Vera Therapeutics, Inc.
For the period ended Sep 30, 2026. Filed Nov 5, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 5, 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 2026-06-30; filed 2026-08-10.
0001193125-26-342380
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-05.
0001193125-26-449826
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 85 previous paragraphs and 113 current paragraphs.
51 unchanged; 32 reworded; 26 added; 2 removed; 0 previous and 4 current paragraphs rearranged.
Tables are not compared: 5 previous and 6 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (26)
Current report
The ORIGIN 3 key secondary endpoint to support potential full approval is estimated glomerular filtration rate (eGFR). On September 15, 2026, we announced that TRUTAKNA met all prespecified endpoints in the final efficacy analysis of the ORIGIN 3 trial in adults with primary IgAN at risk for disease progression. Topline results from the final analysis of 428 participants are presented below.
Current report
*Does not include one placebo participant who received transient dialysis for acute kidney injury. Updated from the disclosure on September 15, 2026.
Current report
These eGFR results align with the KDIGO treatment goal to reduce the rate of kidney function decline to the physiologic rate (< 1 mL/min/1.73m 2/year). TRUTAKNA also achieved statistically significant reductions in the hierarchically tested endpoints of proteinuria, Gd-IgA1 and hematuria. TRUTAKNA was well tolerated with a favorable safety profile generally comparable to placebo, consistent with previous results from the ORIGIN clinical program. Overall rates of adverse events and infections or infestations were similar between the TRUTAKNA and placebo groups and there were no opportunistic infections or clinically relevant hypogammaglobulinemia. On November 3, 2026, we submitted a supplemental Biologics License Application to the FDA requesting potential full FDA approval in mid-2027. TRUTAKNA has shown positive commercial launch momentum with approximately 700 patient start forms generated as of November 5, 2026.
Current report
We have 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 the ORIGIN 2 or ORIGIN 3 trial until atacicept becomes commercially available in their country or region.
Current report
Product Revenue, Net
Current report
To date, we have generated limited revenue from product sales. TRUTAKNA, our first approved product, received accelerated approval from the FDA in July 2026 to reduce proteinuria in adults with primary IgAN who are at risk for disease progression. We began selling TRUTAKNA in the United States in July 2026 through specialty pharmacy and specialty distributor customers.
Current report
Our net revenue from product sales depends on our prescription mix of commercial payors and governmental programs. Our revenue from product sales is recognized when the control of the product is transferred. In addition, we recognize our best estimate of the consideration that we expect to receive when control of the inventory is transferred to our customers, including reserves and accruals for discounts, distribution fees, product returns, chargebacks, rebates, co-pay assistance and other incentives. Such estimates may be complex and are reviewed and updated quarterly as additional information becomes known.
Current report
For the three and nine months ended September 30, 2026, we recorded net product revenue of $10.3 million from sales of TRUTAKNA.
Current report
Cost of Sales
Current report
Cost of sales includes raw material inputs, direct and indirect costs associated with the manufacturing and distribution of TRUTAKNA, amortization of capitalized intellectual property intangible assets and royalties payable on net sales of TRUTAKNA. Costs associated with the manufacture of TRUTAKNA prior to July 7, 2026, when we received accelerated approval from the FDA, were recorded as research and development expense. Recorded cost of sales will not represent the complete historical cost of inventory sold until we deplete stocks of inventory for which manufacturing or purchases of materials occurred prior to this date.
Current report
For the three and nine months ended September 30, 2026, we recorded cost of sales of $3.3 million related to sales of TRUTAKNA in the United States, compared to zero for the three and nine months ended September 30, 2025.
Current report
Research and development expenses decreased by $15.2 million, or 27%, to $41.3 million in the three months ended September 30, 2026, from $56.5 million in the three months ended September 30, 2025, due to:
Current report
a $15.3 million decrease in contract drug manufacturing costs following FDA approval in July 2026 as we began capitalizing manufacturing costs as inventory during the current period;
Current report
a $2.2 million decrease in consulting and professional services, primarily related to higher regulatory-related consulting and professional services leading up to BLA submission for TRUTAKNA in November 2025; and,
Current report
a $1.5 million decrease in employee compensation and related benefit expenses, related to certain regulatory, medical affairs and pharmacovigilance personnel activities and responsibilities to support our approved commercial product recorded as selling, general and administrative expenses and the allocation of certain indirect manufacturing labor costs associated with commercial product activities to cost of sales;
Current report
partially offset by a $3.6 million increase in clinical trials expenses primarily due to increased enrollment activities for the PIONEER and ORIGIN EXTEND trials.
