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ZUSDURI™ Clinical Review Published in Reviews in Urology™ Highlights Durable Efficacy and Manageable Safety Profile in Recurrent Low-Grade, Intermediate-Risk Non–Muscle Invasive Bladder Cancer
Globenewswire· 2025-10-02 12:00
Core Insights - UroGen Pharma Ltd. announced the publication of a comprehensive review of ZUSDURI™ (mitomycin) for intravesical solution, the first FDA-approved treatment for adults with recurrent, low-grade, intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC) [1][2] Company Overview - UroGen Pharma is focused on developing innovative solutions for urothelial and specialty cancers, utilizing proprietary RTGel technology for sustained release of medications [11] - The company is headquartered in Princeton, NJ, with operations in Israel [11] Product Information - ZUSDURI is a non-surgical treatment option that has shown robust and durable complete response rates in clinical trials for recurrent LG-IR-NMIBC [2][3] - The drug is administered in an outpatient setting without the need for general anesthesia, making it a convenient option for patients [2] Clinical Development - The clinical development program for ZUSDURI includes three late-phase trials: OPTIMA II, ATLAS, and ENVISION, which evaluated its safety and efficacy [3][6] - The ENVISION trial enrolled 240 patients and assessed the complete response rate at three months post-treatment [8] Efficacy and Safety - Complete response rates in late-stage trials ranged from 64.8% to 79.6% at three months, with 80.6% of patients remaining disease-free at 18 months following complete response [6] - Adverse events were primarily localized to the lower urinary tract, with serious adverse reactions occurring in 12% of patients [6] Patient Demographics - Patients in the ZUSDURI clinical trials were predominantly elderly, with median ages between 67 and 70 years, and a significant proportion had multiple tumors and larger tumor sizes [4] Market Context - LG-IR-NMIBC affects approximately 82,000 individuals annually in the U.S., with around 59,000 being recurrent cases [7] - The standard care for NMIBC typically involves transurethral resection of bladder tumor (TURBT), but many patients experience recurrences [7]
UroGen Pharma (NasdaqGM:URGN) FY Conference Transcript
2025-09-08 14:02
UroGen Pharma FY Conference Summary Company Overview - UroGen Pharma Ltd. is a leading biotech company focused on urothelial cancer, traded on NASDAQ under the ticker URGN [7][9] - The company was founded in 2004, based on research from Israel, and developed RTGel technology for drug delivery in the urinary tract [8][9] Key Products and Market Opportunities - **Jelmyto (mitomycin)**: Launched in 2020 for low-grade urothelial cancer, targeting a patient population of approximately 6,000-7,000 annually in the U.S. [9][13] - **Zosduri (UGN-102, mitomycin)**: Approved by the FDA on June 12, 2025, for recurrent low-grade intermediate risk non-muscle invasive bladder cancer, targeting about 60,000 patients annually in the U.S. [10][11][13] - The market opportunity for Zosduri is estimated to exceed $5 billion, assuming a treatment cost of $100,000 per patient [13] Launch and Sales Strategy - UroGen has expanded its sales force from 52 to 82 representatives to target 8,500 physicians, covering 90% of the Zosduri opportunity [14][15] - The company provides comprehensive support for physicians, including reimbursement assistance and training for product administration [15][16] - Initial enthusiasm from the physician community is high, with 90% of patients preferring outpatient treatment over traditional surgical procedures [21][22] Clinical Data and Patient Outcomes - Zosduri has shown promising clinical results, with 80% of patients achieving complete response at three months and 72% maintaining this response at 24 months [16][17] - The product is the first FDA-approved non-surgical therapy for this patient population, representing a significant shift in treatment paradigms [21][22] Pipeline and Future Developments - UroGen is advancing its pipeline with UGN-103 and UGN-104, both in phase 3 trials, with UGN-103 expected to submit an NDA by the end of 2026 [27][29][32] - The company is also exploring a multi-drug immunotherapy program and an oncolytic virus (UGN-501) for potential use in bladder cancer and other cancers [32][33] Financial Position - UroGen reported cash reserves of $162 million as of June, sufficient to fund the Zosduri launch and support a path to profitability [34] Conclusion - UroGen Pharma is positioned for growth with its innovative therapies in the urothelial cancer space, a strong pipeline, and a solid financial foundation to support its strategic initiatives [34]
UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2025-09-08 12:00
Company Overview - UroGen Pharma Ltd. is a biotech company focused on developing and commercializing innovative solutions for urothelial and specialty cancers [4] - The company has developed RTGel, a proprietary sustained-release hydrogel-based platform technology aimed at improving therapeutic profiles of existing drugs [4] - UroGen's first commercial product treats low-grade upper tract urothelial cancer, while its second product is the first FDA-approved medication for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer [4] Recent Developments - UroGen announced the grant of inducement restricted stock units (RSUs) to 40 new employees to support the commercialization of its approved products Jelmyto and ZUSDURI™ [1] - A total of up to 67,700 ordinary shares are issuable upon the vesting and settlement of the RSUs, which will vest equally over three years [2] - The RSUs were granted as an inducement material to each employee entering employment with UroGen, in accordance with Nasdaq Listing Rule 5635(c)(4) [3]
UroGen Pharma (URGN) 2025 Conference Transcript
2025-09-04 20:55
UroGen Pharma (URGN) Conference Call Summary Company Overview - **Company**: UroGen Pharma Ltd. - **Focus**: Development and commercialization of treatments for urothelial cancers, specifically bladder cancer Key Products - **Jelmyto**: Approved for low-grade upper tract urothelial carcinoma - **Market Size**: 7,000 new patients annually in the U.S., with 3,500 historically undergoing kidney removal - **Sales Projection**: Expected to reach $94 to $98 million in 2025, with a potential peak around $150 million [20][21][22] - **Zosduri (UGN-102)**: Targeting low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC) - **Market Size**: 80,000 new bladder cancer patients annually, with 60,000 having recurrent low-grade, intermediate-risk disease - **Revenue Potential**: Estimated at $1 billion plus, with a target of capturing 20% of the market [41][42] Core Technology - **RTGel**: A reverse-thermal hydrogel technology that allows drugs to remain in the bladder for extended periods, enhancing treatment efficacy for urothelial cancers [10][11] Clinical Data - **Jelmyto**: High complete response rates with minimal morbidity, offering a less invasive alternative to kidney removal [12][13] - **Zosduri**: - 80% complete response rate in clinical trials, with durability data showing 72% effectiveness at two years [33][34] - Positioned as a primary therapy, distinct from other adjuvant therapies in development [33] Competitive Landscape - **Current Competitors**: Other companies are developing treatments for high-grade bladder cancer but not yet in the intermediate-risk space [35][36] - **Future Competition**: Anticipated as more products enter the market targeting similar patient populations [36] Commercialization Strategy - **J-Code Importance**: Critical for reimbursement and adoption in urology practices, expected to be established by January 1 [44][45] - **Sales Team Expansion**: Increased from 52 to 82 representatives to enhance market presence and support [62] Financial Position - **Cash Reserves**: Ended Q2 with $162 million, sufficient to reach profitability without immediate capital raising [68][69] - **Debt**: $125 million in debt with Pharmakon, indicating a manageable financial structure [69] Future Outlook - **Growth Potential**: Total addressable market for bladder cancer treatments estimated at over $5 billion, with significant opportunities for both Jelmyto and Zosduri [41][42] - **Long-term Strategy**: Plans to expand into other urothelial cancers and explore additional business development opportunities [64][66] Additional Insights - **Patient Preference**: 90% of patients preferred non-surgical Zosduri treatment over traditional TURBT procedures, indicating strong market demand [38] - **Operational Readiness**: Focus on activating sites and training staff to ensure smooth drug rollout post-J-code [52][53] This summary encapsulates the key points discussed during the UroGen Pharma conference call, highlighting the company's strategic direction, product offerings, and market potential.
