Atara Biotherapeutics, Inc. · NASDAQ:ATRA
Atara Biotherapeutics — Investor Presentation (January 2021)
57 slides from Atara Biotherapeutics's investor presentation, Jan 11, 2021
Slide 1: Investor Presentation January 11, 2021
Investor Presentation January 11, 2021 Nasdaq: ATRA Exhibit 99.1
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: Mission: Pioneering Off-the-Shelf, Allogeneic T-cell Immunotherapies
Ola PTLD champion Ayden PTLD champion Jon PTLD champion Doug PTLD champion Jessica PTLD champion 1982-2019 Atara mourns the loss of Jessica, who passed away on September 25, 2019 while awaiting a new heart and kidney transplant. Her memory continues to fuel our urgency in developing new therapies fo
Slide 4: Highly Experienced Executive Team Dedicated to Transforming the Lives of Patients
Highly Experienced Executive Team Dedicated to Transforming the Lives of Patients Kristin Yarema, Ph.D. Chief Commercial Officer Pascal Touchon President and Chief Executive Officer Joe Newell Chief Operations Officer AJ Joshi, M.D. Chief Medical Officer Utpal Koppikar Chief Financial Officer Jakob
Slide 5: We Are a Leading Allogeneic T-Cell Immunotherapy Company
We Are a Leading Allogeneic T-Cell Immunotherapy Company ATA188: Potentially Transformative MS Treatment in Randomized Controlled Trial Tab-cel®: First-In-Kind, Late-Stage, Oncology Program Differentiated Allogeneic Cell Therapy Platform Next-Gen Allogeneic CAR T Portfolio, Validated by Bayer Collab
Slide 6: We Are Rapidly Advancing Across Multiple Fronts
We Are Rapidly Advancing Across Multiple Fronts Today Within Next 24 months Tab-cel® ATA188 CAR T Allogeneic T-cell Platform Expertise Nearing BLA initiation Potential for first allogeneic T-cell immunotherapy on the market in 2022 Growing open label clinical dataset suggesting transformative potent
Slide 7: Platform Potential to Treat a Wide Range of EBV-Associated Diseases or Tumors
Platform Potential to Treat a Wide Range of EBV-Associated Diseases or Hematological / Solid Tumors Through Engineered CAR or TCR Healthy Donor Cells Minimal HLA matching needed Designed to target root cause of EBV-driven diseases Favorable safety profile Robust manufacturing process No genetic engi
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 Cell Therapy Other Allogeneic Cell Therapy No GvHD but other risks Individually manufactured Long manufacturing time, high COGM, complex logistics Low GvHD but other risks if need for
Slide 9: Robust T-Cell Immunotherapy Pipeline
Program Indication Target Preclinical Phase 1 Phase 2 Phase 3 Registration Next Milestone Tab-cel® (tabelecleucel) RR EBV+ PTLD following HCT and SOT EBV Q3 2021: Rolling BLA completion Multi-Cohort: EBV+ cancers(1) EBV 2023: Ph2 Study data expected Nasopharyngeal carcinoma(2) EBV 2021: Add’l transl
Slide 10: 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 process with data confirming potential scale up into perfusio
Slide 11: Three Strategic Priorities Driving Long-Term Value
Three Strategic Priorities Driving Long-Term Value Tab-cel® ATA188 Next-Gen CAR T BTD program for high unmet need in ultra rare population, with meaningful label expansion potential Compelling efficacy profile in Phase 2 and Phase 3 IA with favorable safety profile Next Step: Initiate rolling BLA an
Slide 12: Upcoming Key Catalysts Over the Next 24 Months
ü ü ü ü Tab-cel® (tabelecleucel) ATA188 Update on long-term clinical data from Phase 1a OLE study in an appropriate forum H1 and H2 2021 Present top-line Phase 1 data for mesothelin-targeted autologous CAR T for patients with advanced mesothelioma Q4 2021 ATA2271 Q3 2021 Complete FDA Biologics Licen
Slide 13: Atara is Well-Capitalized With Planned Cash Runway Into 2023
Atara is Well-Capitalized With Planned Cash Runway Into 2023 $327.2 million Cash, cash equivalents, and short-term investments as of Sept 30, 2020 $544.2 million Proforma cash, cash equivalents, and short-term investments as of Sept 30, 2020 - including Bayer collaboration upfront and Dec 7, 2020 fo
Slide 14: Atara Strategic Priorities: Tab-cel
Atara Strategic Priorities to Create Value: Tab-cel® ATA188 CAR T Tab-cel® (tabelecleucel) Investigational T-cell immunotherapy for EBV-associated ultra-rare diseases FDA breakthrough designation and EMA PRIME for EBV+ PTLD
Slide 15: A Common Virus—EBV—Causes Rare and Serious Cancers
