Novavax, a clinical-stage biotechnology company shares soared over 80% Monday after NVAX received a $384 million investment for its COVID-19 vaccine candidate and beat Wall Street earnings expectations for first quarter earnings.
Novavax said the Coalition for Epidemic Preparedness Innovations will invest up to $384 million in the development of NVX-CoV2373, Novavax’s vaccine candidate for SARS-CoV-2, the coronavirus that causes COVID-19. Funding will be used for combined safety and effectiveness testing of the vaccine, Novavax said.
- Novavax to Receive up to $388 Million Funding from CEPI for COVID-19 Vaccine Development and Manufacturing
- Funds clinical development of NVX-CoV2373 through Phase 2
- Supports rapid scale-up of vaccine manufacturing
- Allows for increased production of Matrix-M adjuvant Reserves global large-scale manufacturing capacity
Market Summary > Novavax, Inc.NASDAQ NVAX
Closed May 11, 2020″ $24.50 +5.77 (+30.81%)
After hours” $37.91 +13.41 (+54.73%)
Novavax, Inc.NASDAQ NVAX Reported Earnings After Close Monday
($0.58) Beat (Exp $0.69) EPS AND $3.4 Million Beat $1.9 Million Revenue Forecast
Earnings
Novavax reported a first-quarter loss of $25.9 million, or 58 cents a share, compared a loss of $43.2 million, or $2.11 a share, in the year-ago period. Revenue fell to $3.4 million from $4 million in the year-ago quarter. Analysts surveyed by FactSet had forecast a loss of 69 cents a share on revenue of $1.9 million.’
Highlights
- CEPI increases investment up to $388 million for NVX‑CoV2373 vaccine development & manufacturing NVX‑CoV2373
- Phase I trial initiating in May with preliminary results in July
- NanoFlu recently achieved all primary endpoints in pivotal Phase 3 clinical trial
NVX-CoV2373 through Phase 2
In January, Novavax identified 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.
About Novavax
Novavax, Inc. is a clinical-stage biotechnology company committed to delivering novel products to prevent a broad range of infectious diseases. Using innovative proprietary recombinant nanoparticle vaccine technology, we produce vaccine candidates to efficiently and effectively respond to both known and emerging disease threats. Our vaccine candidates are genetically engineered three-dimensional nanostructures that incorporate recombinant proteins critical to disease pathogenesis.(Via Website)
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