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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported):
October 16, 2024
NOVAVAX, INC.
(Exact name of registrant as specified
in charter)
Delaware |
|
0-26770 |
|
22-2816046 |
(State or Other Jurisdiction
of Incorporation) |
|
(Commission File Number) |
|
(I.R.S. Employer
Identification No.) |
700 Quince Orchard Road
Gaithersburg, Maryland 20878
(Address of Principal Executive Offices,
including Zip Code)
(240) 268-2000
(Registrant’s telephone number,
including area code)
(Former name or former address, if changed since
last report.)
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General
Instruction A.2. below):
¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section
12(b) of the Act:
Title of each class |
|
Trading
Symbol(s) |
|
Name of each exchange on which
registered |
Common Stock, Par Value $0.01 per share |
|
NVAX |
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The Nasdaq Global Select Market |
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2
of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ¨
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 7.01. Regulation FD Disclosure.
On October 16, 2024, Novavax, Inc. (“Novavax”)
issued the press release furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
The information in Item 7.01 is being furnished and
shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise
subject to the liabilities of that Section and shall not be deemed incorporated by reference into any registration statement or other
document filed pursuant to the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall
be expressly set forth by specific reference in such filing. In addition, the contents of Novavax’s website are not incorporated
by reference into this Current Report on Form 8-K and you should not consider information provided on Novavax’s website to be part
of this Current Report on Form 8-K.
Item 8.01. Other Events.
On October 11, 2024, the U.S. Food and Drug Administration
(“FDA”) notified Novavax that the FDA has placed a clinical hold on Novavax’s Investigational New Drug Application (“IND”)
for its COVID-19-Influenza Combination (“CIC”) and standalone influenza vaccine candidates. The clinical hold is due to a
spontaneous report of a serious adverse event (“SAE”) of motor neuropathy in a single CIC Phase 2 trial participant outside
of the U.S. who received the vaccine in January 2023. The trial completed in July 2023 and the participant reported the SAE in September
2024. The FDA indicated they will provide an official clinical hold letter to Novavax within 30 days. The clinical hold may impact the
timing of the initiation of, and data for, the Phase 3 immunogenicity trial for its CIC and standalone influenza vaccine candidate.
Cautionary
Note Regarding Forward-Looking Statements
This
Current Report on Form 8-K includes forward-looking statements, including statements related to the potential resolution of the clinical
hold placed on Novavax’s IND for its CIC and standalone influenza vaccine candidates and the timing of the initiation of, and data
for, the Phase 3 immunogenicity trial for Novavax’s CIC and standalone influenza vaccine candidates. 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 Novavax’s current
beliefs and expectations about the future of its 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. These 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, assay validation and stability testing, necessary to satisfy applicable regulatory authorities;
challenges or delay clinical trials or in obtaining regulatory authorization for its product candidates; manufacturing, distribution or
export delays or challenges; Novavax's substantial dependence on Serum Institute of India Pvt. Ltd. and Serum Life Sciences Limited for
co-formulation and filling and PCI Pharma Services for finishing Novavax’s COVID-19 vaccine and the impact of any delays or disruptions
in their operations; difficulty obtaining scarce raw materials and supplies, including for Novavax’s proprietary adjuvant; resource
constraints, including human capital and manufacturing capacity; on the ability of Novavax to pursue planned regulatory pathways potential
regulatory actions; challenges in implementing Novavax’s global restructuring and cost reduction plan and additional cost reduction
program; and those other risk factors identified in the “Risk Factors” and “Management's Discussion and Analysis of
Financial Condition and Results of Operations” sections of Novavax's Annual Report on Form 10-K for the year ended December 31,
2023, and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (“SEC”). Novavax
cautions investors not to place considerable reliance on forward-looking statements contained in this Current Report on Form 8-K. Investors
are encouraged to read Novavax’s filings with the SEC, available at www.sec.gov and www.novavax.com,
for a discussion of these and other risks and uncertainties. The forward-looking statements in this Current Report on Form 8-K speak only
as of the date of this Current Report on Form 8-K, and Novavax undertakes no obligation to update or revise any of the statements. Novavax’s
business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others
should give careful consideration to these risks and uncertainties.
