinical holds were lifted in May 2025, and the BLA was resubmitted in July 2025 with a target action date of January 10, 2026[168](index=168&type=chunk) [Financial Overview](index=34&type=section&id=Financial%20Overview) This section provides a high-level summary of the company's financial performance, including net income, accumulated deficit, and primary revenue sources - **Net income was $40.4 million** for the six months ended June 30, 2025, compared to a **net loss of $(50.8) million** for the same period in 2024[171](index=171&type=chunk) - **Accumulated deficit as of June 30, 2025, was $2.0 billion**[171](index=171&type=chunk) Cash, Cash Equivalents and Short-term Investments (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :--------------------------------------- | :-------------- | :---------------- | | Total cash, cash equivalents and short-term investments | $22,323 | $42,496 | - Commercialization revenue is primarily from Pierre Fabre, derived from upfront license fees, milestone payments, and inventory sales, subject to the HCRx Agreement[172](index=172&type=chunk) [Revenues](index=34&type=section&id=Revenues) This section analyzes the company's commercialization revenue, detailing changes and the factors influencing them, particularly from collaboration agreements Commercialization Revenue (in thousands) | Period | 2025 | 2024 | Increase (Decrease) | | :--------------------------------------- | :------- | :------- | :------------------ | | Three Months Ended June 30, | $17,575 | $28,640 | $(11,065) | | Six Months Ended June 30, | $115,724 | $55,997 | $59,727 | - The six-month increase was primarily due to **revenue recognized from the transfer of manufacturing responsibilities to Pierre Fabre** as of March 31, 2025[184](index=184&type=chunk) - The three-month decrease was due to **no remaining revenue associated with the Initial Territory Obligation** in 2025, as it was fully recognized by March 31, 2025[184](index=184&type=chunk) [Cost of Commercialization Revenue](index=34&type=section&id=Cost%20of%20Commercialization%20Revenue) This section discusses the costs directly associated with generating commercialization revenue, explaining fluctuations based on operational changes Cost of Commercialization Revenue (in thousands) | Period | 2025 | 2024 | Increase (Decrease) | | :--------------------------------------- | :------- | :------- | :------------------ | | Three Months Ended June 30, | $554 | $4,627 | $(4,073) | | Six Months Ended June 30, | $20,993 | $6,612 | $14,381 | - The six-month increase was primarily due to the **cost of inventory sold to Pierre Fabre** on March 31, 2025, according to the A&R Commercialization Agreement Amendment[185](index=185&type=chunk) - The three-month decrease is primarily due to there being **no manufacturing activities in the 2025 period** following the transfer of such activities to Pierre Fabre as of March 31, 2025[185](index=185&type=chunk) [Research and Development Expenses](index=34&type=section&id=Research%20and%20Development%20Expenses) This section details the company's research and development expenditures, explaining changes driven by program transitions and workforce adjustments Research and Development Expenses (in thousands) | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Technical operations and quality expenses | $2,537 | $21,519 | $21,810 | $49,038 | | Medical and safety expenses | $3,628 | $8,302 | $8,963 | $21,828 | | Regulatory expenses | $1,145 | $3,511 | $3,970 | $7,972 | | Total research and development expenses | $7,310 | $33,332 | $34,743 | $78,838 | - **Decreases in R&D expenses** were primarily due to the transition of tab-cel manufacturing activities to Pierre Fabre and reduced headcount following workforce reductions[186](index=186&type=chunk) - Medical and safety expenses also decreased due to a **$3.0 million MSK sublicensing fee refund** and a decrease in CAR T research and development activities[187](index=187&type=chunk) [General and Administrative Expenses](index=35&type=section&id=General%20and%20Administrative%20Expenses) This section analyzes general and administrative expenses, highlighting the impact of cost-saving measures and workforce reductions General and Administrative Expenses (in thousands) | Period | 2025 | 2024 | Increase (Decrease) | | :--------------------------------------- | :------- | :------- | :------------------ | | Three Months Ended June 30, | $6,514 | $8,912 | $(2,398) | | Six Months Ended June 30, | $17,989 | $20,025 | $(2,036) | - The **decrease in general and administrative expenses** was primarily due to reduced headcount following the January and March 2025 reductions in force[189](index=189&type=chunk) [Other Income (Expense), Net](index=35&type=section&id=Other%20Income%20(Expense),%20Net) This section reports on non-operating income and expenses, including interest income and expense, and their contributing factors Other Income (Expense), Net (in thousands) | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Interest income | $143 | $450 | $379 | $1,054 | | Interest expense | $(972) | $(1,262) | $(1,989) | $(2,415) | | Other income (expense), net | $(807) | $(818) | $(1,599) | $(1,299) | - **Interest income decreased** due to lower average balances of cash, cash equivalents, and available-for-sale securities[190](index=190&type=chunk) - **Interest expense decreased** primarily due to decreased interest expense recognized on the liability related to the sale of future revenues under the HCRx Agreement[191](index=191&type=chunk) [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's ability to meet its short-term and long-term financial obligations, detailing funding sources and future capital needs - The company has historically funded operations primarily through equity financings, pre-funded warrants, and upfront fees and milestone payments from collaboration agreements[193](index=193&type=chunk) Cash, Cash Equivalents and Short-term Investments (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :--------------------------------------- | :-------------- | :---------------- | | Cash and cash equivalents | $16,903 | $25,030 | | Short-term investments | $5,420 | $17,466 | | Total cash, cash equivalents and short-term investments | $22,323 | $42,496 | - Existing cash, cash equivalents, and short-term investments as of June 30, 2025, are **insufficient to fund planned operations for at least 12 months**, raising substantial doubt about the company's ability to continue as a **going concern**[206](index=206&type=chunk) - The company plans to secure additional capital through public or private security offerings, debt, and/or strategic transactions, and anticipates a **$40 million milestone payment** from Pierre Fabre upon tab-cel BLA approval[204](index=204&type=chunk)[207](index=207&type=chunk) [Cash Flows](index=38&type=section&id=Cash%20Flows) This section analyzes the company's cash inflows and outflows from operating, investing, and financing activities, explaining significant changes Net Cash Flows (in thousands) | Item | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | | Net cash used in operating activities | $(35,456) | $(40,257) | | Net cash provided by investing activities | $12,129 | $21,913 | | Net cash provided by financing activities | $15,054 | $23,817 | - **Net cash used in operating activities decreased by $4.8 million**, primarily due to changes in net working capital following the transfer of manufacturing responsibilities to Pierre Fabre in the first quarter of 2025[201](index=201&type=chunk) - **Net cash provided by financing activities** in the six months ended June 30, 2025, primarily consisted of **$15.3 million in proceeds** from the issuance of prefunded warrants and shares in an underwritten registered direct offering[203](index=203&type=chunk) [Operating Capital Requirements and Plan of Operations](index=39&type=section&id=Operating%20Capital%20Requirements%20and%20Plan%20of%20Operations) This section outlines the company's projected funding needs and strategies to secure additional capital to support future operations and development - The company expects that existing cash, cash equivalents, and short-term investments as of June 30, 2025, combined with an anticipated **$40 million milestone payment**, will provide significant cash runway, but is **insufficient for the next 12 months**[204](index=204&type=chunk)[206](index=206&type=chunk) - Future funding requirements depend on clinical study outcomes, regulatory approvals, commercialization success, and the ability to raise additional capital through equity, debt, or strategic partnerships[208](index=208&type=chunk)[209](index=209&type=chunk)[214](index=214&type=chunk) - The company anticipates generating **losses for the foreseeable future** and will need substantial additional funding in the near term[204](index=204&type=chunk) [Contractual Obligations and Commitments](index=40&type=section&id=Contractual%20Obligations%20and%20Commitments) This section details the company's significant contractual obligations and commitments, including leases and manufacturing agreements - Contractual obligations primarily consist of non-cancellable operating and finance leases and agreements with CROs and CMOs[211](index=211&type=chunk) - No material changes were reported since the Annual Report on Form 10-K for the year ended December 31, 2024, other than those discussed in this document (e.g., assignment of manufacturing agreements to Pierre Fabre)[211](index=211&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=40&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section states that there were no material changes to the company's market risk disclosures, including interest rate risk and foreign currency exchange rate risk, during the six months ended June 30, 2025, compared to the previous annual report - **No material changes** to interest rate risk, market risk, or foreign currency exchange rate risk disclosures were reported during the six months ended June 30, 2025[212](index=212&type=chunk) [Item 4. Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) This section confirms the effectiveness of the company's disclosure controls and procedures as of June 30, 2025, and reports no material changes in internal control over financial reporting during the quarter - The Chief Executive Officer and Chief Accounting Officer concluded that **disclosure controls and procedures were effective** as of June 30, 2025[215](index=215&type=chunk) - **No material change in internal control over financial reporting** was identified during the three months ended June 30, 2025[216](index=216&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) This section states that the company is not currently involved in any material legal proceedings - The company is **not currently involved in any material legal proceedings**[217](index=217&type=chunk) [Item 1A. Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) This section details the significant risks associated with investing in the company, covering financial stability, product development, manufacturing, reliance on third parties, intellectual property, market acceptance, regulatory compliance, and general operational challenges - Activities to review strategic alternatives may not result in a transaction or deliver expected benefits, potentially leading to **liquidation and dissolution**[220](index=220&type=chunk)[226](index=226&type=chunk) - The company has incurred **substantial losses since inception**, and future profitability is uncertain, requiring significant near-term financing to continue operations[229](index=229&type=chunk)[237](index=237&type=chunk) - Development and commercialization of T-cell immunotherapies face heightened regulatory scrutiny, lengthy and expensive clinical trials with uncertain outcomes, and potential for undesirable side effects[259](index=259&type=chunk)[270](index=270&type=chunk)[278](index=278&type=chunk) - Dependence on Pierre Fabre for manufacturing and commercialization of tab-cel worldwide poses risks if they fail to meet contractual, regulatory, or other obligations[327](index=327&type=chunk) - Inability to obtain and maintain sufficient intellectual property protection or defend against infringement claims could adversely affect commercialization efforts[333](index=333&type=chunk)[344](index=344&type=chunk) - Market acceptance and adequate reimbursement for products are uncertain, facing intense competition from existing and new therapies[361](index=361&type=chunk)[381](index=381&type=chunk) - The company is subject to complex and changing healthcare laws and regulations (e.g., BPCIA, ACA, IRA, GDPR, HIPAA) and cybersecurity risks, which could lead to fines, liabilities, and reputational harm[367](index=367&type=chunk)[390](index=390&type=chunk)[433](index=433&type=chunk)[449](index=449&type=chunk) [Item 5. Other Information](index=88&type=section&id=Item%205.%20Other%20Information) This section confirms that no Rule 10b5-1 trading arrangements were adopted or terminated by the company's directors or executive officers during the three months ended June 30, 2025 - None of the company's directors or executive officers adopted or terminated any **Rule 10b5-1 trading arrangements** during the three months ended June 30, 2025[468](index=468&type=chunk) [Item 6. Exhibits](index=89&type=section&id=Item%206.%20Exhibits) This section lists the exhibits accompanying the Quarterly Report on Form 10-Q, including corporate governance documents, warrant forms, commercialization agreement amendments, and regulatory certifications - Exhibits include amendments to the Certificate of Incorporation and Bylaws, form of pre-funded warrant, and Amendment No. 2 to the Amended and Restated Commercialization Agreement with Pierre Fabre[469](index=469&type=chunk) - Certifications by the Chief Executive Officer and Principal Financial and Accounting Officer are included pursuant to Section 302 and Section 906 of the Sarbanes-Oxley Act of 2002[469](index=469&type=chunk) [Signatures](index=90&type=section&id=Signatures) This section contains the official signatures of the company's President and Chief Executive Officer and Chief Accounting Officer, certifying the submission of the Quarterly Report on Form 10-Q - The report was signed by AnhCo Thieu Nguyen, President and Chief Executive Officer, and Yanina Grant-Huerta, Chief Accounting Officer, on August 11, 2025[472](index=472&type=chunk)

[Filing Information](index=1&type=section&id=Filing%20Information) This section provides the official identification details and securities information for the registrant, Atara Biotherapeutics, Inc [Registrant Details](index=1&type=section&id=Registrant%20Details) This section provides the official identification details for Atara Biotherapeutics, Inc. as the registrant for this Form 8-K filing, including its incorporation state, address, and contact information - Registrant: Atara Biotherapeutics, Inc.[1](index=1&type=chunk) - Incorporation Jurisdiction: Delaware[1](index=1&type=chunk) - Principal Executive Offices: 2380 Conejo Spectrum Street Suite 200, Thousand Oaks, California 91320[1](index=1&type=chunk) [Securities Information](index=1&type=section&id=Securities%20Information) This part details the registrant's securities registered under Section 12(b) of the Act, specifically its Common Stock, and confirms its status regarding emerging growth company provisions Securities Registered Under Section 12(b) | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | :------------------ | :---------------- | :-------------------------------------- | | Common Stock, par value $0.0001 per share | ATRA | The Nasdaq Stock Market LLC | - The registrant is not an emerging growth company.[5](index=5&type=chunk) [Current Report Items](index=2&type=section&id=Current%20Report%20Items) This section outlines preliminary financial estimates, regulatory and business updates for Tabelecleucel, and lists accompanying exhibits [Item 2.02 Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) Atara Biotherapeutics, Inc. announced preliminary estimates for its cash, cash equivalents, and short-term investments as of June 30, 2025. The company explicitly stated that this is a preliminary estimate and does not provide a complete understanding of its financial condition or results of operations for the second quarter - Preliminary estimate of cash, cash equivalents, and short-term investments as of June 30, 2025, was announced on July 14, 2025.[6](index=6&type=chunk) - The preliminary estimate does not present all necessary information for a complete understanding of the Company's financial condition or results of operations for the second quarter ended June 30, 2025.[6](index=6&type=chunk) [Item 8.01 Other Events](index=2&type=section&id=Item%208.01%20Other%20Events) The Company issued a press release on July 14, 2025, providing updates on the regulatory and business status of its product, Tabelecleucel (Tab-cel®). This press release is filed as an exhibit to the 8-K - On July 14, 2025, the Company issued a press release titled 'Atara Biotherapeutics Provides Regulatory and Business Updates on Tabelecleucel (Tab-cel®)'.[7](index=7&type=chunk) - The press release is filed as Exhibit 99.1 and incorporated by reference.[7](index=7&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=2&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section lists the exhibits accompanying the Form 8-K filing, which include the press release mentioned in Item 8.01 and the interactive data file for the cover page Exhibits | Exhibit No. | Description | | :------------ | :---------------------------------------------- | | 99.1 | Press release, dated July 14, 2025 | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | [Signatures](index=3&type=section&id=Signatures) This section formally confirms the authorization and signing of the report by the company's executive leadership [Signatures](index=3&type=section&id=Signatures) The report is formally signed on behalf of Atara Biotherapeutics, Inc. by its President and Chief Executive Officer, AnhCo Nguyen, Ph.D., confirming due authorization for the filing - The report was signed on July 14, 2025.[12](index=12&type=chunk) - Signed by AnhCo Nguyen, Ph.D., President and Chief Executive Officer of ATARA BIOTHERAPEUTICS, INC.[13](index=13&type=chunk)

