UroGen Pharma Ltd.

Previous wording

We are a biotechnology company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers. We have developedRTGel reverse-thermal hydrogel, a proprietary sustained release, hydrogel-based technology that has the potential to improve therapeutic profiles of existing drugs. Our technology is designed to enable longer exposure of urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Our approved productsJelmyto (mitomycin) for pyelocalyceal solution andZusduri(mitomycin) for intravesical solution are designed to ablate tumors by non-surgical means and to treat several forms of non-muscle invasive urothelial cancer, including low-grade upper tract urothelial cancer (“low-grade UTUC”) and recurrent low-grade intermediate risk non-muscle invasive bladder cancer (“low-grade intermediate risk NMIBC”), respectively. In addition, our immuno-uro-oncology pipeline includes UGN-301 (zalifrelimab) intravesical solution, an anti-CTLA-4 antibody, which we intend to study as both a monotherapy and combination therapy, and UGN-501 (formerly known as ICVB-1042), a next-generation investigational oncolytic virus.

Current wording

We are a biotechnology company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers. We have developedRTGel reverse-thermal hydrogel, a proprietary sustained release, hydrogel-based technology that has the potential to improve therapeutic profiles of existing drugs. Our technology is designed to enable longer exposure of urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Our approved productsJelmyto (mitomycin) for pyelocalyceal solution andZusduri(mitomycin) for intravesical solution are designed to ablate tumors by non-surgical means and to treat several forms of non-muscle invasive urothelial cancer, including low-grade upper tract urothelial cancer (“low-grade UTUC”) and recurrent low-grade intermediate risk non-muscle invasive bladder cancer (“low-grade intermediate risk NMIBC”), respectively. In addition, our immuno-uro-oncology pipeline includes UGN-501 (formerly known as ICVB-1042), a next-generation investigational oncolytic virus.

Previous wording

We believeZusdurihas the potential to become the new standard of care for recurrent low-grade intermediate risk NMIBC as the first and only FDA-approved non-surgical treatment. The existing standard of care for low-grade intermediate risk NMIBC is a surgical procedure typically performed under general anesthesia called transurethral resection of bladder tumor (“TURBT”). Due to high recurrence rates of low-grade intermediate risk NMIBC, repeat TURBTs may be necessary. We estimate that approximately 68% of low-grade intermediate risk NMIBC patients have two or more recurrences, with approximately 23% of recurrent patients having five or more recurrences. Repeated TURBT procedures to treat these recurrences can impact patients’ physical health and quality of life. We estimate that patients who have had two to four procedures have an estimated 14% greater risk of death than patients who have only had one procedure.

Current wording

We believeZusdurihas the potential to become the new standard of care for recurrent low-grade intermediate risk NMIBC as the first and only FDA-approved non-surgical treatment. The existing standard of care for low-grade intermediate risk NMIBC is a surgical procedure typically performed under general anesthesia called transurethral resection of bladder tumor (“TURBT”). Due to high recurrence rates of low-grade intermediate risk NMIBC, repeat TURBTs may be necessary. We estimate that approximately 68% of low-grade intermediate risk NMIBC patients have two or more recurrences, with approximately 23% of recurrent patients having five or more recurrences. Repeated TURBT procedures to treat these recurrences can impact patients’ physical health and quality of life. Patients who have had two to four procedures have an estimated 14% greater risk of death than patients who have only had one procedure.

Previous wording

In June 2020, we initiated our commercial launch ofJelmyto in the United States. We have staffed, trained and prepared a customer-facing team that includes territory business managers with deep experience in both urology and oncology. These territory business manager positions are led by regional business director positions, who are in turn supported by regional operations manager positions. Each region is additionally supported by clinical nurse educators to provide education and training around instillation, as well as field reimbursement managers to help ensure access and reimbursement for appropriate patients and key account directors who engage with C-suite individuals to introduce aJelmytoservice line. In addition, our organization currently includes several medical science liaisons who appropriately engage with physicians interested in learning more about UroGen,Jelmyto and our technology, both in person and virtually. In total, our customer-facing team comprises approximately 100 colleagues.

Current wording

In June 2020, we initiated our commercial launch ofJelmyto in the United States. We have staffed, trained and prepared a customer-facing team that includes territory business managers with deep experience in both urology and oncology. These territory business manager positions are led by regional business director positions, who are in turn supported by regional operations manager positions. Each region is additionally supported by clinical nurse educators to provide education and training around instillation, as well as field reimbursement managers to help ensure access and reimbursement for appropriate patients and key account directors who engage with C-suite individuals to introduce aJelmytoservice line. In addition, our organization currently includes several medical science liaisons who appropriately engage with physicians interested in learning more about UroGen,Jelmyto and our technology, both in person and virtually. In total, our customer-facing team comprises approximately 130 colleagues.

