Gilead Sciences, Inc. · NASDAQ:GILD
Gilead Sciences — Investor Day (March 2024)
88 slides from Gilead Sciences's investor day presentation, Mar 14, 2024
Slide 1: Kite Cell Therapy Analyst & Investor Event
Kite Cell Therapy Analyst & Investor Event 14 March 2024 FOR INVESTOR USE ONLY; NOT FOR PROMOTIONAL USE
Slide 2: Forward-Looking Statements
Forward-Looking Statements Statements included in this presentation that are not historical in nature are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Gilead cautions readers that forward-looking statements are subject to certain risks and un
Slide 3: Patient quote: Having an incurable cancer
“Having an incurable cancer, you think about it every day.” Laurie, diagnosed with non- Hodgkin lymphoma
Slide 4: Welcome to Kite
Welcome to Kite C i n d y Pe r e t t i e EVP & Head of Kite
Slide 5: Kite Analyst Event: Global Leader in Cell Therapy
Kite Analyst Event: Global Leader in Cell Therapy • Building best-in-class commercial capabilities and extending leadership • Driving differentiation vs in-class and out-of-class competitors Leading Commercial Execution • Building class share with ATC growth & innovative model of community expansion
Slide 6: Initial Impressions – Fall 2023
Initial Impressions – Fall 2023 Commercial Manufacturing Broad Pipeline Execution Excellence Key Opportunities 1 2 3 4 5 Cell Therapy Academic & Multiple Cell Therapy Research & Class Share Community Setting Myeloma Beyond Oncology Translational Science Reinforce Robust, Deepen & Expand Develop & La
Slide 7: Setting the Standard for Cell Therapy
Setting the Standard for Cell Therapy Manufacturing and Specialized Clinical Internal T-Cell Market Presence Supply Chain Development Expertise Excellence Investment Investment Investment Investment ATC network and commercial Four commercial Strategically designed studies The largest clinical and re
Slide 8: Continued Cell Therapy Leadership Ambitions
Continued Cell Therapy Leadership Ambitions 30+ Countries 15+ 40%+ Indications Class Share2 150K+ 3-day Patients Manufacturing Treated1 TAT 1. Of hematologic cancers 2. Of eligible population using CAR T-cell therapy. Increase curative potential to reach more eligible patients 8
Slide 9: Advancing Portfolio into $40B+ Markets
Advancing Portfolio into $40B+ Markets Kite Sales $1.9B Future Cell Therapy Market Potential1 $1.5B Multiple Myeloma Lymphoma & Leukemia $10B - $12B $15B - $20B $0.9B $0.6B Autoimmune Solid Tumors $15B - $20B 1. 2034 estimate. 2020 2021 2022 2023 Significant market opportunities across existing & fu
Slide 10: Strategic Priorities to Deliver on Ambitions
Strategic Priorities to Deliver on Ambitions Grow Kite’s Best-in- Capitalize on Kite’s Position Kite for Deploy a Class Autologous CAR T Leadership in Next Gen Auto and Fit-for-Purpose Platform Clinically Ready Areas Potential Pivots Organization Increase Healthcare Next Gen Lymphoma, Examples Inclu
Slide 11: Agenda
Agenda Morning Session – 10:00 am – 12:45 pm Speakers Welcome C i n d y Pe r e t t i e Commercial Execution EVP & Head of Kite Manufacturing Excellence Warner Biddle Site Tour SVP Global Head of Commercial Lunch – 12:45 pm Chris McDonald S V P G l o b a l H e a d o f Te c h n i c a l O p e r a t i o
Slide 12: Leading Commercial Execution
Leading Commercial Execution Warner Biddle S V P, G l o b a l H e a d o f Commercial
Slide 13: Kite Analyst Event: Global Leader in Cell Therapy
Commercial Leadership Kite Analyst Event: Global Leader in Cell Therapy • Building best-in-class commercial capabilities and extending leadership • Driving differentiation vs in-class and out-of-class competitors Leading Commercial Execution • Building class share with ATC growth & innovative model
Slide 14: Strong Track Record of CAR T Leadership
Commercial Leadership Strong Track Record of CAR T Leadership Cell Therapy Revenues ($M) $1,869 $156 Strong FY23 Growth 19,500+ Patients of 28% YoY $1,459 $60 $658 5 Indications $430 Global Presence in 25+ Countries $871 $36 Leading Brand Share $607 $293 $10 $456 $1,055 $83 $201 $968 Broad Global AT