Core Perspective - The acceptance of the Biologics License Application (BLA) for tabelecleucel by the FDA represents a significant advancement for patients with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), who currently have limited treatment options and a very short lifespan following initial treatment failure [1][3] Group 1: Company Developments - Pierre Fabre Pharmaceuticals (PFP) has announced the acceptance of the BLA for tabelecleucel, which is targeted for FDA action by January 10, 2026, marking it as the first approved therapy in the U.S. for EBV+ PTLD [1] - Atara Biotherapeutics resubmitted the tabelecleucel BLA on July 11, 2025, after addressing manufacturing facility observations from a previous Complete Response Letter [2] - PFP has taken over global responsibility for tabelecleucel manufacturing for European markets and clinical trial supply since March 31, 2025, following a transfer of the Investigational New Drug Application from Atara Biotherapeutics [5] Group 2: Product Information - Tabelecleucel is an allogeneic, off-the-shelf, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells, with data from over 430 patients included in the BLA [3] - The therapy has already received marketing authorization in Europe under the brand name EBVALLO™ in December 2022, and in the UK and Switzerland in May 2023 and May 2024, respectively [4] Group 3: Industry Context - The mission of PFP is to provide breakthrough therapies in oncology and rare diseases, focusing on patient populations with high unmet needs [6] - Pierre Fabre Laboratories, the parent company of PFP, operates in 43 countries with over 10,000 employees and aims to create long-term value for patients through innovative partnerships and acquisitions [7]

Core Insights - Pierre Fabre Laboratories has taken over global clinical trial activities for the tabelecleucel clinical program, marking a significant milestone in its development [1] - The pivotal Phase 3 ALLELE Study is currently enrolling patients with EBV+PTLD following standard therapy failure, demonstrating the commitment to advancing clinical research [1][2] - Atara Biotherapeutics has resubmitted the tabelecleucel Biologics License Application (BLA) to the FDA, addressing previous manufacturing concerns [1][5] Clinical Studies - The ALLELE Study (NCT03394365) focuses on tabelecleucel for patients with EBV+ PTLD after failure of prior therapies, highlighting its potential in treating this condition [2] - Another study, NCT04554914, is evaluating tabelecleucel for various EBV-associated diseases, indicating a broader application of this therapy [3] Product Information - Tabelecleucel is an allogeneic, off-the-shelf EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells, differing from autologous CAR-T therapies [4] - The therapy received marketing authorization in December 2022 under the brand name EBVALLO® for treating r/r EBV+ PTLD in patients aged two years and older [5] Company Overview - Pierre Fabre Pharmaceuticals aims to deliver breakthrough therapies in oncology and rare diseases, focusing on high unmet medical needs [8] - The company operates globally, with a presence in 43 countries and over 10,000 employees, emphasizing its commitment to long-term patient value [9][10] Strategic Partnerships - In December 2023, Atara announced an expanded partnership with Pierre Fabre Laboratories for tabelecleucel, enhancing its market reach beyond Europe to the U.S. and other global markets [6]

Financial Data and Key Metrics Changes - The meeting reported that proxies were received for approximately 76% of the total outstanding shares, indicating a strong shareholder engagement [8] - The preliminary results showed that all proposals were approved, including the election of directors and the advisory vote on executive compensation [11][12] Business Line Data and Key Metrics Changes - No specific business line data or key metrics were discussed during the meeting [10] Market Data and Key Metrics Changes - No specific market data or key metrics were provided during the meeting [10] Company Strategy and Development Direction and Industry Competition - The company is focused on maintaining strong governance through the election of directors and the advisory vote on executive compensation, reflecting a commitment to shareholder interests [9][12] Management's Comments on Operating Environment and Future Outlook - Management did not provide specific comments on the operating environment or future outlook during the meeting [10] Other Important Information - The meeting was conducted virtually, and all voting was completed online, ensuring accessibility for shareholders [3][5] - The results of the voting will be published in a current report on Form 8-K within four business days [12] Q&A Session Summary - There were no questions submitted during the Q&A session [10]

[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents Atara Biotherapeutics' unaudited Q1 2025 and 2024 financial statements, detailing the shift to net income and ongoing liquidity challenges [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Presents Atara Biotherapeutics' unaudited Q1 2025 and 2024 financial statements, detailing the shift to net income and ongoing liquidity challenges [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Details Atara's financial position, showing changes in assets, liabilities, and equity from December 2024 to March 2025 Balance Sheet Metrics (in thousands) | Metric | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :----------------------------- | :----------------------------- | | Cash and cash equivalents | $13,841 | $25,030 | | Short-term investments | — | $17,466 | | Total current assets | $27,182 | $64,894 | | Total assets | $62,038 | $109,098 | | Total current liabilities | $47,892 | $134,574 | | Total liabilities | $117,110 | $206,381 | | Total stockholders' equity (deficit) | $(55,072) | $(97,283) | - Total current assets decreased significantly from **$64.9 million** at December 31, 2024, to **$27.2 million** at March 31, 2025, primarily due to the reduction in short-term investments and inventories[16](index=16&type=chunk) - Total liabilities decreased from **$206.4 million** to **$117.1 million**, largely driven by a substantial reduction in deferred revenue[16](index=16&type=chunk) - Stockholders' deficit improved from **$(97.3) million** to **$(55.1) million**, reflecting a positive change in equity[16](index=16&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20(Loss)) Outlines Atara's financial performance, including revenue, expenses, and net income (loss) for Q1 2025 and 2024 Statements of Operations Metrics (in thousands) | Metric (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :-------------------- | :-------------------------------- | :-------------------------------- | | Commercialization revenue | $98,149 | $27,357 | | Cost of commercialization revenue | $20,439 | $1,985 | | Research and development expenses | $27,433 | $45,506 | | General and administrative expenses | $11,475 | $11,113 | | Net income (loss) | $38,010 | $(31,752) | | Basic (loss) earnings per common share | $3.53 | $(5.65) | | Diluted (loss) earnings per common share | $3.50 | $(5.65) | - Commercialization revenue increased significantly by **$70.8 million**, from **$27.4 million** in Q1 2024 to **$98.1 million** in Q1 2025, primarily due to the transfer of manufacturing responsibilities to Pierre Fabre[18](index=18&type=chunk)[179](index=179&type=chunk) - The company reported a net income of **$38.0 million** in Q1 2025, a substantial improvement from a net loss of **$(31.8) million** in Q1 2024[18](index=18&type=chunk) - Research and development expenses decreased by **$18.1 million**, from **$45.5 million** in Q1 2024 to **$27.4 million** in Q1 2025, mainly due to reduced manufacturing activities for tab-cel and the pausing of CAR T programs[18](index=18&type=chunk)[181](index=181&type=chunk) [Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20(Deficit)) Tracks changes in Atara's stockholders' equity (deficit) from January 1 to March 31, 2025, driven by net income Stockholders' Equity Changes (in thousands) | Metric (in thousands) | Balance as of January 1, 2025 | Balance as of March 31, 2025 | | :-------------------- | :---------------------------- | :--------------------------- | | Total Stockholders' Equity (Deficit) | $(97,283) | $(55,072) | | Net (loss) income | — | $38,010 | | Stock-based compensation expense | — | $4,209 | - The total stockholders' deficit improved from **$(97.3) million** at January 1, 2025, to **$(55.1) million** at March 31, 2025, primarily driven by the net income of **$38.0 million**[20](index=20&type=chunk) - Stock-based compensation expense for the three months ended March 31, 2025, was **$4.2 million**, contributing to additional paid-in capital[20](index=20&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Presents cash inflows and outflows from operating, investing, and financing activities for Q1 2025 and 2024 Cash Flow Activities (in thousands) | Activity (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :---------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(28,138) | $(29,612) | | Net cash provided by investing activities | $17,199 | $14,717 | | Net cash provided by (used in) financing activities | $(250) | $24,141 | | Cash, cash equivalents and restricted cash at end of period | $13,987 | $35,233 | - Net cash used in operating activities decreased by **$1.5 million**, from **$29.6 million** in Q1 2024 to **$28.1 million** in Q1 2025, mainly due to changes in net working capital following the transfer of manufacturing responsibilities to Pierre Fabre[23](index=23&type=chunk)[196](index=196&type=chunk) - Net cash provided by investing activities increased to **$17.2 million** in Q1 2025 from **$14.7 million** in Q1 2024, primarily from maturities and sales of short-term investments[23](index=23&type=chunk)[197](index=197&type=chunk) - Net cash used in financing activities was **$(0.3) million** in Q1 2025, a significant change from **$24.1 million** provided in Q1 2024, which included proceeds from pre-funded warrants and ATM facilities[23](index=23&type=chunk)[198](index=198&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed explanations and disclosures supporting the condensed consolidated financial statements [1. Description of Business](index=10&type=section&id=1.