```markdown PART I—FINANCIAL INFORMATION [ITEM 1. FINANCIAL STATEMENTS](index=3&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS.) ImmunityBio's unaudited Q2 2023 and FY 2022 consolidated financial statements cover balance sheets, operations, cash flows, and detailed notes [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20%E2%80%93%20As%20of%20June%2030%2C%202023%20and%20December%2031%2C%202022) Total assets decreased to **$291.23 million**, liabilities rose to **$936.41 million**, and stockholders' deficit widened to **$(645.18) million** Key Financial Data | Metric | June 30, 2023 (Unaudited, in thousands) | December 31, 2022 (in thousands) | | :----------------------------------- | :------------------------------------ | :--------------------------------- | | Total Assets | $291,227 | $362,356 | | Total Liabilities | $936,410 | $812,176 | | Total Stockholders' Deficit | $(645,183) | $(449,820) | | Cash and Cash Equivalents | $43,506 | $104,641 | | Related-party promissory notes, net | $481,894 | $431,901 | | Related-party convertible note at fair value | $36,618 | — | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20%E2%80%93%20For%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202023%20and%202022) Net loss increased by **46%** to **$(138.21) million** for Q2 2023 and by **29%** to **$(254.80) million** for H1 2023, driven by higher SG&A and interest expenses Key Financial Data | Metric (in thousands) | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenue | $41 | $35 | $401 | $49 | | R&D Expenses | $53,168 | $63,082 | $132,432 | $118,460 | | SG&A Expenses | $32,018 | $16,575 | $64,694 | $57,183 | | Loss from Operations | $(85,145) | $(79,622) | $(196,725) | $(175,594) | | Interest Expense | $(32,235) | $(9,698) | $(62,051) | $(18,189) | | Net Loss | $(138,213) | $(94,835) | $(254,796) | $(197,833) | | Net Loss per Share | $(0.32) | $(0.24) | $(0.59) | $(0.50) | [Condensed Consolidated Statements of Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss%20%E2%80%93%20For%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202023%20and%202022) Comprehensive loss attributable to common stockholders increased to **$(137.89) million** for Q2 2023 and **$(254.45) million** for H1 2023 Key Financial Data | Metric (in thousands) | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :------------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net Loss | $(138,213) | $(94,835) | $(254,796) | $(197,833) | | Total Other Comprehensive (Loss) Income | $(7) | $257 | $(223) | $(114) | | Comprehensive Loss Attributable to ImmunityBio Common Stockholders | $(137,886) | $(94,331) | $(254,445) | $(197,528) | [Condensed Consolidated Statements of Stockholders' Deficit](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Deficit%20%E2%80%93%20For%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202023%20and%202022) Total stockholders' deficit increased from **$(449.82) million** at December 31, 2022, to **$(645.18) million** at June 30, 2023 Key Financial Data | Metric (in thousands) | December 31, 2022 | June 30, 2023 | | :-------------------- | :---------------- | :------------ | | Total Stockholders' Deficit | $(449,820) | $(645,183) | | Net Loss (6 months) | — | $(254,222) | | Additional Paid-in Capital | $1,930,936 | $1,990,590 | | Accumulated Deficit | $(2,378,488) | $(2,632,710) | - Issuance of shares in a registered direct offering contributed **$24.26 million** to additional paid-in capital during the six months ended June 30, 2023[18](index=18&type=chunk) - Stock-based compensation expense totaled **$21.94 million** for the six months ended June 30, 2023[18](index=18&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20%E2%80%93%20For%20the%20six%20months%20ended%20June%2030%2C%202023%20and%202022) Net cash used in operating activities was **$(164.08) million** in H1 2023, while financing activities provided **$120.30 million** Key Financial Data | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Operating activities | $(164,083) | $(166,182) | | Investing activities | $(17,088) | $47,359 | | Financing activities | $120,300 | $(313) | | Net change in cash, cash equivalents, and restricted cash | $(61,135) | $(119,056) | | Cash, cash equivalents, and restricted cash, end of period | $43,830 | $62,224 | - Key financing inflows in H1 2023 included **$59.7 million** from related-party promissory notes and **$47.18 million** from equity offerings[27](index=27&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures for the condensed consolidated financial statements, covering business, accounting policies, and financial line items [1. Description of Business](index=11&type=section&id=1.