UroGen Pharma Ltd.

Previous wording

Low-grade UTUC is a rare cancer that develops in the lining of the upper urinary tract, which consists of the kidneys and ureters. In the United States, there are approximately 6,000 to 7,000 new or recurrent low-grade UTUC patients annually. It is a challenging condition to treat due to the complex anatomy of the urinary tract system. Prior toJelmyto, the current standard of care included endoscopic resection(s) and radical nephroureterectomy (“RNU”), the latter which involves the removal of the renal pelvis, kidney, ureter and bladder cuff. Treatment is further complicated by the fact that low-grade UTUC is most commonly diagnosed in patients over 70 years of age, who may already have compromised kidney function and may suffer further complications as a result of a major surgery. We are focused on changing the way urothelial cancers are treated, an area in which there has been no significant advancements in recent years.Jelmyto is the first drug therapy of its kind, providing an alternative to endoscopic resection(s) and/or RNU.

Current wording

Low-grade UTUC is a rare cancer that develops in the lining of the upper urinary tract, which consists of the kidneys and ureters. In the United States, there are approximately 6,000 to 7,000 new or recurrent low-grade UTUC patients annually. It is a challenging condition to treat due to the complex anatomy of the urinary tract system. Prior toJelmyto,* *the standard of care included endoscopic resection(s) and radical nephroureterectomy (“RNU”), the latter which involves the removal of the renal pelvis, kidney, ureter and bladder cuff. Treatment is further complicated by the fact that low-grade UTUC is most commonly diagnosed in patients over 70 years of age, who may already have compromised kidney function and may suffer further complications as a result of a major surgery. We are focused on changing the way urothelial cancers are treated, an area in which there has been no significant advancements in recent years.Jelmyto is the first drug therapy of its kind, providing an alternative to endoscopic resection(s) and/or RNU.

Previous wording

In February 2025, we presented additional new data from the long-term follow-up study to UroGen’s Phase 3 Olympus trial. Among patients from the trial who achieved a CR after primary chemoablation withJelmyto (n=41, 20 of whom entered the long-term follow-up study), the median DOR was 47.8 months (median follow-up 28.1 months [95% CI 13.1, 57.5]). The study results were published in the March 2025 issue ofThe Journal of Urology.

Current wording

In February 2025, we presented additional new data from the long-term follow-up study to UroGen’s Phase 3 Olympus trial. Among patients from the trial who achieved a CR after primary chemoablation withJelmyto (n=41, 20 of whom entered the long-term follow-up study), the median duration of response was 47.8 months (median follow-up 28.1 months [95% CI 13.1, 57.5]). The study results were published in the March 2025 issue ofThe Journal of Urology.

Previous 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 ofZusduri remained 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 ofZusduri remained 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. 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 ofZusduri was 72.2% (95% CI, 64.1%, 78.8%). Median follow-up time was 23.7 months after the three-month CR. The median duration of response had not yet been reached. In May 2026, we announced 36-month DOR data from the Phase 3 ENVISION trial. The 36-month DOR by Kaplan-Meier estimate for patients who achieved a CR at three months after the first instillation ofZusduriwas 64.5% (95% CI, 54.6%, 72.8%). Median follow-up time was 35.5 months after the three-month CR, and the median duration of response had not been reached.

Previous wording

Additionally, in July 2025 we announced outcomes from the five-year long-term extension study of the single-arm, Phase 2b OPTIMA II study. Among the 41 patients who achieved CR at three months post-treatment withZusduri in the OPTIMA II trial, 25 remained in CR at 12 months and 17 entered the long-term follow-up study. For the 41 patients achieving CR at three months, the median Kaplan-Meier estimate of DOR was 24.2 months (95% CI 9.7, 42.1) with a median follow-up of 35.8 months. For the 17 patients in the long-term follow-up study, the median DOR was 42.1 months by Kaplan-Meier estimate (95% CI: 24.2, NE), with a median follow-up of 50.4 months. Results of the long-term extension study were published online in the Journal of Clinical Genitourinary Cancer in July 2025*.*

Current wording

Additionally, in July 2025 we announced outcomes from the five-year long-term extension study of the single-arm, Phase 2b OPTIMA II study. Among the 41 patients who achieved CR at three months post-treatment withZusduri in the OPTIMA II trial, 25 remained in CR at 12 months and 17 entered the long-term follow-up study. For the 41 patients achieving CR at three months, the median Kaplan-Meier estimate of duration of response was 24.2 months (95% CI 9.7, 42.1) with a median follow-up of 35.8 months. For the 17 patients in the long-term follow-up study, the median duration of response was 42.1 months by Kaplan-Meier estimate (95% CI: 24.2, NE), with a median follow-up of 50.4 months. Results of the long-term extension study were published online in the Journal of Clinical Genitourinary Cancer in July 2025*.*

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 evaluating 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 was assessed by the CR rate at the three-month visit. Patients who had a CR at the three-month visit, defined as having no detectable disease in the bladder, entered 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. In November 2025 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 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.

