On August 9, 2019 UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in uro-oncology, reported financial results for the second quarter ended June 30, 2019 and provided an overview of the Company’s recent developments (Press release, UroGen Pharma, AUG 9, 2019, View Source [SID1234538547]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Our team has continued to make significant progress on key initiatives during the second quarter, including the submission of the CMC modules to our rolling New Drug Application (NDA) for UGN-101. We have locked the database on our Phase 3 OLYMPUS study and are on track to complete the submission in Q4 as we prepare for a potential approval and launch in the first half of 2020," said Liz Barrett, President and Chief Executive Officer of UroGen. "We are confident that our account-based commercial strategy will allow for seamless adoption and integration into urology practices following anticipated approval. We look forward to sharing further details about UGN-101 commercial preparations, ongoing clinical programs, and new developments at our Investor Day on September 24, 2019."
Recent Highlights and Upcoming Milestones
UGN-101 Clinical Development:
UroGen recently submitted the CMC modules to the rolling NDA for investigational agent UGN-101 for the treatment of patients with low-grade upper tract urothelial cancer (LG UTUC). Completion and acceptance of the Company’s rolling NDA submission remains on track for 2H 2019. If approved, the Company expects to launch UGN-101 in the United States in 1H 2020. It would be the first medicine approved for this unique, orphan indication.
At the 114th American Urological Association (AUA) Annual Meeting in Chicago, a presentation in the plenary session highlighted findings from a secondary analysis from the pivotal Phase 3 OLYMPUS trial which demonstrated the unmet need and potential for UGN-101 to transform the treatment paradigm for patients with LG UTUC.
The Company expects to announce updated Phase 3 data from the OLYMPUS trial at its upcoming Investor Day on September 24, 2019.
Pipeline Advancement:
UGN-102:
The Company continues to enroll patients in its Phase 2b OPTIMA II clinical trial of investigational agent UGN-102 (mitomycin gel) for intravesical instillation as a first line-chemoablation agent in the treatment of patients with intermediate risk low-grade non-muscle invasive bladder cancer (LG NMIBC), a form of disease associated with a high risk of recurrence. UGN-102 has the potential to address an unmet need for the approximately 80,000 patients with intermediate risk LG NMIBC.
The OPTIMA II trial is enrolling ahead of schedule, and the company plans to present early complete response data on a portion of patients at its upcoming Investor Day on September 24, 2019.
If approved, UGN-102 would represent a novel advance in the treatment of recurrent non-muscle invasive bladder cancer, as there are currently no drugs approved by the FDA as first-line treatment for LG NMIBC.
UGN-201:
The Company is developing investigational agent UGN-201, a TLR7/8 immunomodulatory agent for the treatment of high-grade bladder disease. UroGen is exploring the utility of UGN-201 in the context of novel combinatorial immunotherapy for NMIBC.
Commercial Preparations:
UroGen has made considerable progress to accelerate educational initiatives to drive awareness of the significant unmet need for patients with LG UTUC where current SOC is kidney removal. Little education and support have previously been available for patients and stakeholders and UroGen is in a unique position to lead in this space. These pre-commercial activities and infrastructure build out will help to reinforce rapid adoption and seamless integration of UGN-101 into urology practices following anticipated regulatory approval.
In conjunction with the Company’s educational efforts, UroGen is also engaging in a proactive market access strategy to define the cost burden to the system for LG UTUC via an HEOR study.
Corporate:
Robert G. Uzzo, M.D., FACS, Chair of the Department of Surgical Oncology at Fox Chase Cancer Center in Philadelphia, PA, has joined UroGen as a special advisor working closely with UroGen’s Medical Affairs team. Dr. Uzzo is well-known as a key opinion leader in the field of urological oncology and has made important clinical and scientific contributions to the field.
In the second quarter, UroGen entered into an agreement with Janssen Research & Development, LLC (Janssen) to conduct an early-stage feasibility evaluation in a therapeutic area of mutual interest. UroGen and Janssen will each conduct certain activities under the terms of the agreement.
The Company will host a live webcast in conjunction with its Investor Day taking place on Tuesday, September 24th at 10:00AM Eastern Time in New York, NY.
Second Quarter 2019 Financial Results; 2019 Guidance
As of June 30, 2019, cash, cash equivalents and marketable securities totaled $233.3 million.
Research and development expenses for the three months ended June 30, 2019 were $10.0 million, including non-cash share-based compensation expense of $2.0 million. Research and development expenses for the six months ended June 30, 2019 were $19.7 million, including non-cash share-based compensation expense of $4.3 million.
General and administrative expenses for the three months ended June 30, 2019 were $13.8 million, including non-cash share-based compensation expense of $5.2 million. General and administrative expenses for the six months ended June 30, 2019 were $26.5 million, including non-cash share-based compensation expense of $10.3 million.
The Company reported a net loss of $22.5 million, or basic and diluted net loss per ordinary share of $1.08, for the three months ended June 30, 2019. The Company reported a net loss of $43.9 million, or basic and diluted net loss per ordinary share of $2.19, for the six months ended June 30, 2019.
The 2019 financial guidance set forth during the Company’s year-end earnings call on February 28, 2019 remains the same based on current business goals and anticipated activities.
Conference Call & Webcast Information
Members of UroGen’s management team will host a live conference call and webcast on Monday, August 12, 2019 at 8:30 am Eastern Time to review the Company’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 View Source 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. Alternatively, please call (888) 771-4371 (U.S.) or (847) 585-4405 (International) to listen to the live conference call. The conference ID number for the live call will be 48773603. An archive of the webcast will be available for two weeks on the Company’s website.