Calliditas has filed to raise SEK 650 million ($75 million) through an IPO in Sweden. The financing will set Calliditas up to start enrolling autoimmune kidney disease patients in a pivotal trial later this year.
Sweden-based Calliditas’ lead drug is Nefecon, an oral formulation of the corticosteroid budesonide. The formulation is designed to get the active ingredient to B cells in the ileum and control the output of IgA antibodies. In doing so, Calliditas thinks Nefecon can stop the accumulation of the antibodies in the kidneys of patients with IgA nephropathy, thereby improving the function of the organ.
“This is the only drug, as far as we're aware, that's being developed to focus on the origin of the disease. By treating this locally in the gut ..., we're actually able to get an effect in the kidney, which is ultimately the organ that is affected and is destroyed by autoimmune complexes that get stuck in its filtration mechanism,” Calliditas CEO Renee Aguiar-Lucander said.
Calliditas has put Nefecon through a phase 2b that linked the drug to a statistically significant drop in levels of proteinuria—a protein that indicates kidney damage—and stabilization of kidney function. That done, the biotech is now seeking cash to execute the next stage of its strategy.
The IPO will offer more than 14 million shares at SEK 45 a piece, setting Calliditas up for a gross haul of SEK 650 million. Existing shareholders have committed to buy up around one-sixth of the offering. An over-allotment could add close to SEK 100 million to the total.
If the IPO goes according to plan, Calliditas will emerge with the money to start enrolling patients in a pivotal, 19-country phase 3 trial later this year. The trial mostly replicates the design of the phase 2b. If over nine months of daily doses Nefecon performs as well as in the phase 2b, Calliditas will file for FDA approval under the 505(b)(2) pathway. Calliditas plans to partner Nefecon in other territories.
In anticipation of going it alone in the U.S., Calliditas will funnel around one-fifth of the IPO haul into market access preparations, health economics and other factors key to commercial success. The work will set Calliditas up to make the case that Nefecon is good value to payers and patients with IgA nephropathy, who are currently treated with blood pressure lowering agents and off-label steroids.