Arcus Biosciences, Inc.
For the period ended Mar 31, 2026. Filed May 5, 2026.
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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.
Mar 31, 2026 · Filed May 5, 2026
RCUS$18.28+3.3%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-10-28.
0001724521-25-000116
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-05.
0001724521-26-000034
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe 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 112 previous paragraphs and 80 current paragraphs.
45 unchanged; 22 reworded; 11 added; 45 removed; 0 previous and 2 current paragraphs rearranged.
Tables are not compared: 4 previous and 4 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 (11)
Current report
We are a late clinical-stage biopharmaceutical company focused on developing differentiated molecules for patients with cancer and inflammatory and autoimmune diseases. Our most advanced molecules are in Phase 3 registrational studies for various cancer indications and we expect our next wave of clinical-stage molecules to come from our inflammation and autoimmune disease programs. Our vision is to leverage our internal small-molecule discovery capabilities to create, develop and commercialize highly differentiated therapies that can have a meaningful impact on patients.
Current report
*Taiho has development and commercial rights in Japan and other countries in Asia, excluding China, for casdatifan (the “Taiho Territory”).
Current report
‡Gilead retains/holds time-limited option rights.
Current report
•In April 2026, we announced that the period for Gilead’s option rights under the Gilead Collaboration Agreement entered into in 2020, as amended, will end on July 14, 2026, following Gilead’s decision to not make the option continuation payment. Accordingly, Gilead will not have option rights to additional programs in our early-stage pipeline, including the CCR6, CD89 and CD40L programs, but will maintain its existing time-limited options to programs including AB801 (an investigational small molecule AXL inhibitor), AB598 (an investigational anti-CD39 monoclonal antibody), AB102 (an investigational MRGPRX2 antagonist), and an investigational TNF small molecule inhibitor.
Current report
•In April 2026, we announced the discontinuation of the Phase 3 STAR-121 study due to futility. STAR-121 evaluated domvanalimab plus the anti-PD-1 antibody zimberelimab and chemotherapy versus pembrolizumab plus chemotherapy as a first-line treatment for metastatic NSCLC.
Current report
The level of our future R&D investment will depend on a number of factors and uncertainties including the breadth of our clinical programs, the outcome of our efforts, and our collaboration activities. We expect R&D expenses to decline in the near term relative to what we have incurred as we wind down studies for domvanalimab. Streamlining initiatives we have undertaken across our R&D operations in connection with this wind-down, together with efficiencies we are pursuing across our programs outside the Gilead collaboration, are expected to further reduce costs. These decreases will be partially offset by our increased investment in the development of casdatifan and advancement of our small-molecule inflammation and immunology programs. We solely own casdatifan and lead its global development and commercialization, working with strategic partners in certain regions. As we advance our clinical-stage programs, including casdatifan, and prepare to seek regulatory approval, we may need to expand our late-stage development and commercial capabilities, which will require increased investment.
Current report
Study discontinued or substantially completed
Current report
R&D expenses were flat for the three months ended March 31, 2026, with (i) late-stage development programs increasing due to our investment in casdatifan and our Phase 3 PRISM-1 study for quemliclustat, partially offset by the wind-down of studies related to domvanalimab, (ii) early-stage development activities decreasing primarily due to the absence of prior year Phase 2 study costs for domvanalimab, and (iii) partnership reimbursements decreasing, primarily due to Gilead-led activities representing a larger share of total joint development costs and a shift towards programs fully funded by us.
Current report
We expect R&D expenses to decline in the near term relative to what we have incurred as we wind down studies for domvanalimab. Streamlining initiatives we have undertaken across our R&D operations in connection with this wind-down, together with efficiencies we are pursuing across our programs outside the Gilead collaboration, are expected to further reduce costs. These decreases will be partially offset by our increased investment in the development of casdatifan and advancement of our small-molecule inflammation and immunology programs.
Current report
The increase in G&A expenses for the three months ended March 31, 2026, was primarily due to a $2 million increase in non-cash stock-based compensation, which was primarily attributable to a separation agreement with an officer.
Current report
We have a $250 million term loan facility with Hercules. Under this facility, $100 million has been drawn. Additional tranches totaling $150 million will be available to support strategic initiatives, subject to the achievement of certain clinical and regulatory milestones and lender approval. See Note 11, Long-term debt, in Part I, Item 1, to our Condensed Consolidated Financial Statements for further discussion.
