Financial Data and Key Metrics Changes - UroGen Pharma reported net product revenues of $24.2 million for the second quarter of 2025, an 11% increase compared to $21.8 million in the same period in 2024, driven by underlying demand growth of 7% and price favorability [9][30] - The net loss for the second quarter of 2025 was $49.9 million, or $1.5 per basic and diluted share, compared to a net loss of $33.4 million, or $0.82 per basic and diluted share in the same period in 2024 [32][33] - Cash, cash equivalents, and marketable securities totaled $161.6 million as of June 30, 2025, providing sufficient capital for the launch of Zysturi and support for the pipeline [12][33] Business Line Data and Key Metrics Changes - Jelmyto continues to show strong growth with net product revenues of $24.2 million, reflecting continued adoption and usage among urologists [9][30] - Zysturi, the newly approved product, is expected to penetrate a total available market exceeding $5 billion annually, with an expanded sales team of 82 territories as of August 1, up from 50 previously [7][8] Market Data and Key Metrics Changes - The total available market for Zysturi is estimated to exceed $5 billion annually, indicating a significant opportunity for UroGen Pharma as it transitions from a rare disease-focused company to a multi-product organization [7][8] - Approximately 59,000 annual patients in the US face recurrence of low-grade, intermediate-risk, non-muscle invasive bladder cancer, highlighting the unmet medical need that Zysturi addresses [6] Company Strategy and Development Direction - UroGen Pharma aims to develop and commercialize a differentiated portfolio of treatments addressing unmet needs across urothelial and specialty cancers, with Zysturi being a primary growth driver [4][10] - The company is focused on a disciplined strategic launch of Zysturi, leveraging learnings from the launch of Jelmyto to ensure a successful market entry [8][9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the launch of Zysturi, noting strong interest from healthcare providers and the potential for significant patient uptake once a permanent J code is assigned [41][42] - The company anticipates broader reimbursement and market access in 2026, which is expected to significantly enhance adoption rates [28][34] Other Important Information - The phase three Utopia trial for UGN-103 is fully enrolled, with initial complete response data expected by the end of 2025, which will be shared with the FDA to inform the regulatory path forward [11][21] - UroGen's long-term goal includes expanding its product portfolio while driving commercial success and profitability [12][33] Q&A Session Summary Question: Metrics for July regarding Zysturi launch - Management indicated that it is still early to provide specific metrics but noted positive receptivity from healthcare providers and a strong interest in the new treatment option [36][39] Question: Reimbursement process for Zysturi - The reimbursement process is currently manual due to the miscellaneous J code, and while it is too early to report paid claims, practices are being educated on the claims process [49][54] Question: Comparison of Zysturi launch to Jelmyto - Management noted that while there are similarities in the launch process, the demographic for Zysturi is much larger, allowing for potentially quicker adoption compared to Jelmyto [57][58] Question: Utopia trial and FDA discussions - Management has not yet interacted with the FDA regarding the Utopia trial but expects to do so once sufficient data is available [60][62] Question: Expansion of prescribers post-J code assignment - Management indicated that they will expand outreach beyond the initial 2,000 identified prescribers once the permanent J code is assigned, targeting a broader segment of the urology market [74][78] Question: Impact of Zysturi on Jelmyto sales - It is too early to determine if Zysturi's launch will have a positive impact on Jelmyto sales, but management believes that increased market presence will support steady growth for Jelmyto [78][79]