Previous wording

We estimate that the annual treatable population of low-grade intermediate risk NMIBC in the United States is approximately 82,000, of which approximately 23,000 are estimated to be newly diagnosed and 59,000 are estimated to be recurrent patients.Zusduri is administered locally using the standard practice of intravesical instillation directly into the bladder via a catheter. The instillation into the bladder is expected to take place in a physician’s office as a non-operative outpatient treatment, in comparison with TURBT or similar surgical procedures, which are operations often conducted under general anesthesia and may require an overnight stay. Complete surgical tumor removal often has limited success due to the inability to properly identify, reach and resect all tumors. We believe that an effective chemoablation agent can potentially provide better eradication of tumors irrespective of the detectability and location of the tumors. In addition, by reducing the need for surgery, patients may avoid potential complications associated with surgery and anesthesia. We estimate that approximately 68% of low-grade intermediate risk NMIBC patients have two or more recurrences, with approximately 23% having five or more recurrences. Repeated TURBT procedures to treat these recurrences can impact patients’ physical health and quality of life. We estimate that around 35% of patients will experience an adverse event within 90 days of undergoing a TURBT, and patients who have had two to four procedures have an estimated 14% greater risk of death than patients who have only had one procedure.

Current wording

We estimate that the annual treatable population of low-grade intermediate risk NMIBC in the United States is approximately 82,000, of which approximately 23,000 are estimated to be newly diagnosed and 59,000 are estimated to be recurrent patients.Zusduri is administered locally using the standard practice of intravesical instillation directly into the bladder via a urinary catheter. The instillation into the bladder is expected to take place in a physician’s office as a non-operative outpatient treatment, in comparison with TURBT or similar surgical procedures, which are operations usually conducted under general anesthesia and may require an overnight stay. Complete surgical tumor removal often has limited success due to the inability to properly identify, reach and resect all tumors. We believe that an effective chemoablation agent can potentially provide better eradication of tumors irrespective of the detectability and location of the tumors. In addition, by potentially reducing the need for surgery, patients may avoid potential complications associated with surgery and anesthesia. We estimate that approximately 68% of low-grade intermediate risk NMIBC patients have two or more recurrences, with approximately 23% having five or more recurrences. Repeated TURBT procedures to treat these recurrences can impact patients’ physical health and quality of life. Around 35% of patients will experience an adverse event within 90 days of undergoing a TURBT, and patients who have had two to four procedures have an estimated 14% greater risk of death than patients who have only had one procedure.

Previous wording

In June 2024, we announced secondary endpoint DOR data from the Phase 3 ENVISION trial investigatingZusdurifor intravesical solution in patients with recurrent low-grade intermediate risk NMIBC. In the ENVISION trial, the 12-month DOR data by Kaplan-Meier estimate for patients who achieved a CR at three months after the first instillation ofZusduriwas 82.3% (95% CI, 75.9%, 87.1%). The ENVISION trial met its primary endpoint with patients having a 79.6% (73.9%, 84.5%) CR rate at three months after the first instillation ofZusduri. Among the patients in the ENVISION trial who achieved a CR at three months, 76.4% (69.8%, 82.3%) maintained a CR at 12 months. Among all 240 patients enrolled in the ENVISION trial, 60.8% (54.3%, 67.0%) were in CR at 12 months. In the ENVISION trial, DOR Kaplan-Meier estimates at 15 (n=43) and 18 (n=9) months were both 80.9% (95% CI, 73.9%, 86.2%) with a median follow-up time of 13.8 months after the three-month CR. The ENVISION trial demonstrated a similar safety profile to that observed in the OPTIMA II and ATLAS trials, with treatment-emergent adverse events typically mild-to-moderate in severity. The ENVISION trial data was published online inThe Journal of Urology in October 2024 and was included in the February 2025 print edition.

Current wording

In June 2024, we announced secondary endpoint DOR data from the Phase 3 ENVISION trial investigatingZusdurifor intravesical solution in patients with recurrent low-grade intermediate risk NMIBC. In the ENVISION trial, the 12-month DOR data by Kaplan-Meier estimate for patients who achieved a CR at three months after the first instillation ofZusduriwas 82.3% (95% CI, 75.9%, 87.1%). The ENVISION trial met its primary endpoint with patients having a 79.6% (73.9%, 84.5%) CR rate at three months after the first instillation ofZusduri. Among the patients in the ENVISION trial who achieved a CR at three months, 76.4% (69.8%, 82.3%) maintained a CR at 12 months. Among all 240 patients enrolled in the ENVISION trial, 60.8% (54.3%, 67.0%) were in CR at 12 months. The ENVISION trial demonstrated a similar safety profile to that observed in the OPTIMA II and ATLAS trials, with treatment-emergent adverse events typically mild-to-moderate in severity. The ENVISION trial data were published online inThe Journal of Urology in October 2024 and were included in the February 2025 print edition.

