First allogeneic T-Cell therapy BLA offers hope to EBV+ PTLD patients who have limited treatment options and lifespan measured in only a few weeks to months following failure of initial treatmentEBV+ PTLD is an ultra-rare, acute, and potentially deadly blood malignancy that occurs after hematopoietic cell transplant (HCT) or solid organ transplant (SOT) when T-cell activity is impaired by immunosuppressionTabelecleucel has a Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026 and w ...

Atara Biotherapeutics resubmitted the tabelecleucel Biologics License Application (BLA) to the U.S. Food and Drug Administration on July 11 Pierre Fabre Laboratories is now responsible for all global clinical trial activities for the tabelecleucel clinical program Enrollment is ongoing for pivotal, Phase 3 ALLELE Study (NCT03394365) investigating tabelecleucel in patients with EBV+PTLD in Solid Organ Transplant and Allogeneic Hematopoietic Cell Transplant after failure of standard therapy NCT04554914 also o ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 14, 2025 Atara Biotherapeutics, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-36548 46-0920988 (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS Employer Identification No.) 2380 Conejo Spectrum Street Suite 200 Thousand Oaks, Californi ...

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]

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 ...

[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].

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]