Atara Biotherapeutics, Inc. · NASDAQ:ATRA
Atara Biotherapeutics — Q1 2019 Earnings Presentation
33 slides from Atara Biotherapeutics's earnings presentation, May 9, 2019
Slide 1: Investor Presentation
Ola EBV+ PTLD survivor Investor Presentation May 9, 2019 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: Strong Recent Execution on Our Objectives
Strong Recent Execution on Our Objectives Two Phase 3 studies for patients with EBV-associated post-transplant lymphoproliferative disorder (PTLD) ongoing Tab-cel® Phase 1b/2 study in combination with KEYTRUDA® for patients with EBV- associated nasopharyngeal carcinoma (NPC) enrolling Next-gen
Slide 4: Innovative Off-the-Shelf, Allogeneic T-Cell Platform
Innovative Off-the-Shelf, Allogeneic T-Cell Platform EBV-specific T cells from healthy donors Next-generation CAR T technologies State-of-the-art T-cell manufacturing Atara MatchMeTM HLA matching and logistics 4
Slide 5: State-of-the-Art T-Cell Manufacturing
State-of-the-Art T-Cell Manufacturing Dedicated, expandable ATOM (Atara T-cell Operations & Manufacturing) facility in Thousand Oaks, CA Flexibility to produce multiple T-cell and CAR T immunotherapies Integrated research and process science to enable rapid development and leverage research co
Slide 6: Three major near-term value creation opportunities
Pioneering Off-the-Shelf, Allogeneic T-Cell Immunotherapies Three major near-term value creation opportunities Tab-cel® Multiple Next-gen (tabelecleucel) sclerosis CAR T 6
Slide 7: Robust T-Cell Immunotherapy Pipeline
Robust T-Cell Immunotherapy Pipeline Indication/Program Target Preclinical Phase 1 Phase 2 Phase 3 Registration RR EBV+ PTLD following HCT EBV MATCH RR EBV+ PTLD following SOT EBV ALLELE Tab-cel® (tabelecleucel) Nasopharyngeal carcinoma(1) EBV EBV+ cancers(2) EBV Autologous Multiple ATA190: Progress
Slide 8: Tab-cel (tabelecleucel)
Pioneering Off-the-Shelf, Allogeneic T-Cell Immunotherapies Three major near-term value creation opportunities Tab-cel® Multiple Next-generation (tabelecleucel) sclerosis CAR T EBV-associated cancers Developing first Mesothelin-targeted T-cell immunotherapy in CAR T immunotherapy FDA breakthrough au
Slide 9: Epstein-Barr Virus (EBV) – The Original Oncovirus
Epstein-Barr Virus (EBV) – The Original Oncovirus Background EBV-associated diseases Present in >95% of individuals Infectious mononucleosis (mono) by age 40 Post transplant lymphoproliferative Persistent lifelong, disorder (PTLD) asymptomatic infection — Other hematologic malignancies: PID/
Slide 10: EBV-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD)
EBV-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) Rare B-cell lymphoma that occurs in immunosuppressed patients after transplant Aggressive cancer that often rapidly progresses to death after diagnosis — Bone marrow transplant (HCT) post-transplant risk up to recovery of immun
Slide 11: Potential to Transform Treatment of Rituximab Relapsed/Refractory EBV+ PTLD
Potential to Transform Treatment of Rituximab Relapsed/Refractory 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 decrease of response (CR) diagnos
Slide 12: Tab-cel – Off-the-Shelf, Allogeneic T-Cell Immunotherapy
Tab-cel® – Off-the-Shelf, Allogeneic T-Cell Immunotherapy with Potential Compelling Therapeutic Advantages Available in No Specific Two-hour ~3 days pretreatment EBV targeting monitoring with T cells required to limit off- following delivered from tumor toxicity 5-10 minute inventory IV infusion 12
Slide 13: Tab-cel Multicenter EAP Results for Patients with EBV+ PTLD
Tab-cel® Multicenter EAP Results for Patients with EBV+ PTLD Observed overall response rates for patients who failed rituximab(1) 80% 83% Phase 3 design(2) — Global, multicenter, open-label — 35 patients per indication 37% ORR – primary Phase 3 endpoint threshold(3) N=5 N=6 HCT SOT EAP: Expanded A
Slide 14: Tab-cel Phase 2 Study Positive Long-Term Outcomes for Patients with EBV+ PTLD
Tab-cel® Phase 2 Study Positive Long-Term Outcomes for Patients with EBV+ PTLD 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=87.5% 1.0 Resp
Slide 15: Tab-cel – Compelling EBV+ PTLD Value Proposition
Tab-cel® – Compelling EBV+ PTLD Value Proposition High and durable Off-the-shelf response data(1) Few Cost- treatment- effective related therapy(2) serious events 10%-15% pediatric Low cost of population administration Potential to minimize Repeat (1) Prockop S, et al., Proc ASCO 2015 risk of graft
Slide 16: Tab-cel for EBV-Associated Metastatic Nasopharyngeal Carcinoma (EBV+ NPC)
Tab-cel® for EBV-Associated Metastatic Nasopharyngeal Carcinoma (EBV+ NPC) Head & neck cancer 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-cel®
Slide 17: Tab-cel – Pipeline in a Product
Tab-cel® – Pipeline in a Product EBV+ PTLD Submit EU CMA application in 2020 EBV+ NPC Phase 1b/2 with KEYTRUDA® enrolling EBV+ cancers Phase 2 multi-cohort study planned CMA: conditional marketing authorization 17
Slide 18: Multiple sclerosis
