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: November 30, 2023
(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 is a copy of an announcement published by Calliditas
Therapeutics AB on November 30, 2023.
The information contained in this Form 6-K, including Exhibit 99.1,
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: November 30, 2023 |
By: |
/s/ Fredrik Johansson |
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Fredrik Johansson
Chief Financial Officer |
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Exhibit 99.1
![](https://www.sec.gov/Archives/edgar/data/1795579/000110465923122416/tm2331840d1_ex99-1img01.jpg)
Stockholm, Sweden | | November
30, 2023 |
Calliditas initiates clinical study to evaluate setanaxib
in Alport Syndrome
Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm:
CALTX) (“Calliditas”) today announced the initiation of a Phase 2 clinical study to evaluate setanaxib in Alport syndrome.
Calliditas is a company focused
on developing and commercializing novel treatments in rare diseases with significant unmet medical needs.
This randomized, double-blind, placebo-controlled
study will evaluate setanaxib in approximately 20 patients with a genetic diagnosis of Alport syndrome and significant proteinuria despite
treatment with a renin- angiotensin system (RAS) blocker. The duration of treatment is 24 weeks. The objective is to evaluate the safety
and tolerability of setanaxib in patients with Alport syndrome, as well as the effect of setanaxib on UPCR and eGFR compared to placebo.
“There
is an urgent clinical need in Alport syndrome for treatments that delay the progression to kidney failure,” said Dr Rachel Lennon,
Professor of Nephrology and Honorary Consultant Pediatric Nephrologist, University of Manchester (UK), and Coordinating Investigator for
the study. “Alport syndrome can occur as early as the teenage years, when it causes major disruption to learning and education.
Clinical trials allow new treatments such as setanaxib to be evaluated for safety and effectiveness in Alport syndrome.”
Setanaxib is also being evaluated in Phase 2 studies in squamous
cell carcinoma of the head and neck, primary biliary cholangitis, and idiopathic pulmonary fibrosis.
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 November 30, 2023 at 8:30 a.m. CET.
![](https://www.sec.gov/Archives/edgar/data/1795579/000110465923122416/tm2331840d1_ex99-1img01.jpg)
About Calliditas
Calliditas Therapeutics is a commercial stage 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, developed under the
name Nefecon®, has been granted accelerated approval by the US FDA under the trade name TARPEYO® and conditional marketing authorization
by the European Commission under the trade name Kinpeygo®. Kinpeygo is being commercialized in the European Union Member States by
Calliditas’ partner, STADA Arzneimittel AG. Additionally, Calliditas is conducting a Phase 2b clinical trial in primary biliary
cholangitis, a Phase 2 proof-of- concept trial in head and neck cancer, and a Phase 2a trial in Alport syndrome with its NOX inhibitor
product candidate, setanaxib. 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).
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, clinical development plans, business plans, and regulatory submissions. 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 (including as to the timing of the
Company’s clinical trial of setanaxib in Alport syndrome), strategy, goals and anticipated timelines, competition from other
biopharmaceutical companies, revenue and product sales projections or forecasts 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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