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 ...

Atara Biotherapeutics, Inc. (NASDAQ:ATRA) Q1 2021 Earnings Conference Call May 4, 2021 4:30 PM ET Company Participants Eric Hyllengren - Vice President of Investor Relations and Finance Pascal Touchon - President and Chief Executive Officer Jakob Dupont - Executive Vice President and Global Head of Research and Development Utpal Koppikar - Chief Financial Officer Joe Newell - Chief Operations Officer AJ Joshi - Chief Medical Officer Kristin Yarema - Chief Commercial Officer Conference Call Participants John ...

Atara Biotherapeutics, Inc. (NASDAQ:ATRA) Q4 2020 Earnings Conference Call March 1, 2020 4:30 PM ET Company Participants Eric Hyllengren - VP, IR & Finance Pascal Touchon - President and CEO Jakob Dupont - EVP and Global Head, Research & Development AJ Joshi - CMO Kristin Yarema - CCO Conference Call Participants John Newman - Canaccord Salim Syed - Mizuho Michael DiFiore - Evercore Anupam Rama - JPMorgan Ernie Rodriguez - Cowen and Co. Matt Phipps - William Blair Ken Chan - Jefferies Operator Good afternoo ...

PART I [Item 1. Business](index=5&type=section&id=Item%201.%20Business) Atara Biotherapeutics develops allogeneic EBV T-cell immunotherapies for serious diseases, with a pipeline including tab-cel®, ATA188, and CAR T programs [Overview](index=5&type=section&id=Overview) Atara Biotherapeutics is a pioneer in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with serious diseases, including solid tumors, hematologic cancers and autoimmune disease[14](index=14&type=chunk) - The company's strategic priorities include: **Tab-cel®** (Phase 3 for EBV-driven post-transplant lymphoproliferative disease), **ATA188** (targeting EBV antigens for multiple sclerosis), and **CAR T Programs** (ATA2271/ATA3271 partnered with Bayer, and ATA3219 targeting CD19)[14](index=14&type=chunk) - Atara's off-the-shelf, allogeneic T-cell platform allows for rapid delivery of manufactured T-cell immunotherapy products, differing from autologous treatments that require patient-specific cell modification[15](index=15&type=chunk) - In December 2020, Atara entered into a Research, Development and License Agreement with Bayer for ATA2271 and ATA3271, granting Bayer an exclusive, field-limited license[16](index=16&type=chunk) [Pipeline](index=6&type=section&id=Pipeline) Atara's pipeline includes investigational agents such as Tab-cel® for EBV+ PTLD, ATA188 for Multiple Sclerosis, and CAR T Programs - Atara's pipeline includes investigational agents such as **Tab-cel®** for EBV+ PTLD, **ATA188** for Multiple Sclerosis, and **CAR T Programs** (ATA2271, ATA3271, ATA3219)[18](index=18&type=chunk) - **Tab-cel®** is in Phase 3 development for EBV+ PTLD and a Phase 2 multi-cohort study for other EBV-driven diseases[18](index=18&type=chunk) - **ATA2271** (autologous) and **ATA3271** (allogeneic) are CAR T immunotherapies targeting mesothelin, partnered with Bayer[18](index=18&type=chunk) - **ATA3219** is an allogeneic CAR T targeting CD19, developed as a potential best-in-class product[18](index=18&type=chunk) [Tab-cel®](index=6&type=section&id=Tab-cel%C2%AE) Tab-cel® is an allogeneic EBV-specific T-cell immunotherapy in Phase 3 development for EBV+ PTLD, holding Breakthrough Therapy and PRIME designations - **Tab-cel®** is an allogeneic EBV-specific T-cell immunotherapy in Phase 3 development for EBV+ PTLD patients who have failed rituximab or rituximab plus chemotherapy[23](index=23&type=chunk) - **Tab-cel®** has received **Breakthrough Therapy Designation (BTD)** from the FDA and **PRIority MEdicines (PRIME)** designation from the EMA for EBV+ PTLD after HCT, and orphan designation in the U.S. and EU for EBV+ PTLD following HCT or SOT[23](index=23&type=chunk) - Interim analysis of the ALLELE study in Q3 2020 showed a **50% objective response rate (ORR)** with a safety profile consistent with previously published data[25](index=25&type=chunk) - Atara plans to complete a rolling BLA submission for EBV+ PTLD in the U.S. in **Q3 2021**, with potential approval in **H1 2022**, and an MAA submission in the EU in **Q4 2021**, with potential approval in **H2 2022**[28](index=28&type=chunk) [Tab-cel® Multi-Cohort Study](index=8&type=section&id=Tab-cel%C2%AE%20Multi-Cohort%20Study) A Phase 2 multi-cohort study for tab-cel® was initiated in Q3 2020 to evaluate its use in earlier lines of therapy and other EBV-driven diseases - A Phase 2 multi-cohort study for **tab-cel®** was initiated in **Q3 2020** in the U.S. and EU to evaluate its use in earlier lines of therapy and other immunodeficiency-associated lymphoproliferative diseases (IA-LPDs) and EBV-driven diseases[30](index=30&type=chunk) - Data from the Phase 2 study is expected in **2023**, with previous data showing encouraging clinical activity and a favorable safety profile in EBV+ AID-LPD and EBV+ PID-LPD patients[30](index=30&type=chunk) [Tab-cel® for NPC](index=8&type=section&id=Tab-cel%C2%AE%20for%20NPC) Atara's Phase 1b study of tab-cel® combined with KEYTRUDA® for NPC achieved safety endpoints and stable disease, but the Phase 2 portion will not proceed due to strategic prioritization - Atara's Phase 1b study of **tab-cel®** in combination with **KEYTRUDA®** for platinum-resistant or recurrent EBV-driven Nasopharyngeal Carcinoma (NPC) achieved safety endpoints and stable disease in some patients[33](index=33&type=chunk) - Due to strategic prioritization on IA-LPDs, Atara will not initiate the Phase 2 portion of the NPC study but plans to generate additional translational data in **2021**[33](index=33&type=chunk) [ATA188](index=9&type=section&id=ATA188) ATA188 is an allogeneic T-cell immunotherapy targeting EBV antigens for multiple sclerosis, with a Phase 2 trial initiated in June 2020 - **ATA188** is an allogeneic T-cell immunotherapy targeting EBV antigens for the potential treatment of multiple sclerosis (MS), particularly progressive MS (PMS)[34](index=34&type=chunk)[39](index=39&type=chunk) - Phase 1a study data showed **ATA188** was well-tolerated with no dose-limiting toxicities and a higher proportion of patients demonstrating sustained disability improvement (SDI) with increasing dose (**42%** in cohorts 3 and 4)[41](index=41&type=chunk) - A randomized, double-blind, placebo-controlled Phase 2 trial (RCT) for **ATA188** in PMS patients was initiated in **June 2020**, with the primary endpoint changed to EDSS disability improvement and planned interim analysis in **H1 2022**[44](index=44&type=chunk) Estimated U.S. Market Opportunity for PMS (2025) | Indicator | Value | | :---------- | :------ | | Potential Annual U.S. Market Opportunity in PMS (by 2025) | At least $3.5 billion | [CAR T Programs](index=11&type=section&id=CAR%20T%20Programs) Atara's CAR T pipeline includes autologous ATA2271 and allogeneic ATA3271 targeting mesothelin, partnered with Bayer, and allogeneic ATA3219 targeting CD19 - Atara's CAR T pipeline includes autologous **ATA2271** and allogeneic **ATA3271** targeting mesothelin for solid tumors, partnered with Bayer[47](index=47&type=chunk) - **ATA2271**, designed with a novel 1XX CAR co-stimulatory signaling domain and PD-1 dominant negative receptor (DNR), initiated a Phase 1 clinical study for advanced mesothelioma in **September 2020**, with first data expected in **Q4 2021**[48](index=48&type=chunk) - **ATA3271** is an off-the-shelf allogeneic CAR T therapy targeting mesothelin, with IND-enabling studies initiated and IND filing expected in **H2 2022**[49](index=49&type=chunk) - **ATA3219** is an off-the-shelf allogeneic CD19 CAR T immunotherapy for B-cell malignancies, with IND-enabling studies initiated and IND filing planned for **Q4 2021 or Q1 2022**[53](index=53&type=chunk) [Additional Programs and Platform Expansion Activities](index=12&type=section&id=Additional%20Programs%20and%20Platform%20Expansion%20Activities) Atara is advancing preclinical programs, including multi-targeted CAR T immunotherapies and HPV-associated cancer therapies, through collaborations - Atara has preclinical programs including multi-targeted CAR T immunotherapies for acute myeloid leukemia (**ATA2321**) and B-cell malignancies (**ATA2431**) in collaboration with Moffitt Cancer Center[54](index=54&type=chunk) - The company is also collaborating with QIMR Berghofer on **ATA368** for human papillomavirus (HPV) associated cancers[54](index=54&type=chunk) [Competition](index=12&type=section&id=Competition) Atara faces intense competition from numerous pharmaceutical and biotechnology companies, academic institutions, and government agencies with greater resources - Atara faces intense competition from pharmaceutical and biotechnology companies, academic institutions, and government agencies, many of which have greater resources and market presence[56](index=56&type=chunk) - For EBV+ PTLD, competitors include **Viracta Therapeutics** and **AlloVir**, which are developing product candidates for EBV+ lymphomas and multi-virus T-cell products, respectively[59](index=59&type=chunk) - The MS market is highly competitive with at least **20 approved therapies** and numerous candidates in Phase 3 studies from major pharmaceutical companies[60](index=60&type=chunk)[61](index=61&type=chunk) - In the CAR T space, four autologous therapies are already approved (**Novartis' Kymriah®**, **Gilead/Kite's Yescarta®** and **TecartusTM**, **Bristol-Myers Squibb's Breyanzi®**), with many other allogeneic and off-the-shelf CAR T therapies in development[62](index=62&type=chunk) [Terms of Certain License and Research and Development Collaboration Agreements](index=13&type=section&id=Terms%20of%20Certain%20License%20and%20Research%20and%20Development%20Collaboration%20Agreements) Atara has strategic license and collaboration agreements, including with Bayer for CAR T programs and with MSK and QIMR Berghofer for T-cell therapies - Atara granted Bayer an exclusive, field-limited license for **ATA2271** and **ATA3271**, targeting mesothelin, with Bayer responsible for further development and commercialization[64](index=64&type=chunk)[65](index=65&type=chunk) Bayer License Agreement Financial Terms (December 2020) | Payment Type | Amount | | :------------- | :------- | | Upfront Cash Payment (net of taxes) | $45.0 million | | Upfront Reimbursement for R&D Activities | $15.0 