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ImmunityBio, Inc.: Q1 FY2026 earnings call

What management said about Q1 FY2026, from the documents filed with the SEC on 7 May 2026: press release. Guidance figures: 1 kept. The quarter’s numbers.

Key takeaways

  • Net product revenue rose sharply year over year: The company reported net product revenue of $44.2 million for the quarter, up about 168% from Q1 2025 and up 15% from $38.3 million in Q4 2025. Full-year 2025 net product revenue was $113.0 million. Source
  • Net loss rose on non-cash fair value changes: Net loss attributable to common stockholders was $632.8 million, versus $129.6 million a year earlier, mainly from a $530.9 million non-cash fair value charge on warrant, derivative and related-party convertible note liabilities tied to a higher stock price. Source
  • Regulatory approvals expanded across five jurisdictions: ANKTIVA is approved or authorized across five regulatory jurisdictions, representing about 34 countries. The release names a first approval in Asia from the Macau authority. Source
  • NCCN guidance covers papillary-only disease: NCCN guidelines now include ANKTIVA plus BCG for BCG-unresponsive NMIBC with papillary-only disease, in addition to CIS, both at Category 2A. Source
  • Cash position rose to $380.9 million: Cash, cash equivalents and marketable securities were $380.9 million at March 31, 2026, up from $242.8 million at December 31, 2025. Source
  • BCG-naive CIS trial fully enrolled: The pivotal BCG-naive CIS trial (QUILT-2.005) is fully enrolled, and the IDMC confirmed no further enrollment is needed, supporting the planned 2026 sBLA submission. Source

“We continue to see strong demand for ANKTIVA from both new prescribers and physicians expanding use across multiple eligible patients, including in the maintenance setting.”

Richard Adcock, President and CEO of ImmunityBio

Guidance

AreaPeriodFigureAgainst last quarter
Supplemental BLA submission (BCG-naive CIS) Source2026on track for 2026Kept

What changed from last quarter

  • New: Cash, cash equivalents and marketable securities were reported as $380.9 million as of March 31, 2026, a change from the preliminary estimate given in the April 9 release, which described the figure as estimated.
  • New: ANKTIVA commercial availability was reported in Saudi Arabia, and the company stated it was achieved within two months of the MENA partnership announcement. Source
  • New: The first approval in Asia was reported, granted by the Pharmaceutical Administration Bureau of Macau. Source
  • New: NCCN guideline update was described as now covering ANKTIVA plus BCG for BCG-unresponsive NMIBC with papillary-only disease, with Category 2A for both recommendations. Source
  • New: The pivotal BCG-naive CIS trial (QUILT-2.005) was reported as fully enrolled, with the IDMC confirming no additional enrollment is required. Source

Results and growth drivers

  • Net product revenue rose sharply year over year: The company reported net product revenue of $44.2 million for the quarter, up about 168% from Q1 2025 and up 15% from $38.3 million in Q4 2025. Full-year 2025 net product revenue was $113.0 million. Source
  • ANKTIVA unit volume grew 168%: Unit sales volume of ANKTIVA rose 168% in Q1 2026 compared with Q1 2025. Source
  • Net loss rose on non-cash fair value changes: Net loss attributable to common stockholders was $632.8 million, versus $129.6 million a year earlier, mainly from a $530.9 million non-cash fair value charge on warrant, derivative and related-party convertible note liabilities tied to a higher stock price. Source
  • Adjusted net loss was broadly flat: Adjusted net loss attributable to common stockholders was $86.2 million, compared with $82.7 million in Q1 2025, an increase of $3.6 million. Source

Segments and regions

  • Regulatory approvals expanded across five jurisdictions: ANKTIVA is approved or authorized across five regulatory jurisdictions, representing about 34 countries. The release names a first approval in Asia from the Macau authority. Source
  • Saudi Arabia commercial availability reached: ANKTIVA became commercially available in Saudi Arabia within two months of the announced MENA partnership with Biopharma and Cigalah Healthcare. Source

“The full enrollment of our pivotal BCG-naïve NMIBC trial, with independent confirmation that no additional patients are required, supports our planned sBLA submission in 2026.”

Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio

Products and customers

  • Demand from new and existing prescribers: Management said it sees strong demand from new prescribers and physicians expanding use across multiple eligible patients, including in the maintenance setting. Source
  • NCCN guidance covers papillary-only disease: NCCN guidelines now include ANKTIVA plus BCG for BCG-unresponsive NMIBC with papillary-only disease, in addition to CIS, both at Category 2A. Source

Costs, margins and pricing

  • R&D expense increased on trial and headcount costs: R&D expense rose $19.8 million to $68.0 million, mainly from higher clinical trial costs, headcount-related costs, consulting fees and external manufacturing costs. Source
  • SG&A expense increased on commercial spending: SG&A expense rose $13.1 million to $45.8 million, mainly from professional services, headcount-related costs, commercial-related expenses, other expense and equipment expense. Source
  • Other expense driven by fair value changes: Other expense, net rose to $563.0 million from $65.5 million, mainly from non-cash fair value changes in warrant, derivative and related-party convertible note liabilities, plus a one-time write-off of a convertible note receivable. Source

Demand and the order book

  • Revenue growth attributed to commercial activity: Product revenue rose $27.7 million, attributed to higher net trade sales of ANKTIVA from ongoing commercial activities. Source

Capital, cash and returns to shareholders

  • Cash position rose to $380.9 million: Cash, cash equivalents and marketable securities were $380.9 million at March 31, 2026, up from $242.8 million at December 31, 2025. Source
  • Financing inflow lifted cash balance: Net cash provided by financing activities was $223.9 million in the quarter, against net cash used in operating activities of $75.4 million. Source
  • Stockholders' deficit deepened: Total ImmunityBio stockholders' deficit was $870.0 million at March 31, 2026, against $500.5 million at December 31, 2025, with total liabilities of $1,515.8 million. Source

Strategy and investment

  • BCG-naive CIS trial fully enrolled: The pivotal BCG-naive CIS trial (QUILT-2.005) is fully enrolled, and the IDMC confirmed no further enrollment is needed, supporting the planned 2026 sBLA submission. Source
  • NSCLC and cell therapy programs advancing: Management said the NSCLC program is advancing in a randomized trial for patients who progressed after prior checkpoint inhibitor therapy, alongside CD19-targeted therapies and PD-L1 t-haNK in glioblastoma. Source

People and leadership

  • More experienced commercial organization: Management said the company enters Q2 with a strong cash position, growing revenues and a more experienced commercial organization positioned to support continued growth. Source

Coming up, as management said on 7 May 2026

  • BCG-naive sBLA submission: Management said the supplemental BLA for the BCG-naive CIS indication is on track for 2026. Source
  • Additional market launches: Management said additional markets for ANKTIVA are anticipated this year. Source

Earlier plans management reported on

  • On track: The supplemental BLA submission was described as on track for 2026, consistent with the prior quarter's statement. Source
  • Met: The April 9 preliminary net product revenue of approximately $44.2 million matches the $44.2 million reported in this release. Source

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.