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].

分组1 - Atara Biotherapeutics reported a quarterly loss of $1.19 per share, significantly better than the Zacks Consensus Estimate of a loss of $3.82, and an improvement from a loss of $14 per share a year ago, resulting in an earnings surprise of 68.85% [1] - The company achieved revenues of $32.75 million for the quarter ended December 2024, exceeding the Zacks Consensus Estimate by 150.02%, compared to revenues of $4.25 million in the same quarter last year [2] - Atara Biotherapeutics has surpassed consensus EPS estimates three times over the last four quarters, indicating a positive trend in performance [2] 分组2 - The stock has underperformed the market, losing approximately 48.9% since the beginning of the year, while the S&P 500 has declined by only 2.4% [3] - The current consensus EPS estimate for the upcoming quarter is -$3.94 on revenues of $0.2 million, and for the current fiscal year, it is -$10.32 on revenues of $64.5 million [7] - The Medical - Biomedical and Genetics industry, to which Atara belongs, is currently ranked in the top 26% of over 250 Zacks industries, suggesting a favorable industry outlook [8]

Financial Performance - The company reported a net loss of $85.4 million for the year ended December 31, 2024[187]. - As of December 31, 2024, the company had total cash, cash equivalents, and short-term investments of $42.5 million, which are insufficient to fund planned operations for at least the next twelve months[197]. - The company has incurred substantial losses since inception and expects to continue incurring significant expenses and operating losses for the foreseeable future[188]. - The company plans to seek additional capital through various means, including private and public equity offerings and debt financings, which may lead to dilution of existing stockholders[199]. - The company may pursue liquidation and dissolution if it fails to identify viable strategic alternatives or raise sufficient capital[184]. Strategic Alternatives and Operations - The company has engaged a financial advisor to explore a range of strategic alternatives, including potential acquisitions or mergers[180]. - The company has paused its CAR-T programs and discontinued development operations as of March 2025[180]. - The company faces significant operational and financial risks associated with pursuing strategic transactions, including potential disruptions and increased costs[183]. - The company may encounter challenges in realizing anticipated benefits from the Fujifilm Transaction, which could disrupt its business operations[202]. Product Development and Regulatory Approval - The company has one approved product, Ebvallo, which is currently approved in the European Economic Area (EEA), the UK, and Switzerland, while all other product candidates remain in preclinical development[203]. - The company faces risks related to the marketing authorization of its product candidates, with substantial dependence on obtaining regulatory approvals for future products[208]. - The company has not obtained regulatory approval for any other product candidates, and there is a possibility that none will ever receive approval[210]. - The company plans to submit the tab-cel BLA in Q2 2024, with FDA acceptance expected by July 2024 and a target action date of January 15, 2025[212]. - The FDA placed a clinical hold on the company's IND applications in January 2025, affecting both tab-cel and ATA3219 due to GMP compliance issues[227]. Clinical Trials and Patient Enrollment - The clinical development process is lengthy and expensive, with inherent uncertainties that can lead to failure at any stage[226]. - Patient enrollment for clinical studies is significantly impacted by various factors, including the COVID-19 pandemic, leading to slower than anticipated enrollment rates[229]. - The company activated additional clinical sites for the ALLELE study, resulting in increased HLA coverage and improved enrollment rates throughout 2018[229]. - The company relies on contract research organizations (CROs) for clinical studies, which introduces risks related to performance and compliance with regulatory requirements[230]. Manufacturing and Supply Chain Risks - Manufacturing processes and compliance with regulations are complex, and any failure in these areas could lead to increased costs and limited supply of products[255]. - The company faces risks related to the development and scale-up of manufacturing processes, which could delay product availability[256]. - Recent contamination issues at a CMO have necessitated pauses in manufacturing activities for products like Ebvallo and tab-cel, impacting production timelines[258]. - The company relies heavily on third-party manufacturers, which poses risks related to regulatory compliance and potential disruptions in supply chains[267]. Intellectual Property and Legal Risks - The company relies on a combination of patents, trademarks, and trade secrets for intellectual property protection, and any inadequacy could adversely affect its ability to compete[288]. - The company faces significant risks related to potential patent infringement claims from third parties, which could lead to costly litigation and hinder development efforts[298]. - The company may face challenges in enforcing its intellectual property rights globally, particularly in jurisdictions with weaker protections[304]. - The company may need to engage in costly and time-consuming legal proceedings to protect its intellectual property, with unpredictable outcomes[307]. Market and Competitive Landscape - The company faces substantial competition from various pharmaceutical and biotechnology enterprises, which may hinder its commercial opportunities if competitors develop superior products[332]. - The company expects its product candidates to be priced at a significant premium over competitive generic products, which may impede adoption without compelling clinical evidence[335]. - The approval of a biosimilar could materially impact the company's business by offering a lower-cost alternative to its products[341]. Regulatory and Compliance Challenges - The company is subject to various healthcare laws and regulations that could expose it to significant compliance costs and legal risks[367]. - The company faces substantial costs to ensure compliance with healthcare laws and regulations, which could lead to significant civil, criminal, and administrative penalties if violations occur[368]. - The company is subject to stringent privacy and data protection laws, such as the EU GDPR, which imposes comprehensive obligations that could increase compliance costs and operational risks[376]. Financial and Stockholder Considerations - The company does not anticipate paying cash dividends in the foreseeable future, with capital appreciation being the sole source of potential gain for stockholders[355]. - Future sales and issuances of common stock may lead to dilution of existing stockholders' ownership and could negatively impact the stock price[356]. - The company qualifies as a "smaller reporting company" and a "non-accelerated filer," which allows it to comply with reduced reporting requirements, potentially making its shares less attractive to investors[362].

