UroGen Pharma Reports Fourth Quarter and Full Year 2024 Financial Results and Announces Updated 18-Month Duration of Response (DOR) of 80.6% from the Phase 3 ENVISION Trial of UGN-102
UroGen Pharma (URGN) reported key financial results and clinical developments for Q4 and full year 2024. The company's flagship product JELMYTO achieved net product revenue of $90.4 million in 2024, up from $82.7 million in 2023, with 12% underlying demand growth.
A significant highlight is the updated 18-month Duration of Response (DOR) data from the Phase 3 ENVISION trial of UGN-102, showing an 80.6% response rate. The FDA is currently reviewing UGN-102's New Drug Application with a PDUFA date set for June 13, 2025. If approved, UGN-102 could address an estimated market opportunity exceeding $5 billion.
Financial position shows $241.7 million in cash and equivalents as of December 31, 2024. The company reported a net loss of $126.9 million ($2.96 per share) for 2024. For 2025, UroGen projects JELMYTO revenues between $94-98 million and operating expenses of $215-225 million.
UroGen Pharma (URGN) ha riportato i risultati finanziari chiave e gli sviluppi clinici per il quarto trimestre e l'intero anno 2024. Il prodotto di punta dell'azienda, JELMYTO, ha raggiunto un fatturato netto di $90,4 milioni nel 2024, in aumento rispetto agli $82,7 milioni del 2023, con una crescita della domanda sottostante del 12%.
Un punto saliente significativo è rappresentato dai dati aggiornati sulla Durata della Risposta (DOR) a 18 mesi dello studio di Fase 3 ENVISION di UGN-102, che mostrano un tasso di risposta dell'80,6%. La FDA sta attualmente esaminando la Domanda di Nuovo Farmaco per UGN-102, con una data PDUFA fissata per il 13 giugno 2025. Se approvato, UGN-102 potrebbe affrontare un'opportunità di mercato stimata superiore ai $5 miliardi.
La posizione finanziaria mostra $241,7 milioni in contante e equivalenti al 31 dicembre 2024. L'azienda ha riportato una perdita netta di $126,9 milioni ($2,96 per azione) per il 2024. Per il 2025, UroGen prevede ricavi da JELMYTO tra $94-98 milioni e spese operative tra $215-225 milioni.
UroGen Pharma (URGN) informó sobre los resultados financieros clave y los desarrollos clínicos para el cuarto trimestre y el año completo 2024. El producto insignia de la compañía, JELMYTO, logró ingresos netos por producto de $90.4 millones en 2024, en comparación con $82.7 millones en 2023, con un crecimiento de la demanda subyacente del 12%.
Un aspecto destacado es la actualización de los datos de 18 meses de la Duración de Respuesta (DOR) del ensayo de Fase 3 ENVISION de UGN-102, que muestra una tasa de respuesta del 80.6%. La FDA está revisando actualmente la Solicitud de Nuevo Medicamento de UGN-102, con una fecha PDUFA establecida para el 13 de junio de 2025. Si se aprueba, UGN-102 podría abordar una oportunidad de mercado estimada en más de $5 mil millones.
La posición financiera muestra $241.7 millones en efectivo y equivalentes a partir del 31 de diciembre de 2024. La compañía reportó una pérdida neta de $126.9 millones ($2.96 por acción) para 2024. Para 2025, UroGen proyecta ingresos de JELMYTO entre $94-98 millones y gastos operativos de $215-225 millones.
UroGen Pharma (URGN)는 2024년 4분기 및 전체 연도에 대한 주요 재무 결과와 임상 개발을 보고했습니다. 회사의 주력 제품인 JELMYTO는 2024년에 9,040만 달러의 순수익을 기록했으며, 이는 2023년의 8,270만 달러에서 증가한 수치로, 기본 수요가 12% 성장했습니다.
주목할 만한 점은 UGN-102의 3상 ENVISION 시험에서 18개월 반응 지속 기간(DOR) 데이터가 업데이트되어 80.6%의 반응률을 보여주었습니다. FDA는 현재 UGN-102의 신약 신청을 검토 중이며, PDUFA 날짜는 2025년 6월 13일로 설정되어 있습니다. 승인될 경우, UGN-102는 50억 달러를 초과하는 예상 시장 기회에 대응할 수 있습니다.
