ImmunityBio, Inc.
For the period ended Jun 30, 2026. Filed Aug 4, 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.
Jun 30, 2026 · Filed Aug 4, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-07.
0001326110-26-000059
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Future Funding RequirementsCurrent 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 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 251 previous paragraphs and 266 current paragraphs.
173 unchanged; 46 reworded; 36 added; 27 removed; 5 previous and 11 current paragraphs rearranged.
Tables are not compared: 4 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 (36)
Current 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.
Current 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.
Current report
•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 report
•First-half 2026 net product revenue of $94.8 million, up 121% compared with the first half of 2025
Current 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
Current 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
Current 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)
Current 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
Current report
•Glioblastoma: Recurrent GBM (registrational trial planned)
Current report
Research and development expense increased $5.6 million primarily attributable to the following:
Current report
•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 report
•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 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:
Current report
•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 report
•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 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.
Current report
Comparison of the Six Months Ended June 30, 2026 and 2025
Current report
*Not meaningful.
Current report
Other Revenues
Current report
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 report
Cost of Sales
Current report
Research and Development Expense
Current report
Research and development expense increased $25.3 million primarily attributable to the following:
Current report
•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 report
•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 report
•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 report
Selling, General and Administrative Expense
Current 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:
Current report
•a $1.2 million increase in equipment expenses that was primarily due to increased software license fees, software purchases, and IT equipment purchases.
Current report
Other Income (Expense), Net
Current report
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 report
•an increase of $343.0 million from the change in fair value of warrant liabilities mainly driven by the increase in our common stock price that resulted in an increase in the fair value of the warrant liabilities and the issuance of July 2025 warrants, for which there was no comparable activity during 2026, partially offset by warrant exercises during 2026;
Current report
•an increase of $291.2 million from the change in fair value of a related-party convertible note driven by the revaluation loss of $332.6 million mainly associated with the increase in our common stock price during the six months ended June 30, 2026, as compared to the revaluation loss of $41.4 million during the six months ended June 30, 2025;
Current report
•an increase of $4.1 million in interest expense related to the revenue interest liability as a result of the increased RIPA debt principal balance; partially offset by
Current report
Shelf Registration Statement
Removed paragraphs (27)
Previous report
•our ability to develop next-generation therapies and vaccines that complement, harness, and amplify the immune system to defeat cancers and infectious diseases;
Previous report
•our expectations regarding the potential benefits of our Cancer BioShield platform (comprises multiple therapeutic modalities to activate immune response) and our strategy and technology;
Previous report
•our ability to utilize multiple modes to induce cell death in cancers and infectious diseases;
Previous report
•our expectations regarding the development, clinical trials timeline, application, commercialization, marketing, prospects and use generally of our product candidates, including hAd5 constructs, and PD-L1 t‑haNK and M-ceNK;
Previous report
•our ability to successfully address any concerns the FDA may have associated with the sBLA for the BCG-unresponsive NMIBC with papillary tumors indication, and whether or not we will receive a CRL if there is a need for the initiation or design of a new RCT, which we could ultimately be required to complete;
Previous report
•our ability to implement an integrated discovery ecosystem and the operation of that planned ecosystem, including being able to regularly add neoepitopes and subsequently formulate new product candidates;
Previous report
•the ability and willingness of strategic collaborators to share our vision and effectively work with us to achieve our goals;
Previous report
•our ability to produce a cytokine fusion protein, a DNA or recombinant protein vaccine, or a cell therapy;
Previous report
•our belief in the potential of our cytokine fusion proteins, DNA or recombinant protein vaccines, or cell therapies, and the fact that our business is based upon the success individually and collectively of these platforms;
Previous report
•our belief regarding the magnitude or duration for additional clinical testing of our cytokine fusion proteins, DNA or recombinant protein vaccines, or cell therapies, along with other product candidate families;
Previous report
•even if we successfully develop and commercialize specific product candidates, our ability to develop and commercialize our other product candidates either alone or in combination with other therapeutic agents;
Previous report
•the ability to obtain and maintain regulatory approval of our approved product and to obtain and maintain regulatory approval of any of our other product candidates, and any related restrictions, limitations and/or warnings in the label of any approved product candidate;
Previous report
•the accuracy of our estimates regarding our future revenue, as well as our future operating expenses, capital requirements and needs for additional financing;
Previous report
•Q1 2026 Revenue Growth with Continued Strong Sales Momentum: $44.2 million, representing an ~168% year-over-year increase compared with Q1 2025 and up 15% from Q4 2025
Previous report
•ANKTIVA Unit Growth: 168% increase in unit sales volume in Q1 2026 compared to Q1 2025
Previous report
•ANKTIVA Regulatory Update: ANKTIVA is now approved or authorized across five regulatory jurisdictions, representing approximately 34 countries, including first approval in Asia by the ISAF of the Macau Special Administrative Region of the People’s Republic of China. Commercial availability achieved within two months of announcing MENA partnership with Biopharma and Cigalah Healthcare.
