Ultragenyx Pharmaceutical Inc.
For the period ended Sep 30, 2025. Filed Nov 5, 2025.
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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.
Sep 30, 2025 · Filed Nov 5, 2025
RARE$15.43-0.9%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-06.
0000950170-25-103290
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-05.
0001193125-25-265126
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 122 previous paragraphs and 120 current paragraphs.
81 unchanged; 35 reworded; 3 added; 6 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 19 previous and 19 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 (3)
Current report
In September 2025, we announced longer term data from the 48-week crossover period that demonstrated patients showed an even greater reduction in mean daily cornstarch intake. The DTX401 group (n=20) had a mean reduction in daily cornstarch intake of 61% at week 96 compared to baseline and the crossover group (n=19) had a mean reduction in daily cornstarch intake of 61% at week 96 compared to week 48. At the end of the crossover period, the DTX401 group saw a reduction in mean nighttime cornstarch of 70% compared to baseline and the crossover group saw a mean reduction of 75% compared to week 48. Two-thirds of participants across both groups eliminated at least one nighttime cornstarch dose following treatment with DTX401. At week 96, 83% (10 out of 12 patients) of the DTX401 group and 95% (18 out of 19 patients) of the crossover group reported “minimally improved” to “much improved” changes in disease burden as measured by the Patient Global Impression of Change (PGIC), a single item questionnaire that asked participants how their condition changed since the start of the study.
Current report
Other (Expense) income (dollars in thousands)
Current report
Cash Provided by (used in) Investing Activities
Removed paragraphs (6)
Previous report
Bayley-4 cognitive raw score, and the key secondary endpoint will be the Multi-domain Responder Index (MDRI) across the five domains of cognition, receptive communication, behavior, gross motor function, and sleep.
Previous report
Clinical review had been ongoing and the FDA acknowledged that the neurodevelopmental outcome data provided are robust and the biomarker data provide additional supportive evidence. The CRL did not note any review issues related to the clinical data package nor clinical inspections, and asked that updated clinical data from current patients be included in the resubmission.
Previous report
for approved products, increases of $3.0 million and $1.6 million for the three and six months ended June 30, 2025, respectively, primarily due to increased compassionate use costs for Dojolvi;
Previous report
for infrastructure, decreases of $2.8 million and $0.8 million for the three and six months ended June 30, 2025, respectively, primarily related to the allocation of certain staffing costs; and
Previous report
Other Income (Expense) (dollars in thousands)
Previous report
Cash Provided by Investing Activities
Reworded paragraphs (35)
Previous wording
In July 2025, we announced that all patients in the 48-week Phase 3 Aspire study have been enrolled. In total, 129 patients, between four and 17 years of age, with a genetically confirmed diagnosis of full maternal UBE3A gene deletion were enrolled and randomized 1:1 to the GTX-102 or the sham comparator group. The primary endpoint will be improvement in cognition assessed by
Current wording
In July 2025, we announced that all patients in the 48-week Phase 3 Aspire study have been enrolled. In total, 129 patients, between four and 17 years of age, with a genetically confirmed diagnosis of full maternal UBE3A gene deletion were enrolled and randomized 1:1 to the GTX-102 or the sham comparator group. Data from this study are expected in the second half of 2026.
Previous wording
The Phase 2/3 Aurora study, which will evaluate GTX-102 in other Angelman syndrome genotypes and ages, is expected to initiate in the second half of 2025.
Current wording
Enrollment has begun in the Phase 2/3 Aurora study, which will evaluate GTX-102 in other Angelman syndrome genotypes and ages.
Previous wording
In July 2025, we announced receiving a Complete Response Letter, or CRL, from the FDA for UX111. The CRL cited specific chemistry, manufacturing and controls, or CMC, related observations that we expect to be readily addressable, related to facilities and processes, and are not directly related to the quality of the product. We will be working with the FDA over the next few months to resolve the observations. Once resolution is achieved with the FDA, we expect to resubmit the BLA and anticipate up to a six-month review period to follow the resubmission.
