Financial Performance - The company reported a net loss of $340.1 million for the year ended December 31, 2021[155]. - As of December 31, 2021, the company had total cash, cash equivalents, and short-term investments of $371.1 million[165]. - The company expects to incur significant operating losses for the foreseeable future as it continues to invest in research and development[156]. - The anticipated $100.0 million from FUJIFILM Diosynth Biotechnologies California Inc. is expected to fund operations into the fourth quarter of 2023[165]. - The company currently has no approved products and thus has no product revenues[161]. - Future capital requirements will depend on the costs of research, regulatory approvals, and commercialization activities[164]. - The company has a limited operating history, making it difficult to assess future viability[158]. - The company may need to raise additional capital through equity or debt financing, which could dilute existing stockholders[168]. Impact of COVID-19 - The ongoing COVID-19 pandemic continues to impact the company's operations and may affect future clinical programs[172]. - The ongoing COVID-19 pandemic continues to adversely affect the company's business operations, impacting manufacturing capabilities and supply chains due to government restrictions and health concerns[173]. - Clinical trials have experienced delays in site initiation and patient enrollment, particularly for the Phase 3 clinical trial of tab-cel® due to COVID-19 related restrictions[174]. - The ongoing COVID-19 pandemic has caused transient interruptions in the supply of raw materials, impacting manufacturing capabilities[223]. Regulatory Challenges - The company has not yet obtained regulatory approval for any product candidates, with a significant dependency on the timely approval of tab-cel® and ATA188 for future success[176]. - The FDA's approval process is unpredictable and may take many years, with the company facing challenges due to the novel nature of its T-cell immunotherapy product candidates[178]. - The company may need to conduct additional clinical trials to establish comparability for tab-cel®, which could significantly delay the BLA submission process[180]. - Regulatory authorities may impose limitations on approved product candidates, affecting commercialization and revenue generation potential[184]. - The company relies on CROs and other third parties for clinical studies, which introduces risks related to their performance and compliance with regulations[199]. - Delays in regulatory approvals for product candidates could limit the company's ability to generate revenues[226]. - Regulatory approval in international jurisdictions is necessary for the company to market its products abroad, and the approval process varies significantly among countries[214]. Clinical Trials and Product Development - The company has not yet demonstrated the ability to successfully complete Phase 2 or Phase 3 clinical studies[158]. - Tab-cel® is being evaluated in the ALLELE study, with a primary endpoint of an overall response rate (ORR) exceeding 20% to be considered successful[190]. - An observed ORR above approximately 37% in a cohort of 33 patients would meet the primary endpoint for that cohort in the ALLELE study[190]. - The company may file a marketing application based on interim data, which could impact the required ORR and approved indications[190]. - The company has experienced slower-than-anticipated enrollment in Phase 3 studies of tab-cel® for patients with EBV+ PTLD, affecting clinical timelines[198]. - Delays in clinical studies may arise from various factors, including patient enrollment challenges and regulatory authority feedback[195]. - Any delays or quality issues in clinical studies could harm the approval and commercial prospects of product candidates[200]. Manufacturing and Supply Chain Risks - The company faces challenges in manufacturing processes for T-cell immunotherapy products, including ensuring a reliable supply and addressing variability in donor T cells[186]. - Manufacturing processes must evolve to support advanced clinical studies and commercialization, with risks of cost overruns and process reproducibility issues[222]. - Manufacturing cellular therapies is susceptible to contamination and equipment failure, which could lead to product defects and supply disruptions[224]. - The company relies on third-party manufacturers and suppliers, which poses risks to maintaining clinical and commercial timelines[232]. - Transitioning manufacturing to a CMO or own facility is necessary to meet projected supply needs for product candidates[233]. - Disruptions in supplier relationships could considerably delay clinical studies and regulatory approvals, impacting revenue generation[239]. Intellectual Property and Competition - The company faces risks related to intellectual property, including potential challenges to the validity and enforceability of patents[246]. - The patent life for products is limited, generally expiring 20 years after filing, which could reduce exclusive marketing