Atara Biotherapeutics, Inc. · NASDAQ:ATRA
Atara Biotherapeutics — Q2 2021 Earnings Presentation
58 slides from Atara Biotherapeutics's earnings presentation, Aug 9, 2021
Slide 1: Investor Presentation
Ola EBV+ PTLD Advocate Investor Presentation August 9, 2021 Nasdaq: ATRA 1
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation and the accompanying oral presentation contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this prese
Slide 3: Pioneering Off-the-Shelf, Allogeneic T-cell Immunotherapies
Pioneering Off-the-Shelf, Allogeneic T-cell Immunotherapies Our mission is to transform the lives of patients with serious diseases through pioneering science, teamwork and Allison a commitment to excellence Ola PTLD Advocate PTLD Advocate Ayden PTLD Advocate Dan Swapna PTLD Advocate MS Advocate Mit
Slide 4: Highly Experienced Executive Team Dedicated to Transforming the Lives of Patients
Highly Experienced Executive Team Dedicated to Transforming the Lives of Patients Pascal Touchon Jakob Dupont, M.D. President and Utpal Koppikar Chief Financial Officer Head of Research and Chief Executive Officer Development Joe Newell AJ Joshi, M.D. Kristin Yarema, Ph.D. Chief Operations Officer C
Slide 5: We Are a Leading Allogeneic T-Cell Immunotherapy Company
We Are a Leading Allogeneic T-Cell Immunotherapy Company Differentiated Allogeneic Cell Therapy Platform Scalable EBV T-cell platform and technologies to develop multiple allogeneic cell therapies Tab-cel®: First-In-Kind, Late-Stage, Oncology Program Expect to complete the MAA submission in November
Slide 6: We Are Rapidly Advancing Across Multiple Fronts
We Are Rapidly Advancing Across Multiple Fronts Today Within Next 15 months Potential for first allogeneic T-cell Tab-cel® Working toward BLA submission immunotherapy on the market in 2022 Disability improvement data from RCT Growing open label clinical dataset ATA188 suggesting transformative poten
Slide 7: Platform Potential to Treat a Wide Range of EBV-Associated Diseases or Hematological / Solid Tumors
Platform Potential to Treat a Wide Range of EBV-Associated Diseases or Hematological / Solid Tumors Through Engineered CAR or TCR EBV-Targeting Engineered T-Cell Products: Oncology Products: Tab-cel® and ATA188 Next-gen CAR T or TCR T CAR EBV TCR EBV TCR Next-Gen CAR HLA Technologies HLA Healthy Don
Slide 8: Our Vision is to Transcend the Limitations of Current Cell Therapy
Our Vision is to Transcend the Limitations of Current Cell Therapy by Harnessing the Power of EBV T-cells Autologous Other Allogeneic Atara Bio Allogeneic Cell Therapy Cell Therapy Cell Therapy Proven only in Limited long-term Durable response in Durable Efficacy some heme clinical data PTLD and PMS
Slide 9: Robust T-Cell Immunotherapy Pipeline
Robust T-Cell Immunotherapy Pipeline Next Program Indication Target Preclinical Phase 1 Phase 2 Phase 3 Registration Milestone Nov ’21: MAA RR EBV+ PTLD following ALLELE Study EBV Q1 ‘22: BLA HCT and SOT submissions Tab-cel® Multi-Cohort: EBV+ 2023: Ph2 Study EBV (tabelecleucel) cancers(1) data expe
Slide 10: Our Platform is Nearing Commercial Scale Readiness
Our Platform is Nearing Commercial Scale Readiness Dedicated, expandable manufacturing facility − Flexibility to produce multiple T-cell and CAR T immunotherapies − Designed to meet global regulatory standards − Commercial manufacturing validation activities near completion Robust manufacturing
Slide 11: Three Strategic Priorities Driving Long-Term Value
Three Strategic Priorities Driving Long-Term Value Tab-cel® ATA188 Next-Gen CAR T First-in-Kind Allogeneic T-Cell Transformative MS Next-Generation Allogeneic Therapy Preparing for Historic Treatment in Randomized CAR T Programs Regulatory Filing Controlled Trial (RCT) Leveraging EBV T Cells • BTD p
Slide 12: Upcoming Key Catalysts Over the Next 15 Months