Removed paragraphs (45)
Previous report
We are a clinical-stage biopharmaceutical company focused on creating best-in-class therapies. Using our robust and highly efficient drug discovery capability, we have created a significant portfolio of investigational products which are in clinical development, with our most advanced molecule, an anti-TIGIT antibody, now in multiple Phase 3 registrational studies targeting lung and GI cancers. Our deep portfolio of novel small molecules and enabling antibodies allows us to create highly differentiated therapies, which we are developing to treat multiple large indications. We expect our clinical-stage portfolio to continue to expand and to include molecules targeting immuno-oncology ("IO"), cancer cell-intrinsic and immunological pathways. Our vision is to create, develop and commercialize highly differentiated therapies that have a meaningful impact on patients.
Previous report
We currently have seven clinical programs focused on unique targets including HIF-2α, TIGIT, PD-1, adenosine A2a and A2b receptors, CD73, CD39, and AXL. In 2020, we entered into the Gilead Collaboration Agreement with Gilead to strategically advance our portfolio through a collaborative relationship. The Gilead Collaboration Agreement and subsequent amendments provide Gilead with exclusive licenses to our anti-PD-1 program (including zimberelimab), anti-TIGIT program (including domvanalimab) and CD73 program (including quemliclustat). They also have time-limited exclusive option rights to our clinical programs. In the second quarter 2025, Gilead returned its license to the adenosine receptor antagonist program (including etrumadenant). Our HIF-2α program (including casdatifan) is no longer subject to Gilead’s option under the Gilead Collaboration Agreement and Gilead has no further rights to the program.
Previous report
cabo: cabozantinib; cas: casdatifan; chemo: chemotherapy; dom: domvanalimab; gem/nab-pac: gemcitabine/nab-paclitaxel; IO: immuno-oncology; ipi: ipilimumab; nivo: nivolumab; pembro: pembrolizumab; quemli: quemliclustat; rego: regorafenib; volru: volrustomig; zanza: zanzalintinib; zim: zimberelimab.
Previous report
**+/- biologic, e.g. bevacizumab or biosimilar, will be included for all patients in whom it is not contraindicated.
Previous report
•In October 2025, Taiho exercised its option for an exclusive license to casdatifan, an investigational small molecule HIF-2α inhibitor, in Japan and certain other territories in Asia (excluding mainland China). In exchange, Taiho will make an option exercise payment to us along with milestone payments upon the achievement of clinical, regulatory and commercialization milestones, and, additionally pay royalties on net sales.
Previous report
•In October 2025, we presented new data for our HIF-2α inhibitor, casdatifan, across all four monotherapy cohorts (n=121) of the Phase 1/1b ARC-20 study in late-line metastatic kidney cancer, most of whom had progressed on at least two prior lines of therapy, including both an anti-PD-1 and a VEGFR tyrosine kinase inhibitor ("TKI"). At the time of data cut-off (August 15, 2025):
Previous report
◦For the pooled analysis of all four monotherapy cohorts, with 15.2 months of median follow-up: median progression-free survival ("mPFS") was 12.2 months, the 18-month landmark PFS was 43%, the 12-month landmark PFS was 50% and the confirmed overall response rate ("cORR") was 31%.
Previous report
◦For the 100mg QD cohort (the Phase 3 PEAK-1 dose and formulation), with 12.4 months of median follow-up: mPFS was not reached, the 18-month landmark PFS was not reached; the 12-month landmark PFS was 60% and the cORR was 35%.
Previous report
◦No unexpected safety signals were observed at the time of DCO, and casdatifan had an acceptable and manageable safety profile across all doses. Across all four cohorts, one patient discontinued treatment due to anemia, and four patients (3%) discontinued due to hypoxia.
Previous report
◦The Phase 1b portion of the study has recruited rapidly and in the context of this rapid enrollment, following observations of potentially immune-mediated adverse events ("AEs"), none of which exceeded Grade 3, a decision was made to temporarily pause recruitment, while continuing to treat participants already enrolled into the study. No grade 4 or 5 events were observed and the majority of AEs were grade 1 or 2.