%20Description%20of%20Business) Describes Atara's focus on T-cell immunotherapy, key programs, manufacturing transfers, and workforce reductions - Atara Biotherapeutics is a leader in T-cell immunotherapy, focusing on its allogeneic Epstein-Barr Virus (EBV) T-cell platform for cancer and autoimmune diseases[26](index=26&type=chunk) - Its most advanced program, tab-cel® (Ebvallo™), is approved in the EEA, UK, and Switzerland, and is in Phase 3 development in the US[27](index=27&type=chunk) - In March 2025, Atara completed the transfer of all manufacturing responsibility for tab-cel to Pierre Fabre Medicament, who also assumed future remediation costs for a third-party manufacturing facility[28](index=28&type=chunk) - The company executed multiple workforce reductions, including approximately **50%** in January 2025 and another **50%** in March 2025, retaining about **35** employees[32](index=32&type=chunk) [2. Summary of Significant Accounting Policies](index=11&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) Outlines key accounting principles, including reverse stock split, going concern issues, and capital raising plans - The company effected a **1-for-25** reverse stock split of its common stock on June 20, 2024, retroactively adjusting all equity-related information[35](index=35&type=chunk) - Atara has incurred significant operating losses since inception, with the exception of Q1 2025, and expects existing capital resources as of March 31, 2025, will not be sufficient to fund operations for at least **12 months**, raising substantial doubt about its ability to continue as a going concern[36](index=36&type=chunk)[37](index=37&type=chunk)[38](index=38&type=chunk) - To address liquidity risk, the company plans to secure additional capital through public/private security offerings, ATM facilities, and/or strategic transactions[38](index=38&type=chunk) Revenue and Net Income (Loss) (in thousands) | Metric | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :-------------------------------- | :--------------------------------------------- | :--------------------------------------------- | | Revenue | $98,149 | $27,357 | | Net income (loss) | $38,010 | $(31,752) | [3. Net Income (Loss) per Common Share](index=12&type=section&id=3.%20Net%20Income%20(Loss)%20per%20Common%20Share) Details the calculation of basic and diluted earnings per common share, including potential dilutive securities Earnings Per Share Metrics (in thousands) | Metric (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :-------------------- | :-------------------------------- | :-------------------------------- | | Weighted average shares outstanding – Basic | 10,764 | 5,623 | | Weighted average shares outstanding – Diluted | 10,851 | 5,623 | | Basic (loss) earnings per common share | $3.53 | $(5.65) | | Diluted (loss) earnings per common share | $3.50 | $(5.65) | - Potential dilutive securities, including unvested RSUs and options, were excluded from diluted EPS calculation in periods of net loss as their effect would be antidilutive[45](index=45&type=chunk) Potential Common Shares Issuable (as of) | Potential Common Shares Issuable (as of) | March 31, 2025 | March 31, 2024 | | :--------------------------------------- | :------------- | :------------- | | Unvested RSUs | 190,231 | 624,208 | | Vested and unvested options | 195,495 | 367,557 | | ESPP share purchase rights | 21,255 | 9,654 | | Total | 406,981 | 1,001,419 | [4. Financial Instruments](index=13&type=section&id=4.%20Financial%20Instruments) Discusses the classification and fair value of financial assets, including available-for-sale securities and cash - The company classifies financial assets at fair value using a three-level hierarchy, with all current available-for-sale securities (money market funds) classified as **Level 1**[47](index=47&type=chunk)[51](index=51&type=chunk) Available-for-Sale Securities (in thousands) | Available-for-Sale Securities (in thousands) | March 31, 2025 Fair Value | December 31, 2024 Fair Value | | :--------------------------------------- | :------------------------ | :--------------------------- | | Money market funds | $12,666 | $13,718 | | U.S. Treasury obligations | — | $27,458 | | Total available-for-sale securities | $12,666 | $41,176 | - Total available-for-sale securities decreased from **$41.2 million** at December 31, 2024, to **$12.7 million** at March 31, 2025, with U.S. Treasury obligations no longer held[51](index=51&type=chunk) Cash, Cash Equivalents and Restricted Cash (in thousands) | Cash, Cash Equivalents and Restricted Cash (in thousands) | March 31, 2025 | December 31, 2024 | | :---------------------------------------------------- | :------------- | :---------------- | | Cash and cash equivalents | $13,841 | $25,030 | | Restricted cash – short term | $146 | $146 | | Total | $13,987 | $25,176 | [5. Out-license Agreements](index=15&type=section&id=5.%20Out-license%20Agreements) Describes agreements with Pierre Fabre, including manufacturing transfer, revenue recognition, and deferred revenue - Atara expanded its commercialization agreement with Pierre Fabre in October 2023, granting exclusive worldwide rights for tab-cel (Ebvallo) and receiving an additional **$20.0 million** upfront payment in January 2024[57](index=57&type=chunk)[61](index=61&type=chunk) - In March 2025, Atara transferred all manufacturing responsibility for tab-cel to Pierre Fabre, who also agreed to assume future remediation costs for a third-party manufacturing facility. This accelerated transfer resulted in a reduction of certain potential future regulatory and commercial milestone payments[28](index=28&type=chunk)[59](index=59&type=chunk)[61](index=61&type=chunk) - Atara recognized **$97.9 million** in commercialization revenue from deferred revenue during Q1 2025, with all revenue associated with the Initial Territory Obligation recognized as of March 31, 2025[72](index=72&type=chunk)[69](index=69&type=chunk) Deferred Revenue Activity (in thousands) | Deferred Revenue Activity (in thousands) | Amount | | :--------------------------------------- | :----- | | Deferred revenue, January 1, 2025 | $95,092 | | Additions | $18,822 | | Recognized into commercialization revenue | $(97,931) | | Deferred revenue March 31, 2025 | $15,983 | [6. Liability Related to the Sale of Future Revenues](index=18&type=section&id=6.%20Liability%20Related%20to%20the%20Sale%20of%20Future%20Revenues) Details the agreement with HCRx for future Ebvallo royalties and milestone payments, and related liability amortization - In December 2022, Atara sold a portion of its future Ebvallo royalties and milestone payments in the Initial Territory to HCR Molag Fund, L.P. (HCRx) for **$31.0 million**, subject to a repayment cap between **185%** and **250%** of the investment[74](index=74&type=chunk)[75](index=75&type=chunk) - The liability is amortized using the effective interest method, with an annual effective interest rate of approximately **9%** as of March 31, 2025[77](index=77&type=chunk) Future Revenues Liability (in thousands) | Liability Related to Sale of Future Revenues (in thousands) | Amount | | :-------------------------------------------------------- | :----- | | Liability balance as of January 1, 2025 | $39,006 | | Accretion of interest expense | $852 | | Liability balance as of March 31, 2025 | $39,872 | | Less: current portion | $(489) | | Long-term liability | $39,383 | [7. Leases](index=19&type=section&id=7.