UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
CURRENT REPORT
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| Item 7.01. | Regulation FD Disclosure. |
Investor Conference
On November 15, 2022, Dr. Patrick Soon-Shiong, the Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio, Inc., a Delaware corporation (the “Company” or “ImmunityBio”) will participate in the 2022 Jefferies London Healthcare Conference (the “Conference”), which is taking place in London from November 15-17, 2022. Dr. Soon-Shiong is scheduled to present at the conference on November 15, 2022 at 4:25 P.M. Greenwich Mean Time (GMT). During the Conference, Dr. Soon-Shiong intends to refer to an updated corporate presentation (the “Investor Presentation”), a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference solely for purposes of this Item 7.01 disclosure. Interested parties can access the live audio webcast of this Conference presentation at https://wsw.com/webcast/jeff255/ibrx/1861731 and a replay of the presentation will be available on the Events section of the Investor Relations page on the Company’s website.
The information furnished pursuant to this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended (the “Securities Act”) or the Exchange Act, except as expressly set forth by specific reference in such a filing. This Current Report on Form 8-K shall not be deemed an admission as to the materiality of any information in the Current Report on Form 8-K that is required to be disclosed solely by Regulation FD.
| Item 8.01. | Other Events. |
The Company is providing updates regarding the registrational development strategy and status for certain of the Company’s product candidates. For example, the Company has completed enrollment of the papillary cohort (cohort B) of its QUILT 3.032 clinical trial studying N-803 plus BCG in adults with BCG-unresponsive non-muscle invasive bladder cancer (“NMIBC”), and the Company has a related Type B meeting scheduled with the United States Food and Drug Administration (“FDA”) in December 2022. In addition, the Company has completed enrollment in the third-line or greater cohort (cohort C) of its QUILT 88 clinical trial studying low-dose chemotherapy in combination with PD-L1 t-haNK, N-803 and aldoxorubicin in subjects with metastatic pancreatic cancer, and the Company has submitted a related briefing book to the FDA and has a related Type B meeting scheduled with the FDA in December 2022. Further, as previously disclosed, in May 2022, the Company announced the submission of a Biologics License Application (“BLA”) to the FDA for N-803 in combination with BCG for the treatment of patients with BCG-unresponsive NMIBC with CIS with or without Ta or T1 disease. In July 2022, the Company announced the FDA had accepted the Company’s BLA for review and set a target Prescription Drug User Fee Act (“PDUFA”) action date of May 23, 2023. It is unclear when the FDA will approve the Company’s BLA, if at all. In anticipation of the PDUFA date and as part of the Company’s overall strategy, the Company is exploring to partner with a large biopharmaceutical company for commercialization of N-803 plus BCG for administration intravesically. While the Company is pursuing discussions with multiple prospective global pharmaceutical partners with a view towards completing a transaction by the first quarter of 2023, there can be no assurance that the Company will complete a transaction on acceptable terms in accordance with this timeline or at all.
