ImmunityBio, Inc.
For the period ended Jun 30, 2025. Filed Aug 5, 2025.
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, 2025 · Filed Aug 5, 2025
IBRX$8.64+7.8%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-12.
0001326110-25-000071
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Future Funding RequirementsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-05.
0001326110-25-000114
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 240 previous paragraphs and 261 current paragraphs.
188 unchanged; 40 reworded; 25 added; 12 removed; 0 previous and 8 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 (25)
Current report
•whether the NCCN will review and/or approve our submission for BCG-unresponsive NMIBC papillary on the anticipated timeline or at all;
Current report
In July 2025, the MHRA granted marketing authorization in the UK for ANKTIVA in combination with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS with or without papillary tumors. This is the first marketing approval outside the U.S. for ANKTIVA.
Current report
•Q2 2025 Revenue Growth with Continued Strong Sales Momentum: $26.4 million, up 60% from Q1 2025, with year to date sales of $42.9 million.
Current report
•ANKTIVA Unit Growth Since J-code: 246% unit sales volume growth in the first half of 2025 compared to the second half of 2024.
Current report
•Cash Position: $153.7 million in cash, cash equivalents and marketable securities as of June 30, 2025, with additional $80 million equity financing closed in July 2025, with warrants which could result in an additional gross proceeds of up to approximately $96.0 million.
Current report
•NSCLC: ImmunityBio has launched ResQ201A, a randomized controlled trial, in the U.S., evaluating its IL-15 superagonist N-803 in combination with tislelizumab, a PD-1 CPI from BeOne Medicines in patients with second-line lung cancer who were progressing on CPIs. The company has also submitted clinical trial applications for ResQ201A in the EU and the UK, with Canada expected to be submitted in early Q3 2025, and with plans underway to submit in Asia.
Current report
•Lymphopenia: The company met with the Division of Non-Malignant Hematology at the FDA in June 2025 to present updated data from its lymphopenia program. The Division was supportive of the findings including the underlying science of stimulating lymphocytes with ANKTIVA and expressed a desire to support an efficient path to approval, noting that additional time will be required to finalize the appropriate development plan. EAP authorization has been activated for the indication for all solid tumors in patients who have failed first-line treatment on chemotherapy, radiotherapy or immunotherapy and exhibit low absolute lymphocyte counts (ALC < 1,000/μL).
Current report
•Lynch Syndrome: Full enrollment reached in the randomized NCI cancer prevention clinical trial using ANKTIVA in combination with adenovirus vaccine in 186 patients with Lynch Syndrome.
Current report
•UK’s MHRA approved marketing authorization application of ANKTIVA in combination with BCG for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer with CIS with or without papillary tumors.
Current report
•Papillary NMIBC: ImmunityBio conducted a Type A meeting with the FDA in June 2025 to discuss its program targeting papillary-only NMIBC and the FDA’s response to the sBLA filing. Contrary to the advice the FDA gave the company in January 2025 to submit the sBLA, the FDA responded with an RTF notice in May 2025 on the basis of requiring a RCT against chemotherapy. At the June 2025 meeting, ImmunityBio provided new data regarding the updated results since the initial BLA filing of papillary-only data as well as real-world data of chemotherapy just published in this indication. In the papillary-only NMIBC new data based on 26 of the 100 subjects in Cohort A and 80 subjects in Cohort B (Papillary Alone) of our QUILT-3.032 trial, demonstrated long-term (36-month) progression free survival and bladder sparing with ANKTIVA in combination with BCG. ImmunityBio presented the newly published real-world data, which demonstrates that compared to chemotherapy, ANKTIVA in combination with BCG led to improved outcomes of progression-free survival and cystectomy avoidance at 36-months. To our knowledge, the results to date of ANKTIVA in combination with BCG represent the longest duration of follow-up with the longest duration of bladder sparing in these subjects. The company indicated at the meeting that it would seek a new meeting request with this new data and withdraw the prior sBLA filing; however, the company is re-evaluating this approach in consultation with its regulatory counsel and may seek to amend the initial filing with the new data rather than withdrawing it, with a commitment to initiate a RCT of chemotherapy-free ANKTIVA in combination with BCG versus chemotherapy in the Papillary Alone indication.
Current report
In addition, ImmunityBio has applied to the NCCN to seek expansion of the BCG-unresponsive NMIBC guidelines to include papillary-only disease, in addition to the currently recognized CIS with or without papillary disease. The NCCN is expected to review the submission at its August 2025 meeting.
Current report
Research and development expense increased $4.1 million primarily attributable to the following:
Current report
Comparison of the Six Months Ended June 30, 2025 and 2024
Current report
Research and Development Expense
Current report
•a $5.4 million decrease in external research and development expense that was primarily due to a reduction in outside service costs, and a reduction in CMO fees and drug materials purchased and used in manufacturing, partially offset by an increase in clinical trial costs; and
Current report
•a $0.3 million decrease in personnel-related costs that was primarily due to a decrease in stock-based compensation costs driven by vesting completion of prior year grants, partially offset by an increase in salary and benefits expense due to new hires, and a decrease in shared service costs charged out during the six months ended June 30, 2025; partially offset by
Current report
•a $0.2 million increase in equipment, depreciation, and facility costs that was primarily due to an increase in facility costs mainly driven by building repairs, partially offset by decreased depreciation expenses due to fully depreciated fixed assets, and decreased software subscription expenses; and
Current report
•a $4.5 million increase in other research and development costs, primarily attributable to higher manufacturing cost due to increased production activities, and increased license fees due to new subscriptions, partially offset by decreased sponsored research agreements.