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 evaluating 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 was assessed by the CR rate at the three-month visit. Patients who had a CR at the three-month visit, defined as having no detectable disease in the bladder, entered 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 achieving CR at three months. In November 2025, we reported a three-month CR rate of 77.8% (95% CI, 68.3%, 85.5%), and in May 2026 reported six-month DOR by Kaplan-Meier estimate of 94.5% (95% CI: 86.1%, 97.9%), consistent with results from the ENVISION clinical trial. The FDA 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 remain on track to submit an NDA for UGN-103 in the third quarter of 2026, with potential FDA approval in 2027.

Previous wording

In February 2025, we acquired ICVB-1042 (now known as UGN-501). UGN-501 is a potent and fast-replicating investigational next generation oncolytic virus being developed as a locally administered cancer treatment. IND-enabling studies are nearing completion, and we plan to submit an IND in the second quarter of 2026 and initiate a Phase 1 clinical trial in NMIBC by the end of 2026. Nonclinical data to date support the potential of UGN-501 to be a best-in-class oncolytic virus, with cytotoxic activity observed across a panel of bladder cancer cell lines representing a broad range of tumor stages and grades. The Phase 1 trial will initially evaluate aqueous intravesical administration of UGN-501, and we plan to evaluate delivery using our proprietary RTGel technology, which may enable prolonged dwell time and enhanced local activity. The initial focus is bladder cancer with the potential to expand into additional tumor types beyond the genitourinary system.

Current wording

In February 2025, we acquired ICVB-1042 (now known as UGN-501). UGN-501 is a potent and fast-replicating investigational next generation oncolytic virus being developed as a locally administered cancer treatment. Nonclinical data to date support the potential of UGN-501 to be a best-in-class oncolytic virus, with cytotoxic activity observed across a panel of bladder cancer cell lines representing a broad range of tumor stages and grades. In July 2026, we announced that the FDA had cleared our IND for UGN-501, enabling the initiation of a Phase 1 clinical trial in patients with NMIBC. The Phase 1 trial will initially evaluate aqueous intravesical administration of UGN-501, and we plan to subsequently evaluate delivery using our proprietaryRTGel technology, which may enable prolonged dwell time and enhanced local activity. The initial focus is bladder cancer with the potential to expand into additional tumor types beyond the genitourinary system. The Phase 1 study is expected to begin in the fourth quarter of 2026 and will evaluate the safety, tolerability, and feasibility of intravesical administration of UGN-501.

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 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 was completed. Safety and dosing data from the first arm evaluating UGN-301 as monotherapy were presented in late 2024.

Current wording

In March 2022, we announced FDA clearance of our IND to begin a novel Phase 1 clinical trial of UGN-301 in patients with recurrent NMIBC. 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 was completed. Safety and dosing data from the first arm evaluating UGN-301 as monotherapy were presented in late 2024.

Previous wording

While the Phase 1 clinical study of UGN-301 confirmed proof of concept for our proprietaryRTGel technology as a viable platform for local delivery of complex immunotherapies, UGN-301’s overall clinical profile did not meet our internal benchmarks for advancement to Phase 2. The program achieved key proof of concept objectives, including sustained bladder exposure with minimal systemic absorption and an acceptable safety and tolerability profile, demonstrating the ability to mitigate CTLA-4–related toxicities, and encouraging efficacy signals. These findings further reinforce the versatility and potential ofRTGel technology to enable localized delivery of immunotherapy candidates. We do not expect to incur significant additional costs related to this program going forward.

Current wording

While the Phase 1 clinical trial of UGN-301 confirmed proof of concept for our proprietaryRTGel technology as a viable platform for local delivery of complex immunotherapies, UGN-301’s overall clinical profile did not meet our internal benchmarks for advancement to Phase 2. The program achieved key proof of concept objectives, including sustained bladder exposure with minimal systemic absorption and an acceptable safety and tolerability profile, demonstrating the ability to mitigate CTLA-4–related toxicities, and encouraging efficacy signals. These findings further reinforce the versatility and potential ofRTGel technology to enable localized delivery of immunotherapy candidates. We do not expect to incur significant additional costs related to this program going forward.

