UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 24, 2019
UROGEN PHARMA LTD.
(Exact name of registrant as specified in its charter)
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Israel | | 001-38079 | | Not applicable |
(State or other jurisdiction of incorporation) | | (Commission File Number) | | (IRS Employer Identification No.) |
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499 Park Avenue New York, New York | | 10014 |
(Address of principal executive offices) | | (Zip Code) |
Registrant’s telephone number, including area code: (646) 768-9780
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class | | Trading Symbol(s) | | Name of each exchange on which registered |
| Ordinary Shares, par value NIS0.01 per share | | URGN | | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
On September 24, 2019, Urogen Pharma, Ltd. (the “Company”) issued a press release titled “UroGen Reports Positive Data from Two Important Studies: UGN-101 OLYMPUS Pivotal Trial in LG UTUC and UGN-102 Phase 2b OPTIMA II Trial in LG Bladder Cancer” (the “Data Press Release”). A copy of the Data Press Release is filed herewith as Exhibit 99.1 and is incorporated herein by reference.
On September 24, 2019, the Company delivered a presentation to investors via webcast relating to, among other things, the data that is the subject of the Data Press Release. A copy of the presentation is filed herewith as Exhibit 99.2 and incorporated herein by reference.
On September 24, 2019, the Company issued a press release titled “UroGen Investor Day Details Positive Clinical Updates, UGN-101 Launch Preparedness, and Pipeline Advances” (the “Recap Press Release”). A copy of the Recap Press Release is filed herewith as Exhibit 99.3 and incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. |
(d)
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Date: September 24, 2019 | | | | UROGEN PHARMA LTD. |
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| | | | By: | | /s/ Peter Pfreundschuh |
| | | | | | Peter Pfreundschuh |
| | | | | | Chief Financial Officer |
