Calliditas Therapeutics' 2022 Annual Report Published

Rhea-AI Summary

On April 26, 2023, Calliditas Therapeutics announced the availability of its 2022 Annual Report on the company's website. The report provides insights into the company's performance, including developments in their lead product, Nefecon, which received FDA accelerated approval as TARPEYO® and conditional marketing authorization in the EU as Kinpeygo®. Additionally, Calliditas is advancing clinical trials for its NOX inhibitor product candidate, setanaxib, targeting primary biliary cholangitis and head & neck cancer. Contact for investor relations is Åsa Hillsten, available via phone or email. The company cautioned that the report contains forward-looking statements that are subject to risks and uncertainties regarding future performance.

Positive

• Publication of the 2022 Annual Report, providing transparency on operations and performance.
• Nefecon granted FDA accelerated approval and EU conditional marketing authorization, bolstering revenue potential.
• Progress in clinical trials for setanaxib, indicating ongoing development in promising areas.

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 is Calliditas Therapeutics' latest press release about?

Calliditas Therapeutics announced the availability of its 2022 Annual Report on April 26, 2023.

Where can I find the 2022 Annual Report for Calliditas Therapeutics?

The 2022 Annual Report can be found on Calliditas Therapeutics' official website.

What product did Calliditas receive FDA approval for?

Calliditas received FDA accelerated approval for Nefecon, now branded as TARPEYO®.

What clinical trials is Calliditas currently conducting?

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

What are the stock symbols for Calliditas Therapeutics?

Calliditas Therapeutics trades under the symbols CALT on Nasdaq and CALTX on Nasdaq Stockholm.