10-Q: ImmunityBio Boosts Revenue, Advances Pipeline Amidst Losses

ImmunityBio reports significant product revenue growth driven by ANKTIVA sales, strengthens cash position through equity offerings, and advances its clinical pipeline despite ongoing net losses and regulatory challenges.

Summary

• Product revenue, net, increased by 434% to $31.78 million for the three months ended September 30, 2025, compared to $5.954 million in the same period of 2024.
• Year-to-date product revenue reached $74.71 million, a 976% increase from $6.944 million in the nine months ended September 30, 2024.
• Net loss attributable to common stockholders decreased to $67.253 million for the three months ended September 30, 2025, from $85.729 million in the prior year period.
• Year-to-date net loss attributable to common stockholders was $289.454 million, an 18% improvement from $354.402 million in the nine months ended September 30, 2024.
• Cash and cash equivalents, and marketable securities totaled $257.8 million as of September 30, 2025, up from $149.8 million at December 31, 2024.
• Net cash used in operating activities was $234.6 million for the nine months ended September 30, 2025, an improvement from $306.1 million in the prior year period.
• ANKTIVA unit sales volume grew 467% year-to-date 2025 compared to fiscal year 2024.
• The MHRA granted marketing authorization in the UK for ANKTIVA in combination with BCG for BCG-unresponsive NMIBC with CIS with or without papillary tumors in July 2025, marking the first approval outside the U.S.
• Early results from the first five recurrent glioblastoma patients treated with ANKTIVA plus Optune Gio device in combination with PD-L1 CAR-NK showed 100% disease control, including three responses (two near complete) and two cases of stable disease, with increased lymphocyte counts in all patients.
• Enrollment has begun in ResQ201A, a global, randomized Phase 3 study evaluating ANKTIVA in combination with TEVIMBRA and docetaxel versus docetaxel alone in patients with checkpoint inhibitor-resistant NSCLC.
• Early results from the QUILT.106 trial showed promising complete responses in the first two patients with late-stage Waldenstrom macroglobulinemia treated with CD19 CAR-NK natural killer cell therapy.
• Updated QUILT-3.032 trial data showed durable 36-month progression-free survival and bladder-sparing benefits of ANKTIVA plus BCG for papillary NMIBC.

Sentiment

Score: 6

Explanation: The company shows strong commercial progress with ANKTIVA and promising early clinical data, leading to improved financial metrics like revenue growth and reduced net loss. However, significant regulatory setbacks (RTF for papillary NMIBC), ongoing operational challenges (Dunkirk facility), and substantial reliance on future capital raises and related-party financing temper the overall positive sentiment. The 'going concern' doubt, despite management's confidence, remains a key concern.

Positives

• Product revenue, net, increased by 434% in Q3 2025 compared to Q3 2024, demonstrating strong commercialization momentum for ANKTIVA.
• Year-to-date ANKTIVA sales reached $74.7 million, reflecting significant market penetration and demand.
• Cash and marketable securities increased to $257.8 million, providing enhanced liquidity.
• Net loss decreased by 22% in Q3 2025 and 18% year-to-date, indicating improved operational efficiency and revenue contribution.
• MHRA marketing authorization for ANKTIVA in the UK expands international market access.
• Positive early clinical data for glioblastoma (100% disease control, including near complete responses) and non-Hodgkin lymphoma (promising complete responses) suggest pipeline potential.
• Initiation of a randomized registration trial for second-line GBM patients and a global Phase 3 study for NSCLC indicates advancement of key pipeline candidates.
• ANKTIVA was selected as the preferred drug of choice for NMIBC patients by a large medication contracting organization covering approximately 80 million lives, enhancing market access.
• The company's copay assistance program for ANKTIVA with payments as low as $25 supports patient access.

