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): January 29, 2013 (January 29, 2013)
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| NewLink Genetics Corporation |
| (Exact name of registrant as specified in its charter) |
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| Delaware | 001-35342 | 42-1491350 |
| (State or other jurisdiction | (Commission | (IRS Employer |
| of incorporation) | File Number) | Identification No.) |
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2503 South Loop Drive Ames, IA | 50010 |
| (Address of principal executive offices) | (Zip Code) |
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Registrant's telephone number, including area code: (515) 296-5555 |
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| 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))
Section 8 - Other Events
Item 8.01. Other Events.
We are filing the following information with the Securities and Exchange Commission for the purpose of updating certain aspects of our publicly disclosed description of our business, as set forth below.
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| | Our Product Pipeline | |
| | The chart below summarizes our current product candidates and their stages of development. | |
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| | | Product Candidate | Phase of Development | Indication | Estimated Upcoming Milestone | | |
| | | HyperAcute Immunotherapy Technology | | | |
| | | HyperAcute Pancreas algenpantucel-L | Phase 3 IMPRESS | Adjuvant to standard‑of‑care in surgically‑resected pancreatic cancer | Mid-2013: 1st interim analysis (if necessary, followed by a 2nd interim analysis 6 to 8 months later) | | |
| | | | | | 2013: Complete enrollment | | |
| | | HyperAcute Pancreas algenpantucel-L | Phase 3 | Locally Advanced Pancreatic Cancer (LAPC) | Late 2014/Early 2015: Complete enrollment | | |
| | | HyperAcute Lung tergenpumatucel-L | Phase 2B/3 | Advanced Non-Small Cell Lung Cancer (NSCLC) | Trial initiated in 2012 | | |
| | | HyperAcute Melanoma | Phase 2: Multiple studies being planned | Advanced melanoma | 2nd half 2013: Launch Phase 2B study | | |
| | | HyperAcute Renal | IND/Regulatory in process | Renal cell cancer | 2nd half 2013: Launch Phase 1 clinical trial | | |
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| | | IDO Pathway Inhibitor Technology | | | |
| | | Indoximod | Phase 1B/2 (1) | 2nd-line metastatic solid tumors in combination with p53 adenovirus | Mid 2013: Update data | | |
| | | | Phase 1B/2 (1) | 2nd-line metastatic solid tumors in combination with Taxotere | Mid 2013: Update data | | |
| | | Provenge® Indoximod | Phase 2 | Advanced prostate cancer | 2014: Complete enrollment | | |
| | | Docetaxel Indoximod | Phase 2 | Metastatic breast cancer | 2013: Update enrollment plans | | |
| | | HyperAcute immunotherapy plus Indoximod | Phase 2B | To be determined | 2nd half 2013: Disclose plan details | | |
| | | NLG-919 IDO Pathway Inhibitor Candidate | Phase 1 | 2nd line metastatic solid tumors | 2nd half 2013: Launch study | | |
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| | | (1) Co-sponsored by the National Cancer Institute | | |
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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.
Dated: January 29, 2013
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| | NewLink Genetics Corporation |
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| By: | /s/ Gordon H. Link, Jr. |
| | Gordon H. Link, Jr. |
| Its: | Chief Financial Officer |
