STOCKHOLM, Feb. 18, 2021 /PRNewswire/ -- "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:
https://tv.streamfabriken.com/calliditas-therapeutics-q4-2020
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
For further information, please contact:
Renée Aguiar-Lucander, CEO at Calliditas
Email: renee.lucander@calliditas.com
Mikael Widell, Investor
Relations
Email: mikael.widell@calliditas.com
Telephone: +46 703 11 99 60
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.
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.
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/calliditas-therapeutics/r/year-end-report--2020,c3289180
The following files are available for download:
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SOURCE Calliditas Therapeutics