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): September 22, 2014
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.) |
20 Firstfield 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))
Item
1.01. Entry into a Material Definitive Agreement.
On September 22, 2014, Novavax, Inc.
(the “Company”) entered into an amendment (“Amendment”) to its Prime Contract (“Prime
Contract”) with the Department of Health and Human Services, Biomedical Advanced Research and Development Authority
(“HHS BARDA”). The Amendment, among other things, extends the base period of performance under the Prime Contract
to September 23, 2016, grants the Company continued access to the remainder of the $97 million base period funding after
September 23, 2014, and awards the Company additional option period funding in the amount of $70 million.
The remainder of the Prime Contract remains
unchanged. The foregoing description of the Amendment does not purport to be complete and is qualified in its entirety by reference
to the Amendment, which will be filed with the Securities and Exchange Commission as an exhibit to the Company’s Quarterly
Report on Form 10-Q for the quarter ended September 30, 2014.
Item 8.01. Other Events.
On September 23, 2014, the Company issued
a press release announcing this transaction. A copy of this press release is attached as Exhibit 99.1 to this Current Report on
Form 8-K and incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
Exhibit
No. |
|
Description |
|
|
|
99.1 |
|
Press release, dated September 23, 2014, announcing the Amendment to the Company’s Prime Contract with HHS BARDA. |
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.
(Registrant) |
|
|
|
|
Date: September 24, 2014 |
|
|
|
By: |
|
/s/ John A. Herrmann III |
|
|
|
|
|
|
Name: |
|
John A. Herrmann III |
|
|
|
|
|
|
Title: |
|
Senior Vice President, General Counsel and
Corporate Secretary |
EXHIBIT INDEX
Exhibit No. |
|
Description |
|
|
|
99.1 |
|
Press release, dated September 23, 2014, announcing the Amendment to the Company’s Prime Contract with HHS BARDA. |
Novavax
Announces BARDA Exercise of Contract Option
| · | Award of Option Period for 24 months |
| · | Additional Option Period Funding Commitment of $70 million |
| · | Clinical, Manufacturing and Product Development Activities Funded Up to Phase 3 |
Gaithersburg, Md. – September 23,
2014– Novavax, Inc. (Nasdaq: NVAX) announced today that it has executed a contract modification with the U.S. Department
of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) to exercise the option period of its
current contract (HHSO100201100012C) for the advanced development of Novavax’ recombinant seasonal and pandemic influenza
vaccines and manufacturing capabilities for pandemic preparedness.
The contract was originally awarded in
February 2011, with funding of up to $97 million over an initial base period ending in February 2014, and subsequently extended
to September 2014. Through the second quarter of 2014, the company recognized approximately $65 million in revenue since the inception
of the contract. The option period adds scope and funding, and extends the contract for a planned 2-year period from September
2014 until September 2016. Under the option period, Novavax shall have continued access to the remainder of the $97 million base
period funding after September 2014, and BARDA has agreed to award additional option period funding in the amount of $70 million.
The additional option period funding will
support development activities leading to a planned Phase 3 clinical study in 2016. Development milestones under the Option period
include completion of the quadrivalent seasonal Phase 2 clinical trial (expected to be initiated in 4Q2014), continued development
of the H7N9/Matrix-M™ adjuvant pandemic influenza vaccine, along with other development work.
“During the last three and a half
years, under our contract with BARDA, we have made tremendous strides in the development of our seasonal and pandemic influenza
products. We are proud to announce that BARDA has elected to roll the remaining base period funding, along with an additional commitment
of $70 million, into our contract that will allow us to further develop these programs to Phase 3 and commercial readiness. Our
partnership with BARDA has been collaborative, constructive and resulted in jointly developed solutions to a number of development
challenges. We believe this collaboration has and will continue to deliver significant value for both parties as we advance toward
Phase 3 and BLA enabling activities,” said Stanley C. Erck, the company’s CEO and President.
About the Novavax BARDA Contract (HHSO100201100012C)
In February 2011, Novavax was awarded a
contract valued at up to $179 million by BARDA for the advanced development of recombinant influenza vaccine products and manufacturing
capabilities for pandemic preparedness. During the contract’s 43-month base period, Novavax has been developing and testing
its novel recombinant virus-like particle (VLP) influenza vaccines to address BARDA’s commitment to advancing recombinant-based
technology as a component of pandemic preparedness. An Option Period has been awarded by BARDA to extend the period of performance
by 24 months. The milestones under the option period are focused on activities leading up to initiation of Phase 3 clinical trials.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage
biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide.
Using innovative proprietary recombinant nanoparticle vaccine technology, the company produces vaccine candidates to efficiently
and effectively respond to both known and newly emergent diseases. Additional information about Novavax is available on the company’s
website, novavax.com.
Novavax Forward-Looking Statements
Statements herein relating to the future
of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that
these forward looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially
from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading “Risk
Factors” in the Novavax Annual Report on Form 10-K for the year ended December 31, 2013, filed with the Securities and Exchange
Commission (SEC). We caution investors not to place considerable reliance on the forward-looking statements contained in this press
release. You are encouraged to read our filings with the SEC, available at sec.gov, 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.
###
Contact: |
Barclay A. Phillips |
|
SVP, Chief Financial Officer and Treasurer |
|
Novavax, Inc. |
|
240-268-2000 |
Novavax (NASDAQ:NVAX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Novavax (NASDAQ:NVAX)
Historical Stock Chart
From Apr 2023 to Apr 2024