Negatives

• The company continues to incur significant net losses, with an accumulated deficit of $3.7 billion as of September 30, 2025.
• Substantial doubt exists regarding the ability to continue as a going concern without additional funding or financial support.
• The sBLA for papillary NMIBC received a Refuse to File (RTF) letter from the FDA, requiring a randomized controlled trial (RCT) against chemotherapy, which is a significant setback and delay.
• An ongoing dispute with the Dunkirk Facility's general contractor and a stay related to Athenex's bankruptcy proceedings have impacted construction needs and facility utilization.
• A written notice of non-compliance with the initial employee headcount requirement for the Dunkirk Facility was received from the landlord, potentially leading to lease termination.
• The ongoing shortage of TICE BCG in the U.S. may adversely impact market uptake of ANKTIVA and delay clinical trials.
• The company relies heavily on a limited number of customers for ANKTIVA distribution, exposing it to concentration risk.
• Significant related-party debt of $505.0 million convertible promissory note due December 31, 2027, which is subordinated to RIPA payment obligations, poses refinancing risk.
• The value of outstanding warrants and the revenue interest liability are subject to material fluctuations based on stock price or projected sales, impacting financial results.
• The company is subject to various legal proceedings, including ongoing derivative actions and an arbitration with Shenzhen Beike Biotechnology Co. Ltd., which could incur substantial costs and divert management resources.

Risks

• Inability to successfully commercialize ANKTIVA or any future approved products in the U.S. or internationally.
• Need for additional financing to fund operations, commercialization, and clinical trials, with no assurance of securing it on favorable terms or at all.
• Payment obligations under the Revenue Interest Purchase Agreement (RIPA) may adversely affect financial position and restrict business operations.
• Debt and revenue interest liability could adversely affect cash flows and limit flexibility to raise additional capital.
• Volatility in the value of outstanding warrants and revenue interest liability due to stock price fluctuations or projected sales, impacting financial results and stock price.
• Potential for delays or failure in clinical trials, including the need for additional trials or modifications based on FDA feedback, increasing costs and delaying regulatory approval.
• Ongoing shortage of TICE BCG in the U.S. may adversely impact ANKTIVA market uptake and delay clinical trials.
• Inaccurate projections regarding market opportunities for approved products and product candidates, leading to smaller than estimated actual markets.
• Undesirable side effects, adverse events, or safety risks of product candidates could halt clinical development, delay regulatory approval, or limit commercial potential.
• Difficulties in manufacturing, including process development, quality control, cGMP compliance, or scaling-up, could delay supply or increase costs.
• Reliance on sole or limited source vendors for reagents, specialized equipment, and materials could impair manufacturing and supply.
• Uncertainties regarding market acceptance, public opinion, and third-party reimbursement coverage for novel cell-based therapies and biologics.
• Significant competition from other biotechnology and pharmaceutical companies, potentially rendering products obsolete.
• Failure to obtain orphan drug status or Breakthrough Therapy, Fast Track, or RMAT designations, or inability to maintain benefits if granted.
• Post-marketing requirements and studies mandated by the FDA could require substantial investment and limit commercial prospects.
• Inability to establish effective sales, marketing, and distribution capabilities or secure suitable collaborators.
• Potential conflicts with strategic collaborators or partners, leading to disputes, delays, or loss of intellectual property rights.
• Dependence on senior management, particularly Dr. Soon-Shiong, with potential conflicts of interest due to his involvement in affiliated companies.
• Risks associated with operating in foreign countries, including differing regulatory requirements, economic instability, and compliance with various international laws.
• Failure to meet obligations of the public-private partnership for the Dunkirk Facility, including construction needs and employee headcount, could lead to loss of access or legal claims.
• Failure to comply with U.S. and foreign regulatory requirements, including those for medical devices, environmental, health, and safety laws, could lead to enforcement actions and significant penalties.
• Changes in U.S. patent law or their interpretation could diminish the value of patents, impairing ability to protect inventions.
• Claims that employees, consultants, or contractors have wrongfully used or disclosed trade secrets or asserted ownership of intellectual property.
• Inability to license or acquire new or necessary intellectual property rights or technology from third parties.
• Geo-political actions could increase uncertainties and costs surrounding patent prosecution and enforcement in foreign countries.

Future Outlook

ImmunityBio anticipates continued significant expenses as it expands commercialization of ANKTIVA, seeks regulatory approvals for new indications and markets, and develops other product candidates. The company expects to incur increasing operating expenses for the foreseeable future, with the timing and magnitude of ANKTIVA sales remaining uncertain. Substantial additional funding will be required for ongoing operations, and the company may seek further equity offerings, debt financings, or strategic partnerships. The company believes existing cash, marketable securities, ANKTIVA sales, and potential affiliated loans will fund operations for at least the next 12 months, alleviating going concern doubt. Future funding requirements are dependent on clinical trial progress, regulatory approvals, commercialization success, and intellectual property protection.