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding clinical trial enrollment and results, the regulatory review process and timing thereof, timing of scheduled meetings with the FDA, the Company’s commercialization strategy for N-803 plus BCG for administration intravesically, and potential strategic partnering transactions, among others. Statements 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,” “goal,” “could,” “estimates,” “scheduled,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “indicate,” “projects,” “seeks,” “should,” “will,” “strategy,” and variations of such words or similar expressions. Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be
forward-looking statements and are not indicative of future performance or results. 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 information may be limited or incomplete, and ImmunityBio’s statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. 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) whether the FDA will approve ImmunityBio’s filed BLA and the risks and uncertainties associated with the regulatory approval process, (ii) the ability of ImmunityBio to execute a partnering relationship with a large biopharmaceutical company for commercialization of N-803 plus BCG for administration intravesically on acceptable terms, if at all, (iii) 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, (iv) ImmunityBio’s ability to retain and hire key personnel, (v) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (vi) ImmunityBio’s ability to successfully commercialize its product candidates and uncertainties around regulatory reviews and approvals, (vii) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its product candidates and future approved products, (viii) ImmunityBio’s ability to obtain, maintain, protect and enforce patent protection and other proprietary rights for its product candidates and technologies, and (ix) the unknown future impact of the COVID-19 pandemic on certain clinical trials or their milestones and/or ImmunityBio’s business 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 10-K filed with the U.S. Securities and Exchange Commission (“SEC”) on March 1, 2022 and the Company’s Form 10-Q filed with the SEC on November 9, 2022, 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.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit | Description | |
| 99.1 | Investor Presentation | |
| 104 | The cover page of this Current Report on Form 8-K, formatted in Inline XBRL | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| IMMUNITYBIO, INC. | ||||||
| Date: November 15, 2022 |
By: | /s/ David Sachs | ||||
| David Sachs Chief Financial Officer | ||||||
Exhibit 99.1 NASDAQ: IBRX Overview Presentation November 2022 11/14/22 1
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, clinical trial enrollment and results, the regulatory review process and timing 11/14/202 2 thereof, timing of regulatory submissions, timing of meetings with regulators, potential implications to be drawn from clinical trials, potential commercialization of product candidates, ImmunityBio’s product candidates as compared to existing treatment options, and intellectual property protection and patent life, among others. Statements 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,” “goal,” “could,” “estimates,” “scheduled,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “indicate,” “projects,” “seeks,” “should,” “will,” “strategy,” and variations of such words or similar expressions. Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. 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 information may be limited or incomplete, and ImmunityBio’s statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. 