%20Description%20of%20Business) ImmunityBio is a clinical-stage biotechnology company developing next-generation therapies and vaccines for cancers and infectious diseases - ImmunityBio is a clinical-stage biotechnology company developing therapies and vaccines for cancers and infectious diseases[34](index=34&type=chunk) - Anktiva (N-803) received Breakthrough Therapy and Fast Track designations for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC)[35](index=35&type=chunk) - The FDA issued a Complete Response Letter (CRL) for Anktiva's BLA in May 2023, citing deficiencies related to third-party contract manufacturing organizations (CMOs) and requesting updated efficacy and safety data[35](index=35&type=chunk) [2. Summary of Significant Accounting Policies](index=12&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This section outlines ImmunityBio's significant accounting policies, including presentation basis, consolidation, liquidity, estimates, and specific accounting treatments - ImmunityBio had an accumulated deficit of **$2.6 billion** and negative cash flows from operations of **$164.1 million** as of June 30, 2023, indicating substantial doubt about its ability to continue as a going concern without additional funding[40](index=40&type=chunk)[41](index=41&type=chunk) - The company plans to fund operations through existing cash, marketable securities, available equity offerings (**$211.4 million** from ATM, **$640.0 million** from shelf registration as of June 30, 2023), and potential loans from affiliated entities[41](index=41&type=chunk) - Warrants are classified as liability-classified instruments and are remeasured at fair value each reporting period, with changes recorded in other (expense) income, net[47](index=47&type=chunk) - A convertible note issued in H1 2023 is accounted for under the Fair Value Option (FVO), with a **$6.8 million** loss recognized from the change in fair value during the six months ended June 30, 2023[48](index=48&type=chunk)[49](index=49&type=chunk)[50](index=50&type=chunk) [3. Financial Statement Details](index=15&type=section&id=3.%20Financial%20Statement%20Details) This section provides detailed breakdowns of specific balance sheet accounts, including prepaid expenses, property, plant, equipment, and accrued liabilities Key Financial Data | Account (in thousands) | June 30, 2023 (Unaudited) | December 31, 2022 | | :--------------------- | :------------------------ | :---------------- | | Prepaid expenses and other current assets | $18,846 | $31,503 | | Property, plant and equipment, net | $151,487 | $143,659 | | Intangible assets, net | $18,992 | $20,003 | | Accrued expenses and other liabilities | $62,335 | $41,825 | | Interest payable on related-party notes | $7,362 | — | - Depreciation expense for property, plant and equipment was **$8.3 million** for the six months ended June 30, 2023, up from **$7.7 million** in 2022[57](index=57&type=chunk) - Amortization expense for finite-lived intangibles was **$1.0 million** for the six months ended June 30, 2023, up from **$0.9 million** in 2022[58](index=58&type=chunk) [4. Financial Instruments](index=18&type=section&id=4.%20Financial%20Instruments) This section details the company's investments in marketable debt and equity securities, including fair values and unrealized gains/losses Key Financial Data | Marketable Debt Securities (in thousands) | June 30, 2023 (Unaudited) | December 31, 2022 | | :---------------------------------------- | :------------------------ | :---------------- | | Amortized Cost | $1,126 | $970 | | Gross Unrealized Gains | $1 | $0 | | Gross Unrealized Losses | $(87) | $(94) | | Fair Value | $1,040 | $876 | Key Financial Data | Marketable Equity Securities (in thousands) | June 30, 2023 (Unaudited) | December 31, 2022 | | :------------------------------------------ | :------------------------ | :---------------- | | Fair Value | $2,249 | $2,507 | | Unrealized Losses (Six Months Ended) | $(258) | $(452) | [5. Fair Value Measurements](index=19&type=section&id=5.%20Fair%20Value%20Measurements) This section details the fair value measurements of financial assets and liabilities, categorized into a three-tier hierarchy (Level 1, 2, and 3) Key Financial Data | Fair Value Measurements (in thousands) | Total (June 30, 2023) | Level 1 | Level 2 | Level 3 | | :------------------------------------- | :-------------------- | :------ | :------ | :------ | | Assets at Fair Value | $46,795 | $45,792 | $1,003 | $0 | | Liabilities at Fair Value | $(64,438) | $0 | $0 | $(64,438) | | Related-party convertible note payable | $(36,618) | — | — | $(36,618) | | Warrant liabilities | $(27,799) | — | — | $(27,799) | - The related-party convertible note's fair value increased by **$6.77 million** during the six months ended June 30, 2023, recorded as a loss in other (expense) income, net[70](index=70&type=chunk) - The fair value of December 2022 Warrants decreased by **$12.27 million**, and February 2023 Warrants decreased by **$5.26 million** during the six months ended June 30, 2023, both recorded as gains in other (expense) income, net[71](index=71&type=chunk)[74](index=74&type=chunk) [6. Collaboration and License Agreements and Acquisition](index=22&type=section&id=6.%20Collaboration%20and%20License%20Agreements%20and%20Acquisition) ImmunityBio is involved in a joint venture for a COVID-19 vaccine and holds various license agreements, incurring annual payments and R&D expenses - ImmunityBio has a **50:50** joint venture with Amyris, Inc. for a next-generation COVID-19 vaccine, accounted for using the equity method, with a **$6.3 million** share of net loss for the six months ended June 30, 2023[77](index=77&type=chunk)[79](index=79&type=chunk) - The company holds license agreements with 3M IPC and AAHI for TLR7/8 agonists and RNA vaccine platforms, involving annual payments (e.g., **$2.25 million** to 3M IPC in June 2023, **$5.5 million** annually to AAHI from 2023-2030) and associated R&D expenses[80](index=80&type=chunk)[81](index=81&type=chunk)[83](index=83&type=chunk)[84](index=84&type=chunk) - In February 2022, ImmunityBio acquired the Dunkirk Facility leasehold interest for approximately **$40.5 million**, committing to **$1.52 billion** in operational expenses over **10 years** and hiring **450** employees, with remaining governmental funding of **$8.0-$10.0 million** as of June 30, 2023[86](index=86&type=chunk)[87](index=87&type=chunk)[88](index=88&type=chunk)[90](index=90&type=chunk) [7. Commitments and Contingencies](index=25&type=section&id=7.