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A Leading Immunotherapy Biotech Company
Broadest Late-Stage Clinical Platform of Antibody Cytokine Fusion Proteins, Albumin-Linked Chemo-Immunomodulators, Vaccine Vectors and Natural Killer cells NASDAQ:IBRX Exhibit 99.1
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forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are usually
identified by the use of words such as "anticipates," "believes," "continues", "could", "estimates," "expects," "intends," "may," "plans,"
"potential", "predicts", "projects," "seeks," "should," "will," and variations of such words or similar expressions. These forward-looking statements are neither forecasts,
promises nor guarantees, and are based on the current beliefs of ImmunityBio's management as well as assumptions made by and information currently available to ImmunityBio. Such statements reflect the current views of ImmunityBio with respect
to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) potential adverse
effects or changes to relationships with employees, suppliers or other parties resulting from the completion of the merger , (ii) the outcome of any legal proceedings that may be instituted against the parties and others related to the merger,
(iii) unexpected costs, charges or expenses resulting from the merger, (iv) uncertainty of the expected financial performance of the combined company following completion of the merger, including the possibility that the expected synergies and
value creation from the merger will not be realized or will not be realized within the expected time period, (v) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs, and the timing
and success of any such continued preclinical and clinical development and planned regulatory submissions, (vi) inability to retain and hire key personnel, and (vii) the unknown future impact of the COVID-19 pandemic delay on certain
clinical trial milestones and/or ImmunityBio's operations or operating expenses. More details about these and other risks that may impact ImmunityBio's business are described under the heading "Risk Factors" in the
Company's Form 8-K filed with the U.S. Securities and Exchange Commission ("SEC") on March 10, 2021 and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC's website at www.sec.gov.
ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press
release, except to the extent required by law. Forward Looking Statements
ImmunityBio: A Leading Immunotherapy
Company 17 First in Human Immunotherapy Molecules and cells 40 Phase I / II / III Clinical Trials 1,800+ Patients Studied 25 Phase II / III Clinical Trials 400,000 Square Feet of Manufacturing and R&D Facilities 3 Trillion Over 3 Trillion
Natural Killer Cells Manufactured to Date > Antibody Cytokine Fusion Proteins A Leading Immunotherapy Platform in Oncology & Infectious Diseases Chemo Immuno Modulators Vaccine Technologies Natural Killer Cells NASDAQ: IBRX 2035+ Worldwide
Patents Extending to 2035 and Beyond
Highly Experienced Management Team with
Proven Track Record Patrick Soon-Shiong, MD Executive Chairman David Sachs, MBA Chief Financial Officer Rich Adcock, MBA Chief Executive Officer Bobby Reddy, MD Chief Medical Officer Lennie Sender, MD Chief Operating Officer Fabio Benedetti, MD
Chief Strategy Officer Shahrooz Rabizadeh, PhD Chief Scientific Officer Fusion Protein & Neoepitope Kayvan Niazi, PhD Chief Science Officer Immunology and Vaccinology Elizabeth Gabitzsch Vice President, Vaccines Sarah Singleton Chief
Communications Officer Hans Klingemann, MD, PhD Chief Scientific Officer Cellular Therapy Manju Saxena, PhD Vice President, Product Dev Cell Therapy Program Sylvain Roy Vice President, Manufacturing Barry Simon, MD Chief Corporate Affairs
