ImmunityBio(IBRX) - 2021 Q4 - Annual Report

PART I Business ImmunityBio is a clinical-stage biotechnology company developing therapies and vaccines for cancers and infectious diseases Our Business and Strategy 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] - Key strategic elements include advancing the approval of its lead product, Anktiva, and accelerating its immunotherapy platform[37] - The company has 17 first-in-human therapeutic agents being studied in 26 actively recruiting clinical trials across 13 indications[35] Our Next-Generation Platforms 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] - The company is developing multiple vaccine technologies, including self-amplifying RNA (saRNA) and a second-generation human adenovirus (hAd5) vector[40][41][43][44] - 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][49] - The DAMP Inducers platform includes Aldoxorubicin, designed to target immune evasion with lower cardiotoxicity than doxorubicin[53][54] Our Pipeline 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][72] - The company's COVID-19 vaccine program focuses on a dual-antigen (Spike + Nucleocapsid) hAd5 vector to generate T-cell and antibody immunity[87][91] - Multiple HIV studies are active, including a Phase 1 "HIV Cure Study" evaluating Anktiva after interrupting antiretroviral therapy (ART)[94][95] Manufacturing, Competition, and IP 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] - In February 2022, the company acquired a leasehold interest in a 409,000 sq. ft. cGMP manufacturing facility in Dunkirk, New York[106] - 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] - Competition is faced from major pharmaceutical companies in areas such as checkpoint inhibitors, cancer vaccines, and NK cell therapies[113] Collaboration and License Agreements 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] - The company has an exclusive worldwide license from CytRx for aldoxorubicin, with potential milestone payments up to $345.7 million[136] - An exclusive, worldwide license was established with EnGeneIC for its EDV nanocell technology for COVID-19 and certain cancers[137] - The company licensed an RNA vaccine platform from IDRI, involving annual maintenance fees of $5.5 million from 2023-2030[139][140] Government Regulation and Human Capital 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][153] - The company may seek accelerated approval pathways such as Fast Track and Breakthrough Therapy designations to expedite development[165][167] - Post-approval, products are subject to ongoing FDA regulation, including cGMP compliance for manufacturing facilities[176] - As of December 31, 2021, the company had 587 employees, with 45% in manufacturing and quality roles[217] Risk Factors 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][237][247] - The company's Executive Chairman and his affiliates beneficially own approximately 78.7% of the company's common stock, giving him voting control[447] - The company relies on third parties and related parties to conduct clinical trials, exposing it to risks of delays and regulatory scrutiny[232][320][333] - The company's product candidates are novel and face uncertainties regarding development, market acceptance, and reimbursement coverage[251][257][290] Properties 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] Legal Proceedings 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] - Complaints have been filed concerning the recent merger, but the company has not yet been served[481] PART II Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 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] - The company has never paid cash dividends and does not plan to in the foreseeable future[487] - As of December 31, 2021, $18.3 million remained available for share repurchases under the company's stock repurchase program[492] Management's Discussion and Analysis of Financial Condition and Results of Operations 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] - 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] - 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][563] Quantitative and Qualitative Disclosures About Market Risk 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][593] - A hypothetical 100 basis point change in interest rates would not have a material impact on the company's financial statements[591] - The company is exposed to foreign currency exchange risk from its subsidiary in Italy, but this exposure is not currently considered material[594][595] Financial Statements and Supplementary Data 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 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] - The independent auditor, Ernst & Young LLP, issued an unqualified opinion on the effectiveness of the company's internal control over financial reporting[889] - There were no material changes in internal control over financial reporting during the fourth quarter of 2021[890] PART III Directors, Executive Officers, Corporate Governance, Compensation, Security Ownership, and Accountant Fees 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][897][898][899][900] PART IV Exhibits and Financial Statement Schedules 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] - A comprehensive list of exhibits is provided, incorporating by reference or filing herewith documents such as the Merger Agreement and material contracts[905]