5 unchanged sentences
We may require additional financing to fund our operations and achieve our goals, and a failure to obtain this capital when needed and on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development, commercialization efforts or other operations.
+Added: Our indebtedness resulting from our loan agreement with Pharmakon Advisors, L.P.
+Added: ("Pharmakon") could adversely affect our financial condition or restrict our future operations.
We are highly dependent on the successful commercialization of our approved products, Jelmyto and Zusduri .
6 unchanged sentences
If our collaboration and licensing arrangements are not successful, we may not be able to capitalize on the market potential of these products and product candidates.
−Removed: We currently rely on third-party subcontractors and single-source suppliers for certain raw materials, compounds and components necessary to produce Jelmyto and Zusduri for commercial use, and to produce and administer UGN-103, UGN-104 and UGN-501 for nonclinical studies and clinical trials, and expect to continue to do so to support commercial scale production of UGN-103, UGN-104 and UGN-501, if approved, or for any approved products that include UGN-501.
+Added: We currently rely on third-party subcontractors and single-source suppliers for certain raw materials, compounds and components necessary to produce Jelmyto and Zusduri for commercial use, and to produce UGN-103, UGN-104 and UGN-501 for nonclinical studies and clinical trials, and expect to continue to do so to support commercial scale production of UGN-103, UGN-104 and UGN-501, if approved, or for any approved products that include UGN-501.
There are significant risks associated with the manufacture of pharmaceutical products and contracting with contract manufacturers, including single-source suppliers.
4 unchanged sentences
If we fail to attract and keep senior management and key personnel, we may be unable to successfully develop our product candidates, conduct our clinical trials and commercialize any of the products we develop.
−Removed: We have incurred significant losses and negative cash flows since our inception, and we anticipate that we will continue to incur losses and negative cash flows as we execute on our strategy and may not generate positive or sufficient cash flows from operations in the future, which may have an adverse impact on our working capital, total assets, stockholders’ equity and our ability to service our indebtedness and commitments.
−Removed: Our indebtedness resulting from our loan agreement with Pharmakon Advisors, L.P.
−Removed: ("Pharmakon") could adversely affect our financial condition or restrict our future operations.
+Added: We have incurred significant losses and negative cash flows since our inception and may not generate positive or sufficient cash flows from operations in the future, which may have an adverse impact on our working capital, total assets, stockholders’ equity and our ability to service our indebtedness and commitments.
If our efforts to obtain, protect or enforce our patents and other intellectual property rights related to Jelmyto , Zusduri , and our product candidates and technologies are not adequate, we may not be able to compete effectively, and we otherwise may be harmed.
We may become involved in lawsuits to protect or enforce our patents or other intellectual property rights or the patents of our licensors, which could be expensive and time consuming.
−Removed: If the FDA concludes that the requirements for our relevant product candidates are not as we expect, the approval pathway for these product candidates will likely take significantly longer, cost significantly more and entail significantly greater complications and risks than anticipated, and in either case may not be successful.
We expect current and future legislation affecting the healthcare industry, including healthcare reform, to impact our business generally and to increase limitations on reimbursement, rebates and other payments, which could adversely affect third-party coverage of our products, our operations, and/or how much or under what circumstances healthcare providers will prescribe or administer our products and product candidates, if approved.
10 unchanged sentences
Risks Related to Our Financial Condition and Capital Requirements
−Removed: We have incurred significant losses and negative cash flows since our inception, and we anticipate that we will continue to incur losses and negative cash flows as we execute on our strategy and may not generate positive or sufficient cash flows from operations in the future, which may have an adverse impact on our working capital, total assets, stockholders’ equity and our ability to service our indebtedness and commitments.
+Added: We have incurred significant losses and negative cash flows since our inception and may not generate positive or sufficient cash flows from operations in the future, which may have an adverse impact on our working capital, total assets, stockholders’ equity and our ability to service our indebtedness and commitments.
