UroGen Advances Long-Term Growth Strategy by Acquiring a Next-Generation Investigational Oncolytic Virus (ICVB-1042) and Announces Multiple Strategic Research Collaborations
UroGen Pharma (NASDAQ: URGN) has expanded its oncology pipeline through the acquisition of ICVB-1042, a next-generation oncolytic virus, from IconOVir Bio. The acquisition involves issuing 374,843 ordinary shares (valued at approximately $4.0 million), a potential $15.0 million milestone payment upon achieving specific worldwide net sales targets, and a low single-digit percentage royalty on product sales.
ICVB-1042 is engineered to selectively destroy cancer cells while maintaining potency and triggering immune responses. This development represents a potential advancement over traditional BCG therapy in bladder cancer treatment. Additionally, UroGen announced multiple strategic research collaborations to explore their RTGel® technology's potential in enhancing immunotherapy effectiveness through improved dwell time.
UroGen Pharma (NASDAQ: URGN) ha ampliato il suo portafoglio oncologico attraverso l'acquisizione di ICVB-1042, un virus oncolitico di nuova generazione, da IconOVir Bio. L'acquisizione prevede l'emissione di 374.843 azioni ordinarie (valutate circa 4,0 milioni di dollari), un pagamento potenziale di 15,0 milioni di dollari al raggiungimento di specifici obiettivi di vendite nette mondiali, e una royalty su vendite di prodotto a una percentuale bassa a cifra singola.
ICVB-1042 è progettato per distruggere selettivamente le cellule tumorali mantenendo la potenza e attivando risposte immunitarie. Questo sviluppo rappresenta un potenziale avanzamento rispetto alla tradizionale terapia BCG nel trattamento del cancro alla vescica. Inoltre, UroGen ha annunciato numerose collaborazioni di ricerca strategiche per esplorare il potenziale della loro tecnologia RTGel® nel migliorare l'efficacia dell'immunoterapia attraverso un tempo di permanenza migliorato.
UroGen Pharma (NASDAQ: URGN) ha ampliado su cartera oncológica mediante la adquisición de ICVB-1042, un virus oncolítico de nueva generación, de IconOVir Bio. La adquisición implica la emisión de 374,843 acciones ordinarias (valoradas en aproximadamente 4.0 millones de dólares), un pago potencial de 15.0 millones de dólares al alcanzar objetivos específicos de ventas netas mundiales, y una regalía de un solo dígito bajo sobre las ventas del producto.
ICVB-1042 está diseñado para destruir selectivamente las células cancerosas mientras mantiene su potencia y desencadena respuestas inmunitarias. Este desarrollo representa un avance potencial sobre la terapia BCG tradicional en el tratamiento del cáncer de vejiga. Además, UroGen anunció múltiples colaboraciones de investigación estratégicas para explorar el potencial de su tecnología RTGel® en mejorar la efectividad de la inmunoterapia a través de un tiempo de permanencia mejorado.
UroGen Pharma (NASDAQ: URGN)는 IconOVir Bio로부터 차세대 온콜리틱 바이러스인 ICVB-1042를 인수하여 종양학 파이프라인을 확장했습니다. 이번 인수에는 약 400만 달러에 해당하는 374,843주의 보통주 발행, 특정 전 세계 순매출 목표를 달성할 경우 1500만 달러의 마일스톤 지급 가능성, 그리고 제품 판매에 대한 저단위 싱글 숫자 로열티가 포함됩니다.
ICVB-1042는 암세포를 선택적으로 파괴하면서도 효능을 유지하고 면역 반응을 유도하도록 설계되었습니다. 이 개발은 방광암 치료에 있어 전통적인 BCG 요법보다 잠재적인 발전을 의미합니다. 또한, UroGen은 개선된 체류 시간을 통해 면역 요법의 효과를 향상시키기 위한 RTGel® 기술의 잠재력을 탐색하기 위해 여러 전략적 연구 협력을 발표했습니다.
