Atara Biotherapeutics, Inc. · NASDAQ:ATRA
Atara Biotherapeutics — Q1 2020 Earnings Presentation
51 slides from Atara Biotherapeutics's earnings presentation, May 6, 2020
Slide 1: Investor Presentation
Doug PTLD champion Investor Presentation May 6, 2020 Nasdaq: ATRA
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 Mission to transform the lives of patients with severe diseases through pioneering science, teamwork and a commitment to excellence Doug PTLD champion Ola PTLD champion Ayden PTLD champion Atara mourns the loss of Jessica, who passed away J
Slide 4: Most Advanced Allogeneic T-cell Company Demonstrating Feasibility of Off-the-Shelf Immunotherapies
Most Advanced Allogeneic T-cell Company Demonstrating the Feasibility of Delivering Off-the-Shelf T-Cell Immunotherapies to Patients • Clinically validated platform with over 300 patients treated • Favorable safety and efficacy profile in EBV-associated diseases Improving based on Atara and academic
Slide 5: Overview of Epstein-Barr Virus (EBV)
Overview of Epstein-Barr Virus (EBV) (1) Background EBV-associated diseases Present in >95% of individuals Infectious mononucleosis (mono) by age 40 Post transplant lymphoproliferative Persistent lifelong, disease (PTLD) asymptomatic infection — Other hematologic malignancies: Infects B ce
Slide 6: EBV T cells are Alpha Beta T cells that Offer Numerous Advantages
EBV T cells are Alpha Beta T cells that Offer Numerous Advantages as the Basis of an Allogeneic Platform SAFETY SAFETY Reduced ability to harm normal cells (GvHD) EXPANSION EXPANSION Proliferation with memory phenotype TRAFFICKING Homing and penetrating target lesions including solid tumors CYTOTOXI
Slide 7: Atara Allogeneic Platform Maintains the Natural Biology of EBV T cells
Atara Allogeneic Platform Maintains the Natural Biology of EBV T cells By Selecting the Most Appropriate HLA Alleles for a Patient We select product from inventory that shares a EBV TCR minimum of two HLA alleles with the patient — For EBV-associated diseases, one of the alleles must be the restri
Slide 8: Platform Can Treat a Wide Range of EBV-Associated Diseases or Tumors
Atara Allogeneic Platform Has the Capability to Treat a Wide Range of EBV-Associated Diseases or Hematological / Solid Tumors Through an Engineered CAR or TCR EBV-associated Diseases Other Hematological or Solid Tumors EBV TCR EBV TCR CAR HLA HLA ATA3219 (Allo CD19) Tab-cel® ATA3271 (Allo MSLN
Slide 9: Atara Off-the-Shelf, Allogeneic EBV T-Cell Platform
Atara Off-the-Shelf, Allogeneic EBV T-Cell Platform SAFETY • Ability to modify with engineered CAR or TCR EXPANSION • Retreatment capability • Scalable bioreactor manufacturing • Proprietary cell selection and logistics • Delivery to patient from inventory within 3 days • Global development & regula
Slide 10: Four Strategic Priorities to Create Value
Four Strategic Priorities to Create Value Tab-cel® (tabelecleucel) ATA188 ATA2271 ATA3219 ATA3271 10
Slide 11: Robust T-Cell Immunotherapy Pipeline
Robust T-Cell Immunotherapy Pipeline Program Indication Target Preclinical Phase 1 Phase 2 Phase 3 Registration RR EBV+ PTLD following HCT EBV ALLELE Study RR EBV+ PTLD following SOT EBV ALLELE Study Tab-cel® (tabelecleucel) Nasopharyngeal carcinoma(1) EBV EBV+ cancers(2) EBV ATA188 Progressive MS E
Slide 12: Four Strategic Priorities to Create Value: Tab-cel
Four Strategic Priorities to Create Value Tab-cel® (tabelecleucel) Investigational T-cell immunotherapy for EBV-associated ultra-rare diseases FDA breakthrough designation & EMA PRIME for EBV+ PTLD ATA188 ATA2271 ATA3219 ATA3271 12
Slide 13: EBV-Associated PTLD: Aggressive, Often Deadly Cancer with No Approved Therapy
