ImmunityBio, Inc.
For the period ended Sep 30, 2026. Filed Nov 9, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 9, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-04.
0001326110-26-000079
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Future Funding RequirementsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-09.
0001326110-26-000099
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Future Funding RequirementsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 266 previous paragraphs and 271 current paragraphs.
178 unchanged; 65 reworded; 24 added; 20 removed; 3 previous and 4 current paragraphs rearranged.
Tables are not compared: 6 previous and 6 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (24)
Current report
As of November 9, 2026, ANKTIVA is approved or authorized in six regulatory jurisdictions, including the FDA, MHRA, EMA, SFDA, EDE, and MoH, expanding its global footprint to 35 countries, for use in combination with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors.
Current report
As of November 9, 2026, ANKTIVA is approved or authorized in six regulatory jurisdictions, including the FDA, MHRA, EMA, SFDA, EDE, and MoH, expanding its global footprint to 35 countries, for use in combination with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors. Additionally, ANKTIVA has received the following approvals or authorizations:
Current report
•FDA approval and EDE marketing authorization in combination with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with high-grade papillary-only tumors; and
Current report
•SFDA accelerated conditional approval and EDE marketing authorization in combination with checkpoint therapy for adult patients with metastatic NSCLC whose disease has progressed following standard-of-care therapy.
Current report
•Pancreatic cancer; and
Current report
•Prostate cancer.
Current report
•On October 14, 2026, the FDA approved our sBLA expanding the approved indication for ANKTIVA in combination with BCG to include adult patients with BCG-unresponsive NMIBC. This expanded indication now includes adult patients with BCG-unresponsive NMIBC with high-grade papillary-only tumors.
Current report
•In November 2026, we reported that the primary endpoint for Cohort A was met in the randomized QUILT-2.005 trial, and we remain on track to submit an sBLA to the FDA in the fourth quarter of 2026 for ANKTIVA in combination with BCG in patients with BCG-naïve NMIBC.
Current report
•In November 2026, we announced approval in Israel of ANKTIVA in combination with BCG for BCG-unresponsive NMIBC with CIS, with or without papillary tumors, bringing the number of global approvals to 35.
Current report
•In November 2026, we announced that the first patients in Europe have received treatment with ANKTIVA in combination with BCG for BCG-unresponsive NMIBC with CIS, with or without papillary tumors, expanding access to ANKTIVA across the region.
Current report
•In October 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 CIS, with or without papillary tumors. Among responders, cystectomy avoidance was 84% at 36 months. The median duration of complete response was 26.6 months, with some responses extending beyond 53 months—emphasizing support for ANKTIVA by a mature dataset.
Current report
•Sepsis: Critically ill adults with sepsis
Current report
The sum of the components shown in the quarterly and year-to-date fluctuation analyses may not equal the total amount reported in millions due to rounding.
Current report
Research and development expense increased $20.3 million primarily attributable to the following:
Current report
•a $0.9 million increase in equipment, depreciation, and facility costs, primarily due to higher facility costs driven by increased facility security costs and increased common area maintenance fees, and higher equipment purchase costs and maintenance costs, partially offset by lower depreciation expenses, and lower building repair costs; partially offset by
Current report
Selling, general and administrative expense increased $17.7 million during the three months ended September 30, 2026, as compared to the three months ended September 30, 2025, primarily attributable to the following:
Current report
•a $0.7 million increase in other expenses that was primarily attributable to increased depreciation and amortization expenses, insurance costs, postage and freight expenses, and offices supplies; and
Current report
•an increase of $30.7 million from the change in fair value of warrant liabilities mainly driven by the revaluation loss of $15.8 million associated with the increase in our common stock price during the three months ended September 30, 2026, as compared to the revaluation gain of $14.9 million during the three months ended September 30, 2025;
Current report
•a decrease of $0.4 million in other income (expense), net, primarily attributable to fluctuations in various miscellaneous items.
Current report
Comparison of the Nine Months Ended September 30, 2026 and 2025
Current report
Research and development expense increased $45.6 million primarily attributable to the following:
Current report
Selling, general and administrative expense increased $40.3 million during the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025, primarily attributable to the following:
Current report
The sum of the components shown in the year-to-date fluctuation analyses may not equal the total amount reported in millions due to rounding.
Current report
On October 14, 2026, the FDA approved our sBLA expanding the approved indication for ANKTIVA in combination with BCG to include adult patients with BCG-unresponsive NMIBC. This expanded indication now includes adult patients with BCG-unresponsive NMIBC with high-grade papillary-only tumors.