Previous report
•Cash Position: $380.9 million in cash, cash equivalents and marketable securities as of March 31, 2026, up from $242.8 million as of December 31, 2025.
Previous report
•Pivotal BCG-Naïve CIS trial (QUILT-2.005): Fully enrolled, with the IDMC confirming no additional enrollment is required. An sBLA submission is on track for 2026.
Previous report
•BCG-Unresponsive NMIBC with Papillary-Only Disease Category 2A NCCN Recommendation: NCCN Clinical Practice Guidelines in Oncology have been updated to include ANKTIVA plus BCG for patients with BCG-unresponsive NMIBC with papillary-only disease in addition to CIS, with or without papillary tumors. Both recommendations are Category 2A, representing uniform consensus.
Previous report
•Glioblastoma: Recurrent GBM (registration trial)
Previous report
Revenue
Previous report
Product Revenue, Net
Previous report
Research and development expense increased $19.8 million primarily attributable to the following:
Previous report
•a $14.6 million increase in external research and development expenses driven by higher clinical trial related costs mainly due to increased fees related to CRO, investigator and lab services, higher consulting fees, contract manufacturing fees, and regulatory expenses;
Previous report
Selling, general and administrative expense increased $13.1 million during the three months ended March 31, 2026, as compared to the three months ended March 31, 2025, primarily attributable to the following:
Previous report
Shelf Registration Statements
Previous report
During 2023, we filed a $750.0 million shelf registration statement with the SEC on Form S-3 for the offering and sale of equity and equity-linked securities, including common stock, preferred stock, debt securities, depositary shares, warrants to purchase common stock, preferred stock or debt securities, subscription rights, purchase contracts, and units. This shelf registration statement expired on February 9, 2026.
Reworded paragraphs (46)
Previous wording
•our ability to obtain incremental approvals for ANKTIVA for new indications, including, without limitation, in BCG-unresponsive NMIBC with CIS, with papillary tumors and NSCLC from the FDA or clearances or approvals from international regulatory agencies for the treatment of patients with NMIBC, NSCLC or other indications;
Current wording
•our ability to successfully commercialize ANKTIVA globally in current and future approved indications (including NMIBC and NSCLC), and to obtain incremental regulatory approvals for new indications (including BCG-unresponsive NMIBC with CIS, with or without papillary tumors, BCG-unresponsive NMIBC papillary only, and NSCLC) from the FDA and applicable international regulatory agencies;
Previous wording
•potential future uses and applications of ANKTIVA, including as a lymphopenia rescue agent in solid tumors or other indications, and use in cancer vaccines and across multiple tumor types;
Current wording
•our expectations regarding the operation and effectiveness of our approved product and product candidates and related benefits, potential future uses and applications of our approved product and product candidates, including potential use in cancer vaccines and across multiple tumor types, and the benefits and uses or our strategy and technology generally;
Previous wording
•our ability to forecast operating results and make period-to-period comparisons predictive of future performance, including due to the impact of fluctuations in warrant, derivative, and fair value accounting measurement values;
Current wording
•our ability to forecast operating results, including estimates regarding our future revenue and operating expenses, and make period-to-period comparisons predictive of future performance, including due to the impact of fluctuations in warrant, derivative, and fair value accounting measurement values;
Previous 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, IND, BLA, NDA or MAA 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
•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;
Previous wording
•our expectations regarding the ease of administration associated with our approved product and product candidates;
Current wording
•our expectations regarding the ease of administration and patient compatibility associated with our approved product and product candidates;
Previous wording
•our expectations regarding the abilities of our international partners to drive commercialization of ANKTIVA in the EU and MENA regions;
Current wording
•our expectations regarding the abilities of our international partners to drive commercialization of ANKTIVA in the EU and Middle East and North Africa regions;
Previous wording
ANKTIVA has been approved by the U.S. FDA, the UK MHRA, the SFDA, and the ISAF of the Macau Special Administrative Region of the People’s Republic of China and has been granted conditional marketing authorization from the EC (EMA) for the EU and Iceland, Liechtenstein, and Norway for use with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors. ANKTIVA has also received 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 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.
