Laying off “substantially all” your workforce is normally a sign that a biotech is in a death spiral, but Acasti Pharma’s CEO is insistent that the move has “energized” the company as it gears up for a phase 3 study of its lead asset.
Last month, the Quebec-based company, which develops new formulations of approved drugs, announced plans to transform into an “agile biopharma” laser-focused on getting its potential subarachnoid hemorrhage treatment GTX-104 to market. In practice, this meant a severe reduction in head count, including discontinuing operations in its home nation of Canada and swapping in a new management team.
A the same time, the company submitted a full protocol for a pivotal phase 3 safety study of GTX-104 to the FDA, with plans to dose the first patient in the second half of this year.
Acasti ended March with $27.9 million in cash and equivalents, which it expects to keep the stripped-back company going through to an FDA approval application for GTX-104 in 2025.
“Our new, highly motivated, and energized organization is entirely focused on achieving critical value inflection milestones in the quarters and years to come," CEO Prashant Kohli said in this morning's full-year earnings report.
GTX-104 is a novel formulation of nimodipine, an approved calcium channel blocker marketed by Bayer as Nimotop to reduce the incidence and severity of ischemic deficits in patients with bleeding around the brain, known as subarachnoid hemorrhage. Acasti hopes that its own version can address the high unmet needs for patients at risk of this event.
With the streamlined company focused solely on GTX-104, Acasti said today that it continues to evaluate “strategic alternatives” for its two de-prioritized assets. One of these, a betamethasone oral-mucosal metered spray called GTX-102, reported promising phase 1 data at the start of the year for a rare, childhood neurological disorder. But it wasn’t enough to keep the biotech interested in that asset or a topical spray for post-herpetic neuralgia called GTX-101.