“We made important clinical and strategic progress this quarter, particularly in advancing NanoFlu, our next-generation flu vaccine candidate,” said
Second Quarter 2019 and Subsequent Operational Highlights
Novavaxreceived input from the U.S. Food and Drug Administration( FDA) on its End-of Phase 2 questions and reached agreement on the Phase 3 clinical trial design, enabling Novavaxto conduct a non-inferiority immunogenicity clinical trial against a licensed quadrivalent comparator. These data would support the future biologics license application and licensure of NanoFlu via the accelerated approval pathway.
Novavaxcontinues to receive input from global regulatory agencies to solicit input on possible pathways to licensure for ResVax. In Europe, we will seek formal scientific advice this fall from the European Medicines Agency(EMA). In the U.S., the FDArecommended that Novavaxconduct an additional Phase 3 clinical trial to confirm efficacy against medically significant RSV disease.
Novavaxpresented key efficacy and safety findings at the World Vaccine Congressin Washington, D.C.and at the Annual Meeting of the European Society for Pediatric Infectious Diseases(ESPID) in Ljubljana, Sloveniafrom the Prepare trial of ResVax. Additional details on these presentations are available on our website.
Novavaxand Catalent Biologics entered into an arrangement under which Catalentpurchased Novavax’ manufacturing equipment and related assets for approximately $18 million, assumed the property leases to two Novavaxproduct development and manufacturing facilities and hired approximately 100 of Novavax’ manufacturing and quality employees. In addition, Catalentwill also provide long-term process development and manufacturing services for specified Novavaxprograms.
May 10, 2019, Novavaxcompleted a reverse stock split of its issued and outstanding common stock at a ratio of 1-for-20.
Financial Results for the Three and Six Months Ended
Share and per share information have been restated to reflect the reverse stock split described above.
Research and development expenses decreased 32% to
General and administrative expenses increased 17% to
Interest income (expense), net for the second quarter of 2019 was
A webcast of the conference call can also be accessed via a link on the home page of the
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.
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, with estimated annual hospitalizations of 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. ResVax is being evaluated in Prepare™, a global Phase 3 clinical trial in 4,636 pregnant women, at least 3,000 of whom received the vaccine, and their infants. Prepare is supported by an
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||30,417||44,542||65,890||89,056|
|General and administrative||9,606||8,224||18,338||16,876|
|Loss from operations||(36,666||)||(41,993||)||(76,889||)||(85,506||)|
|Interest income (expense), net||(2,929||)||(2,596||)||(5,912||)||(5,468||)|
|Other income (expense)||(8||)||97||(20||)||130|
|Basic and diluted net loss per share||$||(1.69||)||$||(2.37||)||$||(3.77||)||$||(5.10||)|
|Basic and diluted weighted average|
|number of common shares outstanding||23,473||18,796||21,966||17,828|
SELECTED CONSOLIDATED BALANCE SHEET DATA
|December 31, 2018|
|Cash and cash equivalents||$||71,995||$||70,154|
|Total restricted cash||6,240||11,805|
|Total current assets||110,218||119,276|
|Total stockholders’ deficit||(185,493||)||(167,935||)|
Senior Manager, Investor & Public Relations
Brandzone/Speak Life Science