Current report
Selling, General and Administrative Expense
Current report
Selling, general and administrative expense decreased $16.1 million during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024. The decrease in selling, general and administrative expense was primarily driven by adecrease of$28.2 million in legal expenses, driven by lower defense costs and litigation settlements, adecrease of$7.4 million in consulting costs primarily driven by insourced related functions, anincrease of$0.6 million in net benefit from shared service costs, and a decrease of $0.4 million in audit and tax fees, partially offset by an $11.4 million increase in recruiting and training expenses, salaries, benefits and commissions, and travel expenses due to growing sales and marketing activities, a$3.3 million increase in stock-based compensation expense primarily due to new grants, a $2.8 million increase in marketing and public relations expenses, an $0.8 million increase in facility costs, a $0.7 million increase in license fees, a $0.7 million increase in distribution cost, a $0.5 million increase in other operating costs, and a $0.3 million increase in depreciation expenses.
Current report
Other expense, net increased $12.3 million during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024. The increase in other expense, net was primarily driven by a $41.4 million increase from the changein fair value of a related-party convertible note, an increase of$11.0 million due to the change in fair value of derivative liabilities, an increase of $9.7 million in interest expense related to the revenue interest liability, a decrease of $3.0 million in interest and investment income, and an increase of$0.2 million in other expense, net, partially offset by a decrease of$28.5 million in interest expensedue to the lower outstanding balance of related-party debt and no amortization of related-party notes discounts as a result of December 2024 debt extinguishment, anda decrease of $24.5 million due to the change in fair value of warrant liabilities.
Current report
At-the-Market Offering
Current report
In April 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. During the three and six months ended June 30, 2025, we received net proceeds totaling $98.2 million from the issuance of shares under the ATM. As of June 30, 2025, we had $195.8 million available for future stock issuances under the ATM.
Current report
UK MHRA Approves ANKTIVA plus BCG for BCG-Unresponsive NMIBC CIS
Current report
In July 2025, the UK MHRA granted marketing authorization for ANKTIVA in combination with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS with or without papillary tumors. This is the first marketing approval we have received outside the U.S. for ANKTIVA. In light of the U.S. Most-Favored-Nation Prescription Drug Pricing policy implemented on May 12, 2025, we are actively evaluating our go-to-market strategy for the UK.
Removed paragraphs (12)
Previous report
•For the three months ended March 31, 2025—marking the first quarter with a permanent J-code that streamlined billing and reimbursement for prescribing providers—ImmunityBio achieved net product revenue of approximately $16.5 million, representing a 129% increase over $7.2 million in Q4 2024.
Previous report
•ANKTIVA unit sales volume in Q1 2025 grew 150% over Q4 2024, with monthly volume in March up 69% over February.
Previous report
•Nearly 200 urology practices across the United States are in the process of registering for ImmunityBio’s rBCG EAP, reflecting continued progress in ImmunityBio’s efforts to address the BCG shortage and broaden the market for ANKTIVA.
Previous report
•The company completed a $75 million equity financing in April 2025 to support ongoing operations.
Previous report
•In January 2025, an in-person meeting was held with leadership of CBER, CDER and OCE of the FDA, at which we provided the long-term cystectomy avoidance response rate results in papillary disease in patients with BCG-unresponsive NMIBC as well as a disease-specific overall survival rate of 99% at 12 months and 96% at 36 months. At this meeting, the leaders were asked, in light of these results, whether we should proceed with an sBLA based on our single-arm QUILT 3.032 clinical trial despite the FDA’s prior guidance that a randomized trial would be required. The FDA leaders present unanimously confirmed that ImmunityBio should expeditiously submit an sBLA for use of ANKTIVA plus BCG in BCG-unresponsive NMIBC for the indication of papillary disease. In March 2025, we submitted this sBLA based on data from the QUILT 3.032 clinical trial, consistent with the Agency’s recent guidance from the January 2025 meeting. On May 2, 2025, we received an RTF letter from the FDA for the sBLA stating that a randomized trial is required. This position is inconsistent with the guidance received at the January 2025 meeting. We are working to reconcile the inconsistency with the FDA as expeditiously as possible.