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) Unaudited financial statements for June 30, 2025, show increased revenue, a wider net loss, decreased cash, and a growing shareholders' deficit, with ongoing losses anticipated Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $92,904 | $171,987 | | Total current assets | $196,868 | $276,135 | | Total Assets | $208,717 | $285,711 | | **Liabilities & Shareholders' Deficit** | | | | Total current liabilities | $47,548 | $45,949 | | Total Liabilities | $302,093 | $294,514 | | Total Shareholders' Deficit | ($93,376) | ($8,803) | Condensed Consolidated Statements of Operations Highlights (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $24,215 | $21,848 | $44,469 | $40,629 | | Gross profit | $20,665 | $19,619 | $38,589 | $36,672 | | Operating loss | ($41,448) | ($25,839) | ($78,362) | ($51,579) | | Net Loss | ($49,940) | ($33,403) | ($93,783) | ($65,689) | | Net loss per share | ($1.05) | ($0.82) | ($1.97) | ($1.69) | Condensed Consolidated Statements of Cash Flow Highlights (Six Months Ended June 30, in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($81,849) | ($55,483) | | Net cash provided by investing activities | $2,443 | $25,516 | | Net cash provided by financing activities | $330 | $154,942 | | **Increase (Decrease) in Cash** | **($79,076)** | **$124,975** | - The company has a history of net losses, with an accumulated deficit of **$900.0 million** as of June 30, 2025. Management expects losses to continue due to the commercial launch of Zusduri and ongoing R&D activities[29](index=29&type=chunk) - Management believes that its cash, cash equivalents, and marketable securities as of June 30, 2025, are sufficient to fund operations for more than one year from the financial statement issuance date[31](index=31&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=33&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition and operations, highlighting Zusduri's FDA approval and commercial launch, increased Jelmyto revenue, rising operating expenses, and sufficient liquidity for the next year [Overview and Key Developments](index=33&type=section&id=Overview%20and%20Key%20Developments) UroGen, a biotechnology company, achieved FDA approval for Zusduri on June 12, 2025, for NMIBC, and is commercially launching it while advancing its pipeline candidates - The FDA approved the New Drug Application (NDA) for Zusduri on **June 12, 2025**, for the treatment of adults with recurrent low-grade intermediate risk NMIBC[146](index=146&type=chunk)[158](index=158&type=chunk) - The company estimates the annual treatable population for Zusduri's indication in the U.S. is approximately **82,000 patients**, representing a potential market opportunity of over **$5.0 billion**[146](index=146&type=chunk) - The company's immuno-uro-oncology pipeline includes UGN-301 (anti-CTLA-4 antibody) and UGN-501 (oncolytic virus), with a **Phase 1 study** of UGN-501 planned for **2026**[145](index=145&type=chunk)[178](index=178&type=chunk) [Results of Operations](index=44&type=section&id=Results%20of%20Operations) Jelmyto revenues increased for the three and six months ended June 30, 2025, but net loss widened significantly due to higher operating, selling, marketing, and R&D expenses Comparison of Results for the Three Months Ended June 30 (in thousands) | Item | 2025 | 2024 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Revenue | $24,215 | $21,848 | $2,367 | Increased volume and price of Jelmyto sales | | R&D Expenses | $18,914 | $15,402 | $3,512 | Higher manufacturing costs for Zusduri and UGN-103 trial costs | | Selling & Marketing | $27,859 | $18,872 | $8,987 | Zusduri commercial preparation and sales force expansion | | Operating Loss | ($41,448) | ($25,839) | ($15,609) | Increased operating expenses outpaced revenue growth | | Net Loss | ($49,940) | ($33,403) | ($16,537) | Higher operating loss | Comparison of Results for the Six Months Ended June 30 (in thousands) | Item | 2025 | 2024 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Revenue | $44,469 | $40,629 | $3,840 | Increased volume of Jelmyto sales | | R&D Expenses | $38,785 | $30,896 | $7,889 | Higher manufacturing costs for Zusduri, UGN-103 trial, and IconOVir asset acquisition | | Selling & Marketing | $49,981 | $35,972 | $14,009 | Zusduri commercial preparation activities | | Operating Loss | ($78,362) | ($51,579) | ($26,783) | Increased operating expenses outpaced revenue growth | | Net Loss | ($93,783) | ($65,689) | ($28,094) | Higher operating loss | [Liquidity and Capital Resources](index=47&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company held **$161.6 million** in cash and equivalents, funded