Plan to Initiate Q4 2018 Rolling New Drug Application (NDA) Submission to the U.S. Food and Drug Administration (FDA) for UGN-101, Ahead of Initial Projection of Q1 2019
Initiated Phase 2b Clinical Trial of UGN-102 (VesiGel™) for the Treatment of Low-Grade Non-Muscle Invasive Bladder Cancer (LG NMIBC)
Conference Call Today at 8:30 a.m. Eastern Time
RA’ANANA, Israel and NEW YORK, Aug. 14, 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 the second quarter ended June 30, 2018 and provided an overview of the Company’s recent developments.
“There aren’t many opportunities in this industry to be first, but with UGN-101 (formerly referred to as MitoGel), we have the potential to have the first drug ever approved for low-grade upper tract urothelial cancer (LG UTUC). We believe that we will be one step closer to this major milestone in the field of uro-oncology with the planned rolling submission of a New Drug Application (NDA) for UGN-101 in the fourth quarter of this year,” said Ron Bentsur, Chief Executive Officer of UroGen. “In the past six months, we have focused on full execution of UGN-101, from clinical development, to regulatory process, to preparing for potential commercialization. We are leveraging the momentum and learnings from our UGN-101 program to initiate our Phase 2b trial for UGN-102 (formerly referred to as VesiGel) which has the potential to treat a significantly larger population, patients diagnosed with low-grade non-muscle invasive bladder cancer (LG NMIBC). As we continue to advance our pipeline, we believe this is just the beginning of what’s possible for UroGen and our RTGel™ platform.”
Recent Highlights and Upcoming Milestones
Second 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 47260983. 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) | ||||||
June 30, 2018 | December 31, 2017 | |||||
Assets | ||||||
CURRENT ASSETS: | ||||||
Cash and cash equivalents | $ | 119,109 | $ | 36,999 | ||
Short-term investments | – | 36,001 | ||||
Restricted deposit | 197 | 198 | ||||
Accounts receivable | 232 | – | ||||
Inventory | 142 | 316 | ||||
Prepaid expenses and other current assets | 1,024 | 958 | ||||
TOTAL CURRENT ASSETS | 120,704 | 74,472 | ||||
NON-CURRENT ASSETS: | ||||||
Property and equipment, net | 718 | 805 | ||||
Restricted deposit | 80 | 29 | ||||
Other non-current assets | – | 244 | ||||
TOTAL ASSETS | $ | 121,502 | $ | 75,550 | ||
Liabilities and Shareholders' equity | ||||||
CURRENT LIABILITIES: | ||||||
Accounts payable and accrued expenses | $ | 5,655 | $ | 4,435 | ||
Employee related accrued expenses | 2,211 | 1,950 | ||||
Deferred revenues | 86 | 650 | ||||
TOTAL CURRENT LIABILITIES | 7,952 | 7,035 | ||||
TOTAL LIABILITIES | 7,952 | 7,035 | ||||
COMMITMENTS AND CONTINGENCIES | ||||||
SHAREHOLDERS’ EQUITY: | ||||||
Ordinary shares, NIS 0.01 par value: 100,000,000 shares authorized at June 30, 2018 and December 31, 2017; 15,853,286 and 13,751,390 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively. | 43 | 37 | ||||
Additional paid-in capital | 192,129 | 115,692 | ||||
Accumulated deficit | (78,622) | (47,214) | ||||
TOTAL SHAREHOLDERS’ EQUITY | 113,550 | 68,515 | ||||
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ | 121,502 | $ | 75,550 | ||
UROGEN PHARMA LTD. | |||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||
(U.S. dollars in thousands, except share and per share data) | |||||||||||
(Unaudited) | |||||||||||
Six months ended June 30, | Three months ended June 30, | ||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||
REVENUES | $ | 845 | $ | 19 | $ | 364 | $ – | ||||
COST OF REVENUES | 748 | 18 | 318 | – | |||||||
GROSS PROFIT | 97 | 1 | 46 | – | |||||||
OPERATING EXPENSES: | |||||||||||
Research and Development Expenses | 15,895 | 6,315 | 8,273 | 3,651 | |||||||
General and Administrative Expenses | 16,276 | 3,175 | 10,207 | 2,300 | |||||||
OPERATING LOSS | 32,074 | 9,489 | 18,434 | 5,951 | |||||||
INTEREST AND OTHER (INCOME) EXPENSES, NET | (766) | 127 | (408) | 248 | |||||||
REALIZED LOSS ON SALE OF SHORT-TERM INVESTMENT | 100 | – | – | – | |||||||
NET LOSS | $ | 31,408 | $ | 9,616 | $ | 18,026 | $ | 6,199 | |||
NET LOSS PER ORDINARY SHARE BASIC AND DILUTED | $ | 2.02 | $ | 1.81 | $ | 1.14 | $ | 0.70 | |||
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER ORDINARY SHARE | 15,528,826 | 5,755,714 | 15,784,393 | 9,204,405 | |||||||
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. UroGen 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 (mitomycin gel for urothelial instillation), formerly known as MitoGel®, and UGN-102 (mitomycin gel for intravesical instillation), formerly known as VesiGel™, 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 (formerly referred to as MitoGel®), UroGen establishing a leadership position in the field of uro-oncology and the ability to commercialize, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: the potential approval of its first therapy; the ability to obtain and maintain regulatory approval; the scope, progress and expansion of developing and commercializing UroGen’s product candidates; and UroGen’s ability to attract or retain key management and personnel. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of our annual report for the year ended December 31, 2017 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
KateB@urogen.com
914-552-0456
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1 https://seer.cancer.gov/statfacts/html/urinb.html
2 BOTOX® is a proprietary trademark of Allergan Pharmaceuticals
3 Yescarta® is a proprietary trademark of Kite Pharma, Inc.