First Quarter 2019 and Subsequent Operational Highlights
February 2019, Novavaxannounced top-line data from the Prepare™ trial, which was designed to determine the efficacy of ResVax™ against medically significant respiratory syncytial virus (RSV)-positive lower respiratory tract infection (LRTI) in infants. ResVax is the first RSV vaccine to demonstrate efficacy in infants.
April 2019, Novavaxpresented additional results at the World Vaccine Congressin Washington, D.C.from the Prepare trial of ResVax. Although the Prepare trial results did not meet the pre-specified primary efficacy endpoint, it demonstrated efficacy against RSV LRTI hospitalizations, a pre-specified secondary endpoint. RSV LRTI hospitalization is not only an important indication of the severity of RSV disease in infants, it also reflects a significant economic burden to global health systems.
January 2019, Novavaxannounced positive top-line results of its Phase 2 clinical trial of NanoFlu comparing various quadrivalent formulations, with or without Novavax’ Matrix-M™ adjuvant, with two U.S.-licensed influenza vaccines in older adults. These results show that NanoFlu with Matrix-M generated enhanced immune responses compared to the unadjuvanted formulation, and importantly, showed superior hemagglutination inhibition antibody (HAI) responses against wild-type A(H3N2) viruses, including drifted strains, when compared to Fluzone® High-Dose, the leading flu vaccine in older adults.
Key Upcoming Events
- Meet with the
FDA, European regulatory agencies, and potentially other national regulatory agencies during the second and third quarters, to assess opportunities for submission of marketing applications for ResVax.
- Reach agreement with the
FDAduring the third quarter of 2019 on a proposed Phase 3 clinical trial design for NanoFlu utilizing accelerated approval criteria for licensure.
- Present ResVax Phase 3 clinical trial data at the 37th Annual Meeting of the
European Society for Paediatric Infectious Diseases (ESPID) on May 7, 2019.
Financial Results for the First Quarter Ended
Research and development expenses decreased 20% to
General and administrative expenses were flat at
Interest income (expense), net was
A webcast of the conference call can also be accessed via a link on the home page of the
About RSV in Infants
Globally, RSV (respiratory syncytial virus) is the leading viral cause of severe lower respiratory tract disease in infants and young children. It is the second leading cause of death in children under one year of age. Estimated annual hospitalizations of 1.4 million and an estimated 27,300 in-hospital deaths were due to RSV acute lower respiratory infection in children under six months of age. RSV results in a total global economic burden of
In the U.S., RSV is the leading cause of hospitalization of infants. Estimated annual hospitalizations are up to 76,000. While RSV can impact all infants, babies under six months of age are among those at highest risk, as approximately 77% of all first-year RSV infections occur before six months. In the U.S., the total economic burden is
ResVax is an RSV fusion (F) protein recombinant nanoparticle vaccine with aluminum phosphate as an adjuvant. It is being developed to protect infants from RSV disease via maternal immunization, which may offer the best method of protection from RSV disease in infants through the first months of life. In
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 globally each year are attributed to influenza. Current estimates for seasonal influenza vaccine growth in the top seven markets (U.S.,
About NanoFlu™ and Matrix M™
NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by
About Accelerated Approval
Accelerated approval may be granted for certain biological products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments. Such an approval will be based on adequate and well-controlled clinical trials establishing that the biological product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit. For seasonal influenza vaccines, the hemagglutination inhibition (HAI) antibody response may be an acceptable surrogate marker of activity that is reasonably likely to predict clinical benefit. To be considered for accelerated approval, a biologics license application for a new seasonal influenza vaccine should include results from one or more well-controlled studies designed to meet immunogenicity endpoints and a commitment to conduct confirmatory post-marketing studies of clinical effectiveness in preventing influenza.
Statements herein relating to the future of
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except per share information)
|Three Months Ended|
|Research and development||35,473||44,514|
|General and administrative||8,732||8,652|
|Loss from operations||(40,223||)||(43,513||)|
|Interest income (expense), net||(2,983||)||(2,872||)|
|Other income (expense)||(12||)||33|
|Basic and diluted net loss per share||$||(0.11||)||$||(0.14||)|
|Basic and diluted weighted average|
|number of common shares outstanding||408,843||336,972|
SELECTED CONSOLIDATED BALANCE SHEET DATA
|Cash and cash equivalents||97,711||70,154|
|Total restricted cash||8,488||11,805|
|Total current assets||123,394||119,276|
|Total stockholders’ deficit||(150,583||)||(167,935||)|