Novavax Reports Third Quarter 2017 Financial Results
Third Quarter Achievements:
Novavaxinitiated a Phase 1/2 clinical trial of its nanoparticle influenza vaccine candidate with its proprietary Matrix-M™ adjuvant (NanoFlu™) in older adults. The trial is a randomized, observer-blinded, active comparator-controlled trial in approximately 330 healthy older adults. The primary objective of the trial is to assess the safety and immunogenicity of two antigen concentrations (15 µg or 60 µg) of NanoFlu compared to a licensed influenza vaccine, Fluzone® High-Dose (Fluzone HD).
Novavaxreported that NanoFlu demonstrated superior immunogenicity and protection compared to the market leader in a preclinical challenge study. In a head-to-head comparison study against Fluzone HD, NanoFlu demonstrated significantly stronger and broader immune responses against matched and unmatched influenza strains, including a series of “drifted” strains evolved over more than a decade of influenza seasons. NanoFlu was also protective in an established challenge model against both a matched and a ten-year old unmatched strain. Data from this study was published in the journal Vaccine.
- The Prepare™ clinical trial for infants via maternal immunization, supported by an
$89 milliongrant from the Bill and Melinda Gates Foundation(BMGF), accelerated into the third global season of enrollment. Prepare’s global footprint is expected to grow from 16 sites in five countries in its first season of enrollment to over 90 sites in 12 countries in 2018.
Anticipated 2017 Event:
- Announce topline data from a Phase 1/2 clinical trial of the NanoFlu vaccine candidate in a head-to-head comparison with Fluzone HD before the end of 2017.
“We were very pleased to initiate and fully enroll the Phase 1/2 clinical trial of our NanoFlu vaccine candidate in older adults, following impressive results in preclinical challenge models. Given this timing, we are well positioned to announce data from the ongoing trial before the end of the year,” said
Financial Results for the Three and Nine Months Ended
Research and development expenses decreased 21% to
General and administrative expenses decreased 40% to
Interest income (expense), net for the third quarter of 2017 and 2016 was
A webcast of the conference call can also be accessed via a link on the home page of the
Statements herein relating to the future of
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except per share information)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Research and development||41,862||52,983||118,779||186,839|
|General and administrative||8,118||13,556||25,911||38,183|
|Loss from operations||(41,628||)||(63,308||)||(123,926||)||(215,068||)|
|Interest income (expense), net||(2,989||)||(2,957||)||(9,021||)||(7,756||)|
|Other income (expense)||10||11||20||(33||)|
|Basic and diluted net loss per share||$||(0.15||)||$||(0.24||)||$||(0.47||)||$||(0.82||)|
|Basic and diluted weighted average number of common shares outstanding||296,435||271,064||284,767||270,669|
|SELECTED CONSOLIDATED BALANCE SHEET DATA
|Cash and cash equivalents||$||104,245||$||144,353|
|Total current assets||225,995||287,830|
|Total notes payable and capital lease obligation||317,407||316,376|
|Total stockholders’ deficit||(74,151||)||(5,546||)|
Source: Novavax, Inc.