%20Commitments%20and%20Contingencies) ImmunityBio has contingent consideration obligations from past acquisitions and is involved in several litigations, including with Sorrento Therapeutics - Contingent consideration of approximately **$2.2 million** is due for VivaBioCell's GMP-in-a-Box technology upon regulatory approval[92](index=92&type=chunk) - Regulatory milestone CVRs of **$304.0 million** from the Altor acquisition were not met by December 31, 2022, and thus terminated. Net sales CVRs of **$304.0 million** remain, with Dr. Soon-Shiong and related parties agreeing to receive shares for **$139.8 million**, while up to **$164.2 million** may be payable in cash to other former Altor stockholders[93](index=93&type=chunk)[94](index=94&type=chunk)[95](index=95&type=chunk) - An arbitration award of approximately **$176.4 million** was issued in favor of NantCell and NANTibody against Sorrento Therapeutics, Inc., subject to bankruptcy court approval of a settlement[107](index=107&type=chunk) - A securities class action was filed on June 30, 2023, alleging materially false and misleading statements regarding third-party CMOs and BLA approval prospects, following the FDA's CRL for Anktiva[110](index=110&type=chunk) [8. Lease Arrangements](index=29&type=section&id=8.%20Lease%20Arrangements) ImmunityBio leases various properties, including related-party facilities, with operating lease right-of-use assets of **$42.56 million** and liabilities of **$50.54 million** Key Financial Data | Lease Metric (in thousands) | June 30, 2023 (Unaudited) | December 31, 2022 | | :-------------------------- | :------------------------ | :---------------- | | Operating lease right-of-use assets | $42,555 | $45,788 | | Total operating lease liabilities | $50,542 | $50,601 | | Weighted-average remaining operating lease term | 6.2 years | 6.6 years | | Weighted-average operating lease discount rate | 10.6% | 10.5% | Key Financial Data | Lease Expense (in thousands) | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--------------------------- | :----------------------------- | :----------------------------- | | Operating lease costs | $5,843 | $5,250 | | Short-term lease costs | $2,029 | — | | Finance lease costs | $45 | — | | Variable lease costs | $1,945 | $2,116 | | Total lease expense | $9,862 | $7,366 | [9. Related-Party Debt](index=31&type=section&id=9.%20Related-Party%20Debt) ImmunityBio has significant related-party debt, totaling **$768.61 million** as of June 30, 2023, with most nonconvertible notes due by December 31, 2023 Key Financial Data | Related-Party Debt (in thousands) | June 30, 2023 (Unaudited) | December 31, 2022 | | :-------------------------------- | :------------------------ | :---------------- | | Related-Party Nonconvertible Notes | $481,894 | $431,901 | | Related-Party Convertible Note at Fair Value | $36,618 | — | | Related-Party Convertible Notes | $250,102 | $241,271 | | Total Related-Party Debt | $768,614 | $673,172 | - A **$30.0 million** convertible promissory note was executed with Nant Capital on March 31, 2023, accounted for at fair value, with its balance increasing to **$36.62 million** by June 30, 2023[119](index=119&type=chunk)[120](index=120&type=chunk) - Interest expense on related-party notes was **$38.20 million** for the six months ended June 30, 2023, compared to **$17.42 million** in 2022[62](index=62&type=chunk) - Most nonconvertible notes (**$505.0 million** principal) are due in 2023, while convertible notes (**$233.23 million** principal) are due in 2025[132](index=132&type=chunk) [10. Related-Party Agreements](index=35&type=section&id=10.%20Related-Party%20Agreements) ImmunityBio engages in various agreements with related parties, primarily entities affiliated with Dr. Soon-Shiong, for shared services, facility licenses, and clinical trials Key Financial Data | Related-Party Balances (in thousands) | June 30, 2023 (Unaudited) | December 31, 2022 | | :------------------------------------ | :------------------------ | :---------------- | | Total due from related parties | $2,025 | $1,890 | | Total due to related parties | $1,159 | $3,469 | - Shared services agreement with NantWorks resulted in **$1.9 million** in SG&A and **$1.0 million** in R&D expense for the six months ended June 30, 2023[136](index=136&type=chunk) - Facility license agreements with NantWorks, 605 Doug St, Duley Road, 605 Nash, 420 Nash, and 23 Alaska incurred significant rent expenses, totaling approximately **$4.8 million** in R&D expense for the six months ended June 30, 2023[139](index=139&type=chunk)[146](index=146&type=chunk)[149](index=149&type=chunk)[152](index=152&type=chunk)[155](index=155&type=chunk)[158](index=158&type=chunk) - Clinical trial and transition services from Immuno-Oncology Clinic, Inc. incurred **$1.4 million** in R&D expense for the six months ended June 30, 2023[142](index=142&type=chunk) [11. Warrant Liabilities](index=39&type=section&id=11.