Full Press Release Details
Interim Report Q1, 2021
Filing of New Drug Application submission to the FDA
"Following the positive top line readout of our pivotal Phase
3 trial NefIgArd, which met both the primary and key secondary endpoints with results being statistically significant and clinically relevant
we commenced the regulatory filing process which ultimately resulted in the timely filing of the submission to the FDA in Q1 as planned.
In April, we received the response from the Food and Drug Administration (FDA) who accepted the submission and granted Priority Review
for the New Drug Application (NDA) for Nefecon. The FDA have set a Prescription Drug User Fee Act (PDUFA) goal date of September 15, 2021.
During Q1, we also submitted a request for accelerated assessment to the EMA, which was granted on April 23rd. These grants reflect the
perceived unmet medical need in IgAN by regulators and, in my view, also the strength and overall quality of our dossier.
In Q1, we also reported positive data from the Phase 1 study of setanaxib,
our lead compound in our NOX inhibition pipeline, paving the way for the use of higher dosing in the pivotal Phase 2/3 study in PBC. We
also hosted an R&D day in January where we laid out the clinical development strategy for the year, presenting the plans for our PBC
study as well as the Phase 2b proof of concept study in head and neck cancer, both slated to start in the second half of 2021. The substantial
preclinical work that has been generated shows compelling data regarding setanaxib's impact on CAF (cancer associated fibroblasts),
paving the way for a significantly improved reach of checkpoint inhibitors.
We also significantly built our US team during the quarter, adding
a Head of Marketing, VP Medical Affairs and Head of Sales. We will continue to build our team in order to be ready to commercialize in
Ren e Aguiar-Lucander, CEO
January 1 - March 31, 2021
| No net sales for the three months ended March 31, 2021 were recognized. For the three months ended March 31, 2020 net sales amounted to SEK 0.5 million. | ||
| Operating loss amounted to SEK 150.8 million and SEK 72.3 million for the three months ended March 31, 2021 and 2020, respectively. | ||
| Loss before income tax amounted to SEK 136.2 million and SEK 63.7 million for the three months ended March 31, 2021 and 2020, respectively. | ||
| Loss per share before and after dilution amounted to SEK 2.51 and SEK 1.65, for the three months ended March 31, 2021 and 2020, respectively. | ||
| Cash amounted to SEK 867.3 million and SEK 728.6 million as of March 31, 2021 and 2020, respectively. |
Significant events during Q1 2021, in summary
Significant events after the end of reporting period, in summary
Investor presentation May 18, 14:30 CET
Audio cast with teleconference, Q1 2021, May 18, 2021, 14:30 (Europe/Stockholm)
Teleconference: SE: +46850558366 UK: + 443333009271 US: 18335268381
| 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:
Ren e Aguiar-Lucander, CEO at Calliditas
Mikael Widell, Investor Relations
Email: mikael.widell@calliditas.com
Telephone: +46 703 11 99 60
The information was submitted for publication,
through the agency of the contact persons set out above, at 07:00 CET on May 18, 2021.
About Calliditas Therapeutics
Calliditas Therapeutics is a biopharma 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 adults with the autoimmune
renal disease primary IgA nephropathy (IgAN), for which there is a high unmet medical need and there are no approved treatments. Calliditas
has recently read out topline data from Part A of its global Phase 3 study in IgAN and, if approved, aims to commercialize Nefecon in
the United States. Calliditas is also planning to start clinical trials with NOX inhibitors in primary biliary cholangitis and head and
neck cancer. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select Market (ticker: CALT). Visit www.calliditas.com
for further information.
Forward-Looking Statements
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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"
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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'
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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.