million | | Additional Translational Activities (up to) | $5.0 million | | Development, Regulatory & Commercial Milestones (up to) | $610.0 million | | Tiered Royalties on Worldwide Net Product Sales | Up to low double digits | - Atara has in-licensed patent rights, know-how, and T-cell libraries from **Memorial Sloan Kettering Cancer Center (MSK)** for clinical-stage T-cell therapies, with milestone payments up to **$33.0 million** and mid-single-digit royalties[66](index=66&type=chunk) - Atara also holds an exclusive, worldwide license from **QIMR Berghofer** for allogeneic T-cell therapy programs, involving milestone and low to mid-single-digit royalty payments[68](index=68&type=chunk)[69](index=69&type=chunk) [Intellectual Property](index=15&type=section&id=Intellectual%20Property) Atara protects its intellectual property through a global patent estate, trademarks, trade secrets, and in-licensing to secure its T-cell immunotherapy platform - Atara protects its intellectual property through U.S. and non-U.S. patent applications, trademarks, trade secrets, know-how, and in-licensing opportunities[71](index=71&type=chunk) - The global patent estate consists of **39 patent families** with over **274 issued patents or applications**, expected to expire between **2023 and 2041**[76](index=76&type=chunk) - The company relies on unpatented trade secrets and confidentiality agreements to protect proprietary know-how and technology[77](index=77&type=chunk) - Atara's global trademark portfolio includes **six different trademark families** with over **90 registrations** and pending applications[78](index=78&type=chunk) [Government Regulation and Product Approval](index=16&type=section&id=Government%20Regulation%20and%20Product%20Approval) Atara's T-cell immunotherapies are regulated as biologics, requiring extensive development, testing, manufacturing, and approval processes by global authorities - Atara's T-cell immunotherapies are regulated as biologics by the FDA and comparable foreign authorities, requiring extensive research, development, testing, manufacturing, and approval processes[79](index=79&type=chunk)[80](index=80&type=chunk) - The U.S. product development process involves preclinical testing, IND submission, IRB approval, human clinical trials (Phase 1, 2, 3), BLA submission, FDA advisory committee review, and facility inspections for cGMP and GTP compliance[81](index=81&type=chunk)[82](index=82&type=chunk)[86](index=86&type=chunk) - **Orphan Drug Designation** provides market exclusivity (**7 years in U.S., 10 years in EU**) for drugs treating rare diseases, along with tax credits and BLA user fee waivers[97](index=97&type=chunk)[98](index=98&type=chunk) - Expedited programs like **Fast Track**, **Priority Review**, **RMAT**, and **Breakthrough Therapy Designation** aim to accelerate development and review for serious or life-threatening conditions, but do not guarantee approval[100](index=100&type=chunk)[101](index=101&type=chunk)[102](index=102&type=chunk)[103](index=103&type=chunk)[104](index=104&type=chunk) - Post-approval requirements include ongoing FDA regulation of manufacturing (cGMP), adverse event reporting, product sampling, distribution, and promotional activities, with strict rules against 'off-label' promotion[106](index=106&type=chunk)[107](index=107&type=chunk)[108](index=108&type=chunk) - Reimbursement for approved products depends on third-party payors (government, commercial insurance), who increasingly challenge prices and impose cost controls, potentially impacting product demand and profitability[110](index=110&type=chunk)[111](index=111&type=chunk) - Foreign regulations for clinical studies, product licensing, pricing, and reimbursement vary significantly, with the EU centralized procedure offering a single marketing authorization for member states[117](index=117&type=chunk)[119](index=119&type=chunk) - Brexit has impacted the UK's regulatory framework, requiring separate marketing authorizations for Great Britain and potentially increasing operational expenses and non-tariff costs for trade with the EU[121](index=121&type=chunk) [Manufacturing](index=28&type=section&id=Manufacturing) Atara's Thousand Oaks facility supports T-cell and CAR T immunotherapies, with ongoing commercial production qualification for tab-cel® and reliance on CMOs for flexibility - Atara's Thousand Oaks, California manufacturing facility is designed to global regulatory standards, supporting multiple T-cell and CAR T immunotherapies, with commercial production qualification activities for **tab-cel®** ongoing[123](index=123&type=chunk) - The company is scaling its EBV T-cell manufacturing platform to improve product yields and reduce costs, leveraging stirred-tank perfusion bioreactors[125](index=125&type=chunk) - Atara also utilizes contract manufacturing organizations (CMOs) like **Cognate BioServices, Inc.