%20Warrant%20Liabilities) ImmunityBio has December 2022 and February 2023 warrant liabilities, with fair values of **$9.4 million** and **$18.4 million** respectively as of June 30, 2023 Key Financial Data | Warrant Type | Shares Outstanding (June 30, 2023) | Exercise Price (Initial) | Fair Value (June 30, 2023, in thousands) | Fair Value (Dec 31, 2022, in thousands) | | :------------- | :--------------------------------- | :----------------------- | :--------------------------------------- | :--------------------------------------- | | Dec 2022 | 9,090,909 | $6.60 | $9,363 | $21,636 | | Feb 2023 | 14,072,615 | $4.2636 | $18,436 | — | - The fair value of December 2022 Warrants decreased by **$12.27 million** during H1 2023, and February 2023 Warrants decreased by **$5.26 million**, both recorded in other (expense) income, net[161](index=161&type=chunk)[164](index=164&type=chunk) - Post-period, the exercise price of February 2023 Warrants was reduced to **$3.2946** per share, and the expiration date extended to July 24, 2026, decreasing potential cash proceeds from **$60.0 million** to **$46.4 million**[162](index=162&type=chunk)[187](index=187&type=chunk) [12. Stockholders' Deficit](index=39&type=section&id=12.%20Stockholders'%20Deficit) ImmunityBio has **$18.3 million** authorized for share repurchases and **$565.6 million** available under its shelf registration statement post-July 2023 offerings - As of June 30, 2023, **$18.3 million** remained authorized for share repurchases[165](index=165&type=chunk) - A **$750.0 million** shelf registration statement was filed in February 2023, with **$640.0 million** available as of June 30, 2023 (reduced to **$565.6 million** after July 2023 offerings)[166](index=166&type=chunk)[187](index=187&type=chunk) - The ATM offering generated **$13.6 million** in net proceeds during Q2 2023, with **$211.4 million** available for future issuances as of June 30, 2023[169](index=169&type=chunk) - Registered direct offerings in December 2022 and February 2023 each generated approximately **$47.0 million** in net proceeds[171](index=171&type=chunk)[172](index=172&type=chunk) [13. Stock-Based Compensation](index=41&type=section&id=13.%20Stock-Based%20Compensation) Stock-based compensation expense totaled **$11.06 million** for Q2 2023 and **$21.94 million** for H1 2023, primarily from RSUs and stock options Key Financial Data | Stock-Based Compensation (in thousands) | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2023 | | :-------------------------------------- | :------------------------------- | :----------------------------- | | Stock options | $3,445 | $7,088 | | RSUs | $7,617 | $14,852 | | Total Stock-Based Compensation Expense | $11,062 | $21,940 | Key Financial Data | Stock Options Activity (June 30, 2023) | Number of Options | Weighted Average Exercise Price | | :------------------------------------- | :---------------- | :------------------------------ | | Outstanding | 10,002,722 | $9.35 | | Vested and exercisable | 5,963,111 | $11.38 | Key Financial Data | RSU Activity (June 30, 2023) | Number of Units | Weighted Average Grant Date Fair Value | | :--------------------------- | :-------------- | :------------------------------------- | | Nonvested balance | 6,029,582 | $18.61 | - Unrecognized compensation cost for stock options is **$15.6 million** (**1.4 years** remaining) and for RSUs is **$53.9 million** (**2.4 years** remaining)[176](index=176&type=chunk)[179](index=179&type=chunk) [14. Income Taxes](index=42&type=section&id=14.%20Income%20Taxes) ImmunityBio has not paid U.S. federal and state income taxes since inception due to net operating losses (NOLs) - ImmunityBio has not paid U.S. federal and state income taxes from inception through June 30, 2023, due to current and accumulated net operating losses (NOLs)[182](index=182&type=chunk) - The company does not expect the Inflation Reduction Act of 2022's Corporate Alternative Minimum Tax (CAMT) to have a material effect on its financial statements[184](index=184&type=chunk) - Federal tax years 2019-2021 and state tax years 2018-2021 remain open to examination[183](index=183&type=chunk) [15. Subsequent Events](index=43&type=section&id=15.%20Subsequent%20Events) Subsequent to June 30, 2023, ImmunityBio completed a registered direct offering for **$40.0 million** and repriced February 2023 Warrants - On July 20, 2023, ImmunityBio completed a registered direct offering, generating approximately **$40.0 million** in gross proceeds from the sale of **14,569,296** shares and warrants[186](index=186&type=chunk) - On July 25, 2023, the exercise price of the February 2023 Warrants was reduced from **$4.2636** to **$3.2946** per share, and the expiration date was extended to July 24, 2026[187](index=187&type=chunk) - The warrant amendment reduced potential net proceeds from warrant exercise from **$60.0 million** to **$46.4 million** and decreased the available shelf registration statement amount to **$565.6 million**[187](index=187&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=44&type=section&id=ITEM%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS.) Management