Table of Contents
- costs related to executing preclinical studies and clinical trials;
- costs related to acquiring, developing and manufacturing materials for preclinical studies and clinical trials;
- fees paid to consultants and other third parties who support our product candidate development;
- other costs incurred in seeking regulatory approval of our product candidates; and
- allocated facility-related costs and overhead.
typically use our employee, consultant and infrastructure resources across our development programs. To date, substantially all of our research and development expenses have been
associated with AVXS-101.
plan to increase our research and development expense for the foreseeable future as we continue our effort to develop AVXS-101 and to advance the development of future product
candidates, subject to the availability of sufficient funding.
successful development of product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing or costs required to complete the remaining
development of AVXS-101 or any future product candidates. This is due to the numerous risks and uncertainties associated with the development of product candidates.
General and Administrative Expense
General and administrative expense consists primarily of salaries and personnel-related costs, including employee benefits and any
stock-based compensation, for employees performing functions other than research and development. This includes personnel in executive, finance and administrative support functions. Other general and
administrative expenses include facility-related costs not otherwise allocated to research and development expense, professional fees for auditing, tax and legal services, expenses associated with
obtaining and maintaining patents and costs of our information systems.
expect that our general and administrative expense will increase as we begin to operate as a public reporting company and continue to develop and potentially commercialize AVXS-101
and our future product candidates. We believe that these increases likely will include increased costs for director and officer liability insurance, costs related to the hiring of additional personnel
and increased fees for outside consultants, lawyers and accountants. We also expect to incur increased costs to comply with corporate governance, internal controls, investor relations, disclosure and
similar requirements applicable to public reporting companies.
Interest Income (Expense)
Interest expense primarily consists of interest expense incurred on our then-outstanding notes payable. Interest income primarily
consists of any interest income earned on our cash and cash equivalents.
To date, we have not been required to pay U.S. federal or state income taxes because we have not generated taxable income.
Prior to the development of treatments for rare and life-threatening neurological genetic diseases, our business was focused on the
stem cell business, including the creation of a