Vera Therapeutics, Inc.
For the period ended Jun 30, 2026. Filed Aug 10, 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.
Jun 30, 2026 · Filed Aug 10, 2026
VERA$29.79-1.2%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-07.
0001193125-26-212143
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-10.
0001193125-26-342380
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 79 previous paragraphs and 85 current paragraphs.
43 unchanged; 32 reworded; 7 added; 2 removed; 2 previous and 3 current paragraphs rearranged.
Tables are not compared: 5 previous and 5 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 (7)
Current report
We are a commercial-stage biotechnology company focused on the pursuit of truth in science to transform medicine in autoimmune disease, starting with the kidney. Our flagship commercial product is TRUTAKNATM (atacicept-vymj), an inhibitor of B-cell activating factor (BAFF) and A Proliferation-Inducing Ligand (APRIL) indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. Beyond IgAN, we are evaluating additional diseases where the reduction of autoantibodies through inhibition of BAFF and APRIL may prove clinically meaningful.
Current report
On July 7, 2026, the U.S. Food and Drug Administration (FDA) granted accelerated approval to TRUTAKNA. The accelerated approval is based on a prespecified interim analysis of the ongoing ORIGIN Phase 3 trial (ORIGIN 3) in which participants treated with TRUTAKNA achieved a 46% reduction in proteinuria from baseline, with a statistically significant and clinically meaningful 42% reduction compared to placebo (p < 0.0001) at 36 weeks. In this registrational program, TRUTAKNA was generally well-tolerated. The final efficacy analysis from ORIGIN 3 is expected in the third quarter of 2026, followed by an anticipated supplemental Biologics License Application submission to the FDA expected in the fourth quarter of 2026 which could lead to potential full FDA approval of TRUTAKNA in 2027.
Current report
TRUTAKNA is a soluble recombinant fusion protein containing the human transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to BAFF and APRIL, the two key cytokines that activate B cells and drive IgAN pathophysiology. In IgAN, activated B cells produce both the antigen and associated antibodies that result in the production of damaging IgA immune complexes. The overlapping roles of BAFF and APRIL in activating B cells support the potential for TRUTAKNA as a disease-modifying therapy. TRUTAKNA is self-administered as an at home, small-volume (1 ml), 150 mg once-weekly autoinjector.
Current report
Prior to receiving accelerated approval from the FDA for TRUTAKNA on July 7, 2026, we recorded all manufacturing costs as research and development expenses as incurred, including costs for materials and work in process that we intend to use for commercial supply. From July 7, 2026 and onward, manufacturing costs incurred for commercial inventory will be capitalized as current assets and later recorded to expense as cost of sales in the periods in which sales of the related inventory are recognized.
Current report
We expect our general and administrative expenses to increase in future periods as we scale up commercial manufacturing capacity, continue to build out a sales, marketing, and distribution infrastructure to support TRUTAKNA and any other approved product candidates, and provide general and administrative support for our operations.
Current report
Other income, net, decreased by $2.0 million, or 22%, to $7.1 million for the six months ended June 30, 2026, from $9.1 million in the six months ended June 30, 2025, primarily due to a decrease of $1.5 million in interest income resulting from lower average balances of marketable securities held during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025 and a decrease in sublease income of $1.0 million due to the expiration of a sublease to a third-party in September 2025, partially offset by an increase of $0.2 million in currency exchange gains and losses and an increase of $0.3 million in unrealized gains and losses.
Current report
In the six months ended June 30, 2025, our financing activities provided $21.8 million of cash, resulting from $23.3 million in net proceeds from borrowings from the initial funding under the 2025 Loan Agreement in June 2025, after repayment of borrowings under the 2021 Loan Agreement, $2.0 million in proceeds from exercise of stock options and issuance of shares under our employee stock purchase plan, and $3.5 million in payment of deferred issuance costs related to unfunded loan commitments under the 2025 Loan Agreement.
Removed paragraphs (2)
Previous report
We are a biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases. Our lead product candidate, atacicept, is currently being evaluated for the treatment of immunoglobulin A nephropathy (IgAN) and other autoimmune kidney diseases. Atacicept is a native human TACI-Fc fusion protein that binds both the B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL) cytokines and is self-administered subcutaneously at home. We are conducting ORIGIN 3, the pivotal Phase 3 trial of atacicept 150 mg in IgAN. The trial met the primary efficacy endpoint of reduction in proteinuria as measured by 24-hour urine protein-to-creatinine ratio (UPCR) at week 36, where participants treated with atacicept achieved a 46% reduction from baseline in UPCR with a statistically significant and clinically meaningful 42% reduction in UPCR compared to placebo (p<0.0001). The incidence of adverse events was generally balanced between the atacicept and placebo groups, with fewer serious adverse events reported with atacicept than placebo, no safety signals indicating immunosuppression, and no deaths in either treatment group. A key secondary endpoint will evaluate the change in estimated glomerular filtration rate (eGFR) at 104 weeks – we anticipate this data will be available in the first quarter of 2027. In November 2025, we submitted a Biologics License Application (BLA) for atacicept for the treatment of adults with IgAN to the U.S. Food and Drug Administration (FDA) through the Accelerated Approval Program. On January 7, 2026, the FDA granted priority review to the application and assigned a Prescription Drug User Fee Act (PDUFA) target action date of July 7, 2026. If approved, atacicept would be the first B-cell modulator inhibiting both BAFF and APRIL for IgAN, offering patients an autoinjector for at-home self-administration.