discusses ImmunityBio's financial condition and operational performance, highlighting its clinical-stage status, significant losses, and funding needs - ImmunityBio is a clinical-stage biotechnology company with minimal revenue and a history of significant operating losses, with an accumulated deficit of **$2.6 billion** as of June 30, 2023[204](index=204&type=chunk) - The FDA issued a Complete Response Letter (CRL) for Anktiva's BLA in May 2023, citing manufacturing deficiencies and requesting updated efficacy and safety data, which has delayed potential approval and commercialization[200](index=200&type=chunk) - The company anticipates needing substantial additional funding to continue product development, seek regulatory approvals, and commercialize product candidates, relying on equity offerings and potential related-party loans[276](index=276&type=chunk)[279](index=279&type=chunk) [Forward-Looking Statements](index=44&type=section&id=Forward-Looking%20Statements) This section outlines numerous forward-looking statements regarding ImmunityBio's future operations, product development, regulatory approvals, and financial performance - Forward-looking statements cover the ability to develop therapies, obtain funding, address FDA issues, commercialize products, and achieve regulatory approvals[189](index=189&type=chunk) - Statements are based on management's beliefs and assumptions as of the report date and are inherently uncertain[191](index=191&type=chunk) - Investors are cautioned not to unduly rely on these statements due to known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially[192](index=192&type=chunk) [Our Business](index=46&type=section&id=Our%20Business) ImmunityBio is a clinical-stage biotechnology company focused on developing next-generation immunotherapies and vaccines for cancer and infectious diseases - ImmunityBio is a clinical-stage biotechnology company developing next-generation therapies and vaccines to defeat cancers and infectious diseases by harnessing and amplifying the immune system[196](index=196&type=chunk) - The company's platforms include **13** novel therapeutic agents in Phase **2** or **3** clinical development for indications such as bladder, pancreatic, and lung cancers, as well as SARS-CoV-2 and HIV[199](index=199&type=chunk) - Anktiva (N-803) received Breakthrough Therapy and Fast Track designations for BCG-unresponsive NMIBC, but its BLA received a Complete Response Letter from the FDA in May 2023 due to deficiencies related to third-party CMOs and CMC issues[200](index=200&type=chunk) [COVID-19 Pandemic](index=48&type=section&id=COVID-19%20Pandemic) The COVID-19 pandemic has not materially impacted ImmunityBio's business to date, but its evolving nature creates ongoing uncertainty regarding future effects - The COVID-19 pandemic has not yet caused a material adverse impact on ImmunityBio's business, but its evolving nature creates ongoing uncertainty[201](index=201&type=chunk) - Potential future impacts include delays in patient enrollment and clinical trial completion, affecting BLA submissions and revenue generation[201](index=201&type=chunk) - The company has addressed potential supply chain interruptions by ensuring sufficient supplies of laboratory and manufacturing materials[203](index=203&type=chunk) [Operating Results](index=48&type=section&id=Operating%20Results) ImmunityBio has generated minimal revenue and incurred net losses since inception, with an accumulated deficit of **$2.6 billion** as of June 30, 2023 - ImmunityBio has generated minimal revenue from non-exclusive license agreements, bioreactor sales, and grant programs, with no approved clinical products for commercial sale[204](index=204&type=chunk) - The company has incurred net losses since inception, with an accumulated deficit of **$2.6 billion** as of June 30, 2023[204](index=204&type=chunk) Key Financial Data | Metric (in millions) | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :------------------- | :----------------------------- | :----------------------------- | | Net Loss Attributable to ImmunityBio Common Stockholders | $(254.2) | $(197.4) | [Collaboration Agreements](index=49&type=section&id=Collaboration%20Agreements) ImmunityBio views strategic collaborations as integral to its operations, leveraging partners' expertise to expand its immunotherapy platforms - Strategic collaborations are integral to ImmunityBio's operations, providing opportunities to leverage partner expertise and expand technology platforms[206](index=206&type=chunk) - The company believes its innovative approach to orchestrate and combine therapies for optimal immune system response will become a therapeutic foundation[207](index=207&type=chunk) - Data from multiple clinical trials indicates N-803 has broad potential to enhance the activity of therapeutic monoclonal antibodies, including checkpoint inhibitors[207](index=207&type=chunk) [Agreements with Related Parties](index=49&type=section&id=Agreements%20with%20Related%20Parties) ImmunityBio has extensive agreements with related parties, primarily entities affiliated with Dr. Patrick Soon-Shiong, including promissory notes and R&D services - ImmunityBio has entered into multiple agreements with related parties, primarily entities affiliated with Dr. Patrick