Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37507 _____________________________________ IMMUNITYBIO, INC. (Exact name of registrant as specified in its ch ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37507 _____________________________________ IMMUNITYBIO, INC. (Exact name of registrant as specified in its c ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) þ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 or ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37507 _____________________________________ IMMUNITYBIO, INC. (Exact name of registrant as specified in its charte ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 or ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37507 _____________________________________ IMMUNITYBIO, INC. (Exact name of registrant as specified in i ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 or ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37507 _____________________________________ IMMUNITYBIO, INC. (Exact name of registrant as specified in its ch ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 or ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37507 _____________________________________ IMMUNITYBIO, INC. (Exact name of registrant as specified in its c ...

PART I [Business](index=4&type=section&id=Item%201.%20Business) ImmunityBio is a clinical-stage biotechnology company developing therapies and vaccines for cancers and infectious diseases [Our Business and Strategy](index=7&type=section&id=Our%20Business%20and%20Strategy) The company develops therapies to defeat cancers and infectious diseases by activating both innate and adaptive immune systems - The company's core approach is to activate both the **innate (NK cells, dendritic cells) and adaptive (B and T cells) immune systems** to achieve long-term immunological memory[32](index=32&type=chunk) - Key strategic elements include advancing the approval of its lead product, **Anktiva**, and accelerating its immunotherapy platform[37](index=37&type=chunk) - The company has **17 first-in-human therapeutic agents** being studied in 26 actively recruiting clinical trials across 13 indications[35](index=35&type=chunk) [Our Next-Generation Platforms](index=10&type=section&id=Our%20Next-Generation%20Platforms) The company's business is built on five core technology platforms including antibody fusion proteins, vaccines, and NK cell therapy - **Anktiva (N-803)**, an IL-15 superagonist fusion protein, has received **Breakthrough Therapy and Fast Track designations** from the FDA for BCG-unresponsive NMIBC CIS[38](index=38&type=chunk) - The company is developing multiple vaccine technologies, including **self-amplifying RNA (saRNA)** and a **second-generation human adenovirus (hAd5) vector**[40](index=40&type=chunk)[41](index=41&type=chunk)[43](index=43&type=chunk)[44](index=44&type=chunk) - The NK Cell Therapy platform includes off-the-shelf engineered cells like **haNK and t-haNK**, which have three modes of killing: innate, antibody-mediated, and CAR-directed[48](index=48&type=chunk)[49](index=49&type=chunk) - The DAMP Inducers platform includes **Aldoxorubicin**, designed to target immune evasion with lower cardiotoxicity than doxorubicin[53](index=53&type=chunk)[54](index=54&type=chunk) [Our Pipeline](index=16&type=section&id=Our%20Pipeline) The pipeline spans oncology and infectious diseases, led by Anktiva in bladder cancer and a T-cell based COVID-19 vaccine Anktiva Phase 2/3 NMIBC CIS Trial (QUILT 3.032) Results | Metric | Result | | :--- | :--- | | Complete Response (CR) Rate | 71% (59 of 83 patients) | | Median Duration of CR | 24.1 months | | Probability of avoiding progression & cystectomy at 24 months (in responders) | >90% | | Treatment-Related Serious Adverse Events (SAEs) | 0% | | Bladder Cancer-Specific Overall Survival at 24 months | 100% | - In a metastatic pancreatic cancer trial, the combination of PD-L1 t-haNK with Anktiva showed a median overall survival of **6.3 months**, more than doubling historical survival[49](index=49&type=chunk)[72](index=72&type=chunk) - The company's COVID-19 vaccine program focuses on a **dual-antigen (Spike + Nucleocapsid) hAd5 vector** to generate T-cell and antibody immunity[87](index=87&type=chunk)[91](index=91&type=chunk) - Multiple HIV studies are active, including a Phase 1 "HIV Cure Study" evaluating **Anktiva** after interrupting antiretroviral therapy (ART)[94](index=94&type=chunk)[95](index=95&type=chunk) [Manufacturing, Competition, and IP](index=26&type=section&id=Manufacturing,%20Competition,%20and%20IP) The company pursues a vertically integrated manufacturing strategy and faces competition from major pharmaceutical firms - The company has adopted a **vertically integrated strategy** to develop products to GMP standards, with established plants and global facility access[98](index=98&type=chunk) - In February 2022, the company acquired a leasehold interest in a **409,000 sq. ft. cGMP manufacturing facility** in Dunkirk, New York[106](index=106&type=chunk) - The company's owned patent portfolio for Anktiva includes approximately **13 issued U.S. patents and 43 foreign patents**, with expirations from 2028 to 2035[118](index=118&type=chunk) - Competition is faced from major pharmaceutical companies