UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report: July 26, 2024
(Commission File No. 001-39308)
CALLIDITAS THERAPEUTICS AB
(Translation of registrant’s name into
English)
Kungsbron 1, D5
SE-111 22
Stockholm, Sweden
(Address of registrant’s principal executive office)
Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form 20-F x
Form 40-F ¨
INFORMATION CONTAINED IN THIS REPORT ON FORM
6-K
Enclosed hereto are copies of announcements published by Calliditas
Therapeutics AB on July 26, 2024.
The information contained in this Form 6-K, including Exhibit 99.1
and 99.2, is hereby incorporated by reference into the registrant’s Registration Statements on Form F-3 (File No. 333-265881) and
Form S-8 (File Nos. 333-240126 and 333-272594).
EXHIBIT INDEX
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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CALLIDITAS THERAPEUTICS AB |
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| Date: July 26, 2024 |
By: |
/s/ Fredrik Johansson |
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|
Fredrik Johansson |
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Chief Financial Officer |
Exhibit 99.1
| Stockholm, Sweden |
July 26, 2024 |
Calliditas announces
positive TRANSFORM Phase 2b topline data in primary biliary cholangitis
Calliditas
Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that the Phase 2b TRANSFORM trial
met its primary endpoint, showing statistically significant improvement in ALP (Alkaline Phosphatase) for both doses tested
versus placebo. The trial evaluated setanaxib, a NOX enzyme inhibitor, in patients with primary biliary cholangitis (PBC) and
elevated liver stiffness.
The TRANSFORM trial is a
double-blind, randomized, placebo-controlled Phase 2b study investigating the effect of setanaxib 800 mg AM + 400 mg PM,
(“1200 mg arm”) and 800 mg BID (“1600 mg arm”) over 24 weeks of treatment. The basis for the analysis
consisted of a dataset of 76 patients with primary biliary cholangitis (PBC) and elevated liver stiffness.
The treatment groups were
relatively well-balanced with no clinically relevant differences between the groups observed at baseline. The result is particularly
encouraging as over 40% of the trial population was on dual therapy, ie was receiving UDCA (ursodeoxycholic acid) and either Ocaliva
(obeticholic acid) or Bezafibrate (PPAR agonist) as base therapy and 13% were receiving all three therapies during the study, reflecting
setanaxib having clinically relevant incremental benefit beyond existing standard of care. Patients treated with setanaxib showed statistically
significant improvements in the primary endpoint of ALP of 19% in the 1600mg arm and 14% in the 1200mg arm and showed positive trends
on liver stiffness assessed by FibroScan® at 24 weeks. Setanaxib treatment was generally well tolerated with overall number of TEAEs
(treatment emergent adverse events), as well as serious TEAEs, being similar between active treatment and placebo. The frequency
of TEAEs leading to study discontinuation was higher in patients receiving active treatment compared to placebo.
“It is very encouraging
to see a statistically significant treatment effect in this hard-to-treat population which is already on multiple medications in this
relatively small study,” said Professor Dave Jones OBE; Director, NHIP Academy; Director, Newcastle Centre for Rare Disease; Professor
of Liver Immunology, Newcastle University; and Honorary Consultant Hepatologist, Newcastle upon Tyne Hospitals.
“These positive data
provide further clinical evidence of the potential of setanaxib in multiple rare diseases, and we are very pleased that we now have additional
positive clinical evidence in support of our unique, first in class NOX platform. We also look forward to the read out of the investigator
led study in IPF as well as the ongoing study in Alport syndrome in due course.” said CEO Renée Aguiar-Lucander.
“I am delighted that
we have seen statistically significant and clinically meaningful improvements in ALP with encouraging trends in other outcomes in this
population of patients with PBC. I’d like to extend my thanks to investigators, clinical trial site staff, and most importantly
patients, who have all contributed to this important study.” said CMO Richard Philipson.
The company is conducting
additional clinical trials with setanaxib and is expecting the investigator led Phase 2 trial in IPF (idiopathic pulmonary fibrosis)
to provide top line data in Q4 2024 / Q1, 2025. There is also an ongoing Phase 2 proof of concept trial in Alport syndrome, which is
expected to deliver top line data in 2025.
For further information,
please contact:
Åsa Hillsten, Head of
IR & Sustainability, Calliditas
Tel.: +46 76 403 35 43, Email:
asa.hillsten@calliditas.com
The information was sent
for publication, through the agency of the contact persons set out above, on July 26, 2024 at 08:00 a.m. CET.