Previous report
Other Income (Expense), Net
Previous report
Other Revenues
Previous report
Other Income (Expense), Net
Previous report
•our ability and the time required to successfully commercialize our approved product;
Previous report
RTF Letter from the FDA for sBLA for BCG-Unresponsive NMIBC Papillary Disease
Previous report
In January 2025, an in-person meeting was held with leadership of CBER, CDER and OCE of the FDA, at which we provided the long-term cystectomy avoidance response rate results in papillary disease in patients with BCG-unresponsive NMIBC as well as a disease-specific overall survival rate of 99% at 12 months and 96% at 36 months. At this meeting, the leaders were asked, in light of these results, whether we should proceed with an sBLA based on our single-arm QUILT 3.032 clinical trial despite the FDA’s prior guidance that a randomized trial would be required. The FDA leaders present unanimously confirmed that ImmunityBio should expeditiously submit an sBLA for use of ANKTIVA plus BCG in BCG-unresponsive NMIBC for the indication of papillary disease. In March 2025, we submitted this sBLA based on data from the QUILT 3.032 clinical trial, consistent with the Agency’s recent guidance from the January 2025 meeting. On May 2, 2025, we received an RTF letter from the FDA for the sBLA stating that a randomized trial is required. This position is inconsistent with the guidance received at the January 2025 meeting. We are working to reconcile the inconsistency with the FDA as expeditiously as possible.
Reworded paragraphs (40)
Previous wording
•our ability to successfully commercialize ANKTIVA or any future approved products;
Current wording
•our ability to successfully commercialize ANKTIVA or any future approved products in the U.S. or internationally;
Previous wording
•our expectations regarding the development, application, commercialization, marketing, prospects and use generally of our product candidates, including hAd5 constructs, and PD-L1 t‑haNK and M-ceNK;
Current wording
•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 wording
•our ability to timely address the May 2025 RTF letter received from the FDA for the sBLA for the BCG-unresponsive NMIBC papillary indication;
Current wording
•our ability to successfully address the May 2025 RTF letter received from the FDA for the sBLA for the BCG-unresponsive NMIBC papillary indication and related FDA meeting stating that a randomized trial against chemotherapy is required, the approach to which we are continuing to evaluate;
Previous wording
ImmunityBio, ImmunityBio Care, ANKTIVA, ThAnktiva, haNK, taNK, ceNK, NK-92, Nant Cancer Vaccine, NANT 001, NANT XL, NANT 001 and Design, QUILT, Outsmart Your Disease, Smart Therapies for Difficult Diseases, NantKwest, VivaBioCell, and Infacell are trademarks or registered trademarks of ImmunityBio, Inc., its subsidiaries and affiliates.
Current wording
ImmunityBio, ImmunityBio Care, ANKTIVA, ThAnktiva, haNK, taNK, ceNK, NK-92, Nant Cancer Vaccine, CancerBioShield, BioShield (and other BioShield-related trademarks), NANT 001, NANT XL, NANT 001 and Design, QUILT, Outsmart Your Disease, Smart Therapies for Difficult Diseases, NantKwest, VivaBioCell, and Infacell are trademarks or registered trademarks of ImmunityBio, Inc., its subsidiaries and affiliates.
Previous wording
ANKTIVA has been approved by the U.S. FDA for use with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS with or without papillary tumors. 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 the FDA.
Current wording
ANKTIVA has been approved by the U.S. FDA and the MHRA for use with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS with or without papillary tumors. 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
ImmunityBio is a vertically-integrated biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. The company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates natural killer cells, T cells, and memory T cells for a long duration response. The company is applying our science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.
Current wording
ImmunityBio is a vertically-integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long duration response. The company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.
Previous wording
ANKTIVA was approved by the FDA in 2024 for use in the United States with BCG for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer with CIS with or without papillary tumors. We began commercial distribution of our approved product in May 2024.
Current wording
ANKTIVA was approved by the FDA in 2024 for use in the U.S. with BCG for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer with CIS with or without papillary tumors. We began commercial distribution of our approved product in May 2024.
Previous wording
We believe there is potential for ANKTIVA to become a therapeutic foundation across all phases of treatment, including in adjunctive therapy, to amplify, reactivate or extend the efficacy of standard of care. ANKTIVA is being clinically evaluated in multiple oncology indications. We believe that other oncology indications with registration potential for ANKTIVA include other types of NMIBC (BCG-unresponsive papillary, for which we submitted an sBLA in March 2025 and received an RTF letter from the FDA in May 2025, BCG-naïve CIS and BCG-naïve papillary), lung, colorectal, prostate and ovarian cancers, and GBM and NHL.
Current wording
We believe there is potential for ANKTIVA to become a therapeutic foundation across all phases of treatment, including in adjunctive therapy, to amplify, reactivate or extend the efficacy of standard of care. ANKTIVA is being clinically evaluated in multiple oncology indications. We believe that other oncology indications with registration potential for ANKTIVA include other types of NMIBC (BCG-unresponsive papillary, for which we submitted an sBLA in March 2025 and received an RTF letter from the FDA in May 2025, which we are continuing to evaluate, BCG-naïve CIS and BCG-naïve papillary), lung, colorectal, prostate and ovarian cancers, and GBM and NHL.
Previous wording
Data from multiple clinical trials suggest ANKTIVA has potential to enhance the activity of therapeutic mAbs, including CPIs (e.g., pembrolizumab/Keytruda), across a wide range of tumor types, including lung cancer. Further, ANKTIVA has been observed to increase lymphocyte count in healthy adults, making it a potential therapy to rescue lymphopenia. We are also exploring or pursuing several other studies of ANKTIVA in combination with our other product candidates, including in prostate cancer (ANKTIVA in combination with hAd5 PSA), colon cancer (ANKTIVA in combination with hAd5 TriAd), and NHL (ANKTIVA in combination with rituximab). We are also exploring ANKTIVA in infectious diseases, including HIV and long COVID.