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 that is usually kept in check by their immune systems In patients w
Slide 16: EBV-Associated Post-Transplant Lymphoproliferative Disease
EBV-Associated Post-Transplant Lymphoproliferative Disease Aggressive, Often Deadly Cancer with No Approved Therapy Average age under 40 years vs. around 65 years for NHL Bone marrow transplant (HCT) EBV+ PTLD risk up to recovery of immune system (~1 year) Solid organ transplant (SOT) Chronic risk o
Slide 17: Tab-cel Long-Term Outcomes for Patients with EBV+ PTLD
Tab-cel® –Long-Term Outcomes for Patients with EBV+ PTLD in Phase 2 and EAP Studies(1,2) Few treatment-related serious adverse events (SAEs): 12 possibly related Serious Adverse Events (SAEs) among 173 patients: no infusion related toxicities, no CRS (cytokine release syndrome) and three possibly re
Slide 18: Tab-cel Achieved 50% Objective Response Rate in Pivotal Phase 3 Interim Analysis
Tab-cel® Achieved 50% Objective Response Rate in Pivotal Phase 3 Study Interim Analysis by Independent Oncologic and Radiographic Assessment 50% N = 35 N = 14 HCT SOT 69% 82% 55% N = 11 N = 11 EAP EAP Phase 2 Phase 2 Investigator Assessed: Phase 2 and EAP ORR for EBV+ PTLD patients who failed rituxi
Slide 19: Significant Recent Regulatory Progress for Tab-cel
Significant Recent Regulatory Progress for Tab-cel® Agreement for rolling BLA submission Agreement on the follow-up period for duration of response needed for currently enrolled patients in pivotal study (ALLELE) Agreement to use prior studies as supportive data in BLA filing Progress on CMC package
Slide 20: Tab-cel EBV+ PTLD – Attractive Ultra-Rare Disease Market
Tab-cel® EBV+ PTLD – Attractive Ultra-Rare Disease Market Atara literature review and team analysis In SOT segment, there is significant variation by organ type. In HCT segment, variation is driven by conditioning regimens, EBV monitoring and prophylactic treatment. Several hundred EBV+ PTLD patient
Slide 21: Market Dynamics in EBV+ PTLD Are Favorable For Rapid Uptake
Market Dynamics in EBV+ PTLD Are Favorable For Rapid Uptake Of A Transformative Targeted Therapy ~50% of EBV+ PTLD patients fail initial treatment ~2-3 months median survival after failing rituximab with or without chemo Many patients suffer chemo-related side effects, including mortality High rates
Slide 22: Tab-cel Compelling Value Proposition for EBV+ PTLD
High and durable treatment effect(1) Excellent safety profile(1) Low cost of administration Tab-cel® –Compelling Value Proposition for EBV+ PTLD Patients and Healthcare System No CRS or neurotoxicity observed No treatment- related mortality No pretreatment required 5-10 minute IV infusion 2-hour mon
Slide 23: Targeted, Highly Efficient Commercialization Model
The Unique Attributes of PTLD and Tab-cel® Allow for a Targeted, Highly Efficient Commercialization Model Finite number of transplant centers and patients monitored routinely Personalized nature of tab-cel facilitates Atara/HCP dialogue HCPs comfortable with virtual communications due to COVID-19 Gr
Slide 24: Tab-cel Additional Phase 2 Study Underway Which May Support Label Expansion
Tab-cel® – Additional Phase 2 is Underway Which May Support Meaningful Label Expansion EBV-205 Phase 2 Study Label expansion opportunity for tab-cel We initiated a tab-cel Phase 2 multi-cohort study in the third quarter of 2020 EBV is the common driver of these diseases and tab-cel® targets them at
Slide 25: EBV+ IA-LPDs Present a Meaningful Opportunity to Expand Tab-cel Label
EBV+ IA-LPDs(1) Present a Meaningful Opportunity to Expand Potential Tab-cel® Label Potentially addressable population of a few thousand 1L and 2L patients Disease incidence AID-LPD: low single digits PID-LPD: high single digits EBV+ Rate AID-LPD: 30-50% PID-LPD: 30-75% U.S. Multi-Cohort Potential L
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) Tab-cel® (tabelecleucel) Investigational T-cell immunotherapy for EBV-associated ultra-rare diseases FDA breakthrough designation & EMA PRIME for EBV+ PTLD
Slide 27: Multiple Sclerosis is a Debilitating Disease 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 Ayden PTLD champion Large patient population ~2.3 million patients diagnosed and living with MS worldwide ~1 million MS patients worldwi
Slide 28: What Could a Transformative Therapy in Progressive MS Look Like?