Management Comments

• We believe our existing cash and cash equivalents, and investments in marketable securities; sales of our approved product; capital to be raised through equity offerings; and our potential ability to borrow from affiliated entities will be sufficient to fund our operations through at least the next 12 months following the issuance date of the condensed consolidated financial statements based primarily upon our Founder, Executive Chairman and Global Chief Scientific and Medical Officers intent and ability to support our operations with additional funds, including loans from affiliated entities, as required, which we believe alleviates such doubt.
• We expect to continue to incur significant expenses as we seek to expand our business, including commercializing our approved product, seeking regulatory approvals, conducting research and development across multiple therapeutic areas, participating in clinical trial activities, continuing to acquire or in-license technologies, maintaining, protecting and expanding our intellectual property, and increasing our manufacturing capabilities.
• We believe there is potential for ANKTIVA to become a therapeutic foundation across all phases of treatment, including in adjunctive therapy, to amplify, reactivate or extend the efficacy of standard of care.
• We believe that other oncology indications with registration potential for ANKTIVA include other types of NMIBC (BCG-unresponsive papillary, BCG-nave CIS and BCG-nave papillary), lung, colorectal, prostate and ovarian cancers, and GBM and NHL.
• We believe that a universal therapeutic CancerBioShield that leverages the power of its platforms – backbone ANKTIVA, off-the-shelf and autologous NK-cell-based therapies, adenovirus-vectored delivered vaccines, and other technologies – provide benefit and hope not only for patients with cancer but also for those with a high risk of developing cancer.

Industry Context

The biotechnology industry is characterized by intense competition and rapid technological development. ImmunityBio's focus on next-generation immunotherapies and cell therapies, particularly for cancers and infectious diseases, aligns with a growing trend towards leveraging the body's natural immune system. The company's ANKTIVA approval and pipeline advancements in areas like glioblastoma and NSCLC position it within highly competitive oncology markets. The ongoing shortage of TICE BCG, a combination therapy for ANKTIVA, highlights broader supply chain vulnerabilities in the pharmaceutical sector. The increasing scrutiny on drug pricing and the implementation of legislation like the IRA also reflect a challenging regulatory and economic landscape for biopharmaceutical companies, potentially impacting market access and profitability.

Comparison to Industry Standards

• The 434% increase in product revenue for ANKTIVA in Q3 2025 compared to Q3 2024 indicates strong initial commercial uptake, which is a positive sign for a newly approved product in the competitive oncology market, especially for BCG-unresponsive NMIBC.
• The early clinical results for glioblastoma (100% disease control, including near complete responses) and Waldenstrom macroglobulinemia (promising complete responses) with ANKTIVA and CAR-NK therapies are notable, as these are aggressive cancers with high unmet needs and often poor outcomes with existing standards of care. For example, glioblastoma typically has a very poor prognosis, with median survival often less than two years, making any disease control rate of 100% in early trials a significant indicator, though further randomized trials are needed.
• The initiation of a randomized Phase 3 study for NSCLC with ANKTIVA in combination with TEVIMBRA and docetaxel positions ImmunityBio against established checkpoint inhibitors (CPIs) like pembrolizumab (Keytruda) and nivolumab (Opdivo), which are widely used in NSCLC. Demonstrating superiority or non-inferiority in CPI-resistant patients would be a significant achievement in a crowded market.
• The Refuse to File (RTF) letter from the FDA for papillary NMIBC, requiring an RCT against chemotherapy, indicates a higher bar for approval than initially anticipated by the company. This contrasts with some accelerated approval pathways seen for other breakthrough therapies, suggesting the FDA is seeking more robust comparative data for this specific indication, potentially due to the availability of existing chemotherapy options.
• The company's accumulated deficit of $3.7 billion and ongoing negative cash flows from operations are common for early-stage biotechnology companies heavily invested in R&D, but the substantial doubt about going concern highlights a critical need for continued capital infusion, which is a common challenge in the capital-intensive biotech sector.