Current wording
In July 2025, we announced that we had received a Complete Response Letter, or CRL, from the FDA for UX111. The CRL cited specific chemistry, manufacturing and controls, or CMC, related observations that we expect to be readily addressable, related to facilities and processes, and are not directly related to the quality of the product. We have had constructive formal and informal discussions with the FDA and currently plan to resubmit the BLA in early 2026. This will be followed by an up to six-month review period, per FDA regulations.
Previous wording
In May 2024, we previously disclosed that the Phase 3 GlucoGene study for the treatment of patients aged eight years and older with GSDIa achieved its primary endpoint, demonstrating that treatment with DTX401 resulted in a statistically significant and clinically meaningful reduction in daily cornstarch intake compared with placebo at Week 48. At Week 48, patients entered a 48-week Crossover Period where patients previously treated with placebo were treated with DTX401. In May 2025 we announced data from this Crossover Period, that demonstrated greater reductions in total daily cornstarch were observed in both the ongoing DTX401 group (-60%) with a mean follow-up of 120 weeks and the Crossover Placebo to DTX401 group (-64%) with a mean duration on therapy with DTX401 of 69 weeks. As of the data cut-off, glycemic control was maintained in participants treated with DTX401 despite significant reductions in daily cornstarch intake. DTX401 has demonstrated a consistent and acceptable safety profile with no new safety signals identified as of the data cut-off.
Current wording
In May 2024, we previously disclosed that the Phase 3 GlucoGene study for the treatment of patients aged eight years and older with GSDIa achieved its primary endpoint, demonstrating that treatment with DTX401 resulted in a statistically significant and clinically meaningful reduction in daily cornstarch intake compared with placebo at Week 48. At Week 48, patients entered a 48-week crossover period where patients previously treated with placebo were treated with DTX401.
Previous wording
These results will be included as part of a BLA submission which is now expected in the fourth quarter of 2025.
Current wording
These results have been included in a rolling BLA submission that began in August 2025 and is expected to complete in the fourth quarter of 2025.
Previous wording
Enrollment is on track in Cohort 4 of the ongoing, dose-finding, stage of the pivotal Cyprus2+study of UX701 for the treatment of Wilson disease. During Stage 1, the safety and efficacy of UX701 is being evaluated across four, sequential dosing cohorts (Cohort 1; 5.0 x 10^12 GC/kg; Cohort 2: 1.0 x 10^13 GC/kg: Cohort 3; 2.0 x 10^13 GC/kg and Cohort 4; 4.0 x 10^13 GC/kg). Enrollment in Cohort 4 is expected to be completed in the second half of 2025.
Current wording
In September 2025, we completed enrollment of five patients in Cohort 4 in the ongoing, dose-finding, stage of the pivotal Cyprus2+study of UX701 for the treatment of Wilson disease. During Stage 1, the safety and efficacy of UX701 is being evaluated across four, sequential dosing cohorts (Cohort 1; 5.0 x 10^12 GC/kg; Cohort 2: 1.0 x 10^13 GC/kg: Cohort 3; 2.0 x 10^13 GC/kg and Cohort 4; 4.0 x 10^13 GC/kg). Data from Stage 1 of this study are expected in the first half of 2026.
Previous wording
We have incurred net losses in each year since inception. Our net losses were $115.0 million and $266.0 million for the three and six months ended June 30, 2025, respectively, and $131.6 million and $302.3 million for the three and six months ended June 30, 2024, respectively. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and from selling, general and administrative costs associated with our operations.
Current wording
We have incurred net losses in each year since inception. Our net losses were $180.4 million and $446.4 million for the three and nine months ended September 30, 2025, respectively, and $133.5 million and $435.8 million for the three and nine months ended September 30, 2024, respectively. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and from selling, general and administrative costs associated with our operations.
Previous wording
Our total revenues were $166.5 million and $305.8 million for the three and six months ended June 30, 2025, and $147.0 million and $255.9 million for the three and six months ended June 30, 2024, respectively. The increase in revenue was largely driven by an increase in demand for our approved products.
Current wording
Our total revenues were $159.9 million and $465.7 million for the three and nine months ended September 30, 2025, and $139.5 million and $395.4 million for the three and nine months ended September 30, 2024, respectively. The increase in revenue was largely driven by an increase in demand for our approved products.