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. ANKTIVA has received FDABreakthrough Therapy designation for use in BCG-unresponsive NMIBC with CIS in adult patients, 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 the treatment of BCG-unresponsive NMIBC with CIS, with or without papillary tumors.
Previous wording
ANKTIVA is now approved in the U.S., UK, and Saudi Arabia for BCG-unresponsive NMIBC with CIS, with or without papillary tumors. In February 2026, the European Commission granted conditional marketing authorization in the EU for ANKTIVA for the same indication. In addition, ANKTIVA is conditionally approved in Saudi Arabia, for use in combination with a CPI, for the treatment of adult patients with metastatic NSCLC whose disease has progressed following standard-of-care therapy. The approved labels highlight ANKTIVA’s ability to simultaneously activate NK cells, cytotoxic T cells, and memory T cells.
Current 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 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 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 TNBC.
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, HCC, and triple-negative breast cancer.
Previous wording
The following is a summary of selected significant developments affecting our business that occurred since the filing of our Annual Report dated December 31, 2025 with the SEC on February 23, 2026:
Current wording
The following is a summary of selected significant developments affecting our business that occurred since the filing of our Quarterly Report dated March 31, 2026 with the SEC on May 7, 2026:
Previous wording
•Bladder Cancer: BCG-unresponsive NMIBC with CIS, with or without papillary tumors (approved), BCG-unresponsive papillary, BCG-naïve NMIBC
Current 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
Previous wording
•Lung Cancer: Progressing, metastatic NSCLC in combination with CPIs (accelerated conditional approval in Saudi Arabia)
Current wording
•Lung Cancer: Progressing, metastatic NSCLC in combination with CPIs (marketing authorization from the EDE and accelerated conditional approval from the SFDA)
Previous wording
We anticipate that strategic collaborations will continue to be an integral part of our operations, providing opportunities to leverage our partners’ expertise and capabilities to gain access to new markets for our approved product and acquire new technologies or further expand the potential of our technologies, approved product and product candidates across relevant platforms. We have initiated strategic commercial partnerships in Europe and the Middle East to expand access to our approved product and expect to continue to form additional commercial partnerships in other regions as our business grows.
Current wording
We anticipate that strategic collaborations will continue to be an integral part of our operations, providing opportunities to leverage our partners’ expertise and capabilities to gain access to new markets for our approved product and acquire new technologies or further expand the potential of our technologies, approved product and product candidates across relevant platforms. We have initiated strategic commercial partnerships in Europe and the Middle East to expand access to our approved product and expect to continue to form additional commercial partnerships in other regions as our business grows. We also have a global arrangement with Serum Institute, one of the world’s largest vaccine manufacturers, to supply us with rBCG for use in our clinical development programs, and a development and supply agreement for the U.S. with JBL for Tokyo-172 BCG to address TICE BCG shortages.
Previous wording
Product revenue, net increased $27.7 million during the three months ended March 31, 2026, as compared to the three months ended March 31, 2025, due to an increase in sales of ANKTIVA.
Current 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.
Previous wording
Other revenues increased during the three months ended March 31, 2026, as compared to the three months ended March 31, 2025, primarily due to increased bioreactor related consumable product sales, and increased license royalty income.
Current 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.
Previous wording
Cost of sales increased $0.2 million during the three months ended March 31, 2026, as compared to the three months ended March 31, 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 in relation to product revenues as we deplete these inventories.
Current 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.
Previous wording
Research and development expense increased $19.8 million during the three months ended March 31, 2026, as compared to the three months ended March 31, 2025. The following table summarizes our research and development expense during the three months ended March 31, 2026 and 2025, together with the changes in those items (in thousands):
Current 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):
Previous wording
•a $2.8 million increase in personnel-related costs, primarily due to higher salaries and benefits driven by increased headcount;
Current wording
•a $3.0 million increase in personnel-related costs, primarily due to higher salaries and benefits driven by increased headcount;
Previous wording
•a $2.0 million increase in other research and development costs, primarily due to higher manufacturing costs, higher distribution costs, and higher software license fees driven by more production and clinical trial activities, partially offset by fewer supplies and materials purchases.
Current 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.
