SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 OR 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): October 2, 2018 (October 1, 2018)
NewLink Genetics Corporation
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
2503 South Loop Drive
(Address of principal executive offices)
Registrant's telephone number, including area code: (515) 296-5555
(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
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Section 8 - Other Events
Item 8.01. Other Events.
On October 1, 2018, NewLink Genetics Corporation issued a press release titled "NewLink Genetics Announces Indoximod Biomarker Data and Prodrug NLG802 Pharmacokinetic Data to be Presented at SITC 2018."
A copy of the press release is attached hereto as Exhibits 99.1 and is incorporated herein by reference.
Section 9 - Financial Statements and Exhibits
Item 9.01. Financial Statements and Exhibits.
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: October 2, 2018
NewLink Genetics Corporation
/s/ Carl W. Langren
Carl W. Langren
Chief Financial Officer
NewLink Genetics Announces Indoximod Biomarker Data and Prodrug NLG802 Pharmacokinetic Data to be Presented at SITC 2018
AMES, Iowa, October 1, 2018 -- NewLink Genetics Corporation (NASDAQ:NLNK) announced today that two abstracts were accepted for presentation at the Society for Immunotherapy of Cancer (SITC) 33rd Annual Meeting being held November 7-11, 2018 in Washington, D.C. These poster presentations will feature pharmacokinetic (PK) data from the Company’s Phase 1a study of NLG802, a prodrug of indoximod, in patients with advanced solid tumors and biomarker data from its Phase 2 study of indoximod in combination with checkpoint inhibition for patients with advanced melanoma. These data will be available during poster sessions on November 9 and 10, 2018.
Abstracts to be Presented at SITC 2018:
Abstract 11213: A phase 1a clinical trial of NLG802, a prodrug of indoximod with enhanced pharmacokinetic properties, Rixe, O., et al.
Abstract 10294: The immunogenomic impact of indoximod on the tumor microenvironment of melanoma patients, Yu, J., et al.
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 chemotherapy, radiation, checkpoint blockade and cancer vaccines across multiple indications such as acute myeloid leukemia (AML), diffuse intrinsic pontine glioma (DIPG) and melanoma.
NLG802 is a prodrug of indoximod. NLG802 has been shown in preclinical trials to increase bioavailability and exposure to indoximod above the levels achievable by direct administration of indoximod. NLG802 is currently being evaluated in clinical trials.
About NewLink Genetics Corporation
NewLink Genetics is a clinical-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 contained in this press release are forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words "will," “to be,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about results of NewLink’s clinical trials for product candidates 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 Genetics 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.
Director of Investor Relations
Sr. VP, Integrated Communications
617-374-8800, ext. 105