We are not profitable and have incurred net losses in each period since we commenced operations in 2004, including net losses of $153.5 million and $126.9 million for the years ended December 31, 2025 and 2024, respectively.
−Removed: As of March 31, 2026, we had an accumulated deficit of $983.3 million.
−Removed: We expect to continue to incur losses and negative cash flows as we execute our strategy, including the ongoing commercial launch of Zusduri , the continued commercialization of Jelmyto , and engaging in further product development activities.
+Added: As of June 30, 2026, we had an accumulated deficit of $997.6 million.
Our ability to ultimately achieve and sustain recurring revenues and profitability is dependent upon our ability to successfully commercialize our products and complete the development of our product candidates and obtain necessary regulatory approvals for and successfully manufacture, market and commercialize our product candidates, if approved.
27 unchanged sentences
Since our inception, almost all our resources have been dedicated to the nonclinical and clinical development of our commercial products Jelmyto and Zusduri .
−Removed: As of March 31, 2026, we had cash and cash equivalents and marketable securities of $140.3 million.
+Added: As of June 30, 2026, we had cash and cash equivalents and marketable securities of $108.0 million.
To fund our operations, develop our product candidates and commercialize Jelmyto and Zusduri , we have relied primarily on equity and debt financings and revenue generated from sales of our approved products.
1 unchanged sentence
In November 2025, we amended the ATM Sales Agreement to remove the aggregate offering price limit of $100.0 million and filed a registration statement on Form S-3 providing for the offer and sale of ordinary shares pursuant to the ATM Sales Agreement having an aggregate offering price of up to $75.0 million, which became effective automatically (the “ATM Prospectus”).
−Removed: As of March 31, 2026, the remaining capacity under the ATM Prospectus was approximately $42.4 million.
+Added: As of June 30, 2026, the remaining capacity under the ATM Prospectus was approximately $42.4 million.
In March 2021, we announced a transaction (the "RTW Transaction") with RTW Investments ("RTW") totaling $75 million in funding for our company, which was received in May 2021, to support the launch of Jelmyto and the development of Zusduri .
3 unchanged sentences
The first tranche of $75.0 million ($72.6 million of proceeds were received, $70.8 million net of additional transaction costs) was funded in March 2022, and the second tranche of $25.0 million was funded in December 2022.
−Removed: 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").
+Added: 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.
124 unchanged sentences
Additionally, the potentially addressable patient population for our product candidates may be limited or may not be amenable to treatment with our product candidates.
−Removed: For instance, our pivotal Phase 3 clinical trial for Jelmyto was designed to evaluate the use of Jelmyto for the treatment of tumors in the renal pelvis (the funnel-like dilated part of the ureter in the kidney) and was not designed to evaluate the use of Jelmyto for the treatment of tumors in the ureter (the tube that connects the kidneys to the bladder).
−Removed: Even though Jelmyto is approved for the treatment of low-grade UTUC, some physicians have chosen, and physicians may choose in the future, to only use it to treat tumors in the renal pelvis and not tumors in the ureter, which would limit the degree of physician adoption and market acceptance of Jelmyto .
−Removed: Even if we obtain significant market share, because the potential target populations are small, we may never achieve profitability without obtaining regulatory approval for additional indications, including the use of the products as first- or second-line therapy.
−Removed: For example, low-grade UTUC is a rare malignant tumor of the cells lining the urinary tract and there is limited scientific literature or other research on the incidence and prevalence of low-grade UTUC.
−Removed: If our estimates of the incidence and prevalence of low-grade UTUC are incorrect, Jelmyto ’s commercial viability may prove to be limited, which may negatively affect our financial results.
Jelmyto, Zusduri and any of our product candidates that receive regulatory approval may fail to achieve the broad degree of physician adoption and use and market acceptance necessary for commercial success.
24 unchanged sentences
We are also aware there are companies among this list conducting clinical trials in various phases in the same indications in which we are developing products.