Soon-Shiong[208](index=208&type=chunk) - A **$30.0 million** variable-rate promissory note was executed with Nant Capital on June 13, 2023, providing **$29.9 million** in net proceeds for regulatory approval, pre-commercialization, and R&D activities[210](index=210&type=chunk)[211](index=211&type=chunk) - A **$30.0 million** convertible promissory note with Nant Capital, executed March 31, 2023, is accounted for at fair value and had a balance of **$36.6 million** as of June 30, 2023[213](index=213&type=chunk)[215](index=215&type=chunk) - The company incurred **$1.4 million** in R&D expense for clinical trial and transition services from Immuno-Oncology Clinic, Inc. during the six months ended June 30, 2023[218](index=218&type=chunk) [Components of our Results of Operations](index=51&type=section&id=Components%20of%20our%20Results%20of%20Operations) This section details ImmunityBio's financial results components, including minimal revenue, increasing R&D and SG&A expenses, and other income/expense items - Revenue is minimal, derived from non-exclusive license agreements, bioreactor sales, and grant programs, with no revenue from therapeutic/vaccine product candidates[220](index=220&type=chunk) - Research and development (R&D) expenses include clinical trial costs, manufacturing, and personnel, and are expected to increase significantly as product candidates advance[222](index=222&type=chunk)[223](index=223&type=chunk)[224](index=224&type=chunk) - Selling, general and administrative (SG&A) expenses, including personnel and professional fees, are expected to increase due to operational expansion, public company costs, and future commercialization efforts[228](index=228&type=chunk)[229](index=229&type=chunk) - Other income and expense includes interest, investment gains/losses, and fair value changes of warrant liabilities and related-party convertible notes[230](index=230&type=chunk) - ImmunityBio has not paid U.S. federal and state income taxes due to current and accumulated net operating losses[231](index=231&type=chunk) [Revenue](index=51&type=section&id=Revenue) ImmunityBio's revenue has been minimal since inception, primarily from non-exclusive license agreements, bioreactor sales, and grant programs - Revenue is minimal, derived from non-exclusive license agreements, bioreactor sales, and grant programs[220](index=220&type=chunk) - No clinical products are approved for commercial sale, and no revenue has been generated from therapeutic or vaccine product candidates[220](index=220&type=chunk) - Substantial future revenue depends on timely development and regulatory approval of product candidates[220](index=220&type=chunk) [Operating Expenses](index=51&type=section&id=Operating%20Expenses) ImmunityBio classifies operating expenses into research and development (R&D) and selling, general and administrative (SG&A), both expected to increase significantly - Operating expenses are classified into research and development (R&D) and selling, general and administrative (SG&A)[221](index=221&type=chunk) - Personnel costs (salaries, benefits, bonuses, stock-based compensation) are a significant component of both R&D and SG&A[221](index=221&type=chunk) - Both R&D and SG&A expenses are expected to increase significantly in the foreseeable future[224](index=224&type=chunk)[229](index=229&type=chunk) [Research and Development](index=51&type=section&id=Research%20and%20Development) R&D expenses cover preclinical studies, clinical trials, manufacturing development, and regulatory filings, and are expected to increase significantly - R&D expense covers preclinical studies, clinical trials, manufacturing development, and regulatory filings[222](index=222&type=chunk) - Expenses are classified as external (e.g., CROs, manufacturing) and internal (e.g., personnel, facilities), and are not directly tied to specific programs[223](index=223&type=chunk) - R&D expenses are expected to increase significantly due to ongoing clinical development and future trials[224](index=224&type=chunk) - The costs of clinical trials vary significantly due to factors like per-patient costs, number of sites, patient enrollment, and regulatory requirements[227](index=227&type=chunk) [Selling, General and Administrative](index=52&type=section&id=Selling%2C%20General%20and%20Administrative) SG&A expenses primarily consist of personnel costs and professional fees, and are expected to increase due to operational expansion and commercialization preparations - SG&A expenses primarily cover salaries and personnel-related costs for non-R&D functions (executive, finance, HR, IT, legal, admin)[228](index=228&type=chunk) - Other SG&A includes facility costs, professional fees, advertising, business transaction costs, patent maintenance, and consulting[228](index=228&type=chunk) - SG&A expenses are expected to increase due to operational expansion, information system build-out, increased headcount, public company operating costs, and future sales/marketing for approved products[229](index=229&type=chunk) [Other Income and Expense](index=53&type=section&id=Other%20Income%20and%20Expense) Other income and expense primarily includes interest, investment gains/losses, and fair value changes of warrant liabilities and convertible notes - Other income and expense includes interest income/expense, unrealized/realized