time[254]. - The company may face significant competition in forming strategic alliances and may not achieve desired outcomes from such efforts[244]. - The company faces significant risks related to patent infringement claims from third parties, which could impede the development and commercialization of its product candidates[258]. - There is a possibility that third-party patents or applications may cover materials or methods related to the company's product candidates, potentially leading to infringement claims[259]. Market Acceptance and Reimbursement - Market acceptance of the company's product candidates is crucial for commercial success, influenced by factors such as efficacy, safety, and reimbursement availability[275]. - The company may struggle to secure adequate coverage and reimbursement from third-party payors, which is essential for successful commercialization[276]. - The healthcare industry is experiencing a primary trend of cost containment, with government authorities and third-party payors limiting coverage and reimbursement levels for medications[277]. - There may be significant delays in obtaining coverage and reimbursement for newly approved drugs, which could adversely affect the commercialization of these products[279]. Corporate Governance and Compliance - The company is highly dependent on its executive officers and key employees, and losing any of them could impede corporate objectives[320]. - Compliance with healthcare laws and regulations is critical, as violations could lead to significant penalties and harm to the company's reputation[325]. - The company currently holds product liability insurance, but it may not be adequate to cover all potential liabilities[330]. - Noncompliance with environmental, health, and safety laws could result in fines or penalties that adversely affect business success[331]. Data Privacy and Cybersecurity - The company acknowledges potential vulnerabilities in its data protection efforts, which could lead to significant operational disruptions and reputational harm[349]. - Unauthorized access or breaches could result in legal claims and liabilities under privacy and data protection laws, potentially harming the company's competitive position[351]. - The company has implemented security measures, but data remains accessible through multiple channels, increasing the risk of breaches[350]. - Any significant data breach could compel the company to comply with breach notification laws, leading to further reputational damage and financial exposure[351].

Atara Biotherapeutics, Inc. (NASDAQ:ATRA) Q3 2021 Earnings Conference Call November 4, 2021 8:30 AM ET Company Participants Eric Hyllengren - VP of IR and Finance Pascal Touchon - President and CEO Jakob Dupont - EVP and Global Head of Research and Development Utpal Koppikar - CFO AJ Joshi - Chief Medical Officer Kristin Yarema - Chief Commercial Officer Conference Call Participants Salim Syed - Mizuho Matt Phipps - William Blair John Newman - Canaccord Tessa Romero - JPMorgan Phil Nadeau - Cowen Jonathan M ...

[PART I. FINANCIAL INFORMATION](index=2&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section covers unaudited financial statements, management's analysis, market risks, and internal controls [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements for the nine months ended September 30, 2021, along with key notes on business, liquidity, and collaboration agreements [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of September 30, 2021, shows a decrease in total assets and stockholders' equity compared to December 31, 2020, primarily due to a reduction in cash, cash equivalents, and short-term investments Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $113,209 | $200,404 | | Short-term investments | $244,036 | $300,255 | | Total current assets | $369,497 | $523,273 | | Total assets | $449,923 | $588,120 | | **Liabilities & Equity** | | | | Total current liabilities | $86,150 | $82,901 | | Total liabilities | $139,782 | $125,781 | | Total stockholders' equity | $310,141 | $462,339 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the nine months ended September 30, 2021, the company reported a net loss of $246.8 million, an increase from the $225.3 million loss in the same period of 2020 Statement of Operations Highlights (Nine Months Ended Sep 30, in thousands) | Account | 2021 | 2020 | | :--- | :--- | :--- | | License and collaboration revenue | $12,792 | $0 | | Research and development | $202,867 | $179,096 | | General and administrative | $56,984 | $48,259 | | **Loss from operations** | **($247,059)** | **($227,355)** | | **Net loss** | **($246,792)** | **($225,313)** | | **Net loss per share** | **($2.67)** | **($3.21)** | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2021, net cash used in operating activities was $186.3 million, while investing activities provided $46.6 million and financing activities provided $52.5 million Cash Flow Summary (Nine Months Ended Sep 30, in thousands) | Activity | 2021 | 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($186,253) | ($176,639) | | Net