IPO filings are back on the biotech menu as an ADHD drug developer submits its Nasdaq paperwork
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The summer months have brought the biotech IPO market to a near standstill after a record run, but activity is slowly starting to ramp back up again as another company is taking the Nasdaq plunge.
ADHD drug developer Cingulate filed for an IPO on Thursday, penciling in a modest $58 million for its raise. Based out of Kansas City, KS, Cingulate has a Phase III-ready ADHD program in addition to a follow-up candidate soon to hit the clinic, as well as a third program still in early preclinical development for anxiety.
Cingulate got started back in 2013 with a founding group of veteran psychiatrists and a CEO in Shane Schaffer who spent more than 25 years in senior roles at Pfizer, Novartis and Sanofi. The group is pitching an alternative delivery method for their ADHD medicines, banking on “precision timed release” to differentiate itself from other players.
Most ADHD meds currently approved, the biotech says in its S-1, are stimulants taken in the morning with quick-acting effects, leaving patients needing additional pills in the afternoon after they experience a “crash.” It’s a market Cingulate believes is ripe for disruption, with stimulants making up 91% of the $15 billion-plus ADHD pie.
Cingulate’s lead candidate, known as CTx-1301, is designed to slowly release its active ingredients in three phases throughout the day. The first portion is an immediate release, accounting for about 35% of the total medicine contained in the pill, and is delivered over 30 minutes. The second part, coming about three to four hours later, comprises 45% of the total and is delivered over a 90-minute period.
These first two release schedules are comparable to some meds on the market such as Focalin, Cingulate says, but CTx-1301 has a third timed release built-in as a “booster” making up the remaining 20%. This booster releases about seven hours after taking the pill and enters the bloodstream over the following 30 minutes.
The program has already passed a Phase I/II test comparing it to Focalin, and a Phase III program is planned to start in the fourth quarter looking at children, adolescents and adults with ADHD. Should the pivotal studies prove successful, an NDA is expected to follow in the first half of 2023.
Cingulate’s follow-up ADHD candidate is aimed solely at children, but relies on the same precision timed release platform. For this program, which is expected to start a Phase I/II study in early 2022, researchers have designed the medicine to release in 45%-35%-20% portions, rather than the 35%-45%-20% schedule for the lead.
Funds from the IPO are expected to go toward both of these clinical programs in addition to a proof of concept study for the preclinical anxiety medication. Cingulate hasn’t listed how much in its S-1 just yet, however.
Also on Thursday, two biotechs set terms for their respective IPOs: Kevin Judice’s DiCE Therapeutics and Tyra Biosciences. Both are expected to price next week with raises topping $100 million each, according to Renaissance Capital.
Once DiCE and Tyra go public, biotech’s combined IPO raise will eclipse $13 billion for 2021, per the Endpoints News tally. With about three and a half months left in the year, activity will likely need to ramp back up to earlier levels to surpass 2020’s record raise of $16.5 billion.