Previous wording

In March 2025, we announced updated 18-month DOR data from the Phase 3 ENVISION trial. The 18-month DOR by Kaplan-Meier estimate for patients who achieved a CR at three months after the first instillation ofZusduriremained consistent with the 12-month DOR data: 80.6% (95% CI, 74.0%, 85.7%) at 18-months (n=101) compared to 82.5% (76.1%, 87.3%) at 12-months (n=146). Median follow-up time was 18.7 months after the three-month CR.

Current wording

In March 2025, we announced 18-month DOR data from the Phase 3 ENVISION trial. The 18-month DOR by Kaplan-Meier estimate for patients who achieved a CR at three months after the first instillation ofZusduriremained consistent with the 12-month DOR data: 80.6% (95% CI, 74.0%, 85.7%) at 18-months (n=101) compared to 82.5% (76.1%, 87.3%) at 12-months (n=146). Median follow-up time was 18.7 months after the three-month CR.

Previous wording

In August 2025, we announced 24-month DOR data from the Phase 3 ENVISION trial. The 24-month DOR by Kaplan-Meier estimate for patients who achieved a CR at three months after the first instillation ofZusduriwas 72.2% (95% CI, 64.1%, 78.8%). Median follow-up time was 23.7 months after the three-month CR. The median DOR has not been reached.

Current wording

In August 2025, we announced 24-month DOR data from the Phase 3 ENVISION trial. The 24-month DOR by Kaplan-Meier estimate for patients who achieved a CR at three months after the first instillation ofZusduriwas 72.2% (95% CI, 64.1%, 78.8%). Median follow-up time was 23.7 months after the three-month CR. The median DOR had not yet been reached.

Previous wording

As a post-marketing commitment, we have agreed with the FDA to complete the ongoing ENVISION trial to further characterize the clinical benefit ofZusdurifor the treatment of patients with recurrent low-grade intermediate risk NMIBC. In addition, we committed to providing the FDA annual updates on DOR for all patients with ongoing CRs. The annual updates will continue until all ongoing patients experience a recurrence of low-grade intermediate risk NMIBC; progression; death; loss to follow-up; or reach 63 months after the first instillation as planned in the protocol, whichever occurs first.

Current wording

As a post-marketing commitment, we have agreed with the FDA to complete the ongoing ENVISION trial to further characterize the clinical benefit ofZusdurifor the treatment of patients with recurrent low-grade intermediate risk NMIBC. In addition, we committed to providing the FDA updates on DOR for all patients with ongoing CRs. The updates will continue until all ongoing patients experience a recurrence of low-grade intermediate risk NMIBC; progression; death; loss to follow-up; or reach 63 months after the first instillation as planned in the protocol, whichever occurs first.

Previous wording

We initiated promotion ofZusduri in the United States in late June 2025 with product available by July 1, 2025.

Current wording

We began promotion ofZusduri in the United States in late June 2025. We initiated a strategic multi-faceted approach to promote broad adoption and patient access toZusduri, leveraging our customer-facing team of territory business managers, regional business directors, regional operations managers, clinical nurse educators, field reimbursement managers and medical science liaisons.Zusduri is now broadly accessible to patients through Commercial, Medicare, and Medicaid insurance programs, with open access for more than 95% of covered lives and approximately 296 million eligible patients. In October 2025,Zusduri was assigned a unique, permanent Healthcare Common Procedure Coding System (“HCPCS”) J-code (J9282) by CMS. The J-code is expected to be effective January 1, 2026.

Previous wording

In April 2024, we announced that the FDA accepted our Investigational New Drug Application (“IND”) for UGN-103 and we initiated our Phase 3 UTOPIA trial, a single-arm, multicenter study that will evaluate the efficacy and safety of UGN-103 in recurrent low-grade intermediate risk NMIBC. In October 2024, we announced the first patient dosed in the UTOPIA trial, and in July 2025, we announced the completion of patient enrollment with 99 patients enrolled across multiple centers globally. Patients in the UTOPIA trial will receive 75 mg of mitomycin via intravesical instillation once a week for six weeks. Efficacy will be assessed by the CR rate at the three-month visit. Patients who have a CR at the three-month visit, defined as having no detectable disease in the bladder, will enter the follow-up period of the study. Patients will remain on study until disease recurrence, disease progression, death, or the last patient completes 12 months of follow-up (i.e., 15 months after the first instillation), whichever occurs first. We expect topline CR data by the end of 2025. If the trial is successful, an NDA submission is projected for 2026, followed by a standard review period and potential FDA approval and, if approved, the commercial launch in 2027.

