Group 1 - The article discusses an ongoing investigation into Atara Biotherapeutics, Inc. regarding potential violations of securities laws, which may impact investor confidence and stock performance [1] - The investigation is being conducted by Levi & Korsinsky, a law firm that specializes in securities class action lawsuits, indicating the seriousness of the allegations against Atara Biotherapeutics [1] - Investors are being reminded to stay informed about the developments of the investigation, as it could lead to significant legal and financial implications for the company [1]

FDA CRL Impact on Atara Biotherapeutics - Shares of Atara Biotherapeutics (ATRA) plunged 40.5% after the FDA issued a complete response letter (CRL) against the company's biologics license application (BLA) for tabelecleucel (tab-cel) [1] - The CRL was linked to observations from a routine pre-license inspection of a third-party manufacturing facility, with no issues raised regarding manufacturing process, clinical efficacy, or safety data [3] - The FDA did not request additional clinical studies to support Ebvallo's approval [3] Ebvallo's Market and Clinical Data - Tab-cel, marketed as Ebvallo in the EU, is a novel T-cell immunotherapy for EBV+ PTLD, a rare hematologic malignancy with high mortality rates [2] - The BLA submission was based on the pivotal phase III ALLELE study, which showed a statistically significant 50% objective response rate in EBV+ PTLD patients [4] Financial and Operational Implications - The CRL has delayed Ebvallo's U.S. market entry, resulting in lost revenue potential [7] - Atara is eligible for a $60 million milestone payment from Pierre Fabre upon FDA approval, which has also been delayed, impacting operational funding [8] - The company reported preliminary cash, cash equivalents, and short-term investments of approximately $43 million as of Dec 31, 2024 [9] Strategic Alternatives and Funding - Atara is exploring strategic alternatives, including acquisition, merger, reverse merger, or sale of assets, to advance its CAR-T assets [11] - The company has signed a non-binding term sheet with Redmile Group for up to $15 million in equity funding to support Ebvallo BLA approval efforts [10] - If additional funding is not secured by Q1 2025, Atara plans to halt all CAR-T activities and focus solely on Ebvallo's approval [10] Industry Comparison - In the past three months, Atara shares have lost 16.8%, compared to the industry's 12.2% decline [2] - Castle Biosciences (CSTL), CytomX Therapeutics (CTMX), and BioMarin Pharmaceutical (BMRN) are better-ranked stocks in the sector, each sporting a Zacks Rank 1 (Strong Buy) [12] - Castle Biosciences' shares have plunged 23.2% in the past three months, while CytomX Therapeutics and BioMarin Pharmaceutical have lost 28.2% and 12.6%, respectively [13][14][15]

Core Viewpoint - Atara Biotherapeutics (ATRA) is positioned as a promising allogeneic T cell immunotherapy company with a strong pipeline and several upcoming catalysts, particularly focusing on its lead product candidate, tabelecleucel (tab-cel) [1][2]. Group 1: Product Development and Regulatory Status - The FDA is expected to make a decision on ATRA's biologics license application for tab-cel on January 15, which is under priority review [2]. - Tab-cel is designed to treat Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD), a rare and high-mortality blood cancer that occurs post-transplant due to compromised T-cell immune responses [3][2]. Group 2: Strategic Partnerships and Financial Position - ATRA has strengthened its cash position through an expanded partnership with Pierre Fabre, which includes exclusive commercialization rights for tab-cel in the U.S. and other global markets [4]. - If tab-cel receives FDA approval, ATRA will be eligible for an additional $60 million milestone payment from Pierre Fabre, enhancing its financial stability [5]. Group 3: Future Development Plans - ATRA plans to report preliminary phase I data on its lead CAR T program, ATA3219, in non-Hodgkin's lymphoma in the first quarter of 2025, which will also inform its potential in autoimmune diseases [6]. - Initial data from a phase I study on ATA3219 in lupus nephritis and extrarenal systemic lupus erythematosus is expected by mid-2025 [6]. Group 4: Stock Performance and Market Sentiment - ATRA's stock has increased by 108.1% over the past six months, contrasting with a 7.3% decline in the industry [7]. - Loss estimates for ATRA in 2025 have improved from $14.68 per share to $13.20 per share over the past 60 days, indicating a positive shift in market sentiment [8].