Slide 15: Core Kite Strengths Supporting Growth
Commercial Leadership Core Kite Strengths Supporting Growth Strength of Comprehensive Manufacturing our Data Network Excellence • OS benefit seen across 2L • Highly rated field teams for • 96% manufacturing & 3L+ LBCL customer experience success rate • Depth of data from 19.5K • Kite Konnect portal
Slide 16: Significant Untapped Potential in Key Markets
Commercial Leadership Significant Untapped Potential in Key Markets 2L+ LBCL1 3L+ LBCL1 Opportunities to Drive Market Growth U.S. Europe2, 3 • Expand ATC capacity • Drive community referrals • Differentiate from out-of-class entrants, CAR T Non-CAR T CAR T Non-CAR T including those without OS data (
Slide 17: Global Commercial Strategy To Extend Kite’s Leadership
Commercial Leadership Global Commercial Strategy To Extend Kite’s Leadership Drive differentiation Grow class globally by Expand access and Create scalable based on the only in- getting treatment demonstrate value of CAR capabilities for future class CAR T with OS closer to the patient T across heal
Slide 18: Compelling Yescarta Differentiation
Commercial Leadership Compelling Yescarta Differentiation Positioning vs. In-class CAR T Yescarta has unmatched survival, combined with Only Yescarta demonstrates statistically excellence in CAR T-cell therapy manufacturing significant OS vs. Salvage ± HDCT + ASCT & delivery in 2L LBCL 43% patients
Slide 19: Complex Treatment Pathway Impacts Patient Access
Commercial Leadership Complex Treatment Pathway Impacts Patient Access 1 2 3 4 Eligibility Eligibility LBCL Diagnosis Recommendation Determination – Determination – & 1L treatment for Consult Clinical Financial 5 6 7 8 Follow-up Check-ins Treatment Apheresis & Cell Infusion with Patient/Caregiver Se
Slide 20: Treatment Closer to Patients Enables Broader Adoption
Commercial Leadership Treatment Closer to Patients Enables Broader Adoption Current Future Pursue individual ATC expansion Connect ATC satellite networks Individual Community 25+ 135+ 285+ treaters and connection Countries Sites in the U.S. Sites ex-U.S. to local hospitals 20
Slide 21: Significant Potential to Reach Many More Patients
Commercial Leadership Significant Potential to Reach Many More Patients Of Every 100 Lymphoma Patients 80 20 Community Academic Not Referred Not Referred Referred 35 15 30 20 50 20 Remains in Community ATC Satellites Community Referrals ATC Academic Not Treated with CAR T Not Referred to ATC Treater
Slide 22: Expanding Across the U.S. Treatment Network
Commercial Leadership Expanding Across the U.S. Treatment Network Existing ATCs (Academic & Large Hospitals) 2L+ LBCL 50% • Winning treatment decision for 20% of patients who Patients are with an active CAR T treater At the ATC 35% • Expanding capacity in existing ATCs Not Referred • Educating Lymph
Slide 23: Expanding Across the U.S. Treatment Network
Commercial Leadership Expanding Across the U.S. Treatment Network Existing ATCs (Academic & Large Hospitals) 2L+ LBCL 50% • Winning treatment decision for 20% of patients who Patients are with an active CAR T treater At the ATC 35% • Expanding capacity in existing ATCs Not Referred • Educating Lymph
Slide 24: Multi-Step Process to Establish Community ATCs
Commercial Leadership Multi-Step Process to Establish Community ATCs Steps to Authorization Authorized 1 2 3 4 5 6 7 ATC Clinical & CAR T Clinical Quality Apheresis Hospital Cell Storage Dry Run Admin Program Audit Partner Partner Capability Mock patient Champion Development Kite review Cell collect
Slide 25: Onboarding a Flagship Community Practice: Learnings
Commercial Leadership Onboarding a Flagship Community Practice: Learnings Sept 2023 Oct 2023 Jan 2024 Feb 2024 Authorized ATC Kite CAR T Clinical Apheresis Cell Storage Hospital Partner Program Development Partner Capability Observations & Expectations What Kite is Doing Motivation in the community