A Leading Immunotherapy Platform in
Oncology and Infectious Diseases Aldoxorubicin Anktiva (N-803) Adenovirus (hAd5) Antibody Cytokine Fusion Proteins Activating NK & T Cells Albumin-Bound Immuno-Modulators Tumoricidal Macrophages Vaccine Technologies Memory T Cells Mechanism of
Action Core Modalities Lead pH- Sensitive Hydrazine Linker Albumin-binding site Cytokine Cytokine Fusion Antibody (IgG1) Natural Killer (NK) Natural Killer Off-the-Shelf NK Cells Autologous Memory ceNK hAd5
ImmunityBio's Immunotherapy
Platform: Antibody Cytokine Fusion Proteins Anktiva (N-803) Antibody Cytokine Fusion Proteins Activating NK & T Cells Mechanism of Action Core Modalities Lead Cytokine Cytokine Fusion Antibody (IgG1)
ImmunityBio's Immunotherapy
Platform: Albumin-Bound Immuno-Modulators Aldoxorubicin Albumin-Bound Immuno-Modulators Tumoricidal Macrophages Mechanism of Action Core Modalities Lead pH- Sensitive Hydrazine Linker Albumin-binding site
ImmunityBio's Immunotherapy
Platform: Vaccine Technologies Adenovirus (hAd5) Vaccine Technologies Memory T Cells Mechanism of Action Core Modalities Lead hAd5
ImmunityBio's Immunotherapy
Platform: Natural Killer Cell Therapy Mechanism of Action Core Modalities Lead Natural Killer (NK) Natural Killer Off-the-Shelf NK Cells Autologous Memory ceNK 1 2 3
A Leading Immunotherapy Platform in:
A Leading Immunotherapy Platform in:
I. Solid Tumors (Continued)
A Leading Immunotherapy Platform in:
II. Liquid Tumors (Oncology) NCT02384954 NCT02989844 NCT02099539 NCT00990717 NCT01885897 NCT03050216 NCT02782546 NCT01898793 NCT02890758 NCT04052061
A Leading Immunotherapy Platform in:
III. Infectious Diseases
A Leading Immunotherapy Platform in:
IV. Pre-Clinical & Pre-IND Pipeline Platforms Phase Product Description Preclinical Pre-IND IND Filed IND Auth Fusion Proteins Adenovirus Natural Killer Antibody Cytokine Fusion Proteins Pre-IND IL-15 Superagonist + Anti CD20 Fusion Protein
N-820: IL-15 / CD20 Pre-IND IL-15 Superagonist + Anti PD-L1 Fusion Protein N-809: IL-15 / PD-L1 Pre-IND Tumor Necrosis Targeting (TNT) TNT + TGFb Trap Fusion Protein N-830: TNT / TGFb Pre-IND Tumor Necrosis Targeting (TNT) TNT + IL-12 Fusion Protein
N-812: TNT / IL-12 NK Platform Pre-IND HER2 t-haNK HER2 t-haNK Pre-IND EGFR t-haNK EGFR t-haNK Pre-IND TxM Induced M-ceNK TxM IL-12 / IL-18 / IL-15 M-ceNK Pre-IND Nanatinostat - Epigenetic Modifier Peptides Pre-IND M2 Macrophage Polarizer to
M1 RP-182 Adenovirus Pre-IND hAd5 Human Papillomavirus (HPV) hAd5 E6/E7 Pre-IND hAd5 to N-803 hAd5 N-803 Pre-Clin hAd5 Influenza hAd5 HA / M Pre-Clin hAd5 COVID-19 ACE2 Decoy hAd5 ACE2 Decoy MSC Phase 1 Mesenchymal Stem Cell w/ GMP-in-a-Box
Mesenchymal Stem Cells (MSC) N-820 N-809 N-830 N-812 HER2 t-haNK EGFR t-haNK M-ceNK RP-182 hAd5 E6/E7 hAd5 N-803 hAd5 HA/M hAd5 ACE2 MSCs w/ GMP-in-a-Box Nanatinostat
A Leading Immunotherapy Platform in:
Bladder Cancer Updated March
Overview of Non-Muscle Invasive
Bladder Cancer (NMIBC) High rates of progression and recurrence for NMIBC make it one of the most expensive cancer to treat Current standard of treatment is Transurethral resection of bladder tumor (TURBT), with or without intravesical therapy
Intravesical BCG is commonly used as an adjuvant treatment after TURBT for intermediate-high-risk NMIBC - side effects are common Patients who have failed BCG therapy require radical cystectomy with urinary diversion or chemotherapy and
radiation Only 50% of patients undergoing radical cystectomy will survive at 5 years BCG Administered Intravesically Intravesical BCG BCG + Anktiva Administered Intravesically Intravesical BCG Anktiva Bladder Catheter Medication Bladder Catheter
