On February 18, 2021 Calliditas Therapeutics reported that Year-End Report, 2020 (Press release, Calliditas Therapeutics, FEB 18, 2021, View Source [SID1234576690])

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Positive Topline Results from Pivotal Phase 3 NefIgArd Trial
"On November 8, 2020, we announced positive topline readout of Part A of our Phase 3 pivotal trial, NefIgArd. The results were statistically significant and clinically relevant: proteinuria showed a 31% reduction versus baseline, a stronger effect than what was seen in the Phase 2b (27%), which is generally not expected when moving from Phase 2 to Phase 3. In addition, eGFR was stabilised in the treated patient population, which in the end is the true treatment goal. This potentially disease modifying effect is to our knowledge unique to Nefecon, which we find extremely exciting, and we look forward to our interactions with regulators during the year as we progress towards potential approval.

We also concluded the purchase of a controlling block in Genkyotex in Q4. This is a company we had followed and where we found the clinical data intriguing and their approach clearly differentiated. Genkyotex had positive interactions with the FDA in 2020, which resulted in an adaptive pivotal Phase 2/3 design in PBC and they also initiated a Phase 1 PK study to look into higher dosing, which read out positively in early 2021. We feel excited about taking on a pioneering role in the area of NOX inhibitors and to initiate studies in PBC, as well as on the basis of comprehensive and compelling animal-based data launch a proof of concept trial in head and neck cancer where today’s immunotherapy has limited reach."

Renée Aguiar-Lucander, CEO

Summary of Q4 2020
October 1 – December 31, 2020

Net sales amounted to SEK 0.4 million and SEK 46.6 million for the three months ended December 31, 2020 and 2019, respectively.
Operating loss amounted to SEK 135.9 million and SEK 18.0 million for the three months ended December 31, 2020 and 2019, respectively.
Loss before income tax amounted to SEK 173.3 million and SEK 23.0 million for the three months ended December 31, 2020 and 2019, respectively.
Loss per share before and after dilution amounted to SEK 3.41 and SEK 0.60, for the three months ended December 31, 2020 and 2019, respectively.
Cash amounted to SEK 996.3 million and SEK 753.5 million as of December 31, 2020 and 2019, respectively
Significant events during Q4 2020, in summary
In November 2020, Calliditas announced positive topline results from Part A from the pivotal Phase 3 NefIgArd trial.
In November 2020, Calliditas acquired a controlling interest in Genkyotex SA followed by a simplified mandatory offer to the shareholders of Genkyotex, after which Calliditas controlled 86.2 percent of the shares in Genkyotex.
Significant events after the end of reporting period, in summary
In January 2021, Calliditas shared the clinical development plan for setanaxib and additional data from Part A of the NefIgArd study at the R&D Day.
Investor Presentation February 18, 14:30 CET
Audio cast with teleconference, Q4 2020, February 18, 2021, 14:30 (Europe/Stockholm)

Webcast: View Source

Teleconference: SE: +46850558356 UK: +443333009262 US: +18338230586

Financial calendar
Publication of the Annual Report 2020 April 27, 2021

Interim Report for the period January 1 – March 31, 2021 May 13, 2021

Interim Report for the period January 1 – June 30, 2021 August 19, 2021

Interim Report for the period January 1 – September 30, 2021 November 18, 2021

Year-end Report for the period January 1 – December 31, 2021 February 24, 2022

The information in the press release is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 07:00 CET on February 18, 2021.