ImmunityBio(IBRX) - 2025 Q3 - Quarterly Report

Product Development and Approval - ANKTIVA has been approved by the U.S. FDA and the MHRA for the treatment of adult patients with BCG-unresponsive NMIBC with CIS, with commercial distribution beginning in May 2024[340][341] - The company submitted a supplemental Biologics License Application (sBLA) for BCG-unresponsive papillary NMIBC in March 2025 and received a Request for Information (RTF) letter from the FDA in May 2025[342] - ANKTIVA is being evaluated in multiple oncology indications, including lung, colorectal, prostate, and ovarian cancers, as well as GBM and NHL[342] - Data from clinical trials suggest ANKTIVA may enhance the activity of therapeutic monoclonal antibodies (mAbs) across various tumor types, including lung cancer[343] - The company is exploring ANKTIVA's potential in treating infectious diseases, including HIV and Long COVID[343] - ANKTIVA has shown potential to increase lymphocyte count in healthy adults, indicating its use as a therapy to rescue lymphopenia[343] - Early results from glioblastoma patients treated with ANKTIVA showed 100% disease control, prompting the initiation of a randomized registration trial[352] - ImmunityBio has begun enrollment in a global Phase 3 study for non-small cell lung cancer, evaluating ANKTIVA in combination with other therapies[352] Financial Performance - Q3 2025 total revenue and other income reached $33.7 million, up from $26.4 million in Q2 2025, representing a growth of approximately 27.6%[352] - Product revenue increased by 434% in Q3 2025 compared to Q3 2024, with year-to-date sales totaling $74.7 million[352] - ANKTIVA unit sales volume grew by 467% year-to-date in 2025 compared to fiscal year 2024[352] - As of September 30, 2025, the cash position was $257.8 million, an increase from $153.7 million as of June 30, 2025[352] - Product revenue, net increased by $25.8 million to $31.78 million for the three months ended September 30, 2025, representing a 434% increase compared to the same period in 2024[381] - Total revenue for the three months ended September 30, 2025, was $32.06 million, up 425% from $6.11 million in 2024[380] - Total revenue for the nine months ended September 30, 2025, was $75.0 million, up from $7.2 million in 2024, marking a 943% increase[390] Expenses and Losses - Research and development expense rose by $0.8 million to $51.23 million, a 2% increase compared to $50.44 million in the prior year[384] - Selling, general and administrative expense increased by $0.4 million to $36.28 million, reflecting a 1% rise from $35.92 million in 2024[387] - Loss from operations improved by $24.62 million, resulting in a loss of $55.63 million for the three months ended September 30, 2025, a 31% decrease from the loss of $80.25 million in 2024[380] - The company reported an accumulated deficit of $3.7 billion as of September 30, 2025, with net losses of $289.5 million and $354.4 million for the nine months ended September 30, 2025, and 2024, respectively[354] - Research and development expenses decreased slightly by $0.2 million to $154.7 million, with a significant expected increase in future R&D investments for product candidates and clinical trials[394][395] - Selling, general and administrative expenses decreased by $15.8 million to $111.3 million, primarily due to a reduction in legal and consulting costs[397] Cash Flow and Financing - Cash and cash equivalents, along with marketable securities, increased to $257.8 million as of September 30, 2025, compared to $149.8 million at the end of 2024[400] - The company has $565.6 million available for use under its $750.0 million shelf registration statement filed in 2023[401] - The company generated net proceeds of approximately $74.8 million from a securities purchase agreement on April 7, 2025, involving the sale of 29,024,768 shares of common stock[404] - The Revenue Interest Purchase Agreement (RIPA) generated a gross purchase price of $100.0 million following the FDA approval of ANKTIVA in April 2024[406] - For the nine months ended September 30, 2025, net cash used in operating activities was $234.6 million, compared to $306.1 million for the same period in 2024[412][413] - Net cash used in investing activities for the nine months ended September 30, 2025, was $193.4 million, significantly higher than $22.1 million for the same period in 2024[416][417] - Net cash provided by financing activities was $345.3 million for the nine months ended September 30, 2025, compared to $174.7 million for the same period in 2024[419][420] Future Outlook and Funding Needs - The company expects significant increases in research and development expenses as it continues to invest in clinical trials and product development[372] - The company anticipates ongoing increases in selling, general and administrative expenses as it commercializes ANKTIVA and expands operations[377] - The company expects to incur significant incremental commercialization expenses for product sales, marketing, manufacturing, and distribution as it scales operations[422] - Future funding requirements will depend on various factors, including the ability to generate sufficient revenues from the approved product and other candidates[427] - The company anticipates needing substantial additional funding to support ongoing operations and commercialization efforts[423][424] - The company has obligations to pay approximately $304.0 million in contingent consideration related to the acquisition of Altor, contingent on net sales exceeding $1.0 billion before December 31, 2026[410] - The company is obligated to pay approximately $2.3 million of contingent consideration related to the acquisition of VivaBioCell upon achieving a regulatory milestone[410] - The company may face dilution of ownership interest if additional capital is raised through equity sales or debt conversions[428] - The company has no committed source of additional capital and may need to delay or reduce research and development programs if unable to raise sufficient funds[428] Regulatory and Market Considerations - The company emphasizes the importance of regulatory approvals and market acceptance for its product candidates[334] - The company is awaiting a decision from the NCCN regarding the expansion of BCG-unresponsive NMIBC guidelines to include papillary-only disease[352] - The company must respond to various technological, regulatory, and market developments, which may incur additional costs[429] - There have been no material changes to financial market risks related to interest rates, foreign currency exchange rates, and stock price volatility[440]