ImmunityBio(IBRX) - 2020 Q1 - Quarterly Report

Part I—FINANCIAL INFORMATION Financial Statements This section presents NantKwest's unaudited condensed consolidated financial statements for Q1 2020, detailing a net loss of $18.4 million and an accumulated deficit of $680.6 million Condensed Consolidated Balance Sheets As of March 31, 2020, total assets decreased to $127.0 million from $143.1 million, reflecting a net loss and reduced marketable debt securities Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2020 (Unaudited) | December 31, 2019 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $16,952 | $15,508 | | Marketable debt securities (current & noncurrent) | $23,263 | $37,641 | | Total current assets | $44,125 | $55,757 | | Total assets | $127,023 | $143,123 | | Liabilities & Stockholders' Equity | | | | Total current liabilities | $14,248 | $11,559 | | Total liabilities | $24,428 | $22,444 | | Accumulated deficit | $(680,574) | $(662,191) | | Total stockholders' equity | $102,595 | $120,679 | Condensed Consolidated Statements of Operations For Q1 2020, the company reported minimal revenue and a net loss of $18.4 million ($0.19 per share), a slight increase from $17.9 million in Q1 2019 Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | | :--- | :--- | :--- | | Revenue | $21 | $5 | | Research and development | $13,234 | $12,598 | | Selling, general and administrative | $5,373 | $5,742 | | Loss from operations | $(18,586) | $(18,335) | | Net loss | $(18,383) | $(17,885) | | Net loss per share (basic and diluted) | $(0.19) | $(0.22) | Condensed Consolidated Statements of Cash Flows Net cash used in operating activities was $12.6 million for Q1 2020, offset by $14.2 million from investing activities, resulting in a $1.4 million net increase in cash Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | $(12,596) | $(13,078) | | Net cash provided by (used in) investing activities | $14,163 | $(19,459) | | Net cash (used in) provided by financing activities | $(123) | $39,195 | | Net increase in cash, cash equivalents, and restricted cash | $1,444 | $6,658 | | Cash, cash equivalents, and restricted cash, end of period | $17,131 | $23,658 | Notes to Unaudited Condensed Consolidated Financial Statements Notes detail business, accounting policies, liquidity challenges with an accumulated deficit of $680.6 million, and significant related-party transactions - The company is a clinical-stage immunotherapy firm focused on using Natural Killer (NK) cells to treat cancer and viral diseases. It faces significant liquidity challenges, with an accumulated deficit of approximately $680.6 million and negative operating cash flow of $12.6 million for the quarter. Management believes existing cash and the ability to borrow from affiliates will fund operations for at least the next 12 months[30][33][35] - In January 2020, the company entered into a Cost Allocation Agreement with related party ImmunityBio to jointly conduct a Phase 2 study (QUILT 3.063) for Merkel Cell Carcinoma, combining NantKwest's haNK cells with ImmunityBio's N-803. The parties will split certain study costs equally[78][79] - The company settled securities litigation in 2019 for $12.0 million, of which $10.8 million was funded by insurance carriers. A separate stockholder derivative action was settled for $0.5 million, with half funded by insurance[87][89] - NantKwest has extensive related-party agreements, primarily with entities affiliated with its Chairman and CEO, including shared services, clinical trial, supply, and collaboration agreements[101][102][106] Stock-Based Compensation Expense (in thousands) | Category | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | | :--- | :--- | :--- | | Research and development | $128 | $111 | | Selling, general and administrative | $317 | $1,240 | | Total | $445 | $1,351 | Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's financial condition and operations, focusing on NK cell immunotherapy, the COVID-19 impact, clinical updates, and a Q1 2020 net loss of $18.4 million Overview and COVID-19 Impact NantKwest focuses on its NK cell platform, anticipating COVID-19 will likely slow clinical trial enrollment and delay commercialization - The company focuses on harnessing the innate immune system using its proprietary Natural Killer (NK) cell platform to treat cancer and viral infectious diseases[140] - The COVID-19 pandemic has not materially impacted Q1 2020 results, but is expected to slow future clinical trial enrollment, potentially delaying commercialization timelines and revenue generation[147][149] - The company's most advanced platform, t-haNK, integrates innate killing, antibody-mediated killing (haNK), and CAR-directed killing (taNK) into a single product[151][159] Clinical and Regulatory Update The company received FDA clearance for the QUILT 88 Phase II study in pancreatic cancer and anticipates Q2 2020 regulatory clearance for two COVID-19 related clinical trials - The FDA cleared the IND application for QUILT 88, a Phase II study of PD-L1.t-haNK combined with other therapies for pancreatic cancer[165] - Regulatory clearance is anticipated in Q2 2020 for two COVID-19 clinical trials: one using haNK cells for hospitalized adults and another using mesenchymal stem cells for severe cases[167][169] Results of Operations Net loss increased to $18.4 million in Q1 2020, with R&D expenses rising to $13.2 million and SG&A decreasing to $5.4 million Comparison of Operations (in thousands) | Line Item | Q1 2020 | Q1 2019 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development | $13,234 | $12,598 | $636 | 5% | | Selling, general and administrative | $5,373 | $5,742 | $(369) | (6%) | | Loss from operations | $(18,586) | $(18,335) | $(251) | 1% | | Net loss | $(18,383) | $(17,885) | $(498) | 3% | - The $0.6 million increase in R&D expense was primarily due to a $0.5 million increase in facility and manufacturing validation costs and a $0.4 million increase in depreciation, partially offset by a $0.6 million decrease in amortization expense[196] - The $0.4 million decrease in SG&A expense was mainly driven by a $0.9 million reduction in stock-based compensation expense, as executive grants finished vesting in March 2019[198] Liquidity and Capital Resources As of March 31, 2020, the company held $17.1 million in cash and $23.3 million in marketable securities, expecting sufficient liquidity for the next 12 months - As of March 31, 2020, the company held $17.1 million in cash, cash equivalents, and restricted cash, and $23.3 million in marketable debt securities[201][202] Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | | :--- | :--- | :--- | | Cash used in operating activities | $(12,596) | $(13,078) | | Cash provided by (used in) investing activities | $14,163 | $(19,459) | | Cash (used in) provided by financing activities | $(123) | $39,195 | - Management expects existing cash, marketable securities, and the ability to borrow from affiliated entities will fund operations for at least the next 12 months, supported by the Chairman and CEO's intent to provide additional funds[212] Quantitative and Qualitative Disclosures about Market Risk No material changes to financial market risks related to interest rates, foreign currency, or inflation have occurred since the 2019 Annual Report on Form 10-K - As of March 31, 2020, there have been no material changes to the financial market risks (interest rate, foreign currency, inflation) described in the company's 2019 Annual Report on Form 10-K[219] Controls and Procedures Management concluded that disclosure controls and procedures were effective as of March 31, 2020, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation as of March 31, 2020, the CEO and CFO concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[221] - No changes in internal control over financial reporting during Q1 2020 have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[222] Part II—OTHER INFORMATION Legal Proceedings The company is not currently a party to any legal proceedings expected to have a material adverse effect on its business - The company is not currently a party to any legal proceedings that are expected to have a material adverse effect on the business[227] Risk Factors This section outlines significant investment risks, including historical losses, financing needs, unproven immunotherapy, clinical trial challenges, and related-party reliance Risks Related to Financial Condition and Capital Requirements The company faces significant financial risks, including historical losses, an accumulated deficit of $680.6 million, the need for substantial financing, and COVID-19 impacts - The company is a clinical-stage firm with a history of significant losses, an accumulated deficit of approximately $680.6 million as of March 31, 2020, and expects to incur losses for the foreseeable future[230] - Substantial additional financing is required to complete development and commercialization, and failure to obtain it could force delays, reduction, or termination of its efforts[235] - The COVID-19 pandemic poses significant risks, including potential disruptions to the supply chain, delays in clinical trial enrollment and completion, and adverse effects on the overall economy and capital markets[239][240] Risks Relating to Business and Industry Business risks include reliance on its novel aNK cell platform, intense competition, dependence on senior management and related parties, and significant manufacturing challenges - The company's business success depends on its novel aNK cell platform, which faces significant development, manufacturing, and regulatory challenges[243][244] - The company faces intense competition from numerous well-resourced biopharmaceutical companies in various cell-based immunotherapy approaches[252][253][256] - The company has limited manufacturing experience, may struggle with large-scale or cost-effective production, and relies on third parties for key supplies[288][290] - The Chairman and CEO, Dr. Soon-Shiong, has significant interests in affiliated companies with agreements with NantKwest, potentially creating conflicts of interest[284] Risks Relating to Government Regulation Extensive government regulation poses risks, including potential delays or failure to obtain regulatory approval, ongoing compliance burdens, and uncertainty regarding pricing and reimbursement - Obtaining regulatory approval is challenging, as the FDA's limited experience with cell-based therapies may lengthen the review process, increasing costs and delaying commercialization[333] - Approved products will be subject to continuous regulatory review and cGMP compliance, with non-compliance potentially leading to sanctions, recalls, or market withdrawal[335][336] - Market acceptance and sales depend on adequate coverage and reimbursement from third-party payors, which is uncertain and subject to downward pressure from healthcare reform[344][350] Risks Relating to Intellectual Property Intellectual property risks include uncertain patent protection, challenges in global enforcement, potential third-party infringement claims, and reliance on third-party licenses - The company relies on patents, trade secrets, and agreements for IP protection, but patent applications may not issue, and issued patents may be challenged or invalidated[361] - Protecting intellectual property globally is difficult and expensive, especially in countries with limited legal recourse, and the company suspects illicit use of its NK-92 cell line in China[371][372] - Third-party patent infringement claims could block product commercialization, require substantial damage payments, or necessitate costly licenses[377][378] Risks Relating to Our Common Stock Risks include concentrated ownership by the CEO and affiliates (~67.2%), controlled company status, stock price volatility, reduced disclosure, and potential NOL limitations - As of March 31, 2020, the Chairman and CEO, Dr. Patrick Soon-Shiong, and his affiliates collectively own approximately 67.2% of the outstanding common stock, granting them significant influence over corporate matters[392] - The company's status as a 'controlled company' under Nasdaq rules allows it to forgo certain corporate governance requirements, such as having a majority of independent directors[408] - As an 'emerging growth company' and 'smaller reporting company,' the company can rely on exemptions from certain disclosure requirements, potentially making its common stock less attractive to investors[409] - The company's ability to use its net operating loss (NOL) carryforwards of approximately $291.8 million (federal) and $255.7 million (state) may be limited under IRC Section 382 due to past and future ownership changes[411][412] Unregistered Sales of Equity Securities and Use of Proceeds No unregistered sales of equity securities or issuer purchases of equity securities were reported during the period - There were no unregistered sales of equity securities or issuer purchases of equity securities during the quarter[422][423] Exhibits This section lists exhibits filed with the quarterly report, including an agreement amendment, CEO/CFO certifications, and XBRL data files - Exhibits filed include the First Amendment to the agreement with Immuno-Oncology Clinic, Inc., CEO/CFO certifications under Rule 13a-14(a) and Section 1350, and XBRL data files[428]