Removed paragraphs (20)
Previous report
ANKTIVA is approved or authorized in five regulatory jurisdictions, expanding its global footprint to 34 countries, for use in combination with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors. ANKTIVA has also received accelerated conditional approval from the SFDA in combination with checkpoint therapy for adult patients with metastatic NSCLC whose disease has progressed following standard-of-care therapy. The approved and conditionally approved labels highlight ANKTIVA’s ability to simultaneously activate NK cells, cytotoxic T cells, and memory T cells.
Previous report
In May 2026, we announced the FDA accepted for review our sBLA for ANKTIVA indicated with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with papillary tumors without CIS and assigned a PDUFA target action date of January 6, 2027. There can be no assurance that the FDA will ultimately approve our sBLA.
Previous report
In July 2026, we announced the EDE of the UAE granted marketing authorization for ANKTIVA indicated with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumours, and BCG-unresponsive NMIBC with papillary tumours without CIS, as well as for ANKTIVA in combination with CPIs for the treatment of adult patients with metastatic NSCLC whose disease has progressed following standard-of-care therapy.
Previous report
•BCG-unresponsive NMIBC with papillary tumors;
Previous report
•Pancreatic cancer;
Previous report
•Prostate cancer; and
Previous report
•Ovarian cancer.
Previous report
•First-half 2026 net product revenue of $94.8 million, up 121% compared with the first half of 2025
Previous report
•In July 2026, we announced the EDE of the UAE granted the broadest marketing authorization for ANKTIVA across BCG-unresponsive NMIBC for CIS and papillary disease and metastatic NSCLC
Previous report
•The FDA accepted for review the company’s sBLA for ANKTIVA indicated with BCG in patients with BCG-unresponsive NMIBC with papillary tumors without CIS and assigned a PDUFA target action date of January 6, 2027
Previous report
•Continued advancement across the clinical pipeline, with multiple anticipated regulatory, clinical, and data milestones expected over the next 12 months, including a planned 2026 sBLA submission for the Phase 2B QUILT-2.005 trial in BCG-naïve NMIBC CIS (with or without papillary tumors)
Previous report
•Entered into an exclusive development and supply agreement with JBL, securing exclusive U.S. rights to develop, import, and commercialize intravesical Tokyo-172 BCG to support long-term supply for patients with NMIBC
Previous report
•Ovarian Cancer: Platinum-resistant ovarian cancer
Previous report
Research and development expense increased $5.6 million primarily attributable to the following:
Previous report
Selling, general and administrative expense increased $9.5 million during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, primarily attributable to the following:
Previous report
•an increase of $48.1 million from the change in fair value of warrant liabilities mainly driven by the increase in our common stock price and a corresponding increase in the fair value of the warrant liabilities;
Previous report
•a decrease of $0.5 million in other income (expense), net, primarily due to income recognized from promotional equipment received during the three months ended June 30, 2026, compared to a loss on asset disposals during the three months ended June 30, 2025.
Previous report
Comparison of the Six Months Ended June 30, 2026 and 2025
Previous report
Research and development expense increased $25.3 million primarily attributable to the following:
Previous report
Selling, general and administrative expense increased $22.6 million during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, primarily attributable to the following:
Reworded paragraphs (65)
Previous wording
•our expectations regarding our ability to utilize the Phase 1/2 aNK, haNK®, taNK, and NK-CAR (t-haNK™) clinical trials data to support the development of our product candidates, including our NK-CAR (t-haNK), MSC, and M-ceNK™ product candidates; the timing or likelihood of regulatory filings or other actions and related regulatory authority responses in the U.S. and jurisdictions outside of the U.S., including any planned meetings, investigational new drug, BLA, NDA or marketing authorization application or similar filings or pursuit of accelerated regulatory approval pathways or orphan drug status and Breakthrough Therapy, Fast Track or RMAT designations and any designation’s impact on BLA submission filing or approval timing and or approval probability;
Current wording
•the timing or likelihood of regulatory filings or other actions and related regulatory authority responses in the U.S. and jurisdictions outside of the U.S., including any planned meetings, investigational new drug, BLA, NDA or marketing authorization application or similar filings or pursuit of accelerated regulatory approval pathways or orphan drug status and Breakthrough Therapy, Fast Track or RMAT designations and any designation’s impact on BLA submission filing or approval timing and or approval probability;
Previous wording
ANKTIVA is approved or authorized in five regulatory jurisdictions, expanding its global footprint to 34 countries, for use in combination with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors. ANKTIVA has also received marketing authorization from the EDE and accelerated conditional approval from the SFDA in combination with checkpoint therapy for adult patients with metastatic NSCLC whose disease has progressed following standard-of-care therapy. Other than as set forth in such specific approved label, our product candidates, including N-803, are investigational agents that are restricted by federal law to investigational use only, and safety and efficacy have not been established by any agency, including, without limitation, the FDA.
