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Operations | 9 Months Ended
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Sep. 30, 2016
Operations [Abstract] |
Operations | Note 2 – Operations The Company’s vaccine candidates currently under development, some of which include adjuvants, will require significant additional research and development efforts that include extensive preclinical studies and clinical testing, and regulatory approval prior to commercial use. As a clinical-stage vaccine company, the Company has primarily funded its operations from proceeds through the sale of its common stock in equity offerings, the issuance of convertible debt and revenue under its prior contract with the Department of Health and Human Services, Biomedical Advanced Research and Development Authority (“HHS BARDA”) and, to a lesser degree, revenue under the grant agreement with the Bill & Melinda Gates Foundation (“BMGF”) and its prior contract with PATH Vaccine Solutions (“PATH”). Management regularly reviews the Company’s cash and cash equivalents and marketable securities relative to its operating budget and forecast to monitor the sufficiency of the Company’s working capital, and anticipates continuing to draw upon available sources of capital to support its product development activities. Following the results of the top-line data from the Phase 3 clinical trial of its RSV F Vaccine in older adults, on November 9, 2016, the Company announced a restructuring plan (the “Restructuring Plan”) designed to meet the following key objectives:
| · | Prioritize development activities to achieve clinical data events during 2017;
| · | Reduce cash burn, extend financial horizon and minimize near-term dilution; and
| · | Maintain operational core competencies to execute development plans.
The Restructuring Plan includes an immediate reduction in workforce of approximately 30%. The Company expects to incur one-time restructuring costs of approximately $3 million to $4 million, including cash severance expenses, in the fourth quarter of 2016. The Restructuring Plan was engineered to support the following high-level operating priorities (each of which is more fully articulated in the program descriptions in Management’s Discussion and Analysis of Financial Condition and Results of Operations):
| · | Continued execution of the global pivotal Phase 3 clinical trial, known as Prepare™, of its RSV F Vaccine for infants via maternal immunization;
| · | Initiation of a multi-arm, dose-ranging Phase 2 clinical trial of its RSV F Vaccine in older adults; and
| · | Initiation of a Phase 1 clinical trial of its Zika vaccine candidate in 2017.

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