ImmunityBio(IBRX) - 2025 Q2 - Quarterly Report

Product Approval and Commercialization - ANKTIVA has been approved by the U.S. FDA and the MHRA for use with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS with or without papillary tumors[317]. - ANKTIVA began commercial distribution in May 2024, with marketing authorization granted in the UK in July 2025[322][323]. - The UK’s MHRA approved the marketing authorization application of ANKTIVA in combination with BCG for treating BCG-unresponsive NMIBC with CIS[333]. - The company has begun generating revenue from its approved product ANKTIVA since May 2024, but significant revenue generation is expected to take time[404]. Financial Performance - Q2 2025 revenue reached $26.4 million, a 60% increase from Q1 2025, with year-to-date sales totaling $42.9 million[333]. - Product revenue, net increased by $25.4 million to $26.4 million for the three months ended June 30, 2025, representing a 2569% increase compared to the same period in 2024[364]. - Total revenue for the three months ended June 30, 2025, was $26.4 million, up from $1.0 million in 2024, marking a 2424% increase[363]. - Product revenue, net increased by $41.9 million to $42.93 million for the six months ended June 30, 2025, representing a 4236% increase compared to the same period in 2024[374]. - Total revenue reached $42.94 million, a significant increase of $41.86 million or 3851% from $1.09 million in the prior year[373]. Research and Development - The company is exploring ANKTIVA's potential in multiple oncology indications, including lung, colorectal, prostate, and ovarian cancers, as well as GBM and NHL[324]. - Data from clinical trials suggest ANKTIVA may enhance the activity of therapeutic mAbs, including CPIs like pembrolizumab, across various tumor types[325]. - The company is developing next-generation therapies, including cytokine fusion proteins, DNA and vaccine vectors, and cell therapies[326]. - The company expects research and development expenses to increase significantly in the foreseeable future due to ongoing clinical trials and product development[368]. - The company has incurred significant expenses related to ongoing clinical trials and operations, with expectations of continued high operating expenses[336]. Financial Position and Cash Flow - As of June 30, 2025, the company had a cash position of $153.7 million, with an additional $80 million equity financing closed in July 2025[333]. - The company reported an accumulated deficit of $3.6 billion as of June 30, 2025, with net losses of $222.2 million and $268.7 million for the six months ended June 30, 2025, and 2024, respectively[337]. - The company has $565.6 million available for use under its $750 million shelf registration statement filed in 2023[384]. - For the six months ended June 30, 2025, net cash used in operating activities was $165.7 million, consisting of a net loss of $222.2 million and $27.7 million of cash used in net working capital[395]. - The company reported a net change in cash and cash equivalents of $(5.8) million for the six months ended June 30, 2025[394]. Strategic Initiatives and Collaborations - The company aims to implement an integrated discovery ecosystem to regularly add neoepitopes and formulate new product candidates[311]. - The company has entered into strategic collaborations to leverage partners' expertise and expand market access for its approved products[339]. - The company is seeking to expand the BCG-unresponsive NMIBC guidelines to include papillary-only disease, with a review expected in August 2025[334]. - The company is evaluating its go-to-market strategy for the UK in light of the U.S. Most-Favored-Nation Prescription Drug Pricing policy implemented on May 12, 2025[420]. Operational Commitments and Obligations - The company committed to spend an aggregate of $1.52 billion on operational expenses for the Dunkirk Facility during the initial 10-year term, with an additional $1.50 billion if the lease is renewed[422]. - The maximum amount payable related to contractual commitments for development, regulatory, and commercial milestones is $88.2 million as of June 30, 2025[422]. - The company has material cash requirements to pay related-party affiliates and third parties under various contractual obligations[412]. - The company is obligated to make payments to Oberland associated with revenue interest liability, which do not have a fixed repayment schedule[414]. Future Outlook and Funding Needs - The company anticipates substantial additional funding will be required to support ongoing operations and commercialization efforts[405]. - The company may need to raise additional funds through public or private equity offerings, debt financings, or strategic partnerships to meet future cash needs[409]. - The company expects to incur approximately $304.0 million in contingent consideration to prior Altor stockholders if worldwide net sales of ANKTIVA exceed $1.0 billion before December 31, 2026[392].