−Removed: In addition, we received from Teva a Paragraph IV Certification Notice Letter in February 2024, providing notification that Teva has submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of Jelmyto .
−Removed: See Part II, Item 1.
−Removed: “Legal Proceedings” for additional discussion.
If we are unable to maintain patent protection for Jelmyto, Jelmyto may be subject to immediate competition from FDA-approved generic entrants after orphan drug exclusivity for Jelmyto expires in April 2027.
51 unchanged sentences
the FDA’s determination of safety and efficacy of our product candidates;
−Removed: the FDA’s determination that the Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act ("FDCA") regulatory pathway (“505(b)(2)”) is available for our product candidates;
the prevalence and severity of adverse events associated with our product candidates;
213 unchanged sentences
Because there are a limited number of suppliers for the raw materials that we use to manufacture our products and product candidates, we may need to engage alternate suppliers to prevent a possible disruption of the manufacture of the materials necessary to produce Jelmyto and Zusduri for commercial sale and our product candidates for our clinical trials and their subsequent commercial sale, if approved.
−Removed: Even if we are able to engage alternate suppliers on reasonable terms, we may face delays or increased costs in our supply chain that could jeopardize the commercialization of Jelmyto and Zusduri .
+Added: Even if we are able to engage alternate suppliers on reasonable terms, we may face delays or increased costs in our supply chain that could jeopardize the commercialization of Jelmyto and Zusduri or any other approved products.
We do not have any control over the availability of these compounds and components beyond our existing contractual arrangements.
If we or our suppliers and manufacturers are unable to purchase these raw materials on acceptable terms, at sufficient quality levels, or in adequate quantities, if at all, the development and commercialization of our product candidates or any future product candidates, would be delayed or there would be a shortage in supply, which would impair our ability to meet our development objectives for our product candidates or generate revenues from the sale of Jelmyto and Zusduri or any other approved products.
+Added: Pursuant to our April 2026 supply agreement with TAPI NL B.V.
+Added: ("TAPI"), we agreed to purchase from TAPI a specified, significant percentage of our commercial requirements for the mitomycin needed for our commercial products.
+Added: If TAPI is unwilling or unable to supply us with our commercial requirements for mitomycin on a timely basis, we may source a qualified alternative mitomycin material from a third-party supplier for the affected shortfall quantities, subject to certain limitations set forth in the agreement.
+Added: However, TAPI is currently our sole supplier of the mitomycin in our two commercial products, and there is substantial uncertainty as to whether we would be able to source qualified alternative mitomycin material from a third-party supplier on a timely basis.
+Added: Accordingly, we are heavily dependent on TAPI for our commercial mitomycin requirements.
We expect to continue to rely on these or other subcontractors and suppliers to support our commercial requirements for Jelmyto, Zusduri , and any of our product candidates if approved for marketing by the FDA or foreign regulatory authorities.
60 unchanged sentences
In addition, tariffs and other trade developments have and may continue to heighten the risks related to the other risk factors described elsewhere in this Quarterly Report.
−Removed: Failure to obtain marketing approval in international jurisdictions would prevent our approved products, Jelmyto and Zusduri, and our product candidates from being marketed abroad.
+Added: Failure to obtain marketing approval in international jurisdictions would prevent our U.S.
+Added: approved products, Jelmyto and Zusduri, and our product candidates from being marketed abroad.*
In order to market and sell our products in the European Union and other jurisdictions, we or our third-party collaborators must obtain separate marketing approvals and comply with numerous and varying regulatory requirements.
43 unchanged sentences
If we fail to manage our growth effectively, our business could be disrupted.*
−Removed: As of March 31, 2026, we had 298 employees, of whom 40 are based in Israel and 258 are based in the United States.
+Added: As of June 30, 2026, we had 300 employees, of whom 40 are based in Israel and 260 are based in the United States.
We will need to continue to expand our development, quality, managerial, operational, finance, marketing, sales and other resources to manage our operations and clinical trials, continue our development activities and commercialize our products and product candidates, if approved.