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 14: 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 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 15: Tab-cel – Ongoing Studies for Patients with EBV+ PTLD
Tab-cel® – Ongoing Studies for Patients with EBV+ PTLD Phase 2 and EAP ORR(1) Updated protocol for ongoing Phase 3 study(2) for EBV+ PTLD patients who failed rituximab — Global, multicenter, open-label 82% — Single Phase 3 study with two EBV+ PTLD patient cohorts (HCT and SOT) 69% — Approximately
Slide 16: 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) 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 17: Proprietary Algorithm Used to Select Tab-cel from Inventory
Proprietary Algorithm Used to Select Tab-cel® from Inventory for Each Patient Based on Appropriate HLA Restriction and Allele RECOGNITION NO RECOGNITION NO RECOGNITION HLA and Antigen Match HLA Restriction Mismatch Antigen Restriction Mismatch T cell T cell T cell TCR TCR TCR EBV EBV Non- HLA HLA HL
Slide 18: EBV+ PTLD – Attractive Ultra-Rare Disease Market
EBV+ PTLD – Attractive Ultra-Rare Disease Market Estimated Incidence in the U.S. in 2018(1) PTLD incidence Low single digits(2) Relapsed/refractory 40%-60% ~46,000 Allogeneic Several hundred transplants EBV+ PTLD patients SOT HCT who have failed ~75% ~25% rituximab ± chemo EBV+ HCT: ~100% SOT: ~60%
Slide 19: Tab-cel – Compelling Value Proposition for Patients and Healthcare System
Tab-cel® – Compelling Value Proposition for EBV+ PTLD Patients and Healthcare System 50%-82% ORR High and durable Few treatment- No CRS >80% survival at treatment related serious observed 2 years in responders effect(1) adverse No treatment- No approved treatment events(1) related mortality Providin
Slide 20: Attractive Future Tab-cel Commercial Opportunity
Attractive Future Tab-cel® Commercial Opportunity Despite Current Clinical Study Constraints CLINICAL COMMERCIAL Potential transformative profile supports PTLD is an ultra-rare disease compelling value proposition Clinical study available at Expect ability to deliver to patients in ~10% of US transp
Slide 21: Tab-cel – EBV-Associated Metastatic Nasopharyngeal Carcinoma
Tab-cel® – EBV-Associated Metastatic Nasopharyngeal Carcinoma (EBV+ NPC) Head & neck solid tumor that is primarily EBV-associated No approved targeted agents Standard treatment: platinum-based chemo ± targeted therapy 5-11 months median overall survival with standard treatment(1) Encouraging tab-c
Slide 22: Tab-cel – NPC Incidence in US, EU5 and East Asia
Tab-cel® – NPC Incidence in US, EU5 and East Asia(1) Higher NPC Ultra-rare incidence disease in in East Asia US and EU5(2) ~71,000 patients ~3,800 patients Vast majority in China Ongoing Phase 1b/2 study in platinum pre-treated, recurrent/metastatic (2L+) EBV+ NPC patient subpopulation (1) Est
Slide 23: Tab-cel – Addressing Other Ultra-Rare EBV-Associated Patient Populations
Tab-cel® – Addressing Other Ultra-Rare EBV-Associated Patient Populations in High Need In immunocompromised patients EBV can cause lymphoproliferative disorders (LPD) — Heterogenous group of ultra-rare diseases — Many patients have a poor prognosis and limited treatment options Phase 2 multi-cohort
Slide 24: Tab-cel – Ultra-Rare Disease Pipeline in a Product
Tab-cel® – Ultra-Rare Disease Pipeline in a Product EBV+ PTLD Phase 3 study with HCT & SOT cohorts ongoing EBV+ NPC Phase 1b/2 with KEYTRUDA® ongoing(1) EBV+ cancers Phase 2 multi-cohort study planned(2) (1) Phase 1b/2 study in combination with anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patien
Slide 25: Four Strategic Priorities to Create Value: ATA188
Four Strategic Priorities to Create Value ATA188 ATA2271 ATA3219 ATA3271 EBV T-cell immunotherapy for progressive multiple sclerosis (MS) 25
Slide 26: What is ATA188?
