UroGen Pharma Reports First Quarter 2019 Financial Results and Recent Corporate Developments

Recent Data Presentation Highlights Consistent Complete Response Rate
and Strong Durability at Six-Months in Evaluable Patients with Low-Grade
Upper Tract Urothelial Cancer (LG UTUC)

Completion of UGN-101 Rolling NDA Submission to the FDA On Track for
2H 2019

Pre-Commercial Activities and Infrastructure Build-out Accelerate
Ahead of Planned U.S. Approval and Launch of UGN-101 in 1H 2020

Conference Call and Webcast to be Held Today at 8:30 AM ET

NEW YORK–(BUSINESS WIRE)–UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical
company developing treatments to address unmet needs in uro-oncology,
today announced financial results for the first quarter ended March 31,
2019 and provided an overview of the Company’s recent developments.

“The accomplishments and performance of UroGen during the first quarter
have set the stage for a pivotal and exciting year ahead as we prepare
for the potential approval and commercialization of UGN-101, our first
investigational candidate. Our top priority remains completion of our
rolling New Drug Application (NDA) for UGN-101 for the treatment of
patients with low-grade upper tract urothelial cancer (LG UTUC) and,
with our commercial preparations well underway, we are confident in our
readiness to deliver on a strong launch in the first half of 2020,” said
Liz Barrett, President and Chief Executive Officer of UroGen. “Our
company sees great possibilities for the RTGel platform within
uro-oncology, especially around new therapeutic modalities. Our goal is
to leverage that and continue to build a company with sustainable growth
via a robust pipeline as well as assessing opportunities via external
partnerships.”

Recent Highlights

  • UGN-101 Clinical Development:

    • At the 114th American Urological Association (AUA)
      Annual Meeting in Chicago, Seth Lerner, M.D. delivered a
      presentation during the plenary session that highlighted the unmet
      need and potential for UGN-101 to change the treatment paradigm
      for patients with LG UTUC.

      • The updated analysis demonstrated that in the OLYMPUS
        intent-to-treat population, 71 patients had undergone primary
        disease evaluation (PDE) at the time of the analysis and 42 of
        the 71 patients (59 percent) achieved a complete response
        (CR). Forty-one patients entered follow-up. At the time of the
        analysis, 27 patients underwent a six-month evaluation, and 24
        out of 27 patients (89 percent) have remained disease free at
        six months. The most common adverse events observed were
        urinary tract infection, ureteral narrowing and stricture
        formation. The majority of ureteral events were reported as
        mild to moderate and have resolved. Full Phase 3 data from the
        OLYMPUS trial is anticipated for 2H 2019.
    • The Company remains on track to complete its rolling NDA for
      UGN-101 in 2H 2019 and is planning for approval in 1H 2020. If
      approved, UGN-101 would be the first drug approved for the
      non-surgical treatment of LG UTUC. Full data is planned for 2H
      2019.
  • Pipeline Advancement:

    • UGN-102:

      • The Company continues to enroll patients in its Phase 2b
        OPTIMA II clinical trial of 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.
      • Initial data from the OPTIMA II trial of UGN-102 is expected
        in 2H 2019.
      • There are currently no drugs approved by the FDA as first-line
        treatment for LG NMIBC. UGN-102 represents a substantial
        opportunity in UroGen’s pipeline and has the potential to be a
        treatment option for up to approximately 80,000 patients for
        whom repetitive surgical resection via Transurethral Resection
        of Bladder Tumor (TURBT) remains the standard of care.
    • UGN-201:

      • UroGen is currently evaluating the optimal pathway to advance
        UGN-201, a TLR7/8 immunomodulatory agent for the treatment of
        high-grade bladder disease.
  • Commercial Preparations:

    • The Company continues to accelerate its pre-commercial activities
      and infrastructure build-out to support the anticipated U.S.
      approval and launch of UGN-101 targeted for 1H 2020. The focus is
      on building awareness of our RTGel technology and unmet needs in
      UTUC to support rapid adoption and seamless integration of UGN-101
      into the urologist practice following regulatory approval.
    • A strong team of seven medical science liaisons (MSLs) have been
      strategically deployed across the U.S. to engage in scientific
      exchange and clinical support.
    • The Company launched www.UTUC.com,
      the first resource designed to address a void in the urology space
      by educating patients about UTUC and available treatment options.
  • Business Development:

    • UroGen recently 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.