Current wording

In April 2024, we announced that the FDA accepted our Investigational New Drug Application (“IND”) for UGN-103 and we initiated our Phase 3 UTOPIA trial, a single-arm, multicenter study that will evaluate the efficacy and safety of UGN-103 in patients with recurrent low-grade intermediate risk NMIBC. In October 2024, we announced the first patient dosed in the UTOPIA trial, and in July 2025, we announced the completion of patient enrollment with 99 patients enrolled across multiple centers globally. Patients in the UTOPIA trial received 75 mg of mitomycin via intravesical instillation once a week for six weeks. Efficacy will be assessed by the CR rate at the three-month visit. Patients who have a CR at the three-month visit, defined as having no detectable disease in the bladder, will enter the follow-up period of the study. Patients will remain on study until disease recurrence, disease progression, death, or the last patient completes 12 months of follow-up (i.e., 15 months after the first instillation), whichever occurs first. A long-term follow up study will also be conducted following patients remaining in CR for up to five years after initiation of treatment with UGN-103. We reported a three-month CR rate of 77.8% (95% CI, 68.3%, 85.5%), consistent with results from the ENVISION clinical trial. The FDA has agreed with the regulatory plan to submit an NDA based on the data from our Phase 3 UTOPIA trial to support potential approval of UGN-103. We anticipate submitting an NDA for UGN-103 in the second half of 2026 with potential FDA approval in 2027.

Previous wording

Our immuno-uro-oncology pipeline includes UGN-301, an anti-CTLA-4 monoclonal antibody, which we intend to study as a combination therapy with multiple agents. UGN-301 is delivered using our proprietaryRTGel technology, which has been designed to significantly improve the effectiveness of certain intravesical therapies.

Current wording

Our immuno-uro-oncology pipeline previously included UGN-301, an anti-CTLA-4 monoclonal antibody, which we studied as a combination therapy with multiple agents. UGN-301 was delivered using our proprietaryRTGel technology, which has been designed to significantly improve the effectiveness of certain intravesical therapies.

Previous wording

The first combination we are investigating clinically involves the sequential use of UGN-201 (imiquimod), a toll like receptor 7 ("TLR 7") agonist, and UGN-301 in high-grade NMIBC. UGN-201 is a liquid formulation of imiquimod for intravesical administration that has been optimized for delivery in the urinary tract. The second combination we are investigating clinically involves the sequential administration of gemcitabine and UGN-301 to the bladder in high-grade NMIBC. Gemcitabine is a chemotherapy that is used intravesically to treat high grade NMIBC where it is administered as a liquid formulation. We believe these two combinations could elicit both an innate and adaptive immune response, which may translate into a long-lasting acquired immune response, and potentially represent a valid post-TURBT adjuvant treatment of high-grade NMIBC. We are investigating these combinations to determine if they may make local therapy a potentially more effective treatment option while minimizing systemic exposure and potential side effects.

Current wording

The first combination we investigated clinically involved the sequential use of UGN-201 (imiquimod), a toll like receptor 7 ("TLR 7") agonist, and UGN-301 in high-grade NMIBC. UGN-201 is a liquid formulation of imiquimod for intravesical administration that has been optimized for delivery in the urinary tract. The second combination we investigated clinically involved the sequential administration of gemcitabine and UGN-301 to the bladder in high-grade NMIBC. Gemcitabine is a chemotherapy that is used intravesically to treat high grade NMIBC where it is administered as a liquid formulation. We believed these two combinations could elicit both an innate and adaptive immune response, which may translate into a long-lasting acquired immune response, and potentially represent a valid post-TURBT adjuvant treatment of high-grade NMIBC. We investigated these combinations to determine if they could make local therapy a potentially more effective treatment option while minimizing systemic exposure and potential side effects.

Previous wording

In March 2022, we announced FDA clearance of our IND to begin a novel Phase 1 clinical study of UGN-301 in patients with recurrent NMIBC. The novel study design utilizes a Master Protocol that we believe is a more efficient and streamlined approach to development. It will provide more flexibility to add study arms as the trial progresses and is expected to increase efficiency and potentially reduce costs. We expect the Master Protocol will allow us to more quickly evaluate safety, tolerability and dosing of UGN-301 in combination with additional immunomodulators and chemotherapies, with the goal of developing optimized treatment regimens for patients. The multi-arm Phase 1 study, which is expected to support the development of UGN-301 in high-grade NMIBC, was initiated in April 2022 and enrollment in the study is complete. Safety and dosing data from the first arm evaluating UGN-301 as monotherapy was presented in late 2024. The treatments demonstrated an acceptable safety profile and were generally well tolerated across dose levels. Responses were observed in both monotherapy and combination therapy arms, and patient follow-up is ongoing to further assess the durability of these responses. We expect to report updated data in 2025.

Current wording

In March 2022, we announced FDA clearance of our IND to begin a novel Phase 1 clinical study of UGN-301 in patients with recurrent NMIBC. The novel study design utilized a Master Protocol that we believed would be a more efficient and streamlined approach to development. It provided more flexibility to add study arms as the trial progressed to increase efficiency and potentially reduce costs. We expected the Master Protocol would allow us to more quickly evaluate safety, tolerability and dosing of UGN-301 in combination with additional immunomodulators and chemotherapies, with the goal of developing optimized treatment regimens for patients. The multi-arm Phase 1 study, which was expected to support the development of UGN-301 in high-grade NMIBC, was initiated in April 2022 and enrollment in the study is complete. Safety and dosing data from the first arm evaluating UGN-301 as monotherapy was presented in late 2024.

