1. STOCKHOLM, Sept. 16, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas" or the "Company") (Nasdaq Stockholm: CALTX) (NASDAQ:CALT), a biopharma company focused on identifying, developing and commercializing novel treatments in orphan indications, today announced that the European Medicine Agency's (EMA) Committee for Human Medicinal Products (CHMP)) has decided to continue the assessment of the marketing authorization application (MAA) for Nefecon under standard procedure assessment timelines.

    Calliditas was in April, 2021 granted an accelerated assessment procedure on its MAA for Nefecon in IgA Nephropathy and submitted the MAA in May of 2021. With the revised standard assessment timeline Calliditas estimates a potential impact…

    STOCKHOLM, Sept. 16, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas" or the "Company") (Nasdaq Stockholm: CALTX) (NASDAQ:CALT), a biopharma company focused on identifying, developing and commercializing novel treatments in orphan indications, today announced that the European Medicine Agency's (EMA) Committee for Human Medicinal Products (CHMP)) has decided to continue the assessment of the marketing authorization application (MAA) for Nefecon under standard procedure assessment timelines.

    Calliditas was in April, 2021 granted an accelerated assessment procedure on its MAA for Nefecon in IgA Nephropathy and submitted the MAA in May of 2021. With the revised standard assessment timeline Calliditas estimates a potential impact of 3 months on the previously communicated timelines with an expected decision by EMA in the first quarter, 2022.

    "This is the first time that EMA is assessing an application for conditional approval in IgA nephropathy and we acknowledge the need for an in depth review under standard assessment timelines.  We look forward to engaging with the agency to achieve a potential approval for this very deserving patient population as soon as possible." said Renée Aguiar-Lucander, CEO at Calliditas.

    If approved, Nefecon could be available to patients in Europe in mid-2022 and would become the first therapy specifically designed and approved for the treatment of IgAN, and which has the potential to be disease modifying.

    For further information, please contact:

    Renée Aguiar-Lucander, CEO at Calliditas

    E-mail: renee.lucander@calliditas.com

    Marie Galay, Corporate Communications and IR

    Tel.: +44 7955 129 845, e-mail: marie.galay@calliditas.com

    The information in the press release is inside information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons above, on September 16, 2021 at 14:30 (CEST).

    About Calliditas  

    Calliditas Therapeutics is a 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of adults with the autoimmune renal disease primary IgA nephropathy (IgAN), for which there is a high unmet medical need and there are no approved treatments. Calliditas read out topline data from Part A of its global Phase 3 study in IgAN in November 2020 and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to start clinical trials with NOX inhibitors in primary biliary cholangitis and head and neck cancer. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ: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, business 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, the potential for and timing of EMA approval of its regulatory marketing application for Nefecon, 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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  2. STOCKHOLM, Sept. 14, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas" or the "Company") (Nasdaq Stockholm: CALTX) (Nasdaq – CALT), a biopharma company focused on identifying, developing and commercializing novel treatments in orphan indications, today announced that the U.S. Food and Drug Administration (FDA) has extended the PDUFA goal date for its New Drug Application (NDA) seeking accelerated approval for Nefecon to December 15, 2021.

    In March 2021 Calliditas filed for FDA approval using the Accelerated Approval Program, based on the proteinuria endpoint as previously discussed with the Agency, reflecting data from the 200 patients in Part A of the NefIgArd trial.

    In its review of the NDA, the FDA has requested further…

    STOCKHOLM, Sept. 14, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas" or the "Company") (Nasdaq Stockholm: CALTX) (Nasdaq – CALT), a biopharma company focused on identifying, developing and commercializing novel treatments in orphan indications, today announced that the U.S. Food and Drug Administration (FDA) has extended the PDUFA goal date for its New Drug Application (NDA) seeking accelerated approval for Nefecon to December 15, 2021.

    In March 2021 Calliditas filed for FDA approval using the Accelerated Approval Program, based on the proteinuria endpoint as previously discussed with the Agency, reflecting data from the 200 patients in Part A of the NefIgArd trial.

    In its review of the NDA, the FDA has requested further analyses of the NeflgArd trial data which the company has provided to the FDA. The Agency has classified these analyses as a major amendment to the NDA. The amendment mainly provides additional eGFR and other related analyses as further support of the proteinuria data provided in the NDA submission. The FDA has therefore extended the PDUFA goal date to December 15, 2021.

    "Our NDA for Nefecon is the first time that the FDA is considering an approval on the basis of proteinuria as a surrogate endpoint for accelerated approval in IgA nephropathy, requiring an in-depth review process. We will continue to cooperate closely with the FDA as they complete the review of our NDA," said Renée Aguiar-Lucander, CEO at Calliditas.

    For further information, please contact:

    Renée Aguiar-Lucander, CEO at Calliditas

    E-mail: renee.lucander@calliditas.com

    Marie Galay, Corporate Communications and IR

    Tel.: +44 7955 129 845, e-mail: marie.galay@calliditas.com

    The information in the press release is inside information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons above, on September 14, 2021 at 3:10 pm ET.

    About Calliditas  

    Calliditas Therapeutics is a 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of adults with the autoimmune renal disease primary IgA nephropathy (IgAN), for which there is a high unmet medical need and there are no approved treatments. Calliditas read out topline data from Part A of its global Phase 3 study in IgAN in November 2020 and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to start clinical trials with NOX inhibitors in primary biliary cholangitis and head and neck cancer. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ: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, business 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, the potential for and timing of FDA approval of its regulatory marketing application for Nefecon, the potential for FDA's review extension on the NDA for Nefecon to lead to marketing approval, 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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  3. STOCKHOLM, Aug. 31, 2021 /PRNewswire/ -- During August, the number of shares and votes in Calliditas Therapeutics AB (publ) has increased due to the directed share issue of 2,400,000 new shares that the company carried out on August 12, 2021. Thus, as of August 31, 2021, the number of shares and votes in the company amounts to 52,341,584.

    For further information, please contact:

    Mikael Widell, Investor relations

    Tel.: +46 703 11 99 60, email: mikael.widell@calliditas.com

    The information in the press release is such that Calliditas Therapeutics AB (publ) is required to disclose pursuant to the Swedish Financial Instruments Trading Act. The information was submitted for publication, through the agency of the contact persons set out above, at

    STOCKHOLM, Aug. 31, 2021 /PRNewswire/ -- During August, the number of shares and votes in Calliditas Therapeutics AB (publ) has increased due to the directed share issue of 2,400,000 new shares that the company carried out on August 12, 2021. Thus, as of August 31, 2021, the number of shares and votes in the company amounts to 52,341,584.

    For further information, please contact:

    Mikael Widell, Investor relations

    Tel.: +46 703 11 99 60, email: mikael.widell@calliditas.com

    The information in the press release is such that Calliditas Therapeutics AB (publ) is required to disclose pursuant to the Swedish Financial Instruments Trading Act. The information was submitted for publication, through the agency of the contact persons set out above, at 8:00 CEST on August 31, 2021.

    About Calliditas

    Calliditas Therapeutics is a 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of adults with the autoimmune renal disease primary IgA nephropathy (IgAN), for which there is a high unmet medical need and there are no approved treatments. Calliditas has recently read out topline data from Part A of its global Phase 3 study in IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to start clinical trials with NOX inhibitors in primary biliary cholangitis and head and neck cancer. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT).

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  4. STOCKHOLM, Aug. 19, 2021 /PRNewswire/ -- "Following the filing for accelerated approval with the FDA in Q1, we filed our submission for conditional approval with EMA in May. Both FDA and EMA applications are being processed on an accelerated basis and in the U.S our target PDUFA date is September 15th.

    During the 2nd quarter we significantly ramped up our pre commercial activities in the US following the strengthening of the team announced in Q1. We have added significant internal resources as well as entered into some key partnerships, in order to ensure that we are well positioned to initiate commercialization in Q4, subject to a positive outcome of the FDA approval process. 

    During Q2 we also explored avenues to non-dilutive financing by…

    STOCKHOLM, Aug. 19, 2021 /PRNewswire/ -- "Following the filing for accelerated approval with the FDA in Q1, we filed our submission for conditional approval with EMA in May. Both FDA and EMA applications are being processed on an accelerated basis and in the U.S our target PDUFA date is September 15th.

    During the 2nd quarter we significantly ramped up our pre commercial activities in the US following the strengthening of the team announced in Q1. We have added significant internal resources as well as entered into some key partnerships, in order to ensure that we are well positioned to initiate commercialization in Q4, subject to a positive outcome of the FDA approval process. 

    During Q2 we also explored avenues to non-dilutive financing by way of a competitive process in order to provide the company with access to additional capital in advance of, as well as post a potential regulatory approval. In parallel we also ran a successful competitive process focused on securing a strong European commercial partner for Nefecon. The result of these processes which was announced in Q3 resulted in over $100m of non- dilutive capital potentially being available to the company, divided between approximately $50m available pre-approval with the remainder becoming available post FDA and EMA approvals and subsequent US commercialization. These processes, together with the accelerated book building procedure raising approximately gross $37m (SEK 324 million) which we completed in Q3, have significantly enhanced our financial strength after the close of Q2."

    Renée Aguiar-Lucander, CEO

    Summary of Q2 2021

    April 1June 30, 2021

    • No net sales were recognized for the three months ended June 30, 2021 and 2020, respectively.
    • Operating loss amounted to SEK 159.4 million and SEK 66.6 million for the three months ended June 30, 2021 and 2020, respectively.
    • Loss before income tax amounted to SEK 165.2 million and SEK 61.3 million for the three months ended June 30, 2021 and 2020, respectively.
    • Loss per share before and after dilution amounted to SEK 3.20 and SEK 1.50 for the three months ended June 30, 2021 and 2020, respectively.
    • Cash amounted to SEK 709.3 million and SEK 1,459.6 million as of June 30, 2021 and 2020, respectively.

    Significant events during Q2 2021, in summary

    • In April 2021, Calliditas was granted accelerated assessment procedure by the European Medicine Agency's (EMA) Committee for Human Medicinal Products (CHMP) for Nefecon, reducing the maximum timeframe for review of the application for marketing authorization. If approved, Nefecon could be available to patients in Europe in first half of 2022.
    • In April 2021, Calliditas announced that the FDA accepted the submission and granted Priority Review for the NDA for Nefecon. The FDA have set a Prescription Drug User Fee Act (PDUFA) goal date of September 15, 2021. Subject to approval, this would enable commercialization of Nefecon in the US in Q4, 2021.
    • In May 2021, Calliditas announced that the company submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Nefecon.

    Significant events after the end of reporting period, in summary

    • In July 2021, Calliditas signed a loan facility of up to the EUR equivalent of $75 million with Kreos Capital.
    • In July 2021, Calliditas and STADA Arzneimittel AG entered into a license agreement to register and commercialize Nefecon in the European Economic Area (EEA) member states, Switzerland and the UK valued at a total of 97.5 million EUR ($115m) in initial upfront and potential milestone payments, plus royalties.
    • In August 2021, Calliditas received FDA fast track designation for setanaxib in PBC.
    • In August 2021, Calliditas completed an accelerated book building procedure and resolved on a directed share issue in the amount of 2.4 million shares, raising proceeds of SEK 324.0 million before transaction costs.

    Investor presentation August 19, 14:30 CET

    Audio cast with teleconference, Q2 2021, August 19, 2021, 14:30 (Europe/Stockholm)

    Webcast: https://tv.streamfabriken.com/calliditas-therapeutics-q2-2021

    Teleconference: SE: +46850558356 UK: +443333009266 US: +16467224903

    Financial calendar

    Interim Report for the period January 1September 30, 2021                   November 18, 2021

    Year-end Report for the period January 1December 31, 2021                  February 24, 2022

    For further information, please contact:

    Renée Aguiar-Lucander, CEO at Calliditas

    Email: renee.lucander@calliditas.com

    Mikael Widell, Investor Relations

    Email: mikael.widell@calliditas.com

    Telephone: +46 703 11 99 60

    The information was submitted for publication, through the agency of the contact persons set out above, at 07:00 CET on August 19, 2021.

    About Calliditas Therapeutics

    Calliditas Therapeutics is a 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of adults with the autoimmune renal disease primary IgA nephropathy (IgAN), for which there is a high unmet medical need and there are no approved treatments. Calliditas has recently read out topline data from Part A of its global Phase 3 study in IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to start clinical trials with NOX inhibitors in primary biliary cholangitis and head and neck cancer. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.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, business 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, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, and other risks identified in the section entitled "Risk Factors" 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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  5. NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES, AUSTRALIA, CANADA, JAPAN OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL OR WOULD REQUIRE REGISTRATION OR ANY OTHER MEASURES.

    STOCKHOLM, Sweden, Aug. 12, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas" or the "Company") (Nasdaq Stockholm: CALTX) (NASDAQ:CALT), a biopharma company focused on identifying, developing and commercializing novel treatments in orphan indications, today announced, in accordance with the Company's press release earlier today, the closing of a directed share issue consisting of 2,400,000 common shares at a price of SEK 135 per share (the "Issue").

    NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES, AUSTRALIA, CANADA, JAPAN OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL OR WOULD REQUIRE REGISTRATION OR ANY OTHER MEASURES.

    STOCKHOLM, Sweden, Aug. 12, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas" or the "Company") (Nasdaq Stockholm: CALTX) (NASDAQ:CALT), a biopharma company focused on identifying, developing and commercializing novel treatments in orphan indications, today announced, in accordance with the Company's press release earlier today, the closing of a directed share issue consisting of 2,400,000 common shares at a price of SEK 135 per share (the "Issue"). The Issue will raise proceeds for the Company of approximately SEK 324 million before transaction costs. The subscription price in the Issue has been determined through an accelerated book building procedure.

    The Issue in brief

    The Board of Directors of Calliditas has, in accordance with the issue authorization granted by the Annual General Meeting on May 27, 2021, and as indicated in the Company's press release on earlier today, resolved on a directed share issue of 2,400,000 new shares at a subscription price of SEK 135 per share, consequently raising gross proceeds of approximately SEK 324 million. The subscription price in the Issue has been determined through an accelerated book building procedure which is why the Board of Directors' assessment is that the subscription price is in accordance with market conditions. The reasons for the deviation from the shareholders' preferential rights are to raise capital for the development of ongoing projects in a time and cost-effective manner. Moreover, the Company will further strengthen the shareholder base with Swedish and international institutional investors and sector specialist investors through the Issue.

    The Company intends to use the net proceeds from the Issue for:

    i.            ongoing clinical development;

    ii.            pre-commercial development in the United States;

    iii.            commercial activities for Nefecon, if approved for marketing by the FDA later this year; and

    iv.            general corporate purposes.

    The Issue will entail a dilution of approximately 4.6 percent of the number of shares and votes in the Company. Through the Issue, the number of outstanding shares and votes will increase by 2,400,000, from 49,941,584 to 52,341,584. The share capital will increase by SEK 96,000, from SEK 1,997,663.36 to SEK 2,093,663.36.

    In connection with the Issue, the Company has agreed to a lock-up undertaking, with customary exceptions, on future share issuances for a period of 90 days. In addition, members of the Board of Directors and management of Calliditas, who owns shares or warrants, have, in connection with the Issue, agreed not to sell any shares in the Company during a lock-up period of 90 days subject to customary exceptions.

    Advisers

    In conjunction with the Issue, the Company has engaged Carnegie Investment Bank AB (publ) and  Jefferies GmbH as Joint Global Coordinators and Joint Bookrunners, and Kempen & Co as Joint Bookrunner (together the "Banks"). Vinge act as legal adviser to the Company and Baker McKenzie act as legal adviser to the Banks.

    For further information, please contact:

    Renée Aguiar-Lucander, CEO at Calliditas

    E-mail: renee.lucander@calliditas.com

    Marie Galay, Corporate Communications and IR

    Tel.: +44 7955 129 845, e-mail: marie.galay@calliditas.com

    The information in the press release is inside information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons above, on August 12, 2021 at 23:55 (CEST).

    About Calliditas  

    Calliditas Therapeutics is a 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of adults with the autoimmune renal disease primary IgA nephropathy (IgAN), for which there is a high unmet medical need and there are no approved treatments. Calliditas has recently read out topline data from Part A of its global Phase 3 study in IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to start clinical trials with NOX inhibitors in primary biliary cholangitis and head and neck cancer. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT).

    Important information

    The release, announcement or distribution of this press release may, in certain jurisdictions, be subject to restrictions. The recipients of this press release in jurisdictions where this press release has been published or distributed shall inform themselves of and follow such restrictions. The recipient of this press release is responsible for using this press release, and the information contained herein, in accordance with applicable rules in each jurisdiction. This press release does not constitute an offer, or a solicitation of any offer, to buy or subscribe for any securities in Calliditas in any jurisdiction, neither from Calliditas nor from someone else.

    This announcement does not identify or suggest, or purport to identify or suggest, the risks (direct or indirect) that may be associated with an investment in the new shares. Any investment decision in connection with the Directed Share Issue must be made on the basis of all publicly available information relating to the Company and the Company's shares. Such information has not been independently verified by the Joint Bookrunners. The information contained in this announcement is for background purposes only and does not purport to be full or complete. No reliance may be placed for any purpose on the information contained in this announcement or its accuracy or completeness. The Joint Bookrunners are acting for the Company in connection with the transaction and no one else and will not be responsible to anyone other than the Company for providing the protections afforded to its clients nor for giving advice in relation to the transaction or any other matter referred to herein.

    This announcement does not constitute a recommendation concerning any investor's option with respect to the Directed Share Issue. Each investor or prospective investor should conduct his, her or its own investigation, analysis and evaluation of the business and data described in this announcement and publicly available information. The price and value of securities can go down as well as up. Past performance is not a guide to future performance.

    This press release does not constitute or form part of an offer or solicitation to purchase or subscribe for securities in the United States. The securities referred to herein may not be sold in the United States absent registration or an exemption from registration under the US Securities Act of 1933, as amended (the "Securities Act"), and may not be offered or sold within the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. There is no intention to register any securities referred to herein in the United States or to make a public offering of the securities in the United States. The information in this press release may not be announced, published, copied, reproduced or distributed, directly or indirectly, in whole or in part, within or into Australia, Hong Kong, Japan, Canada, New Zeeland, Singapore, South Africa, the United States or in any other jurisdiction where such announcement, publication or distribution of the information would not comply with applicable laws and regulations or where such actions are subject to legal restrictions or would require additional registration or other measures than what is required under Swedish law. Actions taken in violation of this instruction may constitute a crime against applicable securities laws and regulations.

    This press release is not a prospectus for the purposes of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 (the "Prospectus Regulation") and has not been approved by any regulatory authority in any jurisdiction. Calliditas has not authorized any offer to the public of shares or rights in any member state of the EEA and no prospectus for an offering has been or will be prepared in connection with the Directed Share Issue. In any EEA Member State, this communication is only addressed to and is only directed at qualified investors in that Member State within the meaning of the Prospectus Regulation.

    In the United Kingdom, this document and any other materials in relation to the securities described herein is only being distributed to, and is only directed at, and any investment or investment activity to which this document relates is available only to, and will be engaged in only with, "qualified investors" who are (i) persons having professional experience in matters relating to investments who fall within the definition of "investment professionals" in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order"); (ii) high net worth entities falling within Article 49(2)(a) to (d) of the Order; or (iii) any other person to whom it may otherwise lawfully be communicated (all such persons together being referred to as "relevant persons"). In the United Kingdom, any investment or investment activity to which this communication relates is available only to, and will be engaged in only with, relevant persons. Persons who are not relevant persons should not take any action on the basis of this press release and should not act or rely on it.

    Forward-looking statements

    This press release contains forward-looking statements that reflect the Company's intentions, beliefs, or current expectations about and targets for the Company's future results of operations, financial condition, liquidity, performance, prospects, anticipated growth, strategies and opportunities and the markets in which the Company operates. Forward-looking statements are statements that are not historical facts and may be identified by words such as "believe", "expect", "anticipate", "intend", "may", "plan", "estimate", "will", "should", "could", "aim" or "might", or, in each case, their negative, or similar expressions. The forward-looking statements in this press release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurances that they will materialize or prove to be correct. Because these statements are based on assumptions or estimates and are subject to risks and uncertainties, the actual results or outcome could differ materially from those set out in the forward-looking statements as a result of many factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The Company does not guarantee that the assumptions underlying the forward-looking statements in this press release are free from errors and readers of this press release should not place undue reliance on the forward-looking statements in this press release. The information, opinions and forward-looking statements that are expressly or implicitly contained herein speak only as of its date and are subject to change without notice. Neither the Company nor anyone else undertake to review, update, confirm or to release publicly any revisions to any forward-looking statements to reflect events that occur or circumstances that arise in relation to the content of this press release, unless it is not required by law or Nasdaq Stockholm's rule book for issuers.

    Information to distributors

    Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended ("MiFID II"); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the "MiFID II Product Governance Requirements"), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any "manufacturer" (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the shares in Calliditas have been subject to a product approval process, which has determined that such shares are: (i) compatible with an end target market of retail investors and investors who meet the criteria of professional clients and eligible counterparties, each as defined in MiFID II; and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the "Target Market Assessment"). Notwithstanding the Target Market Assessment, Distributors should note that: the price of the shares in Calliditas may decline and investors could lose all or part of their investment; the shares in Calliditas offer no guaranteed income and no capital protection; and an investment in the shares in Calliditas is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the Directed Share Issue. Furthermore, it is noted that, notwithstanding the Target Market Assessment, the Joint Bookrunners will only procure investors who meet the criteria of professional clients and eligible counterparties.

    For the avoidance of doubt, the Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to the shares in Calliditas.

    Each distributor is responsible for undertaking its own target market assessment in respect of the shares in Calliditas and determining appropriate distribution channels.            