Previous wording

On February 14, 2025 (the “Closing Date”), we entered into an asset purchase agreement (the “IconOVir Agreement”) with IconOVir Bio, Inc. (“IconOVir”), pursuant to which we purchased and acquired certain assets of IconOVir (the “Transferred Assets”), including UGN-501 (formerly ICVB-1042) and certain contracts, intellectual property rights, regulatory applications, submissions and registrations, and data and other rights related thereto, and assumed certain liabilities and obligations of IconOVir arising under certain contracts of IconOVir acquired by us.

Current wording

On February 14, 2025 (the “APA Closing Date”), we entered into an asset purchase agreement (the “IconOVir Agreement”) with IconOVir Bio, Inc. (“IconOVir”), pursuant to which we purchased and acquired certain assets of IconOVir (the “Transferred Assets”), including UGN-501 (formerly ICVB-1042) and certain contracts, intellectual property rights, regulatory applications, submissions and registrations, and data and other rights related thereto, and assumed certain liabilities and obligations of IconOVir arising under certain contracts of IconOVir acquired by us.

Previous wording

As consideration for the Transferred Assets and subject to the terms and conditions of the IconOVir Agreement, we (i) issued 374,843 of our ordinary shares to IconOVir, which represented a purchase price of $4.0 million divided by the volume-weighted average closing price of our ordinary shares on The Nasdaq Stock Market over the 30 consecutive trading days ending on (and including) the trading day immediately prior to the Closing Date, (ii) agreed to pay IconOVir a one-time payment of $15.0 million in cash upon the achievement of a cumulative aggregate worldwide net sales milestone for all products, including combination products, that incorporate or comprise ICVB-1042 (“ICVB Products”), (iii) agreed to pay IconOVir a low, single-digit percentage royalty, on an ICVB Product-by-ICVB Product basis, on the annual, worldwide net sales of such ICVB Product during the royalty term, subject to certain reductions as set forth in the IconOVir Agreement, and (iv) agreed to assume certain immaterial liabilities arising under certain acquired contracts.

Current wording

As consideration for the Transferred Assets and subject to the terms and conditions of the IconOVir Agreement, we (i) issued 374,843 of our ordinary shares to IconOVir, which represented a purchase price of $4.0 million divided by the volume-weighted average closing price of our ordinary shares on The Nasdaq Stock Market over the 30 consecutive trading days ending on (and including) the trading day immediately prior to the APA Closing Date, (ii) agreed to pay IconOVir a one-time payment of $15.0 million in cash upon the achievement of a cumulative aggregate worldwide net sales milestone for all products, including combination products, that incorporate or comprise ICVB-1042 (“ICVB Products”), (iii) agreed to pay IconOVir a low, single-digit percentage royalty, on an ICVB Product-by-ICVB Product basis, on the annual, worldwide net sales of such ICVB Product during the royalty term, subject to certain reductions as set forth in the IconOVir Agreement, and (iv) agreed to assume certain immaterial liabilities arising under certain acquired contracts.

Previous wording

Pursuant to the IconOVir Agreement, from the Closing Date until the earlier of the 10 th anniversary of the Closing Date and the first commercial sale of any ICVB Product in any jurisdiction, we agreed to use commercially reasonable efforts to develop and commercialize one ICVB Product. The IconOVir Agreement contains customary representations, warranties and covenants of the parties and also provides for customary indemnification rights of us and IconOVir related to breaches of certain representations, warranties and covenants of the other party and certain assumed liabilities or excluded liabilities and excluded assets, as applicable.

Current wording

Pursuant to the IconOVir Agreement, from the APA Closing Date until the earlier of the 10 th anniversary of the APA Closing Date and the first commercial sale of any ICVB Product in any jurisdiction, we agreed to use commercially reasonable efforts to develop and commercialize one ICVB Product. The IconOVir Agreement contains customary representations, warranties and covenants of the parties and also provides for customary indemnification rights of us and IconOVir related to breaches of certain representations, warranties and covenants of the other party and certain assumed liabilities or excluded liabilities and excluded assets, as applicable.

Previous wording

During the three months ended March 31, 2026 and 2025 we recognized $51.0 million and $20.3 million of revenue, respectively, from sales of our products.

Current wording

During the three and six months ended June 30, 2026, we recognized $72.5 million and $123.4 million of revenue, respectively, from sales of our products.

Previous wording

We are currently focused on advancing our product candidates, and our future research and development expenses will depend on their clinical success. Research and development expenses will continue to be significant.

