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Provides Corporate Update and
Report of Fourth Quarter and Year-End 2017 Financial Results
|·||RSV Phase 3 Prepare™ Trial Outcome De-risked by Successful Informational Analysis|
|·||NanoFlu™ Vaccine Demonstrates Improved Immune Responses Compared to Egg-Based, High-Dose Flu Vaccine|
|·||John J. Trizzino Appointed Chief Business Officer and Chief Financial Officer (as Announced in Separate Press Release)|
Gaithersburg, MD, March 14, 2018 – Novavax, Inc., (Nasdaq: NVAX) today provided a corporate update and announced its financial results for the fourth quarter and twelve months ended December 31, 2017.
“During this last quarter we collected our most significant results to date from our two lead vaccine programs,” said Stanley C. Erck, President and CEO, Novavax, Inc. “This progress gives us enhanced focus and momentum to execute under these programs for the remainder of 2018 and beyond.”
NanoFlu Program Update:
In late February 2018, the Company announced positive top-line results from its Phase 1/2 clinical trial in 330 older adults of its NanoFlu recombinant influenza vaccine, which includes its proprietary Matrix-M™ adjuvant, compared to the leading licensed egg-based, high-dose influenza vaccine for older adults (IIV3-HD). Key findings from the trial show that Novavax’ trivalent NanoFlu vaccine induced significantly higher hemagglutination inhibition (HAI) antibody responses against homologous A-type strains as well as against historic and forward-drifted H3N2 strains. Based on the strength of these trial results, the Company submitted a related manuscript to a peer-reviewed medical journal and is planning to present the data at the World Vaccine Congress meeting on April 4, 2018.
“This influenza season in the Northern Hemisphere has resulted in a serious public health epidemic, largely because of the H3N2 flu strain and the inability of current vaccines to provide adequate protection, particularly to older adults and other vulnerable populations,” said Gregory M. Glenn, M.D., President of Research and Development. “Our NanoFlu vaccine’s head-to-head performance against IIV3-HD demonstrated that it has the potential to address two primary confounding factors related to poor vaccine efficacy: virus drift and vaccine mutation resulting from egg-based manufacturing. With these findings, we are able to initiate manufacturing and clinical operations activities to support our next step, a Phase 2 trial of a quadrivalent formulation of our NanoFlu vaccine, scheduled to begin in the third quarter of this year.”
The following information was filed by Novavax Inc (NVAX) on Thursday, March 15, 2018 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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