ImmunityBio — Q3 2026 Earnings Summary
Financial Performance:
- Net product revenue for Q3 2026 reached $48.7 million, a 53% increase year-over-year compared to $31.8 million in Q3 2025.
- Net product revenue for the first nine months of 2026 totaled $143.6 million, up 92% year-over-year compared to $74.7 million in the same period of 2025.
- Total revenue for Q3 2026 was $48.8 million, compared to $32.1 million in Q3 2025.
- Total revenue for the first nine months of 2026 was $144.3 million, compared to $75.0 million in the first nine months of 2025.
- Net loss attributable to common stockholders was $184.6 million for Q3 2026, compared to $67.3 million in Q3 2025.
- Net loss attributable to common stockholders was $1.0 billion for the first nine months of 2026, compared to $289.5 million in the same period of 2025.
- Adjusted net loss for Q3 2026 was $97.9 million, an increase from $72.4 million in Q3 2025.
- Adjusted net loss for the first nine months of 2026 was $265.2 million, an increase from $245.0 million in the same period of 2025.
- Research and development expense increased to $71.5 million in Q3 2026 from $51.2 million in Q3 2025, and to $200.3 million for the first nine months of 2026 from $154.7 million in the same period of 2025.
- Selling, general and administrative expense increased to $54.0 million in Q3 2026 from $36.3 million in Q3 2025, and to $151.6 million for the first nine months of 2026 from $111.3 million in the same period of 2025.
- Other expense, net increased to $106.6 million in Q3 2026 from $11.7 million in Q3 2025, and to $838.3 million for the first nine months of 2026 from $98.2 million in the same period of 2025.
- Cash and cash equivalents, and marketable securities totaled $334.3 million as of September 30, 2026.
- Cash and cash equivalents were $45.1 million and marketable securities were $289.2 million as of September 30, 2026.
- Total liabilities were $1.75 billion as of September 30, 2026, compared to $1.0 billion as of December 31, 2025.
- Total stockholders' deficit was $1.15 billion as of September 30, 2026, compared to a deficit of $500.5 million as of December 31, 2025.
- Operating cash flow for the first nine months of 2026 was $(217.2) million, compared to $(234.6) million in the same period of 2025.
Guidance and Future Outlook:
- The company plans to submit a supplemental Biologics License Application (sBLA) to the FDA in the fourth quarter of 2026 for ANKTIVA in combination with BCG for BCG-naïve NMIBC patients.
- The company intends to initiate real-world evidence studies to further characterize ANKTIVA's clinical impact in NMIBC.
- Management expects the agreement with Japan BCG Laboratory to provide long-term supply of BCG.
- The company anticipates that continued investment in expanding ANKTIVA's global commercial footprint will create additional opportunities across multiple oncology indications.
- The company plans to pursue global filings for the expanded ANKTIVA indication (BCG-unresponsive NMIBC with papillary-only tumors) following authorization by the Emirates Drug Establishment.
Business Segments and Product Lines:
- ANKTIVA received FDA approval on October 14, 2026, expanding its indication to include adult patients with BCG-unresponsive NMIBC with high-grade papillary-only tumors.
- The primary endpoint for Cohort A of the QUILT-2.005 trial was met in November 2026, evaluating ANKTIVA in combination with BCG for BCG-naïve NMIBC.
- ANKTIVA received approval in Israel in November 2026 for BCG-unresponsive NMIBC with CIS, with or without papillary tumors.
- The first patients in Europe received treatment with ANKTIVA in combination with BCG in November 2026.
- ANKTIVA is now approved or authorized in six regulatory jurisdictions, expanding its global footprint to 35 countries.
- Long-term outcomes from the Phase 2/3 QUILT-3.032 trial published in The Journal of Urology showed an 84% cystectomy avoidance rate at 36 months among responders, with a median complete response duration of 26.6 months.
- The company is advancing clinical programs in metastatic non-small cell lung cancer, GBM, and hematologic malignancies.
- Sales of ANKTIVA drove the increase in net product revenue for both the quarter and the nine-month period.
Market and Competitive Landscape:
- Continued adoption of ANKTIVA among U.S. urologists and strong market access contributed to revenue growth.
- The company is expanding commercial access to ANKTIVA in Europe and other international markets.
- The company highlights its chemotherapy-free immunotherapy approach and novel mechanism of action as differentiators.
Risks and Challenges:
- Net loss was significantly impacted by non-cash changes in the fair value of a related-party convertible note, warrant liabilities, and other derivative liabilities, driven by an increase in the company's common stock price.
- Higher interest expense related to the revenue interest liability contributed to increased losses.
- Risks include potential delays in product availability, regulatory approvals, and clinical trial enrollment.
- Risks include the ability to fund ongoing and anticipated clinical trials and the ability to obtain additional financing.
- Risks include potential product shortages, manufacturing disruptions, and evolving most favored nations drug pricing policies.
- Risks include the ability to obtain, maintain, protect, and enforce patent protection and other proprietary rights.
Management Commentary and Tone:
- Patrick Soon-Shiong, Founder and Executive Chairman, stated that the FDA approval and published data reinforce the clinical potential of the chemotherapy-free approach and ANKTIVA's novel mechanism of action.
- Richard Adcock, President and CEO, noted growing physician interest in the chemotherapy-free approach in the U.S. and Europe and described the label expansion as an opportunity to broaden access for a significantly larger patient population.
- Management expressed confidence in the QUILT-2.005 trial results as a potential avenue for expanding the eligible patient population and supporting long-term growth.
Other Key Points:
- The company reported a one-time write-off of a convertible note receivable in Q1 2026, which contributed to the increase in other expense for the nine-month period.
- A partial conversion of a related-party convertible note occurred in Q1 2026, resulting in a lower balance and decreased interest expense.
- The company's cash and cash equivalents, and marketable securities position increased from $242.8 million at December 31, 2025, to $334.3 million at September 30, 2026.
- The company has a revenue interest liability of $426.3 million as of September 30, 2026.
- The company has a related-party convertible note payable at fair value of $834.9 million as of September 30, 2026.
- Company
- IMMUNITYBIO INC
- Sector
- Healthcare
- Industry
- Biotechnology