Previous report
◦We and AstraZeneca will continue to monitor these participants to further characterize the safety profile of the combination with longer follow-up. These data, along with any discussions with health authorities, will inform next steps for the study.
Previous report
•In October 2025, we presented the first overall survival results from Arm A1 of the Phase 2 EDGE-Gastric study in patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma. At data cutoff (March 3, 2025), safety and efficacy were evaluated in all patients enrolled and treated (n=41) and median study follow-up was 26.4 months.
Previous report
◦Median overall survival ("mOS") was 26.7 months in the overall patient population, 26.7 months in patients with PD-L1 expression ≥1% as measured by TAP scoring (SP263 assay) and not reached in patients with PD-L1 expression ≥5%.
Previous report
◦No unexpected safety signals were observed at the time of data cut off. The safety profile of domvanalimab plus zimberelimab and chemotherapy was generally well tolerated and is consistent with that of anti-PD-1 plus chemotherapy.
Previous report
•Concurrent with our first presentation of this data at European Society for Medical Oncology ("ESMO") congress in October 2025, these data were published in Nature Medicine.
Previous report
Adenosine-Pathway Program (quemliclustat)
Previous report
•In October 2025, we announced that we completed enrollment of PRISM-1, a Phase 3 trial of quemliclustat combined with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in first-line metastatic pancreatic ductal adenocarcinoma, within 12 months of study initiation.
Previous report
The level of our future R&D investment will depend on a number of factors and uncertainties, including the breadth of the joint development program agreed to with Gilead for the optioned programs, the outcome of our efforts, and the amount of cost reimbursements or milestone payments we receive from our collaborators. We expect our R&D expenses to peak in 2025 and then decline meaningfully during the next few years as we advance our programs towards regulatory approval. We also expect to advance new programs into the clinic. All of this will require significant growth in our development capabilities and infrastructure. In addition, our joint development programs with Gilead for the optioned molecules are anticipated to include a significant number of later-stage clinical trials, which typically include a larger number of subjects, are of a longer duration and include more geographic regions. As we advance our clinical-stage programs and prepare to seek regulatory approval, we will also need to increase our late-stage manufacturing activities. As a result, we expect our preclinical, clinical, and contract manufacturing expenses to increase significantly relative to what we have incurred to date.
Previous report
Impairment of Long-Lived Assets
Previous report
Impairment charges consist of impairment of right-of-use assets resulting from updated plans in the first quarter 2024 for a portion of our office space.
Previous report
The decrease in Total revenues for the nine months ended September 30, 2025 was primarily driven by lower development services revenue from the Gilead Collaboration and the prior year $15 million license revenue as a result of Taiho's exercise of its option forquemliclustat in the third quarter 2024. The overall decrease was partially offsetby thecumulative catch-up of $143 million in the second quarter 2025 relating to pausing future development of etrumadenant and Gilead's related return of its license to the program, compared to the prior year cumulative catch-up of $107 million as a result of the Third Gilead Collaboration Agreement Amendment in the first quarter 2024.
Previous report
*Study discontinued or completed
Previous report
The increase in R&D expenses for the three months ended September 30, 2025 was primarily due to costs incurred for our late-stage programs, resulting from increased enrollment and start-up activities for PRISM-1 and PEAK-1 and partially offset by lower costs from STAR-221. Increases in compensation and personnel costs were partially offset by a $2 million decrease in non-cash stock-based compensation.
Previous report
The increase in R&D expenses for the nine months ended September 30, 2025 was primarily driven by higher costs in our early-stage development activities, driven by Phase 2 activities for casdatifan, and clinical and manufacturing costs incurred for our late-stage programs, resulting from increased enrollment and start-up activities for PRISM-1 and PEAK-1 and partially offset by lower costs for STAR-221. Increases in compensation and personnel costs were partially offset by a $6 million decrease in non-cash stock-based compensation.
Previous report
The decrease in G&A expenses for the three months ended September 30, 2025 was primarily driven by a decrease in compensation and personnel costs driven by a $3 million decrease in non-cash stock-based compensation, partially offset by an increase in expenses shared under the Gilead Collaboration.
Previous report
The decrease in G&A expenses for the nine months ended September 30, 2025 was primarily driven by a decrease in compensation and personnel costs driven by a $8 million decrease in non-cash stock-based compensation, partially offset by an increase in expenses shared under the Gilead Collaboration.