Current wording
Data from multiple clinical trials suggest ANKTIVA has potential to enhance the activity of therapeutic mAbs, including CPIs (e.g., pembrolizumab/Keytruda), across a wide range of tumor types, including lung cancer. Further, ANKTIVA has been observed to increase lymphocyte count in healthy adults, making it a potential therapy to rescue lymphopenia. We are also exploring or pursuing several other studies of ANKTIVA in combination with our other product candidates, including in prostate cancer (ANKTIVA in combination with hAd5 PSA), colon cancer (ANKTIVA in combination with hAd5 TriAd), GBM (ANKTIVA in combination with PD-L1 t-haNK), and NHL (ANKTIVA in combination with rituximab). We are also exploring ANKTIVA in infectious diseases, including HIV and Long COVID.
Previous wording
Our proprietary platforms for the development of biologic products and product candidates include: (i) cytokine fusion proteins, (ii) vaccine vectors, and (iii) cell therapies. As of March 2025, our platforms have generated nine first-in-human therapeutic agents (including one agent approved by the FDA) that are currently or planned to be studied in clinical trials in liquid and solid tumors. The indications in the table above are among the most frequent and lethal cancer types and where there are high failure rates for existing standards of care or no available effective treatment. We are constantly monitoring and prioritizing clinical development based upon the availability of our resources and the efficacy and market developments of our competitors’ products and product candidates, among other factors.
Current wording
Our proprietary platforms for the development of biologic products and product candidates include: (i) cytokine fusion proteins, (ii) vaccine vectors, and (iii) cell therapies. As of June 2025, our platforms have generated nine first-in-human therapeutic agents (including one agent approved by the FDA and the MHRA in a specific indication) that are currently or planned to be studied in clinical trials in liquid and solid tumors. The indications in the table above are among the most frequent and lethal cancer types and where there are high failure rates for existing standards of care or no available effective treatment. We are constantly monitoring and prioritizing clinical development based upon the availability of our resources and the efficacy and market developments of our competitors’ products and product candidates, among other factors.
Previous wording
ImmunityBio Platforms – The Development of a Universal Therapeutic Cancer Vaccine
Current wording
ImmunityBio Platforms – The Development of a Universal Therapeutic CancerBioShield
Previous wording
Based on the vision of activating the patient’s immune system, the company continues its efforts to demonstrate that a universal cancer vaccine that leverages the power of its platforms – backbone ANKTIVA, off-the-shelf and autologous NK-cell-based therapies, adenovirus-vectored delivered vaccines, and other technologies – provide benefit and hope not only for patients with cancer but also for those with a high risk of developing cancer.
Current wording
Based on the vision of activating the patient’s immune system, the company continues its efforts to demonstrate that a universal therapeutic CancerBioShield that leverages the power of its platforms – backbone ANKTIVA, off-the-shelf and autologous NK-cell-based therapies, adenovirus-vectored delivered vaccines, and other technologies – provide benefit and hope not only for patients with cancer but also for those with a high risk of developing 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, 2024 with the SEC on March 3, 2025:
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, 2025 with the SEC on May 12, 2025:
Previous wording
We have incurred net losses in each year since our inception and, as of March 31, 2025, we had an accumulated deficit of $3.5 billion. During the three months ended March 31, 2025 and 2024, net losses attributable to ImmunityBio common stockholders were $129.6 million and $134.1 million, respectively. Substantially all of our net losses resulted principally from costs incurred in connection with our ongoing clinical trials and operations, our research and development programs, and from selling, general and administrative costs associated with our operations, including stock-based compensation expense.
Current wording
We have incurred net losses in each year since our inception and, as of June 30, 2025, we had an accumulated deficit of $3.6 billion. During the six months ended June 30, 2025 and 2024, net losses attributable to ImmunityBio common stockholders were $222.2 million and $268.7 million, respectively. Substantially all of our net losses resulted principally from costs incurred in connection with our ongoing clinical trials and operations, our research and development programs, and from selling, general and administrative costs associated with our operations, including stock-based compensation expense.
Previous wording
As of March 31, 2025, we had 671 employees. Personnel of related companies who provide corporate, general and administrative, certain research and development, and other support services under our shared services agreement with NantWorks are not included in this number. See Note 15 “Related-Party Agreements” of the “Notes to Unaudited Condensed Consolidated Financial Statements” that appears in Item 1. “Financial Statements” of this Quarterly Report for more information. In anticipation of the ongoing commercialization of our approved product, we expect to continue to incur significant expenses and increasing operating expenses for the foreseeable future, which may fluctuate significantly from quarter-to-quarter and year-to-year. See “—Future Funding Requirements” below for a discussion of our anticipated expenditures and sources of capital we expect to access to fund these expenditures.
