AMES, IA--(Marketwire - Feb 28, 2013) - NewLink Genetics Corporation ( NASDAQ : NLNK ), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today reported consolidated 2012 financial results and reviewed key 2012 accomplishments.

"We have made significant progress during this past year.The enrollment rate in our pivotal phase 3 IMPRESS trial with our active cellular immunotherapy product candidate for resected pancreatic cancer, algenpantucel-L,has exceeded our original expectations.We initiated both a Phase 3 study in patients with locally advanced pancreatic cancer using algenpantucel-L, and a Phase 2B/3 adaptive design study to evaluate our active cellular immunotherapy using tergenpumatucel-L in patients with progressive or relapsed Stage IIIB/IV non-small cell lung cancer (NSCLC).In addition, weexpect to move our HyperAcute melanoma immunotherapy into controlled phase 2 studies in 2013.We are also expanding our HyperAcute immunotherapy platform to include different tumor types.Furthermore, weexpect to move the first of these into Phase 1 human studies in the second half of 2013," commented Dr. Charles Link, Chairman and Chief Executive Officer of NewLink."Rapid enrollment rate in our pivotal phase 3 IMPRESS pancreatic cancer study should enable us to complete enrollment of this trial in the summer of 2013, ahead of our original schedule."

Full Year 2012 Financial Results

Financial GuidanceNewLink expects to end 2013 with about $40 million in cash, cash equivalents and marketable securities.

Recent Accomplishments

Upcoming ActivitiesNewLink expects to present at the following conferences:

Today's Conference Call and Webcast ReminderThe NewLink management team will host a conference call discussing the company's financial results and recent corporate developments on Thursday, February 28, 2013, at 10:00am EST.The call can be accessed by dialing 1-(877) 363-5052 (domestic) or 1-(914) 495-8600 (international) five minutes prior to the start of the call and providing the passcode 16064630.A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-(855) 859-2056 (domestic) or 1-(404) 537-3406 (international), providing the passcode 16064630.The replay will be available for two weeks from the date of the live call.

About HyperAcute Immunotherapy

NewLink's HyperAcute immunotherapy technology is designed to stimulate the human immune system by exploiting a natural barrier present in humans that protects against infection being transmitted from other mammals.This barrier is related to the enzyme, alpha (1,3) galactosyl transferase, or Alpha-GT, which is expressed in the cells of lower mammals but not present in human cells.The presence of this enzyme results in the incorporation of a non-human form of carbohydrate called alpha (1,3) galactosyl carbohydrates, or Alpha-Gal, on the surface of expressing cells.Introducing Alpha-Gal expressing cells to the human immune system activates an immune response resulting from pre-existing antibodies against Alpha-Gal.Antibodies directed against the Alpha-Gal epitope are potentially the most abundant natural antibody in humans and represent approximately 1% of circulating human antibodies.

NewLink's HyperAcute cancer immunotherapy product candidates are composed of irradiated, live, allogeneic human cancer cells modified to express the gene that makes Alpha-Gal epitopes.This exposure to Alpha-Gal stimulates the human immune system to attack and destroy the immunotherapy cells on which Alpha-Gal is present by activating complement, an important component of the immune system capable of cell destruction.After destruction, NewLink believes the resulting cellular fragments bound by anti-Alpha-Gal antibodies are processed by the immune system to elicit an enhanced multi-faceted immune response to tumor-associated antigens common to both the immunotherapy and the patient's tumor cells.

Originally posted here:
NewLink Genetics Reports Fourth Quarter and Full-Year 2012 Financial Results

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