operations through equity and debt, and believes current liquidity is sufficient for over one year - The company held **$161.6 million** in cash, cash equivalents, and marketable securities as of June 30, 2025[223](index=223&type=chunk) - The company has a loan agreement with Pharmakon, with an additional **$75.0 million** fourth tranche available upon Zusduri's FDA approval, which the company does not intend to draw down[230](index=230&type=chunk)[231](index=231&type=chunk) - Management believes existing cash is sufficient to fund operations **beyond one year** from the report's issuance date[236](index=236&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=52&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces market risks from interest rate fluctuations on its investment portfolio and foreign currency exchange rates, particularly for NIS-denominated operating expenses, without current hedging - The company's primary market risks are interest rate fluctuations on its **$161.6 million** in cash and marketable securities and foreign currency exchange risk[256](index=256&type=chunk) - A significant portion of operating expenses are incurred in New Israeli Shekels (NIS), creating exposure to currency fluctuations against the U.S. dollar; a **10% change** in the NIS-to-Dollar exchange rate would **not have had a material effect** on operating expenses for the six months ended June 30, 2025[258](index=258&type=chunk) [Controls and Procedures](index=54&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation as of June 30, 2025, the principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were **effective**[261](index=261&type=chunk) - **No changes** in internal control over financial reporting occurred during the quarter ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[262](index=262&type=chunk) [PART II. OTHER INFORMATION](index=55&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=55&type=section&id=Item%201.%20Legal%20Proceedings) UroGen is engaged in patent infringement litigation against Teva Pharmaceuticals, seeking to prevent the market entry of Teva's generic Jelmyto before patent expiration, with a trial set for October 2026 - The company filed a lawsuit against Teva Pharmaceuticals on **April 2, 2024**, for patent infringement related to Teva's application to market a generic version of Jelmyto[264](index=264&type=chunk) - The lawsuit alleges infringement of U.S. Patent Numbers 9,040,074, 9,950,069, and 12,268,745, and seeks to prevent market entry of Teva's generic product; a bench trial is scheduled for **October 2026**[264](index=264&type=chunk) [Risk Factors](index=55&type=section&id=Item%201A.%20Risk%20Factors) The company faces material risks including historical losses, financing needs, dependence on product commercialization, clinical development challenges, competition, supply chain reliance, intellectual property protection, and geopolitical instability - The company has a history of significant losses (**$900.0 million** accumulated deficit as of June 30, 2025) and may require additional financing, which may not be available on acceptable terms[266](index=266&type=chunk)[270](index=270&type=chunk) - The business is **highly dependent** on the successful commercialization of its two approved products, Jelmyto and Zusduri, and faces risks related to market adoption, competition, and reimbursement[266](index=266&type=chunk)[296](index=296&type=chunk) - The company relies on third-party, **single-source suppliers** for key components of its products, creating risks of **supply chain disruption** that could impair development and commercialization[267](index=267&type=chunk)[361](index=361&type=chunk) - Significant operations in Israel expose the company to risks from **political, economic, and military instability** in the region[267](index=267&type=chunk)[553](index=553&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=131&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period - The company reported **no unregistered sales** of equity securities[581](index=581&type=chunk) [Defaults Upon Senior Securities](index=131&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the period - The company reported **no defaults** upon senior securities[582](index=582&type=chunk) [Mine Safety Disclosures](index=131&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[582](index=582&type=chunk) [Other Information](index=131&type=section&id=Item%205.%20Other%20Information) There was no other information to report during the period - The company reported **no other information**[583](index=583&type=chunk) [Exhibits](index=132&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate documents and Sarbanes-Oxley certifications from the CEO and CFO - Exhibits filed include **CEO and CFO certifications** pursuant to **Sarbanes-Oxley Sections 302 and 906**, and the company's 2019 Inducement Plan[584](index=584&type=chunk)