Previous wording

In November 2019, we entered into a license agreement with Agenus, pursuant to which Agenus granted us an exclusive, worldwide (not including Argentina, Brazil, Chile, Colombia, Peru, Venezuela and their respective territories and possessions), royalty-bearing, sublicensable license under Agenus’s intellectual property rights to develop, make, use, sell, import, and otherwise commercialize products incorporating a proprietary monoclonal antibody of Agenus known as AGEN1884 (zalifrelimab), an anti-CTLA-4 antagonist, for the treatment of cancers of the urinary tract via intravesical delivery. UGN-301 is an intravesical formulation of zalifrelimab administered usingRTGel technology that is in Phase 1 clinical development for high-grade NMIBC.

Current wording

In November 2019, we entered into a license agreement with Agenus, pursuant to which Agenus granted us an exclusive, worldwide (not including Argentina, Brazil, Chile, Colombia, Peru, Venezuela and their respective territories and possessions), royalty-bearing, sublicensable license under Agenus’s intellectual property rights to develop, make, use, sell, import, and otherwise commercialize products incorporating a proprietary monoclonal antibody of Agenus known as AGEN1884 (zalifrelimab), an anti-CTLA-4 antagonist, for the treatment of cancers of the urinary tract via intravesical delivery. In November 2025, we provided notice to terminate the license agreement with Agenus in connection with our decision to discontinue development of UGN-301. Under the terms of the license agreement, following notice of termination, the agreement will terminate upon the later of (a) the expiration of a 180-day notice period; or (b) completion of all wind-down activities and delivery of all Agenus Improvements (as defined in the license agreement) to Agenus.

Previous wording

For additional information regarding our research and development and license agreements, see Note 13 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report.

Current wording

For additional information regarding our research and development and license agreements, see Note 13 and Note 21 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report.

Previous wording

During the three and six months ended June 30, 2025 we recognized $24.2 million and $44.5 million of revenue, respectively, from sales of our product,Jelmyto.

Current wording

During the three and nine months ended September 30, 2025 we recognized $27.5 million and $72.0 million of revenue, respectively, from sales of our products.

Previous wording

Cost of revenue consists primarily of inventory and related costs associated with the manufacturing, distribution, warehousing and preparation ofJelmyto,including inventory write-downs. In periods prior to receiving FDA approval forJelmyto, we recognized inventory and related costs associated with the manufacture ofJelmyto as research and development expense.

Current wording

Cost of revenue consists primarily of inventory and related costs associated with the manufacturing, distribution, warehousing and preparation ofJelmytoandZusduri,including inventory write-downs. In periods prior to receiving FDA approval forJelmytoandZusduri, we recognized inventory and related manufacturing costs as research and development expense.

Previous wording

Research and development expenses were $18.9 million and $15.4 million for the three months ended June 30, 2025 and 2024, respectively. The increase in research and development expenses of $3.5 million is primarily attributable to higher manufacturing costs forZusduri, which are recognized as research and development expenses prior to our product candidates receiving FDA approval and costs associated with the Phase 3 UTOPIA trial for UGN-103, partially offset by lower clinical trial costs and regulatory expenses in connection withZusduri.

Current wording

Research and development expenses were $14.0 million and $11.4 million for the three months ended September 30, 2025 and 2024, respectively. The increase in research and development expenses of $2.6 million is primarily attributable to costs associated with the Phase 3 UTOPIA trial for UGN-103 and the Phase 3 trial for UGN-104, partially offset by lower clinical trial costs, manufacturing costs, and regulatory expenses in connection withZusduri.

Previous wording

Selling and marketing expenses were $27.9 million and $18.9 million for the three months ended June 30, 2025 and 2024, respectively. The increase in selling and marketing expenses of $9.0 million is primarily attributable toZusduricommercial preparation activities as well as an increase in overall commercial operation costs including the expansion of the sales force, compensation, advisory, meetings, conferences, trainings and software costs.

Current wording

Selling and marketing expenses were $23.7 million and $17.8 million for the three months ended September 30, 2025 and 2024, respectively. The increase in selling and marketing expenses of $5.9 million is primarily attributable toZusduricommercial activities as well as an increase in overall commercial operation costs including the expansion of the sales force, compensation, advisory, meetings, conferences, trainings and back office support costs.

Previous wording

General andadministrative expenses were $15.3 million and $11.2 million for the three months ended June 30, 2025 and 2024, respectively. The increase in general and administrative expenses of $4.1 million is primarily attributable to higher compensation expenses, expenses related to pre-commercialization readiness support related toZusduri, general third-party advisory services, and ongoing managed services.