재무 상태는 2024년 12월 31일 기준으로 현금 및 현금성 자산이 2억 4,170만 달러임을 보여줍니다. 회사는 2024년에 1억 2,690만 달러(주당 2.96달러)의 순손실을 보고했습니다. 2025년에는 UroGen이 JELMYTO 수익을 9,400만 달러에서 9,800만 달러 사이로, 운영 비용을 2억 1,500만 달러에서 2억 2,500만 달러 사이로 예상하고 있습니다.
UroGen Pharma (URGN) a rapporté des résultats financiers clés et des développements cliniques pour le quatrième trimestre et l'année complète 2024. Le produit phare de l'entreprise, JELMYTO, a atteint un chiffre d'affaires net de 90,4 millions de dollars en 2024, contre 82,7 millions de dollars en 2023, avec une croissance de la demande sous-jacente de 12%.
Un point marquant est les données mises à jour sur la Durée de Réponse (DOR) de 18 mois de l'essai de Phase 3 ENVISION de l'UGN-102, montrant un taux de réponse de 80,6%. La FDA examine actuellement la Demande de Nouveau Médicament pour l'UGN-102, avec une date PDUFA fixée au 13 juin 2025. Si approuvé, l'UGN-102 pourrait représenter une opportunité de marché estimée à plus de 5 milliards de dollars.
La position financière montre 241,7 millions de dollars en espèces et équivalents au 31 décembre 2024. L'entreprise a enregistré une perte nette de 126,9 millions de dollars (2,96 dollars par action) pour 2024. Pour 2025, UroGen prévoit des revenus de JELMYTO compris entre 94 et 98 millions de dollars et des dépenses d'exploitation entre 215 et 225 millions de dollars.
UroGen Pharma (URGN) hat die wichtigsten finanziellen Ergebnisse und klinischen Entwicklungen für das vierte Quartal und das Gesamtjahr 2024 berichtet. Das Flaggschiffprodukt des Unternehmens, JELMYTO, erzielte 2024 einen Nettoumsatz von 90,4 Millionen Dollar, ein Anstieg von 82,7 Millionen Dollar im Jahr 2023, mit einem Wachstum der zugrunde liegenden Nachfrage von 12%.
Ein bedeutendes Highlight sind die aktualisierten Daten zur 18-monatigen Reaktionsdauer (DOR) aus der Phase-3-Studie ENVISION von UGN-102, die eine Reaktionsrate von 80,6% zeigt. Die FDA prüft derzeit den Antrag auf Zulassung eines neuen Arzneimittels für UGN-102, mit einem PDUFA-Datum, das auf den 13. Juni 2025 festgelegt ist. Wenn genehmigt, könnte UGN-102 eine geschätzte Marktchance von über 5 Milliarden Dollar ansprechen.
Die finanzielle Lage zeigt zum 31. Dezember 2024 241,7 Millionen Dollar in bar und Äquivalenten. Das Unternehmen berichtete für 2024 von einem Nettoverlust von 126,9 Millionen Dollar (2,96 Dollar pro Aktie). Für 2025 prognostiziert UroGen Einnahmen aus JELMYTO zwischen 94 und 98 Millionen Dollar sowie Betriebskosten zwischen 215 und 225 Millionen Dollar.
- JELMYTO revenue grew 12% year-over-year to $90.4 million in 2024
- Strong cash position of $241.7 million as of December 31, 2024
- UGN-102 showed impressive 80.6% 18-month duration of response in Phase 3 trial
- 33% increase in new prescribers and 13% increase in new patient starts for JELMYTO
- Potential $5 billion market opportunity for UGN-102 if approved
- Net loss increased to $126.9 million in 2024 from $102.2 million in 2023
- Operating expenses expected to increase to $215-225 million in 2025
- R&D expenses increased 25% to $57.1 million in 2024
- SG&A expenses rose 30% to $121.2 million in 2024
Insights
UroGen's Q4 and full-year 2024 results showcase a company successfully progressing both commercially and clinically. The
The
The widening net loss (
The company's pipeline expansion with the ICVB-1042 acquisition and advancement of next-generation mitomycin formulations (UGN-103/104) provides longer-term growth potential beyond UGN-102. The upcoming UGN-102 approval decision represents the most significant near-term value inflection point that could transform UroGen's commercial trajectory.
