It’s been heady for biotechs break­ing in­to a pan­dem­ic stock mar­ket: $233 mil­lion for ADC Ther­a­peu­tics, $165 mil­lion for Zen­tal­is, and $120 mil­lion for ORIC. Now a com­pa­ny that emerged from stealth just 8 months ago — and is now run­ning low on cash — is try­ing to get in on the 9-fig­ure game.

South San Fran­cis­co-based Ap­plied Mol­e­c­u­lar Trans­port has filed for a $100 mil­lion IPO. Found­ed and led by long­time life sci­ences con­sul­tant Tahir Mah­mood, the com­pa­ny builds oral drugs around a car­ri­er mol­e­cule that can cross pro­tec­tive lin­ings in­to the im­mune-cell heavy ar­eas of the gut. They de­buted in Sep­tem­ber, af­ter they be­gan dos­ing Phase I for their lead pro­gram, an ul­cer­a­tive col­i­tis drug that re­cent­ly com­plet­ed ear­ly test­ing in East­ern Eu­rope.

Tahir Mah­mood

That drug, AMT-101, is an IL-10 ag­o­nist that is de­signed to turn down in­flam­ma­tion in au­toim­mune dis­or­ders, in­clud­ing ul­cer­a­tive col­i­tis but al­so pou­ch­i­tis and rheuma­toid arthri­tis. The IPO, the com­pa­ny said, will bankroll both Phase II tri­als for AMT-101 that they plan to be­gin this year, and a Phase I tri­al for AMT-126, an IL-22 ag­o­nist be­ing de­vel­oped for dis­eases that are re­lat­ed to bar­ri­er func­tion — i.e. dis­eases that sci­en­tists be­lieve in­volve breach­es in the cell lin­ing of the gut, such as in­flam­ma­to­ry bow­el dis­ease.

The swift IPO arose at least part­ly out of a sober look at their fi­nan­cials, with man­age­ment con­clud­ing at the end of Q1 that there “was sub­stan­tial doubt about our abil­i­ty to con­tin­ue as a go­ing con­cern” for the fol­low­ing year.

Ap­plied Mol­e­c­u­lar Trans­port was ini­tial­ly found­ed in 2010, as Ap­plied Mol­e­c­u­lar Trans­port, LLC. But in 2016, Ap­plied Mol­e­c­u­lar Trans­port, LLC be­came a whol­ly owned sub­sidiary of a new en­ti­ty — Ap­plied Mol­e­c­u­lar Trans­port Inc. Since then, the com­pa­ny has qui­et­ly raised $105.6 mil­lion in three sep­a­rate rounds: A $32.8 mil­lion Se­ries A in 2016, a $30.9 mil­lion Se­ries B in 2018, and a $41.9 mil­lion Se­ries C in 2019.

The com­pa­ny, though, burned through over $15 mil­lion in Q1 — $10 mil­lion more than they burned through in Q1 2019, when they were still a pre­clin­i­cal com­pa­ny — and was left with just $16 mil­lion left in the tank.

After the FDA lambasted their PD-1 ahead of an adcomm earlier this week, Incyte ran into new trouble Thursday as ODAC panelists voted against an accelerated OK by a wide margin.

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

The FDA on Thursday called to include those with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in appropriate clinical trials, regardless of whether they have received existing alternative treatments.

Historically, many cancer clinical trials have required that participating patients previously received multiple therapies, according to Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

Gene therapy companies have faced huge hurdles trying to deliver healthy genes into muscular dystrophy patients’ muscle cells, so here’s an idea: Why don’t we just replace the muscle cells themselves?

Over the last two years, Vita Therapeutics has been exploring that possibility, building on early stem cell work from Johns Hopkins professor Peter Andersen. And on Tuesday they announced a $32 million Series A to begin to move their first therapy into the clinic, where they hope it will help rebuild muscle in patients with a type of dystrophy that afflicts the arms and legs.