Novavax Reports Second Quarter 2017 Financial Results
Second Quarter and Subsequent Achievements:
Novavax’ nanoparticle flu vaccine demonstrates superior immunogenicity and protection compared to market leader in preclinical challenge studies. In head-to-head comparison studies against Fluzone® High-Dose, Novavax’ nanoparticle influenza vaccine with our proprietary Matrix-M™ adjuvant (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. Further details will be published in the near future in a peer-reviewed journal and presented at scientific conferences.
Topline data from Phase 2 older adult safety and immunogenicity trial (E-205) demonstrated the benefit of adjuvanted formulations and two-dose regimens. Immunogenicity outcomes indicate both Matrix-M and aluminum phosphate adjuvants significantly increased the magnitude, duration and quality of the immune response relative to the RSV F antigen alone. All formulations and regimens were safe and well-tolerated.
The Company announced the path forward for an adjuvanted RSV F protein recombinant nanoparticle vaccine (RSV F Vaccine) in older adults with plans to initiate a Phase 2 efficacy trial in 2018. This approach is driven by an observed 61% reduction in hospitalizations due to COPD exacerbations.
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 has grown from 16 sites in five countries in its first season of enrollment to 80 sites in 11 countries.
Data from the second of two Phase 2 trials of its RSV F Vaccine candidate confirmed an overall reduction of infection of >50% in women of childbearing age, published in the journal Vaccine.
Anticipated 2017 Event:
Initiation of a Phase 1/2 clinical trial of the Company’s NanoFlu vaccine candidate in a head-to-head comparison to Fluzone High-Dose. Data from this trial should be available in the fourth quarter of 2017.
“Novavax has demonstrated considerable progress in our RSV F Vaccine program, highlighted by the continued strong execution of the Prepare trial, and the data from our recent trial in older adults, which confirmed the ability of the vaccine to generate robust immune responses and provided us with a development path forward,” said
Financial Results for the Three and Six Months Ended
Research and development expenses decreased 40% to
General and administrative expenses decreased 37% to
Interest income (expense), net for the second quarter of 2017 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
Six Months Ended
Research and development
General and administrative
Loss from operations
Interest income (expense), net
Other income (expense)
Basic and diluted net loss per share
Basic and diluted weighted average
number of common shares outstanding
SELECTED CONSOLIDATED BALANCE SHEET DATA
Cash and cash equivalents
Total current assets
Total notes payable and capital lease obligation
Total stockholders’ deficit