Financial Performance - Atara Biotherapeutics reported a quarterly loss of $2.93 per share, which was better than the Zacks Consensus Estimate of a loss of $3.77, and a significant improvement from a loss of $16.50 per share a year ago, indicating an earnings surprise of 22.28% [1] - The company posted revenues of $40.19 million for the quarter ended September 2024, surpassing the Zacks Consensus Estimate by 74.74%, compared to revenues of $2.14 million in the same quarter last year [2] Stock Performance - Atara Biotherapeutics shares have declined approximately 8.2% since the beginning of the year, while the S&P 500 has gained 25.8% [3] - The current Zacks Rank for Atara Biotherapeutics is 3 (Hold), suggesting that the shares are expected to perform in line with the market in the near future [6] Earnings Outlook - The consensus EPS estimate for the upcoming quarter is -$5.65 on revenues of $13.1 million, and for the current fiscal year, it is -$12.09 on revenues of $92.1 million [7] - The trend of estimate revisions for Atara Biotherapeutics is mixed, which could change following the recent earnings report [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Atara Biotherapeutics belongs, is currently ranked in the top 29% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8]

Regulatory Approvals and Product Development - Tab-cel (Ebvallo) has received marketing authorization approval for commercial sale in the EEA, UK, and Switzerland, and is currently in Phase 3 development in the U.S. for EBV+ PTLD patients who have failed prior therapies[109] - The tab-cel BLA was submitted in May 2024 and accepted by the FDA in July 2024, with a target action date of January 15, 2025[124] - The FDA accepted the BLA submission for tab-cel in July 2024, granting priority review with a target action date of January 15, 2025[206] - The company reached an agreement with the FDA on the comparability of tab-cel product versions, which is crucial for the BLA submission[206] - The marketing authorization for Ebvallo is granted under "exceptional circumstances," requiring ongoing post-marketing obligations to confirm its benefits[203] - Ebvallo received approvals under the exceptional circumstances regulatory pathway, with annual reassessments determining the continuation of marketing authorizations in the EAA, UK, and Switzerland[216] - The company is focused on obtaining regulatory approval for its clinical-stage product candidates, including tab-cel (tabelecleucel) in the U.S.[201] - Regulatory approval processes for novel therapies, such as T-cell immunotherapies, can be complex and lengthy, potentially impacting commercialization plans[209] - The company may face significant delays or inability to develop and commercialize product candidates if it does not achieve timely regulatory approvals and successful clinical study results[195] - The FDA may require additional clinical studies even if the company believes it has adequate data for regulatory approval[215] Financial Performance and Funding - The company reported net losses of $72.7 million for the nine months ended September 30, 2024, compared to $215.7 million for the same period in 2023, with an accumulated deficit of $2.0 billion as of September 30, 2024[134] - The company expects to continue incurring losses for the foreseeable future and will need additional capital to fund operations, which may include equity offerings and debt financings[159] - Existing cash, cash equivalents, and short-term investments as of September 30, 2024, are insufficient to fund planned operations for at least the next 12 months, raising substantial doubt about the company's ability to continue as a going concern[167] - The company anticipates needing to raise substantial additional funding to finance long-term operations and product development[168] - The company has generated limited revenues from commercialization, with only one product, Ebvallo, approved in the EEA, UK, and Switzerland[182] - The company expects to expend substantial resources on clinical development and manufacturing of T-cell immunotherapy product candidates and preclinical research pipeline expansion[184] - The company plans to secure additional capital through public or private offerings, use of its ATM facility, and strategic transactions to alleviate concerns about its ability to continue as a going concern[187] Workforce and Restructuring - The company announced a reduction in workforce of approximately 30% in November 2023, resulting in restructuring charges of $6.7 million[122] - A strategic reduction in workforce of approximately 25% was announced in January 2024, leading to restructuring charges of $5.1 million[123] - Workforce reductions included a 20% reduction in August 2022, a 30% reduction in November 2023, and a 25% reduction in January 2024, aimed at prioritizing key research and development programs[190] Research and Development - The company has established research collaborations with leading academic institutions to acquire novel technologies and programs[118] - ATA3219 is being developed as a potential best-in-class allogeneic CD19 CAR T immunotherapy, with a Phase 1 study for systemic lupus erythematosus (SLE) planned to start by the end of 2024, and initial data expected in mid-2025[125] - Initial clinical data for the Phase 1 trial of ATA3219 in non-Hodgkin lymphoma (NHL) is anticipated in the first quarter of 2025[125] - The company has an ongoing collaboration with QIMR Berghofer to develop a next-generation EBV vaccine, while discontinuing the development of ATA188 and returning other programs to collaborators[127] Commercialization and Revenue - Commercialization revenues for the three months ended September 30, 2024, were $40.2 million, a significant increase from $2.0 million in the same period of 2023, driven by additional performance obligations under the A&R Commercialization Agreement[147] - The company has out-licensed commercialization rights for Ebvallo to Pierre Fabre and sold certain royalty and milestone interests to HCRx, subject to a specified cap[182] - The company has non-cancellable minimum purchase commitments with CMOs, which could lead to additional costs if not fulfilled[258] - Any delays in the commercialization efforts by Pierre Fabre could adversely impact the company's financial results and operations[262] Manufacturing and Supply Chain Risks - The company faces challenges in manufacturing processes, including ensuring the stability, safety, purity, and potency of T-cell products[212] - The company must establish favorable terms with commercialization partners to gain market acceptance and secure adequate reimbursement[211] - Manufacturing responsibility for tab-cel will transition to Pierre Fabre by December 31, 2025, or upon completion of transfer activities[261] - The company relies on third-party manufacturers for production, which poses risks related to regulatory compliance and quality assurance[258] - The company is currently conducting product-specific qualification to support clinical development and commercial production qualification activities at CMOs' facilities[250] Intellectual Property and Legal Risks - If the company fails to maintain sufficient intellectual property protection, its ability to compete effectively may be adversely affected[266] - The company may face costly and time-consuming litigation if sued for infringing third-party intellectual property rights, which could hinder development efforts[276] - The company has filed numerous patent applications covering its products and candidates, but there is no guarantee that any patents will be issued or that they will be enforceable[273] - The patentability of inventions in the biotechnology field is uncertain due to complex legal and scientific considerations, leading to significant litigation[267] Market and Competitive Landscape - The company faces substantial competition from various pharmaceutical and biotechnology enterprises, which may impact commercial opportunities[307] - There are currently no FDA-approved products for the treatment of EBV+ PTLD, with only Ebvallo approved in the EU for this indication[307] - The company’s estimates of the target patient population for its products may prove incorrect, potentially limiting market opportunities and profitability[1] Reimbursement and Pricing Challenges - The company’s ability to commercialize products depends on obtaining adequate coverage and reimbursement from third-party payors, which is increasingly challenging due to cost containment trends in the healthcare industry[293] - Legislative changes, such as the Affordable Care Act, have significantly impacted the U.S. pharmaceutical industry, affecting pricing and reimbursement for new drug products[296] - The company may experience delays in obtaining coverage and reimbursement for newly approved drugs, which could adversely affect its financial condition[295] - The company must navigate a complex landscape of varying reimbursement policies among third-party payors, which can impact the demand for its products[295]

