Interim Analysis of Pivotal Phase 3 OLYMPUS Trial of UGN-101 (MitoGel™) for the Treatment of Low-Grade Upper Tract Urothelial Carcinoma (LG UTUC) to be Presented at American Urological Association (AUA) Annual Meeting on May 21, 2018
Submission of UGN-101 New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) Expected in Q1 2019
UGN-102 (VesiGel™) Investigational New Drug (IND) Application Planned for Mid-2018
Conference Call Today at 8:30 a.m. Eastern Time
RA’ANANA, Israel, and NEW YORK, May 15, 2018 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, today announced financial results for first quarter ended March 31, 2018 and provided an overview of the Company’s recent developments.
“We are excited about the upcoming late-breaking presentation at AUA of the Interim Analysis of our pivotal Phase 3 OLYMPUS trial of UGN-101 (MitoGel™) for the treatment of LG UTUC. Our team remains intensely focused on our most important milestone - submitting an NDA to the FDA in Q1 2019, with the goal of UGN-101 potentially becoming the first-ever approved treatment for LG UTUC,” said Ron Bentsur, Chief Executive Officer of UroGen. “In addition to UGN-101, we continue to advance our pipeline, as demonstrated by our planned IND submission in mid-2018 for UGN-102 (VesiGel™), as well as other development programs that have the potential to transform existing treatment paradigms across a number of urologic conditions.”
Recent Highlights and Upcoming Milestones
First Quarter 2018 Financial Results
Conference Call & Webcast Information
Members of UroGen’s management team will host a live conference call and webcast today at 8:30 a.m. 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 http://investors.urogen.com. 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 46778272. An archive of the webcast will be available for two weeks on the Company’s website.
UROGEN PHARMA LTD. | ||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
(U.S. dollars in thousands, except share and per share data) | ||||||||
(Unaudited) | ||||||||
March 31, 2018 | December 31, 2017 | |||||||
Assets | ||||||||
CURRENT ASSETS: | ||||||||
Cash and cash equivalents | $ | 127,460 | $ | 36,999 | ||||
Short-term investments | - | 36,001 | ||||||
Restricted deposit | 197 | 198 | ||||||
Accounts receivable | 4 | - | ||||||
Inventory | 349 | 316 | ||||||
Prepaid expenses and other current assets | 726 | 958 | ||||||
TOTAL CURRENT ASSETS | 128,736 | 74,472 | ||||||
NON-CURRENT ASSETS: | ||||||||
Property and equipment, net | 637 | 805 | ||||||
Restricted deposit | 29 | 29 | ||||||
Other non-current assets | - | 244 | ||||||
TOTAL ASSETS | $ | 129,402 | $ | 75,550 | ||||
Liabilities and Shareholders' equity | ||||||||
CURRENT LIABILITIES: | ||||||||
Accounts payable and accrued expenses | $ | 4,048 | $ | 4,435 | ||||
Employee related accrued expenses | 1,291 | 1,950 | ||||||
Deferred revenues | 196 | 650 | ||||||
TOTAL CURRENT LIABILITIES | 5,535 | 7,035 | ||||||
TOTAL LIABILITIES | 5,535 | 7,035 | ||||||
SHAREHOLDERS’ EQUITY: | ||||||||
Ordinary shares, NIS 0.01 par value: 100,000,000 shares authorized at March 31, 2018 and December 31, 2017; 15,473,981 and 13,751,390 shares issued and outstanding at March 31, 2018 and December 31, 2017, respectively. | 42 | 37 | ||||||
Additional paid-in capital | 184,421 | 115,692 | ||||||
Accumulated deficit | (60,596 | ) | (47,214 | ) | ||||
TOTAL SHAREHOLDERS’ EQUITY | 123,867 | 68,515 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ | 129,402 | $ | 75,550 | ||||
UROGEN PHARMA LTD. | ||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
(U.S. dollars in thousands, except share and per share data) | ||||||||
(Unaudited) | ||||||||
Three months ended March 31, | ||||||||
2018 | 2017 | |||||||
REVENUES | $ | 481 | $ | 19 | ||||
COST OF REVENUES | 430 | 18 | ||||||
GROSS PROFIT | 51 | 1 | ||||||
OPERATING EXPENSES: | ||||||||
Research and Development Expenses | 7,622 | 2,664 | ||||||
General and Administrative Expenses | 6,069 | 875 | ||||||
OPERATING LOSS | 13,640 | 3,538 | ||||||
INTEREST AND OTHER INCOME, NET | (358 | ) | (121 | ) | ||||
REALIZED LOSS ON SALE OF SHORT-TERM INVESTMENT | 100 | - | ||||||
NET LOSS | $ | 13,382 | $ | 3,417 | ||||
NET LOSS PER ORDINARY SHARE BASIC AND DILUTED | $ | 0.88 | $ | 1.74 | ||||
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER ORDINARY SHARE | 15,267,939 | 2,307,025 | ||||||
About UroGen Pharma Ltd.
UroGen Pharma Ltd. (Nasdaq:URGN) is a clinical-stage biopharmaceutical company developing advanced non-surgical treatments to address unmet needs in the field of urology, with a focus on uro-oncology. The Company has developed RTGel™, a proprietary sustained release, hydrogel-based platform technology that has the potential to improve 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. UroGen's lead product candidates, UGN-101 (MitoGel™, also known as mitomycin urothelial gel) and UGN-102 (VesiGel™, also known as mitomycin intravesical gel), are designed to potentially remove tumors by non-surgical means and to treat several forms of non-muscle invasive urothelial cancer, including low-grade upper tract urothelial carcinoma and bladder cancer, respectively. UroGen is headquartered in Ra’anana, Israel with U.S. headquarters in New York.
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 with respect to the timing and results of clinical development and commercial prospects of the product candidates in UroGen’s pipeline, including UGN-101 (MitoGel™) and UGN-102 (VesiGel™), the scope and development of UroGen’s product candidate pipeline, results from the OLYMPUS trial, and Allergan’s Phase 2 clinical trial of BotuGel, UroGen’s expectations regarding its ability to fund its operations, and the ability of UroGen to become a leader in the field of uro-oncology, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: the timing and success of clinical trials and potential complications thereof; the ability to obtain and maintain regulatory approval; the labeling for any approved product; the scope, progress and expansion of developing and commercializing UroGen’s 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; and UroGen’s ability to attract or retain key management, members of the board of directors and personnel. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen’s annual report on From 20-F filed with the SEC on March 15, 2018 and other filings that UroGen makes with the SEC from time to time (which are available at http://www.sec.gov), 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.
UROGEN CONTACT:
Kate Bechtold
Director, Corporate Communications & Investor Relations
[email protected]
914-552-0456
1 BOTOX® is a proprietary trademark of Allergan Pharmaceuticals.
We use cookies to tailor your experience, measure site performance and present relevant offers and advertisements. By clicking ‘Accept’ or any content on this site, you agree that cookies can be placed on your browser. You can view our privacy policy to learn more.
If you would like to get more data, alerts and access to Real Vision videos, join us as an Insider Tracking Advantage Ultra member