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  6. STOCKHOLM, Aug. 9, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for its lead NOX inhibitor candidate setanaxib for the treatment of patients with the chronic orphan liver disease primary biliary cholangitis (PBC). Setanaxib has previously been granted orphan drug designation for PBC in the US and Europe.

    The FDA Fast Track program facilitates the expedited development and review of new drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical need. The FDA created this process to expedite the delivery of important new…

    STOCKHOLM, Aug. 9, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for its lead NOX inhibitor candidate setanaxib for the treatment of patients with the chronic orphan liver disease primary biliary cholangitis (PBC). Setanaxib has previously been granted orphan drug designation for PBC in the US and Europe.

    The FDA Fast Track program facilitates the expedited development and review of new drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical need. The FDA created this process to expedite the delivery of important new drugs to patients, and programs with FTD can potentially take advantage of early and frequent communication with the FDA, as well as rolling submission of the marketing application.

    "We are delighted to receive Fast Track designation and look forward to working closely with the FDA towards our aim of establishing setanaxib as the potential first NOX inhibitor for PBC patients," said CEO Renée Aguiar-Lucander.

    In a Phase 2 clinical trial, setanaxib demonstrated evidence of anti-fibrotic activity as measured by Fibroscan, combined with a favorable tolerability profile, as well as a statistically significant impact on fatigue. Following positive results from a Phase 1 study conducted in 2020 which evaluated higher doses of setanaxib in healthy volunteers, Calliditas is planning to initiate a pivotal Phase 2/3 study in PBC, starting in 2H 2021.

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas

    Tel.: +44 79 55 12 98 45, email: marie.galay@calliditas.com

    The information was sent for publication, through the agency of the contact persons set out above, on August 9, 2021, at 8:00 a.m. CET.

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas read out top line data from its ongoing global Phase 3 study within IgAN and has filed for accelerated and conditional approval. If approved, Calliditas aims to commercialize Nefecon itself in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

    About setanaxib

    Setanaxib (GKT831), a NOX1 and NOX4 inhibitor, has shown evidence of anti-fibrotic activity in a Phase II clinical trial in primary biliary cholangitis (PBC, an orphan liver disease). Based on its Phase II results, a phase 2/3 trial with setanaxib in PBC is being planned. In addition, a proof-of-concept study in head and neck cancer is planned to start in the 2nd half of 2021. Setanaxib is also being evaluated in an investigator-initiated Phase II clinical trial in Type 1 Diabetes and Kidney Disease (DKD) as well as being studied in an investigator led Phase II clinical trial in idiopathic pulmonary fibrosis (IPF), a chronic lung disease that results in fibrosis of the lungs.

    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, business plans, regulatory submissions 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, the potential for FDA acceptance for and the success and timeline of the development of setanaxib, 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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  7. STOCKHOLM and BAD VILBEL, Germany, July 21, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT), (Nasdaq Stockholm: CALTX) ("Calliditas") and STADA Arzneimittel AG ("STADA") announced today that they have entered into a license agreement to register and commercialize a novel specialty drug candidate for the treatment of the chronic autoimmune kidney disease Immunoglobulin A Nephropathy (IgAN) in the European Economic Area (EEA) member states, Switzerland and the UK. 

    Under the terms of the agreement, Calliditas is entitled receive an initial upfront payment of 20M EUR ($24m) upon signing and up to an additional 77.5M EUR ($91m) in future payments linked to pre-defined regulatory and commercialization milestones. STADA is also obligated…

    STOCKHOLM and BAD VILBEL, Germany, July 21, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT), (Nasdaq Stockholm: CALTX) ("Calliditas") and STADA Arzneimittel AG ("STADA") announced today that they have entered into a license agreement to register and commercialize a novel specialty drug candidate for the treatment of the chronic autoimmune kidney disease Immunoglobulin A Nephropathy (IgAN) in the European Economic Area (EEA) member states, Switzerland and the UK. 

    Under the terms of the agreement, Calliditas is entitled receive an initial upfront payment of 20M EUR ($24m) upon signing and up to an additional 77.5M EUR ($91m) in future payments linked to pre-defined regulatory and commercialization milestones. STADA is also obligated pay tiered royalties on net sales expressed as a percentage between the low twenties and the low thirties.

    The partnership relates to a novel oral formulation, developed under the project name 'Nefecon', of a potent and well-known active substance – budesonide – designed to target down regulation of IgA1 with a view to be disease modifying. If approved, this value-added specialty medicine, which received an EU orphan-drug designation in 2016, would be the first treatment authorized in the European Union for IgAN, a rare autoimmune disease. IgAN, also known as Berger´s disease, is a serious progressive autoimmune disease in which up to 50% of patients end up at risk of developing end stage renal disease and thus requiring dialysis or a kidney transplant. Prevalence in Europe is estimated at 4 in 10,000, translating into approximately 200,000 patients.

    "We are excited to be entering into this partnership with STADA to bring this IgAN therapy to market in Europe, where there is a significant unmet medical need for this patient population. We look forward to working in close collaboration with STADA to pursue marketing authorization with the goal of bringing the first ever EU-approved medication in IgAN to patients as soon as possible, utilizing STADA's extensive marketing and sales platform throughout Europe," said Renée Aguiar-Lucander, CEO of Calliditas.

    "This partnership, which leverages Calliditas' drug-delivery expertise and clinical data in this under-served patient population, further validates STADA's position as a go-to-partner for specialty pharmaceuticals, as well as for generics and consumer health products," commented STADA CEO Peter Goldschmidt. "This value-added novel formulation for a large orphan indication will complement STADA's offerings in nephrology, where we have built strong expertise over more than a decade through our epoetin zeta biosimilar and where we continue to place a clear strategic focus on seeking further opportunities to bring new options to patients."

    The novel formulation is designed to deliver the drug to the Peyer's patch region of the lower small intestine, where the disease originates as per the predominant pathogenesis models. The formulation uses a unique two-step technology, which allows for the substance to pass through the stomach and intestine without being absorbed, and to be released in a pulse like fashion only when it reaches the ileum in the lower small intestine. In addition to its potent local effect, another advantage of using this active substance is that it has very low bioavailability, with around 90% being inactivated in the liver before it reaches the systemic circulation. This means that a high concentration can be applied locally where needed, whilst limiting systemic exposure.

    On May 28, 2021, Calliditas announced that the company had, under the drug-development candidate name Nefecon, submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for a novel oral formulation of budesonide targeting down regulation of IgA1 for the treatment of primary IgAN.  The company also filed an application for accelerated approval in the US on March 15, 2021 and was granted priority review in April 2021. The commercial brand name for this therapy in Europe will be determined and disclosed at a later date.

    Calliditas´ oral formulation has been granted Accelerated Assessment procedure by the Committee for Human Medicinal Products (CHMP) within the European Medicines Agency, which is intended to expedite access to drugs that the CHMP considers to be of major therapeutic interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation. Accelerated assessment reduces the maximum timeframe for review of the MAA to 150 days (excluding clock-stops).

    IgAN is designated as an orphan disease in both the US and Europe. In Europe, an orphan disease is defined as a disease or condition affecting no more than five in 10,000 European citizens with no satisfactory method of diagnosis, prevention or treatment. Orphan incentives consist of ten years of market exclusivity from the grant date of marketing approval in the EU, protocol assistance and scientific advice, fee reductions on EMA procedural activities and eligibility for EU grants.

    If approved, the product could be available to patients in Europe in the first half of 2022 and would become the first therapy specifically designed and approved for the treatment of IgAN, and which has the potential to be disease modifying.

    Torreya acted as exclusive financial advisor to Calliditas on the transaction.

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas

    Tel.: +44 79 55 12 98 45, email: marie.galay@calliditas.com 

    STADA Arzneimittel AG

    Stadastrasse 2–18

    61118 Bad Vilbel - Germany 

    Phone: +49 (0) 6101 603-165

    Fax: +49 (0) 6101 603-215

    For Media Relations, email: press@stada.de

    Or visit us on the Internet at www.stada.com/press  

    For Investor & Creditor Relations, email: ir@stada.de

    Or visit us on the Internet at www.stada.com/investor-relations

    The information in the press release is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was sent for publication, through the agency of the Calliditas contact person set out above, on July 21, 2021 at 8:45 a.m. CET.

    About STADA Arzneimittel AG

    STADA Arzneimittel AG is headquartered in Bad Vilbel, Germany. The company focuses on a three-pillar strategy consisting of generics, specialty pharma and non-prescription consumer healthcare products. Worldwide, STADA Arzneimittel AG sells its products in approximately 120 countries. In financial year 2020, STADA achieved group sales of EUR 3,010.3 million and adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) of EUR 713.3 million. As of December 31, 2020, STADA employed 12,301 people worldwide.

    About Calliditas

    Calliditas Therapeutics is a 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of adults with the autoimmune renal disease primary IgA nephropathy (IgAN), for which there is a high unmet medical need and there are no approved treatments. Calliditas has recently read out topline data from Part A of its global Phase 3 study in IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to start clinical trials with NOX inhibitors in primary biliary cholangitis and head and neck cancer. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.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, business plans, regulatory submissions and focus, as well as Calliditas's partnership with STADA, the parties' plans with respect to registration and commercialization of the specialty therapy, the terms of the collaboration and the intended benefits therefrom, the regulatory pathway and interactions for Nefecon, including timing of review and assessment of the candidate, and the intended benefits of regulatory designations such as Accelerated Assessment and orphan disease. 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, the conduct of Calliditas's partnership with STADA, the potential for regulatory acceptance for and the success and timeline of its regulatory marketing application for Nefecon, 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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  8. STOCKHOLM, July 15, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the company has signed a loan agreement of up to the Euro equivalent of $75 million with Kreos Capital. Proceeds from the loan will be utilized for the launch of Calliditas' lead product candidate Nefecon, if approved, as well as to support clinical development efforts and for general corporate purposes.

    The loan facility is divided into three tranches of $25 million each. Drawdown of the first $25 million tranche can be made until 31 December 2021 and will be available after the satisfaction of customary closing conditions. Drawdown of the second tranche of $25 million can be made until 30 June 2022

    STOCKHOLM, July 15, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the company has signed a loan agreement of up to the Euro equivalent of $75 million with Kreos Capital. Proceeds from the loan will be utilized for the launch of Calliditas' lead product candidate Nefecon, if approved, as well as to support clinical development efforts and for general corporate purposes.

    The loan facility is divided into three tranches of $25 million each. Drawdown of the first $25 million tranche can be made until 31 December 2021 and will be available after the satisfaction of customary closing conditions. Drawdown of the second tranche of $25 million can be made until 30 June 2022 and will be available subject to accelerated approval of Nefecon by the U.S Food and Drug Administration (FDA). Drawdown of the third and final $25 million tranche can be made until 31 December 2022 and will be available subject to certain revenue milestones and coverage metrics.

    "Signing this loan facility broadens our financing options and gives us access, on a non-dilutive basis, to significant additional capital, which bolsters our ability to invest in our commercial capabilities in the US both on a pre- and post-approval basis, subject to FDA approval later in the year, as well as in to our development activities with NOX inhibitors," said CEO Renée Aguiar-Lucander.

     "This is an important time for Calliditas as the company progresses through the approval process and prepares to commercialise Nefecon. We are very pleased to support the company in bringing their innovative new medicines to patients with IgA nephropathy," commented Aris Constantinides, General Partner at Kreos.

    The loan is denominated in Euro and the loan agreement provides for interest only payments through December 2024, should certain milestones be achieved. The loan is due in December 2025, but is prepayable in full, including the final payment and certain fees, at any time at the option of Calliditas. The senior, secured loan initially bears an interest at a rate of 9.00%, which may be reduced to 7.95% upon reaching certain milestones. The loan is secured by Calliditas' owned intellectual property in the US. Calliditas will pay a customary fee to Kreos for the establishment of the loan and the loan agreement does not contain any financial covenants.

    Carnegie and Lazard acted as advisors to Calliditas in this transaction.

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas

    Tel.: +44 79 55 12 98 45, email: marie.galay@calliditas.com

    The information in the press release is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was sent for publication, through the agency of the contact persons set out above, on July 15, 2021 at 8:20 a.m. CET.

    About Calliditas

    Calliditas Therapeutics is a 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of adults with the autoimmune renal disease primary IgA nephropathy (IgAN), for which there is a high unmet medical need and there are no approved treatments. Calliditas has recently read out topline data from Part A of its global Phase 3 study in IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to start clinical trials with NOX inhibitors in primary biliary cholangitis and head and neck cancer. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

    About Kreos Capital:

    Kreos Capital is the leading growth debt provider in Europe and Israel, backing high-growth companies through every stage of their life cycle. Kreos targets investments in all areas of the Technology and Healthcare sectors and, to date, has committed in excess of €3.1 billion in more than 630 portfolio company transactions, across 17 countries. With over $1.5 billion in current funds under management Kreos can invest between $2 million and $100 million per transaction in both public and private companies across stages. 

    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, business plans, regulatory submissions and focus as well as our plans with respect to the loan facility and the terms thereof. 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, the potential for FDA acceptance for and the success and timeline of its regulatory marketing application for Nefecon, 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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  9. STOCKHOLM, May 28, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the company submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Nefecon, a novel oral formulation targeting down regulation of IgA1 for the treatment of primary IgA Nephropathy (IgAN).

    The submission is based on positive data from Part A of the NefIgArd pivotal Phase 3 study, a randomized, double-blind, placebo-controlled, international multicenter study designed to evaluate the efficacy and safety of Nefecon compared to placebo in 200 adult patients with IgAN. The study achieved its primary endpoint of proteinuria reduction compared to placebo, and also showed…

    STOCKHOLM, May 28, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the company submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Nefecon, a novel oral formulation targeting down regulation of IgA1 for the treatment of primary IgA Nephropathy (IgAN).

    The submission is based on positive data from Part A of the NefIgArd pivotal Phase 3 study, a randomized, double-blind, placebo-controlled, international multicenter study designed to evaluate the efficacy and safety of Nefecon compared to placebo in 200 adult patients with IgAN. The study achieved its primary endpoint of proteinuria reduction compared to placebo, and also showed a renal protective effect by way of stabilization of eGFR at 9 months.

    The submission also includes clinical data from the Phase 2 NEFIGAN trial, which met the same primary and secondary endpoint as the NefIgArd study. The NefIgArd trial also showed that Nefecon was generally well-tolerated, with a safety profile in keeping with the Phase 2b results. Calliditas is the only company which has achieved positive data in randomized, double-blind, placebo-controlled Phase 2b and Phase 3 clinical trials in IgAN.

    "This is another important step forward in our endeavors to bring the first approved medication to patients suffering from IgAN. We look forward to engaging with the agency with the target of achieving an approval in Q1 next year," said CEO Renée Aguiar-Lucander

    As previously reported, the MAA for Nefecon has been granted Accelerated Assessment procedure by EMA's Committee for Human Medicinal Products (CHMP), which is intended to expedite access to drugs that the CHMP considers to be of major therapeutic interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation. Accelerated assessment reduces the maximum timeframe for review of the MAA to 150 days (excluding clock-stops).

    If approved, Nefecon could be available to patients in Europe in H1 2022 and would become the first therapy specifically designed and approved for the treatment of IgAN, and which has the potential to be disease modifying.

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas

    Tel.: +44 79 55 12 98 45, email: marie.galay@calliditas.com

    The information in the press release is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was sent for publication, through the agency of the contact persons set out above, on May 28, 2021 at 2:40 p.m. CET.

    About Calliditas

    Calliditas Therapeutics is a 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of adults with the autoimmune renal disease primary IgA nephropathy (IgAN), for which there is a high unmet medical need and there are no approved treatments. Calliditas has recently read out topline data from Part A of its global Phase 3 study in IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to start clinical trials with NOX inhibitors in primary biliary cholangitis and head and neck cancer. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

    About the NefIgArd Study

    The global Phase 3 clinical trial NefIgArd, which investigated the effect of Nefecon versus placebo in patients with primary IgA nephropathy (IgAN), consists of two parts.

    Part A, which was designed to provide the basis for regulatory submissions and approvals, evaluates data on the efficacy and safety of Nefecon. The first patient in the NefIgArd trial was randomized by Calliditas in November 2018, and in December 2019, Calliditas announced the full recruitment of Part A, across approximately 146 sites in 19 countries. Calliditas read out topline data for Part A in November 2020.

    The trial met its primary objective of demonstrating a statistically significant reduction in urine protein creatinine ratio, UPCR or proteinuria, after 9 months of treatment with 16 mg of Nefecon compared to placebo, with significant continued improvement at 12 months. The primary endpoint analysis showed a 31% mean reduction in the 16 mg arm versus baseline, with placebo showing a 5% mean reduction versus baseline, resulting in a 27% mean reduction at 9 months (p=0.0005) of the 16 mg arm versus placebo. The trial also met the key secondary endpoint, showing a statistically significant difference in estimated glomerular filtration rate or eGFR after 9 months of treatment with Nefecon compared to placebo. The key secondary endpoint, eGFR, showed a treatment benefit of 7% versus placebo at 9 months, reflecting stabilization in the treatment arm and a 7% decline of eGFR in the placebo arm (p=0.0029). This reflected an absolute decline of 4.04 ml/min/1.73m2 in the placebo group over 9 months compared to a 0.17 ml/min/1.73m2 decline in the treatment group. Nefecon was also generally well-tolerated, and the safety profile was in keeping with the Phase 2b results and consistent with the known safety profile of budesonide.

    Part B of the NefIgArd study is designed to be a confirmatory post-market observational trial to confirm long-term renal protection and assess the difference in kidney function between treated and placebo patients as measured by eGFR over a two-year period from the start of dosing of each patient. The 360-patient population of the complete Phase 3 trial includes another 160 patients enrolled in addition to the 200 patients from Part A. The trial was fully recruited in January 2021, and aims to read out data in early 2023, after all patients have completed 2 years in the trial.

    About Nefecon

    Nefecon is a patented oral formulation of a potent and well-known active substance – budesonide – for targeted release. The formulation is designed to deliver the drug to the Peyer's patch region of the lower small intestine, where the disease originates, as per the predominant pathogenesis models. Nefecon is derived from the TARGIT technology, which allows for the substance to pass through the stomach and intestine without being absorbed, and to be released in a pulse like fashion only when it reaches the lower small intestine.

    The combination of dose and optimized release profile is required to be effective in patients with IgAN, as shown in a large Phase 2b trial, completed by Calliditas. In addition to its potent local effect, another advantage of using this active substance is that it has very low bioavailability, i.e. around 90% of it is inactivated in the liver before it reaches the systemic circulation. This means that a high concentration can be applied locally where needed but with only very limited systemic exposure and side effects.

    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, business plans, regulatory submissions 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, the potential for FDA acceptance for and the success and timeline of its regulatory marketing application for Nefecon, 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.

    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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  10. STOCKHOLM, May 28, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") today announced that management will present at the Jefferies Virtual Healthcare Conference on Tuesday, June 1, 2021 at 2:30 pm CET/8:30 am ET. Calliditas will also host 1x1 meetings during the conference. Details for the presentation are as follows:

    Jefferies Virtual Healthcare Conference

    Date: Tuesday, June 1, 2021
    Time: 2:30 pm CET / 8:30 am ET

    Registration Link: https://wsw.com/webcast/jeff174/register.aspx?conf=jeff174&page=calt&mmid=3325730&refer=meetmax&firstname=&lastname=

    The webcast will be archived for a period of 30 days following the conclusion of the event.

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas
    Tel.: +44…

    STOCKHOLM, May 28, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") today announced that management will present at the Jefferies Virtual Healthcare Conference on Tuesday, June 1, 2021 at 2:30 pm CET/8:30 am ET. Calliditas will also host 1x1 meetings during the conference. Details for the presentation are as follows:

    Jefferies Virtual Healthcare Conference

    Date: Tuesday, June 1, 2021

    Time: 2:30 pm CET / 8:30 am ET

    Registration Link: https://wsw.com/webcast/jeff174/register.aspx?conf=jeff174&page=calt&mmid=3325730&refer=meetmax&firstname=&lastname=

    The webcast will be archived for a period of 30 days following the conclusion of the event.

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas

    Tel.: +44 79 55 12 98 45

    email: marie.galay@calliditas.com

    The information was sent for publication, through the agency of the contact persons set out above, on May 28, 2021 at 12:00 p.m. CET.

    About Calliditas

    Calliditas Therapeutics is a 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas successfully reported top line data of its global Phase 3 study in IgAN in November of 2020 and, if approved, aims to commercialize Nefecon in the United States on its own and partner elsewhere. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

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    Jefferies Conference Press Release - En

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  11. STOCKHOLM, May 27, 2021 /PRNewswire/ -- The following resolutions were passed at Calliditas Therapeutics AB (publ) ("Calliditas") annual general meeting held today, on May 27, 2021.

    Adoption of income statement and balance sheet for the financial year 2020 and discharge from liability

    The annual general meeting resolved to adopt the income statement and the consolidated income statement for the financial year 2020 as well as the balance sheet and consolidated balance sheet as of 31 December 2020. The members of the board of directors and the managing director were discharged from liability for the financial year 2020.

    Allocation of profit or loss

    The annual general meeting resolved, in accordance with the board of directors' proposal, that…

    STOCKHOLM, May 27, 2021 /PRNewswire/ -- The following resolutions were passed at Calliditas Therapeutics AB (publ) ("Calliditas") annual general meeting held today, on May 27, 2021.

    Adoption of income statement and balance sheet for the financial year 2020 and discharge from liability

    The annual general meeting resolved to adopt the income statement and the consolidated income statement for the financial year 2020 as well as the balance sheet and consolidated balance sheet as of 31 December 2020. The members of the board of directors and the managing director were discharged from liability for the financial year 2020.

