“Our accomplishments to-date in 2020, including significant progress in our influenza and COVID‑19 vaccine programs, are the most impressive in the company’s history,” said
First Quarter 2020 and Subsequent Operational Highlights
Novavaxannounced in March that NanoFlu, its recombinant quadrivalent seasonal influenza vaccine candidate with Matrix‑M™ adjuvant, achieved all primary objectives in its pivotal Phase 3 clinical trial in older adults. As required by the FDA’s accelerated approval pathway, the trial’s primary objectives were to demonstrate non-inferior immunogenicity of NanoFlu compared to a licensed vaccine (Fluzone® Quadrivalent), using the day 28 ratio of geometric mean titers (GMT) and the difference in seroconversion rates (SCR), as well as the overall safety of NanoFlu. These endpoints were met for all four strains included in NanoFlu. Immunogenicity was measured by hemagglutination inhibition (HAI) assays using egg-derived reagents. NanoFlu was well-tolerated, with a safety profile comparable to Fluzone Quadrivalent with a modest increase in local adverse events (AEs).
- NanoFlu also achieved statistical significance for key secondary endpoints. These key endpoints assessed GMT and SCR, but with an HAI assay based on wild-type reagents. NanoFlu demonstrated significantly higher GMT and SCR than Fluzone Quadrivalent across all four strains included in the vaccine and, importantly, for four tested drifted H3N2 strains not included in the vaccine but circulating this year.
- Results from this Phase 3 clinical trial will support a
U.S.biologics license application (BLA) and licensure of NanoFlu using the U.S.Food and Drug Administration’s (FDA) accelerated approval pathway.
- As announced today, the
Coalition for Epidemic Preparedness Innovations(CEPI) will invest up to an additional $384 millionto advance clinical development of NVX‑CoV2373. Novavaxwill use the CEPI funds to advance NVX‑CoV2373 into clinical testing. With its earlier $4 millioncommitment in March, the extended collaboration brings CEPI’s total investment in NVX‑CoV2373 to $388 million.
- In January,
Novavaxidentified its coronavirus vaccine candidate, NVX‑CoV2373, a stable, prefusion protein made using its proprietary nanoparticle technology. Novavax’ proprietary Matrix‑M adjuvant is included in NVX‑CoV2373, to enhance immune responses and stimulate high levels of neutralizing antibodies.
- NVX‑CoV2373 was highly immunogenic in animal models measuring spike protein-specific antibodies, with ACE‑2 human receptor binding domain blocking activity and SARS‑CoV‑2 wild-type virus neutralizing antibodies observed. Blocking of the binding of the spike protein to the receptor as well as wild-type virus neutralizing antibodies was also observed, with high levels of spike protein-specific antibodies after a single immunization. The already high microneutralization titers seen after one dose increased eight fold with a second dose. High titer microneutralizing antibodies are generally accepted evidence that a vaccine is likely to be protective in humans.
- The NVX‑CoV2373 clinical development plan combines a Phase 1/Phase 2 approach to allow rapid advancement during the current coronavirus pandemic. The Phase 1 portion of this trial will be placebo-controlled and observer blinded in ~130 healthy adults and will include assessment of dosage and vaccination. Recruiting for the trial began this month with preliminary immunogenicity and safety results expected in July.
Novavaxentered into an agreement with Emergent BioSolutions to provide contract development and manufacturing services, supplying Novavaxwith GMP vaccine product for use in its clinical trials. This agreement offers the potential to leverage Emergent’s rapid deployment capabilities and expertise that provide Novavaxscalability and capacity to produce vaccine product.
Novavaxis currently discussing the opportunity to bring ResVax to market globally with multiple potential commercial partners. In addition, Novavaxcontinues to define regulatory licensure requirements and pathways in the U.S., the European Unionand other geographies.
- In March,
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 first quarter of 2020,
Novavaxraised net proceeds of $186 million. Subsequent to quarter-end, through May 8, 2020, Novavaxraised additional net proceeds of $74 million, for a total of $260 millionsince the beginning of the year.
Financial Results for the Three Months Ended
Research and development expenses decreased 52% to
General and administrative expenses increased to
Interest income (expense), net for the first quarter of 2020 and 2019 was
Share and per share data have been restated to reflect the reverse stock split that was completed in
A webcast of the conference call can also be accessed via a link on the home page of the
NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by
NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated efficient binding with receptors targeted by the virus, a critical aspect for effective vaccine protection. A Phase 1 clinical trial of NVX‑CoV2373 will initiate in
Novavax’ patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.
Statements herein relating to the future of
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share information)
|Three Months Ended|
|Research and development||16,895||35,473|
|General and administrative||9,379||8,732|
|Loss from operations||(22,897||)||(40,223||)|
|Interest income (expense), net||(2,967||)||(2,983||)|
|Other income (expense)||--||(12||)|
|Basic and diluted net loss per share||$||(0.58||)||$||(2.11||)|
|Basic and diluted weighted average number of common shares outstanding||44,421||20,442|
SELECTED CONSOLIDATED BALANCE SHEET DATA
|Cash and cash equivalents||$||179,881||$||78,823|
|Total restricted cash||7,311||3,357|
|Total current assets||255,232||97,247|
|Total stockholders’ deficit||(23,971||)||(186,017||)|