Current wording
As of June 30, 2025, we had 685 employees. Personnel of related companies who provide corporate, general and administrative, certain research and development, and other support services under our shared services agreement with NantWorks are not included in this number. See Note 15 “Related-Party Agreements” of the “Notes to Unaudited Condensed Consolidated Financial Statements” that appears in Item 1. “Financial Statements” of this Quarterly Report for more information. In anticipation of the ongoing commercialization of our approved product, we expect to continue to incur significant expenses and increasing operating expenses for the foreseeable future, which may fluctuate significantly from quarter-to-quarter and year-to-year. See “—Future Funding Requirements” below for a discussion of our anticipated expenditures and sources of capital we expect to access to fund these expenditures.
Previous wording
We have only one approved product, ANKTIVA, for which we received approval from the FDA on April 22, 2024. We began commercial distribution of our approved product in May 2024. There can be no assurance that our other product candidates will be approved for commercial sale by the FDA in the near term, if ever.
Current wording
We have only one approved product, ANKTIVA, for which we received approval from the FDA in April 2024 and the MHRA in July 2025. We began commercial distribution of our approved product in the U.S. in May 2024. There can be no assurance that our other product candidates will be approved for commercial sale by the FDA in the near term, if ever.
Previous wording
Product revenue, net increased $16.5 million during the three months ended March 31, 2025, as compared to the three months ended March 31, 2024, due to sales of ANKTIVA, which was approved in April 2024.
Current wording
Product revenue, net increased $25.4 million during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024, due to an increase in sales of ANKTIVA, which was approved in April 2024.
Previous wording
Research and development expense decreased $5.1 million during the three months ended March 31, 2025, as compared to the three months ended March 31, 2024. The following table summarizes our research and development expense during the three months ended March 31, 2025 and 2024, together with the changes in those items (in thousands):
Current wording
Research and development expense increased $4.1 million during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024. The following table summarizes our research and development expense during the three months ended June 30, 2025 and 2024, together with the changes in those items (in thousands):
Previous wording
•a $4.6 million decrease in external manufacturing costs, primarily due to a reduction in CMO fees, and lower consulting costs, partially offset by higher clinical trial related costs; and
Current wording
•an $0.8 million decrease in external research and development expense, primarily due to a reduction in consulting costs and regulatory expenses, partially offset by higher clinical trial related costs and CMO fees; partially offset by
Previous wording
•a $1.0 million decrease in personnel-related costs, primarily due to a decrease in stock based compensation expenses, partially offset by lower shared service costs charged out and higher recruiting and training expenses compared to the prior period; partially offset by
Current wording
•a $0.6 million increase in personnel-related costs, primarily due to an increase in salary and benefits and a decrease in shared service costs charged out, partially offset by a decrease in stock based compensation expenses;
Previous wording
•a $0.3 million increase in equipment, depreciation, and facility costs, primarily due to increased facility expenses driven by building repairs and facility maintenance, partially offset by lower depreciation and amortization expenses and equipment expenses; and
Current wording
•an immaterial decrease in equipment, depreciation, and facility costs, primarily due to lower depreciation and amortization expenses and lower equipment maintenance expenses, partially offset by increased facility expenses driven by building repairs; and offset by
Previous wording
•a $0.2 million increase in other research and development costs, primarily due to higher manufacturing costs and higher distribution costs driven by more production and clinical trial activities and higher license fees, partially offset by fewer sponsored research agreements.
Current wording
•a $4.3 million increase in other research and development costs, primarily due to higher manufacturing costs and higher distribution costs driven by more production and clinical trial activities, and higher license fees, partially offset by fewer sponsored research agreements.
Previous wording
Selling, general and administrative expense decreased $9.2 million during the three months ended March 31, 2025, as compared to the three months ended March 31, 2024. The decrease in selling, general and administrative expense was primarily driven by a$15.4 million decrease in legal expenses mainly due to lower costs related to litigation settlements, a$3.2 million decrease in commercial consulting activities, and a$0.4 million increase in net shared service costs charged out, partially offset by a $5.0 million increase in recruiting and training expenses, salaries, benefits and commissions, and travel expenses due to growing sales and marketing activities, a$2.6 million increase in stock-based compensation due to grants of 2025 equity incentive awards, and increased headcount, a$0.8 million increase in marketing and public relations expenses, a $0.5 million increase in facility costs, a $0.4 million increase in software license fees, a $0.3 million increase in distribution costs and a $0.2 million increase in research agreement costs.
Current wording
Selling, general and administrative expense decreased $6.9 million during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024. The decrease in selling, general and administrative expense was primarily driven by a$12.8 million decrease in legal expenses mainly due to lower costs related to litigation settlements, a $4.2 million decrease in commercial consulting activities, and a $0.2 million decrease in audit fees, partially offset by a $6.3 million increase in recruiting and training expenses, salaries, benefits and commissions, and travel expenses due to growing sales and marketing activities, a $1.9 million increase in marketing and public relations expenses, a $0.7 million increase in stock-based compensation due to the grant of 2025 equity incentive awards, a $0.4 million increase in distribution costs, a $0.3 million increase in facility costs, a $0.3 million increase in software license fees, a $0.2 million increase in depreciation expenses, and a $0.2 million increase in other operating expenses.
