Print Page  Close Window

SEC Filings

VITAE PHARMACEUTICALS, INC filed this Form S-1 on 08/12/2014
Entire Document

Table of Contents

    outsourced professional scientific services;
    laboratory materials and supplies used to support our research activities;
    allocated expenses for rent, utilities and other facility-related costs; and
    software license fees associated with in-licensed products and technology.

        The successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the remainder of the development of, or the period, if any, in which material net cash inflows may commence from any of our other product candidates. This uncertainty is due to the numerous risks and uncertainties associated with the duration and cost of clinical trials which vary significantly over the life of a project as a result of differences arising during clinical development, including:

    the number of clinical sites included in the trials;
    the length of time required to enroll suitable patients;
    the number of patients that ultimately participate in the trials;
    the number of doses patients receive;
    the duration of patient follow-up; and
    the results of our clinical trials.

        Our expenditures are subject to additional uncertainties, including the terms and timing of regulatory approvals, and the expense of filing, prosecuting, defending and enforcing any patent claims or other intellectual property rights. We may never succeed in achieving regulatory approval for any of our product candidates. We may obtain unexpected results from our clinical trials. We may elect to discontinue, delay or modify clinical trials of some product candidates or focus on others. A change in the outcome of any of the foregoing variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate. For example, if the U.S. Food and Drug Administration, or FDA, or other regulatory authorities were to require us to conduct clinical trials beyond those which we currently anticipate, or if we experience significant delays in enrollment in any our clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development. Drug commercialization will take several years and millions of dollars in development costs.

        We track research and development expenses on a program-by-program basis and have allocated common expenses, such as facilities, depreciation, stock-based compensation and other research and development support expenses to each program based on the personnel resources allocated to each program. Below is a summary of our research and development expenses for the six months ended June 30, 2014 and 2013 and the years ended December 31, 2013 and 2012:

  Six Months
June 30,
  2014   2013  
  (in thousands)


  $ 5,971   $ 5,299  




    161     512  

Discovery and Other

    2,889     407  

Contour and Technology Development

    404     452  

Total research and development expenses

  $ 9,425   $ 7,585