Financial Performance - Atara Biotherapeutics reported total revenues of $40.2 million for Q3 2024, a significant increase of $38.1 million compared to $2.1 million in Q3 2023[4]. - Total revenue for the three months ended September 30, 2024, was $40,190,000, a significant increase from $2,138,000 for the same period in 2023, representing a growth of approximately 1,779%[13]. - Commercialization revenue for the nine months ended September 30, 2024, reached $96,187,000, compared to $3,697,000 for the same period in 2023, indicating a growth of about 2,500%[13]. - Atara reported a net loss of $21.9 million, or $2.93 per share, for Q3 2024, compared to a net loss of $69.8 million, or $16.40 per share, for the same period in 2023[4]. - Net loss for the three months ended September 30, 2024, was $21,909,000, compared to a net loss of $69,797,000 for the same period in 2023, showing an improvement of approximately 68.6%[13]. - The company reported a basic and diluted net loss per common share of $2.93 for the three months ended September 30, 2024, compared to $16.40 for the same period in 2023[13]. Cash Position and Expenses - The company has a cash position of $67.2 million as of September 30, 2024, up from $35.3 million as of June 30, 2024, including a $20 million milestone payment from Pierre Fabre[4]. - Net cash used in operating activities decreased to $4.0 million in Q3 2024 from $51.3 million in the same period in 2023[4]. - Atara expects a 35% reduction in full-year 2024 operating expenses compared to 2023, with most reductions already realized starting Q2 2024[5]. - Research and development expenses for Q3 2024 were $43.9 million, down from $56.9 million in Q3 2023[4]. - Research and development expenses for the three months ended September 30, 2024, were $43,924,000, down from $56,888,000 for the same period in 2023, a decrease of about 22.8%[13]. - Cash and cash equivalents rose to $46,453,000 as of September 30, 2024, compared to $25,841,000 at December 31, 2023, an increase of about 80%[12]. Assets and Liabilities - Total current assets decreased to $91,855,000 as of September 30, 2024, down from $101,869,000 at December 31, 2023, reflecting a decline of approximately 9.9%[12]. - Total liabilities decreased to $233,245,000 as of September 30, 2024, compared to $264,735,000 at December 31, 2023, a reduction of about 11.9%[12]. - Total current liabilities increased to $155,979,000 as of September 30, 2024, from $142,226,000 at December 31, 2023, an increase of approximately 9.7%[12]. - The company’s accumulated deficit increased to $(2,041,860,000) as of September 30, 2024, from $(1,969,150,000) at December 31, 2023[12]. Clinical Development - The biologics license application (BLA) for tab-cel is on track with a PDUFA target action date of January 15, 2025, and potential for an additional $60 million milestone payment upon FDA approval[2]. - The first patient has been dosed in the Phase 1 clinical study of ATA3219 for Non-Hodgkin's Lymphoma, with initial clinical data expected in Q1 2025[2]. - Atara plans to initiate a Phase 1 study of ATA3219 for Lupus Nephritis by the end of 2024, with initial data anticipated in mid-2025[2]. - The company is progressing towards an IND submission for ATA3431 in Q4 2025, targeting B-cell malignancies[2].