Pioneering Off-the-Shelf, Allogeneic T-Cell Immunotherapies Three major near-term value creation opportunities Multiple Next-generation sclerosis CAR T Developing first Mesothelin-targeted T-cell immunotherapy in CAR T immunotherapy autoimmune disease for solid tumors Off-the-shelf, allogeneic platf
Slide 19: 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 Loss of EBV-specific CD8+ T-cell function correlates with MS disease progression1-4 Increased Walking aid 0.0 limitation in (1 side) required 1.0 walking ability 2.0 Restricted to Bedridden wheelchair Normal 3.0 neu
Slide 20: B-Cell Targeted Treatment for Progressive MS: Major Achievement, Slows Disability Progression
B-Cell Targeted Treatment for Progressive MS: Major Achievement, Slows Disability Progression Ocrelizumab Phase 3 PPMS study(1) Cumulative probability of 24-week disability progression (%) 10%-15% of PPMS patients expected to have worsening of EDSS at 24 weeks PPMS: Primary Progressive Multiple Scle
Slide 21: Autologous ATA190 Demonstrated Encouraging Results in Patients with Progressive MS
Autologous ATA190 Demonstrated Encouraging Results in 10 Patients with Progressive MS 26 weeks: 6 weeks of treatment and 20 weeks of F/U(1) Patients Well experienced Strong ATA190 Encouraging tolerated improvement EBV reactivity EDSS results 10 7 6 3 Patients with Patients Patients received Patients
Slide 22: Off-the-shelf, Allogeneic ATA188 Phase 1 Study Design for Patients with Progressive MS
Off-the-shelf, Allogeneic ATA188 Phase 1 Study Design for Patients with Progressive MS Multicenter, open-label study ongoing in the U.S. and Australia Objectives Enrollment Treatment Endpoints Safety and 24-30 SPMS and Progressive Safety tolerability PPMS patients dose cohorts EDSS(2) Cl
Slide 23: Realizing the Potential of EBV-Targeted T-Cell Immunotherapy for Multiple Sclerosis
Realizing the Potential of EBV-Targeted T-Cell Immunotherapy for Multiple Sclerosis ATA190 autologous Randomized Phase 2 study to start in H2 2019 ATA188 off-the-shelf, allogeneic Initial safety results at EAN 2019; Additional safety and efficacy results in H2 2019 EAN 2019: 5th Congress of the Euro
Slide 24: Next-generation CAR T
Pioneering Off-the-Shelf, Allogeneic T-Cell Immunotherapies Three major near-term value creation opportunities Next-generation CAR T Mesothelin-targeted CAR T immunotherapy for solid tumors Off-the-shelf, allogeneic platform 24
Slide 25: Atara's Next-Generation CAR T Immunotherapy Strategy
Atara’s Next-Generation CAR T Immunotherapy Strategy Collaborate with academic leaders applying Invest next-gen in world-class T-cell Rapidly advance technologies manufacturing CAR T programs using established targets Leverage with clinical T-cell research, development proof-of-concept and regulator
Slide 26: Advantages of EBV-Specific T-Cell Immunotherapy Platform
Advantages of EBV-Specific T-Cell Immunotherapy Platform EBV present in >95% of individuals by age 40 TCR – Implicated in a wide range of cancers and autoimmune diseases – EBV-specific T cells sourced from established healthy donor networks No gene editing or HLA edits required HLA – Maintaining
Slide 27: Atara Next-Generation and Off-the-Shelf, Allogeneic CAR T Approach
Atara Next-Generation and Off-the-Shelf, Allogeneic CAR T Approach 1 EBV-specific off-the-shelf, allogeneic T cell platform 2 Next-generation 3 Off-the-shelf CAR T CAR technologies with broad applications 27
Slide 28: Next-Generation CAR T Oncology Pipeline Expanding with Novel Technology Collaborations
Next-Generation CAR T Oncology Pipeline Expanding with Novel Technology Collaborations Program Indication Target CAR T Technologies Collaborator PD-1 DNR ATA2271 Solid tumors(1) Mesothelin Novel 1XX co-stimulation Autologous(2) Dual-targeted Novel co-stimulation ATA2321 AML undisclosed Autologous(2)
Slide 29: 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 30: Prioritized Mesothelin-Targeted Next-Generation CAR T Program
Prioritized Mesothelin-Targeted Next-Generation CAR T Program Additional MSK Phase 1 Results to be Presented at ASCO 2019 Positive AACR 2019 results from ongoing MSK Phase 1 study for mesothelin-targeted CAR T 11 malignant pleural mesothelioma patients treated following preconditioning cyclophos
Slide 31: Multiple Key Milestones Expected
Multiple Key Milestones Expected FDA and EMA regulatory discussions to align on a global regulatory strategy for patients with EBV+ PTLD H1 2019 Tab-cel® (tabelecleucel) EU conditional marketing authorization submission planned 2020 for patients with EBV+ PTLD who failed first-line therapy Initial s
Slide 32: Potential to Transform the Lives of Patients with Serious Diseases
Potential to transform the Lives of Patients with Serious Diseases Tab-cel® Multiple Next-generation (tabelecleucel) sclerosis CAR T Pioneering off-the-shelf, allogeneic T-cell immunotherapies Leading academic collaborations & cutting-edge technologies World-class T-cell manufacturing 32
Slide 33: Thank you
Nasdaq: ATRA Thank you Ayden EBV+ PTLD survivor 33
Atara Biotherapeutics — Q1 2019 Earnings Presentation on 6ix