Novavax Second Quarter and Subsequent Achievements:
- Announced positive top-line data from a Phase 2 trial of its RSV F-protein nanoparticle vaccine candidate (RSV F Vaccine) in older adults. The trial demonstrated statistically significant vaccine efficacy in the prevention of symptomatic RSV disease in older adults, the first vaccine to demonstrate efficacy against RSV disease in any population. The trial detected an attack rate of 4.9% for symptomatic RSV disease in 1,600 older adults. Similar to the Company’s findings in prior trials, there were greater than four-fold increases in both anti-F IgG and palivizumab-competing antibody (PCA) concentrations with serological responses in over 90% of vaccinated participants.
Additional details on this data are available via a multimedia news release: http://www.multivu.com/players/English/7590851-novavax-rsv/
- Announced positive top-line data from a Phase 2 trial of its recombinant quadrivalent seasonal influenza virus-like particle candidate (Quadrivalent Seasonal Influenza VLP). The trial, funded in whole or part with Federal funds from the Company’s contract with HHS BARDA, demonstrated that the Quadrivalent Seasonal Influenza VLP vaccine candidate was well-tolerated with no vaccine-related serious adverse events. The trial met its immunogenicity targets and demonstrated potential to meet the
Center for Biological Evaluation and Research(CBER) criteria for accelerated approval.
- Delivered positive top-line data from a Phase 1 clinical trial of its Ebola virus glycoprotein (GP) recombinant nanoparticle vaccine (Ebola GP Vaccine) candidate adjuvanted with Matrix-M™. The trial demonstrated that the adjuvanted Ebola GP Vaccine was highly immunogenic, well-tolerated and resulted in significant antigen dose-sparing.
Gail K. Boudreauxto the Board of Directors. Ms. Boudreaux brings over 30 years of experience from a broad spectrum of health care operations. She most recently served as the Executive Vice President of UnitedHealth Group and was the Chief Executive Officer of UnitedHealthcare. She has been honored as one of Fortune’s 50 Most Powerful Women in American Business for the last six years and was recognized by Modern Healthcare as one of the Top 25 Women in Healthcare.
2015 Anticipated Events:
- Announcement of safety and immunogenicity data from the RSV F Vaccine Phase 2 trial to protect infants via maternal immunization; and
- Initiation of a Phase 3 trial of the RSV F Vaccine in older adults as early as the fourth quarter.
“We have been committed to delivering preliminary results from four of our clinical programs during the second and third quarters of this year. In the last month, we have delivered positive top-line data from three clinical trials; our RSV F Vaccine for older adults, Seasonal Influenza Vaccine, and Ebola GP Vaccine. In addition, our RSV F Vaccine Phase 2 trial to protect infants via maternal immunization is scheduled to report later this quarter. In doing so, we demonstrate the breadth and power of our recombinant vaccine technology,” said
Financial Results for the Three and Six Months Ended
The cost of government contracts revenue in the second quarter of 2015 decreased 47% to
Research and development expenses increased 65% to
General and administrative expenses increased 22% to
A replay of the conference call will be available starting at
Statements herein relating to the future of
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except per share information)|
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Costs and expenses:|
|Cost of government contracts revenue||2,687||5,102||5,307||8,123|
|Research and development||25,042||15,202||50,769||29,720|
|General and administrative||7,088||5,806||12,931||10,114|
|Total costs and expenses||34,817||26,110||69,007||47,957|
|Loss from operations||(20,821||)||(17,851||)||(45,135||)||(32,236||)|
|Interest income (expense), net||108||(31||)||194||(71||)|
|Other income (expense)||72||18||(70||)||18|
|Realized gains on marketable securities||―||―||―||615|
|Basic and diluted net loss per share||$||(0.08||)||$||(0.08||)||$||(0.18||)||$||(0.15||)|
|Basic and diluted weighted average number of common shares outstanding||268,083||217,178||254,727||213,075|
|SELECTED CONSOLIDATED BALANCE SHEET DATA|
|June 30,||December 31,|
|Cash and cash equivalents||$||167,384||$||32,335|
|Total current assets||332,979||188,158|
|Total notes payable and capital lease obligations||823||1,173|
|Total stockholders’ equity||387,603||229,618|
Novavax, Inc. Barclay A. PhillipsSVP, Chief Financial Officer and Treasurer Andrea N. Flynn, Ph.D. Senior Manager, Investor Relations firstname.lastname@example.org 240-268-2000 Russo Partners, LLC David Schull Todd Davenport, Ph.D. email@example.com firstname.lastname@example.org 212-845-4271