63 unchanged sentences
During times of war and other major conflicts, we and the third parties with whom we work may be vulnerable to a heightened risk of these attacks, including retaliatory cyberattacks, that could materially disrupt our systems and operations, supply chain, and ability to produce, sell and distribute our goods and services.
−Removed: For example, we have operations and third parties with whom we work to support our business located in regions experiencing (or expected to experience) geopolitical or other conflicts, including in the Middle East, where businesses have experienced an increase in cyberattacks since the start of the Israel-Hamas conflict.
+Added: For example, we have operations and third parties with whom we work to support our business located in regions experiencing (or expected to experience) geopolitical or other conflicts, including in the Middle East, where businesses have experienced an increase in cyberattacks since the start of the Israel-Hamas conflict in October 2023.
We and the third parties with whom we work are subject to a variety of evolving threats, including, but not limited to, social engineering attacks (including through deep fakes, which may be increasingly more difficult to identify as fake, and phishing attacks), malicious code (such as viruses and worms), malware (including as a result of advanced persistent threat intrusions), denial-of-service attacks, credential stuffing attacks, credential harvesting, personnel misconduct or error, ransomware attacks, supply-chain attacks, software bugs, server malfunctions, software or hardware failures, loss of data or other information technology assets, adware, telecommunications failures, earthquakes, fires, floods, attacks enhanced or facilitated by generative artificial intelligence (“AI”), and other similar threats.
140 unchanged sentences
We rely upon a combination of patents, trade secret protection and confidentiality agreements, assignment of invention agreements and other contractual arrangements to protect the intellectual property related to, among other things, hydrogel-based pharmaceutical compositions for optimal delivery of a drug in internal cavities such as the bladder, the method for treating cancer, in particular urothelial and bladder cancer using hydrogel-based compositions, the method for treating overactive bladder topically without the need for injections, including an in-dwelling ureter catheter system for optimal delivery of a drug into the renal cavity.
−Removed: We seek patent protection for our product candidates, and we hold a broad collection of intellectual property comprised of issued patents, in-licensed patents, pending patent applications, trade secrets and trademarks covering our proprietary RTGel technology, the pharmaceutical compositions, methods of use and manufacturing aspects of our product candidates.
−Removed: In the United States, we currently own, co-own or exclusively license 32 patents that are directed to protect our approved products, Jelmyto and Zusduri , as well as UGN-103 and UGN-104, our proprietary RTGel technology, local compositions comprising different active ingredients, including, among others, compositions comprising UGN-501 and our potential product candidates that are under company research.
−Removed: These IP rights relate to certain aspects of cancer treatment.
−Removed: These issued patents are set to expire between 2030 and 2044.
−Removed: In total, our owned IP portfolio includes 61 granted patents worldwide and 19 pending patent applications filed in the United States, Europe, Israel, Japan, Canada, China, Australia, and Korea.
−Removed: When combined with exclusively licensed assets, the total includes approximately 115 granted patents and 54 pending applications worldwide.
−Removed: These patents and applications are directed to methods, systems, and compositions for the localized treatment of cancer via intravesical administration, including various active ingredients and combinations thereof.
−Removed: These patent applications, if issued, are set to expire between 2031 and 2046.
+Added: We seek patent protection for our approved products, product candidates, and proprietary technologies.
+Added: We rely on a broad collection of intellectual property comprised of owned, co-owned, and in-licensed patents, patent applications, trade secrets, know-how, and trademarks.
+Added: covering our proprietary RTGel technology, the pharmaceutical compositions, methods of use and manufacturing aspects of our product candidates.
+Added: In the United States, we have listed three patents for Jelmyto and three patents for Zusduri in the FDA’s Orange Book, all of which are set to expire in January 2031.
+Added: We also own, co-own or exclusively license patents and pending patent applications relating to UGN-103, UGN-104, and UGN-501, including rights directed to pharmaceutical compositions, formulations, and methods of use.