** and partners like **MSK** and **QIMR Berghofer** for its manufacturing network, ensuring flexibility and supply redundancy[126](index=126&type=chunk)[127](index=127&type=chunk) - Manufacturing operations comply with Code of Federal Regulations Good Manufacturing Practices (GMPs) and Good Tissue Practices (GTPs) for blood-derived starting materials from healthy donors[128](index=128&type=chunk) [Human Capital Management](index=29&type=section&id=Human%20Capital%20Management) Atara had 437 employees as of December 31, 2020, with a human capital strategy focused on attracting, retaining, and motivating qualified personnel - As of **December 31, 2020**, Atara had **437 employees**, with a human capital strategy focused on attracting, retaining, and motivating qualified personnel through performance-based compensation and a collaborative culture[130](index=130&type=chunk) - The company monitors various human capital metrics including employee engagement, vacancy rates, retention, and diversity representation[130](index=130&type=chunk) [COVID-19 Business Update](index=29&type=section&id=COVID-19%20Business%20Update) Atara transitioned most of its workforce to remote work while maintaining essential functions with safety protocols, experiencing only transient delays in clinical operations - Atara has transitioned most of its workforce to remote work while maintaining essential in-person manufacturing and laboratory functions, implementing safety protocols[131](index=131&type=chunk) - Clinical study operations and site initiations have experienced transient delays due to COVID-19, but most sites are open for patient enrollment[133](index=133&type=chunk)[134](index=134&type=chunk) - The COVID-19 pandemic has not materially impacted clinical, R&D, regulatory, or manufacturing operations or timelines to date, but future impacts remain uncertain[134](index=134&type=chunk)[135](index=135&type=chunk) [Item 1A. Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) Atara faces substantial losses, requires significant financing, and navigates complex clinical, manufacturing, IP, and market risks - Atara has incurred substantial losses since inception and anticipates continued, increasing losses, with no approved products or product revenues to date[140](index=140&type=chunk)[141](index=141&type=chunk) - The company requires substantial additional financing to achieve its goals, and failure to obtain capital could force delays or termination of product development or commercialization efforts, potentially causing dilution to existing stockholders[148](index=148&type=chunk)[151](index=151&type=chunk)[153](index=153&type=chunk) - Clinical drug development is a lengthy, expensive, and uncertain process; preclinical or early clinical results are not predictive of future success, and product candidates may fail in later stages or cause undesirable side effects[174](index=174&type=chunk)[181](index=181&type=chunk)[190](index=190&type=chunk) - Manufacturing cellular therapies is complex and susceptible to product loss, contamination, equipment failure, and raw material interruptions, which could increase costs and limit supply[218](index=218&type=chunk)[219](index=219&type=chunk) - Maintaining sufficient intellectual property protection globally is challenging, and infringement claims could lead to costly litigation or prevent commercialization[236](index=236&type=chunk)[246](index=246&type=chunk)[253](index=253&type=chunk) - Commercial success depends on market acceptance and adequate reimbursement from third-party payors, which are uncertain due to intense competition and evolving healthcare legislation and pricing controls[264](index=264&type=chunk)[266](index=266&type=chunk)[269](index=269&type=chunk)[278](index=278&type=chunk) - The company's stock price is volatile, influenced by clinical study results, regulatory actions, competition, and general market conditions, including the impact of the COVID-19 pandemic[291](index=291&type=chunk)[292](index=292&type=chunk)[293](index=293&type=chunk) - Compliance with increasingly stringent privacy, data protection, and data security laws (e.g., GDPR, CCPA) is critical, and failures could result in significant fines, liability, and reputational harm[320](index=320&type=chunk)[321](index=321&type=chunk)[326](index=326&type=chunk)[328](index=328&type=chunk) [Item 1B. Unresolved Staff Comments](index=67&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) There are no unresolved staff comments to report - No unresolved staff comments were reported[344](index=344&type=chunk) [Item 2. Properties](index=67&type=section&id=Item%202.%20Properties) Atara Biotherapeutics maintains its corporate headquarters in South San Francisco, California, and leases significant office, lab, and cellular therapy manufacturing space in Thousand Oaks, California - Corporate headquarters are located in South San Francisco, California, consisting of approximately **13,670 square feet** of office space under a lease expiring in **May 2022**[344](index=344&type=chunk) - The company leases approximately **90,580 square feet** of office, lab, and cellular therapy manufacturing space in Thousand Oaks, California, with an initial **15-year term** commencing in **February 2018**[344](index=344&type=chunk) - An additional **51,160 square feet** of office space is leased in Thousand Oaks, California, with a lease expiring in **February 2026**[344](index=344&type=chunk) [Item 3. Legal Proceedings](index=67&type=section&id=Item%203.