On November 9, 2026 ImmunityBio, Inc. a commercial-stage immunotherapy company, reported continued global expansion, expanded FDA approval, and financial results for the third quarter ended September 30, 2026.

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ImmunityBio continued to advance a broad clinical pipeline spanning bladder cancer, non-small cell lung cancer, and hematologic malignancies with expanded FDA approval and global expansion of ANKTIVA in nonmuscle invasive bladder cancer (NMIBC). ANKTIVA is now approved or authorized in six regulatory jurisdictions, expanding its global footprint to 35 countries, while multiple ongoing clinical and regulatory programs continue to support the Company’s long-term growth strategy.

The Company advanced several key regulatory and clinical programs across its immunotherapy pipeline. It received an expanded label for ANKTIVA in combination with BCG to include adults with BCG-unresponsive NMIBC, including those with papillary-only tumors. In addition, Cohort A of the randomized QUILT-2.005 trial evaluating ANKTIVA in combination with BCG in patients with BCG-naïve NMIBC met its primary endpoint. The Company also initiated its first sales in Europe in early Q4 and obtained approval in Israel in collaboration with its partner, Rafa Laboratories Ltd.

In this quarter (October 2026), ImmunityBio received FDA approval for expanded use of ANKTIVA plus BCG in subjects with BGC-unresponsive nonmuscle invasive bladder cancer (NMIBC). This expanded FDA approval has already been authorized by the Emirates Drug Establishment (United Arab Emirates) and the Company will now pursue global filings for this expanded indication.

The company reported that the primary endpoint for BCG naïve nonmuscle invasive bladder (NMIBC) cancer has been reached in subjects receiving ANKTIVA plus BCG versus those receiving BCG alone. With this positive result the supplemental BLA (sBLA) for BCG naïve NMIBC patients is on track for submission in this quarter.

Global expansion and operational implementation of the launch of ANKTIVA plus BCG in BCG unresponsive NMIBC continues with the approval of ANKTIVA plus BCG in NMIBC in Israel and the first commercial dose administered in Europe.

On October 16, 2026, The Journal of Urology published long-term outcomes from our Phase 2/3 QUILT-3.032 trial of ANKTIVA in combination with BCG in 100 patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors. Among responders, cystectomy avoidance was 84% at 36 months. The median duration of complete response (CR) was 26.6 months, with some responses extending beyond 53 months—emphasizing support for ANKTIVA by a mature dataset.

"The FDA’s recent approval of ANKTIVA plus BCG for papillary-only disease, together with data published in The Journal of Urology showing that more than half of responding patients maintained complete responses beyond 3.5 years, further reinforces the clinical potential of our chemotherapy-free immunotherapy approach and ANKTIVA’s novel mechanism of action," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "We look forward to reviewing the final results from our study in BCG-naïve patients and initiating real-world evidence studies to further characterize ANKTIVA’s clinical impact in NMIBC. We also continued to advance our clinical program in metastatic non-small cell lung cancer, GBM, and hematologic malignancies during the quarter."

Quarterly Financial Highlights

"We continue to see more physicians prescribing ANKTIVA to multiple patients and growing physician interest in our chemotherapy-free approach in the U.S. and Europe," said Richard Adcock, President and CEO of ImmunityBio. "The recent label expansion represents an important opportunity to broaden access to ANKTIVA for a significantly larger patient population. Looking ahead, our QUILT-2.005 trial in BCG-naïve patients offers another potential avenue for expanding the eligible patient population and supporting long-term growth, subject to positive clinical and regulatory approval."

Net product revenue reached $48.7 million, representing 53% year-over-year growth. For the first nine months of 2026, net product revenue totaled $143.6 million, up 92% compared with the first nine months of 2025, and building on full-year 2025 net product revenue of $113.0 million. As of September 30, 2026, the Company had $334.3 million in cash and cash equivalents, and marketable securities.

Cash and Marketable Securities Position

As of September 30, 2026, the Company had consolidated cash and cash equivalents, and marketable securities of $334.3 million.

Third Quarter 2026 Financial Summary

Product Revenue, Net

Product revenue, net increased $17.0 million during the three months ended September 30, 2026, as compared to the three months ended September 30, 2025, due to an increase in sales of ANKTIVA.

Research and Development Expense

Research and development (R&D) expense increased $20.3 million to $71.5 million during the three months ended September 30, 2026, as compared to $51.2 million during the three months ended September 30, 2025, mainly due to increased clinical trial expenses and personnel-related costs, partially offset by decreased manufacturing expenses.

