Financial Performance - Atara Biotherapeutics reported total revenues of $28.6 million for Q2 2024, a significant increase of $27.6 million compared to $1.0 million in Q2 2023[10] - Atara Biotherapeutics reported total revenue of $28.64 million for the three months ended June 30, 2024, compared to $957,000 for the same period in 2023, representing a significant increase[22] - Atara reported a net loss of $19.0 million, or $3.10 per share, for Q2 2024, compared to a net loss of $71.1 million, or $16.91 per share, for the same period in 2023[10] - The company incurred a net loss of $19.05 million for the three months ended June 30, 2024, compared to a net loss of $71.11 million for the same period in 2023, indicating improved financial performance[22] Cash and Investments - Cash, cash equivalents, and short-term investments totaled $35.3 million as of June 30, 2024, down from $46.2 million as of March 31, 2024[9] - Cash and cash equivalents increased to $31.31 million as of June 30, 2024, up from $25.84 million as of December 31, 2023[18] - The company has a cash runway projected to fund operations into 2027, contingent on the timing and receipt of potential milestone payments[16] Research and Development - Research and development expenses decreased to $33.3 million in Q2 2024 from $56.1 million in Q2 2023, reflecting a reduction of approximately 41%[10] - Research and development expenses for the three months ended June 30, 2024, were $33.33 million, down from $56.14 million for the same period in 2023[22] - Atara expects to initiate a Phase 1 study of ATA3219 for systemic lupus erythematosus in Q4 2024, with initial clinical data anticipated in mid-2025[4] - Initial clinical data from the ATA3219 non-Hodgkin's lymphoma study is expected in Q1 2025[2] - Atara plans to expand the Phase 1 study of ATA3219 to include a cohort for severe systemic lupus erythematosus without lymphodepletion in Q4 2024[5] - Atara is advancing its AlloCAR-T programs, including ATA3219 and ATA3431, with ongoing clinical trials and regulatory submissions expected in the near future[16] Milestones and Regulatory Updates - The company received a $20 million milestone payment from Pierre Fabre in August 2024 following the acceptance of the tab-cel BLA, with a potential additional $60 million contingent upon FDA approval[3] - The BLA for tab-cel has been granted Priority Review with a PDUFA action date of January 15, 2025[3] Assets and Liabilities - Total current assets decreased to $62.41 million as of June 30, 2024, from $101.87 million as of December 31, 2023[18] - Total liabilities decreased to $228.15 million as of June 30, 2024, from $264.74 million as of December 31, 2023[19] - The company reported a significant increase in accounts payable, rising to $5.25 million as of June 30, 2024, compared to $3.68 million as of December 31, 2023[19] - Atara's accumulated deficit increased to $2.02 billion as of June 30, 2024, compared to $1.97 billion as of December 31, 2023[19] Operating Expenses - The company anticipates full-year 2024 operating expenses to decrease by approximately 35% from 2023 levels[11]

Atara Biotherapeutics (ATRA) could be a solid choice for investors given its recent upgrade to a Zacks Rank #1 (Strong Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years.In ...

分组1 - Atara Biotherapeutics reported a quarterly loss of $0.23 per share, better than the Zacks Consensus Estimate of a loss of $0.37, and an improvement from a loss of $0.72 per share a year ago, indicating a 37.84% earnings surprise [1] - The company generated revenues of $27.36 million for the quarter ended March 2024, surpassing the Zacks Consensus Estimate by 1.32%, and showing significant growth from $1.23 million in the same quarter last year [1] - Over the last four quarters, Atara Biotherapeutics has exceeded consensus EPS estimates two times and revenue estimates two times [1] 分组2 - The stock has gained approximately 10.3% since the beginning of the year, outperforming the S&P 500's gain of 8.8% [2] - The current consensus EPS estimate for the upcoming quarter is -$0.33 on revenues of $40 million, and for the current fiscal year, it is -$1.30 on revenues of $117 million [4] - The Medical - Biomedical and Genetics industry, to which Atara Biotherapeutics belongs, is currently ranked in the top 35% of over 250 Zacks industries, indicating a favorable outlook for the sector [5]