Upcoming Key Catalysts Over the Next 15 Months Complete FDA Biologics License Application (BLA) rolling submission for patients with EBV+ PTLD Q1 2022 Tab-cel® (tabelecleucel) Present Phase 3 ALLELE data at an appropriate congress Q4 2021 Complete EU Marketing Authorization Application (MAA) submiss
Slide 13: Atara is Well-Capitalized With Planned Cash Runway Into 2023
Atara is Well-Capitalized With Planned Cash Runway Into 2023 Nasdaq: ATRA $373.4 million 84.8 million Cash, cash equivalents, and short-term Shares Outstanding investments as of June 30, 2021 as of June 30, 2021 * Atara Biotherapeutics, Inc. $87.9 million $61.6 million Q2 2021 Q2 2021 Operating Expe
Slide 14: Atara Strategic Priorities to Create Value: Tab-cel
Atara Strategic Priorities to Create Value: Tab-cel® Tab-cel® (tabelecleucel) Investigational T-cell immunotherapy for EBV-associated ultra-rare diseases FDA breakthrough designation and EMA PRIME for EBV+ PTLD ATA188 CAR T 14
Slide 15: A Common Virus—EBV—Causes Rare and Serious Cancers In Patients With Impaired Immune Function
A Common Virus—EBV—Causes Rare and Serious Cancers In Patients With Impaired Immune Function EBV is a common driver of IA-LPDs EBV is a ubiquitous yet typically dormant virus − Once infected, healthy patients harbor lifelong infection Tab-cel® has the potential to transform that is usually kept in
Slide 16: EBV-Associated Post-Transplant Lymphoproliferative Disease
EBV-Associated Post-Transplant Lymphoproliferative Disease Aggressive, Often Deadly Cancer with No Approved Therapy Rare B-cell lymphoma that occurs in immunosuppressed patients after transplant Average age under 40 years vs. around 65 years for NHL — Bone marrow transplant (HCT) Ayden EBV+ PTLD r
Slide 17: Tab-cel Long-Term Outcomes for Patients with EBV+ PTLD in Phase 2 and EAP Studies
Tab-cel® – Long-Term Outcomes for Patients with EBV+ PTLD in Phase 2 and EAP Studies(1,2) Probability of Survival All, n=35, 1-yr OS=68.3% All, n=14, 1-yr OS=64.3% Probability of Survival Non Response, n=11, 1-yr OS=24.2% Non Response, n=7, 1-yr OS=28.6% 1.0 Response, n=24, (20CRs, 4PRs) 1-yr OS=87.
Slide 18: Tab-cel Achieved 50% Objective Response Rate in Pivotal Phase 3 Study
Tab-cel® Achieved 50% Objective Response Rate in Pivotal Phase 3 Study Interim Analysis by Independent Oncologic and Radiographic Assessment Investigator Assessed: Phase 2 and EAP ORR for EBV+ PTLD patients who failed rituximab Interim Analysis by IORA for 82% Phase 3 Pivotal Study 69% Conducted i
Slide 19: Recent Positive Regulatory Progress for Tab-cel
Recent Positive Regulatory Progress for Tab-cel® Alignment on key methodologies for evaluating comparability between Atara product used in the pivotal ALLELE study and the intended commercial product Completed all necessary regulatory and compliance − Will provide data on effectively all lots ma
Slide 20: Tab-cel EBV+ PTLD – Attractive Ultra-Rare Disease Market
Tab-cel® EBV+ PTLD – Attractive Ultra-Rare Disease Market Estimated Incidence in the U.S. in 2019(1) PTLD incidence Low single digits(2) Relapsed/refractory 40%-60% ~48,000 Allogeneic Several hundred transplants EBV+ PTLD patients SOT HCT who have failed ~80% ~20% rituximab ± chemo EBV+ HCT: ~100% P
Slide 21: Market Dynamics in EBV+ PTLD Are Favorable For Rapid Uptake Of A Transformative Targeted Therapy
Market Dynamics in EBV+ PTLD Are Favorable For Rapid Uptake Of A Transformative Targeted Therapy Previously treated EBV+ PTLD is our first planned indication for tab-cel among IA-LPDs Ultra-rare B-cell lymphoma occurring in immunosuppressed post-transplant patients Average age of onset <40 years Sev
Slide 22: Tab-cel – Compelling Value Proposition for EBV+ PTLD Patients and Healthcare System
Tab-cel® – Compelling Value Proposition for EBV+ PTLD Patients and Healthcare System ≥50% ORR in Phase 2, EAP, and Phase 3 IA High and durable No CRS or >80% survival at treatment Excellent safety neurotoxicity observed 2 years in responders in effect(1) profile(1) No treatment- Phase 2 and EAP rela