Corporate Governance

Legal Proceedings

• Shenzhen Beike Biotechnology Co. Ltd. Arbitration: Ongoing arbitration initiated in 2020 for alleged breach of contract related to ANKTIVA licensing in China. Hearing held June 9-13, 2025, with post-hearing briefing continuing through November 2025. ImmunityBio believes claims lack merit.
• Securities Class Action (Salzman v. ImmunityBio, Inc. et al.): Settled for $10.5 million, with final court approval granted on June 16, 2025. Approximately $6.0 million paid by insurers, and the remaining $4.5 million paid by the company during Q2 2025.
• Altor BioScience, LLC, and NantCell, Inc. Matters Against Dr. Hing Wong and HCW Biologics, Inc.: Consolidated arbitration claims and a related Delaware Court of Chancery action were dismissed on December 23 and 24, 2024, following a settlement agreement. The settlement involved HCW transferring certain molecules and intellectual property to ImmunityBio for no monetary consideration.
• Van Luven, Barbieri and Shin Derivative Actions: Three shareholder derivative actions filed between October 2024 and February 2025, alleging breach of fiduciary duty and other claims related to the FDA CRL for ANKTIVA. Consolidated on May 2, 2025, and a settlement agreement for corporate governance reforms and attorneys' fees received preliminary approval on July 29, 2025. Final approval hearing scheduled for November 4, 2025.
• Carlson Derivative Action: Filed November 20, 2024, alleging that September 2023 financing transactions with Dr. Soon-Shiong and affiliates were unfair to the company. Defendants filed a motion to dismiss, and an amended complaint was filed. Defendants' motion to dismiss the amended complaint was filed on July 16, 2025, with a reply brief due November 19, 2025.
• Washington State Attorney General Investigation: Received a request in June 2025 for information and documents relating to the relationship with Access to Advanced Health Institute (AAHI). ImmunityBio is cooperating with the investigation.

Related Party Transactions

• ImmunityBio has a $505.0 million convertible promissory note with Nant Capital, an entity affiliated with Dr. Soon-Shiong, due December 31, 2027, bearing interest at Term SOFR plus 8.0% per annum.
• Dr. Soon-Shiong and his affiliates hold approximately 66.0% of ImmunityBio's common stock outstanding as of September 30, 2025, giving him voting control.
• Dr. Soon-Shiong and his related party hold approximately $139.8 million of net sales CVRs from the Altor acquisition and have irrevocably agreed to receive shares of common stock in satisfaction of their CVRs.
• ImmunityBio has a shared services agreement with NantWorks, an entity controlled by Dr. Soon-Shiong, for corporate, general and administrative, and R&D support services, with charges at cost plus reasonable allocations.
• ImmunityBio leases facility space in Culver City, California, from NantWorks, with license fees of approximately $273,700 per month (subject to annual 3% increase).
• ImmunityBio has multiple agreements with Immuno-Oncology Clinic, Inc. (owned by an officer of the company and managed by NantWorks) to conduct clinical trials.
• ImmunityBio has a supply agreement with NCSC, a 100% owned subsidiary of NantBio, for GMP-in-a-Box bioreactors and consumables.
• ImmunityBio leases facility space in El Segundo, California, from 605 Doug St, LLC, an entity owned by Dr. Soon-Shiong, with base rent of approximately $72,385 per month (subject to annual 3% increase).
• ImmunityBio leases office and cGMP manufacturing facility space in El Segundo, California, from Duley Road, LLC, indirectly controlled by Dr. Soon-Shiong, with base rent of approximately $40,700 per month (subject to annual 3% increase) for one building and approximately $35,800 per month (subject to annual 3% increase) for a second building.
• ImmunityBio leases facility space in El Segundo, California, from 605 Nash, LLC, a related party, with base rent of approximately $20,300 per month for Initial Premises and $170,400 per month for Expansion Premises (both subject to annual 3% increase).
• ImmunityBio leases property in El Segundo, California, from 420 Nash, LLC, a related party, with base rent of approximately $38,250 per month (subject to annual 3% increase).
• A total of 1,638,000 warrants were issued to an affiliate of Dr. Soon-Shiong with an exercise price of $3.24 per share, vesting upon achievement of a performance-based manufacturing capacity condition.