First Quarter 2019 Financial Results; 2019 Guidance

  • As of March 31, 2019, cash and cash equivalents totaled $246.7
    million. This includes net proceeds of approximately $161.4 million
    from a public offering of ordinary shares in January 2019.
  • Research and development expenses for the three months ended March 31,
    2019 were $9.7 million, including non-cash share-based compensation
    expense of $2.3 million.
  • General and administrative expenses for the three months ended March
    31, 2019 were $12.7 million, including non-cash share-based
    compensation expense of $5.1 million.
  • The Company reported a net loss of $21.4 million, or basic and diluted
    net loss per ordinary share of $1.11, for the three months ended March
    31, 2019.
  • The 2019 financial guidance set forth during the Company’s year-end
    earnings call on February 28th 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 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 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 48486174. 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, 2019

 

December 31, 2018

Assets
 
CURRENT ASSETS:
Cash and cash equivalents $ 246,692 $ 101,318
Restricted deposit 407 253
Prepaid expenses and other current assets   1,196   672
TOTAL CURRENT ASSETS 248,295 102,243
 
NON-CURRENT ASSETS:
Property and equipment, net 929 948
Restricted deposit 51 51
Other non-current assets   2,777   317
TOTAL ASSETS $ 252,052 $ 103,559
 
Liabilities and Shareholders’ equity
 
CURRENT LIABILITIES:
Accounts payable and accrued expenses $ 5,942 $ 8,540
Employee related accrued expenses 3,334 4,925
Other current liabilities   1,001  
TOTAL CURRENT LIABILITIES 10,277 13,465
 
NON-CURRENT LIABILITIES:
Long-term lease liability   2,184  
TOTAL NON-CURRENT LIABILITIES   2,184  
TOTAL LIABILITIES 12,461 13,465
TOTAL SHAREHOLDERS’ EQUITY   239,591   90,094
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY $ 252,052 $ 103,559
 
 
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,
  2019     2018  
 
REVENUES $ $ 481
COST OF REVENUES       430  
GROSS PROFIT 51
OPERATING EXPENSES:
Research and development expenses, net 9,726 7,622
General and administrative expenses   12,707     6,069  
OPERATING LOSS 22,433 13,640
FINANCE INCOME, NET   (989 )   (258 )
 
NET LOSS $ 21,444   $ 13,382  
NET LOSS PER ORDINARY SHARE, BASIC AND DILUTED $ 1.11   $ 0.88  
 
WEIGHTED AVERAGE SHARES OUTSTANDING, BASIC AND DILUTED   19,340,082     15,267,939  
 

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™ reverse-thermal hydrogel, 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 investigational candidates,
UGN-101 (mitomycin gel) for instillation, and UGN-102 (mitomycin gel)
for intravesical instillation, are designed to potentially ablate tumors
by non-surgical means and to treat several forms of non-muscle invasive
urothelial cancer, including low-grade upper tract urothelial cancer and
low-grade non-muscle invasive bladder cancer, respectively. UroGen is
headquartered in New York, NY with operations in Los Angeles,
CA and Israel.

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, without limitation: plans to conduct an early stage
feasibility evaluation; the potential of UGN-101 for LG UTUC; the timing
for completion of the rolling NDA for UGN-101; the anticipated timing
for full Phase 3 data from the OLYMPUS trial; the potential approval of
UGN-101 and the timing thereof; the expectation that UGN-101, if
approved, will be the first drug approved for the non-surgical treatment
of LG UTUC; the timing for completion of pre-commercial activities and
infrastructure build-out in anticipation of a potential commercial
launch of UGN-101; the expected readiness of UroGen for a potential
commercial launch of UGN-101 and the strength and timing of the
potential commercial launch of UGN-101; the potential of UroGen’s
proprietary RTGel™ technology platform to improve therapeutic profiles
of existing drugs; the anticipated timing for initial data from the
OPTIMA II trial; the opportunity and potential of UGN-102 for LG NMIBC;
and UroGen’s 2019 guidance. These statements are subject to a number of
risks, uncertainties and assumptions, including, but not limited to: the
timing and success of clinical trials, including the OLYMPUS Phase 3
trial and the OPTIMA II Phase 2b trial and potential safety and other
complications thereof; the ability to obtain regulatory approval within
the timeframe expected, or at all; the ability to maintain regulatory
approval; complications associated with achieving commercial readiness
for the launch of a new product; 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; risks that UroGen’s net loss for 2019 may differ
materially from the anticipated range previously provided by UroGen and
affirmed in this press release due to changes in UroGen’s operating
plans and/or due to estimates that may prove to be incorrect; 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 Form 10-Q filed with the SEC on the
date hereof 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.

Contacts

UROGEN CONTACT:
Kate Bechtold
Director, Corporate
Communications & Investor Relations
Kate.Bechtold@urogen.com
914-552-0456

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