Novavax Reports Fourth Quarter and Full Year 2019 Financial Results
- NanoFlu top-line data from Phase 3 clinical trial expected by the end of this month
Novavaxawarded CEPI funding to support COVID-19 vaccine program
- COVID-19 Phase 1 clinical trial expected to initiate in late spring of 2020
- Company to host conference call today at
4:30 p.m. ET
“We remain on track to announce top-line results from our pivotal Phase 3 clinical trial for NanoFlu by the end of this month. Positive clinical data from this trial would support a subsequent
Fourth Quarter 2019 and Subsequent Operational Highlights
- Results of the pivotal Phase 3 clinical trial for NanoFlu, Novavax’ recombinant quadrivalent seasonal influenza vaccine candidate, are expected later this month. The trial includes 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.
- Positive top-line results from this Phase 3 clinical trial 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. In addition, in January 2020, the FDA granted Fast Track designation for NanoFlu.
Novavaxrecently announced that the Coalition for Epidemic Preparedness Innovations(CEPI) awarded an initial funding of $4 millionto support its effort to develop a COVID-19 vaccine. CEPI and Novavaxare having ongoing discussions on additional funding from CEPI to address Novavax’ costs through Phase 1.
Novavaxbegan efforts to develop a novel vaccine to protect against COVID-19 in January. Novavaxhas produced and is currently assessing multiple nanoparticle vaccine candidates in animal models prior to advancing to clinical trials. Initiation of Phase I clinical testing is expected in May or June 2020. Novavaxexpects to utilize its proprietary Matrix-M™ adjuvant with its COVID-19 vaccine candidate to enhance immune responses.
Novavaxis continuing its discussions with both global regulatory authorities and potential partners to explore the opportunity to bring ResVax to market.
- Earlier today,
Novavaxannounced a commercial license agreement related to its Matrix-M vaccine adjuvant. Matrix-M is a key component of Serum Instituteof India’s malaria vaccine candidate, which it licensed from Jenner Instituteat Oxford University. The vaccine candidate is currently in a Phase 2b clinical trial being conducted in Burkina Fasowith top-line data expected in the second quarter of 2020.
- Through utilization of At-the-market (ATM) offerings during the fourth quarter of 2019,
Novavaxraised net proceeds of $30 million. For the twelve months of 2019, Novavaxraised net proceeds of $97 million. Subsequent to year-end, through March 6, 2020, Novavaxraised additional net proceeds of $156 million.
Financial Results for the Three and Twelve Months Ended
Share and per share data have been restated to reflect the reverse stock split that was completed in
Research and development expenses decreased 32% to
General and administrative expenses decreased to
Interest income (expense), net for the fourth quarter of 2019 was
A webcast of the conference call can also be accessed via a link on the home page of the
About NanoFlu™ and Matrix-M™
NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by
A new strain of coronavirus first appeared in late 2019 in
Statements herein relating to the future of
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except per share information)|
|Three Months Ended||Twelve Months Ended|
|Research and development||29,341||43,415||113,842||173,797|
|Gain on Catalent transaction||--||--||(9,016||)||--|
|General and administrative||8,180||9,224||34,417||34,409|
|Loss from operations||(28,705||)||(46,512||)||(120,581||)||(173,918||)|
|Interest income (expense), net||(3,127||)||(2,819||)||(12,100||)||(10,938||)|
|Other income (expense)||2||(3||)||(13||)||108|
|Basic and diluted net loss per share||$||(1.13||)||$||(2.57||)||$||(5.51||)||$||(9.99||)|
|Basic and diluted weighted average|
|number of common shares outstanding||28,063||19,159||24,100||18,488|
SELECTED CONSOLIDATED BALANCE SHEET DATA
|Cash and cash equivalents||$||78,823||$||70,154|
|Total restricted cash||3,357||11,805|
|Total current assets||97,247||119,276|
|Total stockholders’ deficit||(186,017||)||(167,935||)|
Source: Novavax, Inc.