Sweden's Calliditas seeks $75M IPO haul to bring its oral steroid to patients with an orphan kidney disease
As biotech after biotech elicits enthusiastic investor support for this corner of the IPO market, a Swedish player is joining the Nasdaq line to fund the last leg of its clinical journey.
Calliditas Therapeutics is eyeing a $75 million raise, a modest sum compared to some of the bigger public debuts we’ve seen in recent days — but they could well upsize the offering like other small, obscure companies before them have done.
The pitch centers around the drug that Calliditas was founded on: Nefecon, an oral formulation of the corticosteroid budesonide. After licensing it from Bengt Fellström and Roger Hällgren at Uppsala University, the biotech stayed laser-focused on an orphan autoimmune renal disease known as IgA nephropathy, or IgAN. By suppressing the immune reaction, the hope is that Nefecon can keep patients from progressing to end-stage renal disease.
Having divided the ongoing Phase III trial into two parts, Calliditas is planning to seek accelerated approval if the drug hits the primary endpoint on proteinuria — a biomarker indicating protein in disease — in Part A. Part B would then confirm the clinical benefit of Nefecon post-approval.
In Phase IIb, the company noted, the drug-induced stabilization of kidney function compared to placebo among 150 patients.
The first cut of Phase III data, from 19 sites around the world, is expected in the fourth quarter of this year, setting up an NDA filing for the first half of 2021 and a launch in 2022..
“Although recruitment in the first quarter of 2020 for Part B of NefIgArd exceeded our plans, recruitment rates have slowed and we expect a reduced recruitment rate over the next several months due to the impact of the COVID-19 pandemic,” an SEC filing read. “However, based on existing enrollment in Part B and expected complementary recruitment activities in China, we continue to expect to report data from Part B in 2022.”
While Calliditas intends to commercialize in the US on its own with an initial salesforce of 40 — Andrew Udell, the VP of North America commercial, will be in charge of that — Everest Medicines has paid $15 million upfront to grab the rights in China and Singapore. Regional deals for Europe will follow.
Scandinavian investors made up most of the syndicate, with Stiftelsen Industrifonden (14.91%), Linc AB (12.49%) and Investinor AS (10.67%) ranking as the top shareholders.
CEO Renée Aguiar-Lucander, also holds 1.05% of the stock, the breakdown of which is clearly displayed in her biography on the Calliditas website. This marks the former investment banker and seasoned venture capitalist’s first go on the frontlines of biotech.