UroGen Pharma (NASDAQ: URGN) a élargi son portefeuille en oncologie grâce à l'acquisition d'ICVB-1042, un virus oncolytique de nouvelle génération, auprès d'IconOVir Bio. L'acquisition implique l'émission de 374 843 actions ordinaires (d'une valeur d'environ 4,0 millions de dollars), un paiement potentiel de 15,0 millions de dollars à l'atteinte d'objectifs spécifiques de ventes nettes mondiales, et une redevance à un chiffre unique bas sur les ventes de produits.
ICVB-1042 est conçu pour détruire sélectivement les cellules cancéreuses tout en maintenant sa puissance et en déclenchant des réponses immunitaires. Ce développement représente un potentiel avancement par rapport à la thérapie BCG traditionnelle dans le traitement du cancer de la vessie. De plus, UroGen a annoncé plusieurs collaborations de recherche stratégiques pour explorer le potentiel de sa technologie RTGel® à améliorer l'efficacité de l'immunothérapie grâce à un temps de séjour amélioré.
UroGen Pharma (NASDAQ: URGN) hat seine Onkologie-Pipeline durch die Übernahme von ICVB-1042, einem Onkolytischen Virus der nächsten Generation, von IconOVir Bio erweitert. Die Übernahme umfasst die Ausgabe von 374.843 Stammaktien (im Wert von etwa 4,0 Millionen Dollar), eine potenzielle Meilensteinzahlung von 15,0 Millionen Dollar bei Erreichung bestimmter weltweiter Nettoumsatzziele und eine niedrige einstellige Prozentgebühr auf Produktverkäufe.
ICVB-1042 ist so konzipiert, dass es selektiv Krebszellen zerstört und dabei die Wirksamkeit aufrechterhält und Immunantworten auslöst. Diese Entwicklung stellt einen potenziellen Fortschritt gegenüber der traditionellen BCG-Therapie bei der Behandlung von Blasenkrebs dar. Darüber hinaus kündigte UroGen mehrere strategische Forschungskooperationen an, um das Potenzial ihrer RTGel®-Technologie zur Verbesserung der Wirksamkeit von Immuntherapien durch verlängerte Verweildauer zu erkunden.
- Strategic acquisition of ICVB-1042 expands oncology pipeline
- Structured deal terms with minimal upfront cash investment ($4M in shares)
- Potential for new revenue streams through bladder cancer treatment advancement
- Multiple research collaborations established to enhance RTGel® technology applications
- Future milestone payment obligation of $15M based on sales performance
- Ongoing royalty payment commitments on future product sales
- Share dilution from issuance of 374,843 ordinary shares
Insights
UroGen's strategic acquisition of ICVB-1042 represents a calculated move into next-generation cancer therapeutics, with deal terms structured to minimize upfront risk while maintaining significant upside potential. The $4 million initial payment in shares, coupled with a $15 million sales milestone and single-digit royalties, demonstrates prudent capital allocation while securing a potentially transformative asset.
The bladder cancer treatment market, currently dominated by BCG therapy, presents a substantial opportunity. BCG therapy, while effective, faces persistent supply challenges and significant limitations in terms of resistance and recurrence rates. ICVB-1042's dual mechanism of selective cancer cell destruction and immune response activation could address these limitations, potentially capturing market share in a global bladder cancer treatment market valued at several billion dollars.
The concurrent announcement of multiple research collaborations focused on RTGel technology optimization suggests a comprehensive strategy to enhance UroGen's therapeutic platform. The combination of RTGel's improved dwell time capabilities with various immunotherapies could create significant barriers to entry and expand the company's addressable market beyond current indications.
From a financial perspective, the deal structure preserves UroGen's cash position while adding a promising asset to its pipeline. The use of shares for the upfront payment helps maintain liquidity, while the milestone and royalty structure aligns incentives for successful commercialization. The research collaborations further leverage existing technology investments, potentially creating multiple paths to value creation.