Slide 23: Targeted, Highly Efficient Commercialization Model
The Unique Attributes of PTLD and Tab-cel® Allow for a Targeted, Highly Efficient Commercialization Model Proactive HCP engagement PTLD ecosystem early in patient journey Rapid • Finite number of transplant centers and patients monitored routinely Tab-cel’s support in any care setting, • Personalize
Slide 24: Tab-cel – Additional Phase 2 Study Underway Which May Support Meaningful Label Expansion
Tab-cel® – Additional Phase 2 is Underway Which May Support Meaningful Label Expansion EBV-205 Phase 2 Study EBV+ AID-LPD and EBV+ PID-LPD Label expansion opportunity for tab-cel Study Populations High unmet need We initiated a tab-cel Phase 2 EBV+ PID-LPD Large potential patient population mu
Slide 25: EBV+ IA-LPDs Present a Meaningful Opportunity to Expand Potential Tab-cel Label
EBV+ IA-LPDs(1) Present a Meaningful Opportunity to Expand Potential Tab-cel® Label U.S. Multi-Cohort Potential Label Expansion Populations – 2019(2) Disease incidence AID-LPD: low single digits IA-LPDs U.S. PID-LPD: high single digits Population at Risk ~205,000 Patients Potentially addressable pop
Slide 26: Atara Strategic Priorities to Create Value: ATA188
Atara Strategic Priorities to Create Value: ATA188 ATA188 CAR T EBV T-cell immunotherapy for progressive multiple sclerosis (MS) 26
Slide 27: Multiple Sclerosis is a Debilitating Disease of the Central Nervous System with Few Treatment Options
Multiple Sclerosis (MS) is a Debilitating Disease of the Central Nervous System with Few Treatment Options High Unmet Need Remains for Patients with Progressive MS Large patient population — ~2.3 million patients diagnosed and living with MS worldwide — ~1 million MS patients worldwide have a prog
Slide 28: What Could a Transformative Therapy in Progressive MS Look Like?
What Could a Transformative Therapy in Progressive MS Look Like? ILLUSTRATIVE Time EDSS = 0 (No Disability) Sustained reversal of disability Transformative advance Halted progression Disability Current treatments: ~6 month delay in progression EDSS = 10 (Death) Natural course of progression 28
Slide 29: ATA188 is a Potentially Transformative MS Treatment
ATA188 is a Potentially Transformative MS Treatment Safety Efficacy Activity Targeting Intervention Profile of a Halt or Reverses Targets specific Addresses Safe and Well- Transformative disability Penetrates CNS B cells and underlying tolerated progression plasma cells biology Treatment ✓ ✓ ✓ ✓ ✓ S
Slide 30: Positive Ph1 data in Progressive MS Showing 50% Sustained Disability Improvement
Positive Ph1 data in Progressive MS Showing 50% Sustained Disability Improvement (SDI) in Cohorts 3 – 4 at 15 Months Patients achieving SDI had greater Dose-related increase in subjects per cohort improvements on patient reported instruments exhibiting SDI over 15 months assessing outcomes beyond di
Slide 31: Results Among Subjects in Cohorts 1–4 Who Met SDI Criteria
Results Among Subjects in Cohorts 1–4 Who Met SDI Criteria Within the First 12 Months and/or During the OLE Long-term SDI: As of October 2020, OLE data were available for 16 subjects: • 6 of these subjects had SDI at 12 months, which was maintained at all timepoints evaluated during the OLE • An add
Slide 32: Ongoing Open-Label Extension Period will Allow Patients to be Retreated Annually
Ongoing Open-Label Extension Period will Allow Patients in Phase 1 Study to be Retreated Annually with ATA188 Phase 1 Study Schema DOSE-ESCALATION (Year 1) OPEN-LABEL EXTENSION Cohorts 1–4, N = 6 per cohort (Years 2‒5) DLT Assessment DLT (35 Days) Patients Who Assessment Complete Year Single cycle o
Slide 33: Significant Progress with FDA and Advancing Phase 2 RCT (EMBOLD) for ATA188