About Primary biliary
cholangitis (PBC)
PBC is a progressive and chronic
autoimmune disease of the liver that causes immune injury to biliary epithelial cells, resulting in cholestasis and fibrosis. It is an
orphan disease and, based on its known prevalence rates, we estimate that there are approximately 140,000 patients in the United States,
where the annual incidence ranges from 0.3 to 5.8 cases per 100,000.
About Calliditas
Calliditas Therapeutics is
a biopharma company headquartered in Stockholm, Sweden, focused on identifying, developing, and commercializing novel treatments in orphan
indications with significant unmet medical needs. Calliditas’ common shares are listed on Nasdaq Stockholm (ticker: CALTX) and
its American Depositary Shares are listed on the Nasdaq Global Select Market (ticker: CALT). Visit 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, commercialization efforts, business plans,
regulatory submissions, clinical development plans, revenue and product sales projections or forecasts 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 and operations, the presumed mechanism of action of setanaxib, the safety and
efficacy of setanaxib in PBC or other potential indications, anticipated timelines and other risks identified in the section
entitled “Risk Factors” in Calliditas’ reports filed with the Securities and Exchange Commission. The results of
early clinical trials may not predict those of future, later-stage clinical trials. The clinical data presented herein involves a
limited number of patients, and these results may not be replicated in larger clinical trials. 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.
Exhibit 99.2
| Stockholm, Sweden |
July 26, 2024 |
Calliditas partner STADA
receives European Commission decision for full approval of Kinpeygo® for the treatment of IgA Nephropathy
Calliditas Therapeutics
AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that the European Commission has granted a full
marketing authorization for Kinpeygo for the treatment of adults with primary immunoglobulin A nephropathy (IgAN).
The European Commission has
granted a full marketing authorization of Kinpeygo®. The granting of the full approval results in a significantly broader label
for patients with primary IgAN, moving from a urine protein excretion (UPCR) limitation of > 1.5g/g to encompassing the entire study
population, defined as UPCR of ≥ 0.8g/g, or proteinuria of ≥1.0 g/g over 24 hours. This expanded label is based on
full two-year data set from the Phase 3 NefIgArd clinical trial, published in leading medical journal The Lancet (1).
“This is an important
event for patients suffering from IgAN in Europe as Kinpeygo represents the first ever fully approved medication for this
rare kidney disease. The long-term confirmatory trial met its eGFR endpoint with high statistical significance and we are
delighted that the European Commission has granted a full approval for the broader population” said Renee Aguiar-Lucander, CEO.
Kinpeygo is marketed in in
the EU and UK exclusively by Calliditas’ commercial partner, STADA Arzneimittel AG. The full marketing authorization for Kinpeygo
covers the European Union (EU) member states as well as Iceland, Norway and Liechtenstein. Also, Kinpeygo’s status as an orphan
drug for a rare disease, subject to 10- year market exclusivity running until 2032, was confirmed by the Commission.
This approval triggers a milestone
payment of ten million EUR to Calliditas, which will be recognized as revenue in the third quarter.
| 1) | Efficacy
and safety of a targeted-release formulation of budesonide in patients with primary IgA nephropathy
(NefIgArd): 2-year results from a randomized phase 3 trial - The Lancet |
For further information,
please contact:
Åsa Hillsten, Head of
IR & Sustainability, Calliditas
Tel.: +46 76 403 35 43, Email:
asa.hillsten@calliditas.com
The information was sent
for publication, through the agency of the contact person set out above, on July 26, 2024 at 5 p.m. CET.
About Calliditas
Calliditas Therapeutics is
a biopharma company headquartered in Stockholm, Sweden, focused on identifying, developing, and commercializing novel treatments in orphan
indications with significant unmet medical needs. Calliditas’ common shares are listed on Nasdaq Stockholm (ticker: CALTX)
and its American Depositary Shares are listed on the Nasdaq Global Select Market (ticker: CALT). Visit 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, commercialization efforts, business plans, regulatory submissions,
clinical development 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, continued market acceptance of Kinpeygo, clinical trials, supply chain, strategy, goals and anticipated
timelines, competition from other biopharmaceutical companies, and other risks identified in the section entitled “Risk Factors”
in 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.
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