Previous report
Impairment of Long-Lived Assets
Previous report
The impairment expense for the nine months ended September 30, 2024 was due to our 2024 evaluation and sublease of a portion of our office space, resulting in an impairment charge of $20 million.
Previous report
The decrease in Non-operating income, net for the three months ended September 30, 2025 as compared to the three months ended September 30, 2024, was primarily due to lower investment yields due to a smaller portfolio of investments and interest expense on our long-term debt agreement which we entered into in the third quarter 2024, with an additional draw in June 2025.
Previous report
September 30, 2025 will be sufficient to fund our planned level of operations for a period of at least twelve months following the date of filing of this report and provide funding through our initial pivotal read-outs for domvanalimab, quemliclustat and casdatifan, which include PEAK-1.
Previous report
In the first quarter 2024, we amended and restated the Stock Purchase Agreement and sold 15.2 million shares of our common stock to Gilead at a purchase price of $21.00 per share for total gross proceeds of $320 million. Of the $320 million equity investment, $87 million was determined to be a premium on the purchase of common stock and allocated to the performance obligations created by the Third Gilead Collaboration Agreement Amendment. Gilead acquired an additional 1.4 million shares of our common stock in the February 2025 underwritten offering and subsequently held approximately 29.3% of our outstanding common stock as of September 30, 2025.
Previous report
In the third quarter 2024, we obtained a $250 million term loan facility from Hercules. Under the terms of the term loan facility, $50 million was drawn at closing, $50 million was drawn in the second quarter 2025 and an additional $50 million is committed and fully available at our sole option in minimum increments of $25 million. A second tranche of $100 million will be available to support strategic initiatives, subject to future approval by Hercules. See Note 11, Long-term debt, in Part I, Item 1, to our Condensed Consolidated Financial Statements for further discussion.
Previous report
Cash provided by financing activities for the nine months ended September 30, 2024 was due to net proceeds of $228 million from issuance of our common stock to Gilead under the Third Stock Purchase Agreement Amendment, $47 million from our borrowings under the Hercules Agreement, and proceeds of $6 million for stock issued under our equity award plans.
Previous report
We are obligated to make principal loan payments and an end of term charge under the loan and security agreement with Hercules that we entered into on August 27, 2024 and under which we drew an additional $50 million in June 2025. See Note 11 to our Condensed Consolidated Financial Statements in Part I, Item 1 for further discussion.
Previous report
While our significant accounting policies are described in the notes to our Condensed Consolidated Financial Statements and our Annual Report on Form 10-K filed with the SEC on February 25, 2025, we believe that the accounting policy discussed below is critical to understanding our historical and future performance, as this policy relates to the more significant areas involving management's significant judgments and estimates.
Previous report
Revenue Recognition
Previous report
Standalone selling price
Previous report
As part of the accounting for contracts with customers, we develop assumptions that require judgment to determine the standalone selling price of each performance obligation identified in the contract.
Previous report
In the first quarter 2025, we decided to pause future development of etrumadenant. In June 2025, Gilead terminated its rights to etrumadenant (the adenosine receptor antagonist program). We determined that this was a significant reduction in the scope of the arrangement, which met the definition of a contract modification. We accounted for this contract modification as both a modification of the existing contract and the creation of a new contract. (See Note 5, Revenues, in Part I, Item 1 for further discussion). We determined the standalone selling price of certain performance obligations and allocated the total transaction price to each performance obligation on a relative standalone selling price basis. The estimation of the standalone selling price included estimates for forecasted costs, development timelines, discount rates, and probabilities of technical and regulatory success.
Previous report
Under the applicable accounting rules for such contract modifications, we did not adjust the accounting for completed performance obligations that were distinct from the modified goods or services. However, we were required to adjust revenue previously recognized to reflect the effect of the contract modification due to the updated transaction price allocated to the partially satisfied performance obligations and the updated measure of progress as of the modification date. Accordingly, we recognized a cumulative catch-up to revenue of $143 million based on the updated transaction price and measure of progress for the partially satisfied performance obligations.
Showing the first 40 of 45 passages. Open the source sections for the rest.
