Immunitybio, Inc. · NASDAQ:IBRX
Immunitybio — Investor Presentation (November 2022)
30 slides from Immunitybio's investor presentation, Nov 15, 2022
Slide 1: Overview Presentation November 2022
Exhibit 99.1 NASDAQ: IBRX Overview Presentation November 2022 11/14/22 1
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation and the accompanying verbal remarks contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding data from the clinical trials for certain of ImmunityBio’s product candidates,
Slide 3: Background: History of Driving Shareholder Value in the Biopharmaceutical Industry
Background: History of Driving Shareholder Value in the Biopharmaceutical Industry Through Innovation, Quality and Scale 2001 - 2008 2005 - 2010 American Pharmaceutical Partners (NASDAQ: APPX) Abraxis BioScience (NASDQ: ABII) • One of the nation’s largest injectable manufacturing • 2005: Abraxane -
Slide 4: Background: History of Driving Shareholder Value in the Biopharmaceutical Industry
Background: History of Driving Shareholder Value in the Biopharmaceutical Industry Through Innovation, Quality and Scale • 2000 - 2010: American Pharmaceutical Partners (APP) and Abraxis BioScience (ABII) • 2010 - 2020: Cancer Moonshot Initiative (QUILT Trials): The NANT Cancer Vaccine Natural Kille
Slide 5: Multi Billion Dollar Investment in Scale (2010 – 2022)
Multi Billion Dollar Investment in Scale (2010 – 2022) Immunotherapy Platform Scale Biological Manufacturing Scale Multiple Tumor Type Scale Plant 1 Plant 2 Plant 3 Fusion Proteins NK Cell Cancer Moonshot 2014 to 2020 & Cytokines Therapy Natural Killer Memory Killer (NK) Cell T Cell Crosstalk Killer
Slide 6: Cancer Moonshot: Tipping the Scales From Immuno-Evasion to Immune Activation
Cancer Moonshot: Tipping the Scales From Immuno-Evasion to Immune Activation Across Multiple Tumor Types The NANT Cancer Vaccine: QUILT Trials: 2014 - 2020 Red Green Natural Killer Memory Killer (Cancer Cell) (Normal Cell) Nine (NK) Cell T Cell Crosstalk Response Assessments IBRX Agents Dose Killer
Slide 7: Cancer Moonshot: Tipping the Scales From Immuno-Evasion to Immune Activation
Cancer Moonshot: Tipping the Scales From Immuno-Evasion to Immune Activation Across Multiple Tumor Types The NANT Cancer Vaccine: QUILT Trials: 2014 - 2020 Red Green Natural Killer Memory Killer (Cancer Cell) (Normal Cell) Nine (NK) Cell T Cell Crosstalk IBRX Agents Killer Cells Ad-MUC1 Ad-MUC1 Aden
Slide 8: Cancer Moonshot: Tipping the Scales From Immuno-Evasion to Immune Activation
Cancer Moonshot: Tipping the Scales From Immuno-Evasion to Immune Activation Across Multiple Tumor Types The NANT Cancer Vaccine: QUILT Trials: 2014 - 2020 Red Green Natural Killer Memory Killer (Cancer Cell) (Normal Cell) Nine (NK) Cell T Cell Crosstalk IBRX Agents Killer Cells Ad-MUC1 Ad-MUC1 Aden
Slide 9: Cancer Moonshot: Tipping the Scales From Immuno-Evasion to Immune Activation
Cancer Moonshot: Tipping the Scales From Immuno-Evasion to Immune Activation Across Multiple Tumor Types The NANT Cancer Vaccine: QUILT Trials: 2014 - 2020 th Red >5 Line Metastatic Green Natural Killer Memory Killer (Cancer Cell) Head & Neck (Normal Cell) Nine (NK) Cell T Cell Crosstalk IBRX Agents
Slide 10: Cancer Moonshot: Tipping the Scales From Immuno-Evasion to Immune Activation
Cancer Moonshot: Tipping the Scales From Immuno-Evasion to Immune Activation Across Multiple Tumor Types The NANT Cancer Vaccine: QUILT Trials: 2014 - 2020 Red Green 2021 - 2025 Natural Killer Memory Killer (Cancer Cell) (Normal Cell) Nine Registration Strategy (NK) Cell T Cell Crosstalk IBRX Agents