Previous wording
Total other expense, net increased $26.5 million during the three months ended March 31, 2025, as compared to the three months ended March 31, 2024. Theincrease in total other expense, net was primarily driven by an increase of $42.6 million due to the change in fair value of a related-party convertible note, an increase of $5.5 million in interest expense related to the revenue interest liability, and a $2.2 million decrease in interest and investment income, partially offset by a decrease of $14.1 million mainly due to related-party interest expense, a decrease of $8.3 million due to the change in fair value of derivative liabilities, and a decrease of $1.4 million due to the change in fair value of warrant liabilities.
Current wording
Total other expense, net decreased $14.2 million during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024. Thedecrease in total other expense, net was primarily driven by a decrease of $23.2 million due to the change in fair value of warrant liabilities, a decrease of $14.3 million in interest expense mainly due to the lower outstanding balance of related-party debt and no amortization of related-party notes discounts as a result of December 2024 debt extinguishment, and a decrease of $1.2 million due to the change in fair value of a related-party convertible note, partially offset by an increase of $19.3 million due to the change in fair value of derivative liabilities, an increase of $4.2 million in interest expense related to the revenue interest liability, a $0.7 million decrease in interest and investment income, and an increase of $0.3 million in other expense, net.
Previous wording
Research and development expense decreased $5.1 million primarily attributable to the following:
Current wording
Research and development expense decreased $1.0 million primarily attributable to the following:
Previous wording
From inception through March 31, 2025, we have funded our operations primarily through proceeds from the issuance of related-party promissory notes, sales of common stock under our shelf registration statements and through RDOs, and a RIPA financing.
Current wording
From inception through June 30, 2025, we have funded our operations primarily through proceeds from the issuance of related-party promissory notes, sales of common stock under our shelf registration statements, through RDOs and the ATM, and a RIPA financing.
Previous wording
As of March 31, 2025, we had cash and cash equivalents, and marketable securities of $61.6 million compared to $149.8 million as of December 31, 2024. 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, 2025, we had cash and cash equivalents, and marketable securities of $153.7 million compared to $149.8 million as of December 31, 2024. 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 April 2024, we filed a shelf registration statement with the SEC on Form S-3ASR pursuant to which we may, from time to time, sell an indeterminate amount of our common stock, preferred stock, debt securities, depositary shares, warrants, subscription rights, purchase contracts, or units, and an associated prospectus related to the ATM. As of March 31, 2025, we had $296.5 million available for future stock issuances under the ATM.
Current wording
In April 2024, we filed a shelf registration statement with the SEC on Form S-3ASR pursuant to which we may, from time to time, sell an indeterminate amount of our common stock, preferred stock, debt securities, depositary shares, warrants, subscription rights, purchase contracts, or units, and an associated prospectus related to the ATM. As of June 30, 2025, we had $195.8 million available for future stock issuances under the ATM.
Previous wording
On April 7, 2025, we entered into a securities purchase agreement with an institutional investor for the purchase and sale of 29,024,768 shares of our common stock, as well as warrants that allows such investor to purchase an additional 29,024,768 shares of common stock at an exercise price of $3.101 per share, for a purchase price of $2.584 per share and accompanying warrant, generating net proceeds of approximately $74.8 million, after deducting estimated offering costs. The warrants became immediately exercisable on April 9, 2025 and will expire five years after the issuance date on April 9, 2030.
Current wording
On April 7, 2025, we entered into a securities purchase agreement with an institutional investor for the purchase and sale of 29,024,768 shares of our common stock, as well as warrants that allows such investor to purchase an additional 29,024,768 shares of common stock at an exercise price of $3.101 per share, for a purchase price of $2.584 per share and accompanying warrant. This transaction generated net proceeds of approximately $74.8 million, after deducting estimated offering costs of $0.2 million. The warrants became immediately exercisable on April 9, 2025 and expire on April 9, 2030.
Previous wording
On December 29, 2023, we entered into the RIPA with Infinity and Oberland. Pursuant to the RIPA, Oberland had the option to purchase additional Revenue Interests from us in exchange for a $100.0 million Second Payment upon satisfaction of certain conditions in the RIPA, including receipt of approval from the FDA of our BLA for ANKTIVA on or before June 30, 2024. On April 22, 2024, the FDA approved our product ANKTIVA and as a result, on May 13, 2024 Oberland purchased additional Revenue Interests from us for a gross purchase price of $100.0 million, less certain issuance costs.
Current wording
On December 29, 2023, we entered into the RIPA with Infinity and Oberland. Pursuant to the RIPA, Oberland had the option to purchase additional Revenue Interests from us in exchange for a $100.0 million Second Payment upon satisfaction of certain conditions in the RIPA, including receipt of approval from the FDA of our BLA for ANKTIVA on or before June 30, 2024. In April 2024, the FDA approved our product ANKTIVA and as a result, on May 13, 2024 Oberland purchased additional Revenue Interests from us for a gross purchase price of $100.0 million, less certain issuance costs.
Previous wording
•In connection with our acquisition of VivaBioCell, we are obligated to pay the former owners approximately $2.2 million of contingent consideration upon the achievement of a regulatory milestone relating to the GMP-in-a-Box technology.
