NewLink expects to present at the following conferences:
•Jefferies 2013 Global Healthcare Conference taking place June 3-6 in NYC. •American Society of Clinical Oncology (ASCO) May 31 - June 4, 2013 in Chicago, IL.
First Quarter 2013 Financial Results
•Cash, cash equivalents and certificates of deposit totaled $64.0 million at March 31, 2013. •Total grant revenues for the first quarter 2013 were $302,000 compared with $471,000 for the first quarter 2012. •Research and development expense for the first quarter 2013 was $6.3 million compared with $3.8 million for the first quarter 2012. The $2.5 million increase was primarily due to increased manufacturing and clinical trial expense from the same period in 2012. •General and administrative expense for the first quarter 2013 was $2.0 million compared with $1.5 million for the first quarter 2012. This increase was primarily due to increases in personnel related expenses. •Net loss for the first quarter 2013 was $7.9 million or $.33 per common share (based on 23.9 million weighted average shares outstanding), compared with $4.8 million, or $.23 per common share, for the first quarter 2012 (based on 20.6 million weighted average shares outstanding). The difference in the number of weighted average shares outstanding primarily resulted from NewLink's public offering in February 2013.
NewLink expects to end 2013 with about $40 million in cash, cash equivalents and marketable securities.
About NewLink Genetics Corporation
NewLink Genetics Corporation is a biopharmaceutical company focused on discovering, developing and commercializing novel immunotherapies to improve treatment options for patients with cancer. NewLink's portfolio includes biologic and small-molecule immunotherapy product candidates intended to treat a wide range of oncology indications. NewLink's product candidates are designed to harness multiple components of the immune system to combat cancer without significant incremental toxicity, either as monotherapies or in combination with other treatment regimens.
NewLink's lead product candidate, algenpantucel-L (HyperAcute® pancreas), is being studied in our IMPRESS (Immunotherapy for Pancreatic Resectable cancer Survival Study) Phase 3 trial for patients with surgically resected pancreatic cancer (under a Special Protocol Assessment with the U.S. FDA). Algenpantucel-L is being tested in a second Phase 3 study (PILLAR, "Pancreatic Immunotherapy with algenpantucel-L for Locally Advanced non-Resectable") for patients with locally advanced pancreatic cancer. NewLink is also testing tergenpumatucel-L, an additional HyperAcute® product candidate, in an adaptive design randomized Phase 2B/3 clinical trial currently accruing up to 240 patients with non-small cell lung cancer.
NewLink is also actively developing two small-molecule, IDO (indoleamine-(2, 3)-dioxygenase) pathway inhibitors. The most advanced is indoximod, an orally bioavailable product candidate, that is being studied in various chemotherapy and immunotherapy combination clinical studies. NewLink's second IDO pathway inhibitor, NLG919, has shown promising preclinical results and is expected to enter clinical trials by the end of 2013. For more information please visit http://www.linkp.com. Patient information is available at http://www.pancreaticcancer-clinicaltrials.com.
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