[Overview and Business Highlights](index=1&type=section&id=Overview%20and%20Business%20Highlights) UroGen Pharma achieved a transformative milestone with ZUSDURI™ FDA approval and launch, complementing JELMYTO®'s continued growth and advancing its pipeline [Executive Summary](index=1&type=section&id=Executive%20Summary) UroGen Pharma's Q2 2025 results highlight the transformative FDA approval and commercial launch of ZUSDURI™, establishing the company as a multi-product uro-oncology entity alongside JELMYTO®'s continued growth - The FDA approval of ZUSDURI™ for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) is a **transformative milestone**, establishing UroGen as a multi-product company[3](index=3&type=chunk)[8](index=8&type=chunk) - The company is executing the commercial launch of ZUSDURI™ to address an estimated market opportunity of **over $5 billion**[3](index=3&type=chunk) Q2 2025 Key Metrics Snapshot | Metric | Value | Growth (YoY) | | :--- | :--- | :--- | | JELMYTO® Net Sales | $24.2 million | 11% | | Cash & Marketable Securities | $161.6 million | N/A | [Product Portfolio and Pipeline Update](index=1&type=section&id=Product%20Portfolio%20and%20Pipeline%20Update) UroGen's commercial portfolio expanded with ZUSDURI™'s launch, complementing JELMYTO®'s growth, while the pipeline advances with next-generation formulations and an immuno-oncology candidate [ZUSDURI™ (mitomycin) for intravesical solution](index=1&type=section&id=ZUSDURI%E2%84%A2%20(mitomycin)%20for%20intravesical%20solution) ZUSDURI™ received FDA approval as the first and only medication for recurrent LG-IR-NMIBC, supported by strong Phase 3 and Phase 2b clinical data - On June 12, 2025, ZUSDURI™ (formerly UGN-102) was approved by the FDA, becoming the **first and only approved medication** for adults with recurrent LG-IR-NMIBC[8](index=8&type=chunk) - Updated data from the Phase 3 ENVISION trial demonstrated a **72.2% probability** of patients remaining in complete response at 24 months[8](index=8&type=chunk) - Five-year results from the Phase 2b OPTIMA II trial showed a median duration of response of **approximately 3.5 years**[8](index=8&type=chunk) [JELMYTO® (mitomycin) for pyelocalyceal solution](index=1&type=section&id=JELMYTO%C2%AE%20(mitomycin)%20for%20pyelocalyceal%20solution) JELMYTO® demonstrated 11% year-over-year revenue growth in Q2 2025, driven by increased demand and price favorability, with ongoing real-world data collection JELMYTO® Q2 2025 Performance | Metric | Q2 2025 | Q2 2024 | YoY Growth | | :--- | :--- | :--- | :--- | | Net Product Revenue | $24.2 million | $21.8 million | 11% | - The **11% year-over-year revenue growth** was driven by a **7% increase in underlying demand** and price favorability[8](index=8&type=chunk)[11](index=11&type=chunk) - The uTRACT Registry, a real-world study of JELMYTO®, is ongoing to provide insights into treatment patterns, long-term outcomes, and patient safety[8](index=8&type=chunk) [Pipeline Development](index=1&type=section&id=Pipeline%20Development) UroGen's pipeline advanced with completed enrollment for UGN-103's Phase 3 trial, initiation of UGN-104's Phase 3 study, and completed dose escalation for UGN-301 - **UGN-103 (Next-gen ZUSDURI):** Enrollment is **complete** in the Phase 3 UTOPIA clinical trial for patients with recurrent LG-IR-NMIBC[6](index=6&type=chunk) - **UGN-104 (Next-gen JELMYTO):** A Phase 3 study to evaluate the safety and efficacy of this next-generation product for LG-UTUC has been **initiated**[9](index=9&type=chunk) - **UGN-301 (zalifrelimab):** Enrollment is **complete** in the dose escalation phase for this anti-CTLA4 antibody, showing an acceptable safety profile and observed responses[10](index=10&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Performance) UroGen's Q2 2025 financial performance reflects increased net loss due to