Previous wording
As of June 30, 2025, we had $539.0 million in available cash, cash equivalents, and marketable debt securities.
Current wording
As of September 30, 2025, we had $447.3 million in available cash, cash equivalents, and marketable debt securities.
Previous wording
Our management’s discussion and analysis of our financial condition and results of operations is based on our Condensed Consolidated Financial Statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these 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 the reported 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. There have been no material changes in our critical accounting policies during the six months ended June 30, 2025, as compared to those disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Critical Accounting Policies and Significant Judgments and Estimates” in our Annual Report.
Current wording
Our management’s discussion and analysis of our financial condition and results of operations is based on our Condensed Consolidated Financial Statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these 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 the reported 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. There have been no material changes in our critical accounting policies during the nine months ended September 30, 2025, as compared to those disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Critical Accounting Policies and Significant Judgments and Estimates” in our Annual Report.
Previous wording
Comparison of the three and six months ended June 30, 2025 to the three and six months ended June 30, 2024:
Current wording
Comparison of the three and nine months ended September 30, 2025 to the three and nine months ended September 30, 2024:
Previous wording
Our product sales increased by $7.0 million and $36.0 million for the three and six months ended June 30, 2025, respectively, compared to the same periods in 2024. The increase for the three months ended June 30, 2025 was primarily due to continued progress of the launch of Evkeeza in Japan and in several markets in Europe, Middle East and Africa territories, or EMEA, and the continued increase in demand for our other approved products, partially offset by a decrease in Crysvita product revenue related to timing of orders in Latin America. The increase for the six months ended June 30, 2025 is primarily due to continued progress of the launch of Evkeeza in Japan and several markets in EMEA and an increase in demand for Crysvita in Latin America resulting from an increase in the number of patients on therapy, and the continued increase in demand for our other approved products.
Current wording
Our product sales increased by $17.7 million and $53.8 million for the three and nine months ended September 30, 2025, respectively, compared to the same periods in 2024. The increase for the three and nine months ended September 30, 2025, respectively, is primarily due to increased demand for Crysvita in Latin America resulting from an increase in the number of patients on therapy, continued progress of the launch of Evkeeza in several markets in EMEA and in Japan, and the continued increase in demand for our other approved products.
Previous wording
Our Crysvita royalty revenue increased by $12.5 million and $13.9 million for the three and six months ended June 30, 2025, respectively, as compared to the same periods in 2024. The increases were primarily due to an increase in the number of reimbursed patients on therapy.
Current wording
Our Crysvita royalty revenue increased by $2.7 million and $16.6 million for the three and nine months ended September 30, 2025, respectively, as compared to the same periods in 2024. The increases were primarily due to an increase in the number of reimbursed patients on therapy.
Previous wording
Cost of sales increased by $1.7 million and $12.9 million for the three and six months ended June 30, 2025, respectively, compared to the same periods in 2024. The increase for the three months ended June 30, 2025 was primarily due to an increase in demand for our approved products, partially offset by a decrease related to timing of Crysvita orders in Latin America. The increase in cost of sales for the six months ended June 30, 2025 was primarily due to an increase in demand for Crysvita in Latin America and Evkeeza in EMEA and Japan, and the continued increase in demand for our other approved products.
Current wording
Cost of sales increased by $7.0 million and $19.8 million for the three and nine months ended September 30, 2025, respectively, compared to the same periods in 2024. The increase for the three and nine months ended September 30, 2025 was primarily due to an increase in demand for Crysvita in Latin America, Evkeeza in EMEA and Japan, and the continued increase in demand for our other approved products.
