Novavax Reports First Quarter 2017 Financial Results
First Quarter Achievements:
- Enrollment continued during the second global season in the RSV Phase 3 Prepare™ clinical trial for infants via maternal immunization. Enrollment in the first quarter of 2017 transitioned from the northern hemisphere to southern hemisphere sites in
Argentina, Australia, Chile, New Zealandand South Africa. The second season of enrollment has benefitted greatly from the establishment of the operational infrastructure and experience from the first global season, resulting in material increases in enrollment and enhanced momentum as we move towards the third global season of enrollment.
- Initiation of a randomized, observer-blinded, multi-arm, dose-ranging Phase 2 clinical trial, in one and two dose formulations, both with and without adjuvants, of its RSV F Vaccine in older adults (60 years of age and older). The trial will evaluate safety and immunogenicity of these formulations in older adults as measured by serum microneutralization titers against RSV/A and RSV/B, palivizumab competing antibodies (“PCA”) and anti-F IgG.
Anticipated 2017 Events:
- Announce top-line data from the Phase 2 safety and immunogenicity clinical trial of the RSV F vaccine in older adults in the next 90 days.
- File revised study documents and conduct an informational analysis of the Prepare trial that would provide an indication of the RSV F Vaccine’s potential efficacy against the trial’s primary endpoint before the end of the year.
- Initiate a Phase 1 clinical trial of the Company’s recombinant seasonal influenza vaccine candidate before the end of the year.
- Initiate a Phase 1 clinical trial of the Company’s Zika vaccine candidate before the end of the year.
“We continued to make significant progress in the execution of our two key clinical trials of our RSV F vaccine for both infant via maternal immunization and in older adults. We look forward to reporting important clinical data from our older adult trial in the next 90 days. We’ve also been in discussion with the
Financial Results for the Three Months Ended
Research and development expenses decreased 45% to
General and administrative expenses decreased 16% to
Interest income (expense), net for the first quarter of 2017 was
A webcast of the conference call can also be accessed via a link on the home page of the
Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infections and the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide, with estimated annual infection and mortality rates of 64 million and 160,000, respectively.1 In the U.S., RSV is the leading cause of hospitalization of infants, and globally, is second only to malaria as a cause of death in children under 1 year of age.2 3 Despite the induction of post-infection immunity, repeat infection and lifelong susceptibility to RSV is common. Currently, there is no approved RSV vaccine available.4 5
Statements herein relating to the future of
1 Nair, H. et al. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet, 2010; 375: 1545-1555.
2 Hall, C.B. et al. Respiratory Syncytial Virus-Associated hospitalizations Among Children Less Than 24 Months of Age. Pediatrics, 2013; 132(2): E341-348.
3 Oxford Vaccine Group: http://www.ovg.ox.ac.uk/rsv
4 Glezen, W.P. et al. Risk of primary infection and reinfection with respiratory syncytial virus. Am J Dis Child, 1986; 140:543-546.
5 Glenn GM, et al. Modeling maternal fetal RSV F vaccine induced antibody transfer in guinea pigs. Vaccine, 2015; In press. http://dx.doi.org/10.1016/j.vaccine.2015.08.039.
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except per share information)|
|Three Months Ended|
|Research and development||37,654||68,952|
|General and administrative||8,852||10,528|
|Loss from operations||(40,826||)||(75,262||)|
|Interest income (expense), net||(3,039||)||(1,957||)|
|Other income (expense)||11||(33||)|
|Basic and diluted net loss per share||$||(0.16||)||$||(0.29||)|
|Basic and diluted weighted average|
|number of common shares outstanding||274,178||270,179|
|SELECTED CONSOLIDATED BALANCE SHEET DATA|
|Cash and cash equivalents||$||95,847||$||144,353|
|Total current assets||258,449||287,830|
|Total notes payable and capital lease obligation||316,714||316,376|
|Total stockholders’ deficit||(29,099||)||(5,546||)|
Contact: Investor Relations
Novavax, Inc. Andrea N. Flynn, Ph.D. Associate Director, Investor Relations firstname.lastname@example.org 240-268-2000 Westwicke Partners John Woolfordjohn.email@example.com 443-213-0506 Media Russo Partners, LLC David Schull Todd Davenport, Ph.D. firstname.lastname@example.org 212-845-4271