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July 29, 2016

NewLink Genetics to Eliminate 100 Jobs, 43% of Workforce

  • NewLink Genetics said today it will eliminate 100 jobs—43% of its workforce—as part of a restructuring that followed the Phase III trial failure of its pancreatic cancer candidate algenpantucel-L.

    The company disclosed the layoffs and restructuring in a press release announcing its second-quarter results, as well as a presentation to investors, without specifying which jobs will be eliminated.

    NewLink did say, however, that it recorded $12.3 million in restructuring expenses during Q2, including severance expense, the impairment of fixed assets, and the costs of terminating certain contracts.

    The restructuring comes more than 2 months after NewLink reported that algenpantucel-L missed its primary endpoint in the IMmunotherapy forPancreatic RESectable cancer Study (IMPRESS) Phase III trial, designed to assess the candidate in combination with the standard of care in patients with resected pancreatic cancer.

    Algenpantucel-L failed to show statistically significant improvement in overall survival compared to patients treated with standard of care alone. A total of 722 patients with surgically removed cancers were enrolled at more than 70 sites in the U.S. from May 2010 to September 2013.

    NewLink said today it would wind down commercial manufacturing capacity for algenpantucel-L as part of its restructuring, as well as:

    • Wind down its HyperAcute® Cellular Immunotherapy clinical trials that do not include a checkpoint inhibitor combination
    • Consolidate its facilities space from 133,000 square feet to approximately 66,000 square feet
    • Focus capital spending to primarily support drug discovery and development.

    NewLink said the restructuring was intended to focus company resources on other clinical programs and collaborations. Going forward, the company said, it will focus on:

    • Progressing and accelerating the development of indoximod, for which the company last month reported promising data on the indoleamine-(2,3)-dioxygenase (IDO) pathway inhibitor from two clinical studies at the 2016 American Society of Clinical Oncology Annual Meeting in Chicago
    • Continuing its alliances with Genentech on development of GDC-0919 for solid tumors, as a single agent and with atezolizumab, and with Merck & Co. for its Ebola vaccine candidate V920 (rVSV?G-ZEBOV-GP). On Monday, NewLink announced that the Ebola candidate won both FDA’s Breakthrough Therapy Designation, as well as PRIME (PRIority MEdicines) status from the European Medicines Agency.
    • Advancing other drug discovery programs, including both PTEN and Zika virus
    • Evaluating external opportunities to expand our pipeline.

    “We have the financial resources to realize the potential of our product development pipeline as well as opportunities for the development of other potentially synergistic therapies that could provide benefit to patients with cancer," Nicholas N. Vahanian, M.D., NewLink president and CMO, said in a statement.

    The company said it ended Q2 on June 30, with cash and cash equivalents totaling $160.5 million compared to $197.8 million for the year ending December 31, 2015. Despite that 19% decrease, “NewLink Genetics' goal and expectation remains to finish 2016 with 2 years of cash on hand and the capacity to make incremental investments,” the company stated.

    NewLink finished the second quarter with a net loss of $32.4 million compared to a net loss of $14.1 million for Q2 2015.

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