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trials, we could be required to expend significant additional financial resources and time on the completion of clinical development.
expect our research and development expenses to increase for the foreseeable future as we continue the development of PRT-201. Our current planned development activities include the
- we commenced our first Phase 3 clinical trial of PRT-201 for patients undergoing creation of a radiocephalic AVF in
the third quarter of 2014. Prior to completing enrollment in the first Phase 3 trial, we intend to initiate our second Phase 3 trial. If the results from the first Phase 3 trial
are sufficiently compelling, we intend to meet with the FDA to discuss the possibility of submitting a BLA, supported by the single Phase 3 trial and may decide to submit a BLA to the FDA prior
to completing the second Phase 3 trial;
- we may, based on additional data including the data from our Phase 3 clinical trials and if sufficient funds become
available, choose to conduct a clinical trial of PRT-201 in Europe;
- we may, based on additional data including the data from our Phase 3 clinical trials and if sufficient funds
available, study the effects of a 30 microgram dose of PRT-201 versus placebo on brachiocephalic AVFs and in patients undergoing placement of an arteriovenous graft, or AVG; and
expect to continue to manufacture clinical trial materials in support of our clinical trials.
direct research and development expenses consist principally of external costs, such as fees paid to CROs, investigators, consultants and central laboratories in connection with our
clinical trials, and costs related to acquiring and manufacturing clinical trial materials as well as of salaries and related costs for personnel, including stock-based compensation and travel
General and administrative expenses consist principally of salaries and related costs for personnel, including stock-based compensation
and travel expenses, in executive and other administrative functions. Other general and administrative expenses also include professional fees for legal, patent review, consulting and accounting
services as well as facility related costs. We anticipate increased expenses related to audit, legal, regulatory, and tax-related services associated with maintaining compliance with our NASDAQ
listing and Securities and Exchange Commission requirements, director and officer insurance premiums, and investor relations costs associated with being a public company.
if and when we believe a regulatory approval of our first product candidate appears likely, we anticipate that we will increase our salary and personnel costs and other
expenses as a result of our preparation for commercial operations.
Interest expense, net, consists of interest incurred on debt instruments, amortized deferred financing costs and amortized debt
discount, as offset by any interest income earned on our cash, cash equivalents and marketable securities. The debt discount primarily consists of the fair value of the bifurcated features embedded in
the convertible notes issued in September 2013. As of June 30, 2014, the debt discount had been fully amortized to interest expense.
Other income consists of the gain realized by the sale of fixed assets as well as changes in fair market value of the derivative
liability associated with the convertible notes.
Subsequent to the May 2014 Series D convertible preferred stock financing, our shares of preferred stock are redeemable
beginning in 2019 at their original issuance price plus any declared or accrued but