Previous wording
•an $8.1 million increase in professional service expenses that was primarily attributable to an increase in legal expenses driven by higher defense costs and litigation settlements, an increase in consulting fees driven by commercialization related services, and an increase in audit and tax fees;
Current 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;
Previous wording
•a $2.1 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 $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;
Previous wording
•a $1.4 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 $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;
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;
Current 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
Previous wording
Total other expense, net increased $497.5 million during the three months ended March 31, 2026, as compared to the three months ended March 31, 2025, primarily attributable to the following:
Current 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:
Previous wording
•an increase of $194.0 million from the change in fair value of a related-party convertible note driven by the revaluation loss of $236.6 million associated with the increase in our common stock price during the three months ended March 31, 2026, as compared to the loss of $42.6 million during the three months ended March 31, 2025;
Current 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;
Previous wording
•an increase of $295.0 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;
Current wording
•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 wording
•a $0.4 million increase in equipment, depreciation, and facility costs, primarily due to higher depreciation and amortization expenses driven by the Dunkirk lease amendment; and
Current wording
•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 wording
•a $0.9 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 $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
Previous wording
•an increase of $4.5 million from the change in fair value of derivative liabilities driven by recurring fair value adjustments at the end of each reporting period;
Current wording
•an increase of $7.1 million from the change in fair value of derivative liabilities driven by recurring fair value adjustments at the end of each reporting period;
Previous wording
•an increase of $5.8 million from the change in other expense, net mainly driven by the write-off of our convertible note receivable and all accrued interest, partially offset by a reclassification of cumulative impact from change in fair value of related-party convertible note related to instrument-specific credit risk associated with the partial conversion of the December 2024 Convertible Promissory Note during the three months ended March 31, 2026;
Current wording
•an increase of $5.4 million in other expense, net, primarily driven by the write-off of our convertible note receivable and all accrued interest, partially offset by a reclassification of the cumulative impact from change in fair value of related-party convertible note related to instrument-specific credit risk associated with the partial conversion of the December 2024 Convertible Promissory Note during the three months ended March 31, 2026;
Previous wording
•an increase of $1.4 million in interest and investment income, net, driven by a higher outstanding balance of treasury security holdings; and
Current wording
•an increase of $3.4 million in interest and investment income, net, driven by a higher outstanding balance of treasury security holdings; and
Previous wording
•a decrease of $0.7 million in interest expense due to a decreased interest rate.
Current wording
•a decrease of $2.2 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.
Previous wording
As of March 31, 2026, we had cash and cash equivalents, and marketable securities of $380.9 million compared to $242.8 million as of December 31, 2025. We have typically invested our cash in a variety of financial instruments and classified these investments as available-for-sale. However, after our entry into the RIPA we can no longer invest our excess funds in corporate or European bonds. Certain of our investments are subject to credit, liquidity, market, and interest-rate risks. The general condition of the financial markets and the economy may increase those risks and may affect the value and liquidity of investments and restrict our ability to access the capital markets.
Current wording
As of June 30, 2026, we had cash and cash equivalents, and marketable securities of $357.4 million compared to $242.8 million as of December 31, 2025. We have typically invested our cash in a variety of financial instruments and classified these investments as available-for-sale. However, after our entry into the RIPA we can no longer invest our excess funds in corporate or European bonds. Certain of our investments are subject to credit, liquidity, market, and interest-rate risks. The general condition of the financial markets and the economy may increase those risks and may affect the value and liquidity of investments and restrict our ability to access the capital markets.
Previous wording
In 2021, we entered into the ATM under which we may offer and sell, from time to time at our sole discretion, shares of our common stock through our sales agent. In December 2025, we filed a prospectus supplement to our shelf registration statement in connection with entering into an amendment to the ATM to increase the amount available for future stock issuances under the ATM to $500.0 million. During the three months ended March 31, 2026, we received net proceeds totaling $102.1 million from the issuance of shares under the ATM. As of March 31, 2026, we had $395.4 million available for future stock issuances under the ATM.
Current wording
In 2021, we entered into the ATM under which we may offer and sell, from time to time at our sole discretion, shares of our common stock through our sales agent. In December 2025, we filed a prospectus supplement to our shelf registration statement in connection with entering into an amendment to the ATM to increase the amount available for future stock issuances under the ATM to $500.0 million. During the three and six months ended June 30, 2026, we received net proceeds totaling $45.1 million and $147.2 million, respectively, from the issuance of shares under the ATM. As of June 30, 2026, we had $349.2 million available for future stock issuances under the ATM.