What Could a Transformative Therapy in Progressive MS Look Like? Sustained reversal of disability ILLUSTRATIVE Time EDSS = 0 (No Disability) EDSS = 10 (Death) Current treatments: ~6 month delay in progression Natural course of progression Transformative advance Halted progression Disability
Slide 29: ATA188 is a Potentially Transformative MS Treatment
ATA188 is a Potentially Transformative MS Treatment Halt or Reverses disability progression Safe and Well-tolerated Penetrates CNS Targets specific B cells and plasma cells Addresses underlying biology Profile of a Transformative Treatment Sustained Disability Improvement (SDI) observed in Phase 1a
Slide 30: Positive Ph1a Data in Progressive MS Showing 50% Sustained Disability Improvement
Positive Ph1a data in Progressive MS Showing 50% Sustained Disability Improvement (SDI) in Cohorts 3 – 4 at 15 Months Patients achieving SDI had greater improvements on patient reported instruments assessing outcomes beyond disability Dose-related increase in subjects per cohort exhibiting SDI over
Slide 31: Results Among Subjects 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 EDSS, T25FW and 9HPTa results among subjects in Cohorts 1–4 who met SDI criteria within the first 12 months and/or during the OLE 6 of these subjects had SDI at 12 months, which was maintained
Slide 32: Phase 1a Study Schema and Open-Label Extension
OPEN-LABEL EXTENSION (Years 2‒5) Single cycle of ATA188 treatment Q12M for up to 4 years 5-year end-of-study visit End of study Dose selection for the randomized (part 2) and OLE portion of the study Patients Who Complete Year Patients who discontinued part 1 or decline to participate in the OLE Pha
Slide 33: Significant Progress with the FDA; Advancing Phase 2 RCT
We Have Made Significant Progress with the FDA and are Advancing our Phase 2 RCT 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 duration shoul
Slide 34: Multi-Billion Dollar Potential for a Transformative Therapy in Progressive MS
Multi-Billion Dollar Potential for a Transformative Therapy in Progressive MS Transformative Therapy: ~25% - 50% Higher Treatment Rate1 ~$5B - $7B PMS Overall Market Size Potential Annual US Revenue Opportunity in PMS of ~$3.5B+ Estimated US Market Forecast for Progressive MS (2025) ~45%+ Share for
Slide 35: Atara Strategic Priorities to Create Value: CAR T
Atara Strategic Priorities to Create Value: CAR T CAR T Tab-cel® (tabelecleucel) Investigational T-cell immunotherapy for EBV-associated ultra-rare diseases FDA breakthrough designation & EMA PRIME for EBV+ PTLD ATA188 EBV T-cell immunotherapy for progressive multiple sclerosis (MS) ATA2271/ATA3271
Slide 36: Leveraging Our EBV Platform to Optimize CAR and TCR Therapies
Leveraging Our EBV Platform to Optimize CAR and TCR Therapies Off-the-shelf, allogeneic EBV T cell platform Next-generation CAR technologies Off-the-shelf CAR T with broad applications 1 2 3 EBV TCR HLA EBV TCR HLA Next-Gen CAR T Leveraging EBV T-Cell Natural Biology and Next-Gen Technologies CAR Mu
Slide 37: Atara and Bayer Enter Strategic Collaboration for Mesothelin-Targeted CAR T
Recognizes the leading position of Atara’s technology platform and capabilities in allogeneic cell therapy Agreement is fundamental element of Bayer’s new Cell & Gene Therapy strategy Bayer brings significant development & commercialization capabilities in oncology solid tumors, which complements At
Slide 38: Strategic Collaboration with Bayer for Mesothelin-Targeted CAR T Program
Entered Strategic Collaboration with Bayer to Develop Mesothelin-Targeted CAR T Program in Solid Tumors Mesothelin is a well-established target associated with aggressive solid tumors Unique ScFv that binds to mesothelin above cancer threshold Innovative next-gen CAR T technologies combining novel 1
Slide 39: Developing Off-the-Shelf Allogeneic CD19 Program for B-Cell Malignancies
