“We remain on track to meet our 2018 objectives, as we continue to execute on our clinical milestones for ResVax and NanoFlu,” said
Third Quarter 2018 Operational Highlights
Novavaxexpects to report top-line results from its final efficacy analysis in the first quarter of 2019 and, assuming successful results, expects to submit the Biologics License Application (BLA) and Marketing Authorization Application (MAA) by the first quarter of 2020.
September 2018, Novavaxinitiated a Phase 2 clinical trial in older adults of quadrivalent formulations of NanoFlu, its nanoparticle seasonal influenza vaccine candidate, and in October 2018, Novavaxcompleted enrollment of approximately 1,375 healthy older adults across clinical sites in the U.S. This randomized, observer-blinded, active-controlled trial will assess the safety and tolerability of different doses and formulations of NanoFlu, both adjuvanted with Matrix-M™ and unadjuvanted, as compared to two U.S.-licensed comparators. Phase 2 clinical trial top-line results are expected in the first quarter of 2019.
- During a pre-IND meeting in 2018, the
FDAacknowledged and agreed that the accelerated approval pathway for seasonal influenza vaccines could be available for NanoFlu. Novavaxplans to discuss the Phase 2 data and the proposed Phase 3 study design, and reach agreement on the use of accelerated approval, with the FDAduring an End-of-Phase 2 meeting in the first half of 2019. Novavaxwill bring forward the selected dose/formulation of the Phase 2 clinical trial into its future pivotal Phase 3 immunogenicity clinical trial.
Novavaxannounced the appointment of Rachel King, Co-Founder and Chief Executive Officer of GlycoMimetics, Inc., to its Board of Directors. In addition to extensive experience as an executive in the biotechnology industry, Mrs. King has also worked in the venture capital side of life sciences, and has held executive positions within a global multinational pharmaceutical company.
Key Upcoming Anticipated Events
- Final efficacy results of the Prepare trial are expected in the first quarter of 2019.
- Top-line data from the Phase 2 clinical trial of NanoFlu are expected in the first quarter of 2019.
- An End-of-Phase 2 meeting for NanoFlu is expected in the first half of 2019.
Financial Results for the Three and Nine Months Ended
Research and development expenses decreased 1% to
General and administrative expenses increased 2% to
Interest income (expense), net for the third 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
Globally, RSV (respiratory syncytial virus) is the leading viral cause of severe lower respiratory tract disease in infants and young children.1 It is the second leading cause of death in children under one year of age.2 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.3 RSV results in a total global economic burden of
In the U.S., RSV is the leading cause of hospitalization of infants, with estimated annual hospitalizations of up to 76,000.4,, 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.7 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. 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.8 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||Nine Months Ended|
|September 30,||September 30|
|Research and development||41,326||41,862||130,382||118,779|
|General and administrative||8,309||8,118||25,185||25,911|
|Loss from operations||(41,900||)||(41,628||)||(127,406||)||(123,926||)|
|Interest income (expense), net||(2,651||)||(2,989||)||(8,119||)||(9,021||)|
|Other income (expense)||(19||)||10||111||20|
|Basic and diluted net loss per share||$||(0.12||)||$||(0.15||)||$||(0.37||)||$||(0.47||)|
|Basic and diluted weighted average|
|number of common shares outstanding||382,315||296,435||365,236||284,767|
|SELECTED CONSOLIDATED BALANCE SHEET DATA|
|December 31, 2017|
|Cash and cash equivalents||$||56,496||$||106,307|
|Total restricted cash||18,540||29,124|
|Total current assets||160,541||203,311|
|Total stockholders’ deficit||(126,679||)||(101,732||)|
1 Nair, H., et al. (2010) Lancet. 375:1545-1555
2 Losano R., et al. (2012/Dec15) Lancet. 380: 2095
3 Ting S/Nair H. Lancet. (2017). Sep2;390:946
4 Leader S., et al. (2003) J Pediatr. 143: S127
5 Hall CB. N Engl J Med (2009). 360:588
6 CDC-Stockman LJ. Pediatr Infect Dis J (2012). 31:5
7 Hall CB. (2013) Pediatrics. 132:e341
8 Resolution of the
9 Influenza Vaccines Forecasts. Datamonitor (2013)