-
UGN-102 Pivotal ENVISION trial demonstrated an 18-month DOR of
80.6% (95% CI: 74.0, 85.7), by Kaplan-Meier estimate, for patients who achieved a complete response (CR) at three months after the first instillation of UGN-102 - New drug application (NDA) for UGN-102 under review by the FDA; Prescription Drug User Fee Act (PDUFA) target action date set for June 13, 2025
- Acquired a next-generation investigational oncolytic virus (ICVB-1042) and announced multiple strategic research collaborations in support of long-term growth strategy
-
JELMYTO® achieved net product revenue of
$90.4 million $82.7 million 12% for 2024 and15% for Q4 2024 -
$241.7 million - Conference call and webcast to be held today at 10:00 AM ET
“2024 was a pivotal year for UroGen with achievements across our commercial business and pipeline,” said Liz Barrett, President and Chief Executive Officer of UroGen. “The progress with UGN-102 for low-grade intermediate-risk non-muscle invasive bladder cancer, including completion of the submission of our NDA ahead of schedule and compelling DOR data from the Phase 3 ENVISION trial, further positions us to launch a product that we believe will represent a paradigm shift in care, if approved. UGN-102 is supported by a compelling body of clinical data, and we are very pleased to report today the 18-month DOR of
2024 and Recent Business Highlights:
UGN-102 (mitomycin) for intravesical solution:
- UroGen’s NDA for investigational drug UGN-102 (mitomycin) for intravesical solution as a treatment for low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC), is currently under review by the FDA. The FDA assigned a PDUFA target action date of June 13, 2025.
-
The Company reported updated 18-month DOR data from the Phase 3 ENVISION trial that evaluated UGN-102 in patients with LG-IR-NMIBC. The 18-month DOR data is consistent with prior Kaplan-Meier estimates, with a DOR rate of
80.6% (95% CI: 74.0, 85.7) at 18-months (N=101) compared to82.5% (95% CI: 76.1, 87.3) at 12-months (N=146). Median follow-up time at 18 months was 18.7 months after the three-month CR. - Results from a subgroup analysis of the ENVISION trial were featured in a poster at the American Society of Clinical Oncology’s Genitourinary Cancers Symposium (ASCO-GU 2025) in February 2025. The analysis of pre-specified subgroups (presented by Sandip M Prasad, MD, MPhil et al) suggests that tumor burden and the number of tumors at baseline did not significantly affect the CR rate or DOR for patients treated with UGN-102.
JELMYTO (mitomycin) for pyelocalyceal solution in low-grade upper tract urothelial cancer (LG-UTUC):
-
Generated net product revenue of
$90.4 million $82.7 million 12% year-over-year, partially offset by a decrease in CREATES Act sales, which totaled$3.0 million $4.4 million 33% and13% , respectively, in 2024. -
A long-term study on JELMYTO titled, “Durability of Response of UGN-101: Longitudinal Follow-Up of Multicenter Study,” was published online in Urologic Oncology: Seminars and Investigations in January 2025. The results showed
68% recurrence-free survival rate at three years across a broad patient population with LG-UTUC. - A long-term follow-up study to the OLYMPUS trial evaluating JELMYTO was presented at the Society for Urologic Oncology annual meeting in December 2024. The study reported a median DOR of 47.8 months in patients who achieved a CR after primary chemoablation with JELMYTO. These results were also published online in the Journal of Urology.
Next-generation novel mitomycin-based formulation for urothelial cancers
- Enrollment is ongoing in the Phase 3 UTOPIA trial of investigational drug UGN-103 (mitomycin) for intravesical solution in patients with LG-IR-NMIBC. UGN-103 is a next generation investigational medicine that combines UroGen’s RTGel® technology with a novel mitomycin formulation licensed from medac GmbH. UGN-103 is planned to follow the potential FDA approval and launch of UGN-102 for LG-IR-NMIBC. To learn more about the UTOPIA trial, refer to clinicaltrials.gov/NCT06331299.
- UroGen plans to initiate a Phase 3 trial to explore the safety and efficacy of UGN-104, its next generation product for LG-UTUC in the first half of 2025.
UGN-301 (zalifrelimab), an anti-CTLA4 antibody for use in high-grade non-muscle invasive bladder cancer
- Completed enrollment of the dose escalation phase of UGN-301, alone and in combination with fixed dose UGN-201 or gemcitabine. The treatments demonstrated an acceptable safety profile and were generally well tolerated across dose levels. Responses were observed in both monotherapy and combination therapy arms, and patient follow-up is ongoing to further assess the durability of these responses.
Next-generation investigational oncolytic virus ICVB-1042
- In February 2025, UroGen expanded its pre-clinical oncology portfolio with the purchase of the product candidate ICVB-1042 and certain related assets from IconOVir Bio, Inc. ICVB-1042 is being developed to be a potent, fast-replicating, next-generation oncolytic virus therapy that can be administered locally to treat bladder cancer and potentially other specialty cancers. UroGen hosted a webinar to discuss ICVB-1042 on February 20, 2025 and a replay can be accessed on the Company’s website here.