%20Leases) Covers lease-related expenses, including amortization and impairment for office and lab spaces - Atara recognized an acceleration of amortization expense of **$1.0 million** for an abandoned office space right-of-use asset in Thousand Oaks, CA, in Q1 2025[80](index=80&type=chunk) - A non-cash impairment of **$4.1 million** was recorded for the ARC lab and warehouse space right-of-use asset in Q1 2025, following the decision to pause CAR-T R&D activities and seek to sublease the facility[81](index=81&type=chunk) Lease Liabilities (in thousands) | Lease Liabilities (in thousands) | Operating Leases | Finance Leases | | :------------------------------- | :--------------- | :------------- | | Total lease payments | $49,539 | $2,668 | | Present value of lease liabilities | $39,554 | $2,388 | | Current portion | $12,846 | $1,070 | | Long-term portion | $26,708 | $1,318 | Lease Cost (in thousands) | Lease Cost (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------ | :-------------------------------- | :-------------------------------- | | Total operating lease cost | $3,789 | $4,341 | | Total finance lease cost | $306 | $330 | [8. Restructuring](index=21&type=section&id=8.%20Restructuring) Reports on workforce reductions and associated restructuring charges incurred in Q1 2025 and 2024 - Atara announced workforce reductions of approximately **50%** in January 2025 (**$7.1 million** in charges) and another **50%** in March 2025 (**$2.7 million** in charges), retaining about **35** employees[32](index=32&type=chunk)[91](index=91&type=chunk)[92](index=92&type=chunk) - Total restructuring charges for Q1 2025 were **$9.8 million**, compared to **$4.8 million** in Q1 2024, primarily for severance payments and WARN Act wages[93](index=93&type=chunk) Restructuring Charges (in thousands) | Restructuring Charges (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :----------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development expense | $8,349 | $3,394 | | General and administrative expense | $1,464 | $1,357 | | Total restructuring charges | $9,813 | $4,751 | - As of March 31, 2025, approximately **$7.0 million** in restructuring liabilities remained, with **$6.8 million** current and **$0.1 million** long-term[94](index=94&type=chunk) [9. Commitments and Contingencies](index=22&type=section&id=9.%20Commitments%20and%20Contingencies) Addresses legal disputes, program rights discussions, and assignment of manufacturing agreements - Atara resolved a dispute with Memorial Sloan Kettering Cancer Center (MSK) in March 2025 regarding sub-licensing fees, resulting in MSK returning **$3.0 million** of the **$6.0 million** paid under protest[99](index=99&type=chunk) - The company is in discussions with QIMR Berghofer to return rights to the ATA188 and EBV vaccine programs[100](index=100&type=chunk) - In March 2025, Atara assigned its Fujifilm Master Services and Supply Agreement and other minimum commitment agreements to Pierre Fabre as part of the manufacturing transition[104](index=104&type=chunk)[107](index=107&type=chunk) [10. Stockholders' Equity (Deficit)](index=24&type=section&id=10.%20Stockholders%27%20Equity%20(Deficit)) Provides details on common stock, outstanding warrants, and stock-based compensation expense - As of March 31, 2025, **5,924 thousand** shares of common stock were issued and outstanding, with a total of **1,070,534** shares reserved for future issuance under equity incentive plans[16](index=16&type=chunk)[133](index=133&type=chunk) - No pre-funded warrants were exercised during Q1 2025, with **4,786,277** pre-funded warrants outstanding as of March 31, 2025, from various offerings[113](index=113&type=chunk)[116](index=116&type=chunk)[118](index=118&type=chunk)[120](index=120&type=chunk) - Stock-based compensation expense for Q1 2025 was **$4.2 million**, a decrease from **$8.4 million** in Q1 2024[134](index=134&type=chunk) Stock-based Compensation Expense (in thousands) | Stock-based Compensation Expense (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :---------------------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $1,598 | $4,713 | | General and administrative | $2,611 | $3,684 | | Total | $4,209 | $8,397 | [11. Supplemental Balance Sheet Information](index=27&type=section&id=11.%20Supplemental%20Balance%20Sheet%20Information) Offers additional details on inventories and property and equipment, net, reflecting recent asset transfers Inventories (in thousands) | Inventories (in thousands) | March 31, 2025 | December 31, 2024 | | :------------------------- | :------------- | :---------------- | | Raw Materials | $— | $964 | | Work-in-process | $— | $9,691 | | Total inventories | $— | $10,655 | - Inventories decreased from **$10.7 million** at December 31, 2024, to **zero** at March 31, 2025, reflecting the transfer of manufacturing responsibility and sale of inventory to Pierre Fabre[135](index=135&type=chunk)[59](index=59&type=chunk) Property and Equipment, Net (in thousands) | Property and Equipment, Net (in thousands) | March 31, 2025 | December 31, 2024 | | :--------------------------------------- | :------------- | :---------------- | | Property and equipment, gross | $1,980 | $18,601 | | Less: accumulated depreciation | $(1,695) | $(17,307) | | Property and equipment, net | $285 | $1,294 | - Net property and equipment decreased from **$1.3 million** to **$0.3 million**, largely due to the disposal of assets associated with restructuring activities[136](index=136&type=chunk)[93](index=93&type=chunk) [12. Subsequent Events](index=28&type=section&id=12.%20Subsequent%20Events) Discloses events after the reporting period, including further workforce reductions and a new stock offering - In May 2025, Atara announced a further workforce reduction of approximately **30%**, expecting **$1.4 million** in severance and benefits, retaining about **23** employees[138](index=138&type=chunk) - On May 14, 2025, the company entered into an underwriting agreement for an offering of common stock and pre-funded warrants, expecting net proceeds of **$15.0 million**[139](index=139&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's analysis of Atara's Q1 2025 financial condition and operations, covering strategy, pipeline, manufacturing, and liquidity [Overview](index=29&type=section&id=Overview) Summarizes Atara's T-cell immunotherapy focus, program pauses, manufacturing transfers, and workforce reductions - Atara Biotherapeutics is a T-cell immunotherapy leader, with tab-cel (Ebvallo) approved in EEA, UK, and Switzerland, and in Phase 3 development in the U.S. for EBV+ PTLD[143](index=143&type=chunk) - In March 2025, Atara paused development of allogeneic CAR T cell programs and discontinued CAR T operations, including clinical trials for ATA3219 and development for ATA3431[143](index=143&type=chunk) - The company expanded its commercialization agreement with Pierre Fabre in October 2023 to include worldwide rights for tab-cel, receiving additional upfront and milestone payments[146](index=146&type=chunk) - In March 2025, Atara transferred all manufacturing responsibility for tab-cel to Pierre Fabre, who also assumed costs for third-party manufacturing facility remediation, leading to a reduction in future milestone payments[146](index=146&type=chunk) - Multiple workforce reductions occurred in November 2023 (**30%**), January 2024 (**25%**), January 2025 (**50%**), and March 2025 (**50%**), resulting in significant restructuring charges[152](index=152&type=chunk)[153](index=153&type=chunk)[154](index=154&type=chunk)[155](index=155&type=chunk) [Review of Strategic Alternatives](index=31&type=section&id=Review%20of%20Strategic%20Alternatives) Discusses the board's exploration of strategic alternatives and its temporary pause pending FDA meeting - Atara's board initiated a process in January 2025 to explore strategic alternatives, including potential acquisitions, mergers, or asset sales, initially focusing on CAR-T assets[156](index=156&type=chunk) - The review of strategic alternatives was temporarily paused in April 2025, pending a meeting with the FDA in Q2 2025 to discuss the resubmission of the BLA for tab-cel[156](index=156&type=chunk) [Pipeline](index=31&type=section&id=Pipeline) Provides updates on tab-cel's regulatory status, FDA actions, and the pausing of CAR T and ATA188 programs - Tab-cel (Ebvallo) is approved in the EEA, UK, and Switzerland, and is in Phase 3 clinical development in the U.S. for EBV+ PTLD, holding Breakthrough Therapy Designation[157](index=157&type=chunk) - The FDA issued a Complete Response Letter for tab-cel's BLA in January 2025, citing manufacturing facility inspection findings, but not clinical efficacy or safety data[157](index=157&type=chunk)[158](index=158&type=chunk) - In January 2025, the FDA placed a clinical hold on Atara's IND applications, including tab-cel and ATA3219, due to GMP compliance issues at a third-party manufacturing facility[159](index=159&type=chunk)[163](index=163&type=chunk) - The FDA lifted the clinical holds for the ALLELE study and tab-cel multi-cohort study in May 2025, following satisfactory remediation of issues[163](index=163&type=chunk) - Atara paused development of allogeneic CAR T cell programs (ATA3219, ATA3431) and discontinued development of ATA188 for multiple sclerosis[160](index=160&type=chunk)[161](index=161&type=chunk) [Manufacturing](index=32&type=section&id=Manufacturing) Details the transfer of tab-cel manufacturing responsibilities to Pierre Fabre and related agreements - In March 2025, Atara completed the transfer of all manufacturing responsibility for