Previous wording
Total research and development expenses increased by $3.2 million and decreased by $9.5 million for the three and six months ended June 30, 2025, respectively, compared to the same periods in 2024. The changes in research and development expenses were primarily due to:
Current wording
Total research and development expenses increased by $46.1 million and $36.6 million for the three and nine months ended September 30, 2025, respectively, compared to the same periods in 2024. The changes in research and development expenses were primarily due to:
Previous wording
for gene therapy programs, an increase of $3.7 million and a decrease of $6.6 million for the three and six months ended June 30, 2025, respectively. The increase for the three months ended June 30, 2025, was primarily due to an increase in UX111 manufacturing costs in preparation for commercial launch, partially offset by the timing of the UX401 manufacturing runs for the three months ended June 30, 2024, which did not recur for the three months ended June 30, 2025. The decrease for the six months was primarily due to the timing of the UX701 and DTX301 manufacturing runs and the recognition of contract manufacturing costs for DTX301 for the six months ended June 30, 2024 which did not recur for the six months ended June 30, 2025, partially offset by an increase in UX111 manufacturing costs in preparation for commercial launch;
Current wording
for gene therapy programs, increases of $19.9 million and $13.3 million for the three and nine months ended September 30, 2025, respectively, primarily due to an increase in UX111 manufacturing costs in preparation for commercial launch, partially offset by the timing of the UX401 manufacturing runs for which costs were incurred during the three and nine months ended September 30, 2024, but which did not recur for the three and nine months ended September 30, 2025;
Previous wording
for biologic and nucleic acid programs, increases of $11.7 million and $12.6 million for the three and six months ended June 30, 2025, respectively, primarily related to the continued clinical progress of the GTX102 and UX143 programs and associated clinical development and manufacturing costs;
Current wording
for biologic and nucleic acid programs, increases of $25.8 million and $38.4 million for the three and nine months ended September 30, 2025, respectively, primarily due to an increase in UX143 manufacturing costs in preparation for commercial launch as well as the continued clinical progress of GTX102 and associated clinical development and manufacturing costs;
Previous wording
for translational research, decreases of $3.5 million and $9.1 million for the three and six months ended June 30, 2025, respectively, primarily related to a decrease in manufacturing costs for IND-stage projects;
Current wording
for translational research, a decrease of $8.7 million for the nine months ended September 30, 2025, primarily related to a decrease in manufacturing costs for IND-stage projects; and
Previous wording
for other research and development expenses, decreases of $8.5 million and $7.2 million for the three and six months ended June 30, 2025, respectively, primarily related to decreased staffing and cost efficiencies to support internal manufacturing, and administrative and general support.
Current wording
for other research and development expenses, a decrease of $6.8 million for the nine months ended September 30, 2025, primarily related to decreased staffing and cost efficiencies to support internal manufacturing, and administrative and general support.
Previous wording
Selling, general and administrative expenses increased by $6.0 million and $15.7 million for the three and six months ended June 30, 2025, respectively, compared to the same periods in 2024. The increases were primarily due to higher employee compensation costs and increased marketing expenses as we continue to plan for our future product launches, as well as the recognition of reimbursement for a cost share arrangement that reduced selling, general and administrative expenses for the three and six months ended June 30, 2024, which did not recur during the three and six months ended June 30, 2025.
Current wording
Selling, general and administrative expenses increased by $6.3 million and $21.9 million for the three and nine months ended September 30, 2025, respectively, compared to the same periods in 2024. The increases were primarily due to higher employee compensation costs and increased marketing expenses as we continue to plan for our future product launches.
Previous wording
Interest income decreased by $1.6 million and $3.6 million for the three and six months ended June 30, 2025, respectively, compared to the same periods in 2024, primarily due to lower marketable debt securities balances.
Current wording
Interest income decreased by $4.9 million and $8.5 million for the three and nine months ended September 30, 2025, respectively, compared to the same periods in 2024, primarily due to lower marketable debt securities balances.
Previous wording
Change in fair value of equity investments increased by $4.0 million for the three months ended June 30, 2025, compared to the same period in 2024, primarily due to fluctuations in the value of our investment in Solid Biosciences Inc., or Solid, common stock.
Current wording
Change in fair value of equity investments was $0.7 million and $0.5 million, respectively, for the three and nine months ended September 30, 2025, primarily due to fluctuations in the value of our investment in Solid Biosciences Inc., or Solid, common stock.
Previous wording
The non-cash interest expense on liabilities for sales of future royalties decreased by $1.9 million and $3.4 million for the three and six months ended June 30, 2025, respectively, compared to the same periods in 2024, primarily due to a reduction in total royalty obligation balances as a result of increased royalties generated from our collaboration partner, KKC. To the extent the royalty payments are greater or less than our initial estimates or the timing of such payments is materially different than our original estimates, we prospectively adjust the effective interest rate.