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) whether the FDA will approve ImmunityBio’s filed BLA and the risks and uncertainties associated with the regulatory approval process, (ii) 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, (iii) ImmunityBio’s ability to retain and hire key personnel, (iv) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (v) ImmunityBio’s ability to successfully commercialize its product candidates and uncertainties around regulatory reviews and approvals, (vi) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its product candidates and future approved products, (vii) ImmunityBio’s ability to obtain, maintain, protect and enforce patent protection and other proprietary rights for its product candidates and technologies, and (viii) the unknown future impact of the COVID-19 pandemic on certain clinical trials or their milestones and/or ImmunityBio’s business 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 10-K filed with the U.S. Securities and Exchange Commission (“SEC”) on March 1, 2022 and the Company’s Form 10-Q filed with the SEC on November 9, 2022, and in subsequent filings made by ImmunityBio with the SEC, which a re 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. 2 11/14/202 2
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 - Nation’s first protein (albumin) 190 FDA approved dosage forms nanoparticle chemotherapy approved • 2001: IPO NASDAQ: APPX, market cap $769M • Abraxane approved for breast cancer, lung cancer and pancreatic cancer with state-of-the-art global • 2008: Safe supply of heparin during the heparin manufacturing plant for protein nanoparticles crisis in 2008 • 2010: Abraxis acquired by Celgene for $3.6 billion • 2008: Fresenius SE acquired APPX for $5.6 billion inclusive of CVRs • 2020: Abraxane achieves Blockbuster status of over a $1 billion dollar in sales • 2009: APPX products approached $800 million dollars in sales • 2021: Abraxane global sales at Bristol Meyers Squibb reached $1.2 billion dollars in sales 3 11/14/22
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 Killer Memory Killer (NK) Cell T Cell • Scale in platforms and products across the immune system Crosstalk Killer Cells Dendritic Cell • Scale in biological manufacturing capacity at GMP commercial level • Scale in exploratory clinical trials across multiple tumor types to validate the hypothesis • 2021: Launch of ImmunityBio (NASDAQ: IBRX) Through Merger of NantKwest & NantCell • 2021 - 2025: Registration Strategy and Anticipated Product Launches Product Launches Indications: • Bladder Cancer • N-803 (Anktiva) • Pancreatic Cancer • PD-L1 t-haNK • Lung Cancer • Aldoxorubicin • Glioblastoma • hAd5 E6/E7 • Head & Neck Cancer • hAd5 CEA, MUC1, Brachyury • Lynch Syndrome (Prevention of Cancer) 4 11/14/22
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 Cells Dendritic Cell Plant 5 Plant 6 Plant 4 • NK-92 • NK & T Cell Activators • Subunit Protein Antigens • Memory-Like Cytokine NK Plant 7 Plant 8 DAMP DNA Inducers Vaccine • Aldoxorubicin • hAd5 Adenovirus • Nanatinostat NASDAQ: IBRX Toll Receptor RNA Registration Strategy Activators Vaccine 2021 - 2025 Registration Trials • Bladder Cancer • Pancreatic Cancer • Lung Cancer • Self-Amplifying • TLR 4, 7, 8, 9 Plant 10* Plant 9* Plant 11* • Glioblastoma RNA (saRNA) • Head & Neck Cancer Patent Terms 2038+ • Lynch Syndrome Worldwide Patents Extending to 2035 and Beyond 5 11/14/22 *Through Potential Strategic Collaborators
