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 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 of 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 have 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 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.

Current wording

In October 2026, we announced the publication of final results from the five-year long-term follow-up study of UroGen’s Phase 3 Olympus trial. Among patients who achieved a CR following primary chemoablation withJelmyto (n=41), the median duration of response was 47.8 months, with a median follow-up of 28.1 months (95% CI: 13.1, 60.1). Of the 20 patients who entered the long-term follow-up study, 75% (15/20) remained event-free as of March 2025, with a median follow-up of 53.3 months (95% CI: 27.9, 72.8). Among these patients, the median duration of response was not estimable (95% CI: 43.5, not estimable) due to the low event rate. No progression to high-grade disease was observed during extended follow-up. The final study results were published in the October 2026 issue of theTherapeutic Advances in Urology.

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 aJelmyto service line. In addition, our organization includes 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 160 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 directors, who are supported by regional operations managers. 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 aJelmyto service line. In addition, our organization includes 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 160 colleagues.

Previous wording

In July 2026, we announced that we received a Notice of Allowance from the U.S. Patent and Trademark Office for a new U.S. patent covering methods of treating recurrent low-grade intermediate risk NMIBC without TURBT, supported by data from the ENVISION and ATLAS clinical trials. Once issued, the patent is expected to provide protection into July 2044, further strengthening the intellectual property supportingZusduriand UGN-103, if approved, and reinforcing the long-term commercial opportunity for both products.

Current wording

In July 2026, we announced that we received a Notice of Allowance from the U.S. Patent and Trademark Office for a new U.S. patent covering methods of treating recurrent low-grade intermediate risk NMIBC without TURBT, supported by data from the ENVISION and ATLAS clinical trials. This patent, which was subsequently issued in September 2026 and listed in the FDA's Orange Book, is expected to provide coverage into July 2044, further strengthening the intellectual property supportingZusduriand UGN-103, and reinforcing the long-term commercial opportunity for both products.

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 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.

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. In August 2026, we submitted an NDA for UGN-103 for the treatment of adults with recurrent low-grade intermediate risk NMIBC supported by the clinical data from the ongoing Phase 3 UTOPIA trial, and in October 2026, we announced the FDA's acceptance of the NDA and the assignment of a Prescription Drug User Fee Act ("PDUFA") target action date of June 14, 2027.

Previous wording

In February 2025, the FDA accepted our IND for UGN-104, and we initiated a Phase 3 trial of UGN-104 in low-grade UTUC in June 2025. We expect to complete enrollment in the Phase 3 trial of UGN-104 by the end of 2026.

Current wording

In February 2025, the FDA accepted our IND for UGN-104, and we initiated a Phase 3 trial of UGN-104 in low-grade UTUC in June 2025. We expect to complete enrollment in the Phase 3 trial of UGN-104 by the end of 2026 or in early 2027.

Previous wording

Our pipeline also includes UGN-501, our investigational next-generation oncolytic virus therapy being developed as a locally administered treatment for cancer, for which we plan to initiate a Phase 1 clinical trial in NMIBC by the end of 2026.

Current wording

Our pipeline also includes UGN-501, our investigational next-generation oncolytic virus therapy being developed as a locally administered treatment for cancer, for which we have initiated a Phase 1 clinical trial in NMIBC. In parallel with the Phase 1 study, we are conducting nonclinical studies exploring the formulation of UGN-501 in our proprietaryRTGel technology, which may enable prolonged dwell time and enhanced local activity. While UGN-501 is initially being developed for bladder cancer, we believe UGN-501's underlying properties may have broader applicability across additional solid tumor indications beyond the genitourinary system.

Previous wording

High-grade NMIBC is a highly aggressive form of bladder cancer. TURBT followed by adjuvant intravesical immunotherapy with Bacillus of Calmette and Guerin ("BCG") is the current standard of care therapy for high-grade NMIBC. However, the high rates of recurrence and significant risk of progression to muscle-invasive tumors are particularly dangerous. Radical cystectomy, or bladder removal is strongly advocated in patients with BCG-unresponsive NMIBC (i.e., patients with BCG-refractory and BCG-relapsing tumors in whom further BCG therapy is not recommended) or for patients who cannot tolerate BCG.

Current wording

High-grade NMIBC is a highly aggressive form of bladder cancer. TURBT followed by adjuvant intravesical immunotherapy with BCG is the current standard of care therapy for high-grade NMIBC. However, the high rates of recurrence and significant risk of progression to muscle-invasive tumors are particularly dangerous. Radical cystectomy, or bladder removal is strongly advocated in patients with BCG-unresponsive NMIBC (i.e., patients with BCG-refractory and BCG-relapsing tumors in whom further BCG therapy is not recommended) or for patients who cannot tolerate BCG.