Slide 26: Diverse U.S. Treatment Settings Create Complexity
Commercial Leadership Diverse U.S. Treatment Settings Create Complexity Pre-Infusion Infusion Post-Infusion CAR T Lymphodepleting Infusion Day +30 Evaluation Leukapheresis Day +30 Referral Chemotherapy (Day 0) FACT Accredited ATC Place of Care ATC Payment model Commercial Payers: Single Case Agreeme
Slide 27: Kite Products Now Reimbursed in >25 Countries
Commercial Leadership Kite Products Now Reimbursed in >25 Countries Europe North America Austria Luxembourg Canada Belgium Netherlands United States Asia Czech Republic Norway Israel Denmark Poland Japan England & Wales Portugal Saudi Arabia Finland Scotland South America France Slovakia Australia G
Slide 28: Compelling Cost Effectiveness & Value
Commercial Leadership Compelling Cost Effectiveness & Value Cost/QALY1 • Growing recognition by HTAs and other payer decision makers (e.g., NICE, ICER) that $150,000 $150,000 Yescarta is cost-effective in 2L LBCL • From a U.S. commercial payer perspective, Yescarta demonstrated cost-effectiveness vs
Slide 29: Industry Leading Patient Access & Support Programs
Commercial Leadership Industry Leading Patient Access & Support Programs Find a Treatment Patient Reimbursement Logistics Ongoing Center Enrollment Support Support Commitment Provide patients Register a patient Help with benefits Patients can learn Kite Konnect® Case and healthcare for therapy inves
Slide 30: Fostering A Strong External Ecosystem
Commercial Leadership Fostering A Strong External Ecosystem Help Educate, Engage, and Empower Patients and HCPs 30
Slide 31: Commercial Strategy to Extend Kite's Leadership
Commercial Leadership Commercial Strategy to Extend Kite's Leadership Differentiate & win the treatment decision Grow class & bring CAR T closer to patients 1 • Convert remaining eligible SCT and other modalities • Onboard Community ATCs to reach more patients 2 • Unlock eligible patients at existin
Slide 32: Setting the Industry Manufacturing Standard
Setting the Industry Manufacturing Standard Chris McDonald S V P, G l o b a l H e a d o f Te c h n i c a l O p e r a t i o n s
Slide 33: Kite Analyst Event: Global Leader in Cell Therapy
Best-in-class Manufacturing Kite Analyst Event: Global Leader in Cell Therapy • Building best-in-class commercial capabilities and extending leadership • Driving differentiation vs in-class and out-of-class competitors Leading Commercial Execution • Building class share with ATC growth & innovative
Slide 34: Global Leader in Cell Therapy Manufacturing
Best-in-class Manufacturing Global Leader in Cell Therapy Manufacturing 19,500+ 96% patients treated (clinical trials and success in manufacturing with commercial products) CAR T Cells 14-day >24K median turnaround time in the U.S. for Yescarta manufacturing capacity by 2026 7 days a week >1M aphere
Slide 35: CAR T Manufacturing is Fundamentally Different
Best-in-class Manufacturing CAR T Manufacturing is Fundamentally Different Traditional Manufacturing CAR T-cell Therapies Manufacturing Inherent variability Raw starting materials of starting material Complex manufacturing GMP manufacture process In-process and lot Coordination with release testing
Slide 36: Excellence in Technical Operations Core Capabilities
Best-in-class Manufacturing Excellence in Technical Operations Core Capabilities 1 2 3 4 5 CMC Product Product Launch Facility Design Product Exceptional Development & CMC Lifecycle & Build Supply People Advancing a Supporting global Design, build, Globally supply Mission focused, product through co
Slide 37: Kite’s Industry Leading Turnaround
Best-in-class Manufacturing Kite’s Industry Leading Turnaround 14-day median turnaround in the U.S. Start End 1 day 5 days 8 days Collection & Kite Kite Testing & Hospital Transportation Hospital Transportation Manufacturing Release • Patient • Apheresis • Cell Enrichment, • QC Testing • Awaiting •
Slide 38: Opportunities to Deliver Therapies More Efficiently