Reworded paragraphs (22)
Previous wording
The following chart summarizes our current clinical pipeline:
Current wording
The following chart summarizes our current clinical and late pre-clinical stage portfolio:
Previous wording
Gilead and Arcus co-develop globally and share co-commercialization rights in the U.S. for domvanalimab, zimberelimab and quemliclustat. Gilead holds commercialization rights outside of the U.S. subject to any third-party rights.
Current wording
†If approved, Gilead and Arcus will share co-promotion rights in the U.S. and Gilead holds commercialization rights outside of the U.S. subject to Taiho’s rights for the Taiho Territory.
Previous wording
•In October 2025, we announced eVOLVE-RCC02, a Phase 1b/3 study sponsored and operationalized by AstraZeneca, evaluating casdatifan plus volrustomig, AstraZeneca's investigational anti-PD-1/CTLA-4 bispecific antibody, in first-line, metastatic clear cell renal cell carcinoma ("ccRCC"), has paused recruitment.
Current wording
•In March 2026, we and AstraZeneca agreed not to re-open enrollment in eVOLVE-RCC02, a Phase 1b/3 study sponsored and operationalized by AstraZeneca, evaluating casdatifan in combination with volrustomig, AstraZeneca's investigational anti-PD-1/CTLA-4 bispecific antibody, in first-line, advanced/metastatic clear cell renal cell carcinoma.
Previous wording
Our R&D expenses consist of costs incurred in connection with the R&D of our pipeline programs. These expenses include preclinical and clinical expenses, payroll and personnel expenses, including stock-based compensation for our employees in R&D, laboratory supplies, product licenses, consulting costs, contract research, and depreciation. Shared facility expenses are allocated to functional groups proportionally based on usage. Under certain collaboration agreements we agree to share R&D expenses with our partners. Such cost sharing arrangements may result in receiving reimbursement from our partners or require that we reimburse our partners for qualified expenses. We expense both internal and external R&D costs as they are incurred. We record advance payments for services that will be used or rendered for future R&D activities as prepaid expenses and recognize them as an expense as the related services are performed. We recognize reimbursement for shared costs incurred by us and reimbursed by our partners as a reduction in R&D expense as the underlying costs are incurred.
Current wording
Our R&D expenses consist of costs incurred in connection with the R&D of our pipeline programs. These expenses include preclinical and clinical expenses, payroll and stock-based compensation for our personnel in R&D, laboratory supplies, product licenses, consulting costs, contract research, and fixed asset depreciation. Shared facility expenses are allocated to functional groups proportionally based on usage. Under certain collaboration agreements we agree to share R&D expenses with our partners. Such cost sharing arrangements may result in receiving reimbursement from our partners or require that we reimburse our partners for qualified expenses. We expense both internal and external R&D costs as they are incurred. We record advance payments for services that will be used or rendered for future R&D activities as prepaid expenses and recognize them as an expense as the related services are performed. We recognize reimbursement for shared costs incurred by us and reimbursed by our partners as a reduction in R&D expense as the underlying costs are incurred.
Previous wording
We do not allocate all our costs by investigational product, as a significant amount of R&D expenses include internal costs, such as payroll and other personnel expenses, and certain external costs that are not recorded at the investigational product level. In particular, with respect to internal costs, several of our departments support multiple R&D programs, and we do not allocate those costs by investigational product.
Current wording
We do not allocate all our costs by investigational product, as a significant amount of R&D expenses include internal costs, such as payroll and other personnel expenses, and certain external costs that are not recorded at the investigational product level. In particular, with respect to internal costs, several of our departments support multiple R&D programs.
Previous wording
In addition, under our arrangements with WuXi Biologics, Abmuno and AstraZeneca, we may incur additional clinical and regulatory milestone payments based on the development progress of our investigational products. We may also be required to pay royalties in the event of a successful product launch and our receipt of commercial revenues. Therefore, we are unable to predict the timing or the final cost to complete our clinical programs or validation of our manufacturing and supply processes and delays may occur due to numerous factors. Factors that could cause or contribute to delays or additional costs include, but are not limited to, those discussed in "Item 1A. Risk Factors" of the Quarterly Report.