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 Cells CIS Patient (intravesicular Papillary Ad-MUC1 Ad-MUC1 instillation) 24M W12 6M 9M 12M 15M 18M 21M Adeno Dendritic Cell Ad-Brachy Ad-Brachy Vaccines NASDAQ: IBRX 1 Pap CR* CR CR CR CR CR CR CR Ad-CEA Ad-CEA Registration Trials 100 μg 2 Pap CR* CR CR CR CR CR CR CR • Bladder Cancer Ye-Brachy Ye-Brachy • Pancreatic Cancer Yeast • Lung Cancer 3 Pap CR* CR CR CR CR CR CR CR Ye-CEA Ye-CEA Tumor Targeted Off-the-Shelf Vaccines • Glioblastoma Natural Killer Cells • Head & Neck Cancer Two Three Ye-Ras Ye-Ras 4 Pap IC CR* CR CR CR CR CR CR IBRX Agents IBRX Agents • Lynch Syndrome One haNK haNK PD-L1 t-haNK PD-L1 t-haNK aNK NK Cell NK Cell NK Cell IBRX Agent 200 μg 5 CIS IC IC IC CR CR CR CR 2021 - 2025 CR Registration Strategy N-803 N-803 N-803 N-803 N-803 N-803 N-803 N-803 N-803 N-803 N-803 6 Pap CR* CR CR CR CR CR CR CR BCG BCG Aldoxorubicin Aldoxorubicin Aldoxorubicin Aldoxorubicin Aldox PD-1 Checkpoint Aldox 7 Pap CR* CR CR CR CR CR CR CR 2017 nd 2 Line st nd nd rd nd rd 1 Line 2 Line 2 Line 3 Line 3rd Line 2 & 3 Line Cancer Moonshot Cancer Moonshot Cancer Moonshot Metastatic NMIBC NMIBC Across Multiple Across Multiple 400 μg or Greater Across Multiple Metastatic Metastatic Head Merkel Cell 8 CIS CR* CR CR CR CR CR CR CR** Pancreatic Tumor Types Tumor Types Tumor Types Bladder Bladder Glioblastoma TNBC & Neck Carcinoma Cancer 9 Pap CR* CR CR CR CR CR CR CR 2014 2017 2015 2019 2019 2017 2017 2021 *CR termed as No Recurrence (NR) in Papillary Disease **Negative Cystoscopy Inconclusive Cytology COMPLETE COMPLETE COMPLETE COMPLETE COMPLETE COMPLETE COMPLETE NADAQ: IBRX RESPONSE RESPONSE RESPONSE RESPONSE RESPONSE RESPONSE RESPONSE NantCell & NantKwest Proof of Concept: Complete Responses Across Multiple Tumor Types Merger 6 11/14/22
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 Adeno Dendritic Cell Ad-Brachy Ad-Brachy Vaccines NASDAQ: IBRX Ad-CEA Ad-CEA Registration Trials • Bladder Cancer Ye-Brachy Ye-Brachy • Pancreatic Cancer Yeast • Lung Cancer Ye-CEA Ye-CEA Tumor Targeted Off-the-Shelf Vaccines • Glioblastoma Natural Killer Cells • Head & Neck Cancer Two Three Ye-Ras Ye-Ras IBRX Agents IBRX Agents • Lynch Syndrome One haNK haNK PD-L1 t-haNK PD-L1 t-haNK aNK NK Cell NK Cell NK Cell IBRX Agent 2021 - 2025 Registration Strategy N-803 N-803 N-803 N-803 N-803 N-803 N-803 N-803 N-803 N-803 N-803 BCG BCG Aldoxorubicin Aldoxorubicin Aldoxorubicin Aldoxorubicin Aldox PD-1 Checkpoint Aldox nd 2 Line st nd nd rd nd rd 1 Line 2 Line 2 Line 3 Line 3rd Line Cancer Moonshot 2 & 3 Line Cancer Moonshot Cancer Moonshot Metastatic Across Multiple NMIBC NMIBC Across Multiple or Greater Across Multiple Metastatic Metastatic Head Merkel Cell Tumor Types Pancreatic Tumor Types Tumor Types Bladder Bladder Glioblastoma TNBC & Neck Carcinoma Cancer 2014 2017 2015 2019 2019 2017 2017 2021 COMPLETE COMPLETE COMPLETE COMPLETE PARTIAL COMPLETE COMPLETE NADAQ: IBRX RESPONSE RESPONSE RESPONSE RESPONSE RESPONSE RESPONSE RESPONSE NantCell & NantKwest Proof of Concept: Complete Responses Across Multiple Tumor Types Merger 7 11/14/22
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 Adeno Dendritic Cell Ad-Brachy Ad-Brachy Vaccines NASDAQ: IBRX Ad-CEA Ad-CEA Registration Trials • Bladder Cancer Ye-Brachy Ye-Brachy • Pancreatic Cancer Yeast • Lung Cancer Ye-CEA Ye-CEA Tumor Targeted Off-the-Shelf Vaccines • Glioblastoma Natural Killer Cells • Head & Neck Cancer Two Three Ye-Ras Ye-Ras spIND IBRX Agents IBRX Agents • Lynch Syndrome One haNK haNK PD-L1 t-haNK PD-L1 t-haNK aNK NK Cell NK Cell NK Cell IBRX Agent 2021 - 2025 Registration Strategy N-803 N-803 N-803 N-803 N-803 N-803 N-803 N-803 N-803 N-803 N-803 BCG BCG Aldoxorubicin Aldoxorubicin Aldoxorubicin Aldoxorubicin Aldox PD-1 Checkpoint Aldox nd 2 Line st nd nd rd nd rd 1 Line 2 Line 2 Line 3 Line 3rd Line Cancer Moonshot 2 & 3 Line Cancer Moonshot Cancer Moonshot Metastatic Across Multiple NMIBC NMIBC Across Multiple or Greater Across Multiple Metastatic Metastatic Head Merkel Cell Tumor Types Pancreatic Tumor Types Tumor Types Bladder Bladder Glioblastoma TNBC & Neck Carcinoma Cancer 2014 2017 2015 2019 2019 2017 2017 2021 spIND COMPLETE COMPLETE COMPLETE COMPLETE PARTIAL COMPLETE COMPLETE NADAQ: IBRX RESPONSE RESPONSE RESPONSE RESPONSE RESPONSE RESPONSE RESPONSE NantCell & NantKwest Proof of Concept: Complete Responses Across Multiple Tumor Types Merger 8 11/14/22