%20Legal%20Proceedings) Atara Biotherapeutics is not currently involved in any material legal proceedings - The company is not currently involved in any material legal proceedings[344](index=344&type=chunk) [Item 4. Mine Safety Disclosures](index=67&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Mine Safety Disclosures are not applicable to Atara Biotherapeutics - Mine Safety Disclosures are not applicable[344](index=344&type=chunk) PART II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=68&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Atara's common stock trades on Nasdaq under 'ATRA', has 6 stockholders, no dividends, and experiences significant price volatility - Atara's common stock has been listed on The Nasdaq Global Select Market under the symbol "**ATRA**" since **October 16, 2014**[347](index=347&type=chunk) - As of **February 18, 2021**, there were **6 stockholders of record**[347](index=347&type=chunk) - The company has never declared or paid cash dividends and intends to retain future earnings for business growth[348](index=348&type=chunk) - The stock price has been volatile, fluctuating between **$4.52** and **$54.45 per share** from **January 1, 2018**, through **December 31, 2020**[291](index=291&type=chunk) Five-Year Cumulative Total Return (Indexed to $100) | As of December 31, | Atara Biotherapeutics, Inc. | Nasdaq Composite | Nasdaq Biotechnology | | :------------------- | :-------------------------- | :--------------- | :------------------- | | 2015 | $100.00 | $100.00 | $100.00 | | 2016 | 53.77 | 107.50 | 78.32 | | 2017 | 68.53 | 137.86 | 94.81 | | 2018 | 131.54 | 132.51 | 85.97 | | 2019 | 62.36 | 179.19 | 106.95 | | 2020 | 74.33 | 257.38 | 134.42 | [Item 6. Selected Financial Data](index=73&type=section&id=Item%206.%20Selected%20Financial%20Data) Selected consolidated financial data highlights Atara's consistent net losses, increasing R&D expenses, and fluctuating cash over five years Consolidated Balance Sheet Data (In thousands) | Indicator | 2020 | 2019 | 2018 | 2017 | 2016 | | :---------- | :----- | :----- | :----- | :----- | :----- | | Cash, cash equivalents and short-term investments | $500,659 | $259,109 | $309,631 | $166,096 | $255,682 | | Working capital | $440,372 | $236,249 | $281,510 | $144,544 | $250,878 | | Total assets | $588,120 | $342,942 | $391,839 | $217,779 | $263,914 | | Long-term liabilities | $42,880 | $15,418 | $13,003 | $12,269 | $503 | | Total stockholders' equity | $462,339 | $290,781 | $338,857 | $177,864 | $253,736 | Consolidated Statements of Operations and Comprehensive Loss Data (In thousands, except per share amounts) | Indicator | 2020 | 2019 | 2018 | 2017 | 2016 | | :---------- | :----- | :----- | :----- | :----- | :----- | | Research and development | $244,650 | $216,097 | $167,457 | $81,206 | $56,514 | | General and administrative | $64,402 | $79,584 | $69,654 | $40,326 | $24,728 | | Total operating expenses | $309,052 | $295,681 | $237,111 | $121,532 | $81,242 | | Loss from operations | $(309,052) | $(295,681) | $(237,111) | $(121,532) | $(81,242) | | Net loss | $(306,620) | $(290,976) | $(230,699) | $(119,491) | $(79,049) | | Basic and diluted net loss per common share | $(4.15) | $(5.67) | $(5.27) | $(4.00) | $(2.75) | [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=74&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section analyzes Atara's financial condition, operations, and liquidity, detailing strategic priorities, R&D trends, and critical accounting policies - Atara Biotherapeutics is a clinical-stage company focused on T-cell immunotherapy, with a robust pipeline including **tab-cel®**, **ATA188**, and **CAR T programs**, and has incurred substantial net losses since inception[358](index=358&type=chunk)[364](index=364&type=chunk) - The company has not generated product revenues and expects to continue incurring significant expenses and operating losses as it advances product candidates through clinical development and seeks regulatory approvals[365](index=365&type=chunk)[367](index=367&type=chunk) Research and Development Expenses (In thousands) | Program | 2020 | 2019 | 2018 | 2020 vs 2019 Change | 2019 vs 2018 Change | | :----------------------------------- | :----- | :----- | :----- | :------------------ | :------------------ | | Tab-cel® expenses | $61,196 | $49,179 | $50,822 | $12,017 Increase | $(1,643) Decrease | | ATA188, CAR T and other program expenses | $25,124 | $34,869 | $30,155 | $(9,745) Decrease | $4,714 Increase | | Employee and overhead expenses | $158,330 | $132,049 | $86,480 | $26,281 Increase | $45,569 Increase | | **Total research and development expenses** | **$244,650** | **$216,097** | **$167,457** | **$28,553 Increase** | **$48,640 Increase** | General and Administrative Expenses (In thousands) | Year | 2020 | 2019 | 2018 | 2020 vs 2019 Change | 2019 vs 2018 Change | | :--- | :----- | :----- | :----- | :------------------ | :------------------ | | General and administrative expenses | $64,402 | $79,584 | $69,654 | $(15,182) Decrease | $9,930 Increase | - As of **December 