What is ATA188? ATA188 is an off-the-shelf, allogeneic, EBV T-cell immunotherapy being studied in a Phase 1 clinical trial in progressive forms of MS Off-the-shelf T No Precision Two-hour Administered cells delivered pretreatment targeting to monitoring as an from required in the select EBV followin
Slide 27: High Unmet Need Remains for Patients with Progressive MS
High Unmet Need Remains for Patients with Progressive MS ~43% of MS patients have a progressive Global MS Patients (as of 2017) form of the disease (PMS) ~80% of patients initially diagnosed with relapsing remitting MS (RRMS) are expected to transition to secondary progressive MS (SPMS) PPMS 15%
Slide 28: Non-Specific B Cell Depletion Treatment in Progressive MS
Non-Specific B Cell Depletion Treatment in Progressive MS: Slows Disability Progression, but Does Not Improve Clinical Symptoms Ocrelizumab Phase 3 PPMS study(1) Cumulative probability of 24-week disability progression (%) PPMS: Primary Progressive Multiple Sclerosis (1) Montalban et al. Ocrelizumab
Slide 29: A Novel Approach for Progressive MS: Allogeneic T-Cell Immunotherapy Targeting EBV-Infected B Cells
A Novel Approach for Progressive MS: Off-the-Shelf, Allogeneic T-Cell Immunotherapy Targeting EBV-Infected B Cells ATA188 off-the-shelf, allogeneic Phase 1a dose-escalation study ongoing(1) • First patients retreated in the open label extension (OLE) portion of the Phase 1a study Cohort 3 dose selec
Slide 30: Growing Evidence that EBV Has a Major Role in MS Pathogenesis
Growing Evidence that EBV Has a Major Role in the Pathogenesis of Multiple Sclerosis • Prior EBV infection is required for a patient to develop MS 1 Health CD8+ T-Cell Function • MS may be mediated by B cells that are infected with EBV 2 Relapsing MS • As MS progresses, patient’s ability to mount ce
Slide 31: 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. 31
Slide 32: Optimal Characteristics of a Progressive MS Treatment
Optimal Characteristics of a Progressive MS Treatment Well-tolerated Reverses Penetrates Targets Addresses disability CNS specific underlying progression B cells and biology plasma cells 32
Slide 33: ATA188: Early Findings of Potential Efficacy from Phase 1 Study
ATA188: Early Findings of Potential Efficacy from Phase 1 Study in Patients with Progressive MS Presented at ECTRIMS 2019 Part 1 Study Schema PRIMARY ENDPOINTS DOSE-ESCALATION (Year 1) DLT Safety and identification of the 4 Cohorts, N = 6 per cohort Assessment recommended Phase 2 dose DLT (35 Days)
Slide 34: Definition of Outcome Criteria (Clinical Response)
Definition of Outcome Criteria (Clinical Response) Clinical Improvement1 Clinical Efficacy Criteria assessment with clinically significant improvement Partial Clinical Improvement2 Outcome Fatigue MS Impact Scale-29 T25FW5 9-hole peg test Criteria Severity Score (physical) -20% -20% -0.7 -8 Stable3
Slide 35: Phase 1 Study of ATA188 for Treatment of Progressive MS
Phase 1 Study of ATA188, an Allogeneic EBV-Targeted T-Cell Therapy for the Treatment of Progressive MS Part 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 1 (35 Days) Cohort 4 O
Slide 36: ATA188 Phase 1b Randomized, Placebo-Controlled Study
We Also Initiated the ATA188 Phase 1b Randomized, Placebo- Controlled Study in at Least 36 Progressive MS Patients Part 2 Study Schema DOUBLE-BLIND PERIOD OPEN-LABEL ENDPOINTS (Years 1 and 2) EXTENSION (Years 3‒5) CSF, blood – IgG, oligoclonal bands, ATA188 2 years of RNAseq, NFL R Dose (N=20) ATA
Slide 37: Four Strategic Priorities to Create Value: Mesothelin CAR T
Four Strategic Priorities to Create Value ATA2271 ATA3219 ATA3271 Mesothelin CAR T for solid tumors 37
Slide 38: Exclusive License to Mesothelin-Targeted CAR T Immunotherapy 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 39: ATA2271 – Developing Autologous Mesothelin-Targeted CAR T Program
