NewLink Genetics (NLNK) Tops Q4 EPS Expectations

NewLink Genetics (NASDAQ: NLNK) reported Q4 EPS of $4.05, $4.73 better than the analyst estimate of ($0.68). Revenue for the quarter came in at $159.25 million versus the consensus estimate of $2.98 million.

Program Updates:

HyperAcute® Cancer Immunotherapy Programs

NewLink Genetics' proprietary cancer immunotherapy programs may prove to have broad potential across a spectrum of cancer indications. NewLink Genetics has multiple HyperAcute immunotherapy programs in various stages of development, including pancreatic and lung cancer.

Algenpantucel-L for Patients with Pancreatic Cancer

The Phase 3 pivotal trial, known as IMPRESS, is designed to study standard adjuvant therapy alone or in combination with algenpantucel-L in patients who have undergone surgical resection for pancreatic cancer. This study is fully enrolled, and the first interim analysis previously has been reported.

• The Company revised its timing expectations and stated today that it expects to report on the second interim analysis in the first or second quarter of 2015. The possible outcomes for the second interim look include confirmation of continuing the study as designed to the pre-planned endpoint. The alternative outcome is a decision to proceed with filing with the FDA on the basis of the interim data due to improvement in overall survival rate as determined by the early stopping rules in the trial's Special Protocol Assessment.

The Phase 3 pivotal trial, known as Pancreatic Immunotherapy with algenpantucel-L for Locally Advanced non-Resectable disease or PILLAR is currently enrolling patients.

• The Company reported that it expects to complete enrollment in the second half of 2015. When enrollment is completed, NewLink Genetics will provide guidance on the reporting of the preliminary results.

Tergenpumatucel-L for Patients with Advanced Lung Cancer

Tergenpumatucel-L, NewLink Genetics' HyperAcute Lung Immunotherapy, is being tested in a randomized, Phase 2b study in advanced lung cancer. An update on this program will be provided in the second half of 2015.

IDO/TDO Pathway Inhibitor Programs

In October 2014, the Company announced that it entered into an exclusive, worldwide license agreement with Genentech for the development and commercialization of NLG919, a clinical stage IDO (indoleamine 2,3-dioxygenase) pathway inhibitor, and collaboration for the discovery of the next generation IDO/TDO (tryptophan 2,3-dioxygenase) inhibitors to be developed and commercialized under the agreement. This alliance with Genentech brought NewLink Genetics $150 million in an upfront payment, plus potential milestone payments that exceed $1 billion, royalties and co-promotion rights as well as financial support for NewLink Genetics' work in the collaboration.

• Since announcing this alliance, NewLink Genetics and Genentech have launched both preclinical drug discovery and clinical development teams, which are already hard at work on the collaboration.
• In addition, the Company confirmed that it will continue the development of indoximod, including studies in combination with HyperAcute product candidates. The Company expects to complete enrollment of four different oncology trials by the first half of 2016.

Ebola Vaccine Program with Merck

In addition to the $30 million received in an upfront payment from Merck in November 2014, last week, the Company announced that it earned a $20 million milestone payment relating to the initiation of a pivotal clinical trial in Africa and it has the ability to earn royalties on future potential sales of the vaccine, if approved by regulatory agencies in specified countries based on certain economic criteria.

• The Company is currently collaborating with the Public Health Agency of Canada, the National Institutes of Health, the Center for Disease Control, the United States Department of Defense, and multiple international agencies and is conducting multiple clinical trials around the world.
• In 2014, the Company announced that it received significant funding from the Department of Defense and the Biomedical Advanced Research and Development Authority to support the manufacturing of the vaccine at various dose levels as well as early clinical trials and important groundwork needed to move the candidate to effectiveness trials.
• Dr. Thomas P. Monath, a top vaccine expert was hired to lead NewLink Genetics' infectious disease effort and is building its organization in the Boston area to support this important initiative.

For earnings history and earnings-related data on NewLink Genetics (NLNK) click here.

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