“In keeping with our stated 2018 objectives,
“On the NanoFlu front,” Mr. Erck continued, “the data published in The New England Journal of Medicine demonstrated that NanoFlu induced significantly improved immune response compared to the current leading high-dose influenza vaccine. We are on track to initiate a Phase 2 clinical trial of quadrivalent formulations of NanoFlu in the third quarter of this year. Pending successful Phase 2 data, based on discussions with the
May 2018, Novavax’ Prepare trial reached enrollment of 4,636 pregnant women, at least 3,000 of whom received ResVax.
Novavaxrecently reached agreement with the FDAthat the efficacy analysis to be conducted in the first quarter of 2019 will be the final analysis used to support the future biologics license application (BLA). This agreement was based on meeting the FDA’s minimum standards for evaluation of both the safety and efficacy of ResVax. We anticipate using the same data for filing a marketing authorization application (MAA) submission in Europe. The current and projected numbers of blinded primary endpoint cases provide Novavaxwith confidence that the trial is powered to make a statistically sound efficacy conclusion. Novavaxexpects to report on these data in the first quarter of 2019 and, assuming successful results, expects to submit the BLA and the MAA by the first quarter of 2020.
June 2018, The New England Journal of Medicine published a peer-reviewed letter to the editor detailing the positive results from Novavax’ Phase 1/2 clinical trial in older adults of NanoFlu compared to the leading licensed egg-based, high-dose influenza vaccine. Novavaxhad previously presented top-line results from this clinical trial at the World Vaccine Congressin April 2018.
June 2018, the FDAacknowledged and agreed that the accelerated approval pathway for seasonal influenza vaccines could be available for NanoFlu.
April 2018, Novavaxconducted a public offering of approximately 34.8 million shares of its common stock, resulting in net proceeds of $54 million.
- Final efficacy results of the Prepare trial are expected in the first quarter of 2019.
- The Phase 2 clinical trial of quadrivalent formulations of NanoFlu is expected to begin in the third quarter of 2018.
- Top-line data from the Phase 2 clinical trial of NanoFlu and End of Phase 2 meeting with the
FDAare expected in the first quarter of 2019.
Financial Results for the Three and Six Months Ended
Research and development expenses increased 13% to
General and administrative expenses decreased 8% to
Interest income (expense), net for the second quarter of 2018 was
A webcast of the conference call can also be accessed via a link on the home page of the
About RSV in infants
RSV (respiratory syncytial virus) is the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide. Estimated annual infections of 64 million and an estimated 160,000 deaths make it the second leading cause of death in children under one year of age. RSV results in a total global economic burden of
ResVax is an RSV fusion (F) protein recombinant nanoparticle vaccine with aluminum phosphate. It is being developed to protect infants from RSV disease via maternal immunization and is the only RSV vaccine in a Phase 3 clinical trial for this indication. Protecting infants via maternal immunization has been shown to be effective against influenza, another respiratory virus, in prospective clinical studies. In addition, maternal immunization with tetanus and pertussis vaccines has been shown to be effective in preventing these diseases in infants. Maternal immunization may offer the best method of protection from RSV disease in infants through the first months of life.
Currently, ResVax is being evaluated in Prepare™, a global Phase 3 clinical trial in 4,636 pregnant women, at least 3,000 of whom have received the vaccine, and their infants. Prepare is supported by an
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.1 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 BLA 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||Six Months Ended|
|June 30,||June 30,|
|Research and development||44,542||39,263||89,056||76,916|
|General and administrative||8,224||8,940||16,876||17,793|
|Loss from operations||(41,993||)||(41,471||)||(85,506||)||(82,297||)|
|Interest income (expense), net||(2,596||)||(2,993||)||(5,468||)||(6,032||)|
|Other income (expense)||97||(1||)||130||10|
|Basic and diluted net loss per share||$||(0.12||)||$||(0.16||)||$||(0.25||)||$||(0.32||)|
|Basic and diluted weighted average|
|number of common shares outstanding||375,923||283,444||356,555||278,836|
SELECTED CONSOLIDATED BALANCE SHEET DATA
|December 31, 2017|
|Cash and cash equivalents||$||88,475||$||106,307|
|Total restricted cash||11,084||29,124|
|Total current assets||194,335||203,311|
|Total stockholders’ deficit||(87,707||)||(101,732||)|
1 Resolution of the
2 Influenza Vaccines Forecasts. Datamonitor (2013)