ZUSDURI™ launch preparations and R&D investments, alongside JELMYTO® revenue growth and reaffirmed full-year guidance [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) UroGen reported a wider Q2 2025 net loss of $49.9 million, primarily driven by increased SG&A for ZUSDURI™ launch and higher R&D expenses, despite JELMYTO® revenue growth Q2 2025 Financial Summary (vs. Q2 2024) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | JELMYTO Revenue | $24.2 million | $21.8 million | | R&D Expenses | $18.9 million | $15.4 million | | SG&A Expenses | $43.2 million | $30.1 million | | Net Loss | $49.9 million | $33.4 million | | Net Loss per Share | ($1.05) | ($0.82) | | Cash & Equivalents (End of Period) | $161.6 million | N/A | - The increase in SG&A expenses was primarily driven by **commercial preparation activities for the ZUSDURI™ launch**[13](index=13&type=chunk) - Higher R&D expenses were mainly due to **increased manufacturing costs** and costs associated with the Phase 3 UTOPIA trial for UGN-103[12](index=12&type=chunk) [Financial Statements](index=2&type=section&id=Financial%20Statements) The condensed consolidated financial statements present detailed financial position and operational results for the three and six months ended June 30, 2025, compared to 2024 [Condensed Consolidated Statements of Operations](index=3&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This statement details the company's revenues, expenses, and net loss for the three and six months ended June 30, 2025, and 2024 Condensed Consolidated Statements of Operations (in thousands, except per share data) | | Three months ended June 30, | Six months ended June 30, | | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | **Revenue** | **$ 24,215** | **$ 21,848** | **$ 44,469** | **$ 40,629** | | Gross profit | 20,665 | 19,619 | 38,589 | 36,672 | | Total operating expenses | 62,113 | 45,458 | 116,951 | 88,251 | | **Operating loss** | **(41,448)** | **(25,839)** | **(78,362)** | **(51,579)** | | **Net loss** | **$ (49,940)** | **$ (33,403)** | **$ (93,783)** | **$ (65,689)** | | **Net loss per share** | **$ (1.05)** | **$ (0.82)** | **$ (1.97)** | **$ (1.69)** | [Selected Consolidated Balance Sheets](index=2&type=section&id=Selected%20Consolidated%20Balance%20Sheets) This statement provides a snapshot of the company's assets, liabilities, and equity as of June 30, 2025, and December 31, 2024 Selected Consolidated Balance Sheet Data (in thousands) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $ 161,586 | $ 241,707 | | Total assets | $ 208,717 | $ 285,711 | | Total liabilities | $ 302,093 | $ 294,514 | [Full-Year 2025 Guidance](index=2&type=section&id=Full-Year%202025%20Guidance) UroGen reaffirmed its full-year 2025 guidance, projecting JELMYTO® net product revenues between $94 million and $98 million and total operating expenses from $215 million to $225 million Full-Year 2025 Financial Guidance | Metric | Guidance Range | | :--- | :--- | | JELMYTO Net Product Revenues | $94 - $98 million | | Total Operating Expenses | $215 - $225 million | | Non-cash Share-based Compensation | $11 - $14 million | - The revenue guidance implies an **8% to 12% year-over-year growth rate** for JELMYTO® over 2024 demand-driven sales[19](index=19&type=chunk) [Product and Company Information](index=3&type=section&id=Product%20and%20Company%20Information) This section provides detailed information on UroGen's commercial products, ZUSDURI™ and JELMYTO®, including their uses, mechanisms, and safety profiles, along with company overview [About ZUSDURI™](index=3&type=section&id=About%20ZUSDURI%E2%84%A2) ZUSDURI™ is an FDA-approved, mitomycin-based intravesical solution utilizing RTGel® technology for recurrent LG-IR-NMIBC, with detailed information on its use and safety - ZUSDURI™ is a prescription medicine for adults with recurrent LG-IR-NMIBC whose previous bladder surgery was not effective[25](index=25&type=chunk) - It utilizes UroGen's proprietary **RTGel® technology**, a sustained-release hydrogel, to enable non-surgical treatment of tumors in an outpatient setting[24](index=24&type=chunk) - Important safety information includes contraindication for patients with a perforated bladder and the need for effective contraception for both females and males during and after treatment[26](index=26&type=chunk)[27](index=27&type=chunk)[29](index=29&type=chunk) [About