Previous report
The ORIGIN Phase 2b clinical trial evaluated the safety and efficacy of atacicept in 116 participants with IgAN and reported positive results at 24 weeks in January 2023, 36 weeks in June 2023, and 96 weeks in October 2024. The trial remained blinded through 36 weeks, after which all participants were eligible for the open label extension portion of the study and received atacicept 150 mg through 96 weeks. Atacicept met its primary endpoint at 24 weeks with a statistically significant reduction in UPCR. Through 36 weeks, participants treated with atacicept demonstrated reductions in galactose-deficient IgA1 (Gd-IgA1, the autoantigen produced by B cells in patients with IgAN), hematuria, and UPCR, with stable eGFR. The improvements in Gd-IgA1, hematuria, UPCR and eGFR represent the quartet of findings consistent with IgAN disease modification. The 96-week open label extension results showed consistent and sustained reductions in Gd-IgA1, hematuria, and UPCR, with continued eGFR stabilization at a rate similar to the general population without kidney disease. Atacicept’s safety profile appeared favorable, and comparable to placebo, across the ORIGIN program in IgAN.
Reworded paragraphs (32)
Previous wording
We believe that atacicept has pipeline-in-a-molecule potential, with potential application in multiple diseases. Based on data from the ORIGIN Phase 2b trial, the FDA granted Breakthrough Therapy Designation to atacicept for the treatment of IgAN. We have also committed to providing long-term access to atacicept for ORIGIN participants through ORIGIN EXTEND, a long-term Phase 2 extension study that offers atacicept to participants who completed ORIGIN Phase 2b or 3 until, if approved, commercial availability in their country or region. We are evaluating atacicept in other autoimmune kidney diseases, including primary membranous nephropathy (pMN), focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD), in patients with anti-phospholipase A2 receptor (PLA2R) or anti-nephrin autoantibodies in the Phase 2 PIONEER clinical trial. Initial results from the Phase 2 PIONEER trial are expected in the second quarter of 2026. Potential future indications include anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV), lupus nephritis (LN), Sjogren’s disease, systemic lupus erythematosus (SLE), systemic sclerosis, generalized myasthenia gravis, and idiopathic thrombocytopenic purpura.
Current wording
We believe that atacicept has pipeline-in-a-molecule potential, with potential application in multiple diseases. In the Phase 2 PIONEER clinical trial, for which we expect to report additional results in the fourth quarter of 2026, we are evaluating atacicept in a broader population of IgAN patients as well as other autoimmune kidney diseases, including primary membranous nephropathy (pMN), focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD), in patients with anti-phospholipase A2 receptor or anti-nephrin autoantibodies. Potential future indications include anti-neutrophil cytoplasmic antibody-associated vasculitis, lupus nephritis, Sjogren’s disease, systemic lupus erythematosus, systemic sclerosis, generalized myasthenia gravis, and idiopathic thrombocytopenic purpura.
Previous wording
We also hold worldwide, exclusive development and commercial rights to MAU868, a potentially first-in-class monoclonal antibody to treat reactivated BK virus (BKV) infections, for which we completed a Phase 2 clinical trial in 2022. In January 2025, we acquired worldwide, exclusive development and commercial rights to VT-109, a novel, next-generation dual BAFF/APRIL inhibitor that is in preclinical development. We believe that our current pipeline programs leverage the deep expertise of our team and have strong potential commercial synergies.
Current wording
We also hold worldwide, exclusive development and commercial rights to MAU868, a potentially first-in-class monoclonal antibody to treat reactivated BK virus infections, for which we completed a Phase 2 clinical trial in 2022. In January 2025, we acquired worldwide, exclusive development and commercial rights to VT-109, a novel, next-generation BAFF and APRIL inhibitor that is in preclinical development. We believe that our current pipeline programs leverage the deep expertise of our team and have strong potential commercial synergies.
Previous wording
We do not have any product candidates approved for commercial sale, and we have not generated any revenue from product sales. Our ability to generate revenue sufficient to achieve profitability, if ever, will depend on the successful development and eventual commercialization of one or more of our product candidates, which we expect will take a number of years. We also do not own or operate, and currently have no plans to establish, any manufacturing facilities. We rely, and expect to continue to rely, on third parties for the manufacture of our product candidates for nonclinical and clinical testing, as well as for commercial manufacturing if any of our product candidates obtain marketing approval. We believe that this strategy allows us to maintain a more efficient infrastructure by eliminating the need for us to invest in our own manufacturing facilities, equipment, and personnel while also enabling us to focus our expertise and resources on the development of our product candidates.