Developing Potential Best in Class Off-the-Shelf Allogeneic CD19 Program for B-Cell Malignancies Academic program generated proof of principle for EBV T-cell platform potential to generate off-the-shelf, allogeneic CAR T therapies with high and durable responses, low risk of toxicity, and rapid deli
Slide 40: Thank You
ATARA BIO Thank You
Slide 41: Appendix
Appendix ATARA BIO" “1
Slide 42: Tab-cel
Tab-cel® ATARA BIO" mn
Slide 43: Tab-cel Off-the-Shelf Allogeneic T-Cell Immunotherapy for EBV+ PTLD
Tab-cel® –Off-the-Shelf, Allogeneic T-Cell Immunotherapy with Potential to Transform Treatment of EBV+ PTLD Week -10 36-year-old with Fanconia anemia diagnosed with EBV+ PTLD Week -4 Week 10 Week 15 Week 0 Increase in tumor burden Disease progression after 3 cycles of rituximab Tab-cel® response: ra
Slide 44: 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 Primary: Overall Response Rate (ORR) Secondary: Overall Survival (OS); Duration of Response (DOR) Inventory Check an
Slide 45: ATA188
ATA 188 ATARA BIO" 45
Slide 46: ATA188 Off-the-shelf T cells delivered from inventory
ATA188 Off-the-shelf T cells delivered from inventory Phase 1 trial successfully demonstrated safety and No pretreatment required in the clinical trial protocol Precision targeting to select EBV antigens limits off-target activity Two-hour monitoring following 5-10 minute IV infusion Administered as
Slide 47: The Role of EBV in Multiple Sclerosis
The Role of EBV in Multiple Sclerosis
Slide 48: Growing Evidence that EBV Has a Major Role in MS
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 accumulation in lymphoid structures and target organs implicated in MS, including the CNS,
Slide 49: 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.
Slide 50: MS Treatment: Modest Efficacy Benefit from Current Options
MS Treatment: Modest Efficacy Benefit from Current Options 26% 20% 6-mth CDP Siponimod vs. Placebo in SPMS (EXPAND) Source: Kappos, D.L. et al, Lancet 2018; Montalban X. et al, NEJM, 2017 Current therapies delay progression but do not fundamentally alter its course B-cell hypothesis in MS validated
Slide 51: 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 Planned expansion to at least 80 patients in Phase 2 double-blind placebo-controlled study Plan to change primary endpoint to EDSS improvement endpoint while maintaining other disabil
Slide 52: Updated ATA188 Phase 2 Randomized, 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 DOUBLE-BLIND PERIOD OPEN-LABEL EXTENSION KEY ENDPOINTS Primary (clinical): EDSS at 12m Secondary: SD
Slide 53: Platform Supports a Biologics-Like Supply Chain for ATA188
We Have Demonstrated Each Element of Our Platform to Support a Biologics-Like Supply Chain for ATA188 at Commercial Scale PRODUCTIVITY OF ONE LEUKOPAK Proven scalable bioreactor manufacturing Additional yield improvements in development Proprietary cell selection and efficient logistics ~ 3-day deli
Slide 54: CAR T Portfolio
CAR T Portfolio ATARA BIO" a
Slide 55: Atara Off-the-Shelf, Allogeneic CAR T Immunotherapy Strategy
Atara Off-the-Shelf, Allogeneic CAR T Immunotherapy Strategy Invest in world-class T-cell manufacturing Leverage T-cell research, development and regulatory experience Collaborate with academic leaders applying next-gen technologies Rapidly advance autologous CAR T for proof-of-concept followed by o
Slide 56: Exclusive License to Mesothelin-Targeted CAR T 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 Aberrant mesothelin expression promotes cancer cell proliferation and confers resistance to apoptosis Associated with mesothelioma, triple
Slide 57: Atara CAR T Pipeline – Applying Next-Generation Technologies
Atara CAR T Pipeline – Applying Next-Generation Technologies in Collaboration with Academic Leaders AML: acute myeloid leukemia; DNR: Dominant Negative Receptor Worldwide license agreement and research, development and manufacturing collaboration with Bayer to develop Atara’s allogeneic off-the-shel
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