Current wording
ANKTIVA has also been approved by the FDA and received marketing authorization from the EDE for use in combination with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with high-grade papillary-only tumors and has also received marketing authorization from the EDE and accelerated conditional approval from the SFDA in combination with checkpoint therapy for adult patients with metastatic NSCLC whose disease has progressed following standard-of-care therapy.
Previous wording
ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 superagonist, ANKTIVA. Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by a portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy.
Current wording
ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 receptor superagonist, ANKTIVA. Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by a portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy.
Previous wording
ANKTIVA is our lead biological product and a first-in-class IL-15 receptor superagonist antibody-cytokine fusion protein. We are commercializing ANKTIVA for the treatment of BCG-unresponsive NMIBC with CIS, with or without papillary tumors.
Current wording
ANKTIVA is our lead biological product and a first-in-class IL-15 receptor superagonist antibody-cytokine fusion protein. We are commercializing ANKTIVA for BCG-unresponsive NMIBC. ANKTIVA in combination with BCG was initially approved by the FDA in April 2024 for the treatment of adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors. On October 14, 2026, the FDA approved our sBLA expanding the approved indication for ANKTIVA in combination with BCG to include adult patients with BCG-unresponsive NMIBC. This expanded indication now includes adult patients with BCG-unresponsive NMIBC with high-grade papillary-only tumors.
Previous wording
We are seeking to expand development of ANKTIVA in combination with current standard-of-care therapies across multiple solid and liquid tumor indications including:
Current wording
We are seeking to increase international approvals of our existing U.S. label and expand the development of ANKTIVA in combination with current standard-of-care therapies across multiple solid and liquid tumor indications including:
Previous wording
In addition, ANKTIVA has been selected by the NCI for evaluation in a cancer prevention study in patients with Lynch syndrome, and we are evaluating the combination of ANKTIVA with other agents in colorectal cancer. The company is also supporting an ongoing EAP for rBCG to help address U.S. supply constraints. We are also establishing or conducting trials in multiple myeloma, HCC, and triple-negative breast cancer.
Current wording
In addition, ANKTIVA has been selected by the NCI for evaluation in a cancer prevention study in patients with Lynch syndrome, and we are evaluating the combination of ANKTIVA with other agents in colorectal cancer. The company is also supporting an ongoing EAP for rBCG to help address U.S. supply constraints. We are also establishing or conducting trials in multiple myeloma, hepatocellular carcinoma, and triple-negative breast cancer.
Previous wording
•Q2 2026 net product revenue of $50.7 million, up 92% year-over-year and 15% sequentially from Q1 2026, marking the eighth consecutive quarter of sequential revenue growth since the commercial launch of ANKTIVA, driven by continued adoption among U.S. urologists and strong market access
Current wording
•Q3 2026 net product revenue of $48.7 million, up 53% year-over-year, driven by continued adoption among U.S. urologists and strong market access
Previous wording
•Bladder Cancer: BCG-unresponsive NMIBC with CIS, with or without papillary tumors (approved), BCG-unresponsive papillary (PDUFA target action date (January 6, 2027)), BCG-naïve NMIBC
Current wording
•Bladder Cancer: BCG-unresponsive NMIBC with CIS, with or without papillary tumors (approved), BCG-unresponsive NMIBC with high-grade papillary-only tumors (approved), BCG-naïve NMIBC, and MIBC
Previous wording
Product revenue, net increased $24.3 million during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, due to an increase in sales of ANKTIVA.
Current wording
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.
Previous wording
Other revenues increased $0.6 million during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, primarily due to increased bioreactor and related consumable product sales.
Current wording
Other revenues decreased $0.2 million during the three months ended September 30, 2026, as compared to the three months ended September 30, 2025, primarily due to decreased bioreactor and related consumable product sales, and decreased license royalty income.
Previous wording
Cost of sales increased $0.2 million during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025. Cost of sales consists primarily of third-party manufacturing, distribution, and overhead costs. All costs associated with the production of ANKTIVA prior to receiving regulatory approval were expensed inresearch and development expense, on the condensed consolidated statement of operations in the period incurred and therefore are not reflected in cost of sales. As a result, our initial product gross margin is higher as our pre-launch inventory costs are not included in the cost of sales. We expect the cost of sales for ANKTIVA to increase and product gross margin to normalize in relation to product revenues as we deplete these inventories.
