UroGen raises $120M after bladder cancer chemo gel succeeds in two Phase III trials

UroGen Pharma’s hydrogel formulation of a decades-old cancer drug met the primary endpoints in two Phase III trials of a subset of bladder cancer, the biotech said Thursday morning.

The data intrigued investors enough to back a $120 million private placement that will help bankroll a potential NDA filing in the second half of next year, as well as a potential launch of the drug, CEO and president Liz Barrett told Endpoints News.

Backers of the placement, priced at $9.54 per share, include RA Capital, Great Point Partners, Acorn Bioventures, Monograph Capital and Horton Capital Partners. Shares of UroGen $URGN were up about 40% in early-morning trading.

The New Jersey biotech hopes to provide patients who have low-grade, intermediate-risk non-muscle invasive bladder cancer a non-surgical option for their disease, which has high recurrence rates and impacts about 82,000 new patients in the US annually, according to UroGen.

Its investigational candidate, UGN-102, is a sustained-release, intravesical formulation of mitomycin, which has been approved for decades for adjuvant treatment of various cancers. A urinary catheter is used to deliver UGN-102.

UGN-102 is given via six weekly administrations and met the main goal in the open-label 282-patient ATLAS trial, showing a 55% reduction in risk of recurrence, progression or death. That was assessed after the secondary endpoint of complete response rate.

Mark Schoenberg

At three months, the complete response rate was 64.8% for patients on just UGN-102, and 63.6% for patients who had a standard surgical procedure, trans urethral resection of bladder tumor, or TURBT, UroGen said.

If patients didn’t completely respond to either UGN-102 or to the first surgery, they could undergo TURBT to further reduce the cancer, medical chief Mark Schoenberg said. He noted for the people who didn’t receive additional surgery, the UGN-102 group had a more durable recurrence-free survival than TURBT alone.

The trial included patients with a new diagnosis as well as those who previously had such tumors and were experiencing recurrence.

In the other Phase III, a single-arm trial dubbed ENVISION, all patients had a prior history of cancer and also received six weekly administrations of UGN-102. At three months following initial treatment, the complete response rate was 79.2%. More data are expected next year, with the key secondary endpoint of duration of response being the focus ahead of an NDA filing in 2024. Barrett said the company expects “well above 12 months” for the median duration of response.

UroGen said there were no serious adverse events for patients on UGN-102 and the side effects “mimic exactly what urologists are familiar with, with respect to mitomycin therapy generally,” Schoenberg said. That includes mild-to-moderate urgency and frequency in needing to use the restroom, and bleeding during urination. The events were “time-limited, easy to manage and self-resolving — so nothing unusual,” the medical chief said.

The company had run into trouble with its late-stage plans for the asset previously, with a Phase III trial suspension, which led to a trial redesign with the FDA.

Mitomycin is also the ingredient in UroGen’s Jelmyto, approved by FDA in 2020 for low-grade upper tract urothelial cancer. The drug brought in revenues of $17.2 million in the first quarter, a 27% increase year-over-year. Chaired by Kite Pharma founder Arie Belldegrun, the company is also investigating an anti-CTLA-4 known as UGN-301 for certain uro-oncology indications.

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