Best-in-class Manufacturing Opportunities to Deliver Therapies More Efficiently Example Approval of 5-day manufacturing 1 TAT Reduction reduces overall TAT by 2 days in the U.S. for Yescarta Deliver quality, speed & reliability Time to treatment is a critical Manufacturing automation factor for pati
Slide 39: Advancing Towards Full Automation
Best-in-class Manufacturing Advancing Towards Full Automation Example: PBMC enrichment and PBMC seed prep & excess formulation in one Enrichment machine, replacing a manual step Apheresis Available in Isolation Semi-Automated Process Fully-Automated Process Activation Manufacturing Example: One mach
Slide 40: Capacity Expansion to Support Broader CAR T Adoption
Best-in-class Manufacturing Capacity Expansion to Support Broader CAR T Adoption Maryland Semi-automated process – Installed Manufacturing FDA approved site April 2022 Capacity by 2026 >24K • Pre-built clean rooms allow Amsterdam rapid fit out Manual process – moving to • Automation increases capaci
Slide 41: Delivering Consistent Cost Improvements
Best-in-class Manufacturing Delivering Consistent Cost Improvements Kite 2023 Acquisition Increased Volumes 2030 Procurement Efficiencies Automation 2019 ~50% Reduction Global Rapid Manufacturing Increased Output Reduce Deviations Operational Excellence Internalize Vector ~25% Planned Reduction1 Red
Slide 42: Rapidly Advancing Plans for Anito-cel Manufacturing
Best-in-class Manufacturing Rapidly Advancing Plans for Anito-cel Manufacturing What’s Next Rapidly completing technology transfer Establish a fully-automated Initiated capital project to install manufacturing process additional manufacturing capacity Develop internal LVV manufacturing process Gener
Slide 43: Maryland: One of Three T-cell Manufacturing Facilities
Best-in-class Manufacturing Maryland: One of Three T-cell Manufacturing Facilities Facility Design Facility Features Capabilities for the Future • Modular Cleanrooms – • Automation Projects & • 75,000 SF Shell Space Ballroom Design Equipment • Additional ~10m investment to • Redundant Utilities – •
Slide 44: Cell Manufacturing
Best-in-class Manufacturing Cell Manufacturing 44
Slide 45: Manufacturing Tour – Key Information
Best-in-class Manufacturing Manufacturing Tour – Key Information Tour Details Staggered tour times, running a new group every few minutes Name badge has your group number Tour guides are standing to the left Please Remember No photography No food or drink Please keep your broader questions for the Q
Slide 46: Agenda
Agenda Morning Session – 10:00 am – 12:45 pm Speakers Welcome C i n d y Pe r e t t i e Commercial EVP & Head of Kite Manufacturing Warner Biddle Site Tour SVP Global Head of Commercial Lunch – 12:45 pm Chris McDonald S V P G l o b a l H e a d o f Te c h n i c a l O p e r a t i o n s Afternoon Sessio
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Slide 48: Investing Today to Maintain Leadership Tomorrow
Investing Today to Maintain Leadership Tomorrow
Slide 49: Multiple Myeloma
Multiple Myeloma Frank Neumann, MD, PhD Warner Biddle S V P, G l o b a l H e a d o f S V P, G l o b a l H e a d o f Clinical Development Commercial
Slide 50: Kite Analyst Event: Global Leader in Cell Therapy
Kite Analyst Event: Global Leader in Cell Therapy • Building best-in-class commercial capabilities and extending leadership • Driving differentiation vs in-class and out-of-class competitors Leading Commercial Execution • Building class share with ATC growth & innovative model of community expansion
Slide 51: Arcellx Partnership Value Drivers and Structure
Multiple Myeloma Expansion Arcellx Partnership Value Drivers and Structure • Global leadership and only vertically • Potential best-in-class, autologous integrated company in cell therapy myeloma asset in anito-cel • Global manufacturing footprint and capacity • Novel binder architecture available f
Slide 52: Anito-cel Advantages Present Substantial Opportunity
