UroGen Pharma Reports Third Quarter 2018 Financial Results and Completed UGN-101 OLYMPUS Trial Enrollment
Following a Recent Pre-New Drug Application (NDA) Meeting with the
Breakthrough Therapy Designation (BTD) Previously Granted by the
Company On Track to Initiate UGN-101 Rolling NDA Submission to the
Conference Call Today at
RA’ANANA,
At the pre-NDA meeting, the company presented updated data from this open-label, single arm Phase 3 study. The meeting resulted in agreement on the required information for the NDA submission and suitability for NDA submission of primary endpoint (Complete Response) data for the approximately 65 patients enrolled to date.
UroGen plans to present the topline data in
“We are pleased by the FDA’s support for UGN-101 and recognition of the
potential clinical benefit that UGN-101 presents for LG UTUC as a
potentially organ-sparing, non-invasive therapy for this disease,” said
Breakthrough Therapy Designation (BTD) was granted by the
Additional Highlights and Upcoming Milestones
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UGN-102 Clinical Development :- UroGen is enrolling patients as part of its Phase 2b single-arm, open-label, multi-center trial designed to assess the efficacy and safety of UGN-102 (mitomycin gel) for intravesical instillation as a potential first-line chemoablation agent in the treatment of patients with LG Non-Muscle Invasive Bladder Cancer (NMIBC) at risk for recurrence.
- Initial data from the trial is expected in 1H 2019.
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Similar to LG UTUC, there are currently no drugs approved by the
FDA as first-line treatment for NMIBC, and only three drugs have been approved by theFDA , all as adjuvant treatments, following TURBT (transurethral resection of bladder tumor). - UGN-102 represents a very substantial opportunity in UroGen’s pipeline with the potential to initially address up to approximately 85,000 patients for whom TURBT is no longer effective.1
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Advancing the Potential of the RTGel Platform:
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Allergan continues to enroll patients in its Phase 2 trial of BotuGel, UroGen’s RTGel in combination with BOTOX®2, for the treatment of overactive bladder. This clinical trial, if successful, has the potential to demonstrate the broad applicability of the RTGel platform beyond uro-oncology. Phase 2 data is expected in 2019.
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Corporate Developments:
- UroGen strengthened its leadership team with the appointment of Jones “Woody” Bryan, Ph.D., as Senior Vice President, Business Development. Dr. Bryan is a seasoned industry veteran who brings over 25 years of industry experience. He is focused on the integration of corporate strategy and business development to assess potential partnerships, both inbound and outbound, and bolster UroGen’s product portfolio.
Third Quarter 2018 Financial Results
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As of
September 30, 2018 , cash and cash equivalents totaled$109.5 million . -
Research and development expenses for the nine months ended
September 30, 2018 were$25.5 million , including non-cash share-based compensation expense of$9.1 million . Research and development expenses for the three months endedSeptember 30, 2018 were$9.6 million , including non-cash share-based compensation expense of$3.8 million . -
General and administrative expenses for the nine months ended
September 30, 2018 were$27.0 million , including non-cash share-based compensation expense of$12.7 million . General and administrative expenses for the three months endedSeptember 30, 2018 were$10.7 million , including non-cash share-based compensation expense of$5.7 million . -
The Company reported a net loss of
$51.9 million , or basic and diluted net loss per ordinary share of$3.30 , for the nine months endedSeptember 30, 2018 . The Company reported a net loss of$20.5 million , or basic and diluted net loss per ordinary share of$1.28 , for the three months endedSeptember 30, 2018 .
Conference Call & Webcast Information
Members of UroGen’s management team will host a live conference call and
webcast today at
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 47697839. 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) | ||||||||||
September 30,
2018 |
December 31, |
|||||||||
Assets | ||||||||||
CURRENT ASSETS: | ||||||||||
Cash and cash equivalents | $ | 109,483 | $ | 36,999 | ||||||
Short-term investments | — | 36,001 | ||||||||
Restricted deposit | 197 | 198 | ||||||||
Accounts receivable | 112 | — | ||||||||
Inventory | — | 316 | ||||||||
Prepaid expenses and other current assets | 1,679 | 958 | ||||||||
TOTAL CURRENT ASSETS | 111,471 | 74,472 | ||||||||
NON-CURRENT ASSETS: | ||||||||||
Property and equipment, net | 992 | 805 | ||||||||
Restricted deposit | 81 | 29 | ||||||||
Other non-current assets | 14 | 244 | ||||||||
TOTAL ASSETS | $ | 112,558 | $ | 75,550 | ||||||
Liabilities and Shareholders' equity | ||||||||||
LIABILITIES: | ||||||||||
Accounts payable and accrued expenses | $ | 6,291 | $ | 4,435 | ||||||
Employee related accrued expenses | 2,684 | 1,950 | ||||||||
Deferred revenues | — | 650 | ||||||||
TOTAL LIABILITIES | 8,975 | 7,035 | ||||||||
TOTAL SHAREHOLDERS’ EQUITY | 103,583 | 68,515 | ||||||||
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ | 112,558 | $ | 75,550 | ||||||
UROGEN PHARMA LTD. | ||||||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||||||
(U.S. dollars in thousands, except share and per share data) | ||||||||||||||||||||
(Unaudited) | ||||||||||||||||||||
Nine months ended September 30, | Three months ended September 30, | |||||||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||||||
REVENUES | $ | 1,128 | $ | 7,831 | $ | 283 | $ | 7,812 | ||||||||||||
COST OF REVENUES | 1,803 | 313 | 1,055 | 295 | ||||||||||||||||
GROSS PROFIT | (675 | ) | 7,518 | (772 | ) | 7,517 | ||||||||||||||
OPERATING EXPENSES: | ||||||||||||||||||||
Research and development expenses | 25,469 | 11,936 | 9,574 | 5,621 | ||||||||||||||||
General and administrative expenses | 27,019 | 5,374 | 10,743 | 2,199 | ||||||||||||||||
OPERATING LOSS | 53,163 | 9,792 | 21,089 | 303 | ||||||||||||||||
INTEREST AND OTHER (INCOME) EXPENSES, NET | (1,323 | ) | 122 | (556 | ) | (5 | ) | |||||||||||||
REALIZED LOSS ON SALE OF SHORT-TERM INVESTMENT | 100 | — | — | — | ||||||||||||||||
NET LOSS | $ | 51,940 | $ | 9,914 | $ | 20,533 | $ | 298 | ||||||||||||
NET LOSS PER ORDINARY SHARE, BASIC AND DILUTED | $ | 3.30 | $ | 1.31 | $ | 1.28 | $ | 0.02 | ||||||||||||
WEIGHTED AVERAGE SHARES OUTSTANDING, BASIC AND DILUTED | 15,721,445 | 8,223,124 | 16,092,583 | 13,051,117 | ||||||||||||||||
About
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 effect of Breakthrough Therapy Designation
on the potential regulatory approval of UGN-101, timing and results of
clinical development and commercial prospects of UGN-101, and submission
of a rolling NDA for UGN-101, the timing and results of clinical
development of UGN-102, and the timing and clinical application of RTGel
including with respect to BotuGel, 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 Pharma’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 Pharma’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 Pharma’s Form 20-F filed with the
1 Cutress, 2012; NIH SEER Stat;
2
BOTOX® is a proprietary trademark of
View source version on businesswire.com: https://www.businesswire.com/news/home/20181112005199/en/
Source:
UROGEN:
Kate Bechtold, 914-552-0456
Director, Corporate
Communications & Investor Relations
Kate.Bechtold@urogen.com