UroGen Pharma Announces ENVISION and Jelmyto Data, Q1 2024 Results and Highlights

UroGen Pharma Ltd., a biopharmaceutical company focused on developing treatments for urothelial and specialty cancers, announced its financial results for the first quarter ending March 31, 2024. The company also shared updates on its recent advancements and upcoming milestones.

Key Highlights:

UGN-102 (mitomycin) for intravesical solution: In January 2024, UroGen began a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for UGN-102, aimed at treating low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The submission is expected to be completed in the third quarter of 2024, with a potential FDA decision in the first quarter of 2025. UroGen anticipates that UGN-102 will address a significant market opportunity exceeding $3 billion if approved.

In May 2024, a subgroup analysis from the UGN-102 ATLAS trial was presented at the American Urological Association (AUA) 2024 Annual Meeting in San Antonio, Texas. The analysis revealed promising results for patients with new and recurrent LG-IR-NMIBC treated with UGN-102 ± TURBT (transurethral resection of bladder tumor), showing high probabilities of disease-free survival and complete response.

JELMYTO (mitomycin) for pyelocalyceal solution in low-grade upper tract urothelial cancer (LG-UTUC): A post-hoc analysis of the OLYMPUS trial, soon to be published, assessed the long-term treatment effects of JELMYTO on LG-UTUC. Out of 71 patients enrolled in OLYMPUS, 41 achieved a complete response (CR). Follow-up data indicated a median duration of response of 47.8 months, with 75% of patients in a 5-year rollover study showing no disease recurrence. JELMYTO also exhibited continued growth, with net product sales reaching $18.8 million in the first quarter of 2024, compared to $17.2 million in the same period in 2023, reflecting approximately 10% year-over-year growth.

Next-Generation Mitomycin-Based Formulation: In January 2024, UroGen entered into a license and supply agreement with medac GmbH to develop next-generation mitomycin-based formulations for urothelial cancers. This collaboration combines UroGen’s RTGel® technology with medac’s mitomycin formulation. The FDA accepted UroGen's Investigational New Drug (IND) application for UGN-103 in April 2024. UroGen plans to begin Phase 3 studies for UGN-103 in LG-IR-NMIBC and UGN-104 in LG-UTUC in 2024.

Financial Overview for Q1 2024: UroGen reported JELMYTO net product revenues of $18.8 million, compared to $17.2 million in the same period in 2023. Research and development expenses were $15.5 million, up from $12.5 million in the first quarter of 2023. Selling, general, and administrative expenses rose to $27.3 million from $24.5 million in the same period in 2023. Non-cash financing expenses related to the prepaid forward obligation amounted to $5.7 million, and interest expenses on long-term debt were $2.4 million. The net loss for the first quarter of 2024 was $32.3 million or ($0.97) per share, compared to a net loss of $30.2 million or ($1.30) per share in the first quarter of 2023.

As of March 31, 2024, UroGen's cash, cash equivalents, and marketable securities totaled $164.5 million. The company reiterated its full-year 2024 net product revenue guidance for JELMYTO, ranging from $95 to $102 million, and expected operating expenses between $175 to $185 million.

UroGen’s leadership, including CEO Liz Barrett, highlighted the significant progress made in both its commercial and development efforts. Barrett emphasized the potential of UGN-102 to become a major growth driver for the company if approved, setting a new standard of care for LG-IR-NMIBC.

The company’s strategic advancements and strong financial performance underscore UroGen's commitment to bringing innovative cancer treatments to market, addressing unmet medical needs in urothelial and specialty cancers.