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
NewLink Genetics
Corporation
(Exact name of registrant as specified in its charter)
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Delaware
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42-1491350
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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2503 South Loop Drive
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(Address of principal executive offices)
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(Zip Code)
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Registrant’s telephone number, including area code:
(515) 296-5555
Not applicable
(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):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common Stock
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NLNK
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The Nasdaq Stock Market
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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.
The information in this Item 7.01, including
Exhibit 99.1 attached hereto, 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 (the
“Exchange Act”), or otherwise subject to the liabilities of that section, nor shall be deemed
incorporated by reference in any filing by
the Company under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general
incorporation language in such filing.
Item 8.01 Other Events.
On
December 20, 2019,
the Company announced that, after priority review, the U.S. Food and Drug Administration (“
FDA”) had granted approval of ERVEBO®, or
Zaire Ebola virus vaccine V920 (rVSV∆G-ZEBOV-GP). The approval represents the first vaccine approved by the FDA for the Ebola virus and follows the
November 11, 2019 grant by the European Commission of a marketing authorization for ERVEBO® across 31
European countries. The FDA’s approval of this Ebola vaccine will trigger the issuance of a priority review voucher owned by Merck Sharp and Dohme Corp. and in which NewLink has a substantial economic interest. Thereafter, NewLink will have the
right to monetize its share of interest in the voucher.
Item 9.01 Financial Statements and Exhibits.
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Exhibit
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Description
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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.
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NEWLINK GENETICS CORPORATION
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By:
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Title: General Counsel
(Principal Executive Officer)
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