Key risk factors include clinical development uncertainties, regulatory timelines, and potential competition from other emerging therapies. However, the established precedent of immunological approaches in bladder cancer treatment could provide a clearer regulatory pathway compared to entirely novel therapeutic modalities.
- ICVB-1042 is an Oncolytic Virus Engineered to Selectively Destroy Cancer Cells While Retaining Potency and Trigger a Robust Immune Response
- Strategic Research Collaborations Focused on Exploring the Potential of UroGen’s Innovative RTGel® Technology to Enhance the Clinical Effectiveness of Multiple Immunotherapies
- Conference Call Webcast to be Held Today at 12:00 PM ET
“UroGen’s long-term growth strategy is built on advancing our uro-oncology pipeline, expanding our portfolio, and driving innovation in cancer treatment,” said Liz Barrett, President and Chief Executive Officer of UroGen. “The acquisition of ICVB-1042, a next-generation investigational oncolytic virus, marks a significant milestone in our plan to develop novel, locally administered therapies for bladder cancer and other specialty cancers. This strategic investment underscores our commitment to identifying and advancing high-impact therapies that address critical unmet needs. Through targeted acquisitions and research collaborations, we are strengthening UroGen’s leadership in oncology and laying the foundation for sustained innovation and growth.”
The use of biological agents to treat bladder cancer has its roots in the development of Bacillus Calmette-Guérin (BCG) therapy. Much like BCG therapy, ICVB-1042 is being developed to activate the immune system within the tumor microenvironment, but unlike BCG therapy, ICVB-1042 has the potential to selectively destroy cancer cells while retaining potency and trigger a robust immune response. A fusion of potency and cancer cell destruction would mark a groundbreaking step forward, unlocking new possibilities in the fight against cancer.
“The treatment of bladder cancer has long been shaped by immunological approaches such as BCG therapy. UroGen now seeks to advance bladder cancer treatment with highly targeted, next-generation viral immunotherapies like ICVB-1042,” said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. “ICVB-1042 may represent an exciting leap forward, with several attributes we believe differentiate this asset from other oncolytic viruses. Supported by a robust non-clinical data package, we are eager to develop this investigational therapy as a potential new treatment in localized cancer.”
Asset Purchase
On February 14, 2025, UroGen acquired certain assets of IconOVir, including product candidate ICVB-1042, and assumed certain liabilities and obligations of IconOVir arising under certain acquired contracts. As consideration for the assets, UroGen issued IconOVir 374,843 of its ordinary shares (representing a value of approximately
Conference Call & Webcast Information
Members of UroGen’s management team will host a live conference call and webcast today at 12:00 PM ET to discuss the Company’s long-term growth strategy. The live webcast can be accessed by visiting the Investors section of the Company’s website at http://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.
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 low-grade upper tract urothelial cancer and investigational treatment UGN-102 (mitomycin) for intravesical solution for patients with LG-IR-NMIBC 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: UroGen’s long-term growth strategy; UroGen’s targeted acquisitions and research collaborations strengthening UroGen’s leadership in oncology and laying the foundation for sustained innovation and growth; the focus of UroGen’s strategic research collaborations; the potential of ICBV-1042 to selectively target cancer cells while retaining potency, triggering an immune response, and minimizing systemic exposure; the belief that ICVB-1042 has several attributes that differentiate it from other oncolytic viruses; 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 “believe,” “plan,” “potential,” “will,” or other words that convey uncertainty of future events or outcomes are used to identify these forward-looking statements. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: prior results may not be indicative of results that may be observed in the future; the ability to maintain regulatory approval; 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; 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’s financial condition and need for additional capital; and UroGen may not successfully develop and receive regulatory approval of any other product that incorporates RTGel technology. 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 (which is available at www.sec.gov), 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, Communications
cindy.romano@urogen.com
609-460-3583 ext. 1083
Source: UroGen Pharma Ltd.
FAQ
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