31, 2020**, cash, cash equivalents, and short-term investments totaled **$500.7 million**, expected to fund operations into **2023**, including BLA filing and potential commercial launch of **tab-cel®** in the U.S[364](index=364&type=chunk)[417](index=417&type=chunk) Net Cash Flows (In thousands) | Activity | 2020 | 2019 | 2018 | | :--------- | :------- | :------- | :------- | | Operating activities | $(180,759) | $(235,626) | $(179,772) | | Investing activities | $(120,728) | $60,459 | $(196,289) | | Financing activities | $427,574 | $188,786 | $357,536 | | **Net increase (decrease) in cash, cash equivalents and restricted cash** | **$126,087** | **$13,619** | **$(18,525)** | [Overview](index=74&type=section&id=Overview) Atara Biotherapeutics is a clinical-stage T-cell immunotherapy pioneer with a pipeline including tab-cel®, ATA188, and CAR T programs, and has incurred significant net losses - Atara Biotherapeutics is a pioneer in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with serious diseases, including solid tumors, hematologic cancers and autoimmune disease[358](index=358&type=chunk) - The company's strategic priorities include **Tab-cel®** (Phase 3 for EBV+ PTLD), **ATA188** (for multiple sclerosis), and **CAR T Programs** (ATA2271, ATA3271, ATA3219)[358](index=358&type=chunk) - Atara entered into a Research, Development and License Agreement with Bayer in **December 2020** for **ATA2271** and **ATA3271**, with Bayer responsible for further development and commercialization[360](index=360&type=chunk) - Net losses were **$306.6 million**, **$291.0 million**, and **$230.7 million** for the years ended **December 31, 2020, 2019, and 2018**, respectively, with an accumulated deficit of **$1.1 billion** as of **December 31, 2020**[364](index=364&type=chunk) [Financial Overview](index=75&type=section&id=Financial%20Overview) Atara has no product revenues, with R&D as the largest expense, driven by clinical development and manufacturing, while G&A covers compensation and pre-commercial activities - Atara has not generated revenues from product sales and does not expect to until regulatory approval and commercialization of product candidates[365](index=365&type=chunk) - Research and development expenses are the largest component of operating expenses, primarily driven by preclinical and clinical development, manufacturing, and licensing agreements[366](index=366&type=chunk) - Planned R&D activities include continuing Phase 3 for **tab-cel®**, developing **ATA188** and CAR T programs, and expanding into additional indications[367](index=367&type=chunk) - General and administrative expenses primarily cover compensation, professional services, and pre-commercial activities[372](index=372&type=chunk) - Interest and other income, net, primarily consists of interest earned on cash, cash equivalents, and short-term investments[373](index=373&type=chunk) [Results of Operations](index=79&type=section&id=Results%20of%20Operations) This section details the changes in Atara's research and development and general and administrative expenses over the past three years Research and Development Expenses (In thousands) | Program | 2020 | 2019 | 2018 | 2020 vs 2019 Change | 2019 vs 2018 Change | | :----------------------------------- | :----- | :----- | :----- | :------------------ | :------------------ | | Tab-cel® expenses | $61,196 | $49,179 | $50,822 | $12,017 Increase | $(1,643) Decrease | | ATA188, CAR T and other program expenses | $25,124 | $34,869 | $30,155 | $(9,745) Decrease | $4,714 Increase | | Employee and overhead expenses | $158,330 | $132,049 | $86,480 | $26,281 Increase | $45,569 Increase | | **Total research and development expenses** | **$244,650** | **$216,097** | **$167,457** | **$28,553 Increase** | **$48,640 Increase** | General and Administrative Expenses (In thousands) | Year | 2020 | 2019 | 2018 | 2020 vs 2019 Change | 2019 vs 2018 Change | | :--- | :----- | :----- | :----- | :------------------ | :------------------ | | General and administrative expenses | $64,402 | $79,584 | $69,654 | $(15,182) Decrease | $9,930 Increase | [Quarterly Results of Operations Data (unaudited)](index=80&type=section&id=Quarterly%20Results%20of%20Operations%20Data%20(unaudited)) This section provides unaudited quarterly statements of operations data for 2020 and 2019, detailing research and development, general and administrative expenses, and net loss Unaudited Quarterly Statement of Operations Data (2020, In thousands, except per share amounts) | Quarter | Research and development | General and administrative | Total operating expenses | Loss from operations | Net loss | Basic and diluted net loss per common share | | :-------- | :----------------------- | :------------------------- | :----------------------- | :------------------- | :------- | :------------------------------------------ | | March 31 | $57,659 | $17,038 | $74,697 | $(74,697) | $(73,509) | $(1.20) | | June 30 | $61,560 | $16,392 | $77,952 | $(77,952) | $(77,456) | $(1.14) | | September 30 | $59,877 | $14,829 | $74,706 | $(74,706) | $(74,348) | $(0.92) | | December 31 | $65,554 | $16,143 | $81,697 | $(81,697) | $(81,307) | $(0.95) | Unaudited Quarterly Statement of Operations Data (2019, In thousands, except per share amounts) | Quarter | Research and development | General and administrative | Total operating expenses | Loss from operations | Net loss | Basic and diluted net loss per common share | | :-------- | :----------------------- | :------------------------- | :----------------------- | :------------------- | :------- | :------------------------------------------ | | March 31 | $48,668 | $19,223 | $67,891 | $(67,891) | $(66,257) | $(1.44) | | June 30 | $52,251 | $23,284 | $75,535 | $(75,535) | $(74,328) | $(1.60) | | September 30 | $53,538 | $19,018 | $72,556 | $(72,556) | $(71,895) | $(1.31) | | December 31 | $61,640 | $18,059 | $79,699 | $(79,699) | $(78,496) | $(1.36) | [Liquidity and Capital Resources](index=80&type=section&id=Liquidity%20and%20Capital%20Resources) Atara has funded operations primarily through equity issuances and the Bayer License Agreement, with existing capital expected to fund operations into 2023 - Atara has funded operations primarily through equity issuances and upfront fees from the Bayer License Agreement[398](index=398&type=chunk) - In **December 2020**, the company completed a public offering raising approximately **$164.3 million** net proceeds, and in **Q2 2020**, another offering raised approximately **$189.3 million** net proceeds[400](index=400&type=chunk) - Atara also utilized ATM facilities, selling **4,785,514 shares** for **$68.0 million** net proceeds in **2020**[404](index=404&type=chunk) Cash, Cash Equivalents and Short-Term Investments (In thousands) | Category | December 31, 2020 | December 31, 2019 | | :--------- | :------------------ | :------------------ | | Cash and cash equivalents | $200,404 | $74,317 | | Short-term investments | $300,255 | $184,792 | | **Total** | **$500,659** | **$259,109** | Net Cash Flows (In thousands) | Activity | 2020 | 2019 | 2018 | | :--------- | :------- | :------- | :------- | | Operating activities | $(180,759) | $(235,626) | $(179,772) | | Investing activities | $(120,728) | $60,459 | $(196,289) | | Financing activities | $427,574 | $188,786 | $357,536 | | **Net increase (decrease) in cash, cash equivalents and restricted cash** | **$126,087** | **$13,619** | **$(18,525)** | - Existing cash, cash equivalents, and short-term investments as of **December 31, 2020**, along with projected U.S. **tab-cel®** sales (if approved), are expected to fund operations into **2023**[417](index=417&type=chunk) Contractual Obligations as of December 31, 2020 (In thousands) | Obligation Type | Total | Less than 1 Year | 1-3 Years | 3-5 Years | More than 5 Years | | :---------------- | :------ | :--------------- | :---------- | :---------- | :---------------- | | Operating lease obligations | $23,188 | $3,177 | $5,531 | $5,180 | $9,300 | | Finance lease obligations | $441 | $282 | $159 | — | — | | Purchase obligations (1) | $12,720 | $12,720 | — | — | — | | **Total contractual obligations** | **$36,349** | **$16,179** | **$5,690** | **$5,180** | **$9,300** | [Item 7A. Quantitative and Qualitative Disclosures About Market Risk](index=85&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Atara's market risk primarily stems from interest rate changes affecting its diversified short-term investment portfolio, prioritizing liquidity and capital preservation - Atara's primary market risk exposure is interest rate sensitivity, affecting its **$500.7 million** in cash, cash equivalents, and short-term investments as of **December 31, 2020**[428](index=428&type=chunk) - The investment portfolio consists of money market funds, U.S. Treasury, government agency and corporate debt obligations, commercial paper, and asset-backed securities, all classified as available-for-sale[429](index=429&type=chunk) - The company's investment objective is to preserve principal and maximize income without significantly increasing risk, with no hedging of interest rate risk[429](index=429&type=chunk) [Item 8. Financial Statements and Supplementary Data](index=86&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents Atara's audited consolidated financial statements for 2020, including balance sheets, income statements, cash flows, and notes detailing key accounting policies - The financial statements include audited consolidated balance sheets as of **December 31, 2020 and 2019**, and related consolidated statements of operations and comprehensive loss, stockholders' equity, and cash flows for the three years ended **December 31, 2020**[434](index=434&type=chunk) - The report includes an unqualified opinion on the financial statements and the effectiveness of internal control over financial reporting by **Deloitte & Touche LLP**[434](index=434&type=chunk)[435](index=435&type=chunk) - Critical audit matters identified include accounting for the **Bayer License Agreement** and the estimation of accrued and prepaid research and development expenses[443](index=443&type=chunk)[447](index=447&type=chunk) - Key accounting policies discussed include revenue recognition (**ASC 606**), stock-based compensation, and income taxes, with a full valuation allowance maintained on net deferred tax assets[470](index=470&type=chunk)[489](index=489&type=chunk)[507](index=507&type=chunk) [Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=115&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) There have been no changes in or disagreements with accountants on accounting and financial disclosure - No changes in or disagreements with accountants on accounting and financial disclosure were reported[599](index=599&type=chunk) [Item 9A. Controls and Procedures](index=115&type=section&id=Item%209A.