Dance Biopharm filed for $75 million initial public offering on Wednesday night, seeking new money from investors to further develop its own device to deliver insulin to diabetics through their lungs.
I know you're probably wondering, does the world need a second inhaled insulin device, particularly with so many question marks still hovering over MannKind's Afrezza? The answer will depend, partly, on whether or not Dance Biopharm can convince investors to buy into its IPO. Investors haven't exactly warmed to MannKind, even with last week's positive recommendation from the FDA advisory panel. But there are some key differences between Dance Biopharm and MannKind which may make the former more compelling.
This is a photo of Dance Biopharm's device, called Dance 501:
The device has a coolish look. That mist coming out the working end is supposed to represent vaporized insulin. Unlike Afrezza, which delivers dry insulin powder into the lungs, Dance Biopharm's Dance 501 uses liquid insulin which is vaporized by the electronic gadgetry inside that black housing. Dance Biopharm claims using liquid insulin will reduce the cough and other respiratory side effects seen with powdered insulin.
Dance Biopharm recently completed a phase II study of Dance 501 in type 2 diabetics. A phase III study in type 2 diabetics is planned. This puts them well behind MannKind, which is waiting for an FDA approval decision for Afrezza, expected on or before July 15. In its S-1 filing with the SEC, Dance Biopharm says it will try to seek U.S. approval for Dance 501 by submitted a 505(b)2 application, which would allow the company to run a single phase III study and rely (presumably) on efficacy and safety data from already-approved insulin. This might be a faster route to approval for Dance 501 but only if FDA allows it, which isn't clear.
Dance Biopharm is run by John Patton, a co-founder of Nektar Therapeutics (NKTR - Get Report), which along with Pfizer (PFE), developed the Exubera inhaled insulin device. Exubera was a commercial flop, as everyone remembers, so Dance Biopharm is Patton's shot at inhaled insulin redemption.
Investors willing to make a bet on inhaled insulin may also prefer Dance Biopharm over MannKind because the former's balance sheet is a lot cleaner. The years of delays and rescue financing required to keep Afrezza's development afloat has bloated MannKind's capital structure with debt and a small mountain of outstanding shares.