gains/losses on investments, and fair value changes of warrant liabilities and convertible notes[230](index=230&type=chunk) [Income Taxes](index=53&type=section&id=Income%20Taxes) ImmunityBio is subject to U.S. federal and state income taxes, as well as taxes in Italy and South Korea, but has not paid U.S. taxes due to NOLs [Discussion of Condensed Consolidated Results of Operations](index=53&type=section&id=Discussion%20of%20Condensed%20Consolidated%20Results%20of%20Operations) ImmunityBio's net loss increased by **46%** to **$(138.21) million** for Q2 2023 and by **29%** to **$(254.80) million** for H1 2023 Key Financial Data | Metric (in thousands) | June 30, 2023 | June 30, 2022 | $ Change | % Change | | :-------------------- | :------------ | :------------ | :------- | :------- | | Revenue | $41 | $35 | $6 | 17% | | R&D Expenses | $53,168 | $63,082 | $(9,914) | (16)% | | SG&A Expenses | $32,018 | $16,575 | $15,443 | 93% | | Interest Expense | $(32,235) | $(9,698) | $(22,537) | 232% | | Net Loss | $(138,213) | $(94,835) | $(43,378) | 46% | - Other expense, net, increased by **$37.9 million** (**249%**) due to higher interest expense (**$22.5 million**), increased loss from warrant liabilities fair value changes (**$10.0 million**), and convertible notes fair value changes (**$6.8 million**)[238](index=238&type=chunk) [Comparison of the Three Months Ended June 30, 2023 and 2022](index=53&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030%2C%202023%20and%202022) Net loss increased by **46%** to **$(138.21) million** for Q2 2023, driven by a **93%** rise in SG&A and a **232%** surge in interest expense [Revenue](index=53&type=section&id=Revenue) Revenue for Q2 2023 and Q2 2022 was minimal, less than **$0.1 million**, primarily from bioreactor sales - Revenue for the three months ended June 30, 2023 and 2022 was less than **$0.1 million**, primarily from bioreactor sales[233](index=233&type=chunk) [Research and Development Expense](index=54&type=section&id=Research%20and%20Development%20Expense) R&D expense decreased by **$9.9 million** (**16%**) for Q2 2023, mainly due to lower external R&D costs and reductions in laboratory supplies Key Financial Data | R&D Expense (in thousands) | June 30, 2023 | June 30, 2022 | $ Change | | :------------------------- | :------------ | :------------ | :------- | | External R&D expenses | $11,380 | $16,532 | $(5,152) | | Internal R&D expenses | $41,788 | $46,550 | $(4,762) | | Total R&D expenses | $53,168 | $63,082 | $(9,914) | - Decrease in external R&D was due to lower regulatory/compliance costs, CMO fees, and clinical trial activities[237](index=237&type=chunk) - Decrease in other R&D costs was due to reductions in laboratory and material supplies[237](index=237&type=chunk) [Selling, General and Administrative Expense](index=54&type=section&id=Selling%2C%20General%20and%20Administrative%20Expense) SG&A expense increased by **$15.4 million** (**93%**) for Q2 2023, primarily driven by higher legal expenses and personnel costs - SG&A expense increased by **$15.4 million** (**93%**) for the three months ended June 30, 2023[236](index=236&type=chunk) - Primary drivers were a **$14.0 million** increase in legal expenses, a **$0.9 million** increase in personnel costs, and a **$0.6 million** increase in license fees[236](index=236&type=chunk) - Partially offset by a **$0.5 million** reduction in insurance costs[236](index=236&type=chunk) [Other Expense, Net](index=55&type=section&id=Other%20Expense%2C%20Net) Other expense, net, increased by **$37.9 million** (**249%**) for Q2 2023, mainly due to higher interest expense and losses from fair value changes - Other expense, net, increased by **$37.9 million** (**249%**) for the three months ended June 30, 2023[238](index=238&type=chunk) - Key drivers included a **$22.5 million** increase in interest expense, a **$10.0 million** higher loss from warrant liabilities fair value changes, and a **$6.8 million** higher loss from convertible notes fair value changes[238](index=238&type=chunk) - Partially offset by a **$1.7 million** increase in net interest and investment income[238](index=238&type=chunk) [Comparison of the Six Months Ended June 30, 2023 and 2022](index=55&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030%2C%202023%20and%202022) Net loss increased by **29%** to **$(254.80) million** for H1 2023, driven by a **241%** increase in interest expense and higher R&D and SG&A costs Key Financial Data | Metric (in thousands) | June 30, 2023 | June 30, 2022 | $ Change | % Change | | :-------------------- | :------------ | :------------ | :------- | :------- | | Revenue | $401 | $49 | $352 | 718% |\n| R&D Expenses | $132,432 | $118,460 | $13,972 | 12% |\n| SG&A Expenses | $64,694 | $57,183 | $7,511 | 13% |\n| Interest Expense | $(62,051) | $(18,189) | $(43,862) | 241% |\n| Net Loss | $(254,796) | $(197,833) | $(56,963) | 29% | - Other expense, net, increased by **$35.8 million** (**161%**), primarily due to a **$43.9 million** increase in interest expense and a **$6.8 million** loss from convertible notes, partially offset by a **$17.5 million** gain from warrant liabilities fair value changes[244](index=244&type=chunk) [Revenue](index=55&type=section&id=Revenue) Revenue increased by **$0.4 million** for H1 2023, primarily driven by an increase in grant