NLNK-20130129-8K


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)


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))






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.

 
 
 
 
Our Product Pipeline
 
 
The chart below summarizes our current product candidates and their stages of development.
 
 
 
 
 
 
 
 
 
 
 
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
 
 
 
 
 
 
 
 
 
 
 
 
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
 
 
 
 
 
 
 
 
 
 
 
 
     (1) Co-sponsored by the National Cancer Institute
 
 
 
 
 







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


 
NewLink Genetics Corporation
 
 
 
 
By:
/s/ Gordon H. Link, Jr.
 
  Gordon H. Link, Jr.
Its:
  Chief Financial Officer