Current wording
We currently have only one product approved for commercial sale and expect to record limited revenue from product sales during the third quarter of 2026. Our ability to generate revenue sufficient to achieve profitability, if ever, will depend on the successful commercialization of our lead product and development of our product candidates, which we expect will take a number of years. We also do not own or operate, and currently have no plans to establish, any manufacturing facilities. We rely, and expect to continue to rely, on third parties for the manufacture of our lead product and product candidates. We believe that this strategy allows us to maintain a more efficient infrastructure by eliminating the need for us to invest in our own manufacturing facilities, equipment, and personnel while also enabling us to focus our expertise and resources on the successful commercialization of our lead product and development of our product candidates.
Previous wording
To date, we have funded our operations primarily through proceeds from the sale of shares of our common stock, redeemable convertible preferred stock, debt financing and convertible promissory notes. As of March 31, 2026, we had $596.8 million in cash, cash equivalents and marketable securities, compared to $714.6 million as of December 31, 2025.
Current wording
To date, we have funded our operations primarily through proceeds from the sale of shares of our common stock, redeemable convertible preferred stock, debt financing and convertible promissory notes. As of June 30, 2026, we had $499.2 million in cash, cash equivalents and marketable securities, compared to $714.6 million as of December 31, 2025.
Previous wording
We have incurred significant operating losses since the commencement of our operations. Our net losses were $121.0 million and $51.7 million for the three months ended March 31, 2026 and 2025, respectively, and we expect to incur significant and increasing losses for the foreseeable future as we continue to advance our product candidates toward commercialization. Our net losses may fluctuate significantly from period to period, depending on the timing of expenditures on our research and development activities. As of March 31, 2026, we had an accumulated deficit of $881.9 million, compared to $760.9 million as of December 31, 2025. Our primary use of cash is to fund operating expenses, which consist of research and development and general and administrative expenditures. Cash used to fund operating expenses depends on the timing of when we pay these expenses, as reflected in the changes in our working capital balances.
Current wording
We have incurred significant operating losses since the commencement of our operations. Our net losses were $109.5 million and $76.5 million for the three months ended June 30, 2026 and 2025, respectively, and we expect to incur significant and increasing losses for the foreseeable future as we commercialize our lead product and continue to advance our product candidates toward commercialization. Our net losses may fluctuate significantly from period to period, depending on the timing of expenditures on our research and development activities. As of June 30, 2026, we had an accumulated deficit of $991.4 million, compared to $760.9 million as of December 31, 2025. Our primary use of cash is to fund operating expenses, which consist of research and development and general and administrative expenditures. Cash used to fund operating expenses depends on the timing of when we pay these expenses, as reflected in the changes in our working capital balances.
Previous wording
We expect to continue to incur net operating losses for at least the next several years, and we expect our research and development expenses, general and administrative expenses, and capital expenditures will continue to increase. We expect our expenses and capital requirements will increase significantly in connection with our ongoing activities as we:
Current wording
We expect to continue to incur net operating losses in the near term, and we expect our research and development expenses, general and administrative expenses, and capital expenditures will continue to increase. We expect our expenses and capital requirements will increase significantly in connection with our ongoing activities as we:
Previous wording
initiate or continue nonclinical studies and clinical trials for our product candidates; seek regulatory approvals for any product candidates that successfully complete clinical trials;
Current wording
initiate or continue nonclinical studies and clinical trials for our lead product and product candidates;
Previous wording
establish a sales, marketing and distribution infrastructure to commercialize any approved product candidates and related additional commercial manufacturing costs;
Current wording
establish a sales, marketing and distribution infrastructure to commercialize approved product candidates and related additional commercial manufacturing costs;
Previous wording
add clinical, operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts.
Current wording
add clinical, operational, financial and management information systems and personnel, including personnel to support our product development and commercialization efforts.
Previous wording
We will require substantial additional funding to develop our product candidates and support our continuing operations. Until such time that we can generate significant revenue from product sales or other sources, if ever, we expect to finance our operations through the sale of equity, debt financings, or other capital sources, which could include income from collaborations, strategic partnerships, or marketing, distribution, licensing or other strategic arrangements with third parties, or from grants. We may be unable to raise additional funds or to enter into such agreements or arrangements on favorable terms, or at all. Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and the disruptions to, and volatility in, the credit and financial markets in the United States and worldwide. Our failure to obtain sufficient funds on acceptable terms when needed could have a material adverse effect on our business, results of operations or financial condition, including requiring us to have to delay, reduce or eliminate our product development or future commercialization efforts. Insufficient liquidity may also require us to relinquish rights to product candidates at an earlier stage of development or on less favorable terms than we would otherwise choose. The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our development efforts. We cannot provide assurance that we will ever be profitable or generate positive cash flow from operating activities.
