UroGen Pharma Enters Material Definitive Agreement

TL;DR

**URGN just signed a big deal, details pending, could move the stock.**

AI Summary

UroGen Pharma Ltd. filed an 8-K on January 17, 2024, reporting an "Entry into a Material Definitive Agreement" and "Other Events" that occurred on January 16, 2024. This filing indicates that UroGen Pharma, an Israeli pharmaceutical company, has entered into a significant new agreement. For investors, this matters because material agreements can significantly impact a company's financial health, future revenue streams, or strategic direction, potentially affecting the stock price of URGN.

Why It Matters

This filing signals a potentially significant business development for UroGen Pharma, which could influence its financial performance and stock valuation. Investors should monitor for details of this agreement to assess its impact.

Risk Assessment

Risk Level: medium — The filing indicates a material agreement but provides no details, creating uncertainty about its nature and potential impact, which could be positive or negative.

Analyst Insight

Smart investors should await further details regarding the 'Material Definitive Agreement' and 'Other Events' before making any investment decisions, as the current filing lacks specific information to assess impact.

Key Players & Entities

• UroGen Pharma Ltd. (company) — the registrant filing the 8-K
• January 16, 2024 (date) — date of the earliest event reported
• January 17, 2024 (date) — date the 8-K was filed
• 001-38079 (other) — Commission File Number for UroGen Pharma Ltd.
• URGN (other) — trading symbol for UroGen Pharma Ltd. on The Nasdaq Stock Market LLC

Forward-Looking Statements

• UroGen Pharma Ltd. will file an amendment or a subsequent 8-K providing details of the material definitive agreement. (UroGen Pharma Ltd.) — high confidence, target: 2024-02-16

FAQ

Filing Documents

• d731454d8k.htm (8-K) — 31KB
• 0001193125-24-009259.txt ( ) — 152KB
• urgn-20240116.xsd (EX-101.SCH) — 3KB
• urgn-20240116_lab.xml (EX-101.LAB) — 18KB
• urgn-20240116_pre.xml (EX-101.PRE) — 11KB
• d731454d8k_htm.xml (XML) — 3KB

01

Item 1.01 Entry into a Material Definitive Agreement. On January 16, 2024, UroGen Pharma Ltd. (the "Company") entered into a license and supply agreement (the "Agreement") with Medac Gesellschaft fr klinische Spezialprparate m.b.H. ("medac"), pursuant to which medac granted to the Company an exclusive, worldwide, royalty-free, sublicensable license under medac's intellectual property rights to develop, commercialize, import, export, use, distribute and register the pharmaceutical lyophilized product—a specific 80 mg formulation of mitomycin and 640 mg urea, manufactured according to medac's proprietary lyophilization process (the "Product")—as an integrated part of a pharmaceutical product that includes the Product and a reverse thermal gel, including the Company's RTGel reverse thermal hydrogels (the "Combined Product"). The Product was developed pursuant to a Development Agreement between the Company and medac dated August 18, 2019, as amended. Pursuant to the Agreement, medac has agreed to manufacture and supply the Company's requirements for Product for commercial use at an agreed upon price, which may be renegotiated on an annual basis upon request of one of the parties. The Company is responsible for development, commercialization, and regulatory approval activities, and medac agreed to use commercially reasonable efforts to provide reasonable and timely assistance for information and documents regarding the Product for use in obtaining and maintaining regulatory approvals. Pursuant to the Agreement, the Company retains the unlimited right to source from a party other than medac any lyophilized mitomycin for use in any Company product, including Jelmyto (mitomycin) for pyelocalyceal solution and UGN-102, that: a) includes mannitol as an excipient; and b) is not manufactured according to the medac patents listed in the Agreement. Unless earlier terminated in accordance with the terms of the Agreement, the Agreement (a) will remain in effect for the Unite

01

Item 8.01 Other Events. On January 17, 2024, the Company announced its plan to initiate a Phase 3 study in 2024 to explore the safety and efficacy of UGN-103 in low-grade, intermediate risk, non-muscle invasive bladder cancer. UGN-103 is intended to be a next-generation version of UGN-102 that combines medac's mitomycin formulation (i.e., the Product) with the Company's RTGel technology, which the Company believes will provide advantages related to production, cost, supply and product convenience. With medac's intellectual property protection for its mitomycin formulation expected to last until June 2035 and the Company's pending U.S. patent applications, the Company projects potential intellectual property protection on UGN-103 until December 2041.

Forward-Looking Statements

Forward-Looking Statements This report contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including without limitation statements regarding activities to be performed under the Agreement, the timing for the planned Phase 3 trial of UGN-103, the potential advantages of UGN-103 and anticipated intellectual property protection. The words "estimate," "may," "plan," "project," "potential," "will," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including risks relating to the preliminary results may not be indicative of results that may be observed in the future; the timing and success of clinical trials and potential safety and other complications thereof; unforeseen delays that may impact the timing of progressing clinical trials, reporting data and initiating product launches; the ability to obtain regulatory approval within the timeframe expected, or at all; the findings from the durability of response endpoint from the ENVISION Phase 3 study may not be positive, and in such event, our NDA pathway could be negatively impacted; even if the durability of response endpoint data from the ENVISION Phase 3 study are positive, there is no guarantee that our NDA for UGN-102 will be sufficient to support approval of UGN-102 on the timeframe expected, or at all; the ability to maintain regulatory approval; complications associated with commercialization activities; the labeling for any approved product; competition in the Company's industry; the scope, progress and expansion of developing and commercializing the Company's product candidates; the Company's pending patent applications may not be successful and in such event the duration of our

SIGNATURES

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. Date: January 17, 2024 UROGEN PHARMA LTD. By: /s/ Don Kim Don Kim Chief Financial Officer

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View this 8-K filing on SEC EDGAR