Slide 11: Registrational Development Strategy & Status
Nov 2022 Registrational Development Strategy & Status Investigational Anticipated Registrational Current Status Product Trial Indications (2023 – 2025) • BCG-Unresponsive Bladder Cancer CIS • BLA Filed, PDUFA May 2023 N-803 + BCG • BCG-Unresponsive Bladder Cancer Papillary • Enrollment Completed, FD
Slide 12: Late-Stage U.S. Clinical Trial Updates: Bladder Cancer
Orchestrating the Immune System Late-Stage U.S. Clinical Trial Updates: First-in-Class Comprehensive Platforms NK + T Cells • Bladder Cancer • Anktiva (N-803) • Pancreatic Cancer Natural Killer Cells • PD-L1 t-haNK • Lung Cancer DAMP Inducers • Head & Neck Cancer • Aldoxorubicin • Lynch Syndrome Mem
Slide 13: Late-Stage U.S. Clinical Trial Updates
Orchestrating the Immune System Late-Stage U.S. Clinical Trial Updates: First-in-Class Comprehensive Platforms NK + T Cells • Bladder Cancer • Anktiva (N-803) • Pancreatic Cancer Natural Killer Cells • PD-L1 t-haNK • Lung Cancer DAMP Inducers • Head & Neck Cancer • Aldoxorubicin • Lynch Syndrome Mem
Slide 14: N-803 (Anktiva) Potentiates NK Cell Induced Immunogenic Cell Death in BCG Infected Bladder Cancer Cell
N-803 (Anktiva) Potentiates the NK Cell Induced Immunogenic Cell Death in a BCG Infected Bladder Cancer Cell BCG Unresponsive Infected Stressed Cell N-803 (IL-15) Activation of Immunogenic NMIBC Cell Expressing Recruiting NK & T Cells Ligands for NK NK & T Cells Cell Death to Infected Cell QUILT 303
Slide 15: Summary of Efficacy of N-803 + BCG
Summary of Efficacy of N-803 + BCG Published November 10, 2022 71% CR Rate At Any Time 62% 53% 12 Months 24 Months Complete Response Complete Response 90% 26.6 89% Avoidance of Months Median Cystectomy Free Cystectomy Duration of CR At 24 Months DOI: https://doi.org/10.1056/EVIDoa2200167 In Responde
Slide 16: Complete Response Rate (CRR) Across Subgroups
Complete Response Rate (CRR) Across Subgroups Response rates for subgroups are shown. The vertical dashed line represents the threshold required for the lower limit of the 95% confidence interval (CI) to meet the primary end point. ‘BCG-unresp. Given BCG’ represents patients previously defined as ba
Slide 17: N-803 (Anktiva) + BCG Safety Summary
N-803 (Anktiva) Safety and tolerability Summary of profile comparable to + Safety BCG alone BCG 0% 0% 1% Immune Related Treatment Related Treatment Related SAEs Grade 4 and 5 AEs SAEs 2% Treatment Related Discontinuation Adverse reactions considered Most common treatment related The AE profile is co
Slide 18: Summary: Anktiva + BCG in BCG Unresponsive Bladder Cancer CIS & Papillary
Summary: Anktiva + BCG in BCG Unresponsive Bladder Cancer CIS & Papillary • First-in-class IL-15 superagonist: N-803 (Anktiva) enhances trained immunity and promotes long-term innate immune memory • Efficacy: BCG-unresponsive CIS (median follow-up 23.9 months) Data Cutoff: January 2022 • 71 % comple
Slide 19: Late-Stage U.S. Clinical Trial Updates: Pancreatic Cancer
Orchestrating the Immune System Late-Stage U.S. Clinical Trial Updates: First-in-Class Comprehensive Platforms NK + T Cells • Bladder Cancer • Anktiva (N-803) • Pancreatic Cancer Natural Killer Cells • PD-L1 t-haNK • Lung Cancer DAMP Inducers • Head & Neck Cancer • Aldoxorubicin • Lynch Syndrome Mem
Slide 20: Addressing Advanced Pancreatic Cancer with Combination Immunotherapy