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 Killer Cells Ad-MUC1 Ad-MUC1 Adeno Dendritic Cell Ad-Brachy Ad-Brachy Vaccines NASDAQ: IBRX Ad-CEA Ad-CEA Registration Trials • Bladder Cancer Ye-Brachy Ye-Brachy • Pancreatic Cancer Pre-Treatment Yeast th • Lung C 5an Line cer Ye-CEA Ye-CEA Tumor Targeted Off-the-Shelf Vaccines • Glioblastoma Natural Killer Cells • Head & Neck Cancer Two Three Ye-Ras Ye-Ras IBRX Agents IBRX Agents • Lynch Syndrome One haNK haNK PD-L1 t-haNK PD-L1 t-haNK aNK NK Cell NK Cell NK Cell IBRX Agent 2021 - 2025 Registration Strategy N-803 N-803 N-803 N-803 N-803 N-803 N-803 N-803 N-803 N-803 N-803 BCG BCG Aldoxorubicin Aldoxorubicin Aldoxorubicin Aldoxorubicin Aldox PD-1 Checkpoint Aldox nd 2 Line st nd nd rd nd rd 1 Line 2 Line 2 Line 3 Line 3rd Line Cancer Moonshot 2 & 3 Line Post-Treatment Cancer Moonshot Cancer Moonshot Metastatic Across Multiple NMIBC NMIBC Across Multiple or Greater Across Multiple Metastatic Metastatic Head Merkel Cell COMPLETE Tumor Types Pancreatic Tumor Types Tumor Types Bladder Bladder RESPONSE Glioblastoma TNBC & Neck Carcinoma Cancer After 2-Cycles 2014 2017 2015 2019 2019 2017 2017 2021 COMPLETE COMPLETE COMPLETE COMPLETE PARTIAL COMPLETE COMPLETE NADAQ: IBRX RESPONSE RESPONSE RESPONSE RESPONSE RESPONSE RESPONSE RESPONSE NantCell & NantKwest Proof of Concept: Complete Responses Across Multiple Tumor Types Merger 9 11/14/22
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 Killer Cells Registration Trials Ad-MUC1 Ad-MUC1 Adeno Dendritic Cell Ad-Brachy Ad-Brachy • Bladder Cancer Vaccines • Pancreatic Cancer Ad-CEA Ad-CEA • Lung Cancer Ye-Brachy Ye-Brachy • Glioblastoma Yeast Ye-CEA Ye-CEA • Head & Neck Cancer Tumor Targeted Off-the-Shelf Vaccines Natural Killer Cells • Lynch Syndrome Two Three Ye-Ras Ye-Ras IBRX Agents IBRX Agents One haNK haNK PD-L1 t-haNK PD-L1 t-haNK aNK NK Cell NK Cell NK Cell IBRX Agent N-803 N-803 N-803 N-803 N-803 N-803 N-803 N-803 N-803 N-803 N-803 BCG BCG Aldoxorubicin Aldoxorubicin Aldoxorubicin Aldoxorubicin Aldox PD-1 Checkpoint Aldox nd 2 Line st nd nd rd nd rd 1 Line 2 Line 2 Line 3 Line 3rd Line Cancer Moonshot 2 & 3 Line Cancer Moonshot Cancer Moonshot Metastatic Across Multiple NMIBC NMIBC Across Multiple or Greater Across Multiple Metastatic Metastatic Head Merkel Cell Tumor Types Pancreatic Tumor Types Tumor Types Bladder Bladder Glioblastoma TNBC & Neck Carcinoma Cancer 2014 2017 2015 2019 2019 2017 2017 2021 COMPLETE COMPLETE COMPLETE COMPLETE PARTIAL COMPLETE COMPLETE RESPONSE RESPONSE RESPONSE RESPONSE RESPONSE RESPONSE RESPONSE NADAQ: IBRX NantCell & NantKwest Proof of Concept: Complete Responses Across Multiple Tumor Types 10 Merger 11/14/22
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, FDA Type B Meeting Scheduled Dec 2022 N-803 + BCG IL-15 Superagonist Anktiva, N-803 • BCG Naïve Bladder Cancer CIS & Papillary • Actively Enrolling N-803 + BCG nd • 2 Line Lung Cancer • LungMAP Actively Enrolling, Multi-Center Trial N-803 + Checkpoint rd • ≥3 Line Metastatic Pancreatic Cancer • Enrollment Completed, FDA Type B Meeting Scheduled Dec 2022 N-803 + PD-L1 t-haNK + Aldox PD-L1 t-haNK nd • >2 Line Glioblastoma • Phase 2 Randomized Trial N-803 + PD-L1 t-haNK + Aldox rd • ≥3 Line Metastatic Pancreatic Cancer • Enrollment Completed, FDA Type B Meeting Scheduled Dec 2022 Aldoxorubicin N-803 + PD-L1 t-haNK + Aldox + Adenovirus Vector • HPV Head & Neck Cancer • IND Anticipated 1H 2023 N-803 + hAd5 E6/E7 + PD-L1 t-haNK hAd5 E6/E7 Adenovirus Vector • Lynch Syndrome - Prevention of Colon Cancer • FDA / IRB Authorized: Initiation of Multi-Center Trial hAd5 CEA, MUC1, N-803 + hAd5 CEA, MUC1, Brachyury Anticipated Q1 2023. NIH Sponsored Trial Brachyury 11 11/14/22