Previous wording
During the three months ended March 31, 2026, institutional holders exercised a total of 17,191,435 warrants pursuant to the April and July 2025 warrant agreements with exercise prices ranging from $3.101 per share to $3.240 per share resulting in the issuance of 17,191,435 shares of the company’s common stock for proceeds totaling $53.5 million. As of March 31, 2026, a total of 47,862,136 warrants remain outstanding under the warrant agreements. See Note 16 “Warrant Liabilities” of the “Notes to Unaudited Condensed Consolidated Financial Statements” that appears in Part I, Item 1. “Financial Statements” of this Quarterly Report for more information.
Current wording
During the six months ended June 30, 2026, institutional holders exercised a total of 17,191,435 warrants pursuant to the April and July 2025 warrant agreements with exercise prices ranging from $3.101 per share to $3.240 per share resulting in the issuance of 17,191,435 shares of the company’s common stock for proceeds totaling $53.5 million. As of June 30, 2026, a total of 47,862,136 warrants remained outstanding under the warrant agreements. See Note 13 “Warrant Liabilities” of the “Notes to Unaudited Condensed Consolidated Financial Statements” that appears in Part I, Item 1. “Financial Statements” of this Quarterly Report for more information.
Previous wording
During the three months ended March 31, 2026, net cash used in operating activities of $75.4 million consisted of a net loss of $632.8 million and $0.5 million of cash used in net working capital, partially offset by $557.9 million in adjustments for non-cash items. The changes in net working capital consisted primarily of an increase of $5.0 million in inventories, a decrease of $1.9 million in operating lease liabilities, an increase of $1.1 million in other assets, and an increase of $0.7 million in accounts receivable, net, partially offset by an increase of $3.9 million in accounts payable, an increase of $3.1 million in accrued expenses and other liabilities, a decrease of $0.6 million in prepaid expenses and other current assets, and an increase of $0.6 million with related parties. Adjustments for non-cash items primarily consisted of a $295.4 million change in fair value of warrant liabilities, a $236.6 million change in the fair value of a related-party convertible note, $8.3 million of non-cash interest expense related to the revenue interest liability, $8.2 million in stock-based compensation expense, a $7.4 million write-off of a convertible note receivable, $4.4 million in depreciation and amortization expense, and $1.7 million in non-cash lease expense related to operating lease right‑of‑use assets, reduced by $1.5 million of accretion of discounts on marketable debt securities, $1.4 million due to a realized gain on instrument-specific credit risk, a $1.1 million change in the fair value of derivative liabilities, and $0.1 million in non-cash interest.
Current wording
During the six months ended June 30, 2026, net cash used in operating activities of $141.9 million consisted of a net loss of $863.2 million and $1.0 million of cash used in net working capital, partially offset by $722.3 million in adjustments for non-cash items. The changes in net working capital consisted primarily of an increase of $10.9 million in accounts receivable, net, a decrease of $4.0 million in operating lease liabilities, an increase of $4.0 million in inventories, and an increase of $0.7 million in other assets, partially offset by an increase of $11.7 million in accrued expenses and other liabilities, an increase of $3.7 million in accounts payable, a decrease of $2.1 million in prepaid expenses and other current assets, and an increase of $1.1 million with related parties. Adjustments for non-cash items primarily consisted of a $339.6 million change in fair value of warrant liabilities, a $332.6 million change in the fair value of a related-party convertible note, $19.6 million of non-cash interest expense related to the revenue interest liability, $16.7 million in stock-based compensation expense, $8.8 million in depreciation and amortization expense, a $7.4 million write-off of a convertible note receivable, and $3.5 million in non-cash lease expense related to operating lease right‑of‑use assets, reduced by $3.8 million of accretion of discounts on marketable debt securities, $1.4 million due to a realized gain on instrument-specific credit risk, a $0.4 million change in the fair value of derivative liabilities, $0.2 million in other items, and $0.1 million in non-cash interest.
Previous wording
During the three months ended March 31, 2025, net cash used in operating activities of $85.9 million consisted of a net loss of $129.7 million and $22.0 million of cash used in net working capital, partially offset by $65.8 million in adjustments for non-cash items. The changes in net working capital consisted primarily of an increase of $14.7 million in accounts receivable, net, a decrease of $12.9 million in accrued expenses and other liabilities, a decrease of $1.7 million in operating lease liabilities, an increase of $0.2 million in inventories, and an increase of $0.1 million in other assets, partially offset by an increase of $6.4 million in accounts payable, a decrease of $1.1 million in prepaid expenses and other current assets, and an increase of $0.1 million with related parties. Adjustments for non-cash items primarily consisted of a $42.6 million change in the fair value of a related-party convertible note, $13.3 million of non-cash interest expense related to the revenue interest liability, $9.5 million in stock-based compensation expense, $3.8 million in depreciation and amortization expense, $1.6 million in non-cash lease expense related to operating lease right‑of‑use assets, a $0.4 million change in fair value of warrant liabilities, and $0.3 million in other items, reduced by a $5.6 million change in the fair value of derivative liabilities, and $0.1 million in non-cash interest and accretion of discounts on marketable debt securities.
