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10-Q
PROTEON THERAPEUTICS INC filed this Form 10-Q on 08/07/2017
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CAUTIONARY NOTE FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q contains forward-looking statements, which reflect our current views with respect to, among other things, our operations and financial performance. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q are forward-looking statements. You can identify these forward-looking statements by the use of words such as “outlook,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “seeks,” “approximately,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. These forward-looking statements are subject to various risks and uncertainties. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. These forward-looking statements include, but are not limited to, statements about:

 

  · the timing of completing enrollment or releasing data or results of our ongoing and planned clinical trials for vonapanitase (formerly PRT-201);

  · our estimates regarding the amount of funds we require to complete our Phase 3 clinical trial for vonapanitase;

  · our interpretation of the data from our completed Phase 2 and Phase 3 clinical trials for vonapanitase;

  · whether and when we may submit a Biologics License Application or a supplemental Biologics License Application;

  · whether we will need to conduct any additional studies after our Phase 3 trials;

  · our estimates regarding the amount of funds required to fund operations into the fourth quarter of 2019;

  · our plans to fund our chemistry, manufacturing and controls;

  · our estimates regarding expenses, future revenues, capital requirements, the sufficiency of our current and expected cash resources and our need for additional financing and plans for additional financing;

  · our estimate of when we will require additional funding;

  · our plans to commercialize and bring vonapanitase to market;

  · the timing of, and our ability to obtain and maintain, regulatory approvals for our product candidates, including vonapanitase;

  · the timing of a clinical trial of vonapanitase in Europe, results and submission of a Marketing Authorization Application;

  · the rate and degree of market acceptance and clinical utility of any approved product candidate and the general market for the prevention of vascular access failure;

  · the potential benefits of strategic partnership agreements and our ability to enter into selective strategic partnership arrangements;

  · our ability to quickly and efficiently identify and develop additional product candidates;

  · our search for additional product opportunities;

  · our commercialization, marketing, distribution and manufacturing capabilities, strategy and expenses;

  · timing to recruit and expand our employee base and sales force, both in and outside the United States;

  · plans to initiate or continue Phase 1 or Phase 1/2 trials in symptomatic peripheral artery disease or other indications;

  · the reimbursement of vonapanitase;

  · our research and development costs;

  · the sufficiency of existing facilities to meet our needs;

  · our estimates regarding general and administrative costs and salary and personnel costs, costs associated with preparation for commercial operations and costs associated with being a public company;

  · our intellectual property position;

  · our plans to seek patent protection in available countries;

  · our expectations that vonapanitase will qualify for a 12-year period of exclusivity and our ability to obtain and maintain other forms of exclusivity relevant to our business;

  · our reliance on and the expected performance of our third party suppliers and manufacturers;

  · our plans to build out compliance, financial and operating infrastructure after Phase 3 completion;

  · our plans to improve existing, and implement new, systems to manage our business;

 

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