Table of Contents
subject to significant uncertainty. We have no manufacturing facilities and all of our manufacturing activities are contracted out to third parties. Additionally, we currently use third-party
clinical research organizations, or CROs, to carry out our clinical development activities and we do not yet have a sales organization. If we obtain regulatory approval for PRT-201, we expect to incur
significant commercialization expenses related to product sales, marketing, manufacturing, and distribution. Accordingly, we may seek to fund our operations through public or private equity or debt
financings or other sources, including strategic collaborations. We may, however, be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all.
Our failure to raise capital or enter into such other arrangements as and when needed would have a negative impact on our financial condition and our ability to develop PRT-201 or any additional
product candidates, if developed.
To date, our revenue has been derived solely from government grants. We did not receive any government grants during the reported
periods and have no plans to receive additional government grants in the future.
Research and development expenses consist primarily of costs incurred for the development of PRT-201, which
- employee-related expenses, including salaries, benefits, travel and stock-based compensation expense;
- expenses incurred under
agreements with CROs and investigative sites that will conduct our clinical trials;
- the cost of acquiring, developing, and manufacturing clinical trial materials;
- costs associated with regulatory operations; and
- facilities, depreciation, and other expenses, which include direct and allocated expenses for
rent and maintenance of
facilities, insurance, and other supplies.
expense research and development costs to operations as incurred. We recognize costs for certain development activities, such as clinical trials, based on an evaluation of the
progress to completion of specific tasks using data such as patient enrollment, clinical site activations or information provided to us by our vendors.
cannot determine with certainty the duration and completion costs of the current or future clinical trials or if, when, or to what extent we will generate revenues from the
commercialization and sale of PRT-201. We may never succeed in achieving regulatory approval for PRT-201. The duration, costs, and timing of clinical trials and development of PRT-201 will depend on a
variety of factors, which include:
- the scope, rate of progress, and expense of our ongoing as well as any additional clinical trials and other research and
- uncertainties in clinical trial enrollment rate;
- future clinical trial results;
- significant and changing government regulation; and
- the timing and receipt of any regulatory approvals.
change in any of these factors could mean a significant change in the costs and timing associated with the development of PRT-201. For example, if the FDA, or another regulatory
authority were to require us to conduct clinical trials beyond those that we currently anticipate will be required for the completion of clinical development or if we experience significant delays in
enrollment in any of our