pioneering California company that’s spent tens of millions and nearly three decades trying to develop therapies using stem cells is shutting down after failing to move treatments through clinical trials — but advocates of stem cell treatments say they’re convinced the approach still holds great promise.
StemCells Inc., based in Newark, Calif., has long been seen as a leader in regenerative medicine. The field aims to use highly flexible stem cells — which have the potential to develop into heart, muscle, brain, or any other type of cell — to heal damaged tissues and organs. The company has been working on treatments for spinal cord injury, Alzheimer’s, and dry age-related macular degeneration, which causes vision loss.
The company was once the darling of private investors and of the California Institute of Regenerative Medicine, a government agency funded by the state’s taxpayers to further stem cell research. And a mid-stage clinical trial of its spinal cord treatment seemed promising.
But StemCells pulled the plug on the trial this week, reporting that the treatment didn’t have a strong enough impact to justify continuing the study.
The company plans to sell off its intellectual property, which includes trade secrets and data from its studies. Cofounder Irv Weissman said he believes that data includes valuable clues to aid in the development of stem cell treatments.
Some analysts, however, aren’t so sure what the company has in the way of novel intellectual property.
StemCells was “never forthcoming with the details” of their technology, said Dr. Larry Goldstein, director of the University of California, San Diego, Stem Cell Program.
But Goldstein said he didn’t read a broader message into the company’s failure.
“Biotech is like prospecting for gold — only a small fraction of companies make it through the gauntlet,” Goldstein said. “Disappointing clinical trial results happen all the time. … You can’t get too alarmed when one thing, such as StemCells Inc., fails.”
The company was launched in 1988 by two lauded scientists: Weissman, the director of Stanford University’s Institute of Stem Cell Biology and Regenerative Medicine, and Fred “Rusty” Gage, a genetics professor at San Diego’s Salk Institute. It went public in 1992, and by 1995 was enjoying stocks peaking above $175 a share.
But StemCells has been teetering on the edge of insolvency for quite some time now. Its troubles stem in part from high R&D costs, and in part from a complicated relationship with CIRM, the California state agency that funds stem cell research.
In 2012, CIRM awarded StemCells Inc. $20 million to pursue its Alzheimer’s disease therapeutic. But by mid-2014, after having received about $9 million in public funds, the company said it wasn’t worth launching clinical trials: Early studies didn’t demonstrate that the treatment would materially help Alzheimer’s patients.
“It’s always disappointing when a program that takes a bold approach to treating deadly and disabling diseases like Alzheimer’s fails,” Kevin McCormack, a representative for CIRM, said in an email. “It’s the nature of science that not every experiment works, and the nature of business is that not every company succeeds.”
StemCells then became embroiled in a serious conflict-of-interest dispute when it appointed former CIRM president Alan Trounson to its board almost immediately after he’d resigned from the government agency.
CIRM had no involvement in StemCells’s spinal cord trial that ended this month, having distanced itself from StemCells since the 2014 fracas.
As recently as last week, StemCells Inc. appeared to be rallying: The company filed a registration statement on May 24 with the Securities and Exchange Commission to raise $30 million. It also attempted a 1-for-12 reverse stock split in early May, in order to bump up the stock price.
That clearly didn’t pan out, however — and stocks crashed Tuesday, closing out trading at 57 cents per share. StemCells Inc. said in a statement that it had about $5.5 million in cash and cash equivalents on hand; it plans to lay off its 50 employees by August.