With another wave of layoffs and CEO exit, AMT seeks out 'strategic alternatives'

With its lead chronic pouchitis treatment stuck in limbo as the company searches for a phase 3 partner, it looks like Applied Molecular Transport has finally thrown in the towel.

The biotech will let go of 57% of its workforce and seek out “strategic alternatives” for the business, according to a postmarket release Monday. Tahir Mahmood, Ph.D., will leave his role as CEO while remaining on the board, with President and Chief Operating Officer Shawn Cross taking over the top seat for the time being.

“We continue to believe our proprietary technology, that enables the design of novel oral biologics, is an important innovation in the field of therapeutics,” Cross said in the release. “However, after an extensive assessment of our clinical programs and the current business environment, we have made the difficult decision to pause research and development as we close out existing programs and explore ending the AMT-101 Castro trial in rheumatoid arthritis at its current enrollment.”

AMT has tapped up MTS Health Partners to seek out ways to continue its clinical and preclinical programs either internally or via partnerships, the biotech added.

The outlook has been bleak at the company for a while now. AMT already laid off 40% of its staff and froze early-stage pipeline activities back in May 2022 in order to keep lead asset AMT-101 in the game. But, as of earlier this month, the biotech had failed to find the necessary partner to take the candidate into phase 3.

AMT-101 is an oral, gut-selective, fusion protein of interleukin-1 (IL-1). The company ended last year on a downer, with AMT-101 producing a lower clinical remission rate in ulcerative colitis patients than the placebo cohort. This followed a fail in July when the therapy was put up against Humira in the same indication.

AMT has had better luck in the pouchitis indication, where it received orphan-drug designation from the FDA in November. Pouchitis is an inflammation that can occur at the site of colon surgery and for which there are no current FDA-approved products.

A phase 2 trial in April showed that AMT-101 helped 36.4% of patients achieve stool frequency response, setting the company up to enter phase 3. But, since then, the biotech has struggled to move into the next stage.

AMT-101 is also in a phase 2 trial in combination with anti-TNFα therapy for rheumatoid arthritis patients who are partial or non-responders to anti-TNFα therapy. A top-line readout is due at some point this year.

The company’s only other remaining asset is AMT-126, an oral fusion of IL-22 that completed a phase 1 trial in healthy volunteers last year. The company already said it was “evaluating next steps for the program” in its fourth-quarter earnings release.

AMT ended February with $47.4 million in cash and equivalents available, of which it expects to lose $4.8 million to employee severance costs.

In a grim reminder of the tough funding environment for biotechs extending into 2023, AMT’s news comes just a day after Codiak Biosciences filed for bankruptcy in the wake of its own layoffs and pipeline culls. Nucleic acid therapy biotech Exicure also disclosed plans to seek strategic alternatives, including a potential transactions, at market close Monday