Current wording
We will require substantial additional funding to successfully commercialize our lead product, develop our product candidates and support our continuing operations. Until such time that we can generate significant revenue from product sales or other sources, if ever, we expect to finance our operations through the sale of equity, debt financings, or other capital sources, which could include income from collaborations, strategic partnerships, or marketing, distribution, licensing or other strategic arrangements with third parties, or from grants. We may be unable to raise additional funds or to enter into such agreements or arrangements on favorable terms, or at all. Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and the disruptions to, and volatility in, the credit and financial markets in the United States and worldwide. Our failure to obtain sufficient funds on acceptable terms when needed could have a material adverse effect on our business, results of operations or financial condition, including requiring us to have to delay, reduce or eliminate our product development or commercialization efforts. Insufficient liquidity may also require us to relinquish rights to our lead product or product candidates at an earlier stage of development or on less favorable terms than we would otherwise choose. The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our development efforts. We cannot provide assurance that we will ever be profitable or generate positive cash flow from operating activities.
Previous wording
We believe that our existing cash, cash equivalents and marketable securities held as of March 31, 2026, will be sufficient to fund our planned operations and capital expenditure requirements for at least the next 12 months from the date of this Quarterly Report on Form 10-Q. However, should adverse geopolitical or macroeconomic events, such as those discussed above, any recession or depression associated with those events or other events described herein, continue for a prolonged period, our results of operations, financial condition, liquidity and cash flows could be materially impacted as a result of a lower likelihood of effectively and efficiently developing and successfully commercializing our product candidates.
Current wording
We believe that our existing cash, cash equivalents and marketable securities held as of June 30, 2026, will be sufficient to fund our planned operations and capital expenditure requirements for at least the next 12 months from the date of this Quarterly Report on Form 10-Q. However, should adverse geopolitical or macroeconomic events, such as those discussed above, any recession or depression associated with those events or other events described herein, continue for a prolonged period, our results of operations, financial condition, liquidity and cash flows could be materially impacted as a result of a lower likelihood of successfully commercializing our lead product and effectively developing our product candidates.
Previous wording
Comparison of the Three Months Ended March 31, 2026 and 2025
Current wording
Comparison of the Three and Six Months Ended June 30, 2026 and 2025
Previous wording
Research and development expenses represent a substantial portion of our operating expenses. Our research and development expenses consist primarily of direct and indirect expenses incurred in connection with the research and development of our product candidates. Direct expenses include costs incurred under agreements with third parties, including contract research organizations, contract drug manufacturing organizations and consultants directly related to our research and development of product candidates, and license and milestone fees incurred as a result of our contractual obligations for our development candidates. Unless and until we receive marketing approval for our product candidate, all drug manufacturing costs are expensed as research and development. Indirect expenses include employee compensation and other personnel-related expenses, including stock-based compensation, facilities and depreciation related to buildings and equipment used by research and development personnel and activities and other expenses.
Current wording
Research and development expenses represent a substantial portion of our operating expenses. Our research and development expenses consist primarily of direct and indirect expenses incurred in connection with the research and development of our lead product and product candidates. Direct expenses include costs incurred under agreements with third parties, including contract research organizations, contract drug manufacturing organizations and consultants directly related to our research and development of our lead product and product candidates, and license and milestone fees incurred as a result of our contractual obligations for our development candidates. Until we receive marketing approval for a product candidate, all drug manufacturing costs are expensed as research and development. Indirect expenses include employee compensation and other personnel-related expenses, including stock-based compensation, facilities and depreciation related to buildings and equipment used by research and development personnel and activities and other expenses.
Previous wording
Research and development expenses increased by $44.7 million, or 108%, to $86.0 million in the three months ended March 31, 2026, from $41.3 million in the three months ended March 31, 2025, due to an increase of $20.9 million in contract drug manufacturing costs for clinical and potential commercial use, an increase of $14.4 million in license and milestone expense related to current period recognition of a $15.0 million milestone payment due upon filing of the BLA, an increase of $2.4 million in clinical trial expenses mainly due to increased expenses for the PIONEER and ORIGIN EXTEND trials, an increase of $8.6 million for employee compensation and related benefit expenses, including a $3.0 million increase in stock-based compensation expense, due to growth in research and development headcount, and an increase of $0.4 million in facilities and other, including a $0.2 million increase in travel expenses supporting research and development activities, due mostly to travel associated with medical conferences, offset by a decrease of $1.8 million in consulting and professional services, primarily related to advisory board and expert forum activities that incurred in 2025.
