Dive Brief:
- Vital Therapies is giving up on developing its sole product candidate, a cell-based therapy aimed at restoring failing livers, according to a Wednesday morning announcement.
- The "bio-artificial liver," also known as the ELAD system, failed to meet the primary or secondary endpoints of a Phase 3 trial that evaluated it in 151 people with severe acute alcoholic hepatitis. The ELAD System didn't meet statistical significance in improving survival rates, leading Vital to stop further development and explore strategic options for the overall company.
- After some investors built up the stock over the summer to share prices of more than $9, it opened Wednesday down more than 90%, trading at roughly 60 cents per share.
Dive Insight:
Vital is confronting a crisis expected of a small biotech with no approved products and, now, no promising drug candidates.
The company itself put it plainly in a recent Securities and Exchange Commission filing: "We are totally dependent upon the success of the ELAD System, our sole product candidate."
Wall Street built up the company's market value to a peak of roughly $400 million this summer, seemingly in anticipation of good data from its liver system. But the crash came quick for Vital; after trading with a $266 million value Tuesday, and a $372 million two weeks ago, the biotech's market cap now sits at less than $30 million.
There's no obvious path forward for Vital.
Russell Cox jumped ship from Jazz Pharmaceutical as its chief operating officer to serve as Vital's CEO in January 2018. He may now regret touting the company last December as "so well positioned for the future" when the company announced his hiring.
Given current operation levels, the company's chief financial officer Michael Swanson said on an Aug. 2 earnings call they can fund the business through the first quarter of 2019, with $31 million in cash and equivalents.
That timeframe does not give the company much time to find something promising or valuable from previous R&D efforts.