cash provided by (used in) investing activities | $46,582 | ($83,836) | | Net cash provided by financing activities | $52,476 | $248,778 | | **Net decrease in cash** | **($87,195)** | **($11,697)** | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes provide details on the company's business, accounting policies, and financial statement line items, including liquidity and collaboration agreements - Atara is a pioneer in T-cell immunotherapy, leveraging its allogeneic EBV T-cell platform to develop therapies for solid tumors, hematologic cancers, and autoimmune diseases[31](index=31&type=chunk) - The company expects that its existing cash, cash equivalents, and short-term investments as of September 30, 2021, will be sufficient to fund planned operations for at least the next twelve months[35](index=35&type=chunk) - The company recognized **$5.4 million** and **$12.8 million** in license and collaboration revenue for the three and nine months ended September 30, 2021, respectively, under its agreements with Bayer[68](index=68&type=chunk) - Effective October 2, 2021, Atara entered into a commercialization agreement with Pierre Fabre for tab-cel® in Europe and other select markets, receiving an upfront cash payment of **$45.0 million**[97](index=97&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses business strategy, pipeline progress, and financial results, highlighting key program updates, expense trends, and liquidity outlook [Pipeline and Program Updates](index=23&type=section&id=Pipeline%20and%20Program%20Updates) This section details significant progress across key programs, including imminent EU MAA and planned U.S. BLA for tab-cel®, and advancements in ATA188 and CAR T programs - **Tab-cel®:** - EU Marketing Authorization Application (MAA) for EBV+ PTLD to be submitted imminently, with a potential decision in H2 2022 - U.S. Biologics License Application (BLA) submission planned for Q2 2022[105](index=105&type=chunk) - **ATA188 (Multiple Sclerosis):** - An interim analysis of the Phase 2 EMBOLD study is planned for the first half of 2022 to assess efficacy and safety[107](index=107&type=chunk) - **CAR T Programs:** - **ATA2271/ATA3271 (partnered with Bayer):** Partner Bayer is expected to file an IND for the allogeneic ATA3271 in H2 2022 - **ATA3219 (in-house):** An IND submission for B-cell malignancies is planned for Q1 2022[108](index=108&type=chunk)[109](index=109&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) Comparing the nine months ended September 30, 2021, to the same period in 2020, revenue from the Bayer collaboration was $12.8 million, while R&D and G&A expenses increased due to program expansion and headcount growth Research and Development Expenses (Nine Months Ended Sep 30, in thousands) | Program | 2021 | 2020 | Change | | :--- | :--- | :--- | :--- | | Tab-cel® expenses | $36,874 | $45,426 | ($8,552) | | ATA188, CAR T and other program expenses | $24,134 | $14,339 | $9,795 | | Employee and overhead expenses | $141,859 | $119,331 | $22,528 | | **Total R&D Expenses** | **$202,867** | **$179,096** | **$23,771** | General and Administrative Expenses (in thousands) | Period | 2021 | 2020 | Change | | :--- | :--- | :--- | :--- | | Three Months Ended Sep 30 | $19,849 | $14,829 | $5,020 | | Nine Months Ended Sep 30 | $56,984 | $48,259 | $8,725 | [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2021, the company had $357.2 million in cash, cash equivalents, and short-term investments, expected to fund operations into Q2 2023, supplemented by $51.2 million from ATM facility sales - The company expects that existing cash, cash equivalents, and short-term investments as of September 30, 2021, together with the **$45.0 million** upfront payment from Pierre Fabre, will be sufficient to fund planned operations into the **second quarter of 2023**[140](index=140&type=chunk)[148](index=148&type=chunk) Cash Position (in thousands) | Account | Sep 30, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $113,209 | $200,404 | | Short-term investments | $244,036 | $300,255 | | **Total** | **$357,245** | **$500,659** | - During the nine months ended September 30, 2021, the company sold **3.4 million shares** under its ATM facility for net proceeds of **$51.2 million**[136](index=136&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company states that there have been no material changes to its market risk disclosures, including interest rate and foreign currency exchange rate risk, since its Annual Report on Form 10-K for the year ended December 31, 2020 - There were no material changes to the company's interest rate risk, market risk, and foreign currency exchange rate risk disclosures during the nine months ended September 30, 2021[159](index=159&type=chunk) [Item 4. Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Based on an evaluation as of September 30, 2021, the company's CEO and CFO concluded that disclosure controls and procedures were effective, with no material changes in internal control over financial reporting during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of September 30, 2021[161](index=161&type=chunk) - No change in internal control over financial reporting occurred during the quarter that has materially affected, or is reasonably likely to materially affect, internal controls[162](index=162&type=chunk) [PART II. OTHER INFORMATION](index=33&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, equity sales, and other required disclosures, including exhibits [Item 1. Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently involved in any material legal proceedings - The company reports no material legal proceedings[164](index=164&type=chunk) [Item 1A. Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant business risks, including financial sustainability, early-stage product development, regulatory challenges, manufacturing complexities, and reliance on third-party collaborations - **Financial Risks:** The company has a history of substantial losses, has no products approved for sale, and will require significant additional financing to achieve its goals[166](index=166&type=chunk)[172](index=172&type=chunk) - **Development & Regulatory Risks:** Product candidates are in early development stages and represent new therapeutic approaches (allogeneic T-cell immunotherapy) that could face heightened regulatory scrutiny, development delays, or failure in clinical trials[179](index=179&type=chunk)[193](index=193&type=chunk)[202](index=202&type=chunk) - **COVID-19 Impact:** The pandemic could materially and adversely affect business operations, clinical trials, manufacturing, and supply chains[181](index=181&type=chunk) - **Manufacturing Risks:** The company faces risks related to the complex and highly regulated process of manufacturing cellular therapies, including process scale-up, product loss due to contamination, and reliance on its sole manufacturing facility and third-party CMOs[230](index=230&type=chunk)[233](index=233&type=chunk)[240](index=240&type=chunk) - **Commercialization Risks:** Success depends on market acceptance, obtaining adequate reimbursement from payors, and navigating competition from established therapies[291](index=291&type=chunk)[293](index=293&type=chunk)[306](index=306&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=74&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the period - None reported[376](index=376&type=chunk) [Item 5. Other Information](index=74&type=section&id=Item%205.%20Other%20Information) The company reports no other information required to be disclosed - None reported[376](index=376&type=chunk) [Item 6. Exhibits](index=75&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the quarterly report, including an amendment to a manufacturing agreement, certifications by the CEO and CFO, and Inline XBRL documents - Exhibits filed include CEO and CFO certifications (**31.1**, **31.2**, **32.1**) and an amendment to the Commercial Manufacturing Services Agreement with Cognate BioServices, Inc. (**10.1**)[381](index=381&type=chunk)[382](index=382&type=chunk)[383](index=383&type=chunk)[384](index=384&type=chunk)

Tab-cel® Program - Atara expects to complete the MAA submission for Tab-cel® in November 2021 and BLA submission in Q1 2022[10] - Tab-cel® achieved a 50% Objective Response Rate (ORR) in the pivotal Phase 3 study interim analysis by Independent Oncologic and Radiographic Assessment (IORA)[36] - Phase 2 study showed 83% responders in HCT and 86% responders in SOT, with 81.6% CR and 85.7% PR in HCT, and 100% CR and 87.5% PR in SOT at 2 years[33] - The company estimates several hundred addressable EBV+ PTLD patients per year in the US with no approved therapeutic solutions[42] ATA188 Program - The company plans to present Phase 1 translational data and 2-year clinical data from Phase 1 OLE study at ECTRIMS in October 2021[21] - Atara plans to conduct a formal interim analysis in H1 2022 for the Phase 2 randomized controlled trial (RCT) of ATA188[76] - Phase 1 data in Progressive MS showed 50% Sustained Disability Improvement (SDI) in Cohorts 3 – 4 at 15 Months[63] - The company estimates a potential annual US revenue opportunity in Progressive MS of ~$35 billion+, with each 10% of market share equating to ~$750 million - $1 billion in revenue[84] CAR T Program - Atara will receive $60 million in cash upon signing and is eligible to receive up to $610 million in development, regulatory, and commercial milestone payments, plus tiered royalties up to low double-digit percentage of net sales from Bayer collaboration[88] - ATA3271 IND Submission is expected in H2 2022 and ATA3219 IND filing in Q1 2022[91,21]

Atara Biotherapeutics, Inc. (NASDAQ:ATRA) Q2 2021 Earnings Conference Call August 9, 2021 4:30 PM ET Company Participants Eric Hyllengren - Vice President of Investor Relations & Finance Pascal Touchon - President & Chief Executive Officer Jakob Dupont - Executive Vice President and Global Head of Research and Development AJ Joshi - Chief Medical Officer Jose Vidal - Head of GMP Quality & Process Sciences Conference Call Participants John Newman - Canaccord Genuity Jonathan Miller - Evercore ISI Salim Syed ...