Product Development and Approvals - Tab-cel (Ebvallo) has received marketing authorization approval in the EU and UK and is currently in Phase 3 development in the U.S. for EBV+ PTLD patients who have failed prior therapies[81] - The company expects to submit the Biologics License Application (BLA) for tab-cel in Q2 2024, with pivotal data covering over 430 patients treated across multiple diseases[84] - ATA3219, an allogeneic CAR T therapy targeting CD19, received a Safe to Proceed letter from the FDA, with a Phase 1 study planned for Q4 2024[85] - The company plans to expand the Phase 1 LN Study and add a new cohort in severe SLE without lymphodepletion in Q4 2024, with initial clinical data anticipated in the second half of 2025[86] - The company expects to file an IND submission for ATA3431 in the second half of 2025, following promising preclinical data[88] - The company initiated enrollment of a multi-center, Phase 1 open-label, dose escalation clinical trial for ATA3219 in NHL, with initial clinical data anticipated in Q4 2024[86] - The company has paused development on ATA188 while exploring strategic options for this asset[81] - The company has paused development on ATA188 while exploring strategic options for this asset[88] Financial Performance - Commercialization revenues were $27.4 million for the three months ended March 31, 2024, compared to $0.9 million in the same period in 2023, reflecting an increase of $26.5 million[101] - The cost of commercialization revenue was $2.0 million for the three months ended March 31, 2024, compared to $0.2 million in the same period in 2023, an increase of $1.8 million[103] - The company had net losses of $31.8 million for the three months ended March 31, 2024, compared to $74.8 million for the same period in 2023[92] - As of March 31, 2024, the company had an accumulated deficit of $2.0 billion[92] - Total research and development expenses were $45.5 million in Q1 2024, down from $62.2 million in Q1 2023, reflecting a decrease of $16.7 million[105] - General and administrative expenses decreased to $11.1 million in Q1 2024 from $13.9 million in Q1 2023, primarily due to lower payroll costs[107] - Net cash used in operating activities was $29.6 million in Q1 2024, a decrease of $8.8 million compared to $38.4 million in Q1 2023[113] - Cash and cash equivalents increased to $35.1 million as of March 31, 2024, compared to $25.8 million as of December 31, 2023[111] - The company raised $9.5 million in gross proceeds from the sale of 12,321,365 shares under the 2023 ATM Facility at an average price of $0.77 per share[110] - Total other income (expense), net was $(481,000) in Q1 2024, compared to $269,000 in Q1 2023, reflecting a decrease of $750,000[108] Strategic Partnerships and Agreements - The company has entered into an amended and restated commercialization agreement with Pierre Fabre, expanding exclusive rights to include all countries globally, with potential milestone payments of up to $600 million[82] - The company has partnered with Pierre Fabre for commercialization in Europe and potential worldwide distribution, with an additional $30 million milestone payment received following EC approval of Ebvallo[82] Workforce and Restructuring - The company announced a workforce reduction of approximately 30% in November 2023, resulting in restructuring charges of $6.7 million[83] - A subsequent strategic workforce reduction of approximately 25% in January 2024 incurred additional restructuring charges of $4.8 million[83] Future Funding and Financial Outlook - The company expects to fund operations into 2027 based on existing cash and anticipated payments from the A&R Commercialization Agreement[116] - As of March 31, 2024, the existing cash, cash equivalents, and short-term 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[117] - The company expects to seek substantial additional funding through public or private equity offerings, debt financings, or strategic arrangements to support ongoing and planned clinical studies[117] - Future funding requirements will depend on various factors, including the timing and costs of clinical studies, regulatory approvals, and commercialization efforts[117] - The company may face substantial dilution of stockholder equity if additional capital is raised through equity securities[117] Research and Development Initiatives - The company has established research collaborations with leading academic institutions to acquire novel technologies and programs[82] - The company continues to evaluate additional product candidates and opportunities to license or acquire technologies to enhance its existing platform[88] Risk Factors - There have been no material changes to the company's contractual obligations and commitments since the last Annual Report filed on March 28, 2024[118] - During the three months ended March 31, 2024, there were no material changes to the company's interest rate risk, market risk, and foreign currency exchange rate risk disclosures[119]