We Have Made Significant Progress with FDA and are Advancing our Phase 2 RCT (EMBOLD) for ATA188, with an Interim Analysis Planned in H1 2022 FDA Registrational Feedback Received for Current RCT Primary endpoint: measuring disability improvement is acceptable; FDA preference for EDSS ‒ Study durat
Slide 34: Phase 1 Translational Data and 2-year Clinical Data to be Presented at ECTRIMS
Phase 1 Translational Data and 2-year Clinical Data From Phase 1 OLE Study to be Presented at ECTRIMS in October 2021 Atara will share the latest on our Phase 1 open label extension study evaluating the safety and potential efficacy of ATA188 in adults with progressive multiple sclerosis (MS) Wi
Slide 35: Multi-Billion Dollar Potential for a Transformative Therapy in Progressive MS
Multi-Billion Dollar Potential for a Transformative Therapy in Progressive MS Estimated US Market Forecast for Progressive MS (2025) 5 YR CAGR: 57% Other therapies up to ~9% 43% Anti-CD20s ’20 ’25 Transformative ~$5B - $7B Therapy: ~45%+ Share for Best- PMS Overall ~25% - 50% Higher in-Class Treatme
Slide 36: Atara Strategic Priorities to Create Value: CAR T
Atara Strategic Priorities to Create Value: CAR T CAR T ATA2271/ATA3271 (Solid Tumors) ATA3219 (B-cell malignancies) Other CAR T 36
Slide 37: Leveraging Our EBV Platform to Optimize CAR and TCR Therapies
Leveraging Our EBV Platform to Optimize CAR and TCR Therapies Off-the-shelf, allogeneic Off-the-shelf CAR T 1 EBV T-cell platform 3 with broad applications Next-Generation Technologies Next-generation Multi-targeted CARs 2 CAR technologies − Dual targeting with gating (“AND”/“OR”) to avoid EBV EBV o
Slide 38: Atara and Bayer Enter Strategic Collaboration for Mesothelin-Targeted CAR T Cell Therapies
Atara Biotherapeutics and Bayer Enter Strategic Collaboration for Mesothelin-Targeted CAR T Cell Therapies For Solid Tumors Worldwide license agreement and research, development and manufacturing collaboration to develop Atara’s allogeneic off-the-shelf mesothelin CAR T program (ATA3271) and autolog
Slide 39: Global Strategic Collaboration for ATA2271 and ATA3271 With Bayer Continues to Progress
Global Strategic Collaboration for ATA2271 and ATA3271 With Bayer Continues to Progress Well with Advancement of the Mesothelin-partnered CAR T Immunotherapy Programs Mesothelin is a well-established target associated with aggressive solid tumors Unique ScFv that binds to mesothelin above cancer
Slide 40: ATA3219: Developing Potential Best in Class Off-the-Shelf Allogeneic CD19 Program
ATA3219: Developing Potential Best in Class Off-the-Shelf Allogeneic CD19 Program for B-Cell Malignancies, With IND Expected in Q1 2022 Academic program generated proof of principle for EBV T-cell platform potential to generate off-the-shelf, allogeneic CAR T therapies with high EBV and durable re
Slide 41: Thank You
ATARA BIO Thank You Nasdaq: ATRA
Slide 42: Appendix
Appendix NAV, XX a ATARA BIO 42
Slide 43: Tab-cel
Tab-cel® ATARA BIO’ 43
Slide 44: Tab-cel – Off-the-Shelf, Allogeneic T-Cell Immunotherapy with Potential to Transform Treatment of EBV+ PTLD
Tab-cel® – Off-the-Shelf, Allogeneic T-Cell Immunotherapy with Potential to Transform Treatment of EBV+ PTLD NEW Week -10 Week -4 Week 0 Week 10 Week 15 Week 29 36-year-old with Increase in Disease Tab-cel® response: Continued Complete Fanconia anemia tumor burden progression after 3 rapid decrease
Slide 45: Tab-cel Has the Potential to Benefit Other Patients with EBV-Driven Cancers
Tab-cel® Has the Potential to Benefit Other Patients with EBV-Driven Cancers Beyond Previously Treated EBV+ PTLD EBV-205 Phase 2 Study Design All Cohorts Include 1L Patients ENDPOINTS EBV+ PID LPD Additional Treatment Primary: Overall EBV+ AID LPD Response Rate (ORR) Quarterly EBV+ PTLD CNS End-of
Slide 46: ATA188
ATA188 NAV, XX a ATARA BIO 46
Slide 47: ATA188: A bold vision to transform MS therapy