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. 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.

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. We believe UGN-501's differentiated mechanism of action and local administration strategy may offer a promising new approach for addressing this unmet need. 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. In November 2026, we announced the first patient dosed in the Phase 1 study.

Previous wording

In November 2025, we made the decision to discontinue development of UGN-301 based on our strategic priorities and provided Agenus, Inc. ("Agenus") notice of termination of the license agreement. 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.

Current wording

In November 2025, we made the decision to discontinue development of UGN-301 based on our strategic priorities and provided notice to Agenus, Inc. ("Agenus") of termination of the license agreement. 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

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.

Current wording

Pursuant to the IconOVir Agreement, from the APA Closing Date until the earlier of the tenth 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 and six months ended June 30, 2026, we recognized $72.5 million and $123.4 million of revenue, respectively, from sales of our products.

Current wording

During the three and nine months ended September 30, 2026, we recognized $89.0 million and $212.4 million of revenue, respectively, from sales of our products.

Previous wording

License fees and development milestone payments related to in-licensed products and technology are expensed as incurred, or achieved in the case of milestones, if it is determined at that point that they have no established alternative future use.

Current wording

License fees and development milestone payments related to in-licensed products and technology are expensed as incurred, or probable of being achieved in the case of milestones, if it is determined at that point that they have no established alternative future use.

Previous wording

We have yet to generate taxable income in Israel. We have historically incurred operating losses resulting in carry forward tax losses totaling approximately $626.7 million as of December 31, 2025. We anticipate that we will continue to generate tax losses and that we will be able to carry forward these tax losses indefinitely to future taxable years. Accordingly, we do not expect to pay taxes in Israel until we have taxable income after the full utilization of our carry forward tax losses. We have provided a full valuation allowance with respect to the deferred tax assets related to these carry forward losses. Income tax expense also consists of our estimate of uncertain tax positions, and related interest and penalties. See Note 17 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report for further information.

Current wording

We have yet to generate taxable income in Israel. We have historically incurred operating losses resulting in carry forward tax losses totaling approximately $626.7 million as of December 31, 2025. We anticipate that we will continue to generate tax losses and that we will be able to carry forward these tax losses indefinitely to future taxable years. Accordingly, we do not expect to pay taxes in Israel until we have taxable income after the full utilization of our carry forward tax losses. We have provided a full valuation allowance with respect to the deferred tax assets related to these carry forward losses. Income tax expense also consists of our estimate of uncertain tax positions, and related interest and penalties. We believe that there is a reasonable possibility that sufficient positive evidence may become available in the near term to allow us to reach a conclusion that a potentially significant portion of the valuation allowance will no longer be needed. See Note 17 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report for further information.

Previous 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.

Current wording

Revenue was $89.0 million and $27.5 million for the three months ended September 30, 2026 and 2025, respectively. The increase in revenue of $61.5 million primarily reflects the volume of sales ofZusduri, which was launched late in the second quarter of 2025.

Previous 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.

Current wording

Cost of revenue was $7.5 million and $3.3 million for the three months ended September 30, 2026 and 2025, respectively. The increase in cost of revenue of $4.2 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 $32.9 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.

Current wording

Selling and marketing expenses were $30.9 million and $23.7 million for the three months ended September 30, 2026 and 2025, respectively. The increase in selling and marketing expenses of $7.2 million is primarily attributable toZusduricommercial activities, including higher brand marketing expenses, commercial personnel-related costs, as well as an increase in overall commercial operations costs.

Previous wording

General andadministrative expenses were $15.5 million and $15.3 million for the three months ended June 30, 2026 and 2025, respectively. The increase in general and administrative expenses of $0.2 million is primarily attributable to slightly higher spending on third-party advisory services.

Current wording

General andadministrative expenses were $16.3 million and $13.9 million for the three months ended September 30, 2026 and 2025, respectively. The increase in general and administrative expenses of $2.4 million is primarily attributable to higher personnel-related costs, partially offset by lower legal costs.

Previous wording

Interest expense was $4.9 million and $4.1 million for the three 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 connection with the Pharmakon refinancing of long-term debt in 2026, partially offset by a lower interest rate.

Current wording

Interest expense was $4.8 million and $3.4 million for the three months ended September 30, 2026 and 2025, respectively. The increase in interest expense was primarily attributable to the additional borrowings of $75.0 million in connection with the Pharmakon refinancing of long-term debt in 2026, partially offset by a lower interest rate.

Previous 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.

Current wording

Interest and other income, net was $0.6 million and $1.0 million for the three months ended September 30, 2026 and 2025, 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, 2026 and 2025.