Regulatory Submissions - Atara Biotherapeutics plans to submit a Biologics License Application (BLA) for tab-cel in Q2 2024, with pivotal data showing a 48.8% Objective Response Rate (ORR) in over 430 patients[2][8]. Financial Performance - Total revenues for Q1 2024 were $27.4 million, a significant increase of $26.2 million compared to $1.2 million in Q1 2023, primarily due to the expanded partnership with Pierre Fabre[8]. - Total revenue for Q1 2024 was $27.357 million, a significant increase from $1.226 million in Q1 2023[20]. - Atara reported a net loss of $31.8 million, or $0.23 per share, for Q1 2024, compared to a net loss of $74.8 million, or $0.72 per share, for the same period in 2023[8]. - Net loss for Q1 2024 was $31.752 million, compared to a net loss of $74.771 million in Q1 2023[20]. - Basic and diluted net loss per common share improved to $(0.23) from $(0.72) year-over-year[20]. Cash and Investments - Cash, cash equivalents, and short-term investments as of March 31, 2024, totaled $46.2 million, down from $51.7 million as of December 31, 2023[7]. - Cash and cash equivalents increased to $35.087 million from $25.841 million as of December 31, 2023[17]. - The company anticipates cash runway into 2027, supported by expected payments of $20 million and $60 million from Pierre Fabre contingent on BLA acceptance and approval[9]. - The company plans to fund its operations into 2027, contingent on cash runway and milestone payments[15]. Operating Expenses - Net cash used in operating activities for Q1 2024 was $29.6 million, a decrease from $38.4 million in the same period in 2023[8]. - Atara expects a 35% reduction in full-year 2024 operating expenses compared to 2023, with most reductions starting in Q2 2024[9]. Research and Development - Research and development expenses for Q1 2024 were $45.5 million, down from $62.2 million in Q1 2023[8]. - Research and development expenses decreased to $45.506 million from $62.156 million year-over-year[20]. - Atara is enrolling patients in a Phase 1 study of ATA3219 for Non-Hodgkin's lymphoma, with initial clinical data expected in Q4 2024[5]. - The company plans to initiate a Phase 1 study of ATA3219 for lupus nephritis in Q4 2024, with initial data anticipated in H1 2025[2][4]. Balance Sheet - Total current liabilities rose to $180.690 million from $142.226 million as of December 31, 2023[18]. - Deferred revenue increased significantly to $123.154 million from $77.833 million[18]. - Total assets slightly decreased to $165.272 million from $165.504 million[17]. Strategic Partnerships - Atara is transitioning activities related to tab-cel to Pierre Fabre, with timing details pending[15].