tab-cel to Pierre Fabre, including the assignment of the Fujifilm MSA[162](index=162&type=chunk)[163](index=163&type=chunk) - Pierre Fabre is now responsible for manufacturing and supplying tabelecleucel worldwide at its cost and has agreed to assume remediation costs for the third-party manufacturing facility[163](index=163&type=chunk) - The Commercial Manufacturing Services Agreement with Charles River Laboratories (CRL MSA) expired on August 31, 2024, with manufacturing responsibility transitioned to Pierre Fabre[164](index=164&type=chunk) [Financial Overview](index=33&type=section&id=Financial%20Overview) Presents a summary of Atara's Q1 2025 net income, accumulated deficit, revenue sources, and expense components - Atara reported net income of **$38.0 million** for Q1 2025, a significant improvement from a net loss of **$(31.8) million** in Q1 2024, but still has an accumulated deficit of **$2.0 billion** as of March 31, 2025[166](index=166&type=chunk) - Commercialization revenue is primarily from agreements with Pierre Fabre, including upfront license fees and milestone payments, and is subject to the HCRx Agreement[167](index=167&type=chunk) - Cost of commercialization revenue includes expenses for cell selection services, in-license sales-related milestone costs, and period manufacturing expenses, with costs for pre-approval Ebvallo production recorded as R&D expense[169](index=169&type=chunk) - Research and development expenses are the largest component of operating expenses, covering preclinical and clinical development, manufacturing, and licensing payments[170](index=170&type=chunk) [Results of Operations](index=35&type=section&id=Results%20of%20Operations) Analyzes the year-over-year changes in commercialization revenue, operating expenses, and other income/expense Operating Results Summary (in thousands) | Metric (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Increase (Decrease) | | :-------------------- | :-------------------------------- | :-------------------------------- | :------------------ | | Commercialization revenue | $98,149 | $27,357 | $70,792 | | Cost of commercialization revenue | $20,439 | $1,985 | $18,454 | | Research and development expenses | $27,433 | $45,506 | $(18,073) | | General and administrative expenses | $11,475 | $11,113 | $362 | | Total other income (expense), net | $(792) | $(481) | $(311) | - Commercialization revenue increased by **$70.8 million** YoY, primarily due to revenue recognition from the transfer of manufacturing responsibilities to Pierre Fabre[179](index=179&type=chunk) - Research and development expenses decreased by **$18.1 million** YoY, driven by reduced tab-cel manufacturing and the pausing of CAR T programs, partially offset by a **$4.1 million** lease impairment[181](index=181&type=chunk) - Medical and safety expense decreased by **$8.2 million** YoY, mainly due to a **$3.0 million** MSK sublicensing fee refund and lower trial costs from the ATA188 Phase 2 EMBOLD study closeout[182](index=182&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) Discusses Atara's cash position, capital sources, future funding needs, and going concern considerations - Atara's liquidity sources include equity financings, pre-funded warrants, upfront fees and milestone payments from collaboration agreements, and the sale of the ATOM Facility[187](index=187&type=chunk) - As of March 31, 2025, cash, cash equivalents, and short-term investments totaled **$13.8 million**, down from **$42.5 million** at December 31, 2024[194](index=194&type=chunk) - The company expects to receive **$15.0 million** in net proceeds from a May 2025 underwritten registered direct offering, which, combined with cost reductions, is anticipated to fund operations through potential BLA approval[199](index=199&type=chunk) - Substantial doubt exists about Atara's ability to continue as a going concern for at least **12 months** after the financial statements' issuance date, necessitating additional capital raises[201](index=201&type=chunk)[233](index=233&type=chunk) Cash Flow Summary (in thousands) | Cash Flows (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------ | :-------------------------------- | :-------------------------------- | | Operating activities | $(28,138) | $(29,612) | | Investing activities | $17,199 | $14,717 | | Financing activities | $(250) | $24,141 | [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section states that there were no material changes to Atara's interest rate risk, market risk, and foreign currency exchange rate risk disclosures during the three months ended March 31, 2025, compared to those reported in the Annual Report on Form 10-K for the year ended December 31, 2024 - No material changes occurred in interest rate risk, market risk, or foreign currency exchange rate risk disclosures during Q1 2025[207](index=207&type=chunk) [Item 4. Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) This section confirms the effectiveness of Atara's disclosure controls and procedures as of March 31, 2025, and reports no material changes in internal control over financial reporting during the quarter - Atara's Chief Executive Officer and Chief Accounting Officer concluded that disclosure controls and procedures were effective as of March 31, 2025[208](index=208&type=chunk) - No changes in internal control over financial reporting materially affected, or are reasonably likely to materially affect, internal control over financial reporting during Q1 2025[209](index=209&type=chunk) [PART II. OTHER INFORMATION](index=40&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, other information, and exhibits for Atara Biotherapeutics [Item 1. Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) This section states that Atara Biotherapeutics is not currently involved in any material legal proceedings - Atara is not currently involved in any material legal proceedings[211](index=211&type=chunk) [Item 1A. Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) Details significant risks to Atara's business, financial condition, and operations, covering finance, development, manufacturing, and IP [Risks Related to Our Financial Results, Capital Needs, and Review of Strategic Alternatives](index=40&type=section&id=Risks%20Related%20to%20Our%20Financial%20Results,%20Capital%20Needs,%20and%20Review%20of%20Strategic%20Alternatives) Addresses risks associated with strategic alternatives, capital requirements, and the company's ability to continue as a going concern - The review of strategic alternatives initiated in January 2025 may not result in a successful transaction or deliver expected benefits, potentially disrupting management and incurring significant expenses[214](index=214&type=chunk)[215](index=215&type=chunk)[216](index=216&type=chunk) - Failure to identify a viable strategic alternative or secure sufficient capital could force the board to pursue liquidation, potentially resulting in a total loss for stockholders[219](index=219&type=chunk)[221](index=221&type=chunk) - Atara has incurred substantial losses since inception and anticipates continued losses in 2026, despite forecasting net income in 2025 due to operating expense reductions[222](index=222&type=chunk)[223](index=223&type=chunk) - The company requires substantial near-term financing, and a failure to obtain it could delay or terminate product development, impair strategic alternative exploration, or lead to business wind-down[230](index=230&type=chunk)[233](index=233&type=chunk)[234](index=234&type=chunk)[236](index=236&type=chunk) [Risks Related to the Development of Our Product and Product Candidates](index=44&type=section&id=Risks%20Related%20to%20the%20Development%20of%20Our%20Product%20and%20Product%20Candidates) Covers risks in product development, regulatory approvals, clinical trials, and the uncertainty of T-cell immunotherapies - Atara has only one approved product (Ebvallo in EEA, UK, Switzerland) and paused allogeneic CAR T programs; failure to successfully develop, manufacture, and commercialize products or candidates could materially harm the business[239](index=239&type=chunk)[240](index=240&type=chunk) - The FDA issued a Complete Response Letter for tab-cel's BLA due to manufacturing facility inspection findings, and clinical holds were placed on IND applications, though holds for tab-cel were lifted in May 2025[252](index=252&type=chunk) - T-cell immunotherapies represent new therapeutic approaches, potentially leading to heightened regulatory scrutiny, delays, or inability to achieve approval or commercialization[256](index=256&type=chunk) - Results from preclinical or earlier clinical studies are not necessarily predictive of future results, and later-stage failures could adversely impact regulatory approval[262](index=262&type=chunk)[264](index=264&type=chunk) - Clinical drug development is lengthy, expensive, and uncertain, with potential delays from enrollment issues, regulatory disagreements, or unforeseen side effects[266](index=266&type=chunk)[267](index=267&type=chunk)[268](index=268&type=chunk) [Risks Related to Manufacturing](index=57&type=section&id=Risks%20Related%20to%20Manufacturing) Highlights