    Allocation of profit or loss

    The annual general meeting resolved, in accordance with the board of directors' proposal, that no dividend shall be paid for 2020 and that the results of the company shall be carried forward.

    Election of board members, auditors, fees to the board of directors and auditors

    The annual general meeting resolved, in accordance with the nomination committee's proposal, that the number of members of the board of directors shall be five without deputies and that the number of auditors shall be one without deputies.

    In accordance with the nomination committee's proposal, Elmar Schnee, Hilde Furberg, Lennart Hansson, Diane Parks and Molly Henderson were re-elected as members of the board of directors for the period until the end of the next annual general meeting. Elmar Schnee was re-elected as the chairman of the board of directors. The audit firm Ernst & Young AB was re-elected auditor of the company for the period until the end of the next annual general meeting, and it was noted that the authorised public accountant Anna Svanberg will continue as auditor in charge.

    The annual general meeting further resolved, in accordance with the nomination committee's proposal and for the time period until the end of the next annual general meeting, that the directors' fees shall be paid with SEK 850,000 to the chairman of the board of directors and with SEK 300,000 to each of the other members, with SEK 150,000 to the chairman of the audit committee and with 75,000 SEK to the other members of the audit committee as well as with SEK 50,000 to the chairman of the remuneration committee and SEK 25,000 to the other members of the remuneration committee. In addition to the above remuneration, it was determined that board members residing in the United States shall receive an additional amount of SEK 140,000 and that board members residing in Europe, but outside the Nordics, shall receive an additional amount of SEK 50,000. The annual general meeting further resolved, in accordance with the nomination committee's proposal, that the remuneration to the auditor shall be paid in accordance with approved statement of costs.

    Nomination committee for the next annual general meeting

    The annual general meeting resolved, in accordance with the nomination committee's proposal, on principles for appointing the nomination committee. In short, the nomination committee should be composed of the chairman of the board of directors together with one representative of each of the three largest shareholders, based on ownership in the company as of the expiry of the third quarter of the financial year.

    Remuneration report

    The annual general meeting approved the board of directors' proposal regarding remuneration report.

    Long-term performance-based incentive program for members of the board of directors

    The annual general meeting resolved, in accordance with the nomination committee's proposal, to adopt a new long-term performance-based incentive program for members of the board of directors, including a resolution to issue not more than 32,000 warrants to ensure delivery of shares to participants under the program. The incentive program entails that the members of the board of directors will be granted share awards, free of charge, that can entitle to shares in Calliditas, subject to the fulfilment of certain performance conditions.

    Long-term incentive program for the management and key personnel

    The annual general meeting resolved, in accordance with the board of directors' proposal, to adopt a new long-term incentive program for the company's management and key personnel, including a resolution to issue not more than 1,500,000 warrants to ensure delivery of shares to participants under the program. The incentive program entails that the participants will be granted options which after three years will entitle the holder to the acquisition of shares in the company at a pre-determined exercise price corresponding to 115 per cent of the volume-weighted average price of Calliditas' share during the ten trading days preceding the granting date.

    Authorisation to issue new shares

    The annual general meeting resolved, in accordance with the board of directors' proposal, to authorise the board of directors, at one or several occasions and for the period up until the next annual general meeting, to increase the company's share capital by issuing new shares. Such share issue resolution may be carried out with or without deviation from the shareholders' preferential rights and with or without provisions for contribution in kind, set-off or other conditions. The authorisation may only be utilised to the extent that it corresponds to a dilution of not more than 20 per cent of the total number of shares outstanding at the time of the general meeting's resolution on the proposed authorisation.

    Amendment to the articles of association

    The annual general meeting resolved, in accordance with the board of directors' proposal, to amend the articles of association as a result of statutory amendments as well as to introduce a new section whereby the board is enabled to collect powers of attorney and to resolve that the shareholders shall be entitled to exercise their voting rights by post prior to a general meeting.

    For further information, please contact:

    Mikael Widell, Head of Communications

    Email: mikael.widell@calliditas.com

    Telephone: +46 703-11 99 60

    The information was submitted for publication, through the agency of the contact person set out above, at 6.30 pm CEST on May 27, 2021.

    About Calliditas

    Calliditas Therapeutics is a 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of adults with the autoimmune renal disease primary IgA nephropathy (IgAN), for which there is a high unmet medical need and there are no approved treatments. Calliditas has recently read out topline data from Part A of its global Phase 3 study in IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to start clinical trials with NOX inhibitors in primary biliary cholangitis and head and neck cancer. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

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    AGM_2021_-_Bulletin from the annual general meeting (Eng)

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  12. STOCKHOLM, May 18, 2021 /PRNewswire/ -- Filing of New Drug Application submission to the FDA

    "Following the positive top line readout of our pivotal Phase 3 trial NefIgArd, which met both the primary and key secondary endpoints with results being statistically significant and clinically relevant we commenced the regulatory filing process which ultimately resulted in the timely filing of the submission to the FDA in Q1 as planned. In April, we received the response from the Food and Drug Administration (FDA) who accepted the submission and granted Priority Review for the New Drug Application (NDA) for Nefecon. The FDA have set a Prescription Drug User Fee Act (PDUFA) goal date of September 15, 2021. During Q1, we also submitted a request for…

    STOCKHOLM, May 18, 2021 /PRNewswire/ -- Filing of New Drug Application submission to the FDA

    "Following the positive top line readout of our pivotal Phase 3 trial NefIgArd, which met both the primary and key secondary endpoints with results being statistically significant and clinically relevant we commenced the regulatory filing process which ultimately resulted in the timely filing of the submission to the FDA in Q1 as planned. In April, we received the response from the Food and Drug Administration (FDA) who accepted the submission and granted Priority Review for the New Drug Application (NDA) for Nefecon. The FDA have set a Prescription Drug User Fee Act (PDUFA) goal date of September 15, 2021. During Q1, we also submitted a request for accelerated assessment to the EMA, which was granted on April 23rd. These grants reflect the perceived unmet medical need in IgAN by regulators and, in my view, also the strength and overall quality of our dossier.

    In Q1, we also reported positive data from the Phase 1 study of setanaxib, our lead compound in our NOX inhibition pipeline, paving the way for the use of higher dosing in the pivotal Phase 2/3 study in PBC. We also hosted an R&D day in January where we laid out the clinical development strategy for the year, presenting the plans for our PBC study as well as the Phase 2b proof of concept study in head and neck cancer, both slated to start in the second half of 2021. The substantial preclinical work that has been generated shows compelling data regarding setanaxib's impact on CAF (cancer associated fibroblasts), paving the way for a significantly improved reach of checkpoint inhibitors.

    We also significantly built our US team during the quarter, adding a Head of Marketing, VP Medical Affairs and Head of Sales. We will continue to build our team in order to be ready to commercialize in Q4, if approved."

    Renée Aguiar-Lucander, CEO

    Summary of Q1 2021

    January 1March 31, 2021

    No net sales for the three months ended March 31, 2021 were recognized. For the three months ended March 31, 2020 net sales amounted to SEK 0.5 million.

    Operating loss amounted to SEK 150.8 million and SEK 72.3 million for the three months ended March 31, 2021 and 2020, respectively.

    Loss before income tax amounted to SEK 136.2 million and SEK 63.7 million for the three months ended March 31, 2021 and 2020, respectively.

    Loss per share before and after dilution amounted to SEK 2.51 and SEK 1.65, for the three months ended March 31, 2021 and 2020, respectively.

    Cash amounted to SEK 867.3 million and SEK 728.6 million as of March 31, 2021 and 2020, respectively.

    Significant events during Q1 2021, in summary

    In January 2021, Calliditas announced a positive readout of the Phase 1 study with setanaxib, which enables clinical trials with higher dosing levels.

    In January 2021, Calliditas shared the clinical development plan for setanaxib, including planned trials in Primary biliary cholangitis (PBC) and head and neck cancer, and additional data from Part A of NeflgArd study at its R&D Day.

    In March 2021, Calliditas announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Nefecon in patients with primary IgA Nephropathy (IgAN).

    Significant events after the end of reporting period, in summary

    In April 2021, Calliditas was granted accelerated assessment procedure by the European Medicine Agency's (EMA) Committee for Human Medicinal Products (CHMP) reducing the maximum timeframe for review of the application for marketing authorization. If approved, Nefecon could be available to patients in Europe in first half of 2022.

    In April 2021, Calliditas announced that the FDA accepted the submission and granted Priority Review for the NDA for Nefecon. The FDA have set a Prescription Drug User Fee Act (PDUFA) goal date of September 15, 2021. Subject to approval, this would enable commercialization of Nefecon in the US in Q4, 2021.

    Investor presentation May 18, 14:30 CET

    Audio cast with teleconference, Q1 2021, May 18, 2021, 14:30 (Europe/Stockholm)

    Webcast: https://tv.streamfabriken.com/calliditas-therapeutics-q1-2021

    Teleconference: SE: +46850558366 UK: + 443333009271 US: 18335268381

    Financial calendar

    Interim Report for the period January 1June 30, 2021                                   August 19, 2021

    Interim Report for the period January 1September 30, 2021                    November 18, 2021

    Year-end Report for the period January 1December 31, 2021                   February 24, 2022

    For further information, please contact:

    Renée Aguiar-Lucander

    CEO at Calliditas

    Email: renee.lucander@calliditas.com 

    Mikael Widell

    Investor Relations

    Email: mikael.widell@calliditas.com

    Telephone: +46 703 11 99 60

    The information was submitted for publication, through the agency of the contact persons set out above, at 07:00 CET on May 18, 2021.

    About Calliditas Therapeutics

    Calliditas Therapeutics is a 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of adults with the autoimmune renal disease primary IgA nephropathy (IgAN), for which there is a high unmet medical need and there are no approved treatments. Calliditas has recently read out topline data from Part A of its global Phase 3 study in IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to start clinical trials with NOX inhibitors in primary biliary cholangitis and head and neck cancer. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.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, business 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, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, and other risks identified in the section entitled "Risk Factors" 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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  13. STOCKHOLM, May 14, 2021 /PRNewswire/ -- On May 18th, 2021, Calliditas Therapeutics AB (publ) ("Calliditas") will publish its financial report for the first quarter of 2021, and at 2.30 pm CET will host a conference call to present and discuss the results.

    The event will be hosted by the company's CEO Renée Aguiar-Lucander and CFO Fredrik Johansson, and will be held in English. The presentation will be webcast live and will also be made available online on the Calliditas website after the call.

    Webcast link: https://tv.streamfabriken.com/calliditas-therapeutics-q1-2021

    Teleconference: SE: +46850558366 UK: + 443333009271  US: + 18335268381

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas

    Tel.: +44 79 55 12 98 45…

    STOCKHOLM, May 14, 2021 /PRNewswire/ -- On May 18th, 2021, Calliditas Therapeutics AB (publ) ("Calliditas") will publish its financial report for the first quarter of 2021, and at 2.30 pm CET will host a conference call to present and discuss the results.

    The event will be hosted by the company's CEO Renée Aguiar-Lucander and CFO Fredrik Johansson, and will be held in English. The presentation will be webcast live and will also be made available online on the Calliditas website after the call.

    Webcast link: https://tv.streamfabriken.com/calliditas-therapeutics-q1-2021

    Teleconference: SE: +46850558366 UK: + 443333009271  US: + 18335268381

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas

    Tel.: +44 79 55 12 98 45, email: marie.galay@calliditas.com

    The information was sent for publication, through the agency of the contact person set out above, on May 14, 2021 at 2:00 p.m. CET.

    About Calliditas

    Calliditas Therapeutics is a 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas successfully reported top line data of its global Phase 3 study in IgAN in November of 2020 and, if approved, aims to commercialize Nefecon in the United States on its own and partner elsewhere. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

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  14. STOCKHOLM, May 3, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that former Head of North America Commercial, Andrew Udell, has been promoted to President, North America, effective immediately. 

    "Andrew has been instrumental in the growth of the US operations over the last 12 months and has done a great job of creating a strong connection between the US and European teams throughout this period of high growth. He is an experienced leader, and I am delighted to continue to work with him in this new role," said CEO Renee Aguiar-Lucander

    In his new role, Mr. Udell will oversee all of Calliditas' US related activities, with direct reports  including sales, marketing and…

    STOCKHOLM, May 3, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that former Head of North America Commercial, Andrew Udell, has been promoted to President, North America, effective immediately. 

    "Andrew has been instrumental in the growth of the US operations over the last 12 months and has done a great job of creating a strong connection between the US and European teams throughout this period of high growth. He is an experienced leader, and I am delighted to continue to work with him in this new role," said CEO Renee Aguiar-Lucander

    In his new role, Mr. Udell will oversee all of Calliditas' US related activities, with direct reports  including sales, marketing and market access. Mr. Udell joined Calliditas in 2019 and has over 20 years of broad commercial experience in the pharmaceutical industry, working with both established and growing pharma companies. 

    "I am thrilled for the opportunity to lead and continue to work with such a strong, talented, and rapidly growing team as we build upon the foundation created in these last few years. It is an exciting and critical time at Calliditas as we prepare for the commercialization of the first potential treatment for patients suffering with IgA nephropathy," expressed Mr. Udell.   

    As previously reported, the FDA has accepted the submission of and granted Priority Review for the New Drug Application (NDA) for Calliditas' lead product candidate, Nefecon, setting a PDUFA goal date of September 15, 2021. Subject to approval by the FDA, Calliditas intends to commercialize Nefecon for IgA nephropathy on its own in the United States.

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas

    Tel.: +44 79 55 12 98 45, email: marie.galay@calliditas.com

    The information was sent for publication, through the agency of the contact persons set out above, on May 3, 2021 at 2.30 p.m. CET.

    About Calliditas

    Calliditas Therapeutics is a 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas successfully reported top line data of its global Phase 3 study in IgAN in November of 2020 and, if approved, aims to commercialize Nefecon in the United States on its own and partner elsewhere. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

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  15. STOCKHOLM, April 28, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT, Nasdaq Stockholm: CALTX))) ("Calliditas") today announced that the U.S. Food and Drug Administration (FDA) has accepted the submission and granted Priority Review for the New Drug Application (NDA) for Nefecon, a down regulator of IgA1 for the treatment of IgA nephropathy (IgAN.) The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of September 15, 2021.

    "We are very excited about being granted priority review, which reflects the unmet medical need of IgAN. We look forward to engaging with the agency and work towards an accelerated approval later this year so that we will be in a position to provide the first approved medication for IgAN patients…

    STOCKHOLM, April 28, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT, Nasdaq Stockholm: CALTX))) ("Calliditas") today announced that the U.S. Food and Drug Administration (FDA) has accepted the submission and granted Priority Review for the New Drug Application (NDA) for Nefecon, a down regulator of IgA1 for the treatment of IgA nephropathy (IgAN.) The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of September 15, 2021.

    "We are very excited about being granted priority review, which reflects the unmet medical need of IgAN. We look forward to engaging with the agency and work towards an accelerated approval later this year so that we will be in a position to provide the first approved medication for IgAN patients," said CEO Renée Aguiar-Lucander.

    As previously reported, Calliditas filed an NDA with the FDA on March 15, 2021. The NDA submission is based on positive data from Part A of the NefIgArd pivotal Phase 3 study, a randomized, double-blind, placebo-controlled, international multicenter study designed to evaluate the efficacy and safety of Nefecon compared to placebo in 200 adult patients with IgAN. The NefIgArd study read out topline data in November 2020 and achieved its primary endpoint of proteinuria reduction compared to placebo as well as showing stabilization of eGFR at 9 months. The submission also includes clinical data from the Phase 2 NEFIGAN trial, which also met the same primary and secondary endpoints as the NefIgArd study. Both studies showed that Nefecon was generally well-tolerated, with a similar safety profile across both sets of results.

    "Having a target action date provides us with a clear timeline as we continue to expand our US organization and prepare for commercialization in the fourth quarter of this year, subject to approval," said Head of North America Commercial Andrew Udell.

    Calliditas has applied for accelerated approval, which allows drugs targeting serious conditions that fill an unmet medical need to be approved based on a surrogate endpoint. The surrogate endpoint in the pivotal Phase 3 trial NefIgArd was reduction of proteinuria versus placebo. The confirmatory Part B of the NefIgArd study, designed to provide data on long-term renal benefit, is fully recruited and is expected to read out in early 2023.

    Calliditas is the only company which has achieved positive data in randomized, double-blind, placebo-controlled Phase 2b and Phase 3 clinical trials in IgAN. If approved, Nefecon would become the first therapy specifically designed and approved for the treatment of IgAN, with the potential to be disease modifying. Subject to approval by the FDA, Calliditas intends to commercialize Nefecon for IgAN on its own in the United States.

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas

    Tel.: +44 79 55 12 98 45, email: marie.galay@calliditas.com

    The information in the press release is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was sent for publication, through the agency of the contact persons set out above, on April 28, 2021 at 09:50 a.m. CET.

    About Calliditas

    Calliditas Therapeutics is a 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

    About the NefIgArd Study

    The global Phase 3 clinical trial NefIgArd, which investigated the effect of Nefecon versus placebo in patients with primary IgA nephropathy (IgAN), consists of two parts.

    Part A, which was designed to provide the basis for regulatory submissions and approvals, evaluates data on the efficacy and safety of Nefecon. The first patient in the NefIgArd trial was randomized by Calliditas in November 2018, and in December 2019, Calliditas announced the full recruitment of Part A, across approximately 146 sites in 19 countries. Calliditas read out topline data for Part A in November 2020.

    The trial met its primary objective of demonstrating a statistically significant reduction in urine protein creatinine ratio, UPCR or proteinuria, after 9 months of treatment with 16 mg of Nefecon compared to placebo, with significant continued improvement at 12 months. The primary endpoint analysis showed a 31% mean reduction in the 16 mg arm versus baseline, with placebo showing a 5% mean reduction versus baseline, resulting in a 27% mean reduction at 9 months (p=0.0005) of the 16 mg arm versus placebo. The trial also met the key secondary endpoint, showing a statistically significant difference in estimated glomerular filtration rate or eGFR after 9 months of treatment with Nefecon compared to placebo. The key secondary endpoint, eGFR, showed a treatment benefit of 7% versus placebo at 9 months, reflecting stabilization in the treatment arm and a 7% decline of eGFR in the placebo arm (p=0.0029). This reflected an absolute decline of 4.04 ml/min/1.73m2 in the placebo group over 9 months compared to a 0.17 ml/min/1.73m2 decline in the treatment group. Nefecon was also generally well-tolerated, and the safety profile was in keeping with the Phase 2b results and consistent with the known safety profile of budesonide.

    Part B of the NefIgArd study is designed to be a confirmatory post-market observational trial to confirm long-term renal protection and assess the difference in kidney function between treated and placebo patients as measured by eGFR over a two-year period from the start of dosing of each patient. The 360-patient population of the complete Phase 3 trial includes another 160 patients enrolled in addition to the 200 patients from Part A. The trial was fully recruited in January 2021, and aims to read out data in early 2023, after all patients have completed 2 years in the trial.

    About Nefecon

    Nefecon is a patented oral formulation of a potent and well-known active substance – budesonide – for targeted release. The formulation is designed to deliver the drug to the Peyer's patch region of the lower small intestine, where the disease originates, as per the predominant pathogenesis models. Nefecon is derived from the TARGIT technology, which allows for the substance to pass through the stomach and intestine without being absorbed, and to be released in a pulse like fashion only when it reaches the lower small intestine.

    The combination of dose and optimized release profile is required to be effective in patients with IgAN, as shown in a large Phase 2b trial, completed by Calliditas. In addition to its potent local effect, another advantage of using this active substance is that it has very low bioavailability, i.e. around 90% of it is inactivated in the liver before it reaches the systemic circulation. This means that a high concentration can be applied locally where needed but with only very limited systemic exposure and side effects.

    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, business plans, regulatory submissions 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, the potential for FDA acceptance for and the success and timeline of its regulatory marketing application for Nefecon, 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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    FDA Response Priority Review 210428 ENG

     

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  16. STOCKHOLM, April 27, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT) (Nasdaq Stockholm: CALTX) announces today that the Board has decided that the interim report for the first quarter 2021 will be published on May 18, 2021. The previously planned date for publication was May 13, 2021, which is the Ascension Day.

    The information was submitted for publication at 14:30 CET on April 27, 2021, by the below contact person.

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas
    Tel.: +44 79 55 12 98 45, email: marie.galay@calliditas.com

    About Calliditas

    Calliditas Therapeutics is a biopharma company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications…

    STOCKHOLM, April 27, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT) (Nasdaq Stockholm: CALTX) announces today that the Board has decided that the interim report for the first quarter 2021 will be published on May 18, 2021. The previously planned date for publication was May 13, 2021, which is the Ascension Day.

    The information was submitted for publication at 14:30 CET on April 27, 2021, by the below contact person.

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas

    Tel.: +44 79 55 12 98 45, email: marie.galay@calliditas.com

    About Calliditas

    Calliditas Therapeutics is a 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

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  17. STOCKHOLM, April 27, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT) (Nasdaq Stockholm: CALTX) today announces that the Annual Report for 2020 now is available at the company's website: www.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 14:30 CET on April 27, 2021.

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas

    Tel.: +44 79 55 12 98 45, email: marie.galay@calliditas.com

    About Calliditas

    Calliditas Therapeutics is a biopharma company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications…

    STOCKHOLM, April 27, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT) (Nasdaq Stockholm: CALTX) today announces that the Annual Report for 2020 now is available at the company's website: www.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 14:30 CET on April 27, 2021.