Stakeholder Impact

• Shareholders: Potential for significant dilution from ongoing equity offerings, warrant exercises, and conversion of related-party debt. Dr. Soon-Shiong's controlling interest limits influence on corporate matters. Volatility in stock price is expected due to clinical trial results, regulatory decisions, and financial performance.
• Employees: Continued investment in R&D and commercialization efforts may lead to hiring, but competition for qualified personnel is intense. Reduction-in-force at Dunkirk Facility has impacted employees there.
• Customers (Healthcare Institutions/Specialty Distributors/Pharmacies): ANKTIVA's commercial distribution is expanding, with selection as a preferred drug by a large medication contracting organization. Copay assistance programs aim to improve patient access. However, reliance on a few key customers creates distribution network risks.
• Patients: ANKTIVA's approval in the U.S. and UK provides a new treatment option for BCG-unresponsive NMIBC. Promising early clinical data in glioblastoma and NHL offer hope for future therapies. However, the TICE BCG shortage could limit access to ANKTIVA, and regulatory delays for new indications impact future treatment availability.
• Creditors (Oberland Capital Management LLC and Nant Capital): The RIPA imposes payment obligations and covenants, senior to other indebtedness. The $505.0 million convertible promissory note to Nant Capital is subordinated, posing refinancing risks.
• Regulatory Authorities (FDA, MHRA): Ongoing interactions for approvals, post-marketing commitments, and addressing RTF letters. Compliance with cGMP, GCP, and other regulations is critical to avoid sanctions.

Next Steps

• Continue to evaluate the submission path for papillary NMIBC and hold a meeting with the FDA in December 2025 to discuss potential regulatory paths.
• Await decision from the NCCN regarding the expansion of BCG-unresponsive NMIBC guidelines to include papillary-only disease.
• Initiate a randomized registration trial for second-line Glioblastoma patients based on early positive results.
• Continue enrollment in ResQ201A, a global, randomized Phase 3 study for checkpoint inhibitor-resistant NSCLC.
• Address the construction needs and resolve the employee headcount non-compliance issue at the Dunkirk Facility.
• Seek additional financing through equity offerings, debt financings, or strategic partnerships to fund future operations and development.
• Complete the QUILT 3.032 clinical trial and submit the final report to the FDA by the end of 2029 as part of post-marketing commitments.
• Evaluate the impact of new accounting standards (ASU 2023-09, ASU 2024-03, ASU 2024-04, ASU 2025-05, ASU 2025-06) on future disclosures and financial statements.
• Continue post-hearing briefing for the Shenzhen Beike Biotechnology Co. Ltd. arbitration through November 2025.
• Await final approval hearing for the consolidated derivative action settlement on November 4, 2025.
• Defendants' reply brief in support of the motion to dismiss the Carlson derivative action is due November 19, 2025.
• The amendment to increase authorized common stock is expected to take effect in November 2025.

Key Dates

Recommendation

ImmunityBio presents a mixed financial and operational picture. The significant increase in product revenue from ANKTIVA and promising early clinical data in other oncology indications are strong positives, demonstrating commercial traction and pipeline potential. The improved cash position from recent equity raises provides near-term liquidity. However, the company continues to incur substantial net losses and faces significant challenges, including the FDA's Refuse to File letter for papillary NMIBC, ongoing issues with the Dunkirk manufacturing facility, and a substantial related-party debt. The 'going concern' disclosure, despite management's mitigating factors, highlights inherent financial risks. While there's clear progress, the regulatory hurdles, operational complexities, and continuous need for capital suggest a 'hold' recommendation. Investors should monitor the resolution of regulatory and manufacturing issues, the pace of ANKTIVA's commercial growth, and the outcomes of ongoing clinical trials before considering a stronger position.

Keywords

Biotechnology, Immunotherapy, ANKTIVA, NMIBC, Cancer Treatment, Clinical Trials, FDA Approval, Oncology, Cell Therapy, Financial Results, SEC Filing, Biologics, Pharmaceuticals, Risk Factors, Capital Raise