Current wording
The non-cash interest expense on liabilities for sales of future royalties decreased by $1.6 million and $5.0 million for the three and nine months ended September 30, 2025, respectively, compared to the same periods in 2024, primarily due to a reduction in total royalty obligation balances as a result of increased royalties generated from our collaboration partner, KKC. To the extent the royalty payments are greater or less than our initial estimates or the timing of such payments is materially different than our original estimates, we prospectively adjust the effective interest rate.
Previous wording
Other income increased by $4.0 million and $6.4 million for the three and six months ended June 30, 2025, respectively, compared to the same periods in 2024. These changes were primarily due to fluctuations in foreign exchange rates.
Current wording
Other (expense) income decreased by $4.1 million and increased by $2.3 million for the three and nine months ended September 30, 2025, respectively, compared to the same periods in 2024. These changes were primarily due to fluctuations in foreign exchange rates.
Previous wording
The provision for incomes taxes increased by $0.1 million and $0.9 million for the three and six months ended June 30, 2025, respectively, compared to the same periods in 2024. These increases were primarily due to increased foreign activities.
Current wording
The provision for incomes taxes increased by $0.6 million and $1.5 million for the three and nine months ended September 30, 2025, respectively, compared to the same periods in 2024. These increases were primarily due to increased foreign activities.
Previous wording
As of June 30, 2025, we had $539.0 million in available cash, cash equivalents, and marketable debt securities. We believe that our existing capital resources will be sufficient to fund our projected operating requirements for at least the next 12 months. Our cash, cash equivalents, and marketable debt securities are held in a variety of deposit accounts, interest-bearing accounts, corporate bond securities, commercial paper, U.S. government securities, asset-backed securities, and money market funds. Cash in excess of immediate requirements is invested with a view toward liquidity and capital preservation, and we seek to minimize the potential effects of concentration and credit risk.
Current wording
As of September 30, 2025, we had $447.3 million in available cash, cash equivalents, and marketable debt securities. We believe that our existing capital resources will be sufficient to fund our projected operating requirements for at least the next 12 months. Our cash, cash equivalents, and marketable debt securities are held in a variety of deposit accounts, interest-bearing accounts, corporate bond securities, commercial paper, U.S. government securities, asset-backed securities, and money market funds. Cash in excess of immediate requirements is invested with a view toward liquidity and capital preservation, and we seek to minimize the potential effects of concentration and credit risk.
Previous wording
In June 2024, we completed an underwritten public offering for the sale of shares of common stock and pre-funded warrants. The total proceeds that we received from the offering were $381.0 million, net of underwriting discounts and commissions.
Current wording
In June 2024, we completed an underwritten public offering for the sale of shares of common stock and pre-funded warrants. The total proceeds received from the offering were $381.0 million, net of underwriting discounts and commissions.
Previous wording
Cash used in operating activities for the six months ended June 30, 2025 was $274.7 million and primarily reflected a net loss of $266.0 million, partially offset by non-cash items of $69.7 million, net, which consisted primarily of stock-based compensation, amortization of discounts on marketable debt securities, depreciation and amortization, non-cash royalty revenue, and non-cash interest expense related to the sale of future royalties. The change in operating assets and liabilities also reflected a net use of cash of $78.4 million, primarily due to a net decrease in accounts payable, accrued and other liabilities primarily due to the payout of the 2024 annual bonuses and decreases in accrued collaboration for payment of a milestone to a collaboration partner of $30.0 million, an increase in prepaid manufacturing expense, as well as an increase in accounts receivable related to timing of orders and collections.
Current wording
Cash used in operating activities for the nine months ended September 30, 2025 was $366.2 million and primarily reflected a net loss of $446.4 million, partially offset by non-cash items of $103.9 million, net, which consisted primarily of stock-based compensation, amortization of discounts on marketable debt securities, depreciation and amortization, non-cash royalty revenue, and non-cash interest expense related to the sale of future royalties. The change in operating assets and liabilities also reflected a net use of cash of $23.6 million, primarily due to a net decrease in accounts payable, accrued, and other liabilities, primarily due to a decrease in accrued collaboration for payments of milestones to collaboration partners.
