On March 2, 2020 UroGen Pharma Ltd. (Nasdaq:URGN) a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases because patients deserve better options, reported financial results for the fourth quarter and full year ended December 31, 2019 and provided an overview of the Company’s recent developments (Press release, UroGen Pharma, MAR 2, 2020, View Source [SID1234555067]).
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"At UroGen, we are eagerly awaiting potential approval of our lead product candidate, UGN-101, for the treatment of patients with low-grade upper tract urothelial cancer (LG UTUC). The significant progress on key clinical, regulatory and commercial milestones in 2019 places us in a position of strength as we prepare to deliver the first non-surgical therapy for the treatment of LG UTUC. Our experienced commercial team has been working tirelessly to ensure we are prepared for launch, and we look forward to providing these patients with a new treatment option," said Liz Barrett, President and Chief Executive Officer (CEO) of UroGen. "We are also advancing multiple pipeline candidates in development for areas of unmet need in both low-grade and high-grade bladder cancer, including UGN-102 and UGN-302, respectively. As our team pioneers new treatments to improve patient care in specialty cancers and urologic diseases, we look forward to maximizing patient and shareholder value through the exciting events on the horizon".
2019 and Recent Highlights
UGN-101 (mitomycin gel) for instillation for Patients with LG UTUC Progress
Reported positive updated durability and complete response data from the pivotal Phase 3 OLYMPUS trial in September 2019. The data were consistent with previously reported results in May 2019 and January 2019.
Completed a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA).
Received FDA filing acceptance and Priority Review of the NDA for UGN-101, with a PDUFA goal date of April 18, 2020. If approved, UGN-101 will be the first non-surgical, chemoablative treatment option for LG UTUC.
UGN-101 Commercial Readiness
Hired an internal team with a track record of success in urology and oncology as well as a veteran sales force leadership team with deep uro-oncology relationships.
Implemented innovative solutions around patient identification, reimbursement and seamless logistics to enhance physician adoption upon launch. Based on recent market research, 88% of urologists desire a new and differentiated treatment option for their patients.
Executed agreements with 3PL, a specialty distributor and a national partner to provide prepared admixture to urology clinics.
Pipeline Expansion and Developments
UGN-102 (mitomycin gel) for intravesical instillation for patients with low-grade intermediate risk non-muscle invasive bladder cancer (LG IR NMIBC)
Completed enrollment ahead of schedule and reported positive interim results from the single-arm, open-label Phase 2b OPTIMA II trial of investigational UGN-102 for patients with LG IR NMIBC.
LG IR NMIBC is defined as those patients with one or two of the following criteria: multifocal disease, large tumors and rapid rates of recurrence. This is a patient population whereby the current standard of care, transurethral resection of bladder tumor, or TURBT, is used repeatedly to address chronic recurrence of disease. These patients experience what can be viewed as a form of surgical failure and many undergo multiple surgical procedures during life to "manage" bladder cancer recurrences.
There are no drugs currently approved by the FDA as first-line treatment for LG IR NMIBC. UGN-102 has the potential to provide a non-surgical treatment alternative for approximately 80,000 patients diagnosed with LG IR NMIBC.
UGN-201 (TLR7/8 agonist) for patients with high-grade non muscle invasive bladder cancer (HG NMIBC)
Shared nonclinical data of investigational UGN-201 (a TLR7/8 agonist) as a monotherapy and in combination with checkpoint inhibitors.
In murine models, UGN-201 in combination with local anti-CTLA-4 increased survival.
Entered into an exclusive worldwide license agreement with Agenus Inc. to develop and commercialize zalifrelimab (AGEN1884, anti-CTLA-4 antibody) via intravesical delivery in combination with UGN-201 for the treatment of high-grade urinary tract cancers, initially targeting HG NMIBC. The combination of UGN-201 and zalifrelimab is referred to as investigational agent UGN-302.
Corporate Achievements
Strengthened the Company’s financial position with a follow-on offering of approximately $162 million in January 2019.
2020 Anticipated Milestones and Product Development Plans
UGN-101
Publication of the final results of the primary endpoint from the OLYMPUS trial in patients with LG UTUC in 1H
UGN-101 potential approval and launch in Q2
UGN-102
Updated durability and complete response data from UGN-102 Phase 2b Study
Initiation of pivotal Phase 3 Study in 2H
UGN-302
Advancement to first in human clinical study following formulation and dose optimization
Fourth Quarter and Full Year 2019 Financial Results; 2020 Guidance
As of December 31, 2019, cash, cash equivalents and marketable securities totaled $195.6 million, excluding restricted cash.
Research and development expenses for the three months ended December 31, 2019 were $20.1 million, including non-cash share-based compensation expense of $1.9 million. Research and development expenses for the year ended December 31, 2019 were $49.3 million, including non-cash share-based compensation expense of $8.3 million. The research and development expenses for the three months and year ended December 31, 2019 included an in-process research and development charge of $10.0 million associated with the execution of the Agenus licensing agreement.
General and administrative expenses for the three months ended December 31, 2019 were $19.7 million, including non-cash share-based compensation expense of $6.2 million. General and administrative expenses for the year ended December 31, 2019 were $60.2 million, including non-cash share-based compensation expense of $21.7 million.
UroGen reported a net loss of $39.0 million, or basic and diluted net loss per ordinary share of $1.86, for the three months ended December 31, 2019. The Company reported a net loss of $105.1 million, or basic and diluted net loss per ordinary share of $5.12, for the year ended December 31, 2019.
The Company anticipates operating expenses in the range of $145 to $155 million for 2020. Non-cash stock-based compensation expense for 2020 is expected to be in the range of $32 to $36 million subject to market conditions, and other non-operating income for 2020 is anticipated to be approximately $2.5 million.
UroGen has 21.0 million ordinary shares outstanding.
Conference Call & Webcast Information
Members of UroGen’s management team will host a live conference call and webcast today 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 49393633. An archive of the webcast will be available for two weeks on the Company’s website.