Current wording
Cost of sales increased $1.1 million during the three months ended September 30, 2026, as compared to the three months ended September 30, 2025, primarily due to an increase in inventory write-offs and increased sales of ANKTIVA. Cost of sales consists primarily of third-party manufacturing, distribution, and overhead costs, and may include charges for excess and obsolete inventory reserves and inventory write-offs. All costs associated with the production of ANKTIVA prior to receiving regulatory approval were expensed inresearch and development expense, on the condensed consolidated statement of operations in the period incurred and therefore are not reflected in cost of sales. As a result, our initial product gross margin is higher as our pre-launch inventory costs are not included in the cost of sales. We expect the cost of sales for ANKTIVA to increase and product gross margin to normalize in relation to product revenues as we deplete these inventories.
Previous wording
Research and development expense increased $5.6 million during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025. The following table summarizes our research and development expense during the three months ended June 30, 2026 and 2025, together with the changes in those items (in thousands):
Current wording
Research and development expense increased $20.3 million during the three months ended September 30, 2026, as compared to the three months ended September 30, 2025. The following table summarizes our research and development expense during the three months ended September 30, 2026 and 2025, together with the changes in those items (in thousands):
Previous wording
•a $1.9 million increase in external research and development expenses, driven by higher clinical trial expenses, and external manufacturing costs, partially offset by lower regulatory expenses and lower external testing expenses;
Current wording
•a $16.6 million increase in external research and development expenses, driven by higher clinical trial expenses, higher consulting fees, and higher contract manufacturing expenses;
Previous wording
•a $3.0 million increase in personnel-related costs, primarily due to higher salaries and benefits driven by increased headcount;
Current wording
•a $5.2 million increase in personnel-related costs, primarily due to higher salaries and benefits, and recruitment costs driven by increased headcount; and
Previous wording
•a $2.4 million increase in other research and development costs, primarily attributable to higher distribution costs driven by higher clinical trial activities, and higher software license fees due to new subscriptions, partially offset by decreased research agreement expenses.
Current wording
•a $2.4 million decrease in other research and development costs, primarily due to decreased material supply purchases, and increased capitalization of overhead costs into inventory, partially offset by increased software license fees.
Previous wording
•a $3.5 million increase in professional service expenses that was primarily attributable to an increase in consulting fees driven by commercialization and marketing related services, and an increase in audit and tax fees, partially offset by a decrease in legal expenses;
Current wording
•a $7.5 million increase in professional services expenses that was primarily attributable to an increase in legal expenses, and an increase in consulting fees driven by commercialization and marketing related services, partially offset by a decrease in audit and tax fees;
Previous wording
•a $4.8 million increase in personnel-related costs including salaries and benefits, commissions, recruiting and training expenses, and travel expenses due to growing sales and marketing activities, partially offset by a decrease in stock-based compensation;
Current wording
•a $6.2 million increase in personnel-related costs, including salaries and benefits, recruiting and training expenses, travel expenses, and stock-based compensation expense due to growth in sales and marketing activities and expansion into new markets;
Previous wording
•a $3.4 million increase in commercial-related expenses that was primarily driven by higher marketing related expenses and higher distribution costs as a result of continued commercialization development and sales growth;
Current wording
•a $3.0 million increase in commercial-related expenses that was primarily driven by higher marketing related expenses and higher distribution costs as a result of continued commercialization development and sales growth;
Previous wording
•a $0.6 million increase in equipment expenses that was primarily due to increased software license fees, and higher IT equipment purchase costs; and
Current wording
•a $0.3 million increase in equipment expenses that was primarily due to increased IT equipment purchase costs.
Previous wording
Other income (expense), net consists primarily of interest and investment income, interest expense, unrealized gains and losses from investments in equity securities, changes in fair value of warrant liabilities, derivative liabilities, and convertible notes, realized gains and losses on debt and equity securities, warrant issuance costs, write-off of a convertible note receivable, and gains and losses on foreign currency transactions.
Current wording
Other income (expense), net consists primarily of interest and investment income, interest expense, unrealized gains and losses from investments in equity securities, changes in fair value of warrant liabilities, derivative liabilities, and convertible notes, realized gains and losses on debt and equity securities, warrant issuance costs, write-off of a convertible note receivable, and gains (losses) on foreign currency transactions.