Current report
Research and development expenses increased by $31.4 million, or 20%, to $187.3 million in the nine months ended September 30, 2026, from $155.9 million in the nine months ended September 30, 2025, due to:
Current report
partially offset by a $5.1 million decrease in consulting and professional services, primarily related to higher regulatory-related consulting and professional services leading up to BLA submission for TRUTAKNA in November 2025; and,
Current report
a $2.1 million decrease in contract drug manufacturing costs following FDA approval in July 2026 as the company began capitalizing inventory for commercial product.
Current report
Selling, General and Administrative Expenses
Current report
Selling, general and administrative expenses increased by $34.0 million, or 124%, to $61.4 million in the three months ended September 30, 2026, from $27.5 million in the three months ended September 30, 2025, primarily due to:
Current report
a $19.7 million increase in employee compensation and related benefits expenses, including stock-based compensation, as a result of increased selling, general and administrative employee headcount including sales personnel, along with the inclusion of certain regulatory, medical affairs, and pharmacovigilance personnel activities and responsibilities to support the commercial launch of TRUTAKNA as selling, general and administrative expenses;
Current report
a $2.2 million increase in other selling, general and administrative expenses that was primarily driven by an increase of $1.7 million in business travel expenses following commercial approval of TRUTAKNA.
Current report
Selling, general and administrative expenses increased by $87.6 million, or 134%, to $153.0 million in the nine months ended September 30, 2026, from $65.3 million in the nine months ended September 30, 2025, primarily due to:
Current report
a $48.5 million increase in employee compensation and related benefits expenses, including stock-based compensation, as a result of increased selling, general and administrative employee headcount including sales personnel, along with the shifting of some regulatory, medical affairs, and pharmacovigilance personnel activities and responsibilities to support the commercial launch of TRUTAKNA;
Current report
a $5.9 million increase in other selling, general and administrative expenses that was primarily driven by an increase of $3.2 million in business travel expenses and an increase of $2.0 million in corporate communications expenses supporting commercial launch of TRUTAKNA.
Removed paragraphs (2)
Previous report
General and Administrative Expenses
Previous report
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.
Reworded paragraphs (32)
Previous wording
You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q and our audited financial statements and notes thereto and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission on February 26, 2026 (the Annual Report).
Current wording
You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q and our audited financial statements and notes thereto and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission on February 26, 2026 (the Annual Report).
Previous wording
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 wording
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 TRUTAKNA® (atacicept-vymj), an inhibitor of B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL) to address the immunological drivers of immunoglobulin A nephropathy (IgAN). Beyond IgAN, we are evaluating additional diseases where the reduction of autoantibodies through inhibition of BAFF and APRIL may prove clinically meaningful.
Previous wording
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 wording
On July 7, 2026, the U.S. Food and Drug Administration (FDA) granted accelerated approval to TRUTAKNA to reduce proteinuria in adults with primary IgAN at risk for disease progression. The accelerated approval is based on a prespecified interim analysis of the ongoing pivotal 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 most common adverse events were infections and local administration reactions. The incidence of adverse events was generally balanced between the TRUTAKNA and placebo groups, with fewer serious adverse events reported in the TRUTAKNA group (n=1 [0.5%]) than in the placebo group (n=11 [5.0%]), no safety signals indicating immunosuppression and no deaths in either treatment group.
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 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.
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, as well as 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 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.
Current wording
We currently have only one product approved for commercial sale and have recorded limited revenue from product sales during 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 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.
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 September 30, 2026, we had $384.0 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 $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.
Current wording
We have incurred significant operating losses since the commencement of our operations. Our net losses were $93.7 million and $80.3 million for the three months ended September 30, 2026 and 2025, respectively, and we expect to incur significant and increasing losses for the foreseeable future as we continue to 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 September 30, 2026, we had an accumulated deficit of $1.1 billion, 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 selling, 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 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:
Current wording
We expect to continue to incur net operating losses in the near term, and we expect our research and development expenses, selling, 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
We also expect to increase the size of our administrative function to support the growth of our business. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and our expenditures on other research and development activities.
Current wording
We also expect the cost of our administrative function to increase as we support anticipated growth of our business. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and our expenditures on other research and development activities.
Previous wording
Comparison of the Three and Six Months Ended June 30, 2026 and 2025
Current wording
Comparison of the Three and Nine Months Ended September 30, 2026 and 2025
Previous 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.
