Novavax Reports First Quarter 2018 Financial Results
First Quarter and Subsequent Achievements:
RSV F Vaccine
May 2018, Novavaxreached enrollment of approximately 4,600 pregnant women in its Prepare™ Phase 3 clinical trial of its RSV F Vaccine for infants via maternal immunization. This milestone enables Novavaxto initiate a prespecified interim efficacy analysis after approximately six months of follow-up of the last infant born to the approximately 4,600 women enrolled (including 3,000 actively vaccinated women). Completion of this analysis is expected in the first quarter of 2019. Since 2015, the Prepare trial is supported by an $89 milliongrant from the Bill & Melinda Gates Foundation(BMGF).
April 2018, Novavaxpresented at the World Vaccine Congresson the status of its Phase 3 clinical trial of its RSV F Vaccine.
April 2018, Novavaxpresented clinical data at the World Vaccine Congressfrom the Phase 1/2 clinical trial in older adults comparing trivalent formulations of NanoFlu to the market-leading licensed egg-based, high-dose influenza vaccine for older adults.
February 2018, Novavaxreported positive top-line results from its Phase 1/2 clinical trial of its trivalent NanoFlu.
April 2018, Novavaxcompleted an underwritten public offering of approximately 34.8 million shares of its common stock, including 4.5 million shares pursuant to the underwriters’ option to purchase additional shares. The shares resulted in net proceeds of $54 million.
- Effective on
March 14, 2018, John J. Trizzino, former Senior Vice President, Commercial Operations since 2014, was promoted to Senior Vice President, Chief Business Officer and Chief Financial Officer.
- Initiation of the Phase 2 clinical trial of quadrivalent formulations of NanoFlu scheduled to begin in the third quarter of 2018.
- Top-line data from the Phase 2 NanoFlu trial and End of Phase 2 meeting with the
FDAexpected in the first quarter of 2019.
- Results of the Prepare Phase 3 interim efficacy analysis for our RSV F Vaccine expected in the first quarter of 2019.
“We had an extremely productive first quarter, including making important advances in our two lead clinical vaccine programs. We are pleased to have reached the enrollment target for our Prepare Phase 3 RSV F Vaccine trial, which clears the path for following these most recent participants and their babies, and subsequently announcing top-line results of our planned interim efficacy analysis in the first quarter of 2019,” said
Financial Results for the First Quarter Ended
Research and development expenses increased 18% to
Interest income (expense), net for the first quarter of 2018 was
A webcast of the conference call can also be accessed via a link on the home page of the
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.2 Despite the induction of post-infection immunity, repeat infection and lifelong susceptibility to RSV is common.3 Currently, there is no approved RSV vaccine available.
About RSV F Vaccine for Infants via Maternal Immunization
Influenza is a world-wide infectious disease that causes illness in humans with symptoms ranging from mild to life-threatening or even death. Serious illness occurs not only in susceptible populations such as infants, young children and older adults, but also in the general population largely because of infection by continuously evolving strains of influenza which can evade the existing protective antibodies in humans. An estimated one million deaths each year are attributed to influenza.4 Current estimates for seasonal influenza vaccine growth in the top seven markets (U.S.,
NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine candidate produced by
Statements herein relating to the future of
2 Leader S. Pediatr Infect Dis J. 2002 Jul;21(7):629-32
3 PLOS. “How immunity to respiratory syncytial virus develops in childhood, deteriorates in adults.” ScienceDaily.
4 Resolution of the
5 Influenza Vaccines Forecasts. Datamonitor (2013)
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except per share information)|
|Three Months Ended|
|Research and development||44,514||37,654|
|General and administrative||8,652||8,852|
|Loss from operations||(43,513||)||(40,826||)|
|Interest income (expense), net||(2,872||)||(3,039||)|
|Other income (expense)||33||11|
|Basic and diluted net loss per share||$||(0.14||)||$||(0.16||)|
|Basic and diluted weighted average|
|number of common shares outstanding||336,972||274,178|
|SELECTED CONSOLIDATED BALANCE SHEET DATA|
|Cash and cash equivalents||$||113,402||$||106,307|
|Total restricted cash||20,439||29,124|
|Total current assets||181,034||203,311|
|Total stockholders’ deficit||(99,369||)||(101,732||)|
Source: Novavax, Inc.