Current wording

The following table sets forth our results of operations for the nine months ended September 30, 2026 and 2025.

Previous wording

Revenue was $123.4 million and $44.5 million for the six months ended June 30, 2026 and 2025, respectively. The increase in revenue of $78.9 million primarily reflects the volume of sales ofZusduri, which was launched late in the second quarter of 2025.

Current wording

Revenue was $212.4 million and $72.0 million for the nine months ended September 30, 2026 and 2025, respectively. The increase in revenue of $140.4 million primarily reflects the volume of sales ofZusduri, which was launched late in the second quarter of 2025.

Previous wording

Cost of revenue was $10.7 million and $5.9 million for the six months ended June 30, 2026 and 2025, respectively. The increase in cost of revenue of $4.8 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 into early 2027 as we depleteZusduriinventories that we expensed prior to receiving FDA approval.

Current wording

Cost of revenue was $18.2 million and $9.2 million for the nine months ended September 30, 2026 and 2025, respectively. The increase in cost of revenue of $9.0 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

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.

Current wording

Research and development expenses were $58.9 million and $52.8 million for the nine months ended September 30, 2026 and 2025, respectively. The increase in research and development expenses of $6.1 million is primarily attributable to increased clinical development costs related to UGN-103 and UGN-104, the PDUFA fee related to the submission of the UGN-103 NDA and increased development costs related to UGN-501, partially offset by 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

Selling and marketing expenses were $65.1 million and $50.0 million for thesix months ended June 30, 2026 and 2025, respectively. The increase in selling and marketing expenses of $15.1 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 $96.0 million and $73.7 million for thenine months ended September 30, 2026 and 2025, respectively. The increase in selling and marketing expenses of $22.3 million is primarily attributable toZusduricommercial activities, including expansion of the sales force and higher brand marketing expenses, commercial personnel-related costs, as well as an increase in overall commercial operations costs.

Previous 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.

Current wording

General andadministrative expenses were $51.2 million and $42.1 million for thenine months ended September 30, 2026 and 2025, respectively. The increase in general and administrative expenses of $9.1 million is primarily attributable to higher compensation expenses, and increased spending on third-party advisory services, including fees recognized in the first quarter of 2026 associated with the debt refinancing.

Previous wording

Financing on prepaid forward obligation was $9.1 million and $9.2 million for the six months ended June 30, 2026 and 2025, 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 $0.1 million was driven primarily by changes in underlying assumptions for remeasuring the effective rate.

Current wording

Financing on prepaid forward obligation was $13.6 million and $13.8 million for the nine months ended September 30, 2026 and 2025, 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 $0.2 million was driven primarily by changes in underlying assumptions for remeasuring the effective rate.

Previous 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.

Current wording

Interest expense was $13.9 million and $11.6 million for the nine months ended September 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

Interest and other income, net was $1.2 million and $3.4 million for the six 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.

Current wording

Interest and other income, net was $1.8 million and $4.4 million for the nine months ended September 30, 2026 and 2025, respectively. The decrease in interest and other income, net was primarily due to lower cash and investment balances.

Previous 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.

Current wording

As of September 30, 2026, we had $90.5 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

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.

Current wording

We have historically incurred losses since our inception and negative cash flows from our operations, and as of September 30, 2026, we had an accumulated deficit of $999.1 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

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.

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, for a lease term of 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 $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.

Current wording

The total obligation for future minimum lease payments under our operating and finance leases is $3.6 million and $4.9 million, respectively, as of September 30, 2026. See Note 11 to the condensed consolidated financial statements appearing elsewhere in this Quarterly Report for further information.

Previous wording

On February 14, 2025, we entered into the IconOVir Agreement pursuant to which we purchased and acquired the Transferred Assets. 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 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

On February 14, 2025, we entered into the IconOVir Agreement pursuant to which we purchased and acquired the Transferred Assets. 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 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

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.

Current wording

Net cash used in operating activities was $93.5 million during the nine months ended September 30, 2026, compared to $124.1 million during the nine months ended September 30, 2025. The $30.6 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 $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.

Current wording

Net cash provided by investing activities was $0.8 million during the nine months ended September 30, 2026, compared to $33.8 million during the nine months ended September 30, 2025. The decrease of $33.0 million primarily reflects larger maturities of marketable securities relative to the reinvestment of marketable securities in the prior year as compared to the nine months ended September 30, 2026.

Previous 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.

Current wording

Net cash provided by financing activities was $67.5 million during the nine months ended September 30, 2026, compared to $8.6 million during the nine months ended September 30, 2025. The increase of $58.9 million is primarily attributable to proceeds from the 2026 Loan Agreement with Pharmakon in the first quarter of 2026.