+Added: Across our owned, co-owned, and exclusively licensed portfolio, we have approximately 165 granted patents and 59 pending patent applications worldwide.
+Added: Our issued patents are set to expire between 2030 and 2044, and our pending applications, if issued, are expected to expire between 2031 and 2046.
Limitations on the scope of our intellectual property rights may limit our ability to prevent third parties from designing around such rights and competing against us.
46 unchanged sentences
Without patent protection for Jelmyto, Zusduri or our product candidates, we may be open to competition from generic versions thereof.
−Removed: We received a Paragraph IV Certification Notice Letter from Teva in February 2024, providing notification that Teva has submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of Jelmyto .
+Added: For example, we received a Paragraph IV Certification Notice Letter from Teva in February 2024, providing notification that Teva submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of Jelmyto .
See Part II, Item 1.
“Legal Proceedings” for additional discussion.
−Removed: If we are unable to maintain patent protection for Jelmyto or Zusduri , they will be subject to immediate competition from generic entrants after regulatory exclusivity expires in April 2027 and Zusduri in June 2028.
+Added: If we are unable to maintain patent protection for Jelmyto or Zusduri , they will be subject to immediate competition from generic entrants after regulatory exclusivity expires for Jelmyto in April 2027 and Zusduri in June 2028.
Further, if we encounter delays in our development efforts, including our clinical trials, the period of time during which we could market our product candidates under patent protection would be reduced.
−Removed: A considerable number of our patents and patent applications are entitled to effective filing dates prior to March 16, 2013.
+Added: A number of our patents and patent applications are entitled to effective filing dates prior to March 16, 2013.
patent applications in which patent claims are entitled to a priority date before March 16, 2013, an interference proceeding can be provoked by a third party, for example a competitor, or instituted by the USPTO to determine who was the first to invent any of the subject matter covered by those patent claims.
50 unchanged sentences
If we are unable to protect our trademarks from infringement, our business prospects may be harmed.*
−Removed: We filed applications for trademarks ( Jelmyto ® , RTGel ® , Zusduri TM and UroGen ® ) that identify our branding elements, such as Jelmyto and Zusduri and our unique technology in the United States, Europe, Israel, Japan and China.
+Added: We filed applications for trademarks ( Jelmyto ® , RTGel ® , Zusduri ® and UroGen ® ) that identify our branding elements, such as Jelmyto and Zusduri and our unique technology in the United States, Europe, Israel, Japan and China.
Although we take steps to monitor the possible infringement or misuse of our trademarks, it is possible that third parties may infringe, dilute or otherwise violate our trademark rights.
6 unchanged sentences
Drug manufacturers may develop, seek approval for, and launch generic versions of our products.
−Removed: For example, we received a Paragraph IV Certification Notice Letter from Teva in February 2024, providing notification to us that Teva has submitted an ANDA to the FDA seeking approval to manufacture, use, or sell a generic version of Jelmyto .
+Added: For example, we received a Paragraph IV Certification Notice Letter from Teva in February 2024, providing notification to us that Teva submitted an ANDA to the FDA seeking approval to manufacture, use, or sell a generic version of Jelmyto .
See Part II, Item 1.
70 unchanged sentences
Risks Related to Government Regulation
−Removed: If the FDA concludes that the requirements for our relevant product candidates are not as we expect, the approval pathway for these product candidates will likely take significantly longer, cost significantly more and entail significantly greater complications and risks than anticipated, and in either case may not be successful.
−Removed: The Drug Price Competition and Patent Term Restoration Act of 1984 (the "Hatch-Waxman Act"), added 505(b)(2) to the FDCA.
−Removed: 505(b)(2) permits the filing of an NDA where at least some of the information required for approval comes from studies that were not conducted by or for the applicant, and for which the applicant has not received a right of reference, which could expedite the development program for certain of our product candidates by potentially decreasing the amount of nonclinical and clinical data that we would need to generate in order to obtain FDA approval.