Current wording
Research and development expenses increased by $46.6 million, or 47%, to $146.1 million in the six months ended June 30, 2026, from $99.5 million in the six months ended June 30, 2025, due to an increase of $15.8 million for employee compensation and related benefit expenses, including a $5.7 million increase in stock-based compensation expense, as a result of growth in research and development employee headcount, an increase of $14.4 million in license and milestone expense related to current period recognition of a $15.0 million milestone payment due upon filing of the BLA, an increase of $13.2 million in contract drug manufacturing costs for clinical and potential commercial use, an increase of $5.3 million in clinical trial expenses mainly due to increased expenses for the PIONEER and ORIGIN EXTEND trials, and an increase of $0.9 million in facilities and other, including a $0.6 million increase in travel expenses supporting research and development activities, partially offset by a decrease of $2.9 million in consulting and professional services, primarily related to advisory board and expert forum activities incurred in 2025.
Previous wording
We expect our research and development expenses to increase in future periods as we seek regulatory approval of atacicept in IgAN in the U.S. and other markets, conduct additional clinical trials of atacicept, and if we expand development of atacicept in other indications or product configurations, or other product candidates.
Current wording
We expect our research and development expenses to increase in future periods as we seek full regulatory approval of atacicept in IgAN in the U.S. and regulatory approval in other non-U.S. markets, conduct additional clinical trials of atacicept, and if we expand development of atacicept in other indications or product configurations, or advance other product candidates.
Previous wording
General and administrative expenses increased by $23.2 million, or 146%, to $39.1 million in the three months ended March 31, 2026, from $15.9 million in the three months ended March 31, 2025, primarily due to an increase of $12.7 million in employee compensation and related benefits expenses, including stock-based compensation, as a result of increased general and administrative employee headcount including sales personnel, an increase of $7.3 million in commercial planning and medical affairs expenses related to marketing, market research, market access, medical information, and health economics activities in preparation for the potential commercialization of atacicept, an increase of $0.9 million in software expenses to support scaling operations, and an increase of $0.4 million in legal, accounting, and audit expenses, offset by a decrease of $0.3 million in consulting expenses, including non-employee director stock-based compensation. The $2.2 million increase in other general and administrative expenses was primarily driven by an increase of $0.8 million in recruiting and placement expenses, an increase of $0.7 million in business travel expenses, and an increase of $0.7 million in corporate communications expenses.
Current wording
General and administrative expenses increased by $53.7 million, or 142%, to $91.5 million in the six months ended June 30, 2026, from $37.9 million in the six months ended June 30, 2025, primarily due to an increase of $28.9 million in employee compensation and related benefits expenses, including stock-based compensation, as a result of increased general and administrative employee headcount including sales personnel, an increase of $18.8 million in commercial planning and medical affairs expenses related to marketing, market research, market access, medical information, and health economics activities in preparation for the anticipated commercial launch of TRUTAKNA, an increase of $1.6 million in software expenses to support scaling operations, and an increase of $0.3 million in legal, accounting, and audit expenses, partially offset by a decrease of $0.1 million in consulting expenses. The $4.2 million increase in other general and administrative expenses was primarily driven by increases of $1.9 million in corporate communications expenses, $1.6 million in business travel expenses, $0.6 million in recruiting and placement expenses, and $0.4 million in information technology expenses.
Previous wording
Other income, net, decreased by $1.4 million, or 25%, to $4.1 million for the three months ended March 31, 2026, from $5.5 million in the three months ended March 31, 2025, primarily due to a decrease of $0.5 million in interest income from a decrease in the average balance of marketable securities held during the three months ended March 31, 2026, as compared to the three months ended March 31, 2025, a decrease in sublease income of $0.5 million due to the expiration of a sublease to a third-party in September 2025, and $0.4 million in amortization of deferred debt issuance costs for unfunded loan commitments relating to the refinancing of the Oxford credit facility in June 2025.
Current wording
Other income, net, decreased by $0.6 million, or 16%, to $3.0 million for the three months ended June 30, 2026, from $3.6 million in the three months ended June 30, 2025, primarily due to a decrease of $1.0 million in interest income resulting from lower average balances of marketable securities held during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, and a decrease in sublease income of $0.5 million due to the expiration of a sublease to a third-party in September 2025, partially offset by a decrease of $0.5 million in amortization of deferred debt issuance costs for unfunded loan commitments relating to the refinancing of the Oxford credit facility in June 2025.
Previous wording
In August 2025, we entered into a Sales Agreement (the Sales Agreement) with TD Securities (USA) LLC (TD Cowen). Under the Sales Agreement, we may offer and sell, from time to time, through TD Cowen as our sales agent and/or principal, shares of our common stock, having an aggregate offering amount of up to $200 million (the Shares). We are not obligated to sell any shares under this agreement. We will pay TD Cowen a commission of up to 3.0% of the gross sales proceeds of any Shares sold through TD Cowen under the Sales Agreement. As of March 31, 2026, there have been no sales under the Sales Agreement.
Current wording
In August 2025, we entered into a Sales Agreement (the Sales Agreement) with TD Securities (USA) LLC (TD Cowen). Under the Sales Agreement, we may offer and sell, from time to time, through TD Cowen as our sales agent and/or principal, shares of our common stock, having an aggregate offering amount of up to $200 million (the Shares). We are not obligated to sell Shares under the Sales Agreement. We will pay TD Cowen a commission of up to 3.0% of the gross sales proceeds of any Shares sold through TD Cowen under the Sales Agreement. As of June 30, 2026, there have been no sales under the Sales Agreement.