Previous wording
Cash used in operating activities for the six months ended June 30, 2024 was $267.7 million and primarily reflected a net loss of $302.3 million, partially offset by non-cash items of $74.3 million, net, which consisted primarily of stock-based compensation, amortization of discounts on marketable debt securities, depreciation and amortization, change in fair value of equity investments, non-cash royalty revenue, and non-cash interest expense related to the sale of future royalties. The change in operating assets and liabilities also reflected a net use of cash of $39.7 million, primarily due to an increase in accounts receivable primarily related to an increase in sales of our approved products and timing of when orders were received, combined with a net decrease in accounts payable, accrued and other liabilities primarily due to the payout of the 2023 annual bonus and for the payment of Medicaid obligations.
Current wording
Cash used in operating activities for the nine months ended September 30, 2024 was $334.7 million and primarily reflected a net loss of $435.8 million, partially offset by non-cash items of $109.9 million, net, which consisted primarily of stock-based compensation, amortization of discounts on marketable debt securities, depreciation and amortization, non-cash royalty revenue, and non-cash interest expense related to the sale of future royalties. The change in operating assets and liabilities also reflected a net use of cash of $8.8 million, primarily due to an increase in accounts receivable primarily related to an increase in sales of our approved products and timing of when orders were received, partially offset by a net decrease in other assets primarily due to a decrease in prepaid manufacturing.
Previous wording
Cash provided by investing activities for the six months ended June 30, 2025 was $191.1 million and was primarily related to $210.9 million from net activities in marketable debt securities, partially offset by the payment to a collaboration partner of $15.0 million for the achievement of a milestone under the collaboration agreement recorded as an intangible asset.
Current wording
Cash provided by investing activities for the nine months ended September 30, 2025 was $308.2 million and was primarily related to $329.6 million from net activities in marketable debt securities, partially offset by the payment to a collaboration partner of $15.0 million for the achievement of a milestone under the collaboration agreement recorded as an intangible asset.
Previous wording
Cash provided by investing activities for the six months ended June 30, 2024 was $155.0 million and was primarily related to $174.8 million from net activities in marketable debt securities, offset by payments to a collaboration partner of $12.5 million for the achievement of milestones under the collaboration agreement recorded as an intangible asset.
Current wording
Cash used in investing activities for the nine months ended September 30, 2024 was $120.5 million and was primarily related to $98.9 million from net activities in marketable debt securities, combined with payments to a collaboration partner of $12.5 million for the achievement of milestones under the collaboration agreement recorded as an intangible asset.
Previous wording
Cash provided by financing activities for the six months ended June 30, 2025 was $83.8 million and was primarily related to net proceeds from our ATM offering.
Current wording
Cash provided by financing activities for the nine months ended September 30, 2025 was $83.8 million and was primarily related to net proceeds from our ATM offering.
Previous wording
Cash provided by financing activities for the six months ended June 30, 2024 was $384.9 million and was primarily related to net proceeds from the issuance of common stock and pre-funded warrants in connection with the underwritten public offering.
Current wording
Cash provided by financing activities for the nine months ended September 30, 2024 was $396.1 million and was primarily related to proceeds from issuance of common stock and pre-funded warrants in connection with the underwritten public offering, net.
Previous wording
Future minimum lease payments under non-cancellable leases as of June 30, 2025, were approximately $43.7 million, of which $15.0 million is due within one year.
Current wording
Future minimum lease payments under non-cancellable leases as of September 30, 2025, were approximately $40.3 million, of which $15.1 million is due within one year.
Previous wording
Manufacturing and service contract obligations primarily relate to manufacturing of inventory for our approved products. As of June 30, 2025, we had obligations of approximately $114.4 million, of which $100.0 million is due within one year.
Current wording
Manufacturing and service contract obligations primarily relate to manufacturing of product for our clinical stage pipeline. As of September 30, 2025, we had obligations of approximately $125.4 million, of which $92.9 million is due within one year.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
As of the data cut-off, glycemic control was maintained in participants treated with DTX401 despite significant reductions in daily cornstarch intake. DTX401 has demonstrated a consistent and acceptable safety profile with no new safety signals identified as of the data cut-off.