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 Memory B & T Cells • Adenovirus (hAd5) 12 11/14/22
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 Memory B & T Cells • Adenovirus (hAd5) 13 11/14/22
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 3032 & T Cell BCG Infection N-803 Immunogenic Cell BCG N-803 NK & T Cell Death Long Term Induced + BCG Activation Stress Synergy Memory Durable Complete BCG + IL-15 Administered Intravesicalily Remission N-803 Trained Macrophage T Cell NK Cell T Cell Infected Cell NK Cell N-803 Expanded & Activated NK & T Cells N-803 BCG Anktiva 14 N-803 is Investigational: Safety and Efficacy have Not been Established. 11/14/22
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 Responders “NEJM Evidence presents innovative original research and fresh, bold ideas in clinical trial design and clinical decision-making.” 15 N-803 is Investigational: Safety and Efficacy have Not been Established. 11/14/22
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 bacillus Calmette–Guerin (BCG) unresponsive who were given additional BCG. CIS denotes carcinoma in situ; ECOG, Eastern Cooperative Oncology Group; and TURBT, transurethral resection of the bladder tumor. 16 N-803 is Investigational: Safety and Efficacy have Not been Established. 11/14/22 PRIMARY ENDPOINT
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 consistent related to treatment leading to AEs were those expected for with PK results showing no interruption of N-803 in intravesical instillation and included combination with BCG occurred systemic distribution dysuria, pollakiuria and hematuria in 13% of Patients N-803 Activity is Local to the Bladder with Zero Systemic IL-15 Levels per PK (Exploratory Endpoint) 17 N-803 is Investigational: Safety and Efficacy have Not been Established. 11/14/22
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 % complete response rate (CR) at any time • 53% CR at 24 months • 26.6 months median duration of CR • 90% cystectomy avoidance rate in responders • Efficacy: BCG-unresponsive Papillary (median follow-up 19.3 months) Data Cutoff: January 2022 • 55% disease free rate at 12 months • 48% disease free rate at 24 months • 94% radical cystectomy avoidance rate • Safety and tolerability profile analogous to BCG alone • Familiar and favorable local intravesical administration with no special handling or storage requirements 18 N-803 is Investigational: Safety and Efficacy have Not been Established. 11/14/22
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 Memory B & T Cells • Adenovirus (hAd5) 19 11/14/22
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) Fully Enrolled Jan 18, 2022 • Data show that ImmunityBio’s combination immunotherapy, Nant Cancer • QUILT-88 (Cohort C) 3rd line or Greater, Fully Enrolled, N=80 Vaccine, is potentially effective in pancreatic cancer where very few treatment options exist • Briefing Book Submitted to the FDA • Nant Cancer Vaccine therapy more than doubles median overall survival (OS) versus historical OS in patients who had progressed after two prior lines of • Type B Meeting Scheduled December 2022 therapy (N=30) with median OS of 6.3 months (95% CI: 5.0, 9.8 months) • When patients with even more advanced disease who failed four to six prior lines of therapy are added, the median OS even with such advanced disease (N=63) is 5.8 months (95% CI: 3.9, 6.9 months) • Treatment-related serious adverse events were uncommon and no treatment- related deaths were reported • The company plans to meet with the FDA in 2022 to discuss the path for the approval of combination therapies for pancreatic cancer 20 N-803, Aldoxorubicin and PD-L1 t-haNK are Investigational: Safety and Efficacy have Not been Established. 11/14/22