Fourth Quarter and Full Year 2024 Financial Results
JELMYTO Revenue: JELMYTO net product revenue was
R&D Expense: Research and development expenses for the fourth quarter of 2024 were
SG&A Expense: Selling, general and administrative expenses for the fourth quarter of 2024 were
Financing on Prepaid Forward Obligation: UroGen reported non-cash financing expense related to the prepaid forward obligation to RTW Investments of
Interest Expense on Long-Term Debt: Interest expense related to the outstanding
Net Loss: UroGen reported a net loss of
Cash & Cash Equivalents: As of December 31, 2024, cash, cash equivalents and marketable securities totaled
For further details on the Company’s financials, refer to Form 10-K, filed with the SEC.
2025 JELMYTO Revenue and Company Operating Expense Guidance: The Company expects full-year 2025 net product revenues from JELMYTO to be in the range of
Conference Call & Webcast Information: Members of UroGen’s management team will host a live conference call and webcast today at 10:00 AM Eastern Time to review UroGen’s financial results and provide a general business update.
The live webcast can be accessed by visiting the Investors section of the Company’s website at investors.UroGen.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast.
UROGEN PHARMA LTD. |
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SELECTED CONSOLIDATED BALANCE SHEETS |
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December 31, 2024 |
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December 31, 2023 |
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Cash and cash equivalents and marketable securities |
|
$ |
241,707 |
|
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$ |
141,470 |
|
Total assets |
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$ |
285,711 |
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$ |
178,311 |
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Total liabilities |
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$ |
294,514 |
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$ |
243,523 |
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Total shareholders' deficit |
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$ |
(8,803 |
) |
|
$ |
(65,212 |
) |
UROGEN PHARMA LTD. |
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CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
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( |
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Three months ended December 31, |
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Year ended December 31, |
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2024 |
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2023 |
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2024 |
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2023 |
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Revenue |
$ |
24,565 |
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$ |
23,530 |
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$ |
90,398 |
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$ |
82,713 |
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Cost of revenue |
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2,471 |
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|
|
2,286 |
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|
|
8,881 |
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|
|
9,361 |
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Gross profit |
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22,094 |
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|
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21,244 |
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81,517 |
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73,352 |
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Operating expenses: |
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Research and development expenses |
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14,894 |
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11,302 |
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57,145 |
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45,614 |
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Selling, general and administrative expenses |
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34,858 |
|
|
|
24,551 |
|
|
|
121,154 |
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|
|
93,274 |
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Total operating expenses |
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49,752 |
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35,853 |
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178,299 |
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138,888 |
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Operating loss |
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(27,658 |
) |
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(14,609 |
) |
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(96,782 |
) |
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(65,536 |
) |
Financing on prepaid forward obligation |
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(6,063 |
) |
|
|
(5,505 |
) |
|
|
(23,411 |
) |
|
|
(21,552 |
) |
Interest expense on long-term debt |
|
(3,892 |
) |
|
|
(3,586 |
) |
|
|
(12,521 |
) |
|
|
(14,715 |
) |
Interest and other income, net |
|
2,750 |
|
|
|
1,538 |
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|
|
8,672 |
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|
|
3,479 |
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Loss before income taxes |
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(34,863 |
) |
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(22,162 |
) |
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(124,042 |
) |
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(98,324 |
) |
Income tax expense |
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(2,649 |
) |
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(3,854 |
) |
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(2,832 |
) |
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(3,920 |
) |
Net loss |
$ |
(37,512 |
) |
|
$ |
(26,016 |
) |
|
$ |
(126,874 |
) |
|
$ |
(102,244 |
) |
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Net loss per ordinary share basic and diluted |
$ |
(0.80 |
) |
|
$ |
(0.72 |
) |
|
$ |
(2.96 |
) |
|
$ |
(3.55 |
) |
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Weighted average shares outstanding, basic and diluted |
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47,030,820 |
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36,153,634 |
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42,876,737 |
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28,834,303 |
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About JELMYTO
JELMYTO® (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel indicated for the treatment of adult patients with LG-UTUC. It is recommended for primary treatment of biopsy-proven LG-UTUC in patients deemed appropriate candidates for renal-sparing therapy. JELMYTO is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding. It is approved for administration in a retrograde manner via ureteral catheter or antegrade through nephrostomy tube. The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemoablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow.
APPROVED USE FOR JELMYTO
JELMYTO® is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).