ATA188 Precision targeting to select EBV antigens limits off-target A bold vision to activity transform MS therapy Off-the-shelf T-cells delivered from inventory Phase 1 trial successfully demonstrated safety and No pretreatment required in the clinical trial protocol Two-hour monitoring following 5
Slide 48: The Role of EBV in Multiple Sclerosis
The Role of EBV in Multiple Sclerosis CONFIDENTIAL 48
Slide 49: Growing Evidence that EBV Has a Major Role in the Pathogenesis of Multiple Sclerosis
Growing Evidence that EBV Has a Major Role in the Pathogenesis of Multiple Sclerosis • Prior EBV infection is necessary for a patient to develop MS 1,4 • MS may be mediated by B cells that are infected with EBV 2 • Defective elimination of EBV-infected autoreactive B cells by CD8+ T-cells results in
Slide 50: Auto-reactive EBV-Infected B cells and Plasma Cells Normally Controlled by EBV T-cells
Auto-reactive EBV-Infected B cells and Plasma Cells Normally Controlled by EBV T-cells Adapted from Pender MP. Neuroscientist 2011; 17:351-367. 50
Slide 51: MS Treatment: Modest Efficacy Benefit from Current Options
MS Treatment: Modest Efficacy Benefit from Current Options Active Secondary Progressive MS Primary Progressive MS 6-mth CDP Siponimod vs. Placebo in SPMS (EXPAND) 24-Wk CDP Ocrelizumab vs. Placebo in PPMS (ORATORIO) 26% 36% 20% 30% • Current therapies delay progression but do not fundamentally alter
Slide 52: Based on Encouraging Clinical Data, We Have Increased our Investment in the ATA188 Program
Based on Encouraging Clinical Data, We Have Increased our Investment in the ATA188 Program ATA188 Investment Summary Expanded to at least 80 patients in Phase 2 double-blind placebo-controlled study Changed primary endpoint to EDSS improvement endpoint while maintaining other disability improvement
Slide 53: Increased Investment and Updated Endpoints in the ATA188 Phase 2 Placebo-Controlled Study
We Have Increased Investment and Updated Endpoints in the ATA188 Phase 2 Randomized, Placebo-Controlled Study in at Least 80 Progressive MS Patients Phase 2 Randomized Placebo-Controlled Study Schema KEY ENDPOINTS DOUBLE-BLIND PERIOD OPEN-LABEL EXTENSION Primary (clinical): EDSS at 12m R ATA188 AT
Slide 54: Biologics-Like Supply Chain for ATA188 at Commercial Scale
We Have Demonstrated Each Element of Our Platform to Support a Biologics-Like Supply Chain for ATA188 at Commercial Scale Data confirms we can scale up Current inventory model projects coverage manufacturing process into bioreactors of ~95% of MS patients with ~10 cell lines PRODUCTIVITY OF ONE LEUK
Slide 55: CAR T Portfolio
CAR T Portfolio NAV, XX a ATARA BIO 55
Slide 56: Atara Off-the-Shelf, Allogeneic CAR T Immunotherapy Strategy
Atara Off-the-Shelf, Allogeneic CAR T Immunotherapy Strategy Rapidly advance Invest autologous CAR T for in world-class T-cell proof-of-concept manufacturing Collaborate followed by off-the-shelf, with academic allogeneic EBV CAR Ts Leverage leaders applying T-cell research, development next-gen and
Slide 57: Exclusive License to Mesothelin-Targeted CAR T Immunotherapy for Solid Tumors from MSK
Exclusive License to Mesothelin-Targeted CAR T Immunotherapy for Solid Tumors from MSK Mesothelin is an attractive target associated with aggressive solid tumors (1,2) Aberrant mesothelin expression promotes cancer cell proliferation and confers resistance to apoptosis — Associated with mesothelio
Slide 58: Atara CAR / TCR Pipeline – Applying Next-Generation Technologies
Atara CAR / TCR Pipeline – Applying Next-Generation Technologies in Collaboration with Academic & Industry Leaders Indication Target Technologies (1) Autologous PD-1 DNR ATA2271 Solid tumors(2) Mesothelin 1XX co-stimulation (1) Off-the-shelf, allogeneic PD-1 DNR ATA3271 Solid tumors(2) Mesothelin 1X
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