Inhaled insulin developer Dance Biopharm withdraws IPO - October 27, 2014

Inhaled insulin developer Dance Biopharm recently withdrew its planned IPO, originally filed in early April and amended in May. Dance’s product, Dance 501, is designed to deliver a liquid recombinant human insulin formulation at mealtimes through a small handheld electronic inhaler. At the time of of the amended IPO filing in May, the company planned to conduct two phase 3 trials to support approval of Dance 501: a one-year study in ~1,000 adults with type 2 diabetes and a six-month trial in ~600 adults with type 1. Based on the most recent feedback from the FDA, the plan is to begin the phase 3 study in type 2 in late 2015. Dance had originally planned to pursue the 505(b)(2) pathway, but a recent round of regulatory feedback has now suggested the traditional NDA route is easier. As we understand it, two factors played into Dance’s decision to withdraw its IPO: (i) its bankers and investors wanted to wait for key Afrezza milestones (e.g., a very positive FDA advisory committeeFDA approval, and the commercialization partnership with Sanofi) to substantiate the market potential of inhaled insulin; and (ii) the company is still gaining some clarity on its regulatory pathway and requirements. We assume Dance will seek further private funding and potentially seek to IPO at some point in the future.