Novavax Reports Second Quarter 2020 Financial and Operational Results
“Novavax’ unprecedented development activities for NVX-CoV2373 and progress continued through the second quarter,” said
Second Quarter 2020 and Recent Highlights
COVID-19 Program
- Announced Phase 1 data from its Phase 1/2 randomized, observer-blinded, placebo-controlled clinical trial of NVX-CoV2373 in healthy adults 18-59 years of age
-- Neutralization levels numerically superior to convalescent serum
-- Significantly higher immune response with 2-dose, Matrix-MTM adjuvanted vaccine
-- Strong T cell responses
-- Reassuringly safe and tolerable vaccine profile
-- Presentation included onNovavax website here
-- Data submitted for peer-review publication and posted to online preprint server at medRxiv.org
- Demonstrated protection and high immunogenicity in animal models
-- Presented data from non-human primate models that demonstrate protection in challenge studies, enhancement of multifunctional T cells, and production of anti-S IgG and neutralizing antibodies
-- Data submitted for peer-review publication and posted to online preprint server at medRxiv.org
- Secured
$2 billion in funding for development and commercialization of NVX-CoV2373
--Coalition for Epidemic Preparedness Innovations (CEPI) funding up to$388 million
--U.S. Department of Defense (DoD ) funding up to$60 million
--U.S. Government funding through Operation Warp Speed (OWS) up to$1.6 billion
- Completed collaborations for global development and commercialization of NVX-CoV2373
-- Partnered with Takeda Pharmaceutical Company Limited for development, manufacture and commercialization inJapan
--Novavax to receive payments based on achievement of certain development and commercial milestones
--Novavax shares in proceeds from vaccine sales
-- Partnered withSerum Institute of India for development and commercialization inIndia and low- and middle-income countries (LMIC)
--Novavax andSerum Institute will split revenue from sale of product, net of agreed costs
- Secured global manufacturing capacity for NVX-CoV2373
-- Acquired Praha Vaccines in a cash transaction of approximately$167 million
-- Includes biologics manufacturing facility and related assets inCzech Republic
-- Facility expected to provide annual capacity approaching 1 billion antigen doses starting in 2021
-- Entered into agreements with FUJIFILM Diosynth Biotechnologies’ (FDB) to manufacture bulk drug substance at facilities inNorth Carolina andTexas
-- Large scale manufacturing initiated at FDB North Carolina site
-- Entered into manufacturing arrangements withAGC Biologics and PolyPeptide Group for large-scale production of Novavax’ Matrix-M adjuvant in bothU.S. andEurope
NanoFlu™ Program
- Successful pivotal NanoFlu Phase 3 clinical trial announced in
March 2020
-- Added important immunogenicity data regarding development of robust T cell mediated responses
-- All results expected to support future BLA submission usingU.S. FDA accelerated approval pathway
-- Company exploring pathways to manufacture for required lot consistency clinical trial
- Phase 2 and Phase 3 data submitted for peer-review publications and posted to online preprint server at medRxiv.org
Corporate
- Strengthened leadership with numerous executive management promotions and hiring
- Appointed
David M. Mott to Novavax’ Board of Directors
-- Brings more than three decades of global management, board and investment experience across multiple private and public biopharmaceutical companies
Financial Results for the Three and Six Months Ended
Research and development expenses increased 15% to
General and administrative expenses increased 84% to
As of
- In June,
Novavax entered into an agreement to sell Series A Convertible preferred stock, convertible into 4,388,850 shares of common stock, to an investment fund affiliated withRA Capital Management (RA Capital ) in a private placement.Novavax received gross proceeds of$200 million .
- Through utilization of at-the-market (ATM) offerings during the second quarter of 2020,
Novavax raised net proceeds of$206.3 million and a total of$392.3 million since the beginning of the year.
Conference Call
A webcast of the conference call can also be accessed via a link on the home page of the
About NVX-CoV2373
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 indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 portion of the Phase 1/2 clinical trial, NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera.
About NanoFlu™
NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by
About Matrix-M™
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.
About
For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.
Forward-Looking Statements
Statements herein relating to the future of
NOVAVAX, INC. | |||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||
(in thousands, except per share information) | |||||||||||||||||
(unaudited) | |||||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||||
2020 | 2019 | 2020 | 2019 | ||||||||||||||
Revenue | $ 35,538 | $ 3,357 | $ 38,915 | $ 7,339 | |||||||||||||
Expenses: | |||||||||||||||||
Research and development | 34,846 | 30,417 | 51,741 | 65,890 | |||||||||||||
General and administrative | 17,719 | 9,606 | 27,098 | 18,338 | |||||||||||||
Total expenses | 52,565 | 40,023 | 78,839 | 84,228 | |||||||||||||
Loss from operations | (17,027) | (36,666) | (39,924) | (76,889) | |||||||||||||
Interest income (expense), net | (3,106) | (2,929) | (6,074) | (5,912) | |||||||||||||
Other income (expense) | 2,612 | (8) | 2,613 | (20) | |||||||||||||
Net loss | $ (17,521) | $ (39,603) | $ (43,385) | $ (82,821) | |||||||||||||
Basic and diluted net loss per share | $ (0.30) | $ (1.69) | $ (0.84) | $ (3.77) | |||||||||||||
Basic and diluted weighted average | |||||||||||||||||
number of common shares outstanding | 58,618 | 23,473 | 51,401 | 21,966 |
SELECTED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
December 31, 2019 | ||||||
(unaudited) | ||||||
Cash and cash equivalents | $ | 424,395 | $ | 78,823 | ||
Marketable securities | 77,902 | -- | ||||
Total restricted cash | 107,179 | 3,357 | ||||
Total current assets | 636,381 | 97,247 | ||||
Working capital | 423,050 | 71,452 | ||||
Total assets | 932,227 | 172,957 | ||||
Notes payable | 321,323 | 320,611 | ||||
Total stockholders’ equity (deficit) | 184,526 | (186,017 | ) | |||
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