in areas such as **checkpoint inhibitors, cancer vaccines, and NK cell therapies**[113](index=113&type=chunk) [Collaboration and License Agreements](index=33&type=section&id=Collaboration%20and%20License%20Agreements) The company maintains several key strategic collaborations and licensing agreements to advance its pipeline and technology platforms - A **50:50 joint venture** was formed with Amyris in December 2021 to commercialize a next-generation COVID-19 RNA vaccine[133](index=133&type=chunk) - The company has an exclusive worldwide license from CytRx for aldoxorubicin, with potential milestone payments up to **$345.7 million**[136](index=136&type=chunk) - An exclusive, worldwide license was established with EnGeneIC for its **EDV nanocell technology** for COVID-19 and certain cancers[137](index=137&type=chunk) - The company licensed an RNA vaccine platform from IDRI, involving annual maintenance fees of **$5.5 million** from 2023-2030[139](index=139&type=chunk)[140](index=140&type=chunk) [Government Regulation and Human Capital](index=37&type=section&id=Government%20Regulation%20and%20Human%20Capital) The company's operations are subject to extensive regulation by the FDA and other global authorities and it employed 587 people in 2021 - The company's products are regulated by the FDA, requiring a rigorous process of **preclinical and clinical trials** before a BLA or NDA can be submitted[151](index=151&type=chunk)[153](index=153&type=chunk) - The company may seek accelerated approval pathways such as **Fast Track and Breakthrough Therapy designations** to expedite development[165](index=165&type=chunk)[167](index=167&type=chunk) - Post-approval, products are subject to ongoing FDA regulation, including **cGMP compliance** for manufacturing facilities[176](index=176&type=chunk) - As of December 31, 2021, the company had **587 employees**, with 45% in manufacturing and quality roles[217](index=217&type=chunk) [Risk Factors](index=54&type=section&id=Item%201A.%20Risk%20Factors) The company faces risks from operating losses, financing needs, clinical trial failures, and high insider voting control - The company has a history of operating losses, with an accumulated deficit of **$2.0 billion** as of December 31, 2021[229](index=229&type=chunk)[237](index=237&type=chunk)[247](index=247&type=chunk) - The company's Executive Chairman and his affiliates beneficially own approximately **78.7% of the company's common stock**, giving him voting control[447](index=447&type=chunk) - The company relies on **third parties and related parties** to conduct clinical trials, exposing it to risks of delays and regulatory scrutiny[232](index=232&type=chunk)[320](index=320&type=chunk)[333](index=333&type=chunk) - The company's product candidates are novel and face uncertainties regarding development, **market acceptance, and reimbursement coverage**[251](index=251&type=chunk)[257](index=257&type=chunk)[290](index=290&type=chunk) [Properties](index=114&type=section&id=Item%202.%20Properties) The company leases multiple facilities for laboratory, manufacturing, and office functions, including a new 409,000 sq. ft. plant Principal Leased Properties as of Dec 31, 2021 | Location | Approx. Rentable Square Feet | Primary Function(s) | | :--- | :--- | :--- | | El Segundo, CA | 168,570 | Laboratory - Research & Manufacturing | | Louisville, CO | 50,838 | Laboratory - Research & Manufacturing | | San Diego, CA | 44,681 | Laboratory - Research & Corporate Office | - On February 14, 2022, the company acquired a leasehold interest in a **409,000 sq. ft. cGMP pharmaceutical manufacturing facility** in Dunkirk, New York[478](index=478&type=chunk) [Legal Proceedings](index=115&type=section&id=Item%203.%20Legal%20Proceedings) The company is involved in various legal proceedings, though none are currently expected to have a material adverse effect - The company is not currently a party to any legal proceedings that management believes are likely to have a **material adverse effect** on the business[481](index=481&type=chunk) - Complaints have been filed concerning the recent merger, but the company has **not yet been served**[481](index=481&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=116&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity,%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's stock trades on Nasdaq as "IBRX", it has never paid dividends, and a stock repurchase program is authorized - The company's common stock began trading under the symbol **"IBRX"** on the Nasdaq Global Select Market on March 9, 2021[485](index=485&type=chunk) - The company has **never paid cash dividends** and does not plan to in the foreseeable future[487](index=487&type=chunk) - As of December 31, 2021, **$18.3 million** remained available for share repurchases under the company's stock repurchase program[492](index=492&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=118&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company reported a net loss of $346.8 million in 2021, driven by increased R&D and SG&A expenses Results of Operations (in thousands) | | For the Year Ended December 31, | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | | **2021** | **2020** | | | | **Revenue** | $934 | $605 | $329 | 54.4% | | **Research