UroGen Pharma(URGN) - 2025 FY - Earnings Call Transcript
2025-09-03 19:15
Financial Data and Key Metrics Changes - The company expects revenues for the product Almighta to be between $94 million and $98 million for the year, indicating year-over-year growth [62] - The peak potential for the XaStorY opportunity is projected to exceed $1 billion, suggesting a clear path to profitability over the next five years [63] Business Line Data and Key Metrics Changes - The total addressable market (TAM) for low-grade intermediate risk non-muscle invasive bladder cancer is over $5 billion, significantly larger than the $700 million TAM for low-grade upper tract urothelial carcinoma [14] - The company reported that 80% of patients achieved a complete response without undergoing TURBT, with 72% remaining recurrence-free at 24 months [23] Market Data and Key Metrics Changes - The company has expanded its sales force to cover 8,500 physicians, targeting 85% to 90% of the market opportunity, with an initial focus on 2,000 physicians more inclined to adopt new products [36][38] - The company anticipates that 70% of utilization will eventually occur in community settings, despite initial usage being more concentrated in hospital settings [36] Company Strategy and Development Direction - The company is focused on lifecycle management, with plans to transition to UGN-one 103, which has a patent extension until December 2041, and aims to target high-grade disease [71][72] - The company is also exploring collaborations to enhance the efficacy of other drugs using its gel technology, indicating a strategy for broader market penetration [88] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming permanent J code expected in January, which is anticipated to accelerate adoption and utilization of their products [44][56] - The management team noted that logistical and reimbursement barriers, rather than clinical concerns, are the primary challenges facing adoption in the urology market [46] Other Important Information - The company is conducting a study on UGN-one 103, with expectations for similar efficacy data to the existing product, and plans to file for approval in 2026 [70][81] - The company is also developing UGN-five 01, an oncolytic virus, with plans to expand its application beyond bladder cancer in the future [89] Q&A Session Summary Question: What is the importance of the J code? - The J code is crucial for urologists as it allows for electronic reimbursement processes, reducing administrative burdens and increasing confidence in product adoption [39][42] Question: How does the company plan to reach community practices? - The company has expanded its sales force and is focusing on a subset of physicians more likely to adopt new products, with a strategy to increase community practice engagement over time [36][38] Question: What is the expectation for breaking even based on the story? - The company has not provided specific guidance on the timeline to breakeven but believes its current cash runway supports a path to profitability given the size of the XaStorY opportunity [62][63]
UroGen Pharma to Present at Upcoming Investor Conferences
Globenewswire· 2025-08-21 12:00
Company Overview - UroGen Pharma Ltd. is a biotech company focused on developing and commercializing innovative solutions for urothelial and specialty cancers, aiming to provide better treatment options for patients [3] - The company has developed RTGel®, a proprietary sustained-release hydrogel-based platform technology that enhances 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 and only FDA-approved medication for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, both designed for non-surgical tumor ablation [3] Upcoming Investor Conferences - UroGen will participate in the Wells Fargo Healthcare Conference on September 3rd at 2:15 PM ET in Boston, MA, in a fireside chat format [2] - The company will also attend the Cantor Fitzgerald Global Healthcare Conference on September 4th at 3:55 PM ET in New York, NY, also in a fireside chat format [2] - Additionally, UroGen will be present at the H.C. Wainwright 27th Annual Global Healthcare Conference on September 8th at 9:00 AM ET in New York, NY, in a fireside chat format [2]
UroGen Pharma: Targeting Profits In 2027
Seeking Alpha· 2025-08-18 19:34
Group 1 - The biotech sector presents numerous attractive covered call opportunities, particularly for investors who can identify the right equities to target [1] - Option premiums in the biotech sector are generally lucrative, and many stocks in this sector offer good liquidity [1] - The Biotech Forum provides a platform for discussions on solid covered call opportunities related to selected biotech stocks [1] Group 2 - UroGen Pharma Ltd. (NASDAQ: URGN) is highlighted as a small-cap biotech company, with renewed focus since the last article published in August of the previous year [2] - The Biotech Forum, led by Bret, offers a model portfolio featuring 12-20 high upside biotech stocks, along with live chat for trade discussions and weekly research updates [2]
Cardinal Health周四盘前下跌 19亿美元收购交易致股价下挫
Xin Lang Cai Jing· 2025-08-14 13:05
Core Viewpoint - Cardinal Health announced the acquisition of UroGen Pharma for $1.9 billion, leading to a decline in its stock price [1] Group 1: Acquisition Details - The acquisition is a cash transaction valued at $1.9 billion [1] - UroGen Pharma is valued at $16 per share, representing a 14% premium over its closing price on Tuesday [1] Group 2: Market Reaction - Following the announcement, Cardinal Health's stock price initially dropped by 4.2% during trading [1] - The stock ultimately closed down 2.7% at $102.45 [1]
UroGen Pharma(URGN) - 2025 Q2 - Earnings Call Transcript
2025-08-07 15:00
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]
UroGen Pharma(URGN) - 2025 Q2 - Quarterly Report
2025-08-07 12:05
[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)