UroGen Announces Strategic Collaboration and Investment Agreements with IntraGel to Access Biodegradable Sustained-Release Gel Platform and Expand Oncology Pipeline

• Collaboration grants UroGen a research license and exclusive options to license and develop up to three oncology products utilizing IntraGel's proprietary SRGel platform
• Agreement also includes an exclusive option to acquire worldwide rights to TumoCure, an investigational therapy for advanced head and neck cancer
  

PRINCETON, N.J., Aug. 20, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotechnology company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced a strategic Option and Research License Agreement (the Option Agreement) and a related equity investment agreement (the Investment Agreement) with IntraGel Therapeutics, Ltd. (IntraGel).

The Option Agreement includes two strategic components. First, UroGen gains access to IntraGel's proprietary SRGel platform, a biodegradable, sustained-release formulation technology designed for localized drug delivery, through a research license and options to obtain an exclusive, worldwide license to develop and commercialize up to three additional oncology products combining the SRGel platform with compounds to be designated by UroGen. Second, UroGen receives an exclusive option to obtain an exclusive, worldwide license to develop and commercialize TumoCure, IntraGel’s investigational therapy for advanced head and neck cancer, following IntraGel's completion of a Phase 2 clinical study.

"This Option Agreement represents an important step in expanding UroGen's oncology pipeline and technological capabilities," said Liz Barrett, President and Chief Executive Officer of UroGen. "IntraGel's biodegradable, sustained-release technology complements our expertise in local drug delivery while creating significant optionality for future innovation. Beyond the opportunity to advance TumoCure following a Phase 2 clinical study, we believe the SRGel technology could potentially enable multiple therapeutic approaches across a range of solid tumors and provide a foundation for new product opportunities over time."

In connection with the Option Agreement, UroGen has also entered into an Investment Agreement with IntraGel, pursuant to which UroGen will invest up to $7 million in the equity securities of IntraGel.

SRGel is a biodegradable depot technology designed to enable sustained local release of therapeutic agents over extended periods. The platform's flexibility supports multiple therapeutic modalities and has potential applicability across a broad range of solid tumor settings.

“UroGen’s leadership in localized oncology therapies and commercial-stage experience make them an ideal partner to help advance the SRGel platform and accelerate the development of TumoCure,” said Peter Siman, Ph.D., Chief Executive Officer and Co-Founder of IntraGel. “We see in this collaboration an important validation of the SRGel platform and the clinical potential of our lead product candidate, TumoCure, while creating a strong pathway to accelerate development across multiple oncology indications.”

TumoCure is an investigational cisplatin treatment formulated with IntraGel’s proprietary SRGel platform, designed to enable prolonged localized drug exposure while limiting systemic exposure.

Presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, early clinical data (N=8) showed that TumoCure was generally well tolerated in Phase 1b patients, showed low systemic cisplatin exposure, and provided early indications of anti-tumor activity in a heavily pretreated patient population, including patients with cisplatin treatment-resistant disease. Investigators also reported improvements in tumor-related symptoms in certain patients. These findings support continued clinical development of TumoCure and further expansion of the SRGel platform as a potential approach for sustained local therapy across additional solid tumors with the goal of minimizing systemic exposure.

About SRGel

SRGel is IntraGel’s proprietary injectable hydrophobic gel-like drug delivery platform designed to enable sustained drug release directly within solid tumors. Built on a proprietary water-free and solvent-free fatty-acids based polymer matrix, SRGel is engineered to provide controlled, and prolonged release of therapeutic agents following a single administration, with applicability for both localized delivery at the target site and sustained local exposure.

The technology is designed, when injected intratumorally, to maintain high local drug concentrations while minimizing systemic exposure and associated toxicities. SRGel has shown early indications of compatibility with a broad range of therapeutic modalities, including small molecules, peptides and biologics, and may be applicable across various therapeutic areas and indications, including weight loss management and inflammatory diseases.

About TumoCure

TumoCure is IntraGel’s lead product candidate and the first clinical application of the SRGel platform. TumoCure consists of cisplatin incorporated into the SRGel biodegradable matrix and is administered as a single intratumoral injection. The investigational therapy is designed to provide sustained delivery of cisplatin directly within tumor tissue over several months while limiting systemic exposure.

TumoCure is Phase 2-ready and is currently being developed for patients with locally advanced, inoperable head and neck cancers, who are ineligible for systemic cisplatin-based chemoradiation. IntraGel is pursuing development through the U.S. Federal Drug Administration (FDA)’s 505(b)(2) regulatory pathway and believes the technology may have future applicability across additional solid tumor indications, including lung, brain, gastrointestinal, ovarian and testicular cancers.

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 is approved to treat low-grade upper tract urothelial cancer, and our second product is approved for adult patients with recurrent LG-IR-NMIBC. Both products are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit www.UroGen.com to learn more or follow us on X, @UroGenPharma.

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: the potential benefits of the Option Agreement with IntraGel; UroGen’s plans to evaluate, develop and potentially commercialize oncology products utilizing the SRGel platform; the potential therapeutic applications of the SRGel platform, including its ability to enable sustained local drug release, maintain high local drug concentrations and limit systemic exposure; the potential applicability of the SRGel platform across multiple therapeutic modalities, therapeutic areas and solid tumor settings, including weight loss management and inflammatory diseases; the intended performance and clinical development of TumoCure, including its potential to provide sustained delivery of cisplatin within tumor tissue while limiting systemic exposure; expectations regarding the continued clinical development of TumoCure, including the planned Phase 2 clinical study; IntraGel’s pursuit of the FDA’s 505(b)(2) regulatory pathway for TumoCure; the potential future applicability of TumoCure across additional solid tumor indications, including lung, brain, gastrointestinal, ovarian and testicular cancers; and the potential of UroGen’s RTGel platform technology to improve the therapeutic profiles of existing drugs and enable longer exposure of urinary tract tissue to medications. Words such as “anticipate,” “believe,” “could,” “may,” “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: preliminary clinical results may not be indicative of results that may be observed in the future; potential safety and other complications related to UroGen’s products and product candidates, as well as the product candidates covered by the Option Agreement; there is no guarantee that the Option Agreement will yield any product candidates that UroGen determines have strategic value, and even if UroGen elects to exercise its option to obtain an exclusive license to one or more product candidates, there is no guarantee that any such products will receive regulatory approval; risks related to our and our licensors’ ability to protect our respective patents and other intellectual property, including the fact that UroGen’s or its licensors’ pending patent applications may not be successful, and in such event, the duration of intellectual property protection would be more limited; the ability to maintain regulatory approval; complications associated with commercialization activities; labeling limitations; competition in UroGen’s industry; the scope, progress and expansion of developing and commercializing UroGen’s products and 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 and UroGen’s products and product candidates may not perform as expected; and the impacts of general macroeconomic and geopolitical conditions on UroGen’s business and financial position. These and other risks and uncertainties are described in the Risk Factors section of UroGen’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the U.S. Securities and Exchange Commission on August 5, 2026. In light of these risks and uncertainties, 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.

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

609-460-3566 ext. 1083