Selling, General and Administrative Expense

Selling, general and administrative (SG&A) expense increased $17.7 million to $54.0 million during the three months ended September 30, 2026, as compared to $36.3 million during the three months ended September 30, 2025, mainly due to increased professional services expenses, personnel-related costs, and commercial-related expenses.

Other Expense, Net

Other expense, net increased $94.9 million to $106.6 million during the three months ended September 30, 2026, as compared to $11.7 million during the three months ended September 30, 2025, primarily due to non-cash changes in the fair value of a related-party convertible note, warrant liabilities, and other derivative liabilities mainly driven by an increase in our common stock price during the quarter, and an increase in interest expense related to the revenue interest liability due to additional funding received in Q1 2026. These changes were partially offset by an increase in interest and investment income combined with a decrease in interest expense due to a lower related-party convertible note balance after a partial loan conversion in Q1 2026.

Net Loss Attributable to ImmunityBio Common Stockholders (Net Loss)

Net loss attributable to ImmunityBio common stockholders was $184.6 million during the three months ended September 30, 2026, as compared to $67.3 million during the three months ended September 30, 2025. The increase in net loss was mainly driven by changes in the fair value of a related-party convertible note, and warrant and derivative liabilities due to an increase in our common stock price during the quarter, higher interest expense related to the revenue interest liability, and higher R&D and SG&A expenses described above, which were partially offset by higher product revenue.

Adjusted Net Loss Attributable to ImmunityBio Common Stockholders (Adjusted Net Loss)

Adjusted net loss attributable to ImmunityBio common stockholders increased $25.5 million to $97.9 million during the three months ended September 30, 2026, as compared to $72.4 million during the three months ended September 30, 2025. Adjusted net loss is a non-GAAP financial measure that excludes the impact of certain items, as shown in the non-GAAP reconciliation table below.

Nine Months Ended 2026 Financial Summary

Product Revenue, Net

Product revenue, net increased $68.9 million during the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025, due to an increase in sales of ANKTIVA.

Research and Development Expense

R&D expense increased $45.6 million to $200.3 million during the nine months ended September 30, 2026, as compared to $154.7 million during the nine months ended September 30, 2025, mainly due to increased clinical trial expenses, contract manufacturing costs, personnel-related costs, and facility costs.

Selling, General and Administrative Expense

SG&A expense increased $40.3 million to $151.6 million during the nine months ended September 30, 2026, as compared to $111.3 million during the nine months ended September 30, 2025, mainly due to increased professional services expenses, personnel-related costs, and commercial-related expenses.

Other Expense, Net

Other expense, net increased $740.1 million to $838.3 million during the nine months ended September 30, 2026, as compared to $98.2 million during the nine months ended September 30, 2025, primarily due to non-cash changes in the fair value of warrant liabilities, a related-party convertible note, and other derivative liabilities mainly driven by an increase in our common stock price during the period, an increase in interest expense related to the revenue interest liability due to additional funding received in Q1 2026, and a one-time write off of a convertible note receivable in Q1 2026. These changes were partially offset by an increase in interest and investment income associated with higher treasury securities holdings combined with a decrease in interest expense due to a lower related-party convertible note balance after a partial loan conversion in Q1 2026.

Net Loss Attributable to ImmunityBio Common Stockholders (Net Loss)

Net loss attributable to ImmunityBio common stockholders was $1.0 billion during the nine months ended September 30, 2026, compared to $289.5 million during the nine months ended September 30, 2025. The increase in net loss was mainly driven by changes in the fair value of a related-party convertible note, and warrant and derivative liabilities due to an increase in our common stock price during the period, higher interest expense related to the revenue interest liability, higher other expense, and higher R&D and SG&A expenses described above, which were partially offset by higher product revenue.

Adjusted Net Loss Attributable to ImmunityBio Common Stockholders (Adjusted Net Loss)

Adjusted net loss attributable to ImmunityBio common stockholders increased $20.2 million to $265.2 million during the nine months ended September 30, 2026, as compared to $245.0 million during the nine months ended September 30, 2025. Adjusted net loss is a non-GAAP financial measure that excludes the impact of certain items, as shown in the non-GAAP reconciliation table below.

(Press release, ImmunityBio, NOV 9, 2026, View Source [SID1234674474])