Multiple Myeloma Expansion Anito-cel Advantages Present Substantial Opportunity Potential Strong Differentiated Compelling Manufacturing D-Domain Phase 1 Data Best-in-Class Profile and Commercial Expertise Market 1 2 3 3rd Largest Impacts >100,000 Potential ~$12B Blood Cancer Patients Annually1 CAR
Slide 53: D-Domain: Optimized Design for Myeloma Cell Killing
Multiple Myeloma Expansion D-Domain: Optimized Design for Myeloma Cell Killing Small construct facilitates 70% Enables more CAR+ cells within Expression transduction efficiency, higher CAR lower overall dose positivity and density on T-cell surface Rapid D-Domain folding, lack of disulfide Enables s
Slide 54: Anito-cel Phase 1 Data is Compelling
Multiple Myeloma Expansion Anito-cel Phase 1 Data is Compelling Durable Responses Despite High-Risk Factors With Manageable Safety 100% 34% 0 ORR Patients with EMD Delayed Neurotoxicity mPFS, mDOR, and mOS not Demonstrated deep and durable 0% ≥ Gr3 CRS; 1 case Gr 3 ICANS; reached (NR) at 26.5 months
Slide 55: Pivotal iMMagine-1 Study Underway
Multiple Myeloma Expansion Pivotal iMMagine-1 Study Underway 1 PRIMARY ENDPOINT A multicenter, open-label study of anito-cel in Overall Response Rate (ORR) per IMWG criteria by patients with R/R MM Independent Review Committee (IRC) • The primary analysis is planned when all subjects have a minimum
Slide 56: Potential Best-in-Class CAR T in Multiple Myeloma
Multiple Myeloma Expansion Potential Best-in-Class CAR T in Multiple Myeloma Today: Leveraging Kite’s CAR T expertise to position anito-cel for a successful launch DIFFERENTIATED PRODUCT INDUSTRY-LEADING MANUFACTURING Establish anito-cel as the preferred MM therapy due Apply Kite’s capabilities to d
Slide 57: Key Clinical Updates in 2024 and Potential 2026 Launch
Multiple Myeloma Expansion Key Clinical Well-Positioned for Updates in 2024 Potential 2026 Launch • Preliminary readout of pivotal • Leveraging Kite’s world-class iMMagine-1 study in 2H24 manufacturing capabilities • Earlier-line study FPI in 2H24 • Established global commercial footprint 57
Slide 58: Clinical Pipeline
Clinical Pipeline Frank Neumann, MD, PhD S V P, G l o b a l H e a d o f Clinical Development
Slide 59: Advancing Towards Next Gen Kite CAR Technology
Advancing Towards Next Gen Kite CAR Technology K-Gen 1 K-Gen 2 K-Gen 3 K-Gen 4 K-Gen 5 Mono-CAR Bicistronic-CAR Fit-CAR Allogeneic-CAR in vivo-CAR • Transformative in • Multiple antigens • Mono or bicistronic • Readily available • Capable of heme malignancies and 2 costimulatory enriched for product
Slide 60: Durable Responses in Challenging Treatment Paradigms
K-Gen 1: Mono-CAR Durable Responses in Challenging Treatment Paradigms ZUMA-1: 3L+ LBCL ZUMA-7: 2L LBCL ZUMA-12: 1L HR LBCL1 Approved Approved Investigational 43% 55% 81% 5-Year OS 4-Year OS 3-Year OS 92% of study patients alive at 5 First and only therapy of any kind First ever 1L LBCL CAR T-cell t
Slide 61: Durable Survival 5 Years Post-Treatment in 3L+ LBCL
K-Gen 1: Mono-CAR Durable Survival 5 Years Post-Treatment in 3L+ LBCL ZUMA-1: 3L+ LBCL Approved 43% 5-Year OS • 92% of ZUMA-1 study patients alive at 5 years needed no additional cancer treatment after their one- time infusion of Yescarta Source: ASH 2021 (ZUMA-1). Yescarta is the only CAR T with 5-
Slide 62: Shifting the Paradigm in 2L R/R LBCL
K-Gen 1: Mono-CAR Shifting the Paradigm in 2L R/R LBCL ZUMA-7: 2L LBCL Approved 27% >4x • First and largest Phase 3 CAR T RCT in 2L LBCL (ZUMA- 7); the only primary analysis with the longest follow up of 2yrs Reduction in Risk of Death median EFS (OS HR 0.726, p=0.0168) • Met its primary EFS AND OS
Slide 63: Phase 2 Shows Rapid, Durable Responses in 1L HR LBCL
K-Gen 1: Mono-CAR Phase 2 Shows Rapid, Durable Responses in 1L HR LBCL ZUMA-12: 1L HR LBCL Investigational 81% 3-yr OS in Ph2 ZUMA-12 • High rate of rapid and durable responses with 86% complete response (primary endpoint) • 73% of patients remained in response • No new safety signals were observed
Slide 64: Diversified Pipeline Across Diseases & Constructs