Previous wording
We use our cash to fund operations, primarily to fund our research and development efforts, clinical trials, establishing and maintaining our intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these operations. Cash used to fund operating expenses is affected by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable, accrued expenses and prepaid assets.
Current wording
We use our cash to fund operations, primarily to fund our research and development efforts, including clinical trials, build a sales, marketing and distribution infrastructure to support commercial activities, establish and maintain our intellectual property portfolio, hire personnel, raise capital, and provide general and administrative support for these operations. Cash used to fund operating expenses is affected by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable, accrued expenses and prepaid assets.
Previous wording
We anticipate that we will continue to incur net losses for the foreseeable future as we continue research and development activities of our product candidates, hire additional staff, including clinical, commercial, operational, administrative and management personnel, and incur additional expenses associated with operating as a public company. We expect to incur significant expenses and operating losses for the foreseeable future as we advance our clinical development activities and our product candidate portfolio and prepare for anticipated commercialization of atacicept. We expect that our research and development and general and administrative costs will increase substantially in connection with conducting additional clinical trials for our research programs and product candidates, contracting with third parties to support nonclinical studies and clinical trials, expanding our intellectual property portfolio, scaling up external commercial manufacturing capacity, building a sales, marketing and distribution infrastructure to commercialize any approved product candidates, and providing general and administrative support for our operations. As a result, we will need additional capital to fund our operations, which we may obtain from additional equity or debt financings, collaborations, licensing arrangements, or other sources.
Current wording
We anticipate that we will continue to incur net losses for the foreseeable future as we continue research and development activities for our lead product and product candidates, hire additional staff, including clinical, commercial, operational, administrative and management personnel, and incur additional expenses associated with operating as a public company. We expect to incur significant expenses and operating losses for the foreseeable future as we continue to commercialize TRUTAKNA and advance our clinical development activities and our product candidate portfolio. We expect that our research and development and selling, general and administrative costs will increase substantially in connection with conducting additional clinical trials for our research programs, lead product, and product candidates, contracting with third parties to support nonclinical studies and clinical trials, expanding our intellectual property portfolio, scaling up external commercial manufacturing capacity, continuing to build a sales, marketing and distribution infrastructure to successfully commercialize TRUTAKNA and any other approved product candidates, and providing general and administrative support for our operations. As a result, we will need additional capital to fund our operations, which we may obtain from additional equity or debt financings, collaborations, licensing arrangements, or other sources.
Previous wording
As of March 31, 2026, we had cash, cash equivalents and marketable securities of $596.8 million, as compared to $714.6 million as of December 31, 2025. We believe, based on our current operating plan, that our cash, cash equivalents and marketable securities as of March 31, 2026 will be sufficient to fund our planned operations and capital expenditure requirements for at least the next 12 months from the date of this Quarterly Report on Form 10-Q.
Current wording
As of June 30, 2026, we had cash, cash equivalents and marketable securities of $499.2 million, as compared to $714.6 million as of December 31, 2025. We believe, based on our current operating plan, that our cash, cash equivalents and marketable securities as of June 30, 2026 will be sufficient to fund our planned operations and capital expenditure requirements for at least the next 12 months from the date of this Quarterly Report on Form 10-Q.
Previous wording
In the three months ended March 31, 2026, we used $106.5 million of cash in operating activities, attributable to a net loss of $121.0 million and an increase in our net operating assets and liabilities of $13.7 million, offset by $15.0 million in license fees attributable to investing activities and adjustments for non-cash charges of $13.3 million. Non-cash charges primarily consisted of $13.2 million of stock-based compensation and $0.6 million net in accretion and amortization of loan exit fees and costs, partially offset by non-cash interest income of $0.8 million related to amortization of discount on purchases of marketable securities. The change in our net operating assets and liabilities was primarily due to a decrease of $8.0 million in accounts payable, an increase of $5.1 million in prepaid expense and other current assets, and a decrease of $0.4 million in accrued and other current liabilities, offset by an increase of $0.1 million in operating lease liabilities.
Current wording
In the six months ended June 30, 2026, we used $206.8 million of cash in operating activities, attributable to a net loss of $230.5 million and an increase in our net operating assets and liabilities of $20.2 million, partially offset by $15.0 million in license fees attributable to investing activities and adjustments for non-cash charges of $28.9 million. Non-cash charges primarily consisted of $29.1 million of stock-based compensation and $1.3 million net in accretion and amortization of loan exit fees and costs, partially offset by non-cash interest income of $1.9 million related to amortization of discount on purchases of marketable securities. The change in our net operating assets and liabilities was primarily due to a decrease of $7.3 million in accounts payable, an increase of $14.6 million in prepaid expense and other current assets, and a decrease of $0.4 million in operating lease liabilities, partially offset by an increase of $2.1 million in accrued and other current liabilities.