ATA2271 – Developing Autologous Mesothelin-Targeted CAR T Program in Solid Tumors with Partners at MSK Mesothelin is an attractive target associated with aggressive solid tumors that is supported by academic data MSLN ScFv Maintains ScFv that binds to mesothelin above cancer threshold Incorpor
Slide 40: Four Strategic Priorities to Create Value: ATA3219
Four Strategic Priorities to Create Value ATA3219 EBV CD19 CAR T Off-the-shelf, allogeneic platform clinical proof-of-concept 40
Slide 41: ATA3219 – Off-the-Shelf, Allogeneic CD19 CAR T Platform
ATA3219 – Off-the-Shelf, Allogeneic CD19 CAR T Platform 1 Off-the-shelf, allogeneic EBV T cell platform 2 Next-generation 3 Off-the-shelf CAR T CAR technologies with broad applications EBV EBV TCR TCR CD19 ScFv HLA HLA Novel 1XX costimulatory domain 41
Slide 42: Academic Allogeneic EBV CD19 CAR T Clinical Proof-of-Principle
Academic Off-the-Shelf, Allogeneic EBV CD19 CAR T Clinical Proof-of-Principle for Patients with R/R B-Cell Malignancies EBV T-cell platform has potential to generate off-the-shelf, allogeneic CAR T with high and durable EBV TCR responses with low risk of toxicity(1) CD19 Durable CR with median f
Slide 43: Atara Development of Off-the-Shelf, Allogeneic EBV CAR T
Atara Development of Off-the-Shelf, Allogeneic EBV CAR T Autologous – Mesothelin CAR T Clinical Proof-of-Concept MSLN ScFv MSLN ScFv Off-the-shelf, allogeneic EBV Mesothelin CAR T MSLN EBV ScFv TCR CD28 costimulatory 1XX costimulatory domain domain + PD-1 DNR MSK MSLN CAR T ATA2271 (NCT02414269, NCT
Slide 44: 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 45: Atara CAR T Pipeline – Applying Next-Generation Technologies
Atara CAR T Pipeline – Applying Next-Generation Technologies in Collaboration with Academic Leaders Indication Target CAR T Technologies Autologous PD-1 DNR ATA2271 Solid tumors(1) Mesothelin 1XX co-stimulation Off-the-shelf, allogeneic PD-1 DNR ATA3271 Solid tumors(1) Mesothelin 1XX co-stimulation
Slide 46: Dedicated State-of-the-Art T-Cell Manufacturing Capacity
Dedicated State-of-the-Art T-Cell Manufacturing Capacity Dedicated, expandable T-cell manufacturing facility in Thousand Oaks, CA Flexibility to produce multiple T-cell and CAR T immunotherapies Highly integrated cross-functional CMC support to enable rapid development Designed to meet globa
Slide 47: Scalable EBV T-Cell Manufacturing
Scalable EBV T-Cell Manufacturing Single EBV+ donor leukopak yields approximately 400 tab-cel® doses(1) HETEROGENEOUS DONOR T CELLS EBV T CELL SELECTION AND EXPANSION EBV+ donor leukapheresis includes small T cells exposed to cells that present EBV antigens, population of T cells with EBV-specific T
Slide 48: Design Principles of Allogeneic Manufacturing Platform Ahead of Tab-cel Launch
The Design Principles Built Into Our Allogeneic Manufacturing ® Platform Serve Us Well As We Approach Tab-cel Commercial Launch Efficient Manufacturing We can serve >95% of patient population with ~40 strategically selected cell lines Our manufacturing process is robust Flexible Supply Chain A
Slide 49: Potential to Transform the Lives of Patients with Serious Diseases
Potential to Transform the Lives of Patients with Serious Diseases Tab-cel® ATA188 ATA2271 ATA3219 (tabelecleucel) ATA3271 SAFETY TRAFFICKING PERSISTENCE EXPANSION CYTOTOXICITY EBV T CELL PLATFORM 49
Slide 50: Multiple Key Milestones Expected in 2020
Multiple Key Milestones Expected in 2020 Submitted clinical trial applications (CTA) to several European countries to enable opening EU clinical sites in 2020 Nov 2019 Tab-cel® Begin enrollment in a Phase 2 multi-cohort study including patients with other EBV+ cancers H2 2020 (tabelecleucel) Initiat
Slide 51: Thank you
Nasdaq: ATRA Thank you Ola PTLD champion
Atara Biotherapeutics — Q1 2020 Earnings Presentation on 6ix