Full Press Release Details
Interim Report Q3, 2020
Expansion of pipeline and positive phase 3 topline data
"On August 13th, we announced a 19.8m acquisition
of a majority stake of 62.7% in Genkyotex, a publicly listed life science company in France. We are
very excited about this acquisition, which complements our existing and long-standing focus on inflammatory disease. This provides
us with a platform with anti-fibrotic and anti-inflammatory compounds, with which we believe can continue to address unmet medical
need in orphan diseases and bring solutions to patients across many different therapeutic areas. We believe that we have significant
opportunities to leverage this platform to the benefit of patients suffering from fibrotic diseases. We believe that the late stage
development, CMC and regulatory expertise which exists in Calliditas can significantly support and enhance the important fundamentals
put in place by Genkyotex. We are confident that this will be value driving, for all the company's stakeholders, over the near
After the close of the quarter, on November 8th, we reported
positive topline results from Part A of our pivotal Phase 3 trial, NefIgArd. The strong data set confirms the results seen in the
successful Phase 2b trial and provides further support for locally treating IgAN at the source, offering patients hope of disease
modification. We will now assemble the regulatory file and submit for accelerated approval with the FDA and conditional approval
with EMA, which is planned for Q1 and H1 respectively next year."
Ren e Aguiar-Lucander, CEO
July 1 - September 30, 2020
Significant events during Q3 2020, in summary
Significant events after the end of reporting period, in
Investor Presentation November 12, 14:30 CET
Audio cast with teleconference, Q3 2020, November 12, 2020,
14:30 (Europe/Stockholm)
Teleconference: SE: +46856642707 UK: +443333009034 US: +18332498405
| Year-end report for the period January 1 - December 31, 2020 | February 18, 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 |
For 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
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 November 12, 2020.
About Calliditas Therapeutics
Calliditas Therapeutics is a specialty
pharmaceutical company based in Stockholm, Sweden. It is focused on developing high quality pharmaceutical products for patients
with a significant unmet medical need in niche indications, in which the Company can partially or completely participate in the
commercialization efforts. The Company is focused on the development and commercialization of the product candidate Nefecon, a
unique two-step formulation optimized to combine a time lag effect with a concentrated release of the active substance budesonide,
within a designated target area. This patented, locally acting formulation is intended for treatment of patients with the inflammatory
renal disease IgA nephropathy (IgAN). Calliditas Therapeutics is running a global Phase 3 study within IgAN and aims to commercialize
Nefecon in the US. The company is listed on Nasdaq Stockholm (ticker: CALTX). Visit www.calliditas.com for further information.
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.