JELMYTO®](index=4&type=section&id=About%20JELMYTO%C2%AE) JELMYTO® is a mitomycin-containing reverse thermal gel approved for LG-UTUC, with details on its mechanism, approved use, and important safety information - JELMYTO® is a prescription medicine for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC)[34](index=34&type=chunk) - Its **reverse thermal gel technology** becomes a semi-solid at body temperature, allowing the drug to remain in the collecting system for **four to six hours** for sustained chemoablative therapy[33](index=33&type=chunk) - Serious side effects can include swelling and narrowing of the ureter (ureteric obstruction) and bone marrow problems leading to decreased blood cell counts[44](index=44&type=chunk) [About UroGen Pharma Ltd.](index=5&type=section&id=About%20UroGen%20Pharma%20Ltd.) UroGen is a biotech company focused on developing and commercializing innovative solutions for urothelial and specialty cancers using its proprietary RTGel® platform, with two approved products - UroGen is a biotech company dedicated to developing and commercializing innovative solutions for urothelial and specialty cancers[42](index=42&type=chunk) - The company's proprietary **RTGel® platform** is a sustained-release, hydrogel-based technology designed to improve the therapeutic profiles of existing drugs for local therapy[42](index=42&type=chunk) [Other Information](index=2&type=section&id=Other%20Information) This section provides details on the conference call for Q2 results and includes cautionary forward-looking statements regarding potential risks and uncertainties [Conference Call & Webcast Information](index=2&type=section&id=Conference%20Call%20%26%20Webcast%20Information) UroGen management hosted a conference call and webcast on August 7, 2025, to discuss financial results and provide a business update - A live conference call and webcast were held on the day of the earnings release to review financial results and provide a general business update[20](index=20&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) This section contains cautionary forward-looking statements, highlighting various risks and uncertainties that could cause actual results to differ materially from projections - The press release includes forward-looking statements regarding the market opportunity for ZUSDURI, pipeline progress, financial guidance, and the potential of its RTGel technology[43](index=43&type=chunk) - These statements are subject to numerous risks and uncertainties, including clinical results, regulatory approval, commercialization challenges, competition, and market acceptance[43](index=43&type=chunk)

Core Insights - UroGen Pharma has achieved a significant milestone with the FDA approval of ZUSDURI for treating adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), marking its transition into a multi-product uro-oncology company [2][7] - The company is targeting a market opportunity exceeding $5 billion and is actively executing the launch plan for ZUSDURI while continuing to grow its existing product, JELMYTO [2][6] - UroGen's financial results for Q2 2025 show a net product revenue of $24.2 million for JELMYTO, reflecting an 11% year-over-year growth driven by underlying demand and price favorability [6][10] Financial Performance - JELMYTO net product revenues for Q2 2025 were $24.2 million, up from $21.8 million in Q2 2024, indicating an 11% increase [10] - Research and Development (R&D) expenses for Q2 2025 were $18.9 million, an increase from $15.4 million in Q2 2024, primarily due to higher manufacturing costs and expenses related to the Phase 3 UTOPIA trial [11] - Selling, General and Administrative (SG&A) expenses rose to $43.2 million in Q2 2025 from $30.1 million in Q2 2024, driven by commercial preparation activities for ZUSDURI [12] - The company reported a net loss of $49.9 million in Q2 2025, compared to a net loss of $33.4 million in the same period in 2024 [15][20] Product Development and Pipeline - Enrollment is complete for the Phase 3 UTOPIA trial of UGN-103, a next-generation mitomycin formulation aimed at improving treatment for recurrent LG-IR-NMIBC [5][8] - UroGen is also advancing its immuno-oncology candidates, with ongoing studies for UGN-301, an anti-CTLA4 antibody for high-grade non-muscle invasive bladder cancer [9] - The company is collecting real-world data through the uTRACT Registry to evaluate JELMYTO's use and outcomes in adult patients with upper tract urothelial carcinoma [7] Market Outlook - UroGen maintains its guidance for full-year 2025 net product revenues for JELMYTO in the range of $94 to $98 million, reflecting an expected growth rate of approximately 8% to 12% over 2024 [16] - The company is well-positioned to support the launch of ZUSDURI and advance its strategic initiatives for sustained growth and innovation [2][6]

