NOTE REGARDING FORWARD-LOOKING
STATEMENTS
This prospectus supplement, the
accompanying prospectus and the other documents we have filed with
the SEC that are incorporated herein by reference include
forward-looking statements. Such forward-looking statements involve
risks and uncertainties, as well as assumptions that, if they never
materialize or prove incorrect, could cause our results to differ
materially from those expressed or implied by such statements. All
statements other than statements of historical fact are statements
that could be deemed forward-looking statements Such
forward-looking statements include, without limitation, statements
about our capabilities, goals, expectations regarding future
revenue and expense levels, and capital raising activities,
including our planned use of proceeds from this offering, and, if
consummated, the Concurrent Convertible Notes Offering; our
operating plans and prospects; potential market sizes and demand
for our product candidates; the efficacy, safety, and intended
utilization of our product candidates; the development of our
clinical-stage product candidates and our recombinant vaccine and
adjuvant technologies; the development of our preclinical product
candidates; our expectations related to enrollment in our clinical
trials; the conduct, timing, and potential results from clinical
trials and other preclinical studies; plans for and potential
timing of regulatory filings; our expectation of manufacturing
capacity, timing, production, distribution, and delivery for our
coronavirus vaccine candidate by us and our partners; our estimate
of the number of individuals who may potentially be reached by
NVX-CoV2373; our expectations with respect to the anticipated
ongoing development and commercialization or licensure of
NVX-CoV2373, including efforts to expand the NVX-CoV2373 label
worldwide as a booster, and to various age groups and geographic
locations, and our seasonal quadrivalent influenza vaccine,
previously known as NanoFlu; the expected timing, content, and
outcomes of regulatory actions; funding from the U.S. government
partnership formerly known as Operation Warp Speed, the U.S.
Department of Defense, and the Coalition for Epidemic Preparedness
Innovations, and payments from the Bill & Melinda Gates
Foundation; funding under our advance purchase agreements and
supply agreements and amendments to, or termination of, any such
agreement; our available cash resources and usage and the
availability of financing generally; plans regarding partnering
activities and business development initiatives; and other matters
referenced herein. Generally, forward-looking statements can be
identified through the use of words or phrases such as “believe,”
“may,” “could,” “will,” “would,” “possible,” “can,” “estimate,”
“continue,” “ongoing,” “consider,” “anticipate,” “intend,” “seek,”
“plan,” “project,” “expect,” “should,” “would,” “aim,” or “assume,”
the negative of these terms, or other comparable terminology,
although not all forward-looking statements contain these
words.
Forward-looking statements are
neither historical facts nor assurances of future performance.
Instead, they are based only on our current beliefs and
expectations about the future of our business, future plans and
strategies, projections, anticipated events and trends, the
economy, and other future conditions. Forward-looking statements
involve estimates, assumptions, risks, and uncertainties that could
cause actual results or outcomes to differ materially from those
expressed or implied in any forward-looking statements, and,
therefore, you should not place considerable reliance on any such
forward-looking statements. Such risks and uncertainties include,
without limitation, challenges satisfying, alone or together with
partners, various safety, efficacy, and product characterization
requirements, including those related to process qualification and
assay validation, necessary to satisfy applicable regulatory
authorities, such as the U.S. Food and Drug Administration, World
Health Organization, United Kingdom Medicines and Healthcare
Products Regulatory Agency, the European Medicines Agency, the
Republic of Korea’s Ministry of Food and Drug Safety, or Japan’s
Ministry of Health, Labour and Welfare; unanticipated challenges or
delays in conducting clinical trials; difficulty obtaining scarce
raw materials and supplies; resource constraints, including human
capital and manufacturing capacity, constraints on the ability of
Novavax to pursue planned regulatory pathways, alone or with
partners, in multiple jurisdictions simultaneously, leading to
staggering of regulatory filings, and potential regulatory actions;
challenges meeting contractual requirements under agreements with
multiple commercial, governmental, and other entities; and other
risks and uncertainties identified under “Risk Factors” in this
prospectus supplement, in the documents incorporated by reference
in this prospectus supplement and in the accompanying base
prospectus. Should one or more of these risks or uncertainties
materialize, or should any of our assumptions prove incorrect,
actual results may vary in material respects from those projected
in these forward-looking statements. There may also be additional
risks that we consider immaterial, or which are unknown. It is not
possible to predict or identify all such risks.
You should read this prospectus
supplement, the accompanying prospectus and the documents that we
reference in this prospectus supplement or the accompanying
prospectus with the understanding that our