Current wording

General andadministrative expenses were $13.9 million and $11.2 million for the three months ended September 30, 2025 and 2024, respectively. The increase in general and administrative expenses of $2.7 million is primarily attributable to higher compensation expenses, expenses related to commercialization support related toZusduri, general third-party advisory services, and ongoing managed services.

Previous wording

Financing on prepaid forward obligation was $4.6 million and $5.8 million for the three months ended June 30, 2025 and 2024, respectively. The measurement of financing on prepaid forward obligation is an accounting estimate under the "imputed interest method" of accounting (see Note 3 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report) which is affected by estimated future payments to RTW, which are based on a percentage of revenues. The decrease in financing on prepaid forward obligation of $1.2 million was driven primarily by changes in underlying assumptions for remeasuring the effective rate.

Current wording

Financing on prepaid forward obligation was $4.6 million and $5.9 million for the three months ended September 30, 2025 and 2024, respectively. The measurement of financing on prepaid forward obligation is an accounting estimate under the "imputed interest method" of accounting (see Note 3 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report) which is affected by estimated future payments to RTW, which are based on a percentage of revenues. The decrease in financing on prepaid forward obligation of $1.3 million was driven primarily by changes in underlying assumptions for remeasuring the effective rate.

Previous wording

Interest expense was $4.1 million and $3.5 million for the three months ended June 30, 2025 and 2024, respectively. The increase in interest expense was primarily attributable to the interest expense on the $25.0 million third tranche under the Pharmakon loan that was funded in September 2024.

Current wording

Interest expense was $3.4 million and $2.7 million for the three months ended September 30, 2025 and 2024, respectively. The increase in interest expense was primarily attributable to the interest expense on the $25.0 million third tranche under the Pharmakon loan that was funded in September 2024.

Previous wording

Interest and other income, net was $1.3 million and $1.7 million for the three months ended June 30, 2025 and 2024, respectively. The decrease in interest and other income, net was primarily due to lower cash and investment balances.

Current wording

Interest and other income, net was $1.0 million and $2.6 million for the three months ended September 30, 2025 and 2024, respectively. The decrease in interest and other income, net was primarily due to lower cash and investment balances.

Previous wording

The following table sets forth our results of operations for the six months ended June 30, 2025 and 2024.

Current wording

The following table sets forth our results of operations for the nine months ended September 30, 2025 and 2024.

Previous wording

Revenue was $44.5 million and $40.6 million for the six months ended June 30, 2025 and 2024, respectively. The increase in revenue of $3.9 million primarily reflects the increased volume of sales ofJelmyto.

Current wording

Revenue was $72.0 million and $65.8 million for the nine months ended September 30, 2025 and 2024, respectively. The increase in revenue of $6.2 million primarily reflects the increased volume of sales ofJelmytoas well as sales ofZusduri, which was launched in the third quarter of 2025.

Previous wording

Cost of revenue was $3.6 million and $2.2 million for the three months ended June 30, 2025 and 2024, respectively. The increase in cost of revenue of $1.4 million is primarily attributable to the increased volume of sales ofJelmytoas well as increased costs related to a higher unit cost ofJelmyto and an inventory write-off.

Current wording

Cost of revenue was $9.2 million and $6.4 million for the nine months ended September 30, 2025 and 2024, respectively. The increase in cost of revenue of $2.8 million is primarily attributable to the increased volume of sales ofJelmytoas well as increased costs related to a higher unit cost ofJelmyto, increased shipping and warehousing expenses and an inventory write-off. In periods prior to receiving FDA approval forZusduri, we recognized inventory and related costs associated with the manufacture ofZusdurias research and development expenses. We expect this to continue to impact cost of revenue through approximately 2027 as we produceZusduriat costs reflecting the full cost of manufacturing and as we deplete inventories that we expensed prior to receiving FDA approval.

Previous wording

Research and development expenses were $38.8 million and $30.9 million for the six months ended June 30, 2025 and 2024, respectively. The increase in research and development expenses of $7.9 million is primarily attributable to higher manufacturing costs forZusduri, which are recognized as research and development expenses prior to our product candidates receiving FDA approval, costs associated with the Phase 3 UTOPIA trial for UGN-103 and the acquisition of certain assets of IconOVir, partially offset by lower clinical trial costs and regulatory expenses in connection withZusduri.

Current wording

Research and development expenses were $52.8 million and $42.3 million for the nine months ended September 30, 2025 and 2024, respectively. The increase in research and development expenses of $10.5 million is primarily attributable to higher manufacturing costs forZusduri, which are recognized as research and development expenses prior to our product candidates receiving FDA approval, costs associated with the Phase 3 UTOPIA trial for UGN-103 and the Phase 3 trial for UGN-104, as well as the acquisition of certain assets of IconOVir, partially offset by lower clinical trial costs and regulatory expenses in connection withZusduri.