Medication Current Standard of Care ImmunityBio's Approach BREAKTHROUGH THERAPY DESIGNATION for BCG-Unresponsive NMIBC CIS 80k Annual New Cases 18k Annual Deaths
Phase I Results in NMIBC Dose
(intravesicular instillation) Patient Stage Response Assessments W12 6M 9M 12M 15M 18M 21M 24M 100 g 1 Pap T1 CR* CR CR CR CR CR CR CR 2 Pap Ta CR* CR CR CR CR CR CR CR 3 Pap T1 CR* CR CR CR CR CR CR CR 200 g 4 Pap T1 IC CR* CR CR CR CR
CR CR 5 CIS IC IC IC CR CR CR CR CR 6 Pap T1 CR* CR CR CR CR CR CR CR 400 g 7 Pap T1 CR* CR CR CR CR CR CR CR 8 CIS CR* CR CR CR CR CR CR CR** 9 Pap Ta CR* CR CR CR CR CR CR CR Anktiva + BCG in High-Risk NMIBC - Phase I Results FDA
granted Fast Track Designation to the pivotal trial based on this Phase I data. 9 of 9 (100%) Patients Disease-Free at 24 Months Data as of Feb 2018 Standard of Care historical response rate is 58-81% at 3-6 months post BCG alone CR - Complete
Response CR* -- No Recurrence (NR) in Papillary Disease CR** -- Negative Cystoscopy Inconclusive Cytology
Phase II / III Data in
BCG-Unresponsive NMIBC CIS Ongoing Study 80 patients accrued to date (fully accrued) Results: 51 CRs at any time have been reached CR Rate at Any Time of 71% (95% CI: 59%, 81%) Overall SAE rate of 11%, no treatment-related SAEs Individual SAE events
were all 1% Primary Endpoint | Complete Response at Any Time Secondary Endpoint | Duration of Complete Response Updated Jan 2021 Primary Endpoint: CR at any time, with lower bound of 95% CI 20% To meet the primary endpoint, 24 out of
80 patients must have had a CR at any time 1H 2021: Initial FDA Readout Ph II / III BCG Unresponsive NMIBC Carcinoma In-Situ CIS 2nd Line 2H 2021: CIS BLA Filing Ph II / III BCG Unresponsive NMIBC Anticipated Next Steps Duration of CR at 12 months
56% (95% CI: 38.8%, 70.3%) probability of patients maintaining CR for 12 months Duration of Complete Response Safety Population - Cohort A (CIS) 12 Months 56% 95% CI (38.8%, 70.3%)
Drug N CR Rate at Anytime Median
Duration of CR in responders Median follow up (months) Cystectomy Free Rate to date % with Extra Vesical Disease Anktiva (N-803) 80 71% 19.2 Months* 10.7 88% 1 Pembrolizumab1 97 41% 16.2 Months 24.1 63% 3 Nadofaragene2 103 53% 9.7 Months 19.7 71% 1
1. ODAC: https://www.fda.gov/media/133542/download, ASCO 2020 2. Boorjian et al. Lancet 2020 Late-Breaking Presentation ASCO GU 2021 (Feb 12) *Kaplan-Meier estimate Presented by Dr. Karim Chamie (UCLA)
https://meetinglibrary.asco.org/record/195299/abstract A historical comparison. Not a head to head comparison
Efficacy & Safety in Patients
with BCG-Unresponsive NMIBC CIS in QUILT-3.032 and Historical Comparison to Keytruda Efficacy Endpoints KEYNOTE-057 Keytruda QUILT-3.032 Anktiva + BCG CR Rate (95% CI) At any time or 3 months 41% (31%, 52%) 71% (59%, 81%) Duration of Response in
Responding Patients Median Duration of CR in Months (range) 16.2 (0.0+ - 26.8) 19.2 (0.0+ - 26.4) Cystectomy Free Rate % Cystectomy Free 63% 89% Immune-Mediated Adverse Event KEYNOTE-057 Keytruda QUILT-3.032 Anktiva + BCG Any
Immune-Mediated AE 21% 0 Grade 3-5 Immune-Mediated AEs 3% 0 Any Immune-Mediated SAE 5% 0 Discontinuation due to Immune-Mediated AEs 4% 0 Discontinuation due to Immune-Mediated SAEs 2% 0 Approved Jan 2020 A historical comparison. Not a head to head
Pancreatic Cancer Updated March
Phase 1/2 Trial of haNK + PD-L1 in
Combination with Chemo Immunomodulation in Advanced Metastatic Pancreatic Cancer NCT03329248 (Closed) QUILT 3.039, 3.060, 3.070, 3.080 NANT Cancer Vaccine Preliminary Data Lock Patients (2nd Line or Greater) Weeks of Follow Up or Until Death 1 2 3 4
