AMES, IA -- (Marketwire) -- 02/28/13 -- 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, we expect 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, we expect 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
•Year-end cash, cash equivalents and marketable securities totaled $21.7 million. •Total grant revenues for 2012 were $1.7 million compared with $1.9 million for 2011. •Research and development (R&D) expense increased $3.5 million to $17.8 million in 2012 due to higher personnel-related expenses and increased clinical trial costs. •General and administrative (G&A) expense increased $1.4 million to $7.1 million in 2012 primarily due to higher personnel-related expenses and public-company costs. •Net loss for 2012 was $23.3 million compared with $18.1 million in 2011.
NewLink expects to end 2013 with about $40 million in cash, cash equivalents and marketable securities.
•Closed Public Offering with aggregate net proceeds of approximately $49.0 million. On February 4, 2013, NewLink closed an underwritten public offering of 4.6 million shares of common stock including 600,000 shares of common stock sold pursuant to the underwriters' exercise of their over-allotment option, at a price to the public of $11.40 per share. •Significant progress in our IMPRESS Phase 3 trial for resected pancreatic cancer patients treated with algenpantucel-L. NewLink expects the first interim analysis in mid-2013 and completion of enrollment in the summer of 2013. •Continued Progress in NewLink's HyperAcute platform of IDO pathway inhibitor drug candidates. NewLink plans to launch a Phase 2 study in metastatic breast cancer evaluating the combination of Taxotere with NewLink's indoximod. NewLink also announced the launch of an investigator sponsored study evaluating indoximod in combination with Dendreon's Provenge® in patients with asymptomatic or minimally symptomatic metastatic hormone refractory prostate cancer.
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