ImmunityBio, Inc.

Previous 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;

Current wording

•our ability to successfully address the May 2025 RTF letter received from the FDA for thesBLA for the BCG-unresponsive NMIBC papillary indication and related FDA meeting stating that an RCT against chemotherapy is required, the approach to which we are continuing to evaluate;

Previous wording

•our ability to obtain, maintain, protect, and enforce patent protection and other proprietary rights for our approved product and our other product candidates and technologies;

Current wording

•our ability to obtain, maintain, protect, and enforce patent protection and other proprietary rights for our approved product, other product candidates, and other technologies in development;

Previous 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.

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 and sustain 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

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.

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 ansBLA 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), 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.

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 CAR-NK (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

•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 wording

•Q3 2025 Revenue and Other Income Growth with Continued Strong Sales Momentum: $33.7 million of total revenue and other income, up from $26.4 million in Q2 2025.

Previous wording

•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 wording

•Cash Position: $257.8 million in cash, cash equivalents, and marketable securities as of September 30, 2025, up from $153.7 million as of June 30, 2025.

Previous wording

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 wording

•Papillary NMIBC: The company shared updated QUILT-3.032 trial data showing durable 36-month progression-free survival and bladder-sparing benefits of ANKTIVA plus BCG. We continue to evaluate our submission path in this indication and have a meeting scheduled with the FDA in December 2025 to discuss potential regulatory paths. 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 CIS with or without papillary tumors. The NCCN reviewed the submission at its August 2025 meeting, and the company is awaiting their decision.

Previous 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.

Current wording

We have incurred net losses in each year since our inception and, as of September 30, 2025, we had an accumulated deficit of $3.7 billion. During the nine months ended September 30, 2025 and 2024, net losses attributable to ImmunityBio common stockholders were $289.5 million and $354.4 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 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.

Current wording

As of September 30, 2025, we had 673 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

Other income (expense), net consists primarily of interest and investment income, interest expense (including amortization of debt discounts), unrealized gains and losses from investments in equity securities and equity-method investments, changes in fair value of warrant liabilities, derivative liabilities, and convertible notes, realized gains and losses on debt and equity securities, and gains and losses on foreign currency transactions.

Current wording

Other income (expense), net consists primarily of interest and investment income, interest expense (including amortization of debt discounts), unrealized gains and losses from investments in equity securities and equity-method investments, changes in fair value of warrant liabilities, derivative liabilities, and convertible notes, realized gains and losses on debt and equity securities, warrants issuance costs, gain from recovery of damaged goods, and gains and losses on foreign currency transactions.

Previous 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.

Current wording

Product revenue, net increased $25.8 million during the three months ended September 30, 2025, as compared to the three months ended September 30, 2024, due to an increase in sales of ANKTIVA, which was approved in April 2024.

Previous wording

Other revenues decreased during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024, primarily due to decreased bioreactor and related consumable product sales.

Current wording

Other revenues increased during the three months ended September 30, 2025, as compared to the three months ended September 30, 2024, primarily due to increased bioreactor and related consumable product sales.

Previous wording

Cost of sales increased $0.1 million during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024. We did not report cost of sales during the three 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 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 September 30, 2025, as compared to the three months ended September 30, 2024. We did not report cost of sales during the three months ended September 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 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.

Previous 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):

Current wording

Research and development expense increased $0.8 million during the three months ended September 30, 2025, as compared to the three months ended September 30, 2024. The following table summarizes our research and development expense during the three months ended September 30, 2025 and 2024, together with the changes in those items (in thousands):

Previous wording

Research and development expense increased $4.1 million primarily attributable to the following:

Current wording

Research and development expense increased $0.8 million primarily attributable to the following:

Previous 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

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; partially offset by

Previous 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;

Current wording

•a $0.7 million increase in personnel-related costs, primarily due to an increase in stock based compensation expenses due to 2025 new grants, and a decrease in shared service costs charged out, partially offset by a decrease in salaries and benefits due to lower headcount;

Previous 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

Current wording

•a $0.4 million decrease in equipment, depreciation, and facility costs, primarily due to lower depreciation and amortization expenses, lower common area maintenance expenses, and lower software purchase expenses, partially offset by increased facility expenses driven by building repairs; and

Previous 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.

Current wording

•a $1.3 million increase in other research and development costs, primarily due to higher manufacturing costs, higher license fees, and higher distribution costs driven by more production and clinical trial activities, partially offset by fewer sponsored research agreements and fewer supplies and materials purchases.

Previous wording

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 wording

We expect our research and development expense to increase for the foreseeable future as we continue to invest in research and development activities related to developing our product candidates and conducting our ongoing and planned clinical trials.

Previous 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.

