Launch of Phase 3 clinical trial with Nefecon in Japan

Stockholm, Sweden July 04, 2024

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announces that its partner Viatris Pharmaceutical Japan G.K.("Viatris") has initiated a phase III clinical trial in Japan with Nefecon, named VR-205 in the Japanese market, in Japanese patients with IgA nephropathy (IgAN).

The clinical trial is a bridging study requiring a limited number of Japanese patients to participate in a study similar in design to that of the global NefIgArd trial. IgA nephropathy is a designated retractable disease in Japan, with an estimated 33,000 patients in Japan* assumed to be suffering from this disease and with limited treatment options for IgAN patients in this country.

Calliditas Therapeutics announces license agreement with Viatris to register and commercialize specialty therapy for IgA nephropathy in Japan - Calliditas Therapeutics AB

*Japan Intractable Disease Information Center

Åsa Hillsten, Head of IR & Sustainability, Calliditas

Tel.: +46 76 403 35 43, Email: [email protected]

The information was sent for publication, through the agency of the contact persons set out above, on July 4, 2024 at 08:30 a.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 the development of Calliditas' pipeline. 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 the timing of Viatris phase III clinical trial in Japan with Nefecon in Japanese patients with IgA nephropathy), 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.