challenges in manufacturing processes, supply chain, regulatory approvals, and facility disruptions - Atara faces numerous manufacturing risks, including challenges in transferring processes, scaling production, ensuring comparability, and maintaining consistent supply, which could increase costs and limit product availability[299](index=299&type=chunk)[300](index=300&type=chunk)[301](index=301&type=chunk) - Product loss due to contamination, equipment failure, or human error is a risk in cellular therapy manufacturing, potentially leading to reduced yields or supply disruptions[302](index=302&type=chunk) - Delays in regulatory approvals for products manufactured at CMO facilities could hinder development plans and revenue generation[305](index=305&type=chunk) - Damage or destruction of manufacturing facilities or interruptions in production could severely impact business operations and supply, with insurance potentially insufficient to cover losses[310](index=310&type=chunk)[311](index=311&type=chunk) [Risks Related to Our Dependence on Third Parties](index=59&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) Discusses risks from reliance on CMOs and partners for manufacturing, commercialization, and strategic alliances - Atara relies on CMOs and partners for product production and material acquisition; problems with these third parties could delay development and commercialization[312](index=312&type=chunk) - The company is entirely dependent on Pierre Fabre for worldwide manufacturing and commercialization of tab-cel; their failure to meet obligations could adversely affect Atara's business and HCRx Agreement obligations[323](index=323&type=chunk)[324](index=324&type=chunk) - Termination, breach, or expiration of the A&R Commercialization Agreement could materially harm Atara's financial position by reducing or eliminating milestone and royalty payments[326](index=326&type=chunk) - Atara may not realize benefits from future strategic alliances or product acquisitions/licenses due to competition, negotiation complexities, or integration challenges[328](index=328&type=chunk)[329](index=329&type=chunk) [Risks Related to Our Intellectual Property](index=62&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) Addresses challenges in protecting intellectual property, patent validity, infringement claims, and trade secret security - Inadequate intellectual property protection for product candidates could adversely affect commercialization and competitive positioning[330](index=330&type=chunk) - Patentability, validity, enforceability, and scope of patents in biotechnology are uncertain, and third parties may challenge or design around Atara's patents[331](index=331&type=chunk)[334](index=334&type=chunk)[335](index=335&type=chunk) - Lawsuits for infringing third-party intellectual property rights could be costly, time-consuming, and delay development or commercialization efforts[341](index=341&type=chunk)[343](index=343&type=chunk)[345](index=345&type=chunk) - Atara may not be able to protect its intellectual property rights globally, as foreign laws may offer less protection, and enforcement proceedings can be expensive and uncertain[346](index=346&type=chunk)[347](index=347&type=chunk) - Breaching license agreements with partners, such as MSK, could lead to loss of development and commercialization rights for product candidates[348](index=348&type=chunk) - Failure to protect trade secrets and proprietary information could allow competitors to duplicate technology, harming Atara's competitive advantage[353](index=353&type=chunk)[355](index=355&type=chunk)[356](index=356&type=chunk) [Risks Related to Commercialization of Our Product and Product Candidates](index=67&type=section&id=Risks%20Related%20to%20Commercialization%20of%20Our%20Product%20and%20Product%20Candidates) Covers market acceptance, reimbursement, regulatory changes, competition, and the ability to market products - Commercial success depends on achieving significant market acceptance among physicians, patients, and payors, which is influenced by efficacy, safety, pricing, and competition[357](index=357&type=chunk) - Lack of coverage and adequate reimbursement from third-party payors in the U.S. and other countries could harm business, as cost containment is a primary trend in healthcare[359](index=359&type=chunk)[360](index=360&type=chunk) - Current and future legislation, including unfavorable pricing regulations or healthcare reform initiatives (e.g., ACA, IRA), may increase costs and affect product pricing and reimbursement[363](index=363&type=chunk)[367](index=367&type=chunk)[368](index=368&type=chunk) - Atara faces substantial competition from pharmaceutical and biotechnology companies, academic institutions, and other therapies, which could reduce sales and pricing power[376](index=376&type=chunk) - Product candidates regulated as biologics may face earlier competition from biosimilars due to the BPCIA, potentially impacting commercial prospects[385](index=385&type=chunk)[387](index=387&type=chunk) - Inability to enter into agreements with third parties to market and sell products could prevent revenue generation from sales[388](index=388&type=chunk) [Risks Related to Ownership of Our Common Stock](index=73&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Common%20Stock) Discusses stock price volatility, stockholder control, potential dilution, anti-takeover provisions, and reporting status - Atara's stock price has been and is expected to remain volatile, influenced by factors such as competitive products, regulatory actions, clinical study results, and financing efforts[391](index=391&type=chunk)[392](index=392&type=chunk) - Principal stockholders own a significant percentage of stock, enabling them to exert control or influence over matters requiring stockholder approval, potentially conflicting with other stockholders' interests[395](index=395&type=chunk) - Future sales and issuances of common stock or rights to purchase common stock could result in additional dilution for existing stockholders and cause the stock price to fall[401](index=401&type=chunk) - Certain terms in charter documents and Delaware law may have anti-takeover effects, discouraging acquisitions or making it difficult to replace current management[402](index=402&type=chunk)[404](index=404&type=chunk)[405](index=405&type=chunk) - As a 'smaller reporting company' and 'non-accelerated filer,' Atara may use reduced reporting requirements, potentially making its stock less attractive to some investors[408](index=408&type=chunk)[409](index=409&type=chunk) [General Risk Factors](index=78&type=section&id=General%20Risk%20Factors) Encompasses risks related to personnel, regulatory compliance, product liability, environmental laws, and IT security - Future success depends on retaining executive officers and attracting/motivating qualified personnel; recent workforce reductions pose risks to coordination, corporate culture, and talent retention[411](index=411&type=chunk)[413](index=413&type=chunk) - Relationships with customers and third-party payors are subject to anti-kickback, fraud and abuse, and privacy laws, potentially leading to criminal sanctions, civil penalties, and reputational harm[414](index=414&type=chunk)[416](index=416&type=chunk) - Employee misconduct, including noncompliance with regulatory standards or inaccurate reporting, could result in significant liability and harm Atara's reputation[417](index=417&type=chunk) - Product liability lawsuits could lead to substantial liabilities, decreased demand, clinical holds, and reputational damage, potentially exceeding insurance coverage[418](index=418&type=chunk)[421](index=421&type=chunk) - Failure to comply with environmental, health, and safety laws could result in fines, penalties, or increased costs[422](index=422&type=chunk)[424](index=424&type=chunk) - Compromised security measures or IT system failures could disrupt services, compromise sensitive information, harm reputation, and expose Atara to liability[443](index=443&type=chunk)[446](index=446&type=chunk)[449](index=449&type=chunk) [Item 5. Other Information](index=86&type=section&id=Item%205.%20Other%20Information) This section confirms that none of Atara's directors or executive officers adopted or terminated any Rule 10b5-1 trading arrangements during the three months ended March 31, 2025 - No directors or executive officers adopted or terminated Rule 10b5-1 trading arrangements during Q1 2025[463](index=463&type=chunk) [Item 6. Exhibits](index=87&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents, warrant forms, and certifications, with specific amendments to license and commercialization agreements - Key exhibits include amendments to the exclusive license agreement with Memorial Sloan Kettering Cancer Center (dated March 11, 2025) and the amended and restated commercialization agreement with Pierre Fabre Medicament (dated March 31, 2025)[465](index=465&type=chunk) - Certifications by the Chief Executive Officer and Principal Financial and Accounting Officer pursuant to the Sarbanes-Oxley Act of 2002 are included[465](index=465&type=chunk) [Signatures](index=88&type=section&id=Signatures) This section contains the required signatures for the Form 10-Q, confirming its submission by authorized officers of Atara Biotherapeutics, Inc - The report is signed by AnhCo Thieu Nguyen, President and Chief Executive Officer, and Yanina Grant-Huerta, Chief Accounting Officer, on May 15, 2025[469](index=469&type=chunk)