Current wording
In addition, under our arrangements with WuXi Biologics, Abmuno and AstraZeneca, we may incur additional clinical and regulatory milestone payments based on the development progress of our investigational products. We may also be required to pay royalties in the event of a successful product launch and our receipt of commercial revenues. Therefore, we are unable to predict the timing or the final cost to complete our clinical programs or validation of our manufacturing and supply processes and delays may occur due to numerous factors. Factors that could cause or contribute to delays or additional costs include, but are not limited to, those discussed in "Part II, Item 1A. Risk Factors" of the Quarterly Report.
Previous wording
G&A expenses consist principally of personnel-related costs including payroll and stock-based compensation for personnel in executive, finance, human resources, information technology, business and corporate development, and other administrative functions. Shared facility expenses are allocated to functional groups proportionally based on usage. Our G&A expenses also include professional fees for legal, consulting, and accounting services, rent and other facilities costs, fixed asset depreciation, and other general operating expenses not otherwise classified as R&D expenses. We do not receive significant reimbursements of these costs through our collaboration with Gilead. We anticipate that our G&A expenses will be stable for the remainder of this year.
Current wording
G&A expenses consist principally of personnel-related costs including payroll and stock-based compensation for personnel in executive, finance, human resources, information technology, business and corporate development, and other administrative functions. Shared facility expenses are allocated to functional groups proportionally based on usage. Our G&A expenses also include professional fees for legal, consulting, and accounting services, rent and other facilities costs, fixed asset depreciation, and other general operating expenses not otherwise classified as R&D expenses. We do not anticipate significant changes in our G&A expenses in the near term.
Previous wording
Non-operating income, net consists primarily of interest earned on our investments in fixed-income marketable securities, interest expense on our loan financing with Hercules and non-cash interest income/expense incurred under the effective interest method on our liability for sale of future royalties to BVF.
Current wording
Non-operating income, net consists primarily of interest earned on our investments in fixed-income marketable securities, and interest expense on the Hercules Agreement.
Previous wording
The decrease in Total revenues for the three months ended September 30, 2025 was primarily driven by the prior year license revenue of $15 million as a result of Taiho's exercise of its option forquemliclustat in the third quarter 2024 and lower development service revenues from the Gilead Collaboration.
Current wording
The decrease in Total revenues for the three months ended March 31, 2026 was primarily driven by lower development services revenue from the Gilead Collaboration.
Previous wording
** Quemliclustat moved from early-stage development and preclinical program to a late-stage development program in the third quarter 2024. Casdatifan moved from early stage development and preclinical to a late-stage development program in the third quarter 2025.
Current wording
** Casdatifan moved from early-stage development and preclinical to a late-stage development program in the third quarter 2025.
Previous wording
R&D expense by quarter may fluctuate due to the timing of clinical manufacturing and standard-of-care therapeutic purchases with a corresponding impact on reimbursements. We expect R&D expenses to decline commencing in the fourth quarter 2025 as costs related to the domvanalimab Phase 3 development program decrease significantly.
Current wording
R&D expense by quarter may fluctuate due to the timing of clinical manufacturing and standard-of-care therapeutic purchases with a corresponding impact on reimbursements.
Previous wording
The decrease in Non-operating income, net for the nine months ended September 30, 2025 as compared to the nine months ended September 30, 2024, was primarily due to lower yields due to a smaller portfolio of investments and the interest expense on our long-term debt agreement which we entered into in the third quarter 2024, with an additional draw in June 2025.
Current wording
The decrease in Non-operating income, net for the three months ended March 31, 2026, was primarily due to: lower yields and a lower average balance for our investment portfolio; and higher interest expense on our long-term debt due to the additional drawdown under our agreement with Hercules at the end of the second quarter 2025.
Previous wording
There was no Income tax expense for the three and nine months ended September 30, 2025 or 2024 due to forecasted full year net operating losses.
Current wording
There was no Income tax expense for the three months ended March 31, 2026 or 2025 due to forecasted full year NOLs.
Previous wording
Our cash and investments are held in a variety of interest-bearing instruments, including money market funds, U.S. government treasury and agency obligations, investments in corporate securities and certificates of deposit. Based on our existing business plan, we believe that our cash, cash equivalents, marketable securities and existing facilities as of
Current wording
Our cash and investments are held in a variety of interest-bearing instruments, including money market funds, U.S. government treasury and agency obligations, investments in corporate securities and certificates of deposit. Based on our existing business plan, we believe that our cash, cash equivalents, and marketable securities as of March 31, 2026 will be sufficient to fund our planned level of operations until at least the second half of 2028.