Core Viewpoint - Atara Biotherapeutics (ATRA) has received a Zacks Rank 2 (Buy) upgrade, indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][2]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on the consensus measure of EPS estimates from sell-side analysts, reflecting the company's changing earnings picture [1]. - Changes in earnings estimates are strongly correlated with near-term stock price movements, primarily due to institutional investors adjusting their valuations based on these estimates [3]. Recent Performance and Projections - Atara Biotherapeutics is projected to earn -$12.09 per share for the fiscal year ending December 2024, representing a year-over-year change of 81.5% [5]. - Over the past three months, the Zacks Consensus Estimate for Atara has increased by 23.2%, indicating a positive trend in earnings estimates [5]. Zacks Rating System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a proven track record of Zacks Rank 1 stocks generating an average annual return of +25% since 1988 [4]. - The upgrade to Zacks Rank 2 places Atara in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [7].

13 August 2024 | 9:20AM EDT Atara Biotherapeutics Inc. (ATRA): 20 EPS: CEO transition; First CD19 oncology data now in 1025, with autoimmune to follow In tandem with 2Q EPS, ATRA announced a CEO transition in which Cokey Nguyen (ATRA's Chief Scientific and Technical Officer) will succeed Pascal Touchon effective September 9. Further updates included delaying the timing for first Ph1 ATA3219 (allogeneic CD19 CAR T) data in relapsed/refractory B-cell non-Hodgkin's lymphoma to 1Q25 vs. 4Q24 prior on slower pat ...

Company Performance - Atara Biotherapeutics reported a quarterly loss of $3.10 per share, significantly worse than the Zacks Consensus Estimate of a loss of $1.25, representing an earnings surprise of -148% [1] - The company's revenues for the quarter ended June 2024 were $28.64 million, missing the Zacks Consensus Estimate by 40.70%, compared to revenues of $0.96 million in the same quarter last year [1] - Over the last four quarters, Atara Biotherapeutics has surpassed consensus EPS estimates two times and topped consensus revenue estimates two times [1] Stock Performance - Atara Biotherapeutics shares have declined approximately 40.9% since the beginning of the year, contrasting with the S&P 500's gain of 12% [2] - The current Zacks Rank for Atara Biotherapeutics is 3 (Hold), indicating that the shares are expected to perform in line with the market in the near future [4] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$7 on revenues of $5.71 million, and for the current fiscal year, it is -$15.75 on revenues of $106.64 million [4] - The trend of estimate revisions for Atara Biotherapeutics is mixed, and future changes in estimates will be closely monitored following the recent earnings report [4] Industry Context - The Medical - Biomedical and Genetics industry, to which Atara Biotherapeutics belongs, is currently in the top 30% of over 250 Zacks industries, indicating a favorable outlook [5] - Praxis Precision Medicines, Inc., another company in the same industry, is expected to report a quarterly loss of $2.38 per share, reflecting a year-over-year change of +67.6% [5][6]