−Removed: However, while we believe that our product candidates are reformulations of existing drugs and, therefore, will not be treated as NCEs, the submission of an NDA under the 505(b)(2) pathway does not preclude the FDA from determining that the product candidate that is the subject of such submission is an NCE and therefore not eligible for review under such regulatory pathway.
−Removed: Our product candidates may not receive the requisite approvals for commercialization, or we may need to conduct additional nonclinical experiments and clinical trials, provide additional data and information, and meet additional standards for regulatory approval.
−Removed: If this were to occur, the time and financial resources required to obtain FDA approval for these product candidates, and complications and risks associated with these product candidates, would likely increase significantly.
−Removed: In addition, notwithstanding the approval of a number of products by the FDA under 505(b)(2) certain competitors and others have objected to the FDA’s interpretation of 505(b)(2).
−Removed: If the FDA’s interpretation of 505(b)(2) is successfully challenged, the FDA may be required to change its 505(b)(2) policies and practices, which could delay or even prevent the FDA from approving any NDA that we submit under 505(b)(2).
−Removed: In addition, the pharmaceutical industry is highly competitive, and 505(b)(2) NDAs are subject to special requirements designed to protect the patent rights of sponsors of previously approved drugs that are referenced in a 505(b)(2) NDA.
−Removed: These requirements may give rise to patent litigation and mandatory delays in approval of our potential future NDAs for up to 30 months depending on the outcome of any litigation.
−Removed: It is not uncommon for a manufacturer of an approved product to file a citizen petition with the FDA seeking to delay approval of, or impose additional approval requirements for, pending competing products.
−Removed: If successful, such petitions can significantly delay, or even prevent, the approval of the new product.
−Removed: However, even if the FDA ultimately denies such a petition, the FDA may substantially delay approval while it considers and responds to the petition.
−Removed: In addition, even if we are able to utilize the 505(b)(2) regulatory pathway for our product candidates, there is no guarantee this would ultimately lead to faster product development or earlier approval.
−Removed: Moreover, even if these product candidates are approved under the 505(b)(2) pathway, as the case may be, the approval may be subject to limitations on the indicated uses for which the products may be marketed or to other conditions of approval or may contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the products.
−Removed: In addition, there have been a number of recent regulatory and legislative initiatives designed to encourage generic competition for pharmaceutical products, including expedited review procedures for generic manufacturers and incentives designed to spur generic competition of branded drugs.
−Removed: In particular, the FDA and the FTC have been focused on brand companies’ denial of drug supply to potential generic competitors for testing.
−Removed: In December 2019, the CREATES Act was enacted, which provides a legislatively defined private right of action under which generic companies can bring suit against companies who refuse access to product for the bioequivalence testing needed to support approval of a generic product.
−Removed: We cannot currently predict the specific outcome or impact on our business of such regulatory and legislative initiatives, litigation or investigation.
−Removed: However, it is our policy, which is in compliance with the CREATES Act, to evaluate requests for samples of our approved product, and to provide samples in response to bona fide requests from qualified third parties, including generic manufacturers, subject to specified conditions.
−Removed: We have provided samples of Jelmyto to certain generic manufacturers.
We expect current and future legislation affecting the healthcare industry, including healthcare reform, to impact our business generally and to increase limitations on reimbursement, rebates and other payments, which could adversely affect third-party coverage of our products, our operations, and/or how much or under what circumstances healthcare providers will prescribe or administer our products, if approved.*
23 unchanged sentences
These actions, presently directed by executive orders or memoranda from the Office of Management and Budget, may propose policy changes that create additional uncertainty for our business.
−Removed: For example, the current administration has announced agreements with several pharmaceutical companies that require the drug manufacturers to offer, through a direct to consumer platform, U.S.