Previous wording

Selling and marketing expenses were $50.0 million and $36.0 million for thesix months ended June 30, 2025 and 2024, respectively. The increase in selling and marketing expenses of $14.0 million is primarily attributable toZusduricommercial preparation activities as well as an increase in overall commercial operation costs including the expansion of the sales force, compensation, advisory, meetings, conferences, trainings and software costs.

Current wording

Selling and marketing expenses were $73.7 million and $53.8 million for thenine months ended September 30, 2025 and 2024, respectively. The increase in selling and marketing expenses of $19.9 million is primarily attributable toZusduricommercial preparation activities as well as an increase in overall commercial operation costs including the expansion of the sales force, compensation, advisory, meetings, conferences, trainings and back office support costs.

Previous wording

General andadministrative expenses were $28.2 million and $21.4 million for thesix months ended June 30, 2025 and 2024, respectively. The increase in general and administrative expenses of $6.8 million is primarily attributable to higher compensation expenses, expenses related to pre-commercialization readiness support related toZusduri, general third-party advisory services, and ongoing managed services.

Current wording

General andadministrative expenses were $42.1 million and $32.5 million for thenine months ended September 30, 2025 and 2024, respectively. The increase in general and administrative expenses of $9.6 million is primarily attributable to higher compensation expenses, expenses related to pre-commercialization readiness support related toZusduri, general third-party advisory services, and ongoing managed services.

Previous wording

Financing on prepaid forward obligation was $9.2 million and $11.4 million for the six months ended June 30, 2025 and 2024, respectively. The measurement of financing on prepaid forward obligation is an accounting estimate under the "imputed interest method" of accounting (see Note 3 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report) which is affected by estimated future payments to RTW, which are based on a percentage of revenues. The decrease in financing on prepaid forward obligation of $2.2 million was driven primarily by changes in underlying assumptions for remeasuring the effective rate.

Current wording

Financing on prepaid forward obligation was $13.8 million and $17.3 million for the nine months ended September 30, 2025 and 2024, respectively. The measurement of financing on prepaid forward obligation is an accounting estimate under the "imputed interest method" of accounting (see Note 3 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report) which is affected by estimated future payments to RTW, which are based on a percentage of revenues. The decrease in financing on prepaid forward obligation of $3.5 million was driven primarily by changes in underlying assumptions for remeasuring the effective rate.

Previous wording

Interest expense was $8.2 million and $5.9 million for the six months ended June 30, 2025 and 2024, respectively. The increase in interest expense was primarily attributed to the interest expense on the $25.0 million third tranche under the Pharmakon loan that was funded in September 2024.

Current wording

Interest expense was $11.6 million and $8.6 million for the nine months ended September 30, 2025 and 2024, respectively. The increase in interest expense was primarily attributed to the interest expense on the $25.0 million third tranche under the Pharmakon loan that was funded in September 2024.

Previous wording

Interest and other income, net was $3.4 million and $3.3 million for the six months ended June 30, 2025 and 2024, respectively. The increase in interest and other income, net was primarily attributable to higher average balances in interest-bearing accounts over the period.

Current wording

Interest and other income, net was $4.4 million and $5.9 million for the nine months ended September 30, 2025 and 2024, respectively. The decrease in interest and other income, net was primarily attributable to lower average balances in interest-bearing accounts over the period and the interest rate environment in 2025 reflected a lower rate trend, resulting in reduced interest income.

Previous wording

As of June 30, 2025, we had $161.6 million in cash and cash equivalents and marketable securities. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation, and is held primarily in U.S. dollars.

Current wording

As of September 30, 2025, we had $127.4 million in cash and cash equivalents and marketable securities. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation, and is held primarily in U.S. dollars.

Previous wording

Through June 30, 2025, we funded our operations primarily through public equity offerings, private placements of equity securities and our funding arrangements with RTW and Pharmakon, andJelmytoproduct sales.

Current wording

Through September 30, 2025, we funded our operations primarily through public equity offerings, private placements of equity securities and our funding arrangements with RTW and Pharmakon, and product sales.

Previous wording

In the first quarter of 2024, we sold 3,400,468 ordinary shares under the ATM Sales Agreement, for gross proceeds of approximately $56.1 million. The net proceeds to us after deducting sales commissions to TD Cowen were approximately $54.7 million. We did not sell any ordinary shares under the ATM Sales Agreement in the six months ended June 30, 2025. The remaining capacity under the ATM Sales Agreement was approximately $27.3 million as of June 30, 2025. The shares will be offered and sold pursuant to our shelf registration statement on Form S-3 filed with the SEC on November 15, 2022, which was declared effective on November 29, 2022, or a subsequent shelf registration statement.