Regulatory Approvals and Commercialization - Tab-cel (Ebvallo) has received marketing authorization approval for commercial sale in the European Economic Area, the UK, and Switzerland, and is currently in Phase 3 development in the U.S. for EBV+ PTLD patients [113]. - The company has entered into a Commercialization Agreement with Pierre Fabre, granting exclusive rights to commercialize tab-cel in Europe and select emerging markets, with an upfront cash payment of $20 million received in January 2024 [115]. - The A&R Commercialization Agreement expanded Pierre Fabre's rights to include all countries worldwide, with additional milestone payments expected upon achieving regulatory milestones [115]. - The company is responsible for conducting ongoing clinical studies for tab-cel at Pierre Fabre's cost, while Pierre Fabre will handle commercialization and distribution [116]. - Tab-cel (Ebvallo) is approved for commercial sale in the EEA, UK, and Switzerland, with a Phase 3 trial ongoing in the U.S. for EBV+ PTLD patients [123]. - The BLA for tab-cel was submitted in May 2024, covering over 430 patients, and accepted by the FDA in July 2024 with a target action date of January 15, 2025 [123]. Financial Performance - The company reported net losses of $50.8 million for the six months ended June 30, 2024, compared to $145.9 million for the same period in 2023, with an accumulated deficit of $2.0 billion [132]. - Cash, cash equivalents, and short-term investments totaled $35.3 million as of June 30, 2024, intended to fund ongoing operations [132]. - Commercialization revenues for the three and six months ended June 30, 2024, were $28.6 million and $56.0 million, respectively, compared to $0.8 million and $1.7 million in the same periods of 2023, representing increases of 3,475% and 3,188% [146]. - Cost of commercialization revenue was $4.6 million and $6.6 million for the three and six months ended June 30, 2024, compared to $2.9 million and $3.1 million in the respective 2023 periods, reflecting increases of 60% and 111% [147]. - Total research and development expenses were $33.3 million and $56.1 million for the three and six months ended June 30, 2024, compared to $56.1 million and $118.3 million in the respective 2023 periods, showing decreases of 40.5% and 52.5% [149]. - General and administrative expenses decreased to $8.9 million and $20.0 million for the three and six months ended June 30, 2024, from $13.3 million and $27.2 million in the same periods of 2023, a reduction of 33.2% and 26.4% [152]. - Interest income for the three and six months ended June 30, 2024, was $0.5 million and $1.1 million, down from $1.7 million and $3.5 million in the respective 2023 periods, a decline of 70.6% and 68.6% [153]. Workforce and Restructuring - A strategic reduction in workforce of approximately 30% in November 2023 resulted in restructuring charges of $6.7 million, primarily for severance payments [121]. - A subsequent workforce reduction of approximately 25% in January 2024 led to restructuring charges of $5.1 million, with severance payments being made through January 2025 [122]. Research and Development - The company has paused development on ATA188 while exploring strategic options for this asset [113]. - Initial clinical data for ATA3219, targeting systemic lupus erythematosus, is anticipated in mid-2025, with a Phase 1 study planned to start in Q4 2024 [124]. - The company plans to expand the Phase 1 LN Study for ATA3219 to include severe SLE patients without lymphodepletion, with initial data also expected in mid-2025 [125]. - The company is progressing towards an IND submission for ATA3431 in the second half of 2025, targeting B-cell malignancies [126]. - The company has paused development on ATA188 while exploring strategic options, having returned some programs to collaborators [127]. Cash Flow and Funding - The company expects to continue incurring losses and negative cash flows from operations for the foreseeable future, necessitating additional capital to fund operations [158]. - The company anticipates that existing cash and investments will fund operations into 2027, contingent on successful commercialization and regulatory approvals [166]. - The company expects to continue generating losses and may need to raise substantial additional funding to finance long-term operations [167]. - As of June 30, 2024, the existing cash and investments are insufficient to fund planned operations for at least the next 12 months, raising substantial doubt about the company's ability to continue as a going concern [168]. - The company plans to seek additional funding through public or private equity offerings, debt financings, or strategic partnerships [169]. - The company has no committed external funding sources other than milestone and royalty payments under the A&R Commercialization Agreement [167]. - The company’s future funding requirements will depend on various factors, including clinical study costs, regulatory approval outcomes, and commercialization efforts [170].