On November 03, 2015 NewLink Genetics Corporation (NASDAQ:NLNK), a biopharmaceutical company at the forefront of developing and commercializing novel immuno-oncology product candidates, including both cellular immunotherapy and checkpoint inhibitor platforms, to improve the lives of patients with cancer, reported consolidated financial results for the third quarter of 2015 and progress in its proprietary and partnered clinical development programs (Press release, NewLink Genetics, NOV 3, 2015, View Source [SID:1234507912]).

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"Our dynamic and experienced team has made significant progress in driving our broad clinical development programs," said Charles Link, M.D., Chairman and Chief Executive Officer. "We look forward to reporting on our strong pipeline of clinical data over the coming year."

Dr. Link added, "GDC-0919, the checkpoint inhibitor program partnered with Genentech continues to make great progress. Both companies are putting substantial resources behind this program, and we continue to be excited about the development plan and the progress of our collaboration."

"As we anticipate the data readout for the IMPRESS trial in 2016, NewLink Genetics continues to advance its investment in manufacturing and pre-commercial activities relating to algenpantucel-L, our HyperAcute Cellular Immunotherapy product candidate for patients with resected pancreatic cancer," said Nicholas Vahanian, M.D., President and Chief Medical Officer. "We await the promise of our cellular immunotherapy agents to educate the immune system to destroy tumor cells in pancreatic and other cancers."

Financial Results for the Three-Month Period Ended September 30, 2015

Cash Position: NewLink Genetics ended the quarter on September 30, 2015, with cash, cash equivalents, and certificates of deposit totaling $200.4 million, compared to $202.8 million for the year ending December 31, 2014 .

R&D Expenses: Research and development expenses in the third quarter of 2015 were $22.5 million, compared to $10.9 million during the comparable period in 2014. The increase is primarily due to clinical trial expenses related to NewLink Genetics’ broad pipeline of product candidates, as well as expenses for manufacturing and research related to the Ebola vaccine candidate. The majority of the Ebola-related expenses are subject to reimbursement under government contracts.

G&A Expenses: General and administrative expenses in the third quarter of 2015 were $7.4 million, compared to $4.9 million during the comparable period in 2014. The increase was primarily due to an increase in share-based compensation expense, consulting and legal fees, and medical affairs and pre-commercial activities.

Net Loss: NewLink Genetics reported a net loss of $15.9 million, or ($0.55) per diluted share, for the third quarter of 2015, compared to a net loss of $5.6 million, or ($0.20) per diluted share, for the comparable period in 2014.

NewLink Genetics ended the quarter with 28,774,911 shares outstanding.

Financial Guidance

NewLink Genetics expects to have more than $160 million in cash and equivalents on December 31, 2015.

Conference Call and Program Updates:

The Company has scheduled a conference call for 8:30 a.m. ET today to discuss these results and to provide an update on clinical and business development activities. Dial-in information for the conference call is set forth at the end of this press release. Programs to be discussed include:

IDO Checkpoint Inhibitor Programs

NewLink Genetics entered into an exclusive worldwide license and collaboration agreement with Genentech, a member of the Roche Group, for the development of the IDO checkpoint inhibitor GDC-0919 and an expanded pipeline of potential IDO/TDO inhibitor candidates in 2014. This product candidate is currently in Phase 1 clinical development for patients with advanced solid tumors.

Key preclinical data is being presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in Bethesda, Maryland on November 6, 2015.

Phase 1 data on GDC-0919 was presented at the ECC/ESMO meeting in Vienna. Key preliminary data showed that GDC-0919 had a favorable safety profile and preliminary evidence of disease stabilization and peripheral pharmacodynamic modulation. Details from the poster presentation are available in the press release found at View Source
The collaboration’s clinical development team has advanced GDC-0919 into a combination study with atezolizumab that is actively enrolling patients. In addition, the collaboration is planning combination studies of GDC-0919 with OX-40 agonists.
NewLink will be eligible to receive in excess of $1 billion in milestone payments based on achievement of certain predetermined milestones as well as escalating double-digit royalties on potential commercial sales of multiple products by Genentech.
Indoximod, NewLink Genetics’ proprietary IDO pathway inhibitor, is in multiple Phase 1 and Phase 2 clinical trials for patients with breast, prostate, pancreatic and brain cancers as well as melanoma. We will provide additional details about our trials on the conference call. Additionally, there will be multiple opportunities for the Company to provide further updates during 2015 and 2016 at academic meetings and associated programs.

HyperAcute Cellular Immunotherapy Programs

NewLink Genetics’ proprietary HyperAcute Cellular Immunotherapy programs may prove to have broad potential for patients across a spectrum of cancer indications, including use in combination with checkpoint inhibitors.

Algenpantucel-L is NewLink Genetics’ HyperAcute Cellular Immunotherapy product candidate for patients with pancreatic cancer. The product is currently being studied in a Phase 3 clinical trial called IMPRESS, or IMmunotherapy for Pancreatic RESectable Cancer Study, in patients with surgically resected pancreatic cancer. The study is powered to show an improvement in overall survival after 442 events, and we continue to expect that final results will be reported in 2016.

PILLAR, or Pancreatic Immunotherapy with Algenpantucel-L for Locally Advanced Non-Resectable Disease, is our Phase 3 clinical trial studying the efficacy of algenpantucel-L for patients with borderline resectable or locally advanced unresectable pancreatic cancer. We expect to complete enrollment in this study in 2015.

Tergenpumatucel-L

Tergenpumatucel-L, NewLink Genetics’ HyperAcute Cellular Immunotherapy product candidate for patients with non-small cell lung cancer (NSCLC), remains in Phase 2. We are eager to learn more about this product in our recently begun trial evaluating tergenpumatucel-L in combination with indoximod and chemotherapy for patients with advanced NSCLC.

Dorgenmeltucel-L

Dorgenmeltucel-L, NewLink Genetics’ HyperAcute Cellular Immunotherapy product candidate for patients with melanoma, continues in a trial evaluating efficacy in combination with the checkpoint inhibitors ipilimumab, nivolumab, and pembrolizumab for patients with advanced melanoma.

Ebola Vaccine

During the third quarter, we announced that NewLink Genetics was awarded an $8.1 million base contract with future options totaling $5.2 million by the Defense Threat Reduction Agency of the United States Department of Defense to support various development activities of the investigational rVSV-ZEBOV (Ebola) vaccine candidate. Additionally, the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services exercised an $18 million option on NewLink Genetics’ existing contract.

NewLink has exclusively licensed research, development, manufacturing and commercialization of the rVSV-ZEBOV (Ebola) vaccine to Merck. This vaccine candidate was originally developed by the Public Health Agency of Canada (PHAC).