Previous wording
In the three months ended March 31, 2025, we used $54.4 million of cash in operating activities, attributable to a net loss of $51.7 million, offset by adjustments for non-cash charges of $6.0 million, $0.8 million in license fees attributable to investing activities, and a decrease in our net operating assets and liabilities of $9.4 million. Non-cash charges primarily consisted of $7.7 million of stock-based compensation, non-cash interest income of $2.5 million related to amortization of discount on purchases of marketable securities, and a $0.5 million reduction in the carrying amount of operating lease right-of-use assets. The change in our net operating assets and liabilities was primarily due to a decrease of $4.8 million in accrued and other current liabilities, an increase of $1.6 million in accounts payable, an increase of $5.9 million in prepaid expense and other current assets, and a decrease of $0.4 million in operating lease liabilities.
Current wording
In the six months ended June 30, 2025, we used $109.2 million of cash in operating activities, attributable to a net loss of $128.2 million, partially offset by adjustments for non-cash charges of $14.3 million, $0.8 million in license fees attributable to investing activities, and a decrease in our net operating assets and liabilities of $3.9 million. Non-cash charges primarily consisted of $17.2 million of stock-based compensation, non-cash interest income of $4.4 million related to amortization of discount on purchases of marketable securities, and a $0.9 million reduction in the carrying amount of operating lease right-of-use assets. The change in our net operating assets and liabilities was primarily due to an increase of $3.3 million in accrued and other current liabilities and an increase of $5.5 million in accounts payable, partially offset by an increase of $4.2 million in prepaid expense and other current assets and a decrease of $0.9 million in operating lease liabilities.
Previous wording
The increase in cash used in operating activities from the three months ended March 31, 2025 to the three months ended March 31, 2026 was primarily attributable to increased research and development and general and administrative expenses.
Current wording
The increase in cash used in operating activities from the six months ended June 30, 2025 to the six months ended June 30, 2026 was primarily attributable to increased research and development and general and administrative expenses.
Previous wording
In the three months ended March 31, 2026, our investing activities used $137.8 million of cash, primarily resulting from $210.6 million used for purchases of marketable securities and $15.0 million paid in license fees, offset by $87.9 million provided by maturities of marketable securities.
Current wording
In the six months ended June 30, 2026, our investing activities used $104.9 million of cash, primarily resulting from $308.6 million used for purchases of marketable securities and $15.0 million paid in license fees, partially offset by $218.9 million provided by maturities of marketable securities.
Previous wording
In the three months ended March 31, 2025, our investing activities provided $15.3 million of cash, primarily resulting from $90.0 million for purchases of marketable securities, offset by $106.2 million provided by maturities of marketable securities.
Current wording
In the six months ended June 30, 2025, our investing activities provided $43.9 million of cash, primarily resulting from $232.3 million provided by maturities of marketable securities, partially offset by $187.3 million used for purchases of marketable securities.
Previous wording
In the three months ended March 31, 2026, our financing activities provided $3.9 million of cash, resulting from proceeds from exercise of stock options and issuance of shares under our employee stock purchase plan.
Current wording
In the six months ended June 30, 2026, our financing activities provided $5.9 million of cash, resulting from proceeds from exercise of stock options and issuance of shares under our employee stock purchase plan.
Previous wording
During the three months ended March 31, 2026, there were no material changes to our contractual obligations and commitments from those described under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Annual Report.
Current wording
During the six months ended June 30, 2026, there were no material changes to our contractual obligations and commitments from those described under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Annual Report.
Previous wording
In June 2025, the Company refinanced its debt under the 2021 Loan Agreement by entering into a new non-revolving loan and security agreement, the proceeds of which were partially used to prepay the outstanding principal balance of the 2021 Loan Agreement in full. As a result, the Company no longer has any contractual obligations and commitments under the 2021 Loan Agreement.
Current wording
In June 2025, we refinanced our debt under the 2021 Loan Agreement by entering into a new non-revolving loan and security agreement, the proceeds of which were partially used to prepay the outstanding principal balance of the 2021 Loan Agreement in full. As a result, we no longer have any contractual obligations and commitments under the 2021 Loan Agreement.
Previous wording
We are permitted to prepay the 2025 Loan in full or in part at any time upon 10 business days’ written notice to Oxford, subject to payment of the applicable Prepayment Fee (as defined below). Upon the earliest to occur of the maturity date, acceleration of the 2025 Loan or prepayment of the 2025 Loan, we are required to make a final payment equal to 5.0% of the aggregate principal amount of the 2025 Loan (the Final Fee). Any prepayments of the 2025 Loan must be accompanied by (a) accrued and unpaid interest thereon, (b) the Final Fee and (c) prepayment fee of (i) 2.0% of the portion of the 2025 Loan being prepaid if the repayment is on or before June 4, 2027 or (ii) 1.0% of the portion of the 2025 Loan being prepaid if the repayment is after June 4, 2027 through June 4, 2028. There is no Prepayment Fee for any prepayments occurring after June 4, 2028.