Current wording
a net $14.4 million increase in license and milestone obligations related to current period recognition of a $15.0 million milestone payment due upon FDA acceptance of the BLA for TRUTAKNA in January 2026;
Previous wording
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 wording
a $14.2 million increase in employee compensation and related benefit expenses, including a $5.8 million increase in stock-based compensation expense, as a result of growth in research and development employee headcount; and,
Previous wording
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 wording
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 are capitalized as inventory and later recorded to expense as cost of sales in the periods in which sales of the related inventory are recognized.
Previous wording
General and administrative expenses consist primarily of compensation and personnel-related expenses, including stock-based compensation, for our personnel in executive management, legal, finance, human resources, corporate communications, sales and marketing and other administrative functions. General and administrative expenses also include professional fees paid for accounting, auditing, legal, tax and consulting services, and other general overhead costs to support our operations. General and administrative expenses are recorded as expense in the period in which they are incurred, and payments we make prior to the receipt of goods or services to be used for general and administrative purposes are deferred as prepaid expenses until the goods or services are received and used.
Current wording
Selling, general and administrative expenses consist primarily of compensation and personnel-related expenses, including stock-based compensation, for our personnel in executive management, legal, finance, human resources, corporate communications, sales and marketing and other administrative functions. Selling, general and administrative expenses also include professional fees paid for accounting, auditing, legal, tax and consulting services, and other general overhead costs to support our operations. Selling, general and administrative expenses are recorded as expense in the period in which they are incurred, and payments we make prior to the receipt of goods or services to be used for selling, general and administrative purposes are deferred as prepaid expenses until the goods or services are received and used.
Previous wording
The following table summarizes our general and administrative expenses incurred during the respective periods:
Current wording
The following table summarizes our selling, general and administrative expenses incurred during the respective periods:
Previous wording
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.
Current wording
a $10.2 million increase in expenses related to marketing, market research, market access, medical information, and health economics activities supporting the commercial launch of TRUTAKNA;
Previous wording
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 wording
We expect our selling, 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.
Previous 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.
Current wording
Other income, net, decreased by $1.6 million, or 45%, to $2.0 million for the three months ended September 30, 2026, from $3.6 million in the three months ended September 30, 2025, primarily due to a decrease of $1.4 million in interest income resulting from lower average balances of marketable securities held during the three months ended September 30, 2026, as compared to the three months ended September 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 $0.1 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
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 wording
Other income, net, decreased by $3.6 million, or 29%, to $9.1 million for the nine months ended September 30, 2026, from $12.7 million in the nine months ended September 30, 2025, primarily due to a decrease of $2.9 million in interest income resulting from lower average balances of marketable securities held during the three months ended September 30, 2026, as compared to the three months ended September 30, 2025 and a decrease in sublease income of $1.4 million due to the expiration of a sublease to a third-party in September 2025, partially offset by a $0.3 million change in realized and unrealized gains and losses, an increase of $0.2 million in currency exchange gains and losses and an increase of $0.1 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 June 2025, we entered into an agreement to refinance our existing debt by replacing the existing $50.0 million in notes payable with $75.0 million in new notes payable. We received aggregate net proceeds of approximately $23.3 million, after deducting debt issuance costs.
Current wording
In June 2025, we entered into an agreement to refinance our existing debt by replacing the existing $50.0 million in notes payable with $75.0 million in new notes payable. We received aggregate net proceeds of approximately $23.3 million, after deducting debt issuance costs. This agreement provides for term loans in an aggregate maximum principal amount of $500.0 million, of which we drew an additional $75.0 million in October 2026.
Previous 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.
Current wording
As of September 30, 2026, we had cash, cash equivalents and marketable securities of $384.0 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 September 30, 2026, together with amounts available for draw pursuant to our Loan Agreement, 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 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.
Current wording
In the nine months ended September 30, 2026, we used $305.9 million of cash in operating activities, attributable to a net loss of $324.2 million and an increase in our net operating assets and liabilities of $41.9 million, partially offset by $15.0 million in license fees attributable to investing activities and adjustments for non-cash charges of $45.2 million. Non-cash charges primarily consisted of $44.8 million of stock-based compensation and $1.9 million net in accretion and amortization of loan exit fees and costs, partially offset by non-cash interest income of $3.0 million related to amortization of discount on purchases of marketable securities. The change in our net operating assets and liabilities was primarily due to an increase of $24.4 million in prepaid expense and other current assets, an increase of $12.0 million in net accounts receivable, an increase of $7.1 million in inventory and a decrease of $1.7 million in accounts payable, partially offset by an increase of $3.6 million in accrued and other current liabilities.