The information
in Item 7.01 is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange
Act of 1934, as amended, or otherwise subject to the liabilities of that Section and shall not be deemed incorporated by reference into
any registration statement or other document filed pursuant to the Securities Act of 1933, as amended, or the Securities Exchange Act
of 1934, as amended, except as shall be expressly set forth by specific reference in such filing. In addition, the contents of Novavax’s
website are not incorporated by reference into this Current Report on Form 8-K and you should not consider information provided on Novavax’s
website to be part of this Current Report on Form 8-K.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
NOVAVAX, INC. |
|
|
|
Date: October 16, 2024 |
By: |
/s/ Mark J. Casey |
|
Name: |
Mark J. Casey |
|
Title: |
Executive Vice President, Chief Legal Officer and Corporate Secretary |
Exhibit 99.1
Press Release | |
|
Update on Novavax’s
COVID-19-Influenza Combination and
Stand-alone Influenza
Phase 3 Trial
GAITHERSBURG, Md., October 16, 2024 –
Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced
that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on Novavax’s Investigational New Drug (IND) application
for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. The clinical hold is due to a spontaneous report
of a serious adverse event (SAE) of motor neuropathy in a single CIC Phase 2 trial participant outside of the U.S. who received the vaccine
in January 2023. The trial completed in July 2023 and the participant reported the SAE in September 2024.
“We are working closely with the FDA to
provide the necessary information that will allow them to better understand this observation and resolve the clinical hold,” said
Robert Walker, MD, Chief Medical Officer, Novavax. “It is important to note that safety is our top priority, and while we do not
believe causality has been established for this serious adverse event, we are committed to working expeditiously to fulfill requests for
more information from the FDA. Our goal is to successfully resolve this matter and to start our Phase 3 trial as soon as possible.”
Data from Novavax’s previous COVID-19 and
influenza trials have shown no signals for motor neuropathy. Investigators have been informed of this action. The COVID-19 IND for
Novavax’s COVID-19 vaccine is not impacted by the clinical hold.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) promotes improved
health by discovering, developing and commercializing innovative vaccines to help protect against serious infectious diseases. Novavax,
a global company based in Gaithersburg, Md., U.S., offers a differentiated vaccine platform that combines a recombinant protein approach,
innovative nanoparticle technology and Novavax's patented Matrix-M adjuvant to enhance the immune response. The Company's portfolio includes
its COVID-19 vaccine and its pipeline includes its CIC and tNIV vaccine candidates. In addition, Novavax's adjuvant is included in the
University of Oxford and Serum Institute of India's R21/Matrix-M malaria vaccine. Please visit novavax.com and LinkedIn
for more information.
Forward-Looking Statements
Statements herein relating to the potential resolution
of the clinical hold placed on Novavax’s IND for its CIC and stand-alone influenza vaccine candidates and the timing of the initiation
of the Phase 3 trial for Novavax’s CIC and stand-alone influenza vaccine candidates are forward-looking statements. Novavax cautions
that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially
from those expressed or implied by such statements. These 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; resource constraints, including human capital
and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges or delays in clinical trials;
manufacturing, distribution or export delays or challenges; Novavax's exclusive dependence on Serum Institute of India Pvt. Ltd. for
co-formulation and filling and the impact of any delays or disruptions in their operations on the delivery of customer orders; and those
other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and
Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2023, and subsequent Quarterly
Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance
on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov
and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press
release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business
is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should
give careful consideration to these risks and uncertainties.
Contacts:
Investors
Luis Sanay, CFA
240-268-2022
ir@novavax.com
Media
Giovanna Chandler
240-720-7804
media@novavax.com
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