Core Insights - ImmunityBio (NASDAQ: IBRX) is focusing on the commercial launch of ANKTIVA (N-803) for treating BCG-unresponsive non-muscle invasive bladder cancer, indicating a strategic positioning for rapid growth in the healthcare sector [2]. Group 1 - The company is leveraging data analytics, technical analysis, and clinical data to manage a diverse portfolio of potential multi-bagger investments in healthcare [1]. - The investment group Compounding Healthcare offers several model healthcare portfolios, a weekly newsletter, a daily watchlist, and a platform for dialogue and questions among investors [2]. - The focus of the investment strategy is on innovative companies that are developing breakthrough therapies and pharmaceuticals, particularly those with catalysts for potential acquisitions [2].

ImmunityBio (IBRX) came out with a quarterly loss of $0.20 per share versus the Zacks Consensus Estimate of a loss of $0.17. This compares to loss of $0.28 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -17.65%. A quarter ago, it was expected that this immunotherapy company would post a loss of $0.16 per share when it actually produced a loss of $0.20, delivering a surprise of -25%. Over the last four quarters, the company h ...

Core Viewpoint - Kuehn Law, PLLC is investigating potential breaches of fiduciary duties by certain officers and directors of ImmunityBio, Inc. (NASDAQ: IBRX), focusing on possible self-dealing that may entitle shareholders to damages and corporate governance reforms [1]. Group 1 - The investigation by Kuehn Law concerns whether ImmunityBio's management acted in the best interests of shareholders [1]. - Shareholders may have the right to seek damages and demand changes in corporate governance practices as a result of the investigation [1]. - The law firm emphasizes the importance of shareholder participation in maintaining the integrity of financial markets [4]. Group 2 - Kuehn Law offers free consultations and covers all case costs for shareholders who wish to participate in the investigation [3]. - Shareholders are encouraged to contact Kuehn Law promptly due to potential time limitations on enforcing their rights [3]. - The firm highlights that shareholder involvement is crucial for ensuring fairness in the financial markets [4].

Core Insights - ImmunityBio's Anktiva received FDA approval in April 2024 for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) [1][8] - The approval is based on significant safety and efficacy results from a late-stage study involving 77 NMIBC CIS patients [8] - Anktiva's unique mechanism of action activates natural killer (NK) and killer T cells, providing a robust immune response against BCG-resistant tumor cells [9] Company Performance - Year to date, ImmunityBio's shares have increased by 44.8%, significantly outperforming the industry, which saw a decline of 4.1% [2] - Following the announcement of insurance coverage for Anktiva, the company's shares gained 16.7% in the past week, enhancing patient access to the drug [16] Clinical Study Results - The study reported a complete response rate of 62%, with the duration of complete response (DOR) exceeding 47 months as of November 2023 [17] - Patients in the study were treated for up to 37 months, with ongoing monitoring for up to five years [3] Product Administration and Supply - Anktiva can be administered by urologists in their offices without special handling, increasing accessibility for patients [18] - ImmunityBio has enough drug substance to produce 170,000 doses of Anktiva, ensuring preparedness for anticipated demand [19] Future Prospects - Initial sales figures for Anktiva combined with BCG are expected to be reported in the second-quarter earnings release in July or August [7] - The company is evaluating Anktiva for other cancer indications and HIV in separate clinical studies [11]

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, 2024 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 ...

ImmunityBio (NASDAQ: IBRX) stock price has gone parabolic as investors cheer the recent approval of Anktiva, its cancer drug. It has risen for two straight days and is now sitting at its highest level since September 2021. It is up by over 770% from its lowest point in 2023, giving it a market cap of almost $6 billion.Are you looking for signals & alerts from pro-traders? Sign-up to Invezz Signals™ for FREE. Takes 2 mins.Future acquisition likely?Copy link to sectionImmunityBio shares have been in a strong ...

ImmunityBio (NASDAQ: IBRX) stock price resumed its strong rally this week after the company achieved a major milestone. After dropping by over 6% in the regular session on Monday, it rebounded by over 20% in the extended session.Are you looking for signals & alerts from pro-traders? Sign-up to Invezz Signals™ for FREE. Takes 2 mins.FDA approves ANKTIVACopy link to sectionThis rally makes ImmunityBio one of the best-performing stocks in Wall Street as it has risen by over 100% in the past 12 months. The jump ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) Commission file number: 001-37507 _____________________________________ IMMUNITYBIO, INC. (Exact name of registrant as specified in its charter) þ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ...

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, 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 i ...

```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&