Current wording
•In connection with our acquisition of VivaBioCell, we are obligated to pay the former owners approximately $2.3 million of contingent consideration upon the achievement of a regulatory milestone relating to the GMP-in-a-Box technology.
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, 2024, net cash used in operating activities of $107.0 million consisted of a net loss of $134.1 million and $3.9 million of cash used in net working capital, partially offset by $31.0 million in adjustments for non-cash items. The changes in net working capital consisted primarily of decreases of $8.9 million in accrued expenses and other liabilities, $0.9 million in operating lease liabilities, and $0.1 million with related parties, partially offset by an increase of $4.3 million in accounts payable, a decrease of $1.6 million in prepaid and other current assets, and a decrease of $0.1 million in other assets. Adjustments for non-cash items primarily consisted of $8.3 million in stock-based compensation expense, $7.9 million in non-cash interest primarily related to the revenue interest liability and related-party promissory notes, $5.5 million in amortization of related-party note discounts, $4.6 million in depreciation and amortization expense, a $2.7 million change in fair value of derivative liabilities, a $1.8 million change in the fair value of warrant liabilities, and $1.3 million in non-cash lease expense related to operating lease right‑of‑use assets, and $0.1 million of other non-cash items, reduced by $0.7 million in unrealized gains on equity securities driven by an increase in the value of our investments, and $0.5 million of accretion of discounts, on marketable debt securities.
Current wording
During the six months ended June 30, 2024, net cash used in operating activities of $207.3 million consisted of a net loss of $268.7 million, partially offset by $59.9 million in adjustments for non-cash items and $1.5 million of cash provided by net working capital. Adjustments for non-cash items primarily consisted of a $21.1 million change in the fair value of warrant liabilities, $17.9 million in stock-based compensation expense, $17.1 million in non-cash interest primarily related to the revenue interest liability and related-party promissory notes, $11.4 million in amortization of related-party note discounts, $9.0 million in depreciation and amortization expense, $2.7 million in non-cash lease expense related to operating lease right‑of‑use assets, and $0.1 million in other non-cash items, reduced by an $18.5 million change in fair value of derivative liabilities and $0.9 million of accretion of discounts on marketable debt securities. The changes in net working capital consisted primarily of an increase of $9.0 million in accounts payable, a decrease of $3.1 million in prepaid and other current assets and a decrease of $0.2 million in other assets, partially offset by decreases of $5.6 million in accrued expenses and other liabilities and $2.4 million in operating lease liabilities, an increase of $1.8 million in inventories and an increase of $1.0 million in accounts receivable, net.
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.
Previous wording
During the three months ended March 31, 2024, net cash used in investing activities was $35.6 million, which included cash outflows of $48.4 million for purchases of marketable debt securities and $1.2 million for purchases of property, plant and equipment, partially offset by proceeds of $14.0 million from maturities and sales of marketable debt and equity securities.
Current wording
During the six months ended June 30, 2024, net cash used in investing activities was $87.1 million, which included cash outflows of $134.1 million for purchases of marketable debt securities and $2.0 million for purchases of property, plant and equipment, partially offset by proceeds of $49.0 million from maturities and sales of marketable debt and equity securities.
Previous wording
During the three months ended March 31, 2025, net cash used in financing activities was $1.0 million, which consisted of $1.2 million related to net share settlement of vested RSUs for payment of payroll tax withholding, partially offset by $0.2 million in proceeds from the exercise of stock options.
Current wording
During the six months ended June 30, 2025, net cash provided by financing activities was $171.8 million, which consisted of $173.1 million in net proceeds from equity offerings and $0.2 million in proceeds from the exercise of stock options, partially offset by $1.5 million related to net share settlement of vested RSUs for payment of payroll tax withholding.
Previous wording
During the three months ended March 31, 2024, net cash provided by financing activities was $10.2 million, which consisted of $14.1 million of proceeds from the exercise of warrants, partially offset by $3.9 million related to net share settlement of vested RSUs for payment of payroll tax withholding.
Current wording
During the six months ended June 30, 2024, net cash provided by financing activities was $159.1 million, which consisted of $96.9 million in net proceeds from payments received pursuant to the RIPA, $57.7 million of proceeds from the exercise of warrants, $4.9 million in net proceeds from the partial exercise of the Oberland stock option, $3.6 million in net proceeds from equity offerings, and $0.4 million in proceeds from the exercise of stock options, partially offset by $4.4 million related to net share settlement of vested RSUs for payment of payroll tax withholding.
Previous wording
Until April 2024, we had no clinical products approved for commercial sale and thus had not generated any revenue from therapeutic and vaccine product candidates that are or were under development. Now that we have received FDA approval for ANKTIVA, we have begun to generate revenue although we expect it to take some time to generate significant revenue from our approved product and we can provide no assurance when, or if, this will occur. We began commercial distribution of our approved product in May 2024; however, we can provide no assurance with respect to our future revenues, market acceptance, reimbursement from third-party payors, or the profitability of our approved product or any other product candidate for which we may obtain approval. We do not expect additional revenue from our other product candidates unless and until we obtain regulatory approval of and commercialize any of our other product candidates, and we do not know when, or if, this will occur. In addition, we expect our operating expenses to significantly increase in connection with our ongoing development activities, particularly as we continue the research, development and clinical trials of, and seek regulatory approval for, our other product candidates. We have also incurred and expect that we will continue to incur in the future additional costs associated with operating as a public company as well as costs related to future fundraising efforts. In addition, subject to obtaining regulatory approval of our other product candidates, we expect to incur significant incremental commercialization expenses for product sales, marketing, manufacturing and distribution. We anticipate that we will need substantial additional funding in connection with our continuing operations.