and development** | $195,958 | $139,507 | $56,451 | 40.5% | | **Selling, general and administrative** | $135,256 | $71,318 | $63,938 | 89.7% | | **Loss from operations** | ($330,280) | ($220,880) | ($109,400) | 49.5% | | **Net loss** | ($349,848) | ($224,187) | ($125,661) | 56.1% | - The increase in R&D expense was driven by a **$32.1 million** increase in compensation and a **$6.9 million** increase in clinical trial costs[540](index=540&type=chunk) - The increase in SG&A expense was mainly due to a **$42.2 million** increase in compensation and a **$19.3 million** increase in professional services fees[542](index=542&type=chunk) - As of December 31, 2021, the company had **$317.9 million** in cash, cash equivalents, and marketable securities and noted **substantial doubt** about its ability to continue as a going concern[547](index=547&type=chunk)[563](index=563&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=138&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk exposure relates to interest rate changes affecting its investment portfolio and variable-rate debt - The company's main market risk is **interest rate sensitivity** on its cash, investments, and a **$300.0 million variable-rate loan**[590](index=590&type=chunk)[593](index=593&type=chunk) - A hypothetical **100 basis point change** in interest rates would not have a material impact on the company's financial statements[591](index=591&type=chunk) - The company is exposed to **foreign currency exchange risk** from its subsidiary in Italy, but this exposure is not currently considered material[594](index=594&type=chunk)[595](index=595&type=chunk) [Financial Statements and Supplementary Data](index=139&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The company's 2021 financial statements show a net loss of $349.8 million and a total stockholders' deficit of $243.9 million Consolidated Balance Sheet Data (in thousands) | | Dec 31, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | **Total Assets** | $468,910 | $221,381 | | **Total Liabilities** | $712,823 | $339,871 | | **Total Stockholders' Deficit** | ($243,913) | ($118,490) | Consolidated Statement of Operations Data (in thousands) | | Year Ended Dec 31, 2021 | Year Ended Dec 31, 2020 | | :--- | :--- | :--- | | **Revenue** | $934 | $605 | | **Total operating expenses** | $331,214 | $221,485 | | **Net loss** | ($349,848) | ($224,187) | Consolidated Cash Flow Data (in thousands) | | Year Ended Dec 31, 2021 | Year Ended Dec 31, 2020 | | :--- | :--- | :--- | | **Net cash used in operating activities** | ($274,419) | ($171,724) | | **Net cash (used in) provided by investing activities** | ($84,886) | ($19,812) | | **Net cash provided by financing activities** | $505,443 | $150,675 | [Controls and Procedures](index=203&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management and the independent auditor concluded that the company's disclosure controls and internal controls were effective as of year-end 2021 - Management concluded that the company's internal control over financial reporting was **effective** as of December 31, 2021, based on the COSO 2013 framework[888](index=888&type=chunk) - The independent auditor, Ernst & Young LLP, issued an **unqualified opinion** on the effectiveness of the company's internal control over financial reporting[889](index=889&type=chunk) - There were **no material changes** in internal control over financial reporting during the fourth quarter of 2021[890](index=890&type=chunk) PART III [Directors, Executive Officers, Corporate Governance, Compensation, Security Ownership, and Accountant Fees](index=205&type=section&id=Items%2010-14) Information regarding directors, compensation, and corporate governance is incorporated by reference from the 2022 proxy statement - Information for Items 10, 11, 12, 13, and 14 is **incorporated by reference** from the company's definitive proxy statement for the 2022 Annual Meeting of Stockholders[896](index=896&type=chunk)[897](index=897&type=chunk)[898](index=898&type=chunk)[899](index=899&type=chunk)[900](index=900&type=chunk) PART IV [Exhibits and Financial Statement Schedules](index=206&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists the financial statements, schedules, and exhibits filed as part of the Annual Report - All required financial statement schedules have been omitted because the information is **included in the consolidated financial statements** or notes thereto[904](index=904&type=chunk) - A comprehensive list of exhibits is provided, incorporating by reference or filing herewith documents such as the **Merger Agreement and material contracts**[905](index=905&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission file number: 001-37507 _____________________________________ IMMUNITYBIO, INC. (Exact name of Registrant as specified in i ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission file number: 001-37507 IMMUNITYBIO, INC. (Exact name of Registrant as specified in its Charter) Delaware 43-1979754 (State or o ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10‑Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission file number: 001-37507 IMMUNITYBIO, INC. (Exact name of Registrant as specified in its Charter) Delaware 43-1979754 (State or ...