Current wording

Our future research and development expenses will depend on the clinical success of our product candidates. As we continue to focus on advancing our product candidates, we expect research and development expenses to continue to be significant.

Previous wording

Revenue was $51.0 million and $20.3 million for the three months ended March 31, 2026 and 2025, respectively. The increase in revenue of $30.7 million primarily reflects the volume of sales ofZusduri, which was launched late in the second quarter of 2025.

Current wording

Revenue was $72.5 million and $24.2 million for the three months ended June 30, 2026 and 2025, respectively. The increase in revenue of $48.3 million primarily reflects the volume of sales ofZusduri, which was launched late in the second quarter of 2025.

Previous wording

Cost of revenue was $4.1 million and $2.3 million for the three months ended March 31, 2026 and 2025, respectively. The increase in cost of revenue of $1.8 million is primarily attributable to increased sales volumes, partially offset given that 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 favorably impact cost of revenue through approximately 2027 as we depleteZusduriinventories that we expensed prior to receiving FDA approval.

Current wording

Cost of revenue was $6.6 million and $3.6 million for the three months ended June 30, 2026 and 2025, respectively. The increase in cost of revenue of $3.0 million is primarily attributable to increased sales volumes, partially offset given that 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 favorably impact cost of revenue into early 2027 as we depleteZusduriinventories that we expensed prior to receiving FDA approval.

Previous wording

Selling and marketing expenses were $32.1 million and $22.1 million for the three months ended March 31, 2026 and 2025, respectively. The increase in selling and marketing expenses of $10.0 million is primarily attributable toZusduricommercial activities, including expansion of the sales force and higher brand marketing expenses, as well as an increase in overall commercial operation costs.

Current wording

Selling and marketing expenses were $32.9 million and $27.9 million for the three months ended June 30, 2026 and 2025, respectively. The increase in selling and marketing expenses of $5.0 million is primarily attributable toZusduricommercial activities, including expansion of the sales force and higher brand marketing expenses, as well as an increase in overall commercial operation costs.

Previous wording

Interest and other income, net was $0.6 million and $2.1 million for the three months ended March 31, 2026 and 2025, 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 $0.6 million and $1.3 million for the three months ended June 30, 2026 and 2025, respectively. The decrease in interest and other income, net was primarily due to lower cash and investment balances.

Previous wording

Research and development expenses were $15.6 million and $19.9 million for the three months ended March 31, 2026 and 2025, respectively. The decrease in research and development expenses of $4.3 million is primarily attributable to the acquisition of UGN-501 in the first quarter of 2025, as well as the costs related to manufacturing ofZusduri which were recognized as research and development expenses in the first quarter of 2025 prior to receiving FDA approval in June 2025.

Current wording

Research and development expenses were $32.9 million and $38.8 million for the six months ended June 30, 2026 and 2025, respectively. The decrease in research and development expenses of $5.9 million is primarily attributable to the acquisition of UGN-501 in the first quarter of 2025, as well as the costs related to manufacturing ofZusduri which were recognized as research and development expenses in the first quarter of 2025 prior to receiving FDA approval in June 2025.

Previous wording

General andadministrative expenses were $19.4 million and $12.8 million for the three months ended March 31, 2026 and 2025, respectively. The increase in general and administrative expenses of $6.6 million is primarily attributable to higher compensation expenses, increased spending on third-party advisory services, including fees recognized in the first quarter of 2026 associated with the debt refinancing.

Current wording

General andadministrative expenses were $34.9 million and $28.2 million for thesix months ended June 30, 2026 and 2025, respectively. The increase in general and administrative expenses of $6.7 million is primarily attributable to higher compensation expenses, increased spending on third-party advisory services, including fees recognized in the first quarter of 2026 associated with the debt refinancing.

Previous wording

Interest expense was $4.2 million and $4.1 million for the three months ended March 31, 2026 and 2025, respectively. The increase in interest expense was primarily attributable to the additional borrowings of $75.0 million in the first quarter of 2026 in connection with the Pharmakon refinancing of long-term debt, offset by a lower interest rate.

Current wording

Interest expense was $9.1 million and $8.2 million for the six months ended June 30, 2026 and 2025, respectively. The increase in interest expense was primarily attributable to the additional borrowings of $75.0 million in the first quarter of 2026 in connection with the Pharmakon refinancing of long-term debt, partially offset by a lower interest rate.

