Business description of Protara-Therapeutics-Inc from last 10-k form

 
3
 
CAUTIONARY NOTE FORWARD-LOOKING STATEMENTS
 
This Annual Report on Form 10-K 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 Annual Report on Form 10-K 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 results of our ongoing and planned clinical trials for PRT-201;
 
·
our estimates regarding the amount of funds we require to complete our two planned Phase 3 clinical trials for PRT-201;
 
·
our estimates regarding the amount of funds required to fund operations into 2018;
 
·
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 PRT-201 to market;
 
·
the timing of, and our ability to, obtain and maintain regulatory approvals for our product candidates, including PRT-201;
 
·
the timing of a clinical trial of PRT-201 in Europe, results and submission of a Marketing Authorization Application;
 
·
our interpretation of the data from our completed Phase 2 trial for PRT-201;
 
·
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 commercialization, marketing, distribution and manufacturing capabilities and strategy and expenses;
 
·
timing to recruit and expand our employee base and sales force, both in and outside the United States;
 
·
plans to initiate Phase 1 or Phase 1/2 trials in other indications;
 
·
the reimbursement of PRT-201;
 
·
our research and development expenses;
 
·
our general and administrative costs and salary and personnel costs;
 
·
the costs associated with preparation for commercial operations;
 
·
the costs associated with being a public company;
 
·
our intellectual property position;
 
·
our plans to seek patent protection in available countries;
 
·
our expectations that PRT-201 will qualify for a 12 year period of exclusivity;
 
·
our reliance on third parties as suppliers and manufactures;
 
·
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;
 
·
future payment of dividends;
 
·
the impact of accounting policies;
 
·
the impact of changes in interest rates; and
 
·
exposure to foreign currency exchange risks.
·
the timing of results of our ongoing and planned clinical trials for PRT-201;
our estimates regarding the amount of funds we require to complete our two planned Phase 3 clinical trials for PRT-201;
our estimates regarding the amount of funds required to fund operations into 2018;
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 PRT-201 to market;
the timing of, and our ability to, obtain and maintain regulatory approvals for our product candidates, including PRT-201;
the timing of a clinical trial of PRT-201 in Europe, results and submission of a Marketing Authorization Application;
our interpretation of the data from our completed Phase 2 trial for PRT-201;
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 commercialization, marketing, distribution and manufacturing capabilities and strategy and expenses;
timing to recruit and expand our employee base and sales force, both in and outside the United States;
plans to initiate Phase 1 or Phase 1/2 trials in other indications;
the reimbursement of PRT-201;
our research and development expenses;
our general and administrative costs and salary and personnel costs;
the costs associated with preparation for commercial operations;
the costs associated with being a public company;
our intellectual property position;
our plans to seek patent protection in available countries;
our expectations that PRT-201 will qualify for a 12 year period of exclusivity;
our reliance on third parties as suppliers and manufactures;
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;
future payment of dividends;
the impact of accounting policies;
the impact of changes in interest rates; and
exposure to foreign currency exchange risks.

All forward-looking statements in this Annual Report on Form 10-K involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed in Part I, Item 1A, Risk Factors, and elsewhere in this Annual Report on Form 10-K.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this Annual Report on Form 10-K.  Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.