UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 For the transition period from to Commission file number 001-36548 ATARA BIOTHERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) | Delaware | 46-0920988 | | --- | --- | | (State or Other Jurisdiction of Incorporation or Organization) | (I.R.S. Employer Identification No.) | | 1280 Rancho Conejo Boulevard | | | Thousand Oaks, CA | 91320 | | (Address of Principal Executive Offices) | (Zip Code) | | Registrant's Teleph ...

Exhibit 99.1 Atara Biotherapeutics Announces First Quarter Financial Results and Operational Progress Atara has transferred all manufacturing responsibility to Pierre Fabre Laboratories, including all costs associated with the manufacturing and supply of tabelecleucel for development and commercialization worldwide Atara expects to reduce its operating expenses year-over-year by approximately 65% in 2025 as a result of implemented cost reduction initiatives • Atara has paused development of its CAR T progra ...

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].

Core Viewpoint - Atara Biotherapeutics is under investigation for potential securities fraud following a significant decline in stock price and operational setbacks related to FDA responses and workforce reductions [1][2][3]. Company Developments - On January 16, 2025, Atara Biotherapeutics received a Complete Response Letter (CRL) from the FDA regarding its EBVALLO treatment, which was related to manufacturing concerns at a third-party facility [2]. - The FDA also placed a clinical hold on Atara's active Investigational New Drug applications, affecting both EBVALLO and the allogeneic CD19 CAR T therapy ATA3219, leading to a suspension of new patient enrollments [2]. - Following the CRL, Atara's stock price fell by $4.82, closing at $7.62, marking a 39% decline [3]. - On January 27, 2025, Atara announced plans to cut 50% of its workforce by June 2025 as part of its response to the ongoing challenges [3]. Legal and Regulatory Context - Wolf Haldenstein Adler Freeman & Herz LLP is investigating claims on behalf of Atara's investors regarding potential securities fraud by the company and its officers [1]. - The firm has a strong reputation in handling securities class actions and derivative litigation across various jurisdictions [4].

Core Viewpoint - Atara Biotherapeutics is under investigation for potential securities fraud following a significant setback with the FDA regarding its EBVALLO treatment, which has led to a substantial decline in stock price and workforce reduction [1][2][3]. Company Developments - On January 16, 2025, Atara Biotherapeutics received a Complete Response Letter (CRL) from the FDA for its EBVALLO treatment, which is intended for patients with Epstein-Barr virus positive post-transplant lymphoproliferative disease [2]. - The CRL was related to observations from a standard pre-license inspection of a third-party manufacturing facility, leading to a clinical hold on Atara's Investigational New Drug applications, including the allogeneic CD19 CAR T therapy ATA3219 [2]. - Following the FDA's decision, Atara's stock price fell by $4.82 per share, closing at $7.62, marking a 39% decline [3]. - The company announced plans to cut 50% of its workforce by June 2025 in response to these challenges [3]. Legal and Regulatory Context - Wolf Haldenstein Adler Freeman & Herz LLP is investigating claims on behalf of Atara's investors regarding potential securities fraud by the company and its officers or directors [1].