Calliditas Therapeutics' 2022 Annual Report Published

Rhea-AI Summary

Calliditas Therapeutics AB has published its 2022 Annual Report, now available on the company's website. The report details the company's focus on developing treatments for orphan diseases, particularly renal and hepatic conditions. The lead product, Nefecon, under the trade names TARPEYO and Kinpeygo, has received FDA accelerated approval and conditional marketing authorization in Europe. Calliditas is also conducting advanced clinical trials for its product candidate setanaxib. This release complies with the Securities Markets Act, emphasizing the regulatory framework surrounding Calliditas' operations and its ongoing commitment to innovation in the biopharma sector.

Positive

• Nefecon (TARPEYO, Kinpeygo) has received accelerated and conditional approvals, enhancing market potential.
• Calliditas is actively conducting Phase 2b/3 and Phase 2 clinical trials, indicating ongoing product development.

Negative

• None.

STOCKHOLM, April 26, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) today announces that the Annual Report for 2022 now is available at the company's website: www.calliditas.com

For further information, please contact:

Åsa Hillsten, Head of Investor Relations, Calliditas Therapeutics AB

Phone: +46 764 03 35 43

E-mail: asa.hillsten@calliditas.com

This information is information that Calliditas Therapeutics AB is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication at 21:00 CET on April 26, 2023.

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 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/3 clinical trial in primary biliary cholangitis and a Phase 2 proof-of-concept trial in head and neck cancer 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, 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, operations, continued and additional regulatory approvals for TARPEYO and Kinpeygo, market acceptance of TARPEYO and Kinpeygo, clinical trials, supply chain, 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.

The following files are available for download:

https://mb.cision.com/Main/16574/3758844/2015485.pdf	Calliditas AR 2022_EN
https://mb.cision.com/Public/16574/3758844/b78c6066b4e9de54.pdf	Calliditas Therapeutics 2022 Annual Report Published

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SOURCE Calliditas Therapeutics

FAQ

What does the 2022 Annual Report of Calliditas Therapeutics include?

The 2022 Annual Report details the company's focus on orphan diseases and includes information on product approvals and clinical trials.

What is the significance of TARPEYO and Kinpeygo for Calliditas Therapeutics?

TARPEYO and Kinpeygo are key products for Calliditas, having received FDA accelerated approval and conditional marketing authorization in Europe.

When was the 2022 Annual Report of Calliditas published?

The 2022 Annual Report was published on April 26, 2023.

What clinical trials is Calliditas currently conducting?

Calliditas is conducting a Phase 2b/3 clinical trial for primary biliary cholangitis and a Phase 2 trial for head and neck cancer with setanaxib.