Financial Performance - For the year ended December 31, 2023, the company reported a net loss of $276.1 million[158]. - As of December 31, 2023, the company had total cash, cash equivalents, and short-term investments of $51.7 million, which is insufficient to fund planned operations for at least the next twelve months[169]. - The company has incurred significant operating losses in every annual reporting period since inception and anticipates continuing to incur substantial losses for the foreseeable future[158]. - The company reported a total stockholders' deficit of $99.2 million for the year ended December 31, 2023, which is below the stockholders' equity requirement under applicable standards[175]. - The company may require additional financing to achieve its goals, and failure to obtain necessary capital could force it to delay or terminate product development efforts[165]. - The company has received a deficiency letter from Nasdaq regarding its common stock bid price falling below the required $1.00 per share[173]. - The company has until July 8, 2024, to regain compliance with Nasdaq's bid price requirement[174]. - If the company fails to regain compliance, it may face delisting from Nasdaq, which could adversely affect the liquidity of its common stock[176]. Workforce and Operational Changes - The company reduced its workforce by approximately 20% in August 2022, followed by a 30% reduction in November 2023, and an additional 25% reduction announced in January 2024, reflecting a focus on key research and development programs[178]. - The company had 225 employees as of December 31, 2023, with a planned reduction of approximately 25% in January 2024[324]. - The company’s ability to attract and retain qualified personnel may be harmed due to workforce reductions, affecting its product development and commercialization efforts[178]. - The company may encounter difficulties in managing growth and operations effectively, especially with the planned workforce reduction[324]. Product Development and Regulatory Challenges - The company has generated limited revenues from commercialization, primarily from its product Ebvallo, which is approved in the EU and the UK[163]. - The company expects to expend substantial resources for the foreseeable future to continue the clinical development and manufacturing of its T-cell immunotherapy product candidates[165]. - The company is heavily reliant on obtaining regulatory approval for its prioritized clinical-stage product candidates, including tab-cel and ATA3219, to generate revenue[189]. - The FDA may require additional information beyond what the company plans to provide for marketing applications, which could delay or prevent approval[194]. - The company plans to submit a Biologics License Application (BLA) for tab-cel in the second quarter of 2024, following a pre-BLA meeting with the FDA[194]. - The company has faced challenges in clinical trials due to the COVID-19 pandemic, impacting patient enrollment and site initiation[187]. - The company has multiple ongoing clinical trials, and adverse findings in any trial could negatively affect others related to the same product candidates[197]. - The approval of product candidates may come with limitations on indications or require costly post-marketing studies, affecting commercialization[198]. - The regulatory approval process for novel product candidates, such as T-cell therapies, is complex and may take longer and be more expensive than for established products[197]. - The FDA's ability to review and process regulatory submissions may be significantly delayed due to global health concerns, impacting the company's business operations[195]. Market and Competitive Landscape - The company faces significant competition from established companies with greater financial resources and expertise in research and development, which may hinder its market position[315]. - The potential market for the company's product candidates may be limited to patients who have failed prior treatments, affecting overall market size[219]. - There are currently no FDA-approved products for the treatment of EBV+ PTLD, with only Ebvallo approved in the EU for this indication[311]. - Six autologous CAR T therapies are currently approved in the U.S. and/or EU, indicating a competitive landscape for CAR-mediated cell therapies[312]. - The company anticipates that its product candidates will be regulated as biological products, which may lead to competition sooner than expected due to the Biologics Price Competition and Innovation Act[318]. Intellectual Property and Legal Risks - The company has filed multiple patent applications for its product candidates, but there is no assurance that these will result in issued patents or provide adequate protection against competitors[274]. - The company is at risk of litigation related to intellectual property rights, which could be costly and time-consuming, potentially delaying development efforts[277][278]. - The company may face claims of misappropriation of trade secrets, which could hinder its ability to develop product candidates if found liable[281]. - Legal proceedings to enforce intellectual property rights could be expensive and time-consuming, with uncertain outcomes that may negatively impact business success[286]. - Protecting trade secrets is challenging, and any unauthorized disclosure could harm the company's competitive position in the market[290]. Financial and Market Conditions - Significant additional capital will be needed in the future, which may involve selling substantial amounts of common stock, potentially leading to dilution for existing stockholders[334]. - The company is exposed to stock price volatility, which may be influenced by market conditions unrelated to its operating performance[326]. - The company has never declared or paid cash dividends on its capital stock, intending to retain future earnings to finance growth and development[333]. - The company qualifies as a "smaller reporting company" and a "non-accelerated filer," which may lead to reduced reporting requirements and potentially make its shares less attractive to investors[342]. Regulatory and Compliance Issues - The company is subject to various healthcare laws and regulations, which could expose it to significant penalties and affect its operations and profitability[349]. - The company must ensure compliance with cGMP regulations, as any failure could lead to regulatory actions, including delays in product approvals and potential recalls[259]. - The company’s future operations may be impacted by compliance costs associated with healthcare regulations, which could lead to significant penalties if violations occur[351]. - The company is dependent on Pierre Fabre for compliance with regulatory requirements and commercialization efforts for tab-cel, which could adversely impact financial results if not met[262][263]. Product Liability and Insurance - Product liability lawsuits pose a risk of incurring substantial liabilities and may limit the commercialization of any developed products[353]. - The company faces increased product liability exposure during human clinical studies and if products are commercially sold, which could result in decreased demand and significant costs[354]. - Current product liability insurance coverage is deemed customary but may not be adequate to cover all potential liabilities, especially if large judgments are awarded in lawsuits[355].

Exhibit 99.1 Atara Biotherapeutics Announces Fourth Quarter and Full Year 2023 Financial Results and Operational Progress Tab-cel U.S. BLA on Track for Submission in Q2 2024 Following Positive Pre-BLA Meeting Allogeneic CAR T Pipeline Expands Into Autoimmune Disease With Plans To Initiate a ATA3219 Lupus Nephritis Study in H2 2024, and Initial Clinical Data Expected H1 2025 ATA3219 NHL Study Enrolling With Initial Clinical Data Expected in Q4 2024 Cash Runway Into 2027 Enables Key Pipeline Readouts | --- | ...