Core Insights - UroGen Pharma announced a 24-month Duration of Response (DOR) of 72.2% for ZUSDURI in patients who achieved a complete response at three months from the Phase 3 ENVISION trial, indicating sustained efficacy for treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) [1][2][3] Company Overview - UroGen Pharma is focused on developing innovative solutions for urothelial and specialty cancers, with ZUSDURI being a significant product for treating recurrent LG-IR-NMIBC [7] - The company utilizes proprietary RTGel technology, which allows for sustained release of medication directly into the bladder, providing a non-surgical treatment option [4][7] Product Details - ZUSDURI (mitomycin) is an FDA-approved intravesical solution for adults with recurrent LG-IR-NMIBC, marking a transformative step in managing this chronic cancer [2][3][8] - The treatment is administered in an outpatient setting, which can improve patient quality of life compared to traditional surgical options [2][4] Clinical Trial Insights - The Phase 3 ENVISION trial involved 240 patients and evaluated the efficacy and safety of ZUSDURI, with a primary endpoint of complete response rate at three months [6] - The trial demonstrated that the event rate remained stable over time for patients who achieved a complete response, reinforcing the therapy's potential as a durable treatment option [2][3] Market Context - LG-IR-NMIBC affects approximately 82,000 individuals annually in the U.S., with around 59,000 experiencing recurrence, highlighting the need for effective treatment options [5] - The existing standard of care involves repeated surgical procedures, which can negatively impact patients' health and quality of life [2][5]

Core Insights - UroGen Pharma Ltd. will report its second quarter 2025 financial results on August 7, 2025, before the stock market opens, followed by a live audio webcast and conference call at 10:00 AM ET [1][2] Company Overview - UroGen Pharma is a biotech company focused on developing and commercializing innovative treatments for urothelial and specialty cancers, emphasizing the need for better patient options [3] - The company has developed RTGel, a proprietary sustained-release hydrogel technology aimed at improving the therapeutic profiles of existing drugs, allowing for longer exposure of urinary tract tissue to medications [3] - UroGen's first product is approved for treating low-grade upper tract urothelial cancer, while its second product is the first FDA-approved treatment for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, both designed for non-surgical tumor ablation [3]

Core Viewpoint - A class action lawsuit has been filed against UroGen Pharma Ltd. for alleged misleading statements regarding its lead product UGN-102, which is intended for treating low-grade intermediate risk non-muscle invasive bladder cancer [1][3]. Company Overview - UroGen Pharma is engaged in the development and commercialization of solutions for specialty cancers, with its lead pipeline product being UGN-102, an intravesical solution for bladder cancer treatment [2]. Allegations in the Lawsuit - The lawsuit claims that UroGen made false statements and failed to disclose critical information about the ENVISION clinical study for UGN-102, including the lack of a concurrent control arm, which undermined the study's ability to demonstrate effectiveness [3]. - It is alleged that UroGen ignored FDA warnings regarding the study design for the new drug application (NDA) for UGN-102, leading to a substantial risk of NDA rejection [3][4]. Impact of FDA Findings - On May 16, 2025, the FDA released a briefing document indicating concerns about the ENVISION study's design, which contributed to a nearly 26% drop in UroGen's stock price [4]. - Following the Oncologic Drugs Advisory Committee's vote against the approval of UGN-102 on May 21, 2025, UroGen's stock price fell nearly 45% [5].