Current wording

Selling, general and administrative expense increased $0.4 million during the three months ended September 30, 2025, as compared to the three months ended September 30, 2024. Theincrease in selling, general and administrative expense was primarily driven bya $4.4 million increase in headcount-related costs, including salaries, benefits and commissions, and travel expenses mainly due to growing sales and marketing activities, a $0.7 million increase in marketing expenses, a $0.6 million increase in software license fees, a $0.5 million increase in stock-based compensation due to new grants, a $0.4 million increase in audit and tax fees, a $0.3 million increase in distribution costs, a $0.3 million increase in facility costs, and a $0.2 million increase in other operating expenses, partially offset by a $4.0 million decrease in commercial consulting activities, primarily due to insourced related functions, anda$3.0 million decrease in legal expenses mainly due to lower litigation settlement costs.

Previous 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.

Current wording

Total other expense, net increased $6.2 million during the three months ended September 30, 2025, as compared to the three months ended September 30, 2024. Theincrease in total other expense, net was primarily driven by a $16.4 million decline in the change in fair value of warrant liabilities compared to the prior period, an increase of $1.4 million in interest expense related to the revenue interest liability, a $1.3 million decline in the change in fair value of derivative liabilities compared to the prior period, a $1.2 million increase in fair value of a related-party convertible note, and an increase of $0.2 million in other income (expense), net, partially offset by a decrease of $14.0 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 $0.3 million increase in interest and investment income.

Previous wording

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 wording

Product revenue, net increased $67.8 million during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024, due to an increase in sales of ANKTIVA, which was approved in April 2024.

Previous wording

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 wording

Other revenues increased slightly during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024 primarily due to increased bioreactor and related consumable product sales, and increased license royalty income.

Previous wording

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 wording

Cost of sales increased $0.4 million during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024. We did not report cost of sales during the nine months ended September 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.

Previous wording

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 wording

Research and development expense decreased $0.2 million during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024. The following table summarizes our research and development expense during the nine months ended September 30, 2025 and 2024, together with the changes in those items (in thousands):

Previous wording

Research and development expense decreased $1.0 million primarily attributable to the following:

Current wording

Research and development expense decreased $0.2 million primarily attributable to the following:

Previous wording

•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 wording

•a $6.2 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 investigator fees and CRO fees; partially offset by

Previous wording

•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 wording

•a $0.3 million increase in personnel-related costs that was primarily due to a decrease in shared service costs charged out, partially offset by a decrease in stock based compensation;

Previous wording

•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 wording

•a $0.1 million decrease in equipment, depreciation, and facility costs that was primarily due to decreased depreciation expenses due to fully depreciated fixed assets, and decreased software subscription expenses, partially offset by an increase in facility costs mainly driven by building repairs; partially offset by

Previous wording

•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 wording

•a $5.8 million increase in other research and development costs, primarily attributable to higher manufacturing costs due to increased production activities, increased license fees due to new subscriptions, and increased distribution costs due to higher clinical trial activities, partially offset by decreased sponsored research agreements and lower inventory materials costs.

Previous wording

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 wording

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 conducting our ongoing and planned clinical trials.

Previous wording

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 wording

Selling, general and administrative expense decreased $15.8 million during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024. The decrease in selling, general and administrative expense was primarily due to adecrease of$31.2 million in legal expenses, driven by lower defense costs and litigation settlements, adecrease of$11.4 million in consulting costs, primarily driven by insourced related functions, and anincrease of$0.5 million in net benefit from shared service costs, partially offset by a $15.8 million increase in recruiting and training expenses, salaries, benefits and commissions, and travel expenses due to growing sales and marketing activities, a$3.8 million increase in stock-based compensation expense primarily due to new grants, a $3.8 million increase in marketing and public relations expenses, a $1.3 million increase in software license fees, a $1.1 million increase in facility costs, a $0.9 million increase in distribution costs, a $0.4 million increase in depreciation expenses, and a $0.2 million increase in other miscellaneous operating expenses.

Previous wording

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 wording

Other expense, net increased $18.5 million during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024. The increase in other expense, net was primarily driven by a $42.6 million increasein fair value of a related-party convertible note, a$12.3 million decline in the change in fair value of derivative liabilities compared to the prior period, an increase of $11.1 million in interest expense related to the revenue interest liability, a decrease of $2.7 million in interest and investment income, and an increase of$0.4 million in other expense, net, partially offset by a decrease of$42.5 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, andan $8.1 million increase in the change in fair value of warrant liabilities compared to the prior period.

Previous 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.

Current wording

As of September 30, 2025, we had cash and cash equivalents, and marketable securities of $257.8 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 June 30, 2025, we had $195.8 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 September 30, 2025, we had $95.3 million available for future stock issuances under the ATM.

Previous wording

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 wording

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 nine months ended September 30, 2025, we received net proceeds totaling $98.2 million and $196.4 million, respectively, from the issuance of shares under the ATM. As of September 30, 2025, we had $95.3 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. 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.

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 offering costs of $0.2 million. The warrants became immediately exercisable on April 9, 2025 and expire on April 9, 2030.

Previous wording

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.

Current wording

On July 28, 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. This transaction generated net proceeds of approximately $75.4 million, after deducting placement agent fees and offering costs totaling $4.6 million. The warrants became immediately exercisable on July 28, 2025 and expire on July 28, 2030.