Current wording
Until April 2024, we had no clinical products approved for commercial sale and thus had not generated any revenue from therapeutic and vaccine product candidates that are or were under development. Now that we have received FDA approval for ANKTIVA, we have begun to generate revenue although we expect it to take some time to generate significant revenue from our approved product and we can provide no assurance when, or if, this will occur. We began commercial distribution of our approved product in May 2024 and our permanent J-code became effective in January 2025; however, we can provide no assurance with respect to our future revenues, market acceptance, reimbursement from third-party payors, or the profitability of our approved product or any other product candidate for which we may obtain approval. We do not expect additional revenue from our other product candidates unless and until we obtain regulatory approval of and commercialize any of our other product candidates, and we do not know when, or if, this will occur. In addition, we expect our operating expenses to significantly increase in connection with our ongoing development activities, particularly as we continue the research, development and clinical trials of, and seek regulatory approval for, our other product candidates. We have also incurred and expect that we will continue to incur in the future additional costs associated with operating as a public company as well as costs related to future fundraising efforts. In addition, subject to obtaining regulatory approval of our other product candidates, we expect to incur significant incremental commercialization expenses for product sales, marketing, manufacturing and distribution.
Previous wording
•We have certain contractual commitments that are expected to be paid within one year, depending on the actual progress of build outs, completion of services, and the realization of milestones associated with third-party agreements. This amount totals $41.8 million and is primarily related to capital expenditures and open purchase orders as of March 31, 2025 for the acquisition of goods and services in the ordinary course of business, and near-term upfront milestone payments to third parties.
Current wording
•We have certain contractual commitments that are expected to be paid depending on the actual progress of build outs, completion of services, and the realization of milestones associated with third-party agreements. These are primarily related to capital expenditures and open purchase orders as of June 30, 2025 for the acquisition of goods and services in the ordinary course of business, and near-term upfront milestone payments to third parties. As of June 30, 2025, the amounts of the contractual commitments that are expected to be paid are $40.6 million within one year and $9.2 million for fiscal year 2026 and beyond.
Previous wording
•In addition, we have contractual commitments that are expected to be paid in fiscal year 2026 and beyond based on the achievement of various development, regulatory and commercial milestones for agreements with third parties. These payments may not be realized or may be modified and are contingent upon the occurrence of various future events, substantially all of which have a high degree of uncertainty of occurring. As of March 31, 2025, the maximum amount that may be payable related to these commitments is $292.9 million.
Current wording
•In addition, we have contractual commitments that are expected to be paid in fiscal year 2026 and beyond based on the achievement of various development, regulatory and commercial milestones for agreements with third parties. These payments may not be realized or may be modified and are contingent upon the occurrence of various future events, substantially all of which have a high degree of uncertainty of occurring. As of June 30, 2025, the maximum amount that may be payable related to these commitments is $88.2 million.
Rearranged current paragraphs (8)
Current report — wording carried from elsewhere
Product revenue, net increased $41.9 million during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, due to an increase in sales of ANKTIVA, which was approved in April 2024.
Current report — wording carried from elsewhere
Other revenues decreased $0.1 million during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024 primarily due to decreased bioreactor and related consumable product sales, partially offset by increased license royalty income.
Current report — wording carried from elsewhere
Cost of sales increased $0.2 million during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024. We did not report cost of sales during the six months ended June 30, 2024. 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 in relation to product revenues as we deplete these inventories.
Current report — wording carried from elsewhere
Research and development expense decreased $1.0 million during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024. The following table summarizes our research and development expense during the six months ended June 30, 2025 and 2024, together with the changes in those items (in thousands):
Current report — wording carried from elsewhere
We expect our research and development expense to increase significantly for the foreseeable future as we continue to invest in research and development activities related to developing our product candidates and conduct our ongoing and planned clinical trials.
Current report — wording carried from elsewhere
We anticipate that we will need substantial additional funding in connection with our continuing operations.
Current report — wording carried from elsewhere
•our ability to successfully commercialize ANKTIVA or any future approved products in the U.S. or internationally;
Current report — wording carried from elsewhere
On July 24, 2025, we entered into a securities purchase agreement with institutional investors for the purchase and sale of 29,629,632 shares of our common stock, as well as warrants that allows such investors to purchase an additional 29,629,632 shares of common stock at an exercise price of $3.240 per share, for a purchase price of $2.700 per share and accompanying warrant, generating net proceeds of approximately $75.3 million, after deducting placement agent fees and estimated offering costs. The warrants became immediately exercisable on July 28, 2025, and will expire five years after the issuance date on July 28, 2030.