+Added: For example, the current administration has announced agreements with certain pharmaceutical companies that require the drug manufacturers to offer, through a direct to consumer platform, U.S.
patients and Medicaid programs prescription drug Most-Favored Nation pricing equal to or lower than those paid in other developed nations, with additional mandates for direct-to-patient discounts and repatriation of foreign revenues.
10 unchanged sentences
At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
+Added: For example, on June 15, 2026, the FDA approved Colorado’s Section 804 Importation Program proposal to import certain drugs from Canada for specific state healthcare programs.
+Added: It is unclear how this and Florida’s similar program, approved by the FDA in 2024, will be implemented and whether they will overcome potential legal, regulatory, or industry challenges in the United States and/or Canada.
If healthcare policies or reforms intended to curb healthcare costs are adopted, or if we experience negative publicity with respect to the pricing of our products or the pricing of pharmaceutical drugs generally, the prices that we charge for any approved products may be limited, our commercial opportunity may be limited and/or our revenues from sales of our products may be negatively impacted.
7 unchanged sentences
In addition, if a product receives the first FDA approval for the indication for which it has Orphan Drug Designation, the product is entitled to orphan drug exclusivity, which means the FDA may not approve any other application to market the same drug for the same indication for a period of seven years, except in limited circumstances, such as a showing of clinical superiority over the product with orphan exclusivity or where the manufacturer is unable to assure sufficient product quantity.
−Removed: Although the FDA has granted Orphan Drug Designation to Jelmyto and UGN-201 for treatment of UTUC and CIS, respectively, we may not receive Orphan Drug Designation for any of our product candidates.
+Added: Although the FDA has granted Orphan Drug Designation to Jelmyto for treatment of UTUC, we may not receive Orphan Drug Designation for any of our product candidates.
If our competitors are able to obtain orphan drug exclusivity for their products that are the same or similar to our product candidates before our drug candidates are approved, we may not be able to have competing product candidates approved by the FDA for a significant period of time.
2 unchanged sentences
Orphan Drug Designation entitles a party to financial incentives, such as opportunities for grant funding towards clinical trial costs, tax advantages, user-fee waivers and market exclusivity for certain periods of time.
−Removed: Jelmyto and UGN-201 have been granted Orphan Drug Designation for the treatment of UTUC and CIS, respectively, in the United States.
+Added: Jelmyto has been granted Orphan Drug Designation for the treatment of UTUC in the United States.
Even if we obtain Orphan Drug Designation for our other product candidates, we may not be the first to obtain regulatory approval for any particular orphan indication due to the uncertainties associated with developing biotechnology products.
139 unchanged sentences
and imprisonment of company officials.
−Removed: In particular, plaintiffs have become increasingly active in bringing privacy-related claims against companies, including class claims and mass arbitration demands.
+Added: In particular, plaintiffs have become increasingly active in bringing privacy-related claims against companies, including class claims and mass arbitration demands, and we have been subject in the past, and may be subject in the future, to such claims and demands.
Some of these claims allow for the recovery of statutory damages on a per-violation basis, and, if viable, carry the potential for monumental statutory damages, depending on the volume of data and the number of violations.
117 unchanged sentences
In November 2025, we filed the ATM Prospectus providing for the offer and sale of ordinary shares pursuant to the ATM Sales Agreement having an aggregate offering price of up to $75.0 million, which became effective automatically.
−Removed: As of March 31, 2026, the remaining capacity under the ATM Prospectus was approximately $42.4 million.
+Added: As of June 30, 2026, the remaining capacity under the ATM Prospectus was approximately $42.4 million.
We have never paid cash dividends on our share capital, and we do not anticipate paying any cash dividends in the foreseeable future.
61 unchanged sentences
Our research and development and other significant operations are located in Israel and, therefore, our results may be adversely affected by political, economic and military conditions in Israel.*
−Removed: Our research and development facility is located in Ra’anana, Israel, and certain of our key vendors and suppliers, including Isotopia Molecular Imaging Ltd., our single contracted supplier for the hydrogel contained in Jelmyto and Zusduri , are located in Israel.