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas

    Tel.: +44 79 55 12 98 45, email: marie.galay@calliditas.com

    About Calliditas

    Calliditas Therapeutics is a 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

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  18. STOCKHOLM, April 26, 2021 /PRNewswire/ -- The shareholders of Calliditas Therapeutics AB (publ), Reg. No. 556659-9766, with registered office in Stockholm, are summoned to the annual general meeting on Thursday 27 May 2021.  

    In order to mitigate the spread of Covid-19, the Board of Directors has decided that the annual general meeting will be conducted by advance voting only, without physical presence of shareholders, proxies and third parties.

    Calliditas Therapeutics welcomes all shareholders to exercise their voting rights at this annual general meeting through advance voting on the basis of temporary statutory rules, according to the procedure set out below. Information on the resolutions passed at the annual general meeting will be published…

    STOCKHOLM, April 26, 2021 /PRNewswire/ -- The shareholders of Calliditas Therapeutics AB (publ), Reg. No. 556659-9766, with registered office in Stockholm, are summoned to the annual general meeting on Thursday 27 May 2021.  

    In order to mitigate the spread of Covid-19, the Board of Directors has decided that the annual general meeting will be conducted by advance voting only, without physical presence of shareholders, proxies and third parties.

    Calliditas Therapeutics welcomes all shareholders to exercise their voting rights at this annual general meeting through advance voting on the basis of temporary statutory rules, according to the procedure set out below. Information on the resolutions passed at the annual general meeting will be published on 27 May 2021, as soon as the result of the voting has been finally confirmed.

    In the advance voting form, the shareholders may request that a resolution on one or several of the matters on the proposed agenda below should be deferred to a so-called continued general meeting, which cannot be conducted solely by way of advance voting. Such continued general meeting shall take place if the annual general meeting so resolves or if shareholders with at least one tenth of all shares in the company so request. The shareholders are reminded of their right to request information according to Chapter 7, Section 32 of the Swedish Companies Act. A request for such information shall be made in writing to Calliditas Therapeutics AB (publ), att. Fredrik Johansson, Kungsbron 1 C8, SE-111 22 Stockholm, Sweden, or by e-mail to fredrik.johansson@calliditas.com no later than 17 May 2021.

    Participation, etc.

    Shareholders who wish to participate, through advance voting, in the meeting must:

    (a) be recorded in the share register maintained by Euroclear Sweden AB on Wednesday 19 May 2021, and

    (b) notify Calliditas Therapeutics of their intention to participate in the annual general meeting by casting their advance votes in accordance with the instructions under the heading "Advance voting" below, so that the advance voting form is received by Euroclear Sweden AB no later than on Wednesday 26 May 2021.

    Shareholders whose shares are registered in the name of a nominee through a bank or a securities institution must temporarily re-register their shares in their own names to be entitled to participate in the meeting. Such registration, which may be temporary, must be duly effected in the share register maintained by Euroclear Sweden AB on Friday 21 May 2021, and the shareholders must therefore advise their nominees well in advance of this date.

    Advance voting

    The shareholders may only exercise their voting rights at the annual general meeting by voting in advance, so-called postal voting in accordance with Section 22 of the Act (2020:198) on temporary exceptions to facilitate the execution of general meetings in companies and other associations. A special form shall be used for advance voting. The form is available on Calliditas Therapeutics' website, www.calliditas.se. The advance voting form is considered as the notification of participation.

    The completed voting form must be received by Euroclear Sweden AB no later than Wednesday 26 May 2021. The form may be submitted via e-mail to GeneralMeetingService@euroclear.com or by post to Calliditas Therapeutics AB (publ), Annual General Meeting 2021, c/o Euroclear Sweden, Box 191, SE-101 23 Stockholm. Shareholders who are natural persons may also cast their advance votes electronically through BankID verification via Euroclear Sweden AB's website. If the shareholder votes in advance by proxy, a power of attorney shall be enclosed to the form. If the shareholder is a legal entity, a certificate of incorporation or a corresponding document shall be enclosed to the form. The shareholder may not provide special instructions or conditions in the voting form. If so, the vote (i.e. the advance vote in its entirety) is invalid. Further instructions and conditions are included in the form for advance voting.

    For questions regarding the annual general meeting or to have the advance voting form sent by post, please contact Euroclear Sweden AB, by telephone +46 8 402 91 33 (Monday-Friday 09:00-16:00 CEST).

    Number of shares and votes

    As per the date of this notice there are a total of 49,941,584 shares outstanding in the company that entitle to one vote per share at the general meeting. As per the date of this notice the company holds no treasury shares.

    Proposed agenda

    1.       Election of a chairman of the meeting

    2.       Election of one or two persons to attest the minutes

    3.       Preparation and approval of the voting register

    4.       Approval of the agenda

    5.       Determination of whether the meeting was duly convened

    6.       Presentation of the annual report and auditor's report and the consolidated financial statements and auditor's report for the Group

    7.       Resolutions regarding

    a.       Adoption of the income statement and balance sheet and the consolidated income statement and consolidated balance sheet,

    b.       Allocation of the company's profit or loss according to the adopted balance sheet,

    c.        Discharge from liability for board members and the managing director

    8.       Determination of the number of members of the Board and the number of auditors

    9.       Determination of fees for the Board of Directors and the auditors

    10.    Election of the Board of Directors

    11.    Election of chairman of the Board of Directors

    12.    Election of accounting firm or auditors

    13.    Resolution on principles for appointing the nomination committee

    14.    Presentation of the Board of Directors' remuneration report for approval

    15.    Resolution on the introduction of a long-term performance-based incentive program for members of the Board of Directors

    a.       Proposal for resolution on adoption of a long-term performance-based incentive program for members of the Board of Directors

    b.       Proposal regarding issue of warrants

    c.        Equity swap agreement with a third party

    16.    Resolution on the introduction of a long-term incentive program for the company's management and key personnel

    a.       Proposal for resolution on adoption of a long-term incentive program for the company's management and key personnel

    b.       Proposal regarding issue of warrants

    c.        Equity swap agreement with a third party

    17.    Resolution to authorize the Board of Directors to issue new shares

    18.    Resolution to amend the articles of association

    Item 1, 8-12 – The nomination committee's proposal to the annual general meeting 2021

    The nomination committee of Calliditas Therapeutics, which consists of Elmar Schnee (chairman of the Board of Directors), Patrik Sobocki (Stiftelsen Industrifonden), Spike Loy (BVF) and Karl Tobieson (Linc AB), proposes the following:

    • that Dain Hård Nevonen, member of the Swedish Bar Association, shall be appointed chairman at the annual general meeting;
    • that the number of members of the Board of Directors shall be five without deputies;
    • that the number of auditors shall be one without deputies;
    • that the directors' fees shall be paid with SEK 850,000 to the chairman of the Board of Directors and SEK 300,000 to each one of the other members who are not employed in the Group, SEK 150,000 to the chairman of the audit committee and SEK 75,000 to the other members of the audit committee who are not employed in the Group as well as SEK 50,000 to the chairman of the remuneration committee and SEK 25,000 to the other members of the remuneration committee who are not employed in the Group. In addition to the above-proposed remuneration for ordinary board work, it is proposed that board members residing in the United States shall receive an additional amount of SEK 140,000 and that board members residing in Europe, but outside the Nordics, shall receive an additional amount of SEK 50,000;
    • that the fee to the auditor shall be paid in accordance with approved statement of costs;
    • that the board members Elmar Schnee, Hilde Furberg, Lennart Hansson, Diane Parks and Molly Henderson are re-elected as board members, for the period up until the end of the next annual general meeting;
    • that Elmar Schnee is re-elected chairman of the Board of Directors;
    • that Ernst & Young AB is re-elected, in accordance with the audit committee's recommendation. Should Ernst & Young AB be re-elected, the nomination committee notes that Ernst & Young AB has communicated that Anna Svanberg will be elected as the auditor in charge; and
    • that the principles for appointing the nomination committee are left unchanged from the previous year.

    A presentation of the individuals proposed for re­election is available at www.calliditas.se/en/.

    Item 2 - Election of one or two persons to attest the minutes

    The Board proposes that Patrik Sobocki (Stiftelsen Industrifonden) and Karl Tobieson (Linc AB), or if one or both of them have an impediment to attend, the person or persons instead appointed by the Board, are elected to approve the minutes of the annual general meeting together with the chairman. The task of approving the minutes of the annual general meeting also includes verifying the voting register and that the advance votes received are correctly stated in the minutes of the annual general meeting.

    Item 3 - Preparation and approval of the voting register

    The voting register proposed for approval is the voting register drawn up by Euroclear Sweden AB on behalf of Calliditas Therapeutics, based on the annual general meeting's share register and advance votes received, as verified and recommended by the persons attesting the minutes.

    Item 7b – Allocation of the company's profit or loss according to the adopted balance sheet

    The Board of Directors proposes that no dividends shall be paid for the financial year 2020.

    Item 13 – Resolution on principles for appointing the nomination committee

    The nomination committee proposes that the annual general meeting resolves that the principles for appointing the nomination committee shall be left unchanged from the previous year, in accordance with the below.

    The nomination committee shall be composed of the chairman of the Board of Directors together with one representative of each of the three largest shareholders, based on ownership in the company as of the expiry of the third quarter of the financial year. Should any of the three largest shareholders renounce its right to appoint one representative to the nomination committee, such right shall transfer to the shareholder who then in turn, after these three, is the largest shareholder in the company. The Board of Directors shall convene the nomination committee. The member representing the largest shareholder shall be appointed chairman of the nomination committee, unless the nomination committee unanimously appoints someone else.

    Should a shareholder having appointed a representative to the nomination committee no longer be among the three largest shareholders at a point in time falling three months before the annual general meeting at the latest, the representative appointed by such shareholder shall resign and the shareholder who is then among the three largest shareholders shall have the right to appoint one representative to the nomination committee. Unless there are specific reasons otherwise, the already established composition of the nomination committee shall, however, remain unchanged in case such change in the ownership is only marginal or occurs during the three-month period prior to the annual general meeting. Where a shareholder has become one of the three largest shareholders due to a material change in the ownership at a point in time falling later than three months before the annual general meeting, such shareholder shall however in any event have the right to take part of the work of the nomination committee and participate in its meetings. Should a member resign from the nomination committee before his or her work is completed, the shareholder who has appointed such member shall appoint a new member, unless that shareholder is no longer one of the three largest shareholders, in which case the largest shareholder in turn shall appoint the substitute member. A shareholder who has appointed a representative to the nomination committee shall have the right to discharge such representative and appoint a new representative.

    Changes to the composition of the nomination committee shall be announced immediately. The term of office for the nomination committee ends when the next nomination committee has been appointed. The nomination committee shall carry out its duties as set out in the Swedish Code of Corporate Governance.

    Item 15 – Resolution on the introduction of a long-term performance-based incentive program for members of the Board of Directors

    The nomination committee proposes that the annual general meeting resolves to implement a long-term performance-based incentive program for members of the Board of Directors of Calliditas Therapeutics ("Board LTIP 2021") in accordance with items 15a – 15b below. The resolutions under items 15a – 15b below are proposed to be conditional upon each other. Should the majority requirement for item 15b below not be met, the nomination committee proposes that Calliditas Therapeutics shall be able to enter into an equity swap agreement with a third party in accordance with item 15c below and resolutions under items 15a and 15c shall then be conditional upon each other.

    Board LTIP 2021 is a program under which the participants will be granted, free of charge, share awards subject to performance vesting ("Share Awards") that entitle to shares in Calliditas Therapeutics to be calculated in accordance with the principles stipulated below, however not more than 32,000 shares. As part of the implementation of Board LTIP 2021, not more than 32,000 warrants can be issued in accordance with item 15b below.

    Proposal for resolution on adoption of a long-term performance-based incentive program for members of the Board of Directors (item 15a)

    The rationale for the proposal

    Board LTIP 2021 is intended for main owner independent members of the Board of Directors in Calliditas Therapeutics. The nomination committee believes that an equity-based incentive program is a central part of an attractive and competitive remuneration package in order to attract, retain and motivate internationally competent members of the Board of Directors, and to focus the participants on delivering exceptional performance which contributes to value creation for all shareholders. Board LTIP 2021 is adapted to the current position and needs of Calliditas Therapeutics. The nomination committee is of the opinion that Board LTIP 2021 will increase and strengthen the participants' dedication to Calliditas Therapeutics' operations, improve Company loyalty and be beneficial to both the shareholders and Calliditas Therapeutics.

    Conditions for Share Awards

    The following conditions shall apply for the Share Awards.

    1.   The Share Awards shall be granted free of charge to the participants as soon as practicable after the annual general meeting.

    2.   The Share Awards shall vest gradually over approximately three years, corresponding to three terms up to the date of, whichever is earliest, (i) the annual general meeting 2024 or (ii) 1 July 2024 (the "Vesting Date"), where each term equals the period from one annual general meeting up until the day falling immediately prior to the next annual general meeting or the Vesting Date, as applicable (each such period a "Term"). The Share Awards shall vest with 1/3 at the end of each Term, provided that the participant is still a Board member of Calliditas Therapeutics on the said date. In addition to the vesting conditions just stated, the Share Awards are subject to performance vesting based on the development of the Calliditas Therapeutics share price, in accordance with the vesting conditions below.

    3.   The Share Awards are subject to performance vesting based on the development of the Calliditas Therapeutics share price over the period from the date the Share Awards are allocated ("Grant Date") up to and including the day before the Vesting Date. The development of the share price will be measured based on the volume-weighted average price of the Calliditas Therapeutics share on Nasdaq Stockholm for the 10 trading days immediately preceding the Grant Date and the 10 trading days immediately preceding the Vesting Date, respectively. In the event Calliditas Therapeutics' share price has increased by more than 60 percent, 100 percent of the Share Awards shall vest, and should the share price have increased by 20 percent, 33 percent of such Share Awards shall vest. In the event of an increase of the share price of between 20 and 60 percent, vesting of the Share Awards will occur linearly. Should the increase of the share price be less than 20 percent, vesting will not occur at all.

    4.   The earliest point in time at which shares may be obtained from vested Share Awards shall be as soon as possible after the Vesting Date and once an assessment of the performance criteria has been made.

    5.   Each vested Share Award entitles the holder to receive one share in Calliditas Therapeutics without any compensation being payable provided that the holder is still a Board member of Calliditas Therapeutics at the relevant time of vesting with the exception of certain customary "good leaver"-situations (including death and permanent incapacity to complete the assignment due to illness or accident) and this shall also apply during the first year up until the day of the annual general meeting 2022.

    6.   The number of Share Awards will be re-calculated in the event that changes occur in Calliditas Therapeutics' equity capital structure, such as a bonus issue, merger, rights issue, share split or reverse share split, reduction of the share capital or similar measures.

    7.   The Share Awards cannot be transferred and may not be pledged.

    8.   The Share Awards can be granted by the parent company as well as any other company within the Calliditas Therapeutics group.

    9.   In the event of a public take-over offer, asset sale, liquidation, merger or any other such transaction affecting Calliditas Therapeutics, the Share Awards will vest in their entirety upon completion of such transaction.

    10.    The Share Awards shall otherwise be subject to the terms set forth in the separate agreements with the participants and the detailed terms for Board LTIP 2021.

    Allocation

    The number of Share Awards that shall be granted to each participant shall equal the below amount for the respective participant divided by the volume-weighted average price of the Calliditas Therapeutics share on Nasdaq Stockholm for the 10 trading days preceding the Grant Date.

    The Share Awards under Board LTIP 2021 shall be awarded in accordance with the following:

    • Share Awards calculated based on SEK 1,300,000 to the chairman of the Board of Directors; and
    • Share Awards calculated based on SEK 500,000 to each of Diane Parks, Hilde Furberg, Lennart Hansson and Molly Henderson.

    In any event, Board LTIP 2021 will comprise a total number of Share Awards which, if all Share Awards are vested in accordance with the vesting conditions above, can entitle to not more than 32,000 shares in Calliditas Therapeutics.

    Preparation of the proposal

    Board LTIP 2021 has been prepared by the nomination committee and has been structured based on an evaluation of prior incentive programs and market practice for comparable European (including Swedish) and American listed companies.

    Dilution

    Assuming a volume-weighted average price of the Calliditas Therapeutics share on Nasdaq Stockholm for the 10 trading days preceding the Grant Date of SEK 115.74 Board LTIP 2021 will comprise not more than 28,512 shares in total, which corresponds to a dilution of approximately 0.06 percent on a fully diluted basis. Taking into account also the shares which may be issued pursuant to previously implemented incentive programs in the Company, the maximum dilution amounts to 5.3 percent on a fully diluted basis. Taking into account also the shares which may be issued pursuant to previously implemented incentive programs in the Company as well as the incentive program to the Company's management and key personnel proposed to the annual general meeting 2021, the maximum dilution amounts to 8.1 on a fully diluted basis. The dilution is only expected to have a marginal effect on the company's key performance indicator "Earnings (loss) per share".

    Information about Calliditas Therapeutics' existing incentive programs can be found in Calliditas Therapeutics' annual report for 2020, note 10, which is available on the Company's website, www.calliditas.se/en/.

    Scope and costs of the program

    Board LTIP 2021 will be accounted for in accordance with "IFRS 2 – Share-based payments". IFRS 2 stipulates that the Share Awards shall be expensed as personnel costs over the vesting period and will be accounted for directly against equity. Personnel costs in accordance with IFRS 2 do not affect the Company's cash flow. Social security costs will be expensed in the income statement during the vesting period.

    Assuming a volume-weighted average price of the Calliditas Therapeutics share on Nasdaq Stockholm for the 10 trading days preceding the Grant Date of SEK 115.74, the annual cost for the Board LTIP 2021, according to IFRS 2, is estimated at approximately SEK 0.5 million pre-tax. The estimated IFRS 2 cost has been calculated with a Monte Carlo simulation. The annual cost for social security contributions is estimated at SEK 0.6 million, based on an annual increase in the share price of 20 percent, the aforementioned assumptions and a social security tax rate of 31.42 percent. The total annual cost for Board LTIP 2021 during the term of the program, including costs according to IFRS 2 and social security charges, is therefore estimated to approximately SEK 1.1 million.

    The total cost of the Board LTIP 2021, including all costs referred to above and social security charges, is estimated to amount to approximately SEK 3.2 million under the above assumptions.

    Delivery of shares under Board LTIP 2021

    In order to ensure the delivery of shares under Board LTIP 2021, the nomination committee proposes that the annual general meeting resolves to issue warrants in accordance with item 15b below.

    Proposal regarding issue of warrants (item 15b)

    In order to ensure the delivery of shares under Board LTIP 2021, the nomination committee proposes that the annual general meeting resolves to issue not more than 32,000 warrants, whereby the Company's share capital can increase by not more than SEK 1,280 in accordance with the following:

    1.   The right to subscribe for the warrants shall, with deviation from the shareholders' pre-emptive rights, only vest with Nefecon AB, a wholly owned subsidiary of Calliditas Therapeutics AB (publ). The reason for the deviation from the shareholders' pre-emptive rights is the implementation of Board LTIP 2021. Nefecon AB shall be entitled to transfer the warrants to participants of Board LTIP 2021, or a financial intermediary in connection with the exercise of Share Awards.

    2.   The warrants shall be issued free of charge and shall be subscribed for on a subscription list no later than 1 July 2021. The Board of Directors may extend the subscription period.

    3.   The detailed terms of the warrants are set out in the complete proposal which is kept available to the shareholders in accordance with the below.

    4.   The exercise price for subscription for shares based on the warrants shall correspond to the share's quota value.

    5.   The CEO shall be authorized to make such minor adjustments that may be necessary in connection with the registration of the new issue.

    6.   Notification of subscription of shares by the exercise of Warrants can be made from and including the day of registration of the Warrants with the Swedish Companies' Office up until and including 31 December 2024.

    7.   Shares which are issued following subscription shall entitle to participation in the distribution of profits for the first time on the nearest record date occurring after the subscription has been exercised.

    Equity swap agreement with a third party (item 15c)

    Should the majority requirement for item 15b above not be met, the nomination committee proposes that the annual general meeting resolves that Board LTIP 2021 shall instead be hedged so that Calliditas Therapeutics can enter into an equity swap agreement with a third party on terms in accordance with market practice, whereby the third party in its own name shall be entitled to acquire and transfer shares of Calliditas Therapeutics to the participants.

    Item 16 – Resolution on the introduction of an incentive program for the company's management and key personnel

    The Board of Directors of Calliditas Therapeutics proposes the introduction of a long-term incentive program for the company's management and key personnel (including employees and consultants) in accordance with the following. The Board of Directors proposes that the annual general meeting resolves to implement a long-term incentive program for management and key personnel (including employees and consultants) in Calliditas Therapeutics ("ESOP 2021") in accordance with items 16a – 16b below. The resolutions under items 16a – 16b below are proposed to be conditional upon each other. Should the majority requirement for item 16b below not be met, the Board of Directors proposes that Calliditas Therapeutics shall be able to enter into an equity swap agreement with a third party in accordance with item 16c below and resolutions under items 16a and 16c shall then be conditional upon each other.

    ESOP 2021 is a program under which the participants will be granted, free of charge, stock options to acquire shares in Calliditas Therapeutics ("Options"), subject to vesting over a three-year period in accordance with the below. The Board of Directors proposes that a maximum of 1,500,000 Options are allocated to the participants.

    Proposal for resolution on adoption of a long-term incentive program for the company's management and key personnel (item 16a)

    The rationale for the proposal

    ESOP 2021 is intended for members of management and key personnel (including employees and consultants) in Calliditas Therapeutics. The Board of Directors of Calliditas Therapeutics believes that an equity-based incentive program in the form of stock options is a central part of an attractive and competitive remuneration package in order to attract, retain and motivate competent members of management and key personnel (including employees and consultants) in Calliditas Therapeutics, and to focus the participants on delivering exceptional performance which contributes to value creation for all shareholders.