Tab-cel® Program - Atara is working towards completing the BLA submission for Tab-cel® in Q3 2021, pending alignment with the FDA [12], with potential for the first allogeneic T-cell immunotherapy on the market in 2022 [12] - Tab-cel® achieved a 50% objective response rate (ORR) in the pivotal Phase 3 study interim analysis by Independent Oncologic and Radiographic Assessment (IORA) for EBV+ PTLD patients who failed rituximab [36] - In Phase 2 and EAP studies, Tab-cel® showed 83% overall survival at 2 years in responders and 79% overall survival at 2 years for all patients [33] - The company estimates that there are several hundred EBV+ PTLD patients in the U S who have failed rituximab ± chemo, representing a high unmet medical need [40] ATA188 Program - Data from the open-label clinical dataset suggests transformative potential in MS, and disability improvement data from the RCT has the potential to unlock a multi-billion dollar opportunity [12] - Phase 1 data in Progressive MS showed 50% sustained disability improvement (SDI) in Cohorts 3 – 4 at 15 months [64] - The estimated US market forecast for Progressive MS in 2025 is a multi-billion dollar opportunity, with each 10% of market share representing approximately $750 million to $1 billion in revenue [83] CAR T Program - Atara has a technologically differentiated portfolio of high-potential, preclinical CAR T assets, with multiple programs showing clinical data in both liquid and solid tumors [12] - Atara entered into a strategic collaboration with Bayer to develop Atara's mesothelin CAR T program (ATA3271) and autologous program (ATA2271), receiving $60 million upfront and eligible for up to $610 million in milestone payments, plus tiered royalties up to low double-digit percentage of net sales [87] Financial Status - Atara is well-capitalized with a planned cash runway into 2023 [25] - The company had 84 1 million shares outstanding as of March 31, 2021 [25] and net cash used in operating activities in Q1 2021 was $65 7 million [25]

Financial Data and Key Metrics Changes - Atara ended Q1 2021 with $435 million in cash, which is expected to fund operations into 2023, including expenses for the BLA filing and U.S. commercial launch of tab-cel [15][16] - The company reported approximately $3.6 million in revenue from the Bayer collaboration during Q1 2021, with expectations of similar revenue in future quarters due to deferred revenue of around $70 million on the balance sheet [68] Business Line Data and Key Metrics Changes - Progress on tab-cel includes active discussions with the FDA regarding comparability data, with plans to complete the BLA submission for PTLD in Q3 2021 [10][16] - The ATA188 program for multiple sclerosis is on track for an interim analysis in the first half of 2022, with ongoing enrollment in the Phase 2 randomized controlled trial [12][20] - The mesothelin CAR T programs, ATA2271 and ATA3271, are advancing with positive collaboration with Bayer, and initial clinical data is expected to be presented in Q4 2021 [13][22] Market Data and Key Metrics Changes - The company is preparing for the commercial launch of tab-cel in the U.S. in the first half of 2022, with a focus on disease state education and payer access preparation [11] - There is strong interest from potential partners for the commercialization of tab-cel in Europe, with a letter of intent submitted to the EMA for MAA submission [10][11] Company Strategy and Development Direction - Atara is focused on three strategic priorities: tab-cel, ATA188 for multiple sclerosis, and next-generation allogeneic CAR T programs [7] - The company aims to establish itself as a leader in allogeneic T-cell therapy, with ongoing efforts to align with regulatory bodies and prepare for commercial launches [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing discussions with the FDA regarding comparability data for tab-cel, which is crucial for the BLA submission [16][41] - The company is optimistic about the potential of ATA188 to be a game-changer in the field of multiple sclerosis, with plans to engage potential partners for further development [51][75] Other Important Information - The British Society of Hematology has updated guidelines recommending the use of EBV-specific immunotherapy for relapsed refractory PTLD, highlighting the relevance of tab-cel [19] - Atara's CAR T programs are distinguished by their use of an allogeneic EBV T-cell platform, which aims to improve efficacy and durability of response [22][23] Q&A Session Summary Question: Regarding the tab-cel filing and patient data - Management confirmed that the number of patients enrolled in the ALLELE study is sufficient for the BLA filing, with ongoing work on comparability data [30][31] Question: On ATA188's interim analysis and FDA discussions - The interim analysis will inform potential adjustments to the study design, with alignment on patient populations being crucial for future pivotal studies [35][38] Question: Timeline for tab-cel multi-cohort study and initial data - Enrollment in the multi-cohort study has been impacted by COVID-19, but recent site activations are expected to accelerate patient enrollment [43] Question: Expectations for mesothelin CAR T data presentation - Initial data from the mesothelin CAR T program will include safety data and tumor assessments, with a focus on response rates and persistence [46][47] Question: Resource allocation for tab-cel, ATA188, and CAR T programs - The company plans to partner for the European launch of tab-cel while self-launching in the U.S., with significant investments in ATA188 and CAR T programs [72][75]