+Added: Our research and development facility is located in Ra’anana, Israel, and certain of our key vendors and suppliers, including Isotopia Molecular Imaging Ltd., our contracted supplier for the hydrogel contained in Jelmyto and Zusduri , are located in Israel.
If these or any future facilities in Israel were to be damaged, destroyed or otherwise unable to operate, whether due to war, acts of hostility, earthquakes, fire, floods, hurricanes, storms, tornadoes, other natural disasters, employee malfeasance, terrorist acts, pandemics, power outages or otherwise, or if performance of our research and development is disrupted for any other reason, such an event could delay our clinical trials or, if our product candidates are approved, jeopardize the ability to manufacture our products as promptly as our prospective customers will likely expect, or possibly at all.
4 unchanged sentences
In response, Israel’s security cabinet declared war against Hamas.
−Removed: Since the commencement of these events, there have been continued hostilities along Israel’s northern border with Lebanon (with Hezbollah) and on other fronts from various extremist groups in region, such as the Houthis in Yemen.
−Removed: In addition, Iran launched significant missile and drone strikes at Israel and Israel attacked a range of targets in Iran.
−Removed: Furthermore, in June 2025, in light of continued nuclear threats and intelligence assessments indicating imminent attacks, Israel launched a military operation directly targeting military and nuclear infrastructure inside Iran, resulting in approximately 12 days of direct hostilities between Israel and Iran and, in February 2026, the United States and Israel launched coordinated military strikes against Iran, which were followed by retaliatory actions by Iran, including missile and drone attacks targeting Israel and U.S.
+Added: Since the commencement of these events, there have been hostilities along Israel’s northern border with Lebanon (with Hezbollah) and on other fronts from various extremist groups in region, such as the Houthis in Yemen.
+Added: In addition, there have been direct hostilities between Iran and Israel.
+Added: For example, in June 2025, in light of continued nuclear threats and intelligence assessments indicating imminent attacks, Israel launched a military operation directly targeting military and nuclear infrastructure inside Iran, resulting in approximately 12 days of direct hostilities between Israel and Iran and, in February 2026, the United States and Israel launched coordinated military strikes against Iran, which were followed by retaliatory actions by Iran, including missile and drone attacks targeting Israel and U.S.
forces and allied assets in the region.
24 unchanged sentences
We are incorporated in Israel.
−Removed: One of our directors resides outside of the United States, and most of the assets of this director are located outside of the United States.
−Removed: Therefore, a judgment obtained against us, or this director, including a judgment based on the civil liability provisions of U.S.
+Added: A judgment obtained against us or any of officers and directors who reside outside of the United States, including a judgment based on the civil liability provisions of U.S.
federal securities laws, may not be collectible in the United States.
−Removed: Moreover, Israeli courts might not enforce judgments rendered outside Israel, which may make it difficult to collect on judgments rendered against us or this director.
−Removed: Additionally, it may also be difficult to effect service of process on this director in the United States or to assert U.S.
−Removed: securities law claims in original actions instituted in Israel.
+Added: Moreover, Israeli courts might not enforce judgments rendered outside Israel, which may make it difficult to collect on judgments rendered against us or such persons.
+Added: It also may be difficult to effect service of process on these persons within the United States.
+Added: Additionally, it may be difficult to initiate an action with respect to U.S.
+Added: securities laws in Israel.
Israeli courts may refuse to hear a claim based on an alleged violation of U.S.
17 unchanged sentences
The loss of one or more of our executive officers could delay or prevent the continued successful implementation of our growth strategy, could affect our ability to manage our company effectively and to carry out our business plan, or could otherwise be detrimental to us.
−Removed: As of March 31, 2026, we had 298 employees.
+Added: As of June 30, 2026, we had 300 employees.
Therefore, knowledge of our product candidates and clinical trials is concentrated among a small number of individuals.
60 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.