%20Controls%20and%20Procedures) Atara Biotherapeutics' management concluded that its disclosure controls and internal control over financial reporting were effective as of December 31, 2020, despite the COVID-19 pandemic - Atara's Chief Executive Officer and Chief Financial Officer concluded that disclosure controls and procedures were effective as of **December 31, 2020**[600](index=600&type=chunk) - Management concluded that internal control over financial reporting was effective as of **December 31, 2020**, based on the **COSO framework**[601](index=601&type=chunk) - No material changes in internal control over financial reporting were identified during the three months ended **December 31, 2020**, despite the impact of the COVID-19 pandemic[604](index=604&type=chunk) [Item 9B. Other Information](index=116&type=section&id=Item%209B.%20Other%20Information) There is no other information to report in this section - No other information was reported in this section[611](index=611&type=chunk) PART III [Item 10. Directors, Executive Officers and Corporate Governance](index=117&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information regarding directors, executive officers, and corporate governance is incorporated by reference from the company's definitive proxy statement, and a Code of Conduct is in place - Information is incorporated by reference to the Registrant's definitive proxy statement relating to its **2021 Annual Meeting of Stockholders**[613](index=613&type=chunk) - Atara has adopted a **Code of Conduct** applicable to officers, directors, and employees, available on its website, intended to qualify as a 'code of ethics' under **Section 406 of the Sarbanes-Oxley Act**[614](index=614&type=chunk) [Item 11. Executive Compensation](index=117&type=section&id=Item%2011.%20Executive%20Compensation) Information regarding executive compensation is incorporated by reference from the company's definitive proxy statement - Information is incorporated by reference to the Registrant's definitive proxy statement[615](index=615&type=chunk) [Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=117&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information regarding security ownership of certain beneficial owners and management, and related stockholder matters, is incorporated by reference from the company's definitive proxy statement - Information is incorporated by reference to the Registrant's definitive proxy statement[615](index=615&type=chunk) [Item 13. Certain Relationships and Related Transactions, and Director Independence](index=117&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information regarding certain relationships and related transactions, and director independence, is incorporated by reference from the company's definitive proxy statement - Information is incorporated by reference to the Registrant's definitive proxy statement[615](index=615&type=chunk) [Item 14. Principal Accounting Fees and Services](index=117&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information regarding principal accounting fees and services is incorporated by reference from the company's definitive proxy statement - Information is incorporated by reference to the Registrant's definitive proxy statement[615](index=615&type=chunk) PART IV [Item 15. Exhibits, Financial Statement Schedules](index=118&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists exhibits and financial statement schedules, including corporate documents, agreements, and certifications, with some portions granted confidential treatment - Financial statements are set forth under **Item 8** of the report[616](index=616&type=chunk) - All financial statement schedules have been omitted as they are not required or the information is provided in the financial statements or notes[616](index=616&type=chunk) - The exhibit index includes corporate documents (e.g., Certificate of Incorporation, Bylaws), warrant forms, equity incentive plans, license agreements (e.g., with Bayer, MSK, QIMR Berghofer), manufacturing agreements, and certifications[618](index=618&type=chunk)[619](index=619&type=chunk)[621](index=621&type=chunk) - Confidential treatment has been granted for portions of certain exhibits, and some exhibit descriptions indicate omitted material as not material or likely to cause competitive harm[622](index=622&type=chunk)[623](index=623&type=chunk) [Item 16. Form 10-K Summary](index=122&type=section&id=Item%2016.%20Form%2010-K%20Summary) There is no Form 10-K Summary provided in this report - No Form 10-K Summary is provided[623](index=623&type=chunk)