Core Insights - UroGen Pharma Ltd. announced positive results from a Phase 3b study on the home administration of ZUSDURI™ (mitomycin) for treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) [1][2] - The study demonstrated that trained home health professionals can safely administer ZUSDURI outside traditional clinical settings, potentially easing patient burden and reducing reliance on hospital resources [2][3] Study Findings - The study involved eight patients, with 75% completing all six scheduled treatments; 75% of patients reported a complete response rate at three months [2][4] - Patients expressed high satisfaction with the home-based treatment, with five out of six recommending it to others [2] - No new safety concerns were identified, and the safety profile was consistent with previous studies, primarily involving mild-to-moderate urinary symptoms [3][4] Treatment Administration - ZUSDURI was administered via urinary catheter once weekly for six weeks, with the first dose given in a clinic and subsequent doses at home [3] - Investigators found no significant differences in safety or efficacy between home and office administration [3] Company Overview - UroGen Pharma is focused on developing innovative treatments for urothelial and specialty cancers, utilizing proprietary RTGel technology for sustained drug release [5][8] - ZUSDURI is specifically approved for treating adults with recurrent LG-IR-NMIBC after unsuccessful bladder surgery [9] Market Context - Approximately 82,000 people in the U.S. are diagnosed with NMIBC annually, with around 59,000 experiencing recurrence [6] - The median age of diagnosis for bladder cancer is 73 years, highlighting the need for convenient treatment options for older patients [6]

Core Viewpoint - A class action lawsuit has been filed against UroGen Pharma Ltd. for alleged misleading statements regarding its lead product UGN-102, which is intended for treating low-grade intermediate risk non-muscle invasive bladder cancer [1][2]. Group 1: Lawsuit Details - The lawsuit covers investors who acquired UroGen securities between July 27, 2023, and May 15, 2025, with a deadline of July 28, 2025, to apply as lead plaintiff [1]. - Allegations include that UroGen's ENVISION clinical study for UGN-102 was inadequately designed, lacking a concurrent control arm, which undermined the evidence of effectiveness [3]. - The FDA had previously warned UroGen about the study design, suggesting a randomized trial, which UroGen did not conduct [4]. Group 2: Stock Price Impact - Following the FDA's briefing document on May 16, 2025, which raised concerns about the study's interpretability, UroGen's stock price fell nearly 26% [4]. - On May 21, 2025, after the Oncologic Drugs Advisory Committee voted against the approval of UGN-102, the stock price dropped nearly 45% [5].

Core Points - A shareholder class action lawsuit has been filed against UroGen Pharma Ltd. alleging that the company made materially false and misleading statements regarding its business and operations [1] - The lawsuit claims that the ENVISION clinical study was inadequately designed, lacking a concurrent control arm, which raises concerns about the effectiveness of UGN-102 [1] - It is alleged that UroGen ignored FDA warnings about the study design, leading to a substantial risk that the New Drug Application (NDA) for UGN-102 would not be approved [1] - The lawsuit asserts that the positive statements made by the company regarding its business and prospects were misleading and lacked a reasonable basis [1] Legal Context - Shareholders who purchased UroGen shares between July 27, 2023, and May 15, 2025, and suffered significant losses are encouraged to discuss their legal rights [2] - The deadline for shareholders to request to be appointed as lead plaintiff in the case is July 28, 2025 [3] - Holzer & Holzer, LLC is representing the shareholders and has a history of recovering substantial amounts for investors affected by corporate misconduct [3]