Diversified Pipeline Across Diseases & Constructs Pipeline as of March 2024 Autologous Allogeneic Manufacturing Innovation Priorities Asset/Study* Indication Research Preclinical Phase 1 Phase 2/3 Filing Axicabtagene ciloleucel (ZUMA-23) 1L HR LBCL Axicabtagene ciloleucel (ZUMA-24) 2L OPT LBCL Life
Slide 65: Overcoming Resistance Mechanisms in LBCL
K-Gen 2: Bicistronic-CAR Overcoming Resistance Mechanisms in LBCL Potential Benefits: Mechanism of Action – Bicistronic CAR • Bicistronics can target 2 antigens (e.g., CD19 and CD20) simultaneously or individually • Potentially provides deeper, more sustained responses • May prevent CD19 antigen esc
Slide 66: Early KITE-363 Bicistronic Data Encouraging
K-Gen 2: Bicistronic-CAR Early KITE-363 Bicistronic Data Encouraging Enhanced Cell Expansion in Preclinical Study Col: Entering replicate data T cell expansion 35006 • KITE-363 is an investigational autologous 3000 anti-CD19 Yescarta 5e6 CAR-T KITE-363 bicistronic CAR T targeting CD19- and/or CD20-
Slide 67: Advancing Towards Next Gen Kite CAR Technology
Advancing Towards Next Gen Kite CAR Technology K-Gen 1 K-Gen 2 K-Gen 3 K-Gen 4 K-Gen 5 Mono-CAR Bicistronic-CAR Fit-CAR Allogeneic-CAR in vivo-CAR • Transformative in • Multiple antigens • Mono or bicistronic • Readily available • Capable of heme malignancies and 2 costimulatory enriched for product
Slide 68: Research
Research Priti Hegde, PhD S V P, G l o b a l H e a d o f R e s e a r c h
Slide 69: Advancing Towards Next Gen Kite CAR Technology
Advancing Towards Next Gen Kite CAR Technology K-Gen 1 K-Gen 2 K-Gen 3 K-Gen 4 K-Gen 5 Mono-CAR Bicistronic-CAR Fit-CAR Allogeneic-CAR in vivo-CAR • Transformative in • Multiple antigens • Mono or bicistronic • Readily available • Capable of heme malignancies and 2 costimulatory enriched for product
Slide 70: Translational Learning Applied to Next Gen CAR T
Translational Learning Applied to Next Gen CAR T Naïve Differentiated RESULTS FROM ZUMA-7 Naïve T-cells result in better Higher naïve T-cells in Apheresis result expansion into memory T-cells in better clinical outcomes Higher proportion of naïve T-cells in apheresis result in higher proportion of n
Slide 71: Research Strategy Expands Leadership in Cell Therapy
Research Strategy Expands Leadership in Cell Therapy Capitalize on CAR T Leadership Position Ourselves at Forefront of Next Gen in Clinically Ready Areas Autologous and Allogeneic Approaches GROW & PROTECT ENTER EXPLORE B-Cell Lymphoma & Multiple High Unmet Need Solid Allogeneic for Heme & Myeloma T
Slide 72: KITE-753: CD19/CD20 Dual-targeting Fast Manufacturing
K-Gen 3: Fit-CAR KITE-753:CD19/CD20 Dual-targeting Fast Manufacturing Key Unmet Need: Speed to treatment especially for those with very aggressive lymphomas Rapid Manufacturing Process (3 days) to Preserve T Cell Stemness Kite’s rapid and enhanced manufacturing process harvests the product early to
Slide 73: KITE-753 Preclinical Data Encouraging
K-Gen 3: Fit-CAR KITE-753 Preclinical Data Encouraging High CAR expression and increased naïve T-cells CAR expression Naïve CD4 cells Naïve CD8 cells 80% 100% • KITE-753 final product 60% 80% 60% 80% exhibits high CAR 40% 40% 60% 40% expression and increased 20% 20% 20% 0% 0% 0% naïve T-cells compar
Slide 74: Address Next Generation CAR-T in Multiple Myeloma
K-Gen 3: Fit-CAR Address Next Generation CAR-T in Multiple Myeloma Challenges to Solve Approach Tumor antigen escape Dual targeting with 2nd antigen Bicistronic Poor persistence in blood Armoring to improve local expansion and persistence Immunosuppressive microenvironment Baseline product character
Slide 75: Research Strategy Expands Leadership in Cell Therapy
Research Strategy Expands Leadership in Cell Therapy Capitalize on CAR T Leadership Position Ourselves at Forefront of Next Gen in Clinically Ready Areas Autologous and Allogeneic Approaches GROW & PROTECT ENTER EXPLORE B-Cell Lymphoma & Multiple High Unmet Need Solid Allogeneic for Heme & Myeloma T