    The proposed program is key for the company's ability to attract, retain and motivate competent key persons in the US as well as in Europe in order to scale up the company's operations and commercial function to prepare for a potential market launch. Calliditas is in a critical phase of developing its lead asset Nefecon. During the fourth quarter of 2020, the company reported positive clinical data from its phase 3 study NefIgArd and in March 2021, the company submitted a filing for market approval in the US. Currently the company are preparing for a commercial launch for Nefecon in the US. This will involve, among many things, growing the current organization by initiating the recruitment of a full commercial organization in the US. When recruiting experienced personnel and other key employees in the US and Europe it will be important for Calliditas to be able to offer attractive compensation terms. A competitive equity-based incentive program will be a key component in order to be able to attract and retain highly skilled and experienced individuals as Calliditas prepares for the commercial launch.

    The Board of Directors of Calliditas Therapeutics believes that ESOP 2021 will fortify the alignment of the interests of the participants and the interests of the shareholders. ESOP 2021 is adapted to the current position and needs of Calliditas Therapeutics. The Board of Directors is of the opinion that ESOP 2021 will increase and strengthen the participants' dedication to Calliditas Therapeutics' operations, improve company loyalty and that ESOP 2021 will be beneficial to both the shareholders and Calliditas Therapeutics.

    Conditions for Options

    The following conditions shall apply for the Options.

    1. The Options shall be granted free of charge to the participants.
    2. The Board of Directors shall resolve upon the allocation of Options between the date of the annual general meeting 2021 and the date of the annual general meeting 2022 (with each respective granting falling on a "Grant Date").
    3. Each Option entitles the holder to acquire one share in Calliditas Therapeutics for a pre-determined exercise price. The exercise price will correspond to 115 percent of the volume weighted average price of the Calliditas Therapeutics share on Nasdaq Stockholm during the ten trading days preceding the Grant Date.
    4. The Options shall vest over a three-year period, with 20 percent on the first anniversary of the Grant Date, with an annual vesting of 40 percent during the second year after the Grant Date, and with an annual vesting of 40 percent during the third year after the Grant Date, and thereafter be exercisable, provided that the holder, with certain exceptions, still is employed by Calliditas Therapeutics (or, in the case of consultants, still provides services to Calliditas Therapeutics).
    5. Following the expiry of the vesting period, the Options may be exercised during a one-year period.
    6. The number of Options shall be subject to customary re-calculation, for example in the event that changes occur in Calliditas Therapeutics' equity capital structure, such as a bonus issue, merger, rights issue, share split or reverse share split, reduction of the share capital or similar measures.
    7. The Options are non-transferable and may not be pledged.
    8. The Options may be granted by the parent company as well as any other company within the Calliditas group.
    9. In the event of a public take-over offer, significant asset sale, liquidation, merger or any other such transaction affecting Calliditas Therapeutics, the Options will vest in their entirety following the completion of a change of control.

    Allocation

    The right to receive Options shall accrue to up to 50 employees or consultants of the company. The Board of Directors may grant Options, on one or several occasions, between the date of the annual general meeting 2021 and the date of the annual general meeting 2022. The maximum number of Options that may be allocated to the participants under ESOP 2021 is 1,500,000.

    The maximum allocation per individual in each category shall be 300,000 Options for Category 1 (CEO), 250,000 Options for Category 2 (Management) and 100,000 Options for Category 3 (Other key personnel and consultants).

    Preparation, administration and the right to amend the terms of the Options

    The Board of Directors is responsible for preparing the detailed terms and conditions of ESOP 2021, in accordance with the above-mentioned terms and guidelines. To this end, the Board of Directors shall be entitled to make adjustments to meet foreign regulations or market conditions, including resolving on cash or other settlement if deemed favorable for Calliditas Therapeutics based on foreign tax regulations. The Board of Directors may also make other adjustments if significant changes in Calliditas Therapeutics or its environment would result in a situation where the adopted terms and conditions of ESOP 2021 no longer serve their purpose.

    Preparation of the proposal

    ESOP 2021 has been initiated by the Board of Directors of Calliditas and has been structured based on an evaluation of prior incentive programs and market practice for comparable European (including Swedish) and American listed companies. ESOP 2021 has been prepared by the Remuneration Committee and reviewed by the Board of Directors.

    Dilution

    Subject to certain recalculation conditions, the maximum number of shares that may be issued under ESOP 2021 is 1,500,000, which corresponds to a dilution of approximately 2.8 percent on a fully diluted basis. Taking into account also the shares which may be issued pursuant to already allocated warrants under the company's outstanding incentive programs, the maximum dilution amounts to approximately 8.1 percent on a fully diluted basis.

    The dilution is expected to have a marginal effect on the company's key performance indicator "Earnings (loss) per share".

    Information about Calliditas Therapeutics' existing incentive programs can be found on Calliditas Therapeutics' website, www.calliditas.se/en/, under "Remuneration" as well as in the company's annual report.

    Scope and costs of the program

    ESOP 2021 will be accounted for in accordance with "IFRS 2 – Share-based payments". IFRS 2 stipulates that the Options shall be expensed as personnel costs over the vesting period. Personnel costs in accordance with IFRS 2 do not affect the company's cash flow. Social security costs will be expensed in the income statement according to UFR 7 during the vesting period.

    Assuming a share price at the time of allocation of Options of SEK 115.74, an annual increase in the share price of 15 percent and that all Options are allocated up-front under the assumptions set out under "Dilution" above, the average annual cost for Calliditas Therapeutics to IFRS 2 is estimated to approximately SEK 11.1 million per year before tax. The average annual social security costs over the vesting period are estimated to approximately a total of SEK 10.1 million, based on the above assumptions, that all Options are fully vested and social security costs of 31.42 percent. It is envisaged that the social security costs associated with ESOP 2021 will be covered by the cash received from the participants at exercise of Options. If necessary, social security costs will be covered by hedging measures through the issue of warrants (see item 16b below) which would be exercised by a financial intermediary in connection with the exercise of the Options. In either case, the social security costs associated with ESOP 2021 will be fully covered and will hence not affect the company's cash flow.

    The total cost of ESOP 2021, including all social security costs, is estimated to amount to approximately SEK 66.2 million under the above assumptions.

    The costs associated with ESOP 2021 are expected to have a marginal effect on Calliditas' key performance indicator "Expenses relating to R&D/operating expenses".

    Delivery of shares under ESOP 2021

    In order to ensure the delivery of shares under ESOP 2021 and if necessary for hedging of social security costs, the Board of Directors proposes that the annual general meeting resolves to issue and use warrants in accordance with item 16b below.

    Proposal regarding issue of warrants (item 16b)

    In order to ensure the delivery of shares under ESOP 2021, and for hedging of social security costs, the Board of Directors proposes that the annual general meeting resolves to issue not more than 1,500,000 warrants (which include warrants to potentially hedge social security costs), whereby the company's share capital could be increased by not more than SEK 60,000.

    The right to subscribe for the warrants shall, with deviation from the shareholders' pre-emptive rights, only be granted Nefecon AB, a wholly owned subsidiary of Calliditas Therapeutics. The reason for the deviation from the shareholders' pre-emptive rights is the implementation of ESOP 2021. Nefecon AB shall be entitled to transfer the warrants to participants or a financial intermediary in connection with exercise.

    The warrants shall be issued free of charge. The exercise price for subscription for shares based on the warrants shall correspond to the share's quota value.

    Equity swap agreement with a third party (item 16c)

    Should the majority requirement for item 16b above not be met, the Board of Directors proposes that the annual general meeting resolves that ESOP 2021 instead shall be hedged through an equity swap agreement with a third party on terms in accordance with market practice, whereby the third party in its own name shall be entitled to acquire and transfer shares of Calliditas Therapeutics to the participants.

    Item 17 – Resolution to authorize the Board of Directors to issue new shares

    The Board of Directors proposes that the annual general meeting resolves to authorize the Board of Directors to, at one or several occasions and for the period up until the next annual general meeting, increase the company's share capital by issuing new shares. Such share issue resolution may be carried out with or without deviation from the shareholders' preferential rights and with or without provisions for contribution in kind, set-off or other conditions. The authorization may only be utilized to the extent that it corresponds to a dilution of not more than 20 percent of the total number of shares outstanding at the time of the general meeting's resolution on the proposed authorization.

    The purpose of the authorization is to increase the financial flexibility of the company and the general flexibility of the Board of Directors. Should the Board of Directors resolve on an issue with deviation from the shareholders' preferential rights, the reason for this shall be to finance an acquisition of operations, to procure capital to finance the development of projects or to commercialize the company' s products. Upon such deviation from the shareholders' preferential rights, the new issue shall be made at market terms and conditions.

    The CEO shall be authorized to make such minor adjustments to this resolution that may be necessary in connection with the registration.

    Item 18 – Resolution to amend the articles of association

    The Board of Directors proposes that the annual general meeting resolves to amend the articles of association. A new section 9 is proposed in the articles of association which allows the Board of Directors to collect powers of attorney in accordance with the procedures described in Chapter 7, Section 4, second paragraph of the Swedish Companies Act (2005:551) and to decide that the shareholders may be permitted to exercise their voting rights by post prior to the shareholders' meetings. As a consequence, the numbering of the following sections is updated accordingly. The Board of Directors also proposes minor adjustments in the articles of association due to legislative changes. The proposed wording is set out below:

    The CEO shall be authorized to make such minor adjustments to this resolution that may be necessary in connection with the registration.

    1 § Business name

    The business name of the company is Calliditas Therapeutics AB. The company is a public company (publ).

    8 § Participation in shareholders' meetings

    Shareholders who wish to participate at a shareholders' meeting shall be registered as shareholders on a transcript of the entire share register as stipulated in Chapter 7, Section 28, third paragraph of the Swedish Companies Act (2005:551) and shall also provide notification of their intention to attend the meeting no later than on the date stipulated in the notice convening the shareholders' meeting. The latter mentioned day must not be a Sunday, any other public holiday, Saturday, Midsummer's Eve, Christmas Eve or New Year's Eve and must not be more than the fifth weekday prior to the meeting. If a shareholder wishes to be joined by proxy (not more than two proxies) at the shareholders' meeting, the number of proxies must be stated in the notice of participation.

    9 § Collection of power of attorneys and postal voting

    The Board of Directors may collect powers of attorney in accordance with the procedure described in Chapter 7, Section 4, second paragraph of the Swedish Companies Act (2005:551). The Board of Directors has the right before a shareholders' meeting to decide that shareholders shall be able to exercise their right to vote by post before the shareholders' meeting.

    Majority requirements

    A resolution in accordance with item 15b and 16b above requires approval of at least nine tenths (9/10) of the shares represented and votes cast at the annual general meeting. Resolutions in accordance with items 17 and 18 above requires approval of at least two thirds (2/3) of the shares represented and votes cast at the annual general meeting.

    Other information

    The annual report and the auditor's report for the financial year 2020, proxy form and advance voting form, the remuneration report and other supporting documents for the general meeting, including complete proposals and statements from the Board of Directors, as well as the statement from the auditor pursuant to Chapter 8, Section 54 of the Swedish Companies Act (2005:551) will be available to the shareholders at the company's office on Kungsbron 1 C8, SE-111 22 Stockholm, Sweden, and on the company's webpage www.calliditas.se/en/, no later than 6 May 2021. The nomination committee's proposal and motivated statement will be available on the address stated above as well as on the website stated above no later than four weeks before the general meeting. Copies of the documents will be sent to the shareholders who so request and who inform the company of their postal address.

    For information on how your personal data is processed, see the integrity policy that is available at Euroclear's webpage www.euroclear.com/dam/ESw/Legal/Privacy-notice-bolagsstammor-engelska.pdf.  

    Stockholm, April 2021

    Calliditas Therapeutics AB (publ)

    The Board of Directors

    This is an in-house translation of the Swedish original wording. In case of differences between the English translation and the Swedish original, the Swedish text shall prevail.

    For further information, please contact:

    Mikael Widell

    Investor relations

    Email: mikael.widell@calliditas.com 

    Telephone: +46 703 11 99 60

    The information was submitted for publication, through the agency of the contact person set out above, at 12:00 pm CEST on April 26, 2021.

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of adults with the autoimmune renal disease primary IgA nephropathy (IgAN), for which there is a high unmet medical need and there are no approved treatments. Calliditas has recently read out topline data from Part A of its global Phase 3 study in IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to start clinical trials with NOX inhibitors in primary biliary cholangitis and head and neck cancer in 2H 2021. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

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  19. STOCKHOLM, April 23, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT, Nasdaq Stockholm: CALTX))) ("Calliditas") today announced that its lead product candidate Nefecon, a novel oral formulation targeting down regulation of IgA1 for the treatment of primary IgA Nephropathy (IgAN), has been granted accelerated assessment procedure by the European Medicine Agency's (EMA) Committee for Human Medicinal Products (CHMP).

    Accelerated assessment, which may be granted when the CHMP concludes that the product is of major public health interest and major therapeutic innovation pursuant to Article 14 (9) of Regulation (EC) No 726/2004, reduces the timeframe for the EMA to review a marketing authorization application (MAA.) Typically, evaluating…

    STOCKHOLM, April 23, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT, Nasdaq Stockholm: CALTX))) ("Calliditas") today announced that its lead product candidate Nefecon, a novel oral formulation targeting down regulation of IgA1 for the treatment of primary IgA Nephropathy (IgAN), has been granted accelerated assessment procedure by the European Medicine Agency's (EMA) Committee for Human Medicinal Products (CHMP).

    Accelerated assessment, which may be granted when the CHMP concludes that the product is of major public health interest and major therapeutic innovation pursuant to Article 14 (9) of Regulation (EC) No 726/2004, reduces the timeframe for the EMA to review a marketing authorization application (MAA.) Typically, evaluating an MAA can take up to 210 procedure days, but accelerated assessment reduces the maximum timeframe for review of the application for marketing authorization to 150 days (excluding clock-stops). Calliditas expects to submit an MAA to the EMA in Q2 2021.

    "We are very excited that CHMP has decided to grant us accelerated assessment, which supports the significant unmet medical need in IgAN.  We look forward to engaging with EMA over the coming months with the goal to be able to bring the first approved product to patients with IgAN as soon as possible," said CEO Renée Aguiar-Lucander.

    If approved, Nefecon could be available to patients in Europe in H1 2022 and would become the first therapy specifically designed and approved for the treatment of IgAN, and which has the potential to be disease modifying.

    For further information, please contact:

    Marie Galay

    IR Manager

    Calliditas

    Tel.: +44 79 55 12 98 45

    email: marie.galay@calliditas.com

    The information in the press release is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was sent for publication, through the agency of the contact persons set out above, on April 23, 2021 at 8:30 a.m. CET.

    About Calliditas

    Calliditas Therapeutics is a 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

    About Nefecon

    Nefecon is a patented oral formulation of a potent and well-known active substance – budesonide – for targeted release. The formulation is designed to deliver the drug to the Peyer's patch region of the lower small intestine, where the disease originates, as per the predominant pathogenesis models. Nefecon is derived from the TARGIT technology, which allows for the substance to pass through the stomach and intestine without being absorbed, and to be released in a pulse like fashion only when it reaches the lower small intestine.

    The combination of dose and optimized release profile is required to be effective in patients with IgAN, as shown in a large Phase 2b trial, completed by Calliditas. In addition to its potent local effect, another advantage of using this active substance is that it has very low bioavailability, i.e. around 90% of it is inactivated in the liver before it reaches the systemic circulation. This means that a high concentration can be applied locally where needed but with only very limited systemic exposure and side effects.

    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, business plans and focus, including the therapeutic potential of Nefecon, our plans for regulatory submissions in Europe, the intended benefits of the EMA's accelerated assessment procedure and the availability of Nefecon to patients in Europe, if approved. 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, our planned applications to seek marketing approvals from regulatory agencies in the U.S. and Europe, acceptance by regulatory agencies with respect to the filing and approval of our regulatory marketing applications for Nefecon, our additional planned studies of Nefecon due to our intended use of the accelerated approval pathway with the FDA and the conditional approval pathway with the EMA, the potential launch and commercialization of Nefecon, if approved, 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.

    This information was brought to you by Cision http://news.cision.com

    https://news.cision.com/calliditas-therapeutics/r/ema-grants-accelerated-assessment-procedure-for-nefecon-for-the-treatment-of-iga-nephropathy,c3331923

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  20. STOCKHOLM, March 15, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT, Nasdaq Stockholm: CALTX))) ("Calliditas") today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Nefecon, a novel oral formulation targeting down regulation of IgA1 for the treatment of primary IgA Nephropathy (IgAN). Calliditas is seeking accelerated approval under Subpart H for the 505(b)(2) application.

    "This is a key milestone in the company's development and we are looking forward to engaging with the agency. This is the first time a drug specifically designed for IgAN is being submitted for approval to the FDA and I believe that we are delivering a very robust data package based on the successful…

    STOCKHOLM, March 15, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALT, Nasdaq Stockholm: CALTX))) ("Calliditas") today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Nefecon, a novel oral formulation targeting down regulation of IgA1 for the treatment of primary IgA Nephropathy (IgAN). Calliditas is seeking accelerated approval under Subpart H for the 505(b)(2) application.

    "This is a key milestone in the company's development and we are looking forward to engaging with the agency. This is the first time a drug specifically designed for IgAN is being submitted for approval to the FDA and I believe that we are delivering a very robust data package based on the successful outcome of our pivotal Phase 3 trial and our large Phase 2b trial, which also met both the primary and key secondary endpoints. Calliditas has long been pioneering a treatment for IgAN based on precision and disease modification that focuses on the origin of the disease, with the hope of bringing help to thousands of patients, so today is truly a special day," said CEO Renée Aguiar-Lucander.

    The NDA submission is based on positive data from Part A of the NefIgArd pivotal Phase 3 study, a randomized, double-blind, placebo-controlled, international multicenter study designed to evaluate the efficacy and safety of Nefecon compared to placebo in 200 adult patients with IgAN. As previously reported, the study achieved its primary endpoint of proteinuria reduction compared to placebo, as well as showing stabilisation of eGFR at 9 months. The NefIgArd trial also showed that Nefecon was generally well-tolerated with a safety profile in keeping with the Phase 2b results. The submission also includes clinical data from the Phase 2 NEFIGAN trial, which also met the same primary and secondary endpoints as the NefIgArd study. Calliditas is the only company which has achieved positive data in randomized, double-blind, placebo-controlled Phase 2b and Phase 3 clinical trials in IgAN.

    Calliditas has applied for accelerated approval, which allows drugs targeting serious conditions that fill an unmet medical need to be approved based on a surrogate endpoint. The surrogate endpoint in the pivotal Phase 3 trial NefIgArd was reduction of proteinuria versus placebo, which is supported by the statistical framework based on the meta-analysis of clinical studies where an intervention was carried out in patients with IgAN, as updated by Thompson A et al, published in 20191.  A confirmatory study designed to provide data on long-term renal benefit is fully recruited and is expected to read out in early 2023.

    If approved, Nefecon would become the first therapy specifically designed and approved for the treatment of IgAN, with the potential to be disease modifying. Subject to approval by the FDA, Calliditas intends to commercialize Nefecon for IgAN on its own in the United States.

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas

    Tel.: +44 79 55 98 12 45, email: marie.galay@calliditas.com

    The information in the press release is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was sent for publication, through the agency of the contact persons set out above, on March 15, 2021 at 07:30 a.m. CET.

    1. Clin J Am Soc Nephrol. 2019;14:469-81.

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of adults with the autoimmune renal disease primary IgA nephropathy (IgAN), for which there is a high unmet medical need and there are no approved treatments. Calliditas has recently read out topline data from Part A of  its global Phase 3 study in IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to start clinical trials with NOX inhibitors in primary biliary cholangitis and head and neck cancer in 2H 2021. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

    About the NefIgArd Study

    The global Phase 3 clinical trial NefIgArd, which investigated the effect of Nefecon versus placebo in patients with primary IgA nephropathy (IgAN), consists of two parts.

    Part A, which was designed to provide the basis for regulatory submissions and approvals, evaluates data on the efficacy and safety of Nefecon. The first patient in the NefIgArd trial was randomized by Calliditas in November 2018, and in December 2019, Calliditas announced the full recruitment of Part A, across approximately 146 sites in 19 countries. Calliditas read out topline data for Part A in November 2020.

    The trial met its primary objective of demonstrating a statistically significant reduction in urine protein creatinine ratio, UPCR or proteinuria, after 9 months of treatment with 16 mg of Nefecon compared to placebo, with significant continued improvement at 12 months. The primary endpoint analysis showed a 31% mean reduction in the 16 mg arm versus baseline, with placebo showing a 5% mean reduction versus baseline, resulting in a 27% mean reduction at 9 months (p=0.0005) of the 16 mg arm versus placebo. The trial also met the key secondary endpoint, showing a statistically significant difference in estimated glomerular filtration rate or eGFR after 9 months of treatment with Nefecon compared to placebo. The key secondary endpoint, eGFR, showed a treatment benefit of 7% versus placebo at 9 months, reflecting stabilisation in the treatment arm and a 7% decline of eGFR in the placebo arm (p=0.0029). This reflected an absolute decline of 4.04 ml/min/1.73m2 in the placebo group over 9 months compared to a 0.17 ml/min/1.73m2 decline in the treatment group. Nefecon was also generally well-tolerated, and the safety profile was in keeping with the Phase 2b results and consistent with the known safety profile of budesonide.

    Part B of the NefIgArd study is designed to be a confirmatory post-market observational trial to confirm long-term renal protection and assess the difference in kidney function between treated and placebo patients as measured by eGFR over a two-year period from the start of dosing of each patient. The 360-patient population of the complete Phase 3 trial includes another 160 patients enrolled in addition to the 200 patients from Part A. The trial was fully recruited in January 2021, and aims to read out data in early 2023, after all patients have completed 2 years in the trial.

