On July 31, 2015 NewLink Genetics Corporation (NASDAQ:NLNK), a biopharmaceutical company at the forefront of developing and commercializing novel immuno-oncology product candidates to improve the lives of patients with cancer, reported consolidated financial results for the second quarter of 2015 and progress in its clinical and business development programs (Press release, NewLink Genetics, JUL 31, 2015, View Source [SID:1234506780]).
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"NewLink Genetics continues to drive forward, and to execute on, its strategy of developing treatment options for patients with cancer using targeted immune response and disruptive checkpoint blockade," said Dr. Charles Link, Chairman and Chief Executive Officer. "We have seven product candidates across multiple cancer types in clinical development from Phase 1 to Phase 3. Our combined platform of product candidates positions us well to execute on our vision of combining cancer vaccines and checkpoint blockade inhibitors through our HyperAcute Immunotherapy and indoleamine 2,3-dioxygenase (IDO) pathway inhibitor platforms."
"During the second quarter, we continued our planned hiring and pre-commercial activities relating to our HyperAcute Immunotherapy algenpantucel-L, which is being studied for adjuvant treatment of patients with surgically resected pancreatic cancer," said Dr. Nicholas Vahanian, President and Chief Medical Officer.
The Company continued to build its presence with key opinion leaders by having a booth and poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The poster (#2070) highlighted encouraging results of the Phase 1b portion of a study showing that the combination of indoximod and temozolomide in temozolomide-refractory patients with progressive or refractory glioblastoma was well tolerated, with preliminary evidence of efficacy. Enrollment of the Phase 2 portion of the study is underway.
In addition, the Company hosted its first-ever analyst day on July 14, outlining its vision and execution plans surrounding its clinical programs. A webcast of the Company’s presentations can be found at View Source
Program Updates:
HyperAcute Immunotherapy Cancer Programs
NewLink Genetics’ proprietary HyperAcute Immunotherapy programs may prove to have broad potential for patients across a spectrum of cancer indications, including use in combination with checkpoint inhibitors. NewLink Genetics has multiple HyperAcute Immunotherapy programs in various stages of clinical development, including for pancreatic cancer, lung cancer, melanoma, renal cell cancer and prostate cancer.
Algenpantucel-L is NewLink Genetics’ HyperAcute Immunotherapy pancreatic cancer candidate in a Phase 3 clinical trial called IMPRESS, or IMmunotherapy for Pancreatic RESsectable Cancer Study. During the second quarter, following the second interim analysis of the study, the Company announced the recommendation of the data safety monitoring committee to proceed without modification to final analysis. The Company has announced that at the time of the second interim analysis, the estimated blended median overall survival in the trial from the time of randomization was 28.5 months for all patients. Median time from surgery to randomization was approximately 1.5 months. Therefore median survival from surgery was estimated to be approximately 30 months for all patients in our study. We believe that the median months of overall survival from randomization in the control arm is in the low twenties. The study is powered to show an improvement in overall survival after 442 events.
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 in patients with borderline resectable or locally advanced pancreatic cancer. We expect to complete enrollment in this study during 2015.
NewLink Genetics’ HyperAcute Immunotherapy product candidate tergenpumatucel-L is being tested versus docetaxel in a randomized Phase 2b study in patients with advanced lung cancer. We are currently enrolling patients in this study.
HyperAcute Immunotherapy product candidate dorgenmeltucel-L for patients with melanoma is being evaluated in a randomized Phase 2 study in combination with the checkpoint inhibitors ipilimumab, nivolumab, and pembrolizumab versus these checkpoint inhibitors alone.
IDO Pathway Inhibitor Programs
NewLink Genetics’ proprietary IDO pathway inhibitor, indoximod, is in multiple Phase 1 and Phase 2 clinical trials for the treatment of patients with breast, prostate, pancreatic and brain cancers as well as melanoma. We expect to complete enrollment of the following studies with indoximod within the next 12-15 months.
NLG2101, a global randomized Phase 2 trial testing indoximod in combination with docetaxel or paclitaxel in patients with metastatic breast cancer, is expected to fully enroll by the end of 2015. NewLink Genetics intends to present preliminary data from this study at an upcoming medical meeting in 2015.
NLG2102 is a Phase 2 trial of the combination of indoximod and temozolomide in refractory or relapsed glioblastoma multiforme patients.
NLG2103 is a Phase 2 trial testing indoximod in combination with the checkpoint inhibitors ipilimumab, nivolumab or pembrolizumab in patients with advanced melanoma. We expect to report top-line Phase 1b results at the Immunotherapy in Cancer Poster Session of the ESMO (Free ESMO Whitepaper)/ECC meeting in Vienna on Saturday, September 26 (#248, abstract 514).
NLG2104 is in a Phase 1b/2 trial testing indoximod in combination with gemcitabine plus nab-paclitaxel in patients with metastatic pancreatic cancer. Top-line Phase 1b results are expected in 2016.
NewLink Genetics has also entered into an exclusive worldwide license and collaboration agreement with Genentech, a member of the Roche Group, for the development of the IDO inhibitor GDC-0919. Based on pre-clinical data presented at ASCO (Free ASCO Whitepaper) by our partner, GDC-0919 demonstrated decreases in plasma kynurenine levels and regulatory T-cells as well as an anti-tumor efficacy when combined with anti-PD-L1 and anti-CTLA4. This product candidate is currently in Phase 1 clinical development in patients with advanced solid tumors, and Phase 1 data on GDC-0919 is expected to be presented in a poster presentation at the ESMO (Free ESMO Whitepaper)/ECC meeting in Vienna on Sunday, September 27 (#157, abstract 346). In addition, a Phase 1 clinical trial, with a planned enrollment target of 224 patients, will study GDC-0919 in combination with Genentech’s PD-L1 inhibitor MPDL3280A for patients with locally advanced or metastatic solid tumors. An additional study is planned for GDC-0919 in combination with an OX40 inhibitor.
Financial Results for the Three-Month Period Ended June 30, 2015
Cash Position: NewLink Genetics ended the quarter on June 30, 2015, with cash and equivalents totaling $207.6 million, compared to $202.8 million for the year ending December 31, 2014.
R&D Expenses: Research and development expenses in the second quarter of 2015 were $16.1 million, compared to $6.5 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. Most of the Ebola-related expenses are subject to reimbursement under government contracts.
Net Income/Loss: NewLink Genetics reported a net loss of $14.1 million, or ($0.49) per diluted share, for the second quarter of 2015, compared to a net loss of $9.2 million, or ($0.33) per diluted share, for the comparable period in 2014.
NewLink Genetics ended the quarter with 28,661,588 shares outstanding.
Financial Guidance
NewLink Genetics expects to have more than $160 million in cash and equivalents on December 31, 2015.
"Our research and development expenses and capital expenditures continue to reflect our commitment to developing a broad pipeline of drug candidates and to ensure that we have the infrastructure in place to support the commercialization and manufacturing of algenpantucel-L," said Jack Henneman, Executive Vice President and Chief Financial Officer. "We will continue to make significant investments for the remainder of 2015 to support these efforts."