Current wording
We are permitted to prepay the 2025 Loan in full or in part at any time upon 10 business days’ written notice to Oxford, subject to payment of the applicable Prepayment Fee (as defined in (c) below). Upon the earliest to occur of the maturity date, acceleration of the 2025 Loan or prepayment of the 2025 Loan, we are required to make a final payment equal to 5.0% of the aggregate principal amount of the 2025 Loan (the Final Fee). Any prepayments of the 2025 Loan must be accompanied by (a) accrued and unpaid interest thereon, (b) the Final Fee and (c) prepayment fee of (i) 2.0% of the portion of the 2025 Loan being prepaid if the repayment is on or before June 4, 2027 or (ii) 1.0% of the portion of the 2025 Loan being prepaid if the repayment is after June 4, 2027 through June 4, 2028 (the Prepayment Fee). There is no Prepayment Fee for any prepayments occurring after June 4, 2028.
Previous wording
Our obligations under the 2025 Loan Agreement are secured by a security interest in substantially all of our assets, other than our intellectual property, which is subject to a negative pledge. The 2025 Loan Agreement contains two financial related covenants. Also included in the 2025 Loan Agreement are customary representations and covenants that, subject to exceptions, restrict our ability to, among other things: declare dividends or redeem or repurchase equity interests; incur additional liens; make loans and investments;
Current wording
Our obligations under the 2025 Loan Agreement are secured by a security interest in substantially all of our assets, other than our intellectual property, which is subject to a negative pledge. The 2025 Loan Agreement contains two financial related covenants. Also included in the 2025 Loan Agreement are customary representations and covenants that, subject to exceptions, restrict our ability to, among other things: declare dividends or redeem or repurchase equity interests; incur additional liens; make loans and investments; incur additional indebtedness; engage in mergers, acquisitions, and asset sales; transact with affiliates; undergo a change in control; add or change business locations; and engage in businesses that are not related to our existing business.
Previous wording
Our critical accounting policies are described in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Significant Judgments and Estimates” in the Annual Report and the notes to our unaudited condensed financial statements appearing elsewhere in this Quarterly Report on Form 10-Q. During the three months ended March 31, 2026, there were no material changes to our critical accounting policies and estimates from those discussed in the Annual Report.
Current wording
Our critical accounting policies are described in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Significant Judgments and Estimates” in the Annual Report and the notes to our unaudited condensed financial statements appearing elsewhere in this Quarterly Report on Form 10-Q. During the six months ended June 30, 2026, there were no material changes to our critical accounting policies and estimates from those discussed in the Annual Report.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
seek regulatory approvals for any product candidates that successfully complete clinical trials;
Current report — wording carried from elsewhere
Research and development expenses increased by $1.9 million, or 3%, to $60.1 million in the three months ended June 30, 2026, from $58.2 million in the three months ended June 30, 2025, due to an increase of $7.2 million for employee compensation and related benefit expenses, including a $2.7 million increase in stock-based compensation expense, as a result of growth in research and development employee headcount, an increase of $3.0 million in clinical trial expenses mainly due to increased expenses for the PIONEER and ORIGIN EXTEND trials, and an increase of $0.5 million in facilities and other, including a $0.3 million increase in travel expenses supporting research and development activities, partially offset by a decrease of $7.8 million in contract drug manufacturing costs for clinical and potential commercial use and a decrease of $1.0 million in consulting and professional services, primarily related to advisory board and expert forum activities incurred in 2025.
Current report — wording carried from elsewhere
General and administrative expenses increased by $30.5 million, or 139%, to $52.4 million in the three months ended June 30, 2026, from $21.9 million in the three months ended June 30, 2025, primarily due to an increase of $16.2 million in employee compensation and related benefits expenses, including stock-based compensation, as a result of increased general and administrative employee headcount including sales personnel, an increase of $11.5 million in commercial planning and medical affairs expenses related to marketing, market research, market access, medical information, and health economics activities in preparation for the anticipated commercial launch of TRUTAKNA, an increase of $0.7 million in software expenses primarily supporting anticipated commercial operations, and an increase of $0.3 million in consulting expenses. The $1.9 million increase in other general and administrative expenses was primarily driven by increases of $1.2 million in corporate communications expenses and $0.9 million in business travel expenses, partially offset by decreases of $0.3 million in recruiting and placement expenses and $0.2 million in rent and facilities expenses.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
In the three months ended March 31, 2025, our financing activities provided $1.5 million of cash, resulting from proceeds from exercise of stock options and issuance of shares under our employee stock purchase plan.
Previous report — wording carried elsewhere
incur additional indebtedness; engage in mergers, acquisitions, and asset sales; transact with affiliates; undergo a change in control; add or change business locations; and engage in businesses that are not related to our existing business.