Previous wording

As of March 31, 2026, we had $140.3 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 June 30, 2026, we had $108.0 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

On March 13, 2024, we entered into an amended and restated loan agreement, which replaced the 2022 Loan Agreement, with Pharmakon for an additional third and fourth tranche of senior secured loan (the "2024 Loan Agreement"). 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. Under the 2024 Loan Agreement, prior to the refinancing described in the immediately following paragraph, all outstanding loans accrued interest using a benchmark rate of three-month SOFR plus 7.25% plus an additional adjustment of 0.26161%.

Current wording

On March 13, 2024, we entered into an amended and restated loan agreement with Pharmakon, which replaced the 2022 Loan Agreement, for an additional third and fourth tranche of senior secured loan (the "2024 Loan Agreement"). 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. Under the 2024 Loan Agreement, prior to the refinancing described in the immediately following paragraph, all outstanding loans accrued interest using a benchmark rate of three-month SOFR plus 7.25% plus an additional adjustment of 0.26161%.

Previous wording

On February 26, 2026 (the "Closing Date"), we entered into a second amended and restated loan agreement, which replaced the 2024 Loan Agreement, with Pharmakon providing for a senior secured term loan facility of up to $250.0 million, consisting of two tranches (the "2026 Loan Agreement"). The first tranche of $200.0 million was advanced on the Closing Date and refinanced our term loan facility under the 2024 Loan Agreement which had $125.0 million of outstanding principal, with the remaining proceeds available for general corporate purposes and working capital. The second tranche of $50.0 million may, at our option, be requested no later than June 30, 2027 for funding to occur no later than August 29, 2027, subject to customary conditions. The term loans mature on the fifth anniversary of the Closing Date.

Current wording

On February 26, 2026 (the "Closing Date"), we entered into a second amended and restated loan agreement with Pharmakon, which replaced the 2024 Loan Agreement, providing for a senior secured term loan facility of up to $250.0 million, consisting of two tranches (the "2026 Loan Agreement"). The first tranche of $200.0 million was advanced on the Closing Date and refinanced our term loan facility under the 2024 Loan Agreement which had $125.0 million of outstanding principal, with the remaining proceeds available for general corporate purposes and working capital. The second tranche of $50.0 million may, at our option, be requested no later than June 30, 2027 for funding to occur no later than August 29, 2027, subject to customary conditions. The term loans mature on the fifth anniversary of the Closing Date.

Previous wording

We have incurred losses since our inception and negative cash flows from our operations, and as of March 31, 2026, we had an accumulated deficit of $983.3 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 June 30, 2026, we had an accumulated deficit of $997.6 million. 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

The total obligation for future minimum lease payments under our operating and finance leases are $3.9 million and $5.5 million, respectively, as of March 31, 2026. 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 $3.8 million and $5.3 million, respectively, as of June 30, 2026. See Note 11 to the condensed consolidated financial statements appearing elsewhere in this Quarterly Report for further information.

Previous wording

Net cash used in operating activities was $45.3 million during the three months ended March 31, 2026, compared to $42.0 million during the three months ended March 31, 2025. The $3.3 million increase was attributable primarily to timing of collections of accounts receivables, inventory purchases, and timing of payments and accruals, partially offset by lower net loss in the first quarter of 2026.

Current wording

Net cash used in operating activities was $78.3 million during the six months ended June 30, 2026, compared to $81.8 million during the six months ended June 30, 2025. The $3.5 million decrease was attributable primarily to a lower net loss in 2026 as compared to 2025, as well as timing of payments and accruals, partially offset by the timing of collections of accounts receivable and inventory purchases.

Previous wording

Net cash used in investing activities was $20.7 million during the three months ended March 31, 2026, compared to $26.0 million during the three months ended March 31, 2025. The net change of $5.3 million primarily reflects lower reinvestments in marketable securities in the first quarter of 2026 as compared to the first quarter of 2025.

Current wording

Net cash used in investing activities was $19.0 million during the six months ended June 30, 2026, compared to cash provided by investing activities of $2.4 million during the six months ended June 30, 2025. The net change of $21.4 million primarily reflects reinvestments in marketable securities in the six months ended June 30, 2026 as compared to 2025.

Previous wording

Net cash provided by financing activities was $65.2 million during the three months ended March 31, 2026, compared to $34 thousand during the three months ended March 31, 2025. The increase of $65.2 million is primarily attributable to proceeds from the 2026 Loan Agreement with Pharmakon in the first quarter of 2026.

Current wording

Net cash provided by financing activities was $65.7 million during the six months ended June 30, 2026, compared to $0.3 million during the six months ended June 30, 2025. The increase of $65.4 million is primarily attributable to proceeds from the 2026 Loan Agreement with Pharmakon in the first quarter of 2026.