Previous wording
Total other expense, net, increased $147.7 million during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, primarily attributable to the following:
Current wording
Total other expense, net, increased $94.9 million during the three months ended September 30, 2026, as compared to the three months ended September 30, 2025, primarily attributable to the following:
Previous wording
•an increase of $97.1 million from the change in fair value of a related-party convertible note driven by the revaluation loss of $96.0 million associated with the increase in our common stock price during the three months ended June 30, 2026, as compared to the revaluation gain of $1.1 million during the three months ended June 30, 2025;
Current wording
•an increase of $59.4 million from the change in fair value of a related-party convertible note driven by the revaluation loss of $60.6 million associated with the increase in our common stock price during the three months ended September 30, 2026, as compared to the revaluation loss of $1.2 million during the three months ended September 30, 2025;
Previous wording
•an increase of $3.8 million in interest expense related to the revenue interest liability as a result of the increased RIPA debt principal balance;
Current wording
•an increase of $5.1 million in interest expense related to the revenue interest liability as a result of the increased revenue interest liability principal balance;
Previous wording
•an increase of $2.6 million from the change in fair value of derivative liabilities driven by recurring fair value adjustments at the end of each reporting period; partially offset by
Current wording
•an increase of $1.8 million from the change in fair value of derivative liabilities driven by recurring fair value adjustments at the end of each reporting period; partially offset by
Previous wording
•an increase of $3.4 million in interest and investment income, net, driven by a higher outstanding balance of treasury security holdings; and
Current wording
•an increase of $1.1 million in interest and investment income, net, driven by a higher outstanding balance of treasury security holdings and an increase in interest rates;
Previous wording
•a decrease of $1.4 million in interest expense due to the lower December 2024 Convertible Promissory Note balance, coupled with a decreased interest rate driven by a lower Term SOFR; and
Current wording
•a decrease of $0.6 million in interest expense due to the lower December 2024 Convertible Promissory Note balance, partially offset by an increase in interest rates; and
Previous wording
Product revenue, net increased $51.9 million during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, due to an increase in sales of ANKTIVA.
Current wording
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.
Previous wording
Other revenues increased $0.6 million during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, primarily due to increased bioreactor and related consumable product sales.
Current wording
Other revenues increased $0.4 million during the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025, primarily due to increased bioreactor and related consumable product sales, and increased license royalty income.
Previous wording
Cost of sales increased $0.3 million during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. Cost of sales consists primarily of third-party manufacturing, distribution, and overhead costs. All costs associated with the production of ANKTIVA prior to receiving regulatory approval were expensed in research and development expense, on the condensed consolidated statement of operations in the period incurred and therefore are not reflected in cost of sales. As a result, our initial product gross margin is higher as our pre-launch inventory costs are not included in the cost of sales. We expect the cost of sales for ANKTIVA to increase and product gross margin to normalize in relation to product revenues as we deplete these inventories.
Current wording
Cost of sales increased $1.5 million during the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025, primarily due to an increase in inventory write-offs and increased sales of ANKTIVA. Cost of sales consists primarily of third-party manufacturing, distribution, and overhead costs, and may include charges for excess and obsolete inventory reserves and inventory write-offs. All costs associated with the production of ANKTIVA prior to receiving regulatory approval were expensed in research and development expense, on the condensed consolidated statement of operations in the period incurred and therefore are not reflected in cost of sales. As a result, our initial product gross margin is higher as our pre-launch inventory costs are not included in the cost of sales. We expect the cost of sales for ANKTIVA to increase and product gross margin to normalize in relation to product revenues as we deplete these inventories.
