Full Press Release Details
Year-End Report, 2020
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.
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."
Ren e Aguiar-Lucander, CEO
October 1 - December 31, 2020
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
Investor Presentation February 18, 14:30 CET
Audio cast with teleconference, Q4 2020, February 18, 2021,
14:30 (Europe/Stockholm)
Teleconference: SE: +46850558356 UK: +443333009262 US: +18338230586
| 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 |
further information, please contact:
Ren e Aguiar-Lucander, CEO at Calliditas
Mikael Widell, Investor Relations
Email: mikael.widell@calliditas.com
Telephone: +46 703 11 99 60
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
About Calliditas Therapeutics
Calliditas Therapeutics is a specialty
pharmaceutical company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan
indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas' lead product
candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant,
for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there
are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon
in the United States. Calliditas is also planning to conduct clinical trials with NOX inhibitors in PBC and oncology. Calliditas
is listed on Nasdaq Stockholm (ticker: CALTX) and The Nasdaq Global Select Market (ticker: CALT).
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation,
statements regarding Calliditas' strategy, business plans and focus. The words "may," "will," "could,"
"would," "should," "expect," "plan," "anticipate," "intend,"
"believe," "estimate," "predict," "project," "potential," "continue,"
"target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking
statements contain these identifying words. Any forward-looking statements in this press release are based on management's
current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual
events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press
release, including, without limitation, any related to Calliditas'' business, operations, clinical trials, supply chain,
strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, and other risks identified in the
section entitled "Risk Factors" Calliditas' reports filed with the Securities and Exchange Commission. Calliditas
cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Calliditas
disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions
or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from
those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Calliditas''
views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.