AMES, IA -- (Marketwire) -- 10/31/12 -- NewLink Genetics Corporation (NASDAQ: NLNK), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today reported consolidated financial results for the third quarter of 2012. NewLink updated the status of its clinical development programs including its HyperAcute® Pancreas Immunotherapy Phase 3 trial (Immunotherapy for Pancreatic Resectable cancer Survival Study or "IMPRESS").
"As we approach the trigger event for the first interim analysis in our IMPRESS pivotal study, we have continued to execute our plan within the financial guidance we provided at the beginning of this year," commented Dr. Charles Link, Chairman and Chief Executive Officer of NewLink.
"In addition to our IMPRESS pivotal study for resected pancreatic patients, we have initiated a separate Phase 3 study for patients with locally advanced disease," said Dr. Nicholas Vahanian, NewLink's President and Chief Medical Officer. "If approved this new indication potentially doubles the number of patients who could be treated with algenpantucel-L. We are also expanding our HyperAcute immunotherapy platform by opening a major Phase 2B/3 study in non-small cell lung cancer."
The third quarter 2012 Financial Results
•Cash, cash equivalents and certificates of deposit totaled $28.3 million at September 30, 2012. •Total grant revenues for the third quarter 2012 were $327,000 compared with $430,000 for the third quarter 2011. Grant revenues will vary depending on the level of research funded under grants as well as changes in the overhead rates and profit factors agreed to under the grants. The decrease in revenue was due to a decrease in research by BPS under various Department of Defense contracts and National Institutes of Health grants as amended. •Research and development (R&D) expense for the third quarter 2012 was $4.8 million compared with $3.3 million for the third quarter 2011. The increase was primarily due to increases in clinical trial expense associated with an increase in the number of patients enrolled in clinical trials and personnel-related expenses associated with both increased headcounts and increased compensation levels. •General and administrative (G&A) expense for the third quarter 2012 was $1.4 million compared with $1.1 million for the third quarter 2011. The increase was primarily due to increases in professional and Board fees and Directors and Officers insurance premiums associated with our new public company status. •Net loss for the third quarter 2012 was $5.9 million or $.28 per common share (based on 20.9 million weighted average shares outstanding), compared with $4.0 million, or $1.09 per common share, for the third quarter 2011 (based on 3.7 million weighted average shares outstanding). The difference in the number of weighted average shares outstanding primarily resulted from NewLink's initial public offering in November 2011, as well as the conversion of all preferred stock to common stock in connection with the initial public offering.
NewLink expects to end 2012 with $20 million to $23 million in cash, cash equivalents and marketable securities.
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