Current wording
During the six months ended June 30, 2025, net cash used in operating activities of $165.7 million consisted of a net loss of $222.2 million and $27.7 million of cash used in net working capital, partially offset by $84.2 million in adjustments for non-cash items. The changes in net working capital consisted primarily of an increase of $19.8 million in accounts receivable, net, a decrease of $4.2 million in accrued expenses and other liabilities, a decrease of $3.6 million in operating lease liabilities, and an increase of $3.1 million in prepaid expenses and other current assets, partially offset by a decrease of $1.6 million in inventories, a decrease of $1.1 million in other assets, and an increase of $0.3 million in accounts payable and related parties. Adjustments for non-cash items primarily consisted of a $41.4 million change in the fair value of a related-party convertible note, $23.3 million of non-cash interest expense related to the revenue interest liability, $19.2 million in stock-based compensation expense, $7.7 million in depreciation and amortization expense, $3.2 million in non-cash lease expense related to operating lease right‑of‑use assets, $0.4 million in other items, and $0.1 million of transaction costs allocable to warrant liabilities, reduced by a $7.5 million change in the fair value of derivative liabilities, a $3.4 million change in fair value of warrant liabilities, $0.1 million in non-cash interest, and $0.1 million of accretion of discounts on marketable debt securities.
Previous wording
During the three months ended March 31, 2026, net cash used in investing activities was $31.7 million, which included cash outflows of $139.1 million for purchases of marketable debt securities, $10.0 million cash paid for other equity securities, and $1.8 million for purchases of property, plant and equipment, partially offset by proceeds of $119.2 million from maturities and sales of marketable debt securities.
Current wording
During the six months ended June 30, 2026, net cash used in investing activities was $139.1 million, which included cash outflows of $303.3 million for purchases of marketable debt securities, $10.0 million cash paid for other equity securities, and $5.3 million for purchases of property, plant and equipment, partially offset by proceeds of $179.5 million from maturities and sales of marketable debt securities.
Previous wording
During the three months ended March 31, 2025, net cash provided by investing activities was $4.1 million, which included proceeds of $5.3 million from maturities of marketable debt securities, partially offset by cash outflows of $1.1 million for purchases of property, plant and equipment, and $0.1 million for purchases of marketable debt securities.
Current wording
During the six months ended June 30, 2025, net cash used in investing activities was $12.0 million, which included cash outflows of $15.2 million for purchases of marketable debt securities and $2.2 million for purchases of property, plant and equipment, partially offset by proceeds of $5.4 million from maturities of marketable debt securities.
Showing the first 40 of 46 pairs. Open the source sections for the rest.
Rearranged current paragraphs (11)
Current report — wording carried from 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.
Current report — wording carried from elsewhere
•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 report — wording carried from elsewhere
•an increase of $2.0 million in interest and investment income, net, driven by a higher outstanding balance of treasury security holdings;
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
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 report — wording carried from elsewhere
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 report — wording carried from elsewhere
We expect our research and development expense to increase significantlyas we pursue label expansions for ANKTIVA in the U.S. and globally, advance our product pipeline, and execute planned clinical trials.
Current report — wording carried from elsewhere
•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 report — wording carried from elsewhere
•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 report — wording carried from elsewhere
•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 report — wording carried from 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.
Rearranged previous paragraphs (5)
Previous report — wording carried elsewhere
•our ability to successfully commercialize ANKTIVA globally in NMIBC, NSCLC or other indications or any future approved products in the U.S. or internationally;
Previous report — wording carried elsewhere
•our expectations regarding the operation and effectiveness of our approved product and product candidates and related benefits;
Previous report — wording carried 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;
Previous report — wording carried elsewhere
•our expectations regarding patient compatibility associated with our approved product and product candidates;
Previous report — wording carried elsewhere
•an increase of $0.3 million in interest expense related to the revenue interest liability; partially offset by