[Q1 2025 Financial Results and Operational Progress](index=1&type=section&id=Atara%20Biotherapeutics%20Announces%20First%20Quarter%20Financial%20Results%20and%20Operational%20Progress) The company secured new financing and implemented major cost reductions to extend its cash runway while focusing resources on its lead program, tab-cel - Atara secured **$16 million in financing**, which is expected to extend its cash runway through the first quarter of 2026[2](index=2&type=chunk)[7](index=7&type=chunk)[13](index=13&type=chunk) - The company is implementing significant cost reductions, including workforce and program cuts, and expects to **reduce operating expenses by approximately 65%** year-over-year in 2025[1](index=1&type=chunk)[6](index=6&type=chunk)[13](index=13&type=chunk) - All manufacturing responsibilities and costs for its lead candidate, tabelecleucel, have been **transferred to partner Pierre Fabre Laboratories**[1](index=1&type=chunk)[4](index=4&type=chunk) - Development of the company's CAR T programs (ATA3219 and ATA3431) has been **discontinued to focus resources on tabelecleucel**[3](index=3&type=chunk) [Operational Highlights & Pipeline Update](index=1&type=section&id=Operational%20Highlights%20%26%20Pipeline%20Update) Atara is advancing tab-cel® by addressing FDA feedback and transferring manufacturing, while discontinuing CAR T programs to conserve resources [Tabelecleucel (tab-cel® or EbvalloTM)](index=1&type=section&id=Tabelecleucel%20(tab-cel%C2%AE%20or%20EbvalloTM)%20for%20Post-Transplant%20Lymphoproliferative%20Disease%20(PTLD)) The company is actively working with the FDA to advance its lead program, tab-cel®, towards a Biologics License Application resubmission - The FDA has **lifted the clinical holds** on EBVALLOTM studies, and Atara plans to resume enrollment in its Phase 3 and Phase 2 studies[4](index=4&type=chunk) - A **Type A meeting with the FDA is scheduled for Q2 2025** to discuss the path for resubmitting the EBVALLOTM Biologics License Application (BLA)[4](index=4&type=chunk) - As of March 2025, all worldwide **manufacturing responsibility for tab-cel has been transferred** to partner Pierre Fabre Laboratories[4](index=4&type=chunk) - Atara remains eligible for **significant milestone payments and royalties** from Pierre Fabre upon potential FDA approval and commercial sales of EBVALLOTM[4](index=4&type=chunk) [CAR T Programs](index=1&type=section&id=CAR%20T%20Programs%20Discontinued) Development of the company's CAR T programs has been paused to prioritize resources for its lead asset - Atara has **paused the development of its CAR T programs** (ATA3219 and ATA3431), with wind-down activities expected to be completed in the second quarter of 2025[3](index=3&type=chunk) [Corporate and Financial Updates](index=2&type=section&id=Corporate%20and%20Financial%20Updates) The company executed a strategic restructuring and secured new financing, resulting in a significant Q1 2025 revenue increase and a return to profitability [Corporate Updates](index=2&type=section&id=Corporate%20Updates) The company undertook a major restructuring, including workforce reductions and new financing, to strengthen its financial position - In May 2025, Atara implemented a strategic restructuring that resulted in a **30% workforce reduction**, retaining approximately 23 essential personnel[6](index=6&type=chunk) - The company entered into an underwriting agreement for an offering with expected **gross proceeds of $16 million** to fund activities towards tab-cel BLA approval and for general corporate purposes[7](index=7&type=chunk) - Atara has **paused its review of strategic options**, such as a merger or sale, pending the outcome of the Type A meeting with the FDA scheduled for Q2 2025[5](index=5&type=chunk) [First Quarter 2025 Financial Results](index=2&type=section&id=First%20Quarter%202025%20Financial%20Results) Q1 2025 saw a dramatic revenue increase and a shift to net income, driven by the Pierre Fabre agreement Q1 2025 Financial Highlights | Financial Metric | Q1 2025 | Q1 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | Total Revenues | $98.1M | $27.4M | +$70.7M | | R&D Expenses | $27.4M | $45.5M | -$18.1M | | G&A Expenses | $11.5M | $11.1M | +$0.4M | | Net Income (Loss) | $38.0M | $(31.8)M | +$69.8M | | Diluted EPS | $3.50 | $(5.65) | +$9.15 | - The significant increase in total revenues was primarily due to **revenue recognized from the Pierre Fabre agreement** following the transfer of manufacturing responsibilities[8](index=8&type=chunk) - Cash, cash equivalents, and short-term investments totaled **$13.8 million** as of March 31, 2025, compared to $42.5 million as of December 31, 2024[8](index=8&type=chunk) [2025 Outlook and Cash Runway](index=3&type=section&id=2025%20Outlook%20and%20Cash%20Runway) Atara projects a 65% reduction in 2025 operating expenses and has extended its cash runway into Q1 2026 with recent financing - The company projects that its cash position as of March 31, 2025, combined with the **$16M gross proceeds** from the May 2025 offering, will fund planned operations into the first quarter of 2026[13](index=13&type=chunk) - Full-year 2025 operating expenses are expected to **decrease by approximately 65%** from 2024, with the largest reduction anticipated in Q2 2025[1](index=1&type=chunk)[13](index=13&type=chunk) - The company has **reduced its headcount by approximately 85%** since December 31, 2024, as part of its cost reduction initiatives[13](index=13&type=chunk) [Financial Statements](index=4&type=section&id=Financial%20Statements) This section provides the unaudited Consolidated Balance Sheets and Statements of Operations as of and for the period ended March 31, 2025 [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) The balance sheet reflects a decrease in total assets and a significant reduction in liabilities, primarily from deferred revenue recognition Consolidated Balance Sheet Summary | Balance Sheet Item (In thousands) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $13,841 | $25,030 | | Total current assets | $27,182 | $64,894 | | **Total assets** | **$62,038** | **$109,098** | | **Liabilities & Equity** | | | | Deferred revenue (current) | $15,983 | $95,092 | | Total current liabilities | $47,892 | $134,574 | | **Total liabilities** | **$117,110** | **$206,381** | | **Total stockholders' (deficit) equity** | **$(55,072)** | **$(97,283)** | - Total assets decreased to **$62.0 million** as of March 31, 2025, from $109.1 million at December 31, 2024[15](index=15&type=chunk) - Total liabilities decreased significantly to **$117.1 million** from $206.4 million, primarily due to a reduction in deferred revenue from $95.1 million to $16.0 million[15](index=15&type=chunk) [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company achieved a significant net income of $38.0 million in Q1 2025, a stark contrast to the net loss in the prior-year period Consolidated Statement of Operations Summary | Statement of Operations (In thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Commercialization revenue | $98,149 | $27,357 | | Total costs and operating expenses | $59,347 | $58,604 | | Income (loss) from operations | $38,802 | $(31,247) | | **Net income (loss)** | **$38,010** | **$(31,752)** | - The company reported a **net income of $38.0 million** for Q1 2025, a significant turnaround from a net loss of $31.8 million in Q1 2024[9](index=9&type=chunk)[17](index=17&type=chunk) - Diluted net income per common share was **$3.50 for Q1 2025**, compared to a diluted net loss per share of $5.65 in the same period of 2024[9](index=9&type=chunk)[17](index=17&type=chunk)

Core Viewpoint - Atara Biotherapeutics (ATRA) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook driven by rising earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system emphasizes the importance of earnings estimate revisions, which are strongly correlated with near-term stock price movements [4][6]. - Institutional investors often adjust their valuations based on changes in earnings estimates, leading to significant buying or selling actions that affect stock prices [4]. Company Performance and Outlook - Atara Biotherapeutics is projected to report earnings of -$5.94 per share for the fiscal year ending December 2025, reflecting a year-over-year change of 47.9% [8]. - Over the past three months, the Zacks Consensus Estimate for Atara has increased by 55%, indicating a positive trend in earnings expectations [8][10]. Zacks Rating System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with only the top 20% receiving a 'Strong Buy' or 'Buy' rating, suggesting superior potential for market-beating returns [9][10]. - The upgrade of Atara Biotherapeutics to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong likelihood of price appreciation in the near term [10].