“The recent initiation of our pivotal NanoFlu Phase 3 clinical trial in older adults represents an important milestone toward gaining approval for our novel vaccine candidate,” said
Third Quarter 2019 and Subsequent Operational Highlights
Novavaxinitiated a pivotal Phase 3 clinical trial for NanoFlu, its recombinant quadrivalent seasonal influenza vaccine candidate, and completed enrollment of 2,652 healthy older adults across 19 U.S. clinical sites. The primary objective of the randomized, observer-blinded, active-controlled trial is to demonstrate non-inferior immunogenicity as measured by hemagglutination inhibition (HAI) titers of vaccine homologous influenza strains and safety compared against a licensed vaccine, Fluzone® Quadrivalent.
- Top-line results from this Phase 3 clinical trial are expected in the first quarter of 2020 and would support a subsequent U.S. biologics license application (BLA) and licensure of NanoFlu using the U.S. Food and Drug Administration’s (
FDA) accelerated approval pathway.
September 19, 2019, a Presidential Executive Order was issued that mandates the modernization of influenza vaccines for the benefit of U.S. national security and public health. This Executive Order reinforces the strategic value of the NanoFlu program in particular because, as a non-egg based vaccine formulated using recombinant nanoparticle technology and combined with a safe and potent adjuvant, NanoFlu has all the characteristics of the better influenza vaccine mandated by the Order. The full Executive Order is available here.
FDAand the European Medicines Agency(EMA) have both recommended that Novavaxconduct an additional Phase 3 clinical trial to confirm the efficacy of ResVax. Novavaxis in continuing discussions with both global regulatory authorities and with potential partners to explore the opportunity to bring ResVax to market globally.
Novavaxpresented additional efficacy and safety findings from the program at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual meeting in August and at the World Vaccine Congress- Europelast week. The presentations included new observations based on the recently completed analyses of the 1-year safety data, including a 56.9% (95% CI 34.5, 71.7%) reduction in the incidence of serious adverse events (SAEs) diagnosed as pneumonia, with confirmation by chest x-ray, that extended through the first year of life.
- The Journal of Infectious Diseasespublished a peer-reviewed manuscript detailing the positive results from Novavax’ Phase 1 clinical trial in healthy adults of the Ebola virus glycoprotein vaccine candidate. Additional details of the manuscript are available here.
Novavaxand Catalent Biologics closed the transaction 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, Catalenthas begun to provide process development and manufacturing services for specified Novavaxprograms.
Financial Results for the Three and Nine Months Ended
Share and per share data have been restated to reflect the reverse stock split that was completed in
Research and development expenses decreased 55% to
General and administrative expenses slightly decreased to
Interest income (expense), net for the third 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||Nine Months Ended|
|September 30,||September 30|
|Research and development||18,611||41,326||84,502||130,382|
|Gain on Catalent transaction||(9,016||)||--||(9,016||)||--|
|General and administrative||7,899||8,309||26,236||25,185|
|Loss from operations||(14,987||)||(41,900||)||(91,876||)||(127,406||)|
|Interest income (expense), net||(3,061||)||(2,651||)||(8,973||)||(8,119||)|
|Other income (expense)||5||(19||)||(15||)||111|
|Basic and diluted net loss per share||$||(0.74||)||$||(2.33||)||$||(4.43||)||$||(7.42||)|
|Basic and diluted weighted average|
|number of common shares outstanding||24,327||19,116||22,761||18,262|
SELECTED CONSOLIDATED BALANCE SHEET DATA
|September 30, 2019||December 31, 2018|
|Cash and cash equivalents||$||71,167||$||70,154|
|Total restricted cash||4,763||11,805|
|Total current assets||89,022||119,276|
|Total stockholders’ deficit||(189,838||)||(167,935||)|
Senior Manager, Investor & Public Relations
Brandzone/Speak Life Science