Core Insights - Atara Biotherapeutics has received FDA clearance for an Investigational New Drug (IND) application for ATA3219, a novel allogeneic CAR T-cell therapy targeting systemic lupus erythematosus (SLE) with kidney involvement [1][2] - The company aims to address the unmet medical need in lupus nephritis through a Phase 1 clinical trial, which will evaluate the safety and preliminary efficacy of ATA3219 [2][3] Company Overview - Atara Biotherapeutics specializes in T-cell immunotherapy, focusing on developing off-the-shelf therapies for cancer and autoimmune diseases [1][7] - The company has extensive clinical experience, having treated over 600 patients with its allogeneic T-cell platform [2][6] - Atara is the first company to receive regulatory approval for an allogeneic T-cell immunotherapy, emphasizing its innovative approach [7] Product Details - ATA3219 is designed as a one-time infusion therapy that utilizes allogeneic Epstein-Barr virus (EBV) sensitized T cells expressing a CD19 CAR construct [5][6] - The therapy aims to provide a best-in-class profile with off-the-shelf availability, reducing the need for leukapheresis and long waiting times associated with autologous therapies [3][5] - Early academic data showed promising results, with 100% of lupus nephritis patients achieving drug-free, durable remission using autologous CD19 CAR T therapy [3][9] Clinical Trial Information - The Phase 1 trial will be a multi-center, open-label, single-arm, dose-escalation study, with subjects receiving lymphodepletion treatment followed by varying doses of ATA3219 [2][3] - The first patient is expected to be enrolled in the second half of 2024, with each dose level designed to enroll 3-6 patients [2][3] Market Context - Lupus nephritis is a serious complication of systemic lupus erythematosus, affecting over 200,000 patients in the U.S., with up to 60% of adult SLE patients developing renal disease [4] - Current therapies for lupus nephritis have suboptimal responses and limitations, highlighting the need for innovative treatments like ATA3219 [3][4]

THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced its recent submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the use of ATA3219 as a monotherapy for the treatment of systemic lupus erythematosus (SLE) with ...

Core Viewpoint - Atara Biotherapeutics (NASDAQ:ATRA) is a commercial-stage biotech focused on cell therapies for Epstein-Barr virus-related diseases and cancer, showing potential for valuation appreciation despite recent trial failures and cash burn uncertainties [1] Pipeline Overview - The most advanced product, Tabelecleucel (tab-cel), is an allogeneic CAR T-cell therapy targeting EBV, approved for EBV-associated PTLD in Europe, with an FDA application planned for Q2 2024 [2][3] - Tab-cel demonstrated a 51.2% response rate and an 84.4% one-year overall survival rate in patients with EBV-positive PTLD [3] - Pierre Fabre will take over tab-cel's global development and commercialization, providing ATRA with upfront cash and future milestone payments [3] Product Development - ATA188, another EBV-directed T cell therapy for multiple sclerosis, failed its phase 2 EMBOLD study, showing only a 6% improvement in disability compared to a prior 33% reduction in phase 1 [4] - ATA3219, targeting CD19, is in early development with an IND cleared for studies in non-Hodgkin's lymphoma and systemic lupus, but no clinical data is available yet [5] Financial Overview - ATRA reported $118.7 million in total current assets, including $64.8 million in cash and equivalents, and recognized $2.1 million in revenues [6] - Total operating expenses were $71.8 million, resulting in a net loss of $69.8 million for the quarter [6] - The company received $15 million from a direct offering and $27 million from the agreement with Pierre Fabre, which may extend their cash runway [7] Strengths and Risks - Strengths include revenues from an approved product and a significant partnership with Pierre Fabre, which could drive revenue growth as tab-cel sales expand [8] - Risks involve uncertainty regarding cash runway and the lack of late-stage drugs in the pipeline, particularly after the failure of the MS drug [9][10] Bottom-Line Summary - ATRA's market cap of $122 million presents potential for significant upside if cash burn can be managed effectively, with opportunities for trial wind-downs, increasing sales, and new approvals for tab-cel [11]