IMPORTANT SAFETY INFORMATION
You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.
Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you:
- are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO. Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose. Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose.
- are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO and for 1 week after the last dose.
- Tell your healthcare provider if you take water pills (diuretic).
How will I receive JELMYTO?
- Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment.
- You will receive your JELMYTO dose from your healthcare provider 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider’s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. Your healthcare provider may recommend up to an additional 11 monthly doses.
- JELMYTO is given to your kidney through a tube called a catheter.
- During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.
After receiving JELMYTO:
- JELMYTO may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 6 hours.
- To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.
- Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.
JELMYTO may cause serious side effects, including:
- Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell your healthcare provider right away if you develop side pain or fever during treatment with JELMYTO.
- Bone marrow problems. JELMYTO can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO.
- The most common side effects of JELMYTO include: urinary tract infection, blood in your urine, side pain, nausea, trouble with urination, kidney problems, vomiting, tiredness, stomach (abdomen) pain.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.
Please see JELMYTO Full Prescribing Information, including the Patient Information, for additional information.
About Upper Tract Urothelial Cancer (UTUC)
Urothelial cancer is the ninth most common cancer globally and the eighth most lethal neoplasm in men in the
About UGN-102
UGN-102 (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, currently in Phase 3 development for the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel® technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting by a trained healthcare professional. UroGen completed the NDA submission in August, ahead of schedule. The FDA accepted the NDA for UGN-102 and assigned a PDUFA goal date of June 13, 2025.
About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel® reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Our first product to treat LG-UTUC and investigational treatment UGN-102 (mitomycin) for intravesical solution for patients with low-grade non-muscle invasive bladder cancer are designed to ablate tumors by non-surgical means. UroGen is headquartered in
Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: statements related to UroGen’s NDA submission, and expected PDUFA target action date for UGN-102; conclusions from the ENVISION data; the estimated patient population and demographics for LG-IR-NMIBC and UTUC; the potential applications of ICVB-1042 in treating bladder cancer as well as other types of cancers; the ENVISION subgroup analyses providing evidence of UGN-102's potential to become an effective and durable treatment option for patients with recurrent LG-IR-NMIBC, regardless of tumor size or focality; plans for UGN-103 to follow the potential FDA approval and launch of UGN-102; the timing for the planned Phase 3 trial to explore the safety and efficacy of UGN-104 in the first half of 2025; the potential for ICVB-1042 to be potent, fast-replicating, and administered locally to treat cancer; 2025 financial guidance; the potential of UroGen’s proprietary RTGel technology to improve therapeutic profiles of existing drugs; and UroGen’s sustained release technology making local delivery potentially more effective as compared to other treatment options. Words such as “estimate,” “believe,” “if,” “may,” “plan,” “potential,” “suggest," “will,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: preliminary results may not be indicative of results that may be observed in the future; the timing and success of clinical trials and potential safety and other complications thereof; unforeseen delays that may impact the timing of progressing clinical trials and reporting data; findings from the durability of response endpoint from the ENVISION Phase 3 study may not be sufficient to support approval of UGN-102 on the timeframe expected, or at all; the PDUFA target action date may be delayed due to various factors outside UroGen’s control; the ability to obtain regulatory approval within the timeframe expected, or at all; the ability to obtain and maintain adequate intellectual property rights and adequately protect and enforce such rights; the ability to obtain and maintain regulatory approval within the timeframe expected, or at all; complications associated with commercialization activities; the labeling for any approved product; competition in UroGen’s industry; the scope, progress and expansion of developing and commercializing UroGen’s product candidates; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies or procedures, such as surgery; UroGen’s ability to attract or retain key management, members of the board of directors and other personnel; UroGen’s RTGel technology may not perform as expected; UroGen may not successfully develop and receive regulatory approval of any other product that incorporates RTGel technology; and UroGen’s financial condition and need for additional capital in the future. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the SEC on November 6, 2024, and in UroGen’s Annual Report on Form 10-K for the year ended December 31, 2024, being filed with the SEC later today, the events and circumstances discussed in such forward-looking statements may not occur, and UroGen’s actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to UroGen as of the date of this release.
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INVESTOR CONTACT:
Vincent Perrone
Senior Director, Investor Relations
vincent.perrone@UroGen.com
609-460-3588 ext. 1093
MEDIA CONTACT:
Cindy Romano
Director, Corporate Communications
cindy.romano@UroGen.com
609-460-3583 ext. 1083
Source: UroGen Pharma Ltd.
FAQ
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