revenue - Revenue increased by **$0.4 million** for the six months ended June 30, 2023, primarily due to more grant revenue[240](index=240&type=chunk) [Research and Development Expense](index=56&type=section&id=Research%20and%20Development%20Expense) R&D expense increased by **$14.0 million** (**12%**) for H1 2023, mainly due to higher external R&D expenses, partially offset by reduced laboratory supplies Key Financial Data | R&D Expense (in thousands) | June 30, 2023 | June 30, 2022 | $ Change | | :------------------------- | :------------ | :------------ | :------- | | External R&D expenses | $45,833 | $26,496 | $19,337 | | Internal R&D expenses | $86,599 | $91,964 | $(5,365) | | Total R&D expenses | $132,432 | $118,460 | $13,972 | - External R&D increased by **$19.3 million** due to higher CMO fees, drug materials, regulatory/compliance costs, and clinical trial costs[243](index=243&type=chunk) - Other R&D costs decreased by **$8.2 million** due to reductions in laboratory and material supplies[243](index=243&type=chunk) [Selling, General and Administrative Expense](index=56&type=section&id=Selling%20General%20and%20Administrative%20Expense) SG&A expense increased by **$7.5 million** (**13%**) for H1 2023, primarily due to higher legal expenses, personnel costs, and license fees - SG&A expense increased by **$7.5 million** (**13%**) for the six months ended June 30, 2023[243](index=243&type=chunk) - Key drivers included a **$4.2 million** increase in legal expenses, a **$2.9 million** increase in personnel costs, and a **$0.9 million** increase in license fees[243](index=243&type=chunk) - Partially offset by a **$1.0 million** reduction in insurance costs and a **$0.5 million** reduction in IT/software purchases[243](index=243&type=chunk) [Other Expense, Net](index=57&type=section&id=Other%20Expense%2C%20Net) Other expense, net, increased by **$35.8 million** (**161%**) for H1 2023, primarily due to higher interest expense and losses from convertible notes - Other expense, net, increased by **$35.8 million** (**161%**) for the six months ended June 30, 2023[244](index=244&type=chunk) - Main drivers were a **$43.9 million** increase in interest expense, a **$6.8 million** higher loss from convertible notes fair value changes, and a **$2.2 million** higher loss on equity method investment[244](index=244&type=chunk) - Partially offset by a **$17.5 million** higher gain from warrant liabilities fair value changes and **$0.7 million** higher net interest and investment income[244](index=244&type=chunk) [Financial Condition, Liquidity and Capital Resources](index=57&type=section&id=Financial%20Condition%2C%20Liquidity%20and%20Capital%20Resources) ImmunityBio's liquidity decreased significantly to **$46.8 million** by June 30, 2023, relying on equity offerings and related-party notes for substantial future funding needs Key Financial Data | Metric (in millions) | June 30, 2023 | December 31, 2022 | | :------------------- | :------------ | :---------------- | | Cash, Cash Equivalents, and Marketable Securities | $46.8 | $108.0 | - Sources of liquidity include **$211.4 million** available from ATM, **$640.0 million** from shelf registration (reduced to **$565.6 million** after July 2023 offerings), and proceeds from related-party promissory notes (**$59.7 million** in H1 2023) and equity offerings (**$47.0 million** in Feb 2023, **$40.0 million** in July 2023)[247](index=247&type=chunk)[248](index=248&type=chunk)[249](index=249&type=chunk)[251](index=251&type=chunk)[252](index=252&type=chunk)[255](index=255&type=chunk)[256](index=256&type=chunk) - Uses of liquidity include **$802.5 million** in related-party debt (excluding discounts), with **$535.0 million** due by December 31, 2023, and potential contingent value rights (CVRs) payments[259](index=259&type=chunk) - The company is exploring a strategic partnership for N-803 commercialization, with negotiations continuing despite the FDA's CRL[257](index=257&type=chunk)[285](index=285&type=chunk) [Sources of Liquidity](index=57&type=section&id=Sources%20of%20Liquidity) ImmunityBio's liquidity decreased to **$46.8 million** by June 30, 2023, relying on equity offerings and related-party promissory notes for funding Key Financial Data | Liquidity Source (in millions) | June 30, 2023 (Unaudited) | December 31, 2022 | | :----------------------------- | :------------------------ | :---------------- | | Cash, Cash Equivalents, and Marketable Securities | $46.8 | $108.0 | - ATM offering generated **$13.6 million** net proceeds in H1 2023, with **$211.4 million** available for future issuances[247](index=247&type=chunk) - Shelf registration statement had **$640.0 million** available as of June 30, 2023 (reduced to **$565.6 million** after July 2023 offerings)[248](index=248&type=chunk)[249](index=249&type=chunk) - Registered direct offerings provided **$47.0 million** net in Feb 2023 and **$40.0 million** gross in July 2023[251](index=251&type=chunk)[252](index=252&type=chunk) - Related-party promissory notes provided **$59.7 million** net proceeds in H1 2023[255](index=255&type=chunk)[256](index=256&type=chunk) - The company is exploring a strategic partnership for N-803 commercialization, with negotiations ongoing despite the FDA's CRL[257](index=257&

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 ...