Previous wording
Research and development expense increased $25.3 million during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. The following table summarizes our research and development expense during the six months ended June 30, 2026 and 2025, together with the changes in those items (in thousands):
Current wording
Research and development expense increased $45.6 million during the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025. The following table summarizes our research and development expense during the nine months ended September 30, 2026 and 2025, together with the changes in those items (in thousands):
Previous wording
•a $16.4 million increase in external research and development expenses, primarily due to higher clinical trial expenses, contract manufacturing expenses, and consulting costs, partially offset by lower regulatory expenses;
Current wording
•a $33.0 million increase in external research and development expenses, primarily due to higher clinical trial expenses, contract manufacturing expenses, and consulting costs, partially offset by lower regulatory expenses;
Previous wording
•a $5.8 million increase in personnel-related costs, primarily due to increased salaries, recruiting costs, travel expenses, and decreased net shared service benefits, partially offset by decreased stock-based compensation expenses;
Current wording
•an $11.0 million increase in personnel-related costs, primarily due to increased salaries, recruiting costs, travel expenses, and decreased net shared service benefits, partially offset by decreased stock-based compensation expenses;
Previous wording
•a $0.3 million increase in equipment, depreciation, and facility costs, primarily due to higher depreciation expenses and lease expenses driven by the Dunkirk Lease amendment, and higher facility security costs, partially offset by lower building repair expenses; and
Current wording
•a $1.6 million increase in equipment, depreciation, and facility costs, primarily due to increased facility security costs, higher depreciation expenses and lease expenses driven by the Dunkirk Lease amendment, increased software purchases, equipment purchases and repairs, and increased common area maintenance costs, partially offset by decreased building repair costs; and
Previous wording
•a $0.4 million increase in other research and development costs, primarily due to higher distribution costs, and higher software license fees, partially offset by fewer supplies and materials purchases, and lower research agreement expenses.
Current wording
•an immaterial change in other research and development costs.
Previous wording
•an $11.6 million increase in professional service expenses that was primarily attributable to increased legal expenses, increased consulting fees driven by commercialization and marketing related services, and higher audit and tax fees;
Current wording
•a $19.1 million increase in professional services expenses, primarily attributable to increased legal expenses, increased consulting fees driven by commercialization and marketing-related services, and higher audit and tax fees;
Previous wording
•a $2.7 million increase in personnel-related costs including salaries and benefits, commissions, recruiting and training expenses, and travel expenses due to growing sales and marketing activities, partially offset by a decrease in stock-based compensation;
Current wording
•an $11.0 million increase in personnel-related costs, including salaries and benefits, commissions, recruiting and training expenses, and travel expenses due to growth in sales and marketing activities and expansion into new markets, partially offset by a decrease in stock-based compensation expense;
Previous wording
•a $2.1 million increase in commercial-related expenses that was primarily driven by higher marketing expenses and higher distribution costs as a result of continued commercialization development and sales growth;
Current wording
•a $6.5 million increase in commercial-related expenses, primarily driven by higher marketing related expenses and higher distribution costs as a result of continued commercialization development and sales growth;
Previous wording
•a $1.6 million increase in other expenses that was primarily attributable to a reduction in net shared service benefits, and an increase in depreciation and amortization expenses; and
Current wording
•a $2.1 million increase in other expenses that was primarily attributable to a reduction in net shared service benefits, an increase in depreciation and amortization expenses, and increases in other miscellaneous items; and
Previous wording
•a $1.2 million increase in equipment expenses that was primarily due to increased software license fees, software purchases, and IT equipment purchases.
Current wording
•a $1.6 million increase in equipment expenses that was primarily due to increased IT equipment purchases, software license fees, and software purchases.
Previous wording
Total other expense, net, increased $645.2 million during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, primarily attributable to the following:
Current wording
Total other expense, net, increased $740.1 million during the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025, primarily attributable to the following:
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Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
•our expectations regarding our ability to utilize the Phase 1/2 aNK, haNK®, taNK, and NK-CAR (t-haNK™) clinical trials data to support the development of our product candidates, including our NK-CAR (t-haNK), MSC, and M-ceNK™ product candidates;
Current report — wording carried from elsewhere
Other than as set forth in such specific approved labels, our product candidates, including N-803, are investigational agents that are restricted by federal law to investigational use only, and safety and efficacy have not been established by any agency, including, without limitation, the FDA.
Current report — wording carried from elsewhere
•2026 year-to-date net product revenue of $143.6 million, up 92% year-over-year
Current report — wording carried from elsewhere
FDA Approval of ANKTIVA in combination with BCG for BCG-unresponsive NMIBC
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
•a $0.6 million increase in other expenses that was primarily attributable to a reduction in net shared service benefits, and an increase in depreciation and amortization expenses.
Previous report — wording carried elsewhere
•a $0.7 million increase in equipment, depreciation, and facility costs, primarily due to higher depreciation expenses and lease expenses driven by the Dunkirk Lease amendment; and
Previous report — wording carried elsewhere
Subsequent to June 30, 2026, institutional holders exercised a total of 6,399,171 warrants pursuant to the February and July 2023 warrant agreements at an exercise price of $3.2946 per share resulting in the issuance of 6,399,171 shares of the company’s common stock for proceeds totaling $21.1 million. As of August 4, 2026, no warrants remain outstanding under the February and July 2023 warrant agreements.