Slide 76: Solving for the Unique Challenges of Solid Tumors
K-Gen 3: Fit-CAR Solving for the Unique Challenges of Solid Tumors Challenge Repercussion Approach Poor effector T-cell Poor proliferation and Enhance T-cell proliferation (CAR T) to tumor cell persistence and expansion ratio Fibroblasts High tumor CRs or deep and durable Dual antigen targeting hete
Slide 77: GPC3-Directed CAR T for Hepatocellular Carcinoma
K-Gen 3: Fit-CAR GPC3-Directed CAR T for Hepatocellular Carcinoma Next-Gen GPC3 Asset • 2L HCC: PFS of <5 months with <5% ORR • Glypican-3 (GPC3) is a glycoprotein that is overexpressed in HCC and other solid tumors, but is not expressed in normal tissues • Most patients with HCC have elevated serum
Slide 78: Exploring Solid Tumors
K-Gen 3: Fit-CAR Exploring Solid Tumors EGFR IL13Ra2 GBM is the most common primary malignant brain tumor in adults. Despite aggressive treatment, including resection, radiation, and chemotherapy, GBM has close to 100% recurrence rate, and is nearly uniformly fatal. Phase 1 Planned combination of Pe
Slide 79: Research Strategy Expands Leadership in Cell Therapy
Research Strategy Expands Leadership in Cell Therapy Capitalize on CAR T Leadership Position Ourselves at Forefront of Next Gen in Clinically Ready Areas Autologous and Allogeneic Approaches GROW & PROTECT ENTER EXPLORE B-Cell Lymphoma & Multiple High Unmet Need Solid Allogeneic for Heme & Myeloma T
Slide 80: Uniquely Positioned to Execute Auto & Allo Autoimmune
K-Gen 4: Allogeneic-CAR Uniquely Positioned to Execute Auto & Allo Autoimmune Industry leading manufacturing Ability to combine Kite cell Developing outpatient expertise capable of scaling to meet therapy clinical expertise with to manage different stakeholders autoimmune disease patient Gilead infl
Slide 81: Research Goals for Allogeneic Autoimmune Therapies
K-Gen 4: Allogeneic-CAR Research Goals for Allogeneic Autoimmune Therapies Goals to Bring CAR T to a Broader Population Rationale for Allogeneic Therapies 1 Requires low or no lymphodepletion • Reduced antigen burden alleviates need for 2 Humanized binder to support potential repeat dosing persisten
Slide 82: Complementing Allogeneic with External Innovation
K-Gen 4: Allogeneic-CAR Complementing Allogeneic with External Innovation • Induced pluripotent stem cell (iPSC) derived CAR-NK Cells • Engineering that improves persistence • Renewable cell source provides product consistency • Low COGS and supports multiple dosing strategy • Potential for enhanced
Slide 83: Innovation Through Technology & Partnerships
K-Gen 5: in vivo-CAR Innovation Through Technology & Partnerships Technology External Development Partnerships • Improve product fitness • Address alternatives to apheresis and lymphodepletion • Non-viral delivery for CAR Ts and increase payload • in vivo CARs 83 83
Slide 84: Growing Capabilities Led by 3 Research Centers
Growing Capabilities Led by 3 Research Centers Foster City, CA Research Center, Philadelphia, PA specializing in: Research Center, • Armored CAR T specializing in: • CAR constructs • Fast CAR Ts • Editing technology • T-cell backpacks • Allogeneic platforms R&D collaboration with: Santa Monica, CA A
Slide 85: Q&A
Cindy Perettie Warner Biddle Chris McDonald EVP & Head of Kite SVP, Global Head SVP, Global Head of of Commercial Technical Operations Q&A Frank Neumann, MD, PhD Priti Hegde, PhD Shelby Geyer SVP, Global Head of SVP, Global Head of VP, Kite Finance Clinical Development Research
Slide 86: Wrap-Up
Creating Possible QGILEAD WH kite
Slide 87: Kite Analyst Event: Global Leader in Cell Therapy
Kite Analyst Event: Global Leader in Cell Therapy • Building best-in-class commercial capabilities and extending leadership • Driving differentiation vs in-class and out-of-class competitors Leading Commercial Execution • Building class share with ATC growth & innovative model of community expansion
Slide 88: Kite Cell Therapy Analyst & Investor Event
Kite Cell Therapy Analyst & Investor Event 14 March 2024