NewLink Genetics Corporation reports first quarter 2012 financial results (Globe Newswire) - May 10, 2012 - Enrollment for P3 trial in pancreatic cancer is expected to complete by Q4 2013; HyperAcute Pancreas P2 clinical trial data will be presented at both the 53rd Annual Meeting of the American Gastroenterological Association in conjunction with DDW on May 22, 2012 and the 2012 ASCO Annual meeting on June 4, 2012
Anticipated P2 data presentation • Anticipated P3 enrollment completion • Pancreatic Cancer
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NewLink Genetics Corporation (Nasdaq:NLNK), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today reported consolidated financial results for the first quarter of 2012, and provided an update on the progress of its clinical development programs.
"During the first quarter of 2012 we continued to advance our pivotal trial in pancreatic cancer and are also moving forward on a number of other HyperAcute immunotherapy development programs including those to treat melanoma and lung and kidney cancers," commented Dr. Charles Link, Chairman and Chief Executive Officer of NewLink. "We also made strides in our IDO pathway inhibitor program and are looking forward to presenting new data for a number of these programs at both DDW and ASCO. We believe that the receipt of patent allowances in both of our core programs will also facilitate our business development activities."
First quarter 2012 Financial Results
Cash, cash equivalents and certificates of deposit totaled $35.8 million at March 31, 2012.
Total grant revenues for first quarter 2012 were $471,000 compared with $604,000 for first 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 reduced research by BPS under various Department of Defense contracts and National Institutes of Health grants.
Research and development (R&D) expense for first quarter 2012 was $3.8 million compared with $3.2 million for first quarter 2011. The increase was primarily due to increases in personnel-related expenses and clinical trial expense.
General and administrative (G&A) expense for first quarter 2012 was $1.5 million compared with $1.3 million for first quarter 2011. The increase was primarily due to increases in personnel-related expenses.
Net loss for first quarter 2012 was $4.8 million or $.23 per common share (based on 20.6 million weighted average shares outstanding), compared with $3.9 million, or $1.07 per common share, for first quarter 2011 (based on 3.6 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.
Financial Guidance
NewLink is maintaining its financial guidance and continues to expect to end 2012 with about $20 million in cash, cash equivalents and marketable securities. NewLink continues to anticipate that this capital should allow it to fund its operations through 2013 based on its current operating plans.
2012 Key Accomplishments to Date
Continued to advance our HyperAcute Pancreas Phase 3 clinical trial. Enrollment is matching our anticipated levels and we continue to expect to complete enrollment before the end of 2013. We still expect that our first interval look will occur at the end of 2012 or early 2013. Data from the HyperAcute Pancreas Phase 2 clinical trial will be presented at both the 53rd Annual Meeting of the American Gastroenterological Association in conjunction with Digestive Disease Week (DDW) on May 22, 2012 and the 2012 American Society of Clinical Oncology (ASCO) Annual meeting on June 4, 2012.
Studies with our IDO pathway inhibitor product candidate in combination with a dendritic cell vaccine or Taxotere continue and we anticipate data from these studies will be presented at ASCO in June, 2012.
Entered into a settlement agreement with the Iowa Economic Development Authority ("IEDA") as the successor organization to the Iowa Department of Economic Development. Under the terms of the settlement agreement we agreed to pay a 0.5% royalty on future product sales up to a cap of $6.8 million in exchange for IEDA's release of our job creation and project expenditure obligations and IEDA's release of the security interest in substantially all of our assets.
The Japan Patent Office issued a notice of allowance for a patent entitled "Antitumor Vaccination Using Allogeneic Tumor Cells Expressing Alpha (1,3)-Galactosyltransferase," which contains broad pharmaceutical composition claims covering NewLink's HyperAcute products for the treatment of cancer. NewLink holds exclusive rights to the allowed application as well as to previously issued counterpart patents in the United States, Canada, Mexico, and Europe.
The United States Patent & Trademark Office (USPTO) allowed broad claims to oral pharmaceutical compositions comprising 1-methyl-D-tryptophan (D-1MT) (US Serial No. 12/175,538) and also to oral pharmaceutical compositions comprising 1-methyl-DL-tryptophan (US Serial No. 11/603,291). The company holds exclusive rights to the allowed applications.
We converted our letter of intent with the National Cancer Institute into a cooperative research and development agreement (CRADA).
Upcoming Activities
NewLink expects to present at the following investor conferences:
Jefferies 2012 Global Healthcare Conference, June 4-7, in New York City, NY.
32nd Annual Canaccord Global Growth Conference, August 14-16, in Boston, MA.
Stifel Nicolaus Weisel Healthcare Conference 2012, September 4-7, in Boston, MA.
Robert W Baird Health Care Conference, September 5-6, in New York City, NY.
NewLink expects to present at the following oncology and pharmacology meetings:
53rd Annual Meeting of the American Gastroenterological Association in conjunction with Digestive Disease Week at the San Diego Convention Center in San Diego, CA, May 19-22, 2012.
2012 American Society of Clinical Oncology (ASCO) Annual meeting June 1-5, 2012 at the McCormick Place, Chicago, IL.
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