Previous 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.
Current wording
In the nine months ended September 30, 2025, we used $171.1 million of cash in operating activities, attributable to a net loss of $208.5 million, offset by adjustments for non-cash charges of $24.0 million, $0.8 million in license fees attributable to investing activities, and a decrease in our net operating assets and liabilities of $12.6 million. Non-cash charges primarily consisted of $27.0 million of stock-based compensation, non-cash interest income of $5.9 million related to amortization of discount on purchases of marketable securities and a $1.3 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 $7.2 million in accrued and other current liabilities, an increase of $10.3 million in accounts payable, an increase of $3.6 million in prepaid expense and other current assets, and a decrease of $1.4 million in operating lease liabilities.
Previous 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.
Current wording
The increase in cash used in operating activities from the nine months ended September 30, 2025 to the nine months ended September 30, 2026 was primarily attributable to increased research and development and selling, general and administrative expenses.
Previous 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.
Current wording
In the nine months ended September 30, 2026, our investing activities used $3.0 million of cash, primarily resulting from $357.1 million used for purchases of marketable securities and $35.0 million paid in license fees, partially offset by $389.8 million provided by maturities of marketable securities.
Previous 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.
Current wording
In the nine months ended September 30, 2025, our investing activities provided $113.6 million of cash, primarily resulting from $400.9 million provided by maturities of marketable securities, offset by $285.9 million used for purchases of marketable securities.
Previous 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.
Current wording
In the nine months ended September 30, 2026, our financing activities provided $9.6 million of cash, resulting from proceeds from exercise of stock options and issuance of shares under our employee stock purchase plan.
Previous wording
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.
Current wording
In the nine months ended September 30, 2025, our financing activities provided $22.6 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, and $2.8 million in proceeds from exercise of stock options and issuance of shares under our employee stock purchase plan, offset by $3.5 million in payment of deferred issuance costs related to unfunded loan commitments under the 2025 Loan Agreement.
Previous 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.
Current wording
During the nine months ended September 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
On June 2, 2025, we entered into a Loan and Security Agreement (the 2025 Loan Agreement) with a loan syndicate involving Oxford Finance, OFCF II, OFCF III, and Oxford Finance Credit Fund IV LP (OFCF IV) (collectively, Oxford). The 2025 Loan Agreement provides for term loans (collectively, the 2025 Loan) in an aggregate maximum principal amount of $500.0 million, of which $75.0 million was funded on June 4, 2025.
Current wording
In June 2025, we entered into a Loan and Security Agreement (the 2025 Loan Agreement) with a loan syndicate involving Oxford Finance, OFCF II, OFCF III, and Oxford Finance Credit Fund IV LP (OFCF IV) (collectively, Oxford). The 2025 Loan Agreement provides for term loans (collectively, the 2025 Loan) in an aggregate maximum principal amount of $500.0 million, of which $75.0 million was funded in June 2025 and an additional $75.0 million was funded in October 2026.
Previous wording
The discussion and analysis of our financial condition and results of operations is based on our unaudited condensed financial statements, which have been prepared in accordance with GAAP. The preparation of these unaudited condensed financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, and the disclosure of contingent assets and liabilities, at the date of the financial statements, as well as expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
Current wording
The discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, and the disclosure of contingent assets and liabilities, at the date of the financial statements, as well as expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
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 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.
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 consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q. During the nine months ended September 30, 2026, there were no material changes to our critical accounting policies and estimates from those discussed in the Annual Report, except as discussed in the notes to our unaudited condensed consolidated financial statements in this Quarterly Report on Form 10-Q with respect to accounting policies adopted upon commercialization of TRUTAKNA.
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
a $8.9 million increase in clinical trial expenses mainly due to increased enrollment activities for the PIONEER and ORIGIN EXTEND trials;
Current report — wording carried from elsewhere
a $1.7 million increase in software expenses primarily supporting commercial operations; and,
Current report — wording carried from elsewhere
a $29.0 million increase in expenses related to marketing, market research, market access, medical information, and health economics activities supporting the commercial launch of TRUTAKNA;
Current report — wording carried from elsewhere
a $3.6 million increase in software expenses primarily supporting commercial operations; and,