    About Nefecon

    Nefecon is a patented oral formulation of a potent and well-known active substance - budesonide - for targeted release. The formulation is designed to deliver the drug to the Peyer's patch region of the lower small intestine, where the disease originates, as per the predominant pathogenesis models. Nefecon is derived from the TARGIT technology, which allows for the substance to pass through the stomach and intestine without being absorbed, and to be released in a pulse like fashion only when it reaches the lower small intestine.

    The combination of dose and optimized release profile is required to be effective in patients with IgAN, as shown in a large Phase 2b trial, completed by Calliditas. In addition to its potent local effect, another advantage of using this active substance is that it has very low bioavailability, i.e. around 90% of it is inactivated in the liver before it reaches the systemic circulation. This means that a high concentration can be applied locally where needed but with only very limited systemic exposure and side effects.

    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, business 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, the potential for FDA acceptance for filing and the success of its regulatory marketing application for Nefecon, 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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  21. STOCKHOLM, March 8, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") today announced the appointment of three industry veterans: Warren Brooks, PhD, as Vice President of US Medical Affairs, Teona Johnson as Head of US Marketing and David Ferraro as Head of US Sales. 

    Calliditas Therapeutics has bolstered its US organization with three pharmaceutical veterans as it moves towards the potential commercialization of its lead product candidate, Nefecon.

    "This is an important step on our continued path to deliver on our promise to build a center of excellence in the US. This shows our long term commitment to building an organization focused on the commercialization of orphan drugs to address unmet medical needs", said Renee

    STOCKHOLM, March 8, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") today announced the appointment of three industry veterans: Warren Brooks, PhD, as Vice President of US Medical Affairs, Teona Johnson as Head of US Marketing and David Ferraro as Head of US Sales. 

    Calliditas Therapeutics has bolstered its US organization with three pharmaceutical veterans as it moves towards the potential commercialization of its lead product candidate, Nefecon.

    "This is an important step on our continued path to deliver on our promise to build a center of excellence in the US. This shows our long term commitment to building an organization focused on the commercialization of orphan drugs to address unmet medical needs", said Renee Aguiar-Lucander, CEO of Calliditas. 

    Warren Brooks, PhD, joins Calliditas from Regeneron, where he served as a Senior Director, National Lead in Immunology in Medical Affairs. Warren was one of the first, and key, members in establishing and building the medical affairs organization at Regeneron, working primarily within Immunology and Allergy. Prior to Regeneron, Warren worked at Centocor, Inc., a subsidiary of Johnson and Johnson, and at AstraZeneca.

    Teona Johnson brings over 15 years of marketing experience, including a proven track record of successfully launching and growing brands in the biopharmaceutical industry. She joins Calliditas after spending over 10 years in leadership roles in marketing at Pfizer Inc. Most recently Teona served as the Global Commercial Director, leading the marketing strategy for Ibrance (palbociclib), a $5+ billion oncology brand. While at Pfizer, Teona planned and executed several launches, including in rare indications.

    David Ferraro joins Calliditas from Kyowa Kirin, Inc., a global specialty pharmaceutical company, where he served as the National Sales Director for the Oncology / Rare Disease business unit. David most recently led the planning and build out of the sales organization to achieve the successful launch of a specialty product in oncology.  Prior to Kyowa Kirin, David held sales and marketing positions of increasing responsibility at Daiichi Sankyo, Sanofi Aventis and Merck & Company.

    "We are very excited to welcome Teona and David to our growing US commercial organization. Both, along with Warren, will play key roles in the further development and execution of our strategy as we expand our US presence," said Andrew Udell, Head of North America, Commercial. 

    For further information, please contact:

    Marie Galay

    IR Manager

    Calliditas

    Tel.: +44 79 55 98 12 45

    email: marie.galay@calliditas.com

    The information was sent for publication, through the agency of the contact persons set out above, on March 8, 2021 at 8:30 a.m. CET.

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to conduct clinical trials with NOX inhibitors in PBC and oncology. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.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, business plans and focus, such as the potential commercialization of Nefecon and the expansion of our US presence. 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, regulatory interactions, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, and other risks identified in the section entitled "Risk Factors" 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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  22. STOCKHOLM, March 4, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") today announced that it will host a Key Opinion Leader (KOL) Perspectives webinar on the Pathophysiology and Treatment of IgA Nephropathy in Clinical Practice on Wednesday, March 10, 2021 at 10:00am Eastern Time.

    The webinar will feature a presentation from KOL Richard Lafayette, M.D., F.A.C.P., Stanford Healthcare, who will discuss the pathophysiology of IgA nephropathy, the connection between the gut and kidney, and how Calliditas' lead clinical candidate, Nefecon, might be used in clinical practice, should it be approved. Dr. Lafayette will be available to answer questions following the formal presentation.

    Calliditas management will also give a corporate…

    STOCKHOLM, March 4, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") today announced that it will host a Key Opinion Leader (KOL) Perspectives webinar on the Pathophysiology and Treatment of IgA Nephropathy in Clinical Practice on Wednesday, March 10, 2021 at 10:00am Eastern Time.

    The webinar will feature a presentation from KOL Richard Lafayette, M.D., F.A.C.P., Stanford Healthcare, who will discuss the pathophysiology of IgA nephropathy, the connection between the gut and kidney, and how Calliditas' lead clinical candidate, Nefecon, might be used in clinical practice, should it be approved. Dr. Lafayette will be available to answer questions following the formal presentation.

    Calliditas management will also give a corporate update and present data from the global Phase 3 NefIgArd trial. The pivotal NefIgArd trial consists of two parts. Part A, which was designed to support regulatory submissions, provided data on the efficacy and safety of Nefecon. Calliditas read out positive topline data from Part A of the trial on 8 November 2020, announcing that the study met its primary endpoint, reduction in proteinuria, and key secondary endpoint stabilization of eGFR.  It also showed that Nefecon was generally well-tolerated. Part B is designed to be a confirmatory post-market approval observational trial to confirm long-term renal protection, and was fully recruited in January 2021.

    To register for the webinar, please click here.

    Dr. Lafayette is Professor of Medicine (Nephrology) and Director of the Stanford Glomerular Disease Center at Stanford University Medical Center in Stanford, CA. His 25-year career in nephrology spans general nephrology, transplant nephrology, and focuses on glomerular disease. During this time, he has served as Senior Associate Chair of Medicine for six years and Clinical Chief of Nephrology for more than a decade. Dr. Lafayette was a member of the first Kidney News Editorial Board and is a member of the ASN Glomerular Diseases Advisory Group.

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas

    Tel.: +44 79 55 98 12 45, email: marie.galay@calliditas.com

    The information was sent for publication, through the agency of the contact persons set out above, on March 4, 2021 at 2:30 p.m. CET.

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to conduct clinical trials with NOX inhibitors in PBC and oncology. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

    About Nefecon

    Nefecon is a patented oral formulation of a potent and well-known active substance - budesonide - for targeted release. The formulation is designed to deliver the drug to the Peyer's patch region of the lower small intestine, where the disease originates, as per the predominant pathogenesis models. Nefecon is derived from the TARGIT technology, which allows for the substance to pass through the stomach and intestine without being absorbed, and to be released in a pulse like fashion only when it reaches the lower small intestine.

    The combination of dose and optimized release profile is required to be effective in patients with IgA nephropathy, as shown in a large Phase 2b trial, completed by the company. In addition to its potent local effect, another advantage of using this active substance is that it has very low bioavailability, i.e. around 90% of it is inactivated in the liver before it reaches the systemic circulation. This means that a high concentration can be applied locally where needed but with only very limited systemic exposure and side effects.

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  23. STOCKHOLM, Feb. 18, 2021 /PRNewswire/ -- "On November 8, 2020, we announced positive topline readout of Part A of our Phase 3 pivotal trial, NefIgArd. The results were statistically significant and clinically relevant: proteinuria showed a 31% reduction versus baseline, a stronger effect than what was seen in the Phase 2b (27%), which is generally not expected when moving from Phase 2 to Phase 3. In addition, eGFR was stabilised in the treated patient population, which in the end is the true treatment goal. This potentially disease modifying effect is to our knowledge unique to Nefecon, which we find extremely exciting, and we look forward to our interactions with regulators during the year as we progress towards potential approval.

    We also…

    STOCKHOLM, Feb. 18, 2021 /PRNewswire/ -- "On November 8, 2020, we announced positive topline readout of Part A of our Phase 3 pivotal trial, NefIgArd. The results were statistically significant and clinically relevant: proteinuria showed a 31% reduction versus baseline, a stronger effect than what was seen in the Phase 2b (27%), which is generally not expected when moving from Phase 2 to Phase 3. In addition, eGFR was stabilised in the treated patient population, which in the end is the true treatment goal. This potentially disease modifying effect is to our knowledge unique to Nefecon, which we find extremely exciting, and we look forward to our interactions with regulators during the year as we progress towards potential approval.

    We also concluded the purchase of a controlling block in Genkyotex in Q4. This is a company we had followed and where we found the clinical data intriguing and their approach clearly differentiated. Genkyotex had positive interactions with the FDA in 2020, which resulted in an adaptive pivotal Phase 2/3 design in PBC and they also initiated a Phase 1 PK study to look into higher dosing, which read out positively in early 2021. We feel excited about taking on a pioneering role in the area of NOX inhibitors and to initiate studies in PBC, as well as on the basis of comprehensive and compelling animal-based data launch a proof of concept trial in head and neck cancer where today's immunotherapy has limited reach."

    Renée Aguiar-Lucander, CEO

    Summary of Q4 2020

    October 1 - December 31, 2020           

    • Net sales amounted to SEK 0.4 million and SEK 46.6 million for the three months ended December 31, 2020 and 2019, respectively.
    • Operating loss amounted to SEK 135.9 million and SEK 18.0 million for the three months ended December 31, 2020 and 2019, respectively.
    • Loss before income tax amounted to SEK 173.3 million and SEK 23.0 million for the three months ended December 31, 2020 and 2019, respectively.
    • Loss per share before and after dilution amounted to SEK 3.41 and SEK 0.60, for the three months ended December 31, 2020 and 2019, respectively.
    • Cash amounted to SEK 996.3 million and SEK 753.5 million as of December 31, 2020 and 2019, respectively

    Significant events during Q4 2020, in summary           

    • In November 2020, Calliditas announced positive topline results from Part A from the pivotal Phase 3 NefIgArd trial.
    • In November 2020, Calliditas acquired a controlling interest in Genkyotex SA followed by a simplified mandatory offer to the shareholders of Genkyotex, after which Calliditas controlled 86.2 percent of the shares in Genkyotex.

    Significant events after the end of reporting period, in summary           

    • In January 2021, Calliditas shared the clinical development plan for setanaxib and additional data from Part A of the NefIgArd study at the R&D Day

    Investor Presentation February 18, 14:30 CET

    Audio cast with teleconference, Q4 2020, February 18, 2021, 14:30 (Europe/Stockholm)

    Webcast: https://tv.streamfabriken.com/calliditas-therapeutics-q4-2020

    Teleconference: SE: +46850558356 UK: +443333009262 US: +18338230586

    Financial calendar

    Publication of the Annual Report 2020                                                                    April 27, 2021

    Interim Report for the period January 1 - March 31, 2021                                      May 13, 2021

    Interim Report for the period January 1 - June 30, 2021                                    August 19, 2021

    Interim Report for the period January 1 - September 30, 2021                     November 18, 2021

    Year-end Report for the period January 1 - December 31, 2021                     February 24, 2022

    For further information, please contact:

    Renée Aguiar-Lucander, CEO at Calliditas

    Email: renee.lucander@calliditas.com

    Mikael Widell, Investor Relations

    Email: mikael.widell@calliditas.com

    Telephone: +46 703 11 99 60

    The information in the press release is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 07:00 CET on February 18, 2021.

    About Calliditas Therapeutics

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to conduct clinical trials with NOX inhibitors in PBC and oncology. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and The Nasdaq Global Select Market (NASDAQ: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, business 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, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, and other risks identified in the section entitled "Risk Factors" 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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  24. STOCKHOLM, Feb. 4, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") today announced that the first patient has been dosed in the global open-label extension (OLE) of the Phase 3 NefIgArd study. OLE offers a 9-month treatment with Nefecon to all qualifying patients who have completed the NefIgArd study and will evaluate the efficacy and safety of Nefecon treatment in patients with IgA Nephropathy (IgAN).

    This study will evaluate patients who have completed the Phase 3 study NefIgArd, which achieved both its primary and key secondary endpoints in the Part A topline data read out on November 8, 2020. All patients will continue on RAS inhibitor therapy (ACEs and/or ARBs) and be treated for 9 months with Nefecon in the OLE study…

    STOCKHOLM, Feb. 4, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") today announced that the first patient has been dosed in the global open-label extension (OLE) of the Phase 3 NefIgArd study. OLE offers a 9-month treatment with Nefecon to all qualifying patients who have completed the NefIgArd study and will evaluate the efficacy and safety of Nefecon treatment in patients with IgA Nephropathy (IgAN).

    This study will evaluate patients who have completed the Phase 3 study NefIgArd, which achieved both its primary and key secondary endpoints in the Part A topline data read out on November 8, 2020. All patients will continue on RAS inhibitor therapy (ACEs and/or ARBs) and be treated for 9 months with Nefecon in the OLE study.

    At the end of the treatment period, change in urine protein to creatinine ratio (UPCR) and change in estimated glomerular filtration rate (eGFR) will be evaluated. Further, a comparison between treatment naïve and those patients who received Nefecon in the Phase 3 NefIgArd study will be made. Three months after completion of treatment, all patients have a scheduled follow up visit.

    "This trial will provide us with information regarding retreatment and will add to the sizeable data set of patients which have already completed efficacy and safety related trials with Nefecon.  We are also glad to be able to provide the active drug to all patients having completed the NefIgArd trial, irrespective of treatment arm, following the positive topline data readout in Part A of the NefIgArd study showing stabilization of eGFR in the treatment arm at 36 weeks", said CEO Renée Aguiar-Lucander.

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas

    Tel.: +44 7955129845, email: marie.galay@calliditas.com

    The information was sent for publication, through the agency of the contact persons set out above, on February 4, 2021 at 8:30 a.m. CET.

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to conduct clinical trials with NOX inhibitors in PBC and oncology. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and The Nasdaq Global Select Market (NASDAQ:CALT).

    About Nefecon

    Nefecon is a patented oral formulation of a potent and well-known active substance - budesonide - for targeted release. The formulation is designed to deliver the drug to the Peyer's patch region of the lower small intestine, where the disease originates, as per the predominant pathogenesis models. Nefecon is derived from the TARGIT technology, which allows for the substance to pass through the stomach and intestine without being absorbed, and to be released in a pulse like fashion only when it reaches the lower small intestine.

    The combination of dose and optimized release profile is required to be effective in patients with IgA nephropathy, as shown in a large Phase 2b trial, completed by the company. In addition to its potent local effect, another advantage of using this active substance is that it has very low bioavailability, i.e. around 90% of it is inactivated in the liver before it reaches the systemic circulation. This means that a high concentration can be applied locally where needed but with only very limited systemic exposure and side effects.

    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 regulatory pathway for Nefecon, plans for submissions for marketing approvals, plans and strategies for commercialization of Nefecon, if approved, the conduct of Part B of the NefIgArd clinical trial and the OLE clinical trial, Calliditas' strategy, business 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 regulatory filings submissions for Nefecon, the continuation of Part B of the NefIgArd study and the OLE study, Calliditas'' business, operations, 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 and other filings 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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  25. STOCKHOLM, Jan. 28, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX - CALTX; Nasdaq - CALT) today announced that despite significant interest, it will not pursue the previously announced proposed global offering due to deterioration in market conditions.

    "This was an opportunistic capital raise against the backdrop of a strong overall market and communicated support from institutions. However, following the sudden and significant market deterioration seen yesterday, we no longer believe that it is in the interest of the company and its current shareholders to pursue the financing at this time," said Renée Aguiar-Lucander, CEO of Calliditas Therapeutics.

    "Calliditas is well capitalized with a cash runway into…

    STOCKHOLM, Jan. 28, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX - CALTX; Nasdaq - CALT) today announced that despite significant interest, it will not pursue the previously announced proposed global offering due to deterioration in market conditions.

    "This was an opportunistic capital raise against the backdrop of a strong overall market and communicated support from institutions. However, following the sudden and significant market deterioration seen yesterday, we no longer believe that it is in the interest of the company and its current shareholders to pursue the financing at this time," said Renée Aguiar-Lucander, CEO of Calliditas Therapeutics.

    "Calliditas is well capitalized with a cash runway into Q3 of 2022 and we believe there are financing options which are more attractive than an equity issuance in the present volatile market circumstances. This decision does not have any impact on the our previously communicated plans with regards to our operations or development pipeline."

    For further information, please contact:

    Renée Aguiar-Lucander, CEO at Calliditas

    Tel.: +46 722 52 10 06, e-mail: renee.lucander@calliditas.com

    Marie Galay, Corporate Communications and IR

    Tel.: +44 7955 129 845, e-mail: marie.galay@calliditas.com

    The information in the press release is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons above, on January 28, 2021 at 2:40 p.m (CET).

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to conduct clinical trials with NOX inhibitors in PBC and oncology. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and The Nasdaq Global Select Market (NASDAQ:CALT).

    Safe Harbor/Forward-Looking Statements

    This announcement contains forward-looking statements, including as to the Company's capital requirements and expected cash runway. These statements are based on expectations in light of the information that is currently available, as well as assumptions that are subject to risks and uncertainties that could cause actual results to differ materially from such statements. These risks and uncertainties include, but are not limited to, domestic and international economic conditions, industry and market conditions, and changes of interest rate and currency exchange rate, in general, and completion and discontinuation of clinical trials, obtaining regulatory approvals, claims and concerns about product safety and efficacy, technological advances, domestic and foreign healthcare reforms, and changes of laws and regulations, in particular, with respect to Nefecon and setanaxib. Calliditas disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. This announcement contains information on pharmaceuticals (including pharmaceuticals under development) but is not intended to, and does not, make any representations, warranties or claims regarding the efficacy or effectiveness of these pharmaceuticals or provide medical advice of any kind.

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  26. STOCKHOLM, Jan. 26, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX: CALTX) (NASDAQ:CALT) will today launch a proposed public offering of American Depositary Shares ("ADSs"), in the United States for trading on The Nasdaq Global Select Market in the United States (the "U.S. Offering") and a concurrent private placement of common shares to certain qualified investors in Europe and other countries outside of the United States (the "Private Placement", and together with the U.S. Offering, the "Global Offering"). The target size of the Global Offering is 4,500,000 common shares plus a potential 30-day over-allotment option of 15 percent of the common shares (including common shares in the form of ADSs) offered by

    STOCKHOLM, Jan. 26, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX: CALTX) (NASDAQ:CALT) will today launch a proposed public offering of American Depositary Shares ("ADSs"), in the United States for trading on The Nasdaq Global Select Market in the United States (the "U.S. Offering") and a concurrent private placement of common shares to certain qualified investors in Europe and other countries outside of the United States (the "Private Placement", and together with the U.S. Offering, the "Global Offering"). The target size of the Global Offering is 4,500,000 common shares plus a potential 30-day over-allotment option of 15 percent of the common shares (including common shares in the form of ADSs) offered by Calliditas at the U.S. Offering price. The Global Offering is subject to market conditions and investor demand and the number of ADSs (which represents two common shares) and common shares that may be offered and the price for such instruments have not yet been determined.

    Calliditas announces that it has today commenced an underwritten global offering with a target size of 4,500,000 common shares, plus a potential 30-day over-allotment of 15 percent of the common shares (including common shares in the form of ADSs) offered by Calliditas at the U.S. Offering price.

    Calliditas will announce the outcome of the Global Offering after pricing in a subsequent press release; however, any further details regarding the offering remain subject to market conditions and investor demand and the Global Offering may not be consummated. Calliditas' common shares are currently listed on Nasdaq Stockholm under the symbol "CALTX", and Calliditas' ADSs are currently listed on The Nasdaq Global Select Market under the symbol "CALT". 

    This company announcement does not constitute an offer to sell nor a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    A registration statement relating to the ADSs referred to herein has been filed with the SEC, but has not yet been declared effective. These ADSs may not be sold, nor may offers to buy these ADSs be accepted prior to the time such registration statement becomes effective. Citigroup Global Markets Inc., Jefferies LLC and Stifel, Nicolaus & Company, Incorporated are acting as the global coordinators and joint book-running managers of the Global Offering. Kempen & Co, LifeSci Capital LLC and Carnegie will act as co-managers for the Global Offering. Citigroup Global Markets Inc. and Jefferies LLC are acting as representatives of the underwriters in the U.S. Offering. Citigroup Global Markets Limited, Jefferies International Limited and Jefferies GmbH are acting as representatives of the underwriters in the Private Placement. Copies of the preliminary prospectus related to the U.S. Offering are available at www.sec.gov. Alternatively, copies of the preliminary prospectus relating to the U.S. Offering may be obtained from Citigroup Global Markets Inc., Attention: Prospectus Department, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by telephone at +1 (800) 831-9146; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, via telephone: +1 877-821-7388 or via email: Prospectus_Department@Jefferies.com or from Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, or by telephone at +1 (415) 364-2720 or by email at syndprospectus@stifel.com.

    For further information, please contact:

    Renée Aguiar-Lucander, CEO at Calliditas

    Tel.: +46 722 52 10 06, e-mail: renee.lucander@calliditas.com

    Marie Galay, Corporate Communications and IR

    Tel.: +44 7955 129 845, e-mail: marie.galay@calliditas.com

    The information in the press release is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons above, on January 26, 2021 at 10:10 p.m (CET).

