On April 29, 2016 NewLink Genetics Corporation (NASDAQ:NLNK), a biopharmaceutical company at the forefront of discovering, developing and commercializing novel immuno-oncology product candidates, including both cellular immunotherapy and checkpoint inhibitor programs, to improve the lives of patients with cancer, reported consolidated financial results for the first quarter of 2016 (Press release, NewLink Genetics, APR 29, 2016, View Source [SID:1234511634]).

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"We had a productive quarter and made solid progress in achieving our mission of bringing patients with cancer better treatment options," said Charles J. Link, Jr., M.D., Chairman, Chief Executive Officer and Chief Scientific Officer. "The pivotal IMPRESS trial for patients with resected pancreatic cancer is moving rapidly toward final analysis. And, we are preparing for multiple updates from both our proprietary and partnered IDO pathway inhibitor clinical programs at key scientific meetings in 2016."

Nicholas Vahanian M.D., President and Chief Medical Officer, added, "With the upcoming clinical trial read outs, we anticipate that these data will bring us closer to clinical validation of our IDO pathway inhibitor program. The team at NewLink Genetics continues with confidence and excitement as our partner, Genentech begins to report on the clinical development of GDC-0919 alone and in combination studies. We look forward to Genentech reporting on the results from these studies this year. "

Program Updates:

HyperAcute Cellular Immunotherapy Program

Algenpantucel-L/IMPRESS Trial

Today, the company reported that it expects to report top-line results from the IMPRESS trial during the second quarter of 2016. Algenpantucel-L is the most advanced clinical program utilizing NewLink Genetics’ HyperAcute Cellular Immunotherapy platform technology. IMPRESS is a randomized, controlled, two-arm Phase 3 trial (n=722) for patients with resected pancreatic cancer designed to test algenpantucel-L in combination with the standard of care versus the standard of care alone.

IDO Pathway Inhibitor Programs

Indoximod

At the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 3 to 7, 2016 in Chicago, NewLink Genetics expects to report on clinical updates on its proprietary IDO pathway inhibitor programs. Abstracts that have been selected include:

Interim data update from a Phase 2 trial with a target enrollment of 80 patients evaluating the addition of indoximod to gemcitabine/nab-paclitaxel for patients with metastatic pancreatic cancer.
Mid-trial and safety data update from a Phase 2 trial with a target enrollment of 96 patients of indoximod and ipilimumab or PD-1 inhibitors for patients with stage 3 or 4 advanced or metastatic melanoma.
Additional data updates expected in the second half of 2016 include:

Mid-trial update from a Phase 2 trial with a target enrollment of 132 patients of indoximod for patients with refractory malignant brain tumors.
Guidance on timing of preliminary results in a randomized Phase 2 trial with a target enrollment of 154 patients of indoximod for patients with metastatic breast cancer.
GDC-0919 Small Molecule Program

The company is anticipating a clinical update from the combination study of GDC-0191. Genentech recently reported that it will update the Phase 1b study with a target enrollment of 224 patients in solid tumors at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) from October 7-11, 2016 in Denmark. The dose-escalation and expansion study combines GDC-0919 and atezolizumab (PD-L1 Mab).

In 2014, NewLink Genetics entered into an exclusive worldwide license agreement with Genentech, a member of the Roche Group, for the development of NLG919, NewLink Genetics’ IDO pathway inhibitor. The parties also entered into a research collaboration for the discovery of next generation IDO/TDO compounds.

Financial Results for the Three-Month Period Ended March 31, 2016

Cash Position: NewLink Genetics ended the quarter on March 31, 2016, with cash, cash equivalents, and certificates of deposit totaling $178 million compared to $197.8 million for the year ending December 31, 2015. The decrease was attributable primarily due to the increased operating expenses for R&D and pre-commercialization development, offset by amounts received under government contracts.

R&D Expenses: Research and development expenses in the first quarter of 2016 were $21.9 million compared to $18 million during the comparable period in 2015. The increase was primarily due to increases in clinical trial and manufacturing expenses related to NewLink Genetics’ broad pipeline of product candidates.

G&A Expenses: General and administrative expenses in the first quarter of 2016 were $9.2 million compared to $8.4 million during the comparable periods in 2015. The increase was primarily due to an increase in share-based compensation expense, as well as increases in travel expenses and medical affairs and marketing.

Net Income/Loss: NewLink Genetics reported a net loss of $23.7 million or a $0.82 loss per diluted share for the first quarter of 2016 compared to net income of $11.2 million or earnings of $0.35 per diluted share for the comparable period in 2015.

NewLink Genetics ended the quarter with 28,860,925 shares outstanding.

Financial Guidance and Upcoming Investor Meetings

NewLink Genetics has reiterated their goal and expectation is to finish 2016 with two years of cash on hand.

We have presented at five investor meetings since the beginning of the year and expect to present at Bank of America Healthcare Conference on May 12 and Cantor Fitzgerald Healthcare Conference on July 12 and 13.

HyperAcute Cellular Immunotherapy Program

HyperAcute Cellular Immunotherapies are unique, tumor-specific product candidates that take advantage of a pre-existing human immune response to initiate a powerful cascade, potentially educating the body’s natural defenses to identify and destroy cancer cells. Unlike certain immuno-oncology products, HyperAcute Cellular Immunotherapies do not require patient tissue or cancer cells and are designed to be easy to administer. HyperAcute Cellular Immunotherapies use allogeneic (disease-specific, not patient-specific), tumor-specific human cell lines that have been modified to express alpha-gal. Intact, whole cells are used rather than cell fragments or purified proteins, which we believe result in the stimulation of a more powerful immune response. Our most advanced clinical program utilizing this technology is for patients with pancreatic cancer. Additionally, there are ongoing clinical development programs and data on induced immune responses targeting non-small-cell lung cancer, melanoma, prostate cancer and kidney cancer.

Indoleamine 2,3-Dioxygenase (IDO) Checkpoint Inhibitor Programs

The indoleamine 2,3-dioxygenase (IDO) pathway regulates immune response by suppressing T cell function and enabling local tumor immune escape. NewLink Genetics is researching two IDO pathway inhibitors, GDC-0919 (in partnership with Genentech) and indoximod, small-molecule product candidates that have the potential to disrupt mechanisms by which tumors evade the immune system.

NewLink Genetics’ indoximod and GDC-0919 each have a distinct mechanism of action within the IDO pathway and are in Phase 1 or 2 clinical trials for a range of cancers, including breast cancer, melanoma, and other solid tumors.