BrainStorm Cell Therapeutics is mapping out the path forward for its experimental amyotrophic lateral sclerosis (ALS) therapy, and while those plans include a new Phase 3 clinical trial the biotech is slimming down its operations in order to pay for it.
About 30% of BrainStorm’s staff will be laid off, the New York-based biotech company said Tuesday. The company’s most recent financial report issued in August lists 44 employees in the U.S. and Israel. The company expects to complete the job cuts by the end of this year.
The corporate shakeup comes nearly a month after an FDA advisory committee voted against backing NurOwn, BrainStorm’s stem cell therapy for ALS. In explaining their votes, committee member expressed concerns that ranged from uncertainty about the efficacy of the therapy as well as questions about its safety. BrainStorm had pointed to benefit in a subgroup of patients, but FDA staffers and some committee members said these findings by themselves were insufficient to support regulatory approval and would need to be explored further in another clinical trial.
The FDA was expected to issue a regulatory decision for NurOwn in early December, but BrainStorm last week withdrew the application with understanding from the FDA that the company could try again. BrainStorm is now providing some detail about those plans. The company is preparing for a double-blind, placebo-controlled Phase 3b study in the U.S., followed by an open-label extension study. BrainStorm said it will continue to publish NurOwn data about biomarkers, long-term safety and survival, and the expanded access program that provides patients with an experimental therapy outside of the context of a clinical trial. In addition to preparing for the trial design and subsequent FDA meeting, BrainStorm said it is consulting with NurOwn principal investigators, an additional panel of independent ALS experts, and a patient advisory group.
Financing the new clinical trial will be challenging. BrainStorm’s last financial report shows a cash position of just $748,000. In addition cutting its expenses, the company said it is exploring options to raise money that include non-dilutive grant funding and capitalizing on its technology for manufacturing exosomes from mesenchymal stem cells.
The layoffs will focus on cutting positions not critical to the Phase 3b study and a new FDA submission. Among those losing a job is Kirk Taylor, executive vice president and chief medical officer. BrainStorm said Taylor’s role largely focused on global medical affairs and launch activities for NurOwn. With commercialization no longer imminent, Taylor’s role and others were eliminated. In a securities filing, BrainStorm said it expects the layoffs will lead to costs and expenses ranging between $450,000 and $900,000, mainly for severance and one-time termination benefits.
“We remain steadfast in our goal to make NurOwn available to the ALS community as quickly as possible, and we believe that this strategic realignment offers our best chance for success,” BrainStorm President and CEO Chaim Lebovits said in a prepared statement. “While remaining open to partnership opportunities that could accelerate growth, the steps we are taking now reflect our unwavering commitment to those battling this horrific disease and our firm belief in the potential value of NurOwn.”
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