5 6 7 8 9 10 11 12 2nd Line or Greater Metastatic Pancreatic Cancer Historical >2L Survival Rate (12 weeks)1 haNK + PD-L1 Inhibitor (Avelumab) Median Overall Survival = 8.0 months (95% CI: 5.0, 12.3) haNK + PD-L1 inhibitor (Avelumab) in
Metastatic Pancreatic Cancer Median Overall Survival 8.0 Months
Exploratory Trial of PD-L1 t-haNK in
Combination with Chemo Immunomodulation in Advanced Metastatic Pancreatic Cancer Weeks of Follow Up or Until Death Patient alive at last follow-up Patients (2nd Line or Greater) 2nd Line or Greater Metastatic Pancreatic Cancer Median Overall
Survival = Not Reached to Date (Jan 2020) PD-L1 t-haNK PD-L1 t-haNK Favorable to haNK + PD-L1 inhibitor (Avelumab) in Metastatic Pancreatic Cancer Median Overall Survival to Date (As of Jan 2020) Not Reached Historical >2L Survival Rate (12
Phase 2 Trial of PD-L1 t-haNK in
Combination with Chemo Immunomodulation in Advanced Metastatic Pancreatic Cancer NCT04390399 (QUILT-88) N=248 Actively Enrolling This is a Phase 2, three-cohort (2 randomized and 1 single-arm), open-label study to evaluate the comparative efficacy
and overall safety of standard-of-care chemotherapy versus standard-of-care chemotherapy in combination with Aldoxorubicin, N-803, and PD-L1 t-haNK in subjects with locally advanced or metastatic pancreatic cancer. Each treatment setting (ie, first
line maintenance, second line, or third line or greater) will be evaluated independently as a separate cohort. Cohort A1st Line therapy (Randomized) Cohort B2nd Line therapy (Randomized) Cohort C3rd Line or greater therapy (Single-Arm) Status:
Enrolling Enrolling Enrolling Days of Follow Up or Until Death W Patients (2nd Line or Greater) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Patient alive at last follow-up Death of patient Patient withdrew from study W Data as of Jan 2021: 18
accrued to date in 3rd Line or Greater (Single Arm) - Cohort C 15 Alive to Date PD-L1 t-haNK + Chemo Immunomodulation in Locally Advanced or Metastatic Pancreatic Cancer (QUILT-88) PD-L1 t-haNK NCT04390399 (QUILT-88) N=248 15 out of 18
Patients Alive to Date (as of Jan 2021)
Lung Cancer Updated March
Phase IIb Data in Lung Cancer 2nd
and 3rd Line NSCLC (QUILT 3.055) In Discussions with Lung-MAP As of December 2020 Shows preliminary evidence of long-term stable disease in 2L/3L NSCLC patients who previously progressed Patients Receiving Checkpoint + Anktiva Tumor Response Over
Time - NSCLC Subjects QUILT 3.055 is an ongoing Phase IIb, basket trial of 11 anatomical tumor types of combination Anktiva + checkpoint 131 patients have been enrolled to date 81 / 131 of these have lung cancer (78 NSCLC and 3 SCLC) 1H 2021: Data
lock anticipated for the QUILT 3.055 lung cancer cohorts In Discussions with Lung-MAP Anticipated Next Steps Multi-Cohort Basket and Status Change in Target Lesion From Baseline Point of Progression (%) 0 point baseline represents patients who were
actively progressing on CPI prior to enrollment of study with Anktiva + CPI
Anktiva as the Backbone to
Checkpoint Therapy Registrational Trial: Anktiva + Checkpoint in First Line Lung Cancer (QUILT 2.023) 1L Squamous & Non-Squamous Non-Small Cell Lung Cancer CPI Alone 1L Non-Small Cell Lung Cancer CPI + Concurrent Chemo 1L Non-Small Cell Lung
Cancer CPI + Concurrent Chemo Actively Enrolling N = 726 N = 404 N = 408 Phase Target Indication Pre-clinical Ph I Ph II Ph III Fusion Proteins Aldoxorubicin Adenovirus Natural Killer Lung III 1L Squamous & Non-Squamous Non-Small Cell Lung
Cancer CPI Alone Anktiva III 1L Non-Small Cell Lung Cancer CPI + Concurrent Chemo Anktiva IIb 2L or Greater Checkpoint Relapsed Non-Small Cell Lung Cancer Anktiva PD-L1 t-haNK
Checkpoint Failure Basket Trial
- 135 Patients Enrolled Phase IIb: Multi-Cohort Basket Trial of CPI Failures Enrolled Patients