NewLink Genetics

We are a biopharmaceutical company focused on discovering, developing and commercializing novel immunotherapeutic products to improve cancer treatment options for patients and physicians. Our portfolio includes biologic and small-molecule immunotherapy product candidates intended to treat a wide range of oncology indications. Our product candidates use allogeneic (non-patient specific) cells from previously established cell lines rather than cells derived from the patient. We believe our approach enables a simpler, more consistent and scalable manufacturing process than therapies based on patient specific tissues or cells. Our lead product candidate, HyperAcute Pancreas cancer immunotherapy, or HyperAcute Pancreas, is being studied in a Phase 3 clinical trial in surgically-resected pancreatic cancer patients. We initiated this trial in May 2010 and have enrolled 200 patients at 55 clinical sites in the United States as of October 25, 2011. We plan to complete the first interim analyses of data from our Phase 3 clinical trial in early 2013. We have also received Fast Track and Orphan Drug designations from the FDA for HyperAcute Pancreas for the adjuvant treatment of surgically-resected pancreatic cancer.

In addition to our HyperAcute product candidates, we are developing NLG8189 (d-1-methyltryptophan, or D-1MT), a small-molecule, orally bioavailable product candidate from our proprietary indoleamine-(2,3)-dioxygenase, or IDO, pathway inhibitor technology. In preclinical models, IDO pathway inhibitors have shown anti-tumor effects in combination with radiotherapy, chemotherapy, targeted therapy or immunotherapy. Through our collaboration with the National Cancer Institute (NCI), we are studying NLG8189 in various chemotherapy and immunotherapy combinations in two Phase 1B/2 safety and efficacy clinical trials.

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:

The information provided on this site includes "forward-looking statements" within the meaning of the federal securities laws. These forward-looking statements are subject to a variety of risks and uncertainties and reflect Newlink Genetics Corporation's current views with respect to future events and financial performance. You can identify forward-looking statements by the use of the words "believe," "expect," "anticipate," "intend," "estimate," "project," "will," "should," and other expressions that predict or indicate future events and trends and that do not relate to historical matters. You should not rely on forward-looking statements because they involve known and unknown risks, uncertainties and other factors, some of which are beyond the control of the Company. These risks, uncertainties and other factors may cause the actual results, performance or achievements of the Company to be materially different from the anticipated future results, performance or achievements expressed or implied by the forward-looking statements.

Page last updated November 8, 2011