Current wording

In the first quarter of 2024, we sold 3,400,468 ordinary shares under the ATM Sales Agreement, for gross proceeds of approximately $56.1 million. The net proceeds to us after deducting sales commissions to TD Cowen were approximately $54.7 million. During the third quarter of 2025, we sold 416,248 ordinary shares under the ATM Sales Agreement, for gross proceeds of approximately $8.2 million. The net proceeds to us after deducting sales commissions to TD Cowen were approximately $8.0 million. The remaining capacity under the ATM Sales Agreement was approximately $19.1 million as of September 30, 2025. The shares will be offered and sold pursuant to our shelf registration statement on Form S-3 filed with the SEC on November 15, 2022, which was declared effective on November 29, 2022, or a subsequent shelf registration statement.

Previous wording

On March 13, 2024, we entered into an amended and restated loan agreement with Pharmakon for an additional third and fourth tranche of senior secured loan. The third tranche of $25.0 million was funded in September 2024. The fourth tranche of $75.0 million became available upon our receipt of FDA approval of our NDA forZusduri and may be drawn at our option no later than August 29, 2025, subject to the satisfaction of customary bringdown conditions and deliverables. We do not intend to draw down the fourth tranche of $75.0 million.

Current wording

On March 13, 2024, we entered into an amended and restated loan agreement with Pharmakon for an additional third and fourth tranche of senior secured loan. The third tranche of $25.0 million was funded in September 2024. The fourth tranche of $75.0 million became available upon our receipt of FDA approval of our NDA forZusduri and could have been drawn at our option no later than August 29, 2025, subject to the satisfaction of customary bringdown conditions and deliverables. We elected not to draw down the fourth tranche.

Previous wording

We have incurred losses since our inception and negative cash flows from our operations, and as of June 30, 2025, we had an accumulated deficit of $900.0 million. We expect to incur losses and have negative net cash flows from operating activities as we execute on our strategy, including the commercial launch ofZusduri, the continued commercialization ofJelmyto, and engaging in further research and development activities. Our primary uses of capital are, and we expect will continue to be, commercialization activities, research and development expense, including third-party clinical research and development services, laboratory and related supplies, clinical costs, including manufacturing costs, legal and other regulatory expense and general and administrative costs.

Current wording

We have incurred losses since our inception and negative cash flows from our operations, and as of September 30, 2025, we had an accumulated deficit of $933.4 million. We expect to incur losses and have negative net cash flows from operating activities as we execute on our strategy, including the commercial launch ofZusduri, the continued commercialization ofJelmyto, and engaging in further research and development activities. Our primary uses of capital are, and we expect will continue to be, commercialization activities, research and development expense, including third-party clinical research and development services, laboratory and related supplies, clinical costs, including manufacturing costs, legal and other regulatory expense and general and administrative costs.

Previous wording

In November 2019, we entered into a new lease agreement, dated effective October 31, 2019, for an office in Princeton, NJ. The lease commencement date was November 29, 2019 and the lease term is 38 months. In June 2022, we signed an amendment to our November 2019 lease agreement to extend the term for an additional three years through January 31, 2026.

Current wording

In November 2019, we entered into a new lease agreement, dated effective October 31, 2019, for an office in Princeton, NJ. The lease commencement date was November 29, 2019 and the lease term is 38 months. In June 2022, we signed an amendment to our November 2019 lease agreement to extend the term for an additional three years through January 31, 2026. In August 2025, we signed an additional extension to our November 2019 lease agreement to extend the lease term through April 30, 2031. We concluded that the lease renewal option in the agreement is not reasonably certain to be exercised.

Previous wording

The total obligation for future minimum lease payments under our operating and finance leases are $1.4 million and $4.8 million, respectively, as of June 30, 2025. See Note 11 to the condensed consolidated financial statements appearing elsewhere in this Quarterly Report for further information.

Current wording

The total obligation for future minimum lease payments under our operating and finance leases are $4.1 million and $6.0 million, respectively, as of September 30, 2025. See Note 11 to the condensed consolidated financial statements appearing elsewhere in this Quarterly Report for further information.

Previous wording

On March 13, 2024, we entered into an amended and restated loan agreement with Pharmakon for an additional third and fourth tranche of senior secured loan. The third tranche of $25.0 million was funded in September 2024. The fourth tranche of $75.0 million became available upon our receipt of FDA approval of our NDA forZusduri and may be drawn at our option no later than August 29, 2025, subject to customary bringdown conditions and deliverables. We do not intend to drawn down the fourth tranche.

Current wording

On March 13, 2024, we entered into an amended and restated loan agreement with Pharmakon for an additional third and fourth tranche of senior secured loan. The third tranche of $25.0 million was funded in September 2024. The fourth tranche of $75.0 million became available upon our receipt of FDA approval of our NDA forZusduri and could have been drawn at our option no later than August 29, 2025, subject to customary bringdown conditions and deliverables. We elected not to draw the fourth tranche.