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 Memory B & T Cells • Adenovirus (hAd5) 21 11/14/22
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: 10.3747/co.27.5495 22 N-803 is Investigational: Safety and Efficacy have Not been Established. 11/14/22
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 therapy of Anktiva, an IL-15 superagonist, and Keytruda targeted at patients with lung cancer who have failed checkpoint inhibitor therapy • The study currently includes nearly 200 U.S. sites and will involve 478 patients when fully enrolled • Nearly 237,000 new cases of lung cancer are estimated to be diagnosed in the U.S. this year, making it the second most common cancer in the U.S. Investigator Initiated Trial - NCT05096663 23 N-803 is Investigational: Safety and Efficacy have Not been Established. 11/14/22
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 Memory B & T Cells • Adenovirus (hAd5) 24 11/14/22
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
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 Memory B & T Cells • Adenovirus (hAd5) 26 11/14/22
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 the most common hereditary colorectal cancer (CRC) syndrome with a population 1 prevalence affecting 1 in 279 Americans • Lynch syndrome accounts for approximately 3% of CRCs 2 and 3% of endometrial cancers 1. Win AK, et al. Prevalence and penetrance of major genes and polygenes for colorectal cancer. Cancer Epidemiol Biomarkers Prev. 2017;26:404–12. • First large scale multi-center clinical trial for the prevention of colon cancer by activating innate NK cells (with Anktiva) 2. Moreira et al 2012, Jiang et al 2019, Kahn et al 2019, Dong et al 2020 and inducing tumor specific CD4+, CD8+, and memory T 3. Lynch Syndrome .DynaMed. February 22, 2019. Retrieved November 18, 2019. cells (with hAd5 CEA, MUC1, Brachyury). • Anticipated initiation of trial Q1 2023 27 N-803 and hAd5 CEA, MUC1, and Brachyury are Investigational: Safety and Efficacy have Not been Established. 11/14/22
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, FDA Type B Meeting Scheduled Dec 2022 N-803 + BCG IL-15 Superagonist Anktiva, N-803 • BCG Naïve Bladder Cancer CIS & Papillary • Actively Enrolling N-803 + BCG nd • 2 Line Lung Cancer • LungMAP Actively Enrolling, Multi-Center Trial N-803 + Checkpoint rd • ≥3 Line Metastatic Pancreatic Cancer • Enrollment Completed, FDA Type B Meeting Scheduled Dec 2022 N-803 + PD-L1 t-haNK + Aldox PD-L1 t-haNK nd • >2 Line Glioblastoma • Phase 2 Randomized Trial N-803 + PD-L1 t-haNK + Aldox rd • ≥3 Line Metastatic Pancreatic Cancer • Enrollment Completed, FDA Type B Meeting Scheduled Dec 2022 Aldoxorubicin N-803 + PD-L1 t-haNK + Aldox + Adenovirus Vector • HPV Head & Neck Cancer • IND Anticipated 1H 2023 N-803 + hAd5 E6/E7 + PD-L1 t-haNK hAd5 E6/E7 Adenovirus Vector • Lynch Syndrome - Prevention of Colon Cancer • FDA / IRB Authorized: Initiation of Multi-Center Trial hAd5 CEA, MUC1, N-803 + hAd5 CEA, MUC1, Brachyury Anticipated Q1 2023. NIH Sponsored Trial Brachyury 28 11/14/22
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 Activators Therapy 2038+ 6 Immune • Aldoxorubicin Worldwide Patents Extending to Enhancing • hAd5 Adenovirus • Self-Amplifying • NK & T Cell Activators • TLR 4, 7, 8, 9 • NK-92 • Nanatinostat 2035 and Beyond RNA (saRNA) • Subunit Protein Antigens • Memory-Like Platforms Cytokine NK >700,000 1,800+ Square Feet of Manufacturing Patients Studied R&D, Office and Corporate Facilities 29
Thank You Outsmart Your Disease 30 11/14/22