Previous wording
To date, we have financed our operations primarily from the sale of our equity securities, upfront or milestone payments from our research, collaboration and license agreements with our strategic partners including Gilead and debt financing. We will need additional funding to support our continuing operations and pursue our long-term development strategy. Until such time that we can generate significant revenue from sales of our investigational products, if ever, we may finance our operations through the sale of equity, debt financings or other capital sources, including existing or potential collaborations with other companies or other strategic transactions. See "Item 1A. Risk Factors" for a discussion of the factors that could impact our liquidity.
Current wording
To date, we have financed our operations primarily from the sale of our equity securities, upfront or milestone payments from our research, collaboration and license agreements with our strategic partners including Gilead and debt financing. We will need substantial additional funding to support our continuing operations and pursue our development strategy. Until such time that we can generate significant revenue from sales of our investigational products, if ever, we expect to finance our operations through the sale of equity, debt financings or other capital sources, including existing or potential collaborations with other companies or other strategic transactions. See "Item 1A. Risk Factors" for a discussion of the factors that could impact our liquidity.
Previous wording
In 2023, we entered into an equity distribution agreement pursuant to which we may, from time to time, sell shares of our common stock having an aggregate offering price of up to $200 million. See Note 13, Stockholders' equity, in Part I, Item 1, to our Condensed Consolidated Financial Statements for further discussion.
Current wording
We have entered into an equity distribution agreement pursuant to which we may, from time to time, sell shares of our common stock having an aggregate offering price of up to $200 million.
Previous wording
In February 2025, we issued through an underwritten offering, 13.6 million shares of our common stock at a price of $11.00 per share, for total gross proceeds of approximately $150 million, before deducting underwriting discounts, commissions and offering expense.
Current wording
In 2025, we issued, through two underwritten offerings, 29.4 million shares of our common stock for total gross proceeds of approximately $438 million, before deducting underwriting discounts, commissions and offering expense.
Previous wording
Net cash used in operating activities was $362 million for the nine months ended September 30, 2025 compared to $70 million for the same period in the prior year. The change in operating cash flows is primarily due to the prior year receipt of the $87 million allocated to the performance obligations created by the Third Gilead Collaboration Agreement Amendment and the timing of receipts from Taiho for development milestones for STAR-121, STAR-221, and PRISM-1.
Current wording
Net cash used in operating activities was $138 million for the three months ended March 31, 2026 compared to $132 million for the same period in the prior year. The change in operating cash flows is primarily due to the timing of receipts from Taiho for development milestones.
Previous wording
Cash provided by investing activities for the nine months ended September 30, 2025 was primarily due to net proceeds from marketable securities of $249 million.
Current wording
Cash provided by investing activities for the three months ended March 31, 2026 was primarily due to net proceeds from marketable securities of $114 million.
Previous wording
Cash used in investing activities for the nine months ended September 30, 2024 was primarily due to net purchases of marketable securities of $130 million.
Current wording
Cash provided by investing activities for the three months ended March 31, 2025 was primarily due to net proceeds from marketable securities of $33 million.
Previous wording
Cash provided by financing activities for the nine months ended September 30, 2025 was due to net proceeds of $150 million from issuance of our common stock, primarily due to the February 2025 underwritten offering, and $49 million from our borrowings under the Hercules Agreement and proceeds of $3 million for stock issued under our equity award plans.
Current wording
Cash provided by financing activities for the three months ended March 31, 2025 was due to net proceeds of $142 million from issuance of our common stock under the February 2025 underwritten offering.
Previous wording
There have been no material changes to our contractual obligations outside the ordinary course of business during the three months ended September 30, 2025, as compared to those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024, other than the following:
Current wording
There have been no material changes to our contractual obligations outside the ordinary course of business during the three months ended March 31, 2026, as compared to those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
Cash provided by financing activities for the three months ended March 31, 2026 was due to proceeds of $3 million for stock issued under our equity award plans.
Current report — wording carried from elsewhere
There have been no material changes to our critical accounting policies and estimates, from those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025.