Financial Position - Atara Biotherapeutics reported cash, cash equivalents, and short-term investments as of December 31, 2024, but specific figures were not disclosed in the preliminary estimate[6] Product Update - The company provided a regulatory and business update on its product EBVALLO™ (tabeleucel) on January 16, 2025[7]

Core Viewpoint - Atara Biotherapeutics (ATRA) shares have increased by 11.4% in the past four weeks, closing at $8.72, with a potential upside indicated by Wall Street analysts' mean price target of $11.60, suggesting a 33% increase from the current price [1] Price Targets and Estimates - The mean estimate consists of five short-term price targets with a standard deviation of $5.81, indicating variability among analysts; the lowest estimate is $5, suggesting a 42.7% decline, while the highest target is $18, indicating a potential surge of 106.4% [2] - A tight clustering of price targets, represented by a low standard deviation, suggests a high degree of agreement among analysts regarding the stock's price movement direction [7] Earnings Estimates - Analysts show growing optimism regarding ATRA's earnings prospects, as indicated by a strong consensus in revising EPS estimates higher, which correlates with near-term stock price movements [9] - The Zacks Consensus Estimate for the current year has increased by 23.9% over the past month, with one estimate rising and no negative revisions [10] - ATRA holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates, indicating a strong potential upside [11] Caution on Price Targets - Solely relying on consensus price targets for investment decisions may not be wise, as empirical research shows that these targets often mislead investors [5][8] - Analysts may set overly optimistic price targets due to business incentives, which can inflate expectations [6]

Core Viewpoint - Atara Biotherapeutics is under investigation for potential securities fraud and unlawful business practices following significant stock price declines due to regulatory issues with its drug application and clinical trials [1][2][3]. Group 1: Regulatory Issues - On January 16, 2025, Atara received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for EBVALLO, leading to a stock price drop of $6.59 per share, or 50.08%, closing at $6.57 per share [2]. - On January 21, 2025, the FDA placed a clinical hold on Atara's active Investigational New Drug (IND) applications due to compliance issues identified during the pre-license inspection, resulting in a further stock price decline of $0.52 per share, or 7.91%, closing at $6.05 per share [3]. Group 2: Legal Investigation - Pomerantz LLP is investigating claims on behalf of Atara investors regarding potential securities fraud or other unlawful business practices by the company and its officers or directors [1].