Document


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): March 14, 2018


NewLink Genetics Corporation
(Exact name of registrant as specified in its charter)
 
 
 
Delaware
001-35342
42-1491350
(State or other jurisdiction
(Commission
(IRS Employer
of incorporation)
File Number)
Identification No.)
 
 
 
 
2503 South Loop Drive
Ames, IA
50010
(Address of principal executive offices)
(Zip Code)
 
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):
[ ] 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))

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   o
 
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  o








Section 8 - Other Events

Item 8.01.    Other Events.
 
On March 14, 2018, NewLink Genetics Corporation, a Delaware corporation, or the Company, issued a press release titled "NewLink Genetics Announces Presentation of Abstracts at AACR Annual Meeting."
A copy of the press release is attached hereto as Exhibit 99.1 and are incorporated herein by reference.






Section 9 - Financial Statements and Exhibits
 
Item 9.01.              Financial Statements and Exhibits.
 
(d)  Exhibits.
 
Exhibit Number
 
Description
99.1
 
Press Release, dated March 14, 2018, entitled “NewLink Genetics Announces Presentation of Abstracts at AACR Annual Meeting








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.
Dated:    March 14, 2018


 
NewLink Genetics Corporation
 
 
 
 
By:
/s/ John B. Henneman III
 
  John B. Henneman III
Its:
  Chief Financial Officer



Exhibit
Exhibit 99.1


https://cdn.kscope.io/41c3ce7d7d8cda716bbf3ed0eba93f97-newlogoa07.jpg
NewLink Genetics Announces Presentation of Abstracts at AACR Annual Meeting
AMES, Iowa, March 14, 2018 -- NewLink Genetics Corporation (NASDAQ: NLNK) today reported that two abstracts pertaining to the company's indoximod program will be presented at the American Association for Cancer Research (AACR) 2018 Annual Meeting in Chicago.

Clinical Trials Plenary Session: Abstract 10973 - Front-line therapy of DIPG using the IDO pathway inhibitor indoximod in combination with radiation and chemotherapy, to be presented during the “Multimodality Immuno-oncology Approaches” session, Sunday, April 15, 2018, 12:45 PM - 2:45 PM CT

Poster Session: Abstract 3753 - Indoximod modulates AhR-driven transcription of genes that control immune function, to be presented during poster session PO.IM02.07, April 17, 2018, 8:00 AM - 12:00 PM CT

The complete text of Clinical Plenary Session abstracts that have not been selected for the press program will be posted to the AACR website on Friday, April 13. The text of clinical trials abstracts that have been selected for inclusion in the press program will not be posted online until the date and time of presentation.
"We are pleased to have been chosen to present these abstracts at the upcoming AACR meeting,” said Charles J. Link, Jr, MD, Chairman, CEO and Chief Scientific Officer. “Encouraging early clinical data of indoximod plus radiation for pediatric patients with DIPG, a rare and lethal form of brain cancer, will be presented. In addition, our data further clarifying indoximod’s differentiated mechanism of action will also be presented."
About Indoximod
Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target involved in regulating the tumor microenvironment and immune escape. Indoximod is being evaluated in combination with treatment regimens including anti-PD-1/PD-L1 agents, cancer vaccines, and chemotherapy across multiple indications such as melanoma, pancreatic cancer and other malignancies.
About NewLink Genetics Corporation
NewLink Genetics is a late-stage biopharmaceutical company focusing on discovering, developing and commercializing novel immuno-oncology product candidates to improve the lives of patients with cancer. NewLink Genetics' IDO pathway inhibitors are designed to harness multiple components of the immune system to combat cancer. For more information, please visit www.NewLinkGenetics.com and follow us on Twitter @NLNKGenetics.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of NewLink Genetics that involve substantial risks and uncertainties.  All statements, other than statements of historical fact, contained in this press release are forward-looking statements, within the meaning of The Private Securities Litigation Reform Act of 1995. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "target," "potential," "will," "could," "should," "seek" or the negative of these terms or other similar expressions are intended to identify forward-looking



Exhibit 99.1


statements, although not all forward-looking statements contain these identifying words.  These forward-looking statements include, among others, statements about  results of its clinical trials for product candidates; its timing of release of data from ongoing clinical studies; its plans related to moving additional indications into clinical development; and any other statements other than statements of historical fact.  Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that NewLink makes due to a number of important factors, including those risks discussed in "Risk Factors" and elsewhere in NewLink Genetics' Annual Report on Form 10-K for the year ended December 31, 2017 and other reports filed with the U.S. Securities and Exchange Commission (SEC).  The forward-looking statements in this press release represent NewLink Genetics’ views as of the date of this press release. NewLink Genetics anticipates that subsequent events and developments will cause its views to change.  However, while it may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.  You should, therefore, not rely on these forward-looking statements as representing NewLink Genetics' views as of any date subsequent to the date of this press release.

Investor Contact:
Lisa Miller
Director of Investor Relations
NewLink Genetics
515-598-2555
lmiller@linkp.com

Media Contact:
Sharon Correia
VP, Integrated Communications
LaVoieHealthScience
617-374-8800, ext. 105
scorreia@lavoiehealthscience.com