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to conduct clinical trials with NOX inhibitors in PBC and oncology. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and The Nasdaq Global Select Market (NASDAQ:CALT).

    Important information

    No announcements or information regarding the proposed public offering may be disseminated to the public in jurisdictions where a prior registration or approval is required for such purpose. No steps have been taken, or will be taken, for the offering of common shares or ADSs in any jurisdiction where such steps would be required. The issue or sale of common shares or ADSs, and the subscription for or purchase of common shares or ADSs, are subject to special legal or statutory restrictions in certain jurisdictions. Calliditas is not liable if these restrictions are not complied with by any other person.

    This press release is not a prospectus for the purposes of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 (the "Prospectus Regulation") and has not been approved by any regulatory authority in any jurisdiction. Calliditas has not authorized any offer to the public of shares or rights in any member state of the EEA and no prospectus has been or will be prepared in connection therewith. In any EEA member state, this communication is only addressed to and is only directed at qualified investors in that member state within the meaning of the Prospectus Regulation.

    In the United Kingdom, this document and any other materials in relation to the securities described herein is only being distributed to, and is only directed at, and any investment or investment activity to which this document relates is available only to, and will be engaged in only with, "qualified investors" who are (i) persons having professional experience in matters relating to investments who fall within the definition of "investment professionals" in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order"); or (ii) high net worth entities falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as "relevant persons"). In the United Kingdom, any investment or investment activity to which this communication relates is available only to, and will be engaged in only with, relevant persons. Persons who are not relevant persons should not take any action on the basis of this document and should not act or rely on it.

    Safe Harbor/Forward-Looking Statements

    This announcement contains forward-looking statements, including as to the intended use of net proceeds from the Global Offering described herein and the timing of the closing of the Global Offering. These statements are based on expectations in light of the information that is currently available, as well as assumptions that are subject to risks and uncertainties that could cause actual results to differ materially from such statements. These risks and uncertainties include, but are not limited to, domestic and international economic conditions, industry and market conditions, and changes of interest rate and currency exchange rate, in general, and completion and discontinuation of clinical trials, obtaining regulatory approvals, claims and concerns about product safety and efficacy, technological advances, domestic and foreign healthcare reforms, and changes of laws and regulations, in particular, with respect to Nefecon and setanaxib. Calliditas disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. This announcement contains information on pharmaceuticals (including pharmaceuticals under development) but is not intended to, and does not, make any representations, warranties or claims regarding the efficacy or effectiveness of these pharmaceuticals or provide medical advice of any kind.

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  27. STOCKHOLM, Jan. 21, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX: CALTX) (NASDAQ:CALT) today announced that all 360 patients have been enrolled for the global Phase 3 clinical trial NefIgArd, which investigates the effect of Nefecon® versus placebo in patients with primary IgA nephropathy (IgAN).

    The NefIgArd trial consists of two parts: Part A and Part B. Part A, which forms the basis for potential regulatory submissions and approvals, provided data on the efficacy and safety of Nefecon. Calliditas read out positive topline data from Part A of the trial on 8 November 2020, announcing that the study met its primary endpoint, reduction in proteinuria, and key secondary endpoint stabilization of eGFR.  It…

    STOCKHOLM, Jan. 21, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX: CALTX) (NASDAQ:CALT) today announced that all 360 patients have been enrolled for the global Phase 3 clinical trial NefIgArd, which investigates the effect of Nefecon® versus placebo in patients with primary IgA nephropathy (IgAN).

    The NefIgArd trial consists of two parts: Part A and Part B. Part A, which forms the basis for potential regulatory submissions and approvals, provided data on the efficacy and safety of Nefecon. Calliditas read out positive topline data from Part A of the trial on 8 November 2020, announcing that the study met its primary endpoint, reduction in proteinuria, and key secondary endpoint stabilization of eGFR.  It also showed that Nefecon was generally well-tolerated.

    Part B is designed to be a confirmatory post-market approval observational trial to confirm long-term renal protection and assess the difference in kidney function between treated and placebo patients as measured by eGFR over a two-year period from the start of dosing of each patient. The 360-patient population of the Phase 3 trial includes the further 160 patients enrolled in addition to the 200 patients from Part A.  

    "To have fully enrolled our Phase 3 pivotal trial is a great milestone, even more so as we achieved this during the pandemic, which reflects the commitment of investigators and patients, as well as that of our experienced clinical team." said Renée Aguiar-Lucander, CEO of Calliditas Therapeutics.

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas

    Tel.: +44 79 55 98 12 45, email: marie.galay@calliditas.com

    The information was sent for publication, through the agency of the contact persons set out above, on January 21, 2021 at 08:30 a.m. CET.

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

    About Nefecon

    Nefecon is a patented oral formulation of a potent and well-known active substance - budesonide - for targeted release. The formulation is designed to deliver the drug to the Peyer's patch region of the lower small intestine, where the disease originates, as per the predominant pathogenesis models. Nefecon is derived from the TARGIT technology, which allows for the substance to pass through the stomach and intestine without being absorbed, and to be released in a pulse like fashion only when it reaches the lower small intestine.

    The combination of dose and optimized release profile is required to be effective in patients with IgA nephropathy, as shown in a large Phase 2b trial, completed by the company. In addition to its potent local effect, another advantage of using this active substance is that it has very low bioavailability, i.e. around 90% of it is inactivated in the liver before it reaches the systemic circulation. This means that a high concentration can be applied locally where needed but with only very limited systemic exposure and side effects.

    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 regulatory pathway for Nefecon, plans for submissions for marketing approvals, plans and strategies for commercialization of Nefecon, if approved, the conduct of Part B of the NefIgArd clinical trial, Calliditas' strategy, business 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 regulatory filings and submissions for Nefecon, the continuation and prospects for the success of Part B of the NefIgArd study, Calliditas'' business, operations, 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 and other filings 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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  28. STOCKHOLM, Jan. 20, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX - CALTX) (NASDAQ - CALT) today announced it will provide information on the near-term clinical development plans for setanaxib in primary biliary cholangitis (PBC) and oncology. It will also present additional data from the Part A of the NefIgArd Phase 3 study, which recently reported positive data.  

    In Q4 of 2020 Calliditas acquired a controlling stake in Genkyotex, which has been developing a first in class platform for NOX inhibition and where the lead compound, setanaxib has been tested in various fibrosis related indications. Following the positive results from the Phase 1 study in January of 2021, which evaluated higher doses of setanaxib…

    STOCKHOLM, Jan. 20, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX - CALTX) (NASDAQ - CALT) today announced it will provide information on the near-term clinical development plans for setanaxib in primary biliary cholangitis (PBC) and oncology. It will also present additional data from the Part A of the NefIgArd Phase 3 study, which recently reported positive data.  

    In Q4 of 2020 Calliditas acquired a controlling stake in Genkyotex, which has been developing a first in class platform for NOX inhibition and where the lead compound, setanaxib has been tested in various fibrosis related indications. Following the positive results from the Phase 1 study in January of 2021, which evaluated higher doses of setanaxib in healthy volunteers, Calliditas is planning to initiate a pivotal Phase 2/3 study in PBC, starting in 2H 2021, with final design and protocol details subject to feedback from the US Food and Drug Administration (FDA). In addition, Calliditas plans to initiate a Phase 2 proof-of-concept study in head and neck cancer this year which will study administration of setanaxib in conjunction with immunotherapy targeting CAFs (cancer associated fibroblasts).

    Calliditas will also provide select data from the recently concluded Part A of the Phase 3 study NefIgArd with the lead candidate drug Nefecon, for the treatment of IgA Nephropathy. The data to be presented include overall baseline characteristics, rate of discontinuation of study treatment (9.5%) and rate of discontinuation from the study (3.5%). It is also confirmed that no adverse clinical effects were seen with regards to weight gain, blood pressure or HbA1c, reflecting a safety profile in keeping with the Phase 2b trial. 

    In addition, presentations on the regulatory submission process, market access and commercial preparations in the US will be included.

    The R&D Day will take place between 1pm and 5pm CET today and will be webcast live and accessible at: https://tv.streamfabriken.com/calliditas-therapeutics-cmd-january-2021.

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas

    Tel.: +44 79 55 98 12 45, email: marie.galay@calliditas.com

    The information in the press release is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was sent for publication, through the agency of the contact persons set out above, on January 20, 2021 at 08:00 a.m. CET.

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.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 regulatory pathway for setanaxib, development plans for setanaxib, plans for the conduct of and likelihood of success of clinical trials of setanaxib, the regulatory pathway for Nefecon, the conduct of and likelihood of success of ongoing clinical trials of Nefecon, plans for submissions for marketing approvals, plans and strategies for commercialization of Nefecon, if approved, Calliditas' strategy, business 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 regulatory submissions for Nefecon, the continuation of Part B of the NefIgArd study, the initiation, timing for completion, and results of any clinical trials with setanaxib, Calliditas' business, operations, 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 and other filings 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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  29. STOCKHOLM, Jan. 18, 2021 /PRNewswire/ -- Genkyotex SA, a subsidiary of Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX - CALTX; NASDAQ - CALT), today announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex's lead asset.

    The Phase 1 study demonstrated that setanaxib is well tolerated at the doses tested, with no safety signal or dose-limiting toxicity being identified.  The results provide an opportunity for the company to pursue a pivotal Phase 2/3 clinical trial in patients with primary biliary cholangitis (PBC), based on interactions with the FDA.  The study assessed the safety and pharmacokinetics of oral setanaxib at selected doses in 46 healthy adult male…

    STOCKHOLM, Jan. 18, 2021 /PRNewswire/ -- Genkyotex SA, a subsidiary of Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX - CALTX; NASDAQ - CALT), today announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex's lead asset.

    The Phase 1 study demonstrated that setanaxib is well tolerated at the doses tested, with no safety signal or dose-limiting toxicity being identified.  The results provide an opportunity for the company to pursue a pivotal Phase 2/3 clinical trial in patients with primary biliary cholangitis (PBC), based on interactions with the FDA.  The study assessed the safety and pharmacokinetics of oral setanaxib at selected doses in 46 healthy adult male and female subjects.  The trial consisted of a single ascending dose (SAD) part and a multiple ascending dose (MAD) part with dosing up to 1600mg/day.

    Previously, doses of up to 800 mg/day were evaluated in a 24-week Phase 2 trial in PBC patients. In that trial, setanaxib dosed at 800 mg/day achieved reductions in markers of cholestasis, including alkaline phosphatase, and in multiple non-invasive markers of liver fibrogenesis, including liver stiffness and PRO-C3 and C3M. Significant improvement in fatigue was also achieved. All doses tested in that trial were well-tolerated, with no safety signal compared to placebo.

    "This result provides a foundation for a clinical development program using higher doses of setanaxib across a variety of orphan indications.  This includes the potential to launch a pivotal phase 2/3 trial with a clearly differentiated drug candidate in PBC but will also allow us to further explore a select number of kidney related orphan diseases in which inflammation and fibrosis play a part.", said CEO Renée Aguiar-Lucander.

    Calliditas acquired 62.7% of the share capital and voting rights of Genkyotex, in November 2020, before submitting a simplified public mandatory offer to the shareholders of Genkyotex on 26 November 2020. Calliditas controls 86.2% of the share capital and total number of votes of Genkyotex.

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas

    Tel.: +44 79 55 98 12 45, email: marie.galay@calliditas.com

    The information was sent for publication, through the agency of the contact persons set out above, on January 18, 2021 at 08:00 a.m. CET.

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

    About Genkyotex

    Genkyotex (Euronext Paris and Brussels: GKTX) is a leader in NOX therapies. Its unique therapeutic approach is based on a selective inhibition of NOX enzymes, which amplify disease processes such as fibrosis, inflammation, pain processing, cancer development, and neurodegeneration. Genkyotex's discovery platform enables the identification of orally available small-molecules that selectively inhibit specific NOX enzymes. From this, Genkyotex has developed a pipeline of first-in-class product candidates targeting one or multiple NOX enzymes. The lead product candidate setanaxib, a NOX1 and NOX4 inhibitor, demonstrated clinical evidence of anti-fibrotic activity in liver fibrosis and improvement of fatigue in patients in a Phase II trial in primary biliary cholangitis (PBC, a fibrotic orphan disease). Setanaxib is also being evaluated in investigator-initiated Phase II clinical trials in Type 1 Diabetes and in idiopathic pulmonary fibrosis (IPF), a chronic lung disease that results in fibrosis of the lungs.

    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 regulatory pathway for setanaxib, development plans for setanaxib, plans for the conduct of and likelihood of success of planned and ongoing clinical trials of setanaxib, Calliditas' strategy, business 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 regulatory filings submissions for setanaxib, the ongoing and planned clinical trials of setanaxib, Calliditas' business, operations, 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 and other filings 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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  30. STOCKHOLM, Jan. 15, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX - CALTX) (NASDAQ - CALT) today announced the program for the upcoming virtual R&D Day for investors, analysts and journalists on January 20, 2021, which will take place between 1pm and 5pm CET. The R&D Day will feature presentations from executive management and Key Opinion Leaders and will be webcast live and accessible at: https://tv.streamfabriken.com/calliditas-therapeutics-cmd-january-2021.

    The agenda will be as follows:

    1:00pm

    Introduction & Corporate overview

    CEO Renée Aguiar-Lucander

    1:20pm

    Pathophysiology of IgA nephropathy & Nefecon Clinical Biomarker Data

    Professor Jonathan Barratt

    1:40pm

    A Review of the Phase 3 NefIgArd Trial Data

    STOCKHOLM, Jan. 15, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX - CALTX) (NASDAQ - CALT) today announced the program for the upcoming virtual R&D Day for investors, analysts and journalists on January 20, 2021, which will take place between 1pm and 5pm CET. The R&D Day will feature presentations from executive management and Key Opinion Leaders and will be webcast live and accessible at: https://tv.streamfabriken.com/calliditas-therapeutics-cmd-january-2021.

    The agenda will be as follows:

    1:00pm

    Introduction & Corporate overview

    CEO Renée Aguiar-Lucander

    1:20pm

    Pathophysiology of IgA nephropathy & Nefecon Clinical Biomarker Data

    Professor Jonathan Barratt

    1:40pm

    A Review of the Phase 3 NefIgArd Trial Data

     CMO Dr Richard Phillipson

    2:00pm

    Commentary on the NefIgArd Phase 3 Data

    Professor Jonathan Barratt

    2:10pm

    Regulatory Review of Nefecon

    Vice President of Regulatory Affairs Frank Bringstrup

    2:20pm

    Live Q&A Session

    Professor Jonathan Barratt, Dr Richard Phillipson & Frank Bringstrup

    2:40pm

    Market Access & Preparations for Commercialization in the USA

     Head of North America Commercial, Andrew Udell, & Vice President Market Access, Christopher Ngai

    3:10pm

    Live Q&A Session

    Andrew Udell and Christopher Ngai

    3:20pm

    Overview of NOX Inhibitors

    Calliditas' Medical Advisor, Dr Philippe Wiesel

    3:40pm

    Setanaxib - Applications in Oncology

    Professor Gareth Thomas                                               

    4:00pm

    Clinical Development - Pipeline Review

    Dr Richard Phillipson

    4:15pm

    Positioning overview

    Renée Aguiar-Lucander

    4:25pm

     Live Q&A Session

     Dr Philippe Wiesel, Professor Gareth Thomas, Dr Richard Phillipson & Renée Aguiar-Lucander                                            

    4:45pm

     Closing Summary

     Renée Aguiar-Lucander, Fredrik Johansson, CFO

                                                   

    5:00pm

    End







    The presentations will be made available on the company's website after the end of the meeting. Please note that the Q&A Sessions will only be available to view live.

    KOL Biographies:

    Professor Jonathan Barratt leads the Renal Research Group within the College of Life Sciences, University of Leicester. His research interests span a range of areas across renal medicine and include glomerular disease, multi-system renal disease and complications of chronic kidney disease, in particular renal associated anemia. He is the IgA nephropathy Rare Disease Group lead for the UK National Registry of Rare Kidney Diseases (RaDaR) and a member of the steering committee for the International IgA Nephropathy Network. He is also a Chief Investigator for five international randomized controlled clinical trials in IgA nephropathy, and has attended both the FDA and EMA as an expert witness for new therapies in IgA nephropathy. He is a member of the FDA and American Society of Nephrology Kidney Health Initiative: Identifying Surrogate Endpoints for Clinical Trials in IgA Nephropathy Work group.

    Professor Gareth J. Thomas is Chair and Professor of Experimental Pathology at University Hospital Southampton NHS Foundation. He leads a group that investigates the effect of the tumor microenvironment on tumor development and progression, particularly the role of cancer-associated fibroblasts in regulating immune escape and tumor invasion. Prior to his current position, Gareth Thomas was Professor of Oral Pathology and Consultant in Oral and Maxillofacial Pathology at Bart's and the London. Gareth Thomas trained in Oral & Maxillofacial Pathology at University College Hospital, London and undertook his PhD as an MRC Clinical Fellow at University College London and the Richard Dimblebey Department of Cancer Research.

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas

    Tel.: +44 79 55 98 12 45, email: marie.galay@calliditas.com

    The information was sent for publication, through the agency of the contact persons set out above, on January 15, 2021 at 9:00 a.m. CET.

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

     

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  31. STOCKHOLM, Dec. 16, 2020 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX - CALTX; NASDAQ - CALT) submitted a simplified public mandatory offer to the shareholders of Genkyotex on 26 November 2020. After the end of the acceptance period on December 11, Calliditas now controls 86.2 percent of the shares in Genkyotex.

    Calliditas acquired 7,236,515 ordinary shares in Genkyotex SA ("Genkyotex") (Euronext Paris & Brussels: FR0013399474 - GKTX) on November 3, 2020, corresponding to 62.7 percent of the share capital and voting rights, from Genkyotex's largest shareholders and management group. On November 26, 2020, Calliditas submitted a simplified public mandatory cash offer of EUR 2.80 and non-transferable contingent rights…

    STOCKHOLM, Dec. 16, 2020 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX - CALTX; NASDAQ - CALT) submitted a simplified public mandatory offer to the shareholders of Genkyotex on 26 November 2020. After the end of the acceptance period on December 11, Calliditas now controls 86.2 percent of the shares in Genkyotex.

    Calliditas acquired 7,236,515 ordinary shares in Genkyotex SA ("Genkyotex") (Euronext Paris & Brussels: FR0013399474 - GKTX) on November 3, 2020, corresponding to 62.7 percent of the share capital and voting rights, from Genkyotex's largest shareholders and management group. On November 26, 2020, Calliditas submitted a simplified public mandatory cash offer of EUR 2.80 and non-transferable contingent rights, per share to the remaining shareholders in Genkyotex. In the final outcome after the acceptance period, 2,885,161 shares have been tendered into the offer. As result Calliditas controls a total of 10,121,676 shares in Genkyotex, which corresponds to 86.2 percent of the share capital and the total number of votes in Genkyotex.

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas

    Tel.: +44 7955129845, email: marie.galay@calliditas.com

    The information was sent for publication, through the agency of the contact persons set out above, on December 16, 2020 at 5.45 p.m. CET.

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 trial within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.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 regulatory pathway for Nefecon, plans for submissions for marketing approvals, plans and strategies for commercialization of Nefecon, if approved, the conduct of Part B of the NefIgArd clinical trial, Calliditas' strategy, business 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 regulatory filings submissions for Nefecon, the continuation of Part B of the NefIgArd study, Calliditas'' business, operations, 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 and other filings 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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  32. STOCKHOLM, Dec. 10, 2020 /PRNewswire/ -- The winner of this year's SwedenBIO Award was announced on Wednesday December 9th. Calliditas Therapeutics AB (publ) ("Calliditas") received the award in recognition of its successful clinical development program of Nefecon, which culminated in the recent positive topline data readout of the pivotal Phase 3 NefIgArd trial.

    SwedenBio annually awards this prize to a company which has excelled in terms of R&D, business development and growth whilst contributing to societal benefit.

    "This year's winner has shown impressive professionalism and staying power with regards to the development of a completely new treatment for patients with IgA Nephropathy, a disease which lacks approved treatments today. With…

    STOCKHOLM, Dec. 10, 2020 /PRNewswire/ -- The winner of this year's SwedenBIO Award was announced on Wednesday December 9th. Calliditas Therapeutics AB (publ) ("Calliditas") received the award in recognition of its successful clinical development program of Nefecon, which culminated in the recent positive topline data readout of the pivotal Phase 3 NefIgArd trial.

    SwedenBio annually awards this prize to a company which has excelled in terms of R&D, business development and growth whilst contributing to societal benefit.

    "This year's winner has shown impressive professionalism and staying power with regards to the development of a completely new treatment for patients with IgA Nephropathy, a disease which lacks approved treatments today. With positive Phase 3 results in place, preparations for a submission for regulatory approval and subsequent commercialization in the US are now underway," said Lars Adlersson, Chairman of SwedenBIO.

    The SwedenBIO Award aims to increase visibility for the life science industry by drawing attention to and rewarding successful and exemplary member companies that have particularly excelled and contributed to positive attention for the industry. A record number of companies were nominated for this year's award.

    "We are delighted to have been selected for this prestigious award, which recognizes the Company's longstanding commitment to addressing a significant unmet medical need for patients with IgA Nephropathy. We look forward to continuing to build on this success to deliver solutions to patients with orphan diseases", said CEO Renée Aguiar-Lucander.

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas

    Tel.: +44 79 55 98 12 45, email: marie.galay@calliditas.com

    The information was sent for publication, through the agency of the contact persons set out above, on December 10, 2020 at 08:00 a.m. CET.