Addressing Advanced Pancreatic Cancer with Combination Immunotherapy N-803 PD-L1 t-haNK Aldoxorubicin January 2022 November 2022 st Cohort A 1 Line therapy (Randomized) Actively Enrolling nd Cohort B 2 Line therapy (Randomized) Actively Enrolling rd Cohort C 3 Line or greater therapy (Single-Arm) Fu
Slide 21: Late-Stage U.S. Clinical Trial Updates: Lung Cancer
Orchestrating the Immune System Late-Stage U.S. Clinical Trial Updates: First-in-Class Comprehensive Platforms NK + T Cells • Bladder Cancer • Anktiva (N-803) • Pancreatic Cancer Natural Killer Cells • PD-L1 t-haNK • Lung Cancer DAMP Inducers • Head & Neck Cancer • Aldoxorubicin • Lynch Syndrome Mem
Slide 22: Median Overall Survival of Anktiva Compared to Any Therapy After Checkpoint Inhibitor Progression
Median Overall Survival of Anktiva Compared to Any Therapy in Patients Who Progressed on Checkpoint Inhibitor QUILT 3.055 Additional Therapy Following Checkpoint Anktiva IL-15 Therapy Following Inhibitor Progression Checkpoint Inhibitor Progression Median OS: 6.1 Months Median OS: 14.1 Months doi: 1
Slide 23: Anktiva Selected by LUNG-MAP for 2nd Line Patients
nd Anktiva Selected by LUNG-MAP for 2 Line Patients who Progressed on Checkpoint Therapy Actively Enrolling ImmunityBio Announces First Participants Have Been Enrolled in Lung-MAP Trial Studying Anktiva to Activate NK and T Cells in Non-Small Cell Lung Cancer April 25, 2022 • Novel combination thera
Slide 24: Late-Stage U.S. Clinical Trial Updates: Head & Neck Cancer
Orchestrating the Immune System Late-Stage U.S. Clinical Trial Updates: First-in-Class Comprehensive Platforms NK + T Cells • Bladder Cancer • Anktiva (N-803) • Pancreatic Cancer Natural Killer Cells • PD-L1 t-haNK • Lung Cancer DAMP Inducers • Head & Neck Cancer • Aldoxorubicin • Lynch Syndrome Mem
Slide 25: Metastatic Head & Neck Cancer
Metastatic Head & Neck Cancer N-803 + PD-L1 t-haNK + Checkpoint Investigator Initiated Trial: NCT04847466 25 N-803 and PD-L1 t-haNK are Investigational: Safety and Efficacy have Not been Established. 11/14/22
Slide 26: Late-Stage U.S. Clinical Trial Updates: Lynch Syndrome
Orchestrating the Immune System Late-Stage U.S. Clinical Trial Updates: First-in-Class Comprehensive Platforms NK + T Cells • Bladder Cancer • Anktiva (N-803) • Pancreatic Cancer Natural Killer Cells • PD-L1 t-haNK • Lung Cancer DAMP Inducers • Head & Neck Cancer • Aldoxorubicin • Lynch Syndrome Mem
Slide 27: Lynch Syndrome – Prevention of Colon Cancer and Endometrial Cancer
Lynch Syndrome – Prevention of Colon Cancer and Endometrial Cancer Investigator Initiated Trial Clinical Trials: NCT05419011 Investigational Agents: N-803 (Anktiva) + hAd5 CEA, MUC1, Brachyury Lifetime risk and mean age at diagnosis for 1 Lynch syndrome associated cancers • Lynch syndrome (LS) is th
Slide 28: Registrational Development Strategy & Status
Nov 2022 Registrational Development Strategy & Status Investigational Anticipated Registrational Current Status Product Trial Indications (2023 – 2025) • BCG-Unresponsive Bladder Cancer CIS • BLA Filed, PDUFA May 2023 N-803 + BCG • BCG-Unresponsive Bladder Cancer Papillary • Enrollment Completed, FD
Slide 29: ImmunityBio: A Leading Immunotherapy Company
ImmunityBio: A Leading Immunotherapy Company Nov 2022 Tipping the Scales from Immune-Evasion to Immune Activation > 5 Trillion Over 5 Trillion Natural Killer NASDAQ: IBRX (NK) Cells Manufactured to Date DAMP DNA RNA Fusion Proteins Toll Receptor NK Cell Inducers Vaccine Vaccine & Cytokines Activator
Slide 30: Thank You
Thank You Outsmart Your Disease 30 11/14/22