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

     

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  33. STOCKHOLM, Dec. 9, 2020 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") today announced that the company will host a Capital Markets Day in Stockholm, Sweden, on January 20, 2021 for investors, analysts and media.

    Presentations will be made by members of Calliditas' management team as well as invited key opinion leaders. The program will include an overview of the company's clinical development program, with a review of the recent successful topline data readout from the Phase 3 clinical study NefIgArd; the lead candidate drug Nefecon's regulatory path towards potential market approval; an update on preparations for US commercialization; and updates on the pipeline. There will be moderated Q&A sessions following the presentations…

    STOCKHOLM, Dec. 9, 2020 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") today announced that the company will host a Capital Markets Day in Stockholm, Sweden, on January 20, 2021 for investors, analysts and media.

    Presentations will be made by members of Calliditas' management team as well as invited key opinion leaders. The program will include an overview of the company's clinical development program, with a review of the recent successful topline data readout from the Phase 3 clinical study NefIgArd; the lead candidate drug Nefecon's regulatory path towards potential market approval; an update on preparations for US commercialization; and updates on the pipeline. There will be moderated Q&A sessions following the presentations.

    The program will run from 1:00 p.m. CET to 5:00 p.m. CET and will be accessible through a webcast via the company's website.

    The Capital Markets Day will be held in English. The presentations will be available on the company's website after the event. Further details will follow shortly.

    If you wish to register now, please send an email to finance@calliditas.com

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas

    Tel.: +44 79 55 98 12 45, email: marie.galay@calliditas.com

    The information was sent for publication through the agency of the contact persons set out above, on December 9, 2020 at 1:00 p.m. CET.

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

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  34. SHANGHAI, China, Dec. 02, 2020 (GLOBE NEWSWIRE) -- Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, today announced that the China Center for Drug Evaluation, National Medical Products Administration (CDE, NMPA) has recommended Breakthrough Therapy Designation (BTD) for Nefecon for the treatment of IgA nephropathy (IgAN).

    Nefecon is a potential first-in-disease, oral, targeted-release formulation of budesonide and is currently being investigated in a Phase 3 global registrational study, NefIgArd, to evaluate its efficacy and safety in patients with primary…

    SHANGHAI, China, Dec. 02, 2020 (GLOBE NEWSWIRE) -- Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, today announced that the China Center for Drug Evaluation, National Medical Products Administration (CDE, NMPA) has recommended Breakthrough Therapy Designation (BTD) for Nefecon for the treatment of IgA nephropathy (IgAN).

    Nefecon is a potential first-in-disease, oral, targeted-release formulation of budesonide and is currently being investigated in a Phase 3 global registrational study, NefIgArd, to evaluate its efficacy and safety in patients with primary IgAN. Everest is currently enrolling patients as part of the NefIgArd clinical trial to support approval for IgAN patients in China.  

    Everest Medicines' licensing partner, Calliditas Therapeutics AB (NASDAQ:CALT) ("Calliditas") reported positive topline results on November 8, 2020 from Part A of the global NefIgArd trial demonstrating Nefecon met its primary endpoint of a statistically significant reduction in urine protein creatinine ratio, or proteinuria, after 9 months of treatment, with significant continued improvement at 12 months. In addition, Nefecon has been granted Orphan Drug Designation for the treatment of IgAN by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).

    "We are thrilled that the CDE has recommended Breakthrough Therapy Designation for Nefecon, reinforcing its potential to serve as the first-ever therapeutic option for an estimated 2 million people living with IgAN in China," said Zhengying Zhu, PhD, Chief Medical Officer for Internal Medicine at Everest Medicines. "We look forward to working closely with the CDE to bring this innovative treatment to patients in China as quickly as possible."

    "Nefecon continues to experience rapid global clinical and regulatory advancements, and in just a few short months has achieved positive top-line data from the NefIgArd Phase 3 global registrational study, first patient dosed and continued enrollment and treatment in NefIgArd in China, and now recommendation for Breakthrough Therapy Designation in China," said Kerry Blanchard, MD, PhD, CEO of Everest Medicines. "We are encouraged by the pace and progress of this important global registrational clinical trial and are committed to accelerating Nefecon's late-stage development in order to bring this novel therapeutic to IgAN patients in China."

    BTD, which is part of the recently revised Drug Registration Regulation, is designed to expedite the development and review of therapies in China that are being developed for treatment of serious diseases for which there is no existing treatment and where preliminary evidence indicates advantages of the therapy over current available treatment options.

    About Nefecon

    Nefecon, an oral, targeted-release formulation of budesonide, is a potential first-in-disease product for the treatment of IgA nephropathy. This novel formulation delivers budesonide to the Peyer's patch in the ileum, which is responsible for the production of secretory immunoglobulin A (IgA). Treatment with Nefecon was previously demonstrated to cause a statistically significant reduction in proteinuria levels and stabilization of eGFR, compared to placebo, in a randomized, double-blind Phase 3 clinical trial conducted by our partner Calliditas Therapeutics AB (NASDAQ:CALT). Nefecon has been granted Orphan Drug Designation for the treatment of IgAN by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize Nefecon in Mainland China, Hong Kong, Macau, Taiwan and Singapore.

    About IgA Nephropathy

    IgA nephropathy (IgAN), a leading cause of chronic kidney disease (CKD) and renal failure, is a chronic, progressive, autoimmune disease associated with progressive renal impairment. A central finding in patients with lgAN is the presence of circulating and glomerular immune complexes comprised of galactose-deficient IgA1, an IgG autoantibody directed against the hinge region O-glycans, and C3. Glomerular sclerosis, renal interstitial fibrosis, renal dysfunction, proteinuria and hypertension are associated with disease progression. 50% of IgAN patients will develop end stage renal disease within 30 years. The standard of care for ESRD is dialysis or kidney transplant, which represents a significant health economic burden as well as a material impact on patients' quality of life. Currently, there are no approved treatments for IgAN in China and globally.

    About Everest Medicines

    Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of eight potentially global first-in-class or best-in-class molecules, many of which are in late stage clinical development. The Company's therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. For more information, please visit its website at www.everestmedicines.com.

    Everest Medicines

    Media in US and Europe:

    Darcie Robinson

    Vice President

    Westwicke PR

    (203) 919-7905

    darcie.robinson@icrinc.com

    Media in China:

    Edmond Lococo

    Managing Director

    ICR Asia

    +86 (10) 6583-7510

    edmond.lococo@icrinc.com



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  35. STOCKHOLM, Nov. 27, 2020 /PRNewswire/ -- Calliditas Therapeutics AB (publ.) publishes the nomination committee's composition for the AGM in 2021. 

    The nomination committee, which is appointed in accordance with the principles adopted by the extraordinary general meeting on September 14, 2017, consists of:

    · Patrick Sobocki, appointed by Stiftelsen Industrifonden

    · Spike Loy, appointed by BVF

    · Karl Tobieson, appointed by Linc AB

    · Elmar Schnee (chairman of the board of directors)

    The nomination committee shall, before the annual general meeting 2021, prepare a proposal for the election of chairman and other members of the board of directors, the election of chairman of the annual meeting, election of auditors, the determination of fees and…

    STOCKHOLM, Nov. 27, 2020 /PRNewswire/ -- Calliditas Therapeutics AB (publ.) publishes the nomination committee's composition for the AGM in 2021. 

    The nomination committee, which is appointed in accordance with the principles adopted by the extraordinary general meeting on September 14, 2017, consists of:

    · Patrick Sobocki, appointed by Stiftelsen Industrifonden

    · Spike Loy, appointed by BVF

    · Karl Tobieson, appointed by Linc AB

    · Elmar Schnee (chairman of the board of directors)

    The nomination committee shall, before the annual general meeting 2021, prepare a proposal for the election of chairman and other members of the board of directors, the election of chairman of the annual meeting, election of auditors, the determination of fees and matters pertaining thereto.

    For more information please visit:

    https://www.calliditas.se/en/nomination-committee-2314/

    Shareholders who wish to submit proposals to the nomination committee for the annual general meeting on May 27, 2021 can do so by e-mail to finance@calliditas.com. Proposals should be submitted to the nomination committee before April 5, 2021.

    For further information, please contact:

    Fredrik Johansson, CFO at Calliditas

    Email: fredrik.johansson@calliditas.com

    Telephone: +46 703 52 91 90

    The information was submitted for publication, through the agency of the contact person set out above, at 4.00 p.m on November 27, 2020.

    About Calliditas Therapeutics

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

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  36. Interim Report Q3, 2020

    STOCKHOLM, Nov. 12, 2020 /PRNewswire/ -- "On August 13th, we announced a €19.8m acquisition of a majority stake of 62.7% in Genkyotex, a publicly listed life science company in France. We are very excited about this acquisition, which complements our existing and long-standing focus on inflammatory disease. This provides us with a platform with anti-fibrotic and anti-inflammatory compounds, with which we believe can continue to address unmet medical need in orphan diseases and bring solutions to patients across many different therapeutic areas. We believe that we have significant opportunities to leverage this platform to the benefit of patients suffering from fibrotic diseases. We believe that the late stage development, CMC and regulatory…

    STOCKHOLM, Nov. 12, 2020 /PRNewswire/ -- "On August 13th, we announced a €19.8m acquisition of a majority stake of 62.7% in Genkyotex, a publicly listed life science company in France. We are very excited about this acquisition, which complements our existing and long-standing focus on inflammatory disease. This provides us with a platform with anti-fibrotic and anti-inflammatory compounds, with which we believe can continue to address unmet medical need in orphan diseases and bring solutions to patients across many different therapeutic areas. We believe that we have significant opportunities to leverage this platform to the benefit of patients suffering from fibrotic diseases. We believe that the late stage development, CMC and regulatory expertise which exists in Calliditas can significantly support and enhance the important fundamentals put in place by Genkyotex. We are confident that this will be value driving, for all the company's stakeholders, over the near and medium term.

    After the close of the quarter, on November 8th, we reported positive topline results from Part A of our pivotal Phase 3 trial, NefIgArd. The strong data set confirms the results seen in the successful Phase 2b trial and provides further support for locally treating IgAN at the source, offering patients hope of disease modification. We will now assemble the regulatory file and submit for accelerated approval with the FDA and conditional approval with EMA, which is planned for Q1 and H1 respectively next year."

    Renée Aguiar-Lucander, CEO

    Summary of Q3 2020

    July 1 - September 30, 2020

    • No net sales were recognized for the three months ended September 30, 2020 and 2019, respectively.
    • Operating loss amounted to SEK 104.9 million and SEK 52.6 million for the three months ended September 30, 2020 and 2019, respectively.
    • Loss before income tax amounted to SEK 137.9 million and SEK 50.1 million for the three months ended September 30, 2020 and 2019, respectively.
    • Loss per share before and after dilution amounted to SEK 2.77 and SEK 1.30, for the three months ended September 30, 2020 and 2019, respectively.
    • Cash amounted to SEK 1,396.9 million and SEK 805.1 million as of September 30, 2020 and 2019, respectively.

    Significant events during Q3 2020, in summary

    • In July 2020, Calliditas announced the exercise of the partial over-allotment option from the IPO on The Nasdaq Global Select Market. Calliditas was thereby provided with additional gross proceeds of approximately USD 6.9 million (approximately SEK 63 million) before deduction of issuance costs.
    • In August 2020, Calliditas announced it has reached an agreement to acquire a controlling interest in Genkyotex SA, a leader in NOX inhibition therapies.

    Significant events after the end of reporting period, in summary

    • In November 2020, Calliditas acquired a controlling interest in Genkyotex SA representing 62,7%.
    • In November 2020, Calliditas announced positive topline results from Part A from the pivotal Phase 3 NefIgArd trial.

    Investor Presentation November 12, 14:30 CET

    Audio cast with teleconference, Q3 2020, November 12, 2020, 14:30 (Europe/Stockholm)

    Webcast: https://tv.streamfabriken.com/calliditas-therapeutics-q3-2020  

    Teleconference: SE: +46856642707 UK: +443333009034 US: +18332498405

    Financial calendar

    Year-end report for the period January 1 - December 31, 2020  February 18, 2021

    Interim report for the period January 1 - March 31, 2021  May 13, 2021

    Interim report for the period January 1 - June 30, 2021  August 19, 2021

    Interim report for the period January 1 - September 30, 2021  November 18, 2021

    For further information, please contact:

    Renée Aguiar-Lucander, CEO at Calliditas

    Email: renee.lucander@calliditas.com

    Mikael Widell, Investor Relations

    Email: mikael.widell@calliditas.com

    Telephone: +46 703 11 99 60

    The information in the press release is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 07:00 CET on November 12, 2020.

    About Calliditas Therapeutics

    Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden. It is focused on developing high quality pharmaceutical products for patients with a significant unmet medical need in niche indications, in which the Company can partially or completely participate in the commercialization efforts. The Company is focused on the development and commercialization of the product candidate Nefecon, a unique two-step formulation optimized to combine a time lag effect with a concentrated release of the active substance budesonide, within a designated target area. This patented, locally acting formulation is intended for treatment of patients with the inflammatory renal disease IgA nephropathy (IgAN). Calliditas Therapeutics is running a global Phase 3 study within IgAN and aims to commercialize Nefecon in the US. The company is listed on Nasdaq Stockholm (TICKER:CALTX). Visit www.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, business 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, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, and other risks identified in the section entitled "Risk Factors" 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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  37. STOCKHOLM, Nov. 11, 2020 /PRNewswire/ -- On November 12, 2020, at 07:00 am CET, Calliditas Therapeutics ("Calliditas") will publish its business update for the third quarter 2020. Calliditas will also host a telephone conference, which will include a presentation of the results, on the same day at 2:30 pm CET. The event will be hosted by the company's CEO, Renée Aguiar-Lucander, and CFO Fredrik Johansson. The presentation will be held in English.

    The presentation will be live on the company's website during the call under Financial Reports and Presentations and will also be made available online after the call. To participate in the telephone conference, please use the dial-in details shown below:

    Dial-in numbers, SE: +46856642707 UK: +443333009034…

    STOCKHOLM, Nov. 11, 2020 /PRNewswire/ -- On November 12, 2020, at 07:00 am CET, Calliditas Therapeutics ("Calliditas") will publish its business update for the third quarter 2020. Calliditas will also host a telephone conference, which will include a presentation of the results, on the same day at 2:30 pm CET. The event will be hosted by the company's CEO, Renée Aguiar-Lucander, and CFO Fredrik Johansson. The presentation will be held in English.

    The presentation will be live on the company's website during the call under Financial Reports and Presentations and will also be made available online after the call. To participate in the telephone conference, please use the dial-in details shown below:

    Dial-in numbers, SE: +46856642707 UK: +443333009034 US: +18332498405

    A link to audio cast can be found on the Calliditas website under Financial Reports and Presentations or here:

    https://financialhearings.com/event/12809

    The information was released for public disclosure on November 11, 2020 at 11:00 a.m CET.

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas

    Tel.: +44 7955129845, email: marie.galay@calliditas.com

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

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  38. SHANGHAI, China, Nov. 10, 2020 (GLOBE NEWSWIRE) -- Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, announced today that its licensing partner, Calliditas Therapeutics AB (NASDAQ:CALT) ("Calliditas"), reported positive topline results from Part A of the global Phase 3 clinical trial NefIgArd, which analyzed the effect of Nefecon® versus placebo in 199 patients with primary IgA nephropathy (IgAN).

    The trial met its primary objective of demonstrating a statistically significant reduction in urine protein creatinine ratio, or proteinuria, after 9 months…

    SHANGHAI, China, Nov. 10, 2020 (GLOBE NEWSWIRE) -- Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, announced today that its licensing partner, Calliditas Therapeutics AB (NASDAQ:CALT) ("Calliditas"), reported positive topline results from Part A of the global Phase 3 clinical trial NefIgArd, which analyzed the effect of Nefecon® versus placebo in 199 patients with primary IgA nephropathy (IgAN).

    The trial met its primary objective of demonstrating a statistically significant reduction in urine protein creatinine ratio, or proteinuria, after 9 months of treatment, with significant continued improvement at 12 months. The trial also met the key secondary endpoint showing a statistically significant difference in estimated glomerular filtration rate or eGFR after 9 months of treatment compared to placebo. The efficacy data indicated a significant and beneficial effect on key factors correlated to the progression to end stage renal disease (ESRD) for IgAN patients. In addition, results showed that Nefecon was generally well-tolerated.

    Based on these results, Calliditas plans to submit for accelerated approval with the US Food and Drug Administration (FDA) in Q1 2021 followed by a submission for conditional approval with the European Medicines Agency in H1 2021. An additional 160 patients are being recruited for inclusion in Part B of the trial, which is designed to be a confirmatory post-market approval observational trial to confirm long-term renal protection.

    In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize Nefecon in Mainland China, Hong Kong, Macau, Taiwan and Singapore. Everest is currently enrolling patients as part of the global Phase 3 clinical trial to support approval for IgAN patients in China.

    "We are very excited to see this strong set of data and look forward to building on these results as we continue to rapidly recruit patients with IgAN in China to support the NeflgArd trial," said Zhengying Zhu, Ph.D, Chief Medical Officer for Internal Medicine at Everest Medicines.

    "These encouraging data reinforce the potential for Nefecon to become the first approved treatment option for patients around the world with IgAN," said Kerry Blanchard, MD, PhD, CEO of Everest Medicines. "There are an estimated 2 million people in China living with IgAN and we are committed to advancing this trial and work to make this important therapy available to patients in China."

    About Nefecon

    Nefecon, an oral, targeted-release formulation of budesonide, is a potential first-in-disease product for the treatment of IgA nephropathy. This novel formulation delivers budesonide to the Peyer's patch in the ileum, which is responsible for the production of secretory immunoglobulin A. Treatment with Nefecon was previously demonstrated to cause a statistically significant reduction in proteinuria levels and stabilization of eGFR, compared to placebo, in a randomized, double-blind Phase 2b clinical trial conducted by our partner Calliditas Therapeutics AB (NASDAQ:CALT).   Nefecon has been granted Orphan Drug Designation for the treatment of IgAN by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize Nefecon in Mainland China, Hong Kong, Macau, Taiwan and Singapore.  

    About IgA Nephropathy

    IgA Nephropathy(IgAN) a leading cause of chronic kidney disease (CKD) and renal failure, is a chronic, progressive, autoimmune disease associated with progressive renal impairment. A central finding in patients with IgAN is the presence of circulating and glomerular immune complexes comprised of galactose-deficient IgA1, an IgG autoantibody directed against the hinge region O-glycans, and C3. Glomerular sclerosis, renal interstitial fibrosis, renal dysfunction, proteinuria and hypertension are associated with disease progression. 50% of IgAN patients will develop end stage renal disease within 30 years. The standard of care for ESRD is dialysis or kidney transplant, which represents a significant health economic burden as well as a material impact on patients' quality of life. Currently, there are no approved treatments for IgAN in China and globally.  

    About Everest Medicines

    Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of eight potentially global first-in-class or best-in-class molecules, many of which are in late stage clinical development. The Company's therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. For more information, please visit its website at www.everestmedicines.com.

    For further information, please contact:

    Everest Medicines

    Media in US and Europe:

    Darcie Robinson

    Vice President

    Westwicke PR

    (203) 919-7905

    darcie.robinson@icrinc.com



    Media in China:

    Edmond Lococo

    Managing Director

    ICR Asia

    +86 (10) 6583-7510

    edmond.lococo@icrinc.com

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  39. STOCKHOLM, Nov. 9, 2020 /PRNewswire/ -- On November 8, 2020, Calliditas announced positive topline results from Part A of the global Phase 3 clinical trial NefIgArd, which investigated the effect of Nefecon® versus placebo in patients with primary IgA nephropathy (IgAN). Calliditas will host a telephone conference with a presentation of the topline results today at 2:30 pm CET. The event will be hosted by the company's CEO, Renée Aguiar-Lucander and CMO, Richard Philipson. The presentation will be held in English.

    The presentation will be live on the company's website during the call under Financial Reports and Presentations and will also be made available online after the call. To participate in the telephone conference, please use the dial-in…

    STOCKHOLM, Nov. 9, 2020 /PRNewswire/ -- On November 8, 2020, Calliditas announced positive topline results from Part A of the global Phase 3 clinical trial NefIgArd, which investigated the effect of Nefecon® versus placebo in patients with primary IgA nephropathy (IgAN). Calliditas will host a telephone conference with a presentation of the topline results today at 2:30 pm CET. The event will be hosted by the company's CEO, Renée Aguiar-Lucander and CMO, Richard Philipson. The presentation will be held in English.

    The presentation will be live on the company's website during the call under Financial Reports and Presentations and will also be made available online after the call. To participate in the telephone conference, please use the dial-in details shown below:

    Dial-in number SE: +46850558358 UK: +443333009266 US: +18332498404

    A link to audio cast can be found on the Calliditas website under Financial Reports and Presentations or here:

    https://financialhearings.com/event/13377

    The information was released for public disclosure on November 9, 2020 at 10:00 CET.

    For further information, please contact:

    Marie Galay

    IR Manager

    Calliditas

    Tel.: +44-7955129845

    email: marie.galay@calliditas.com

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

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  40. STOCKHOLM, Nov. 9, 2020 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALTX) (NASDAQ:CALT) ("Calliditas") today announced positive topline results from Part A of the global Phase 3 clinical trial NefIgArd, which investigated the effect of Nefecon® versus placebo in patients with primary IgA nephropathy (IgAN).

    The trial met its primary objective of demonstrating a statistically significant reduction in urine protein creatinine ratio, UPCR or proteinuria, after 9 months of treatment with 16 mg of Nefecon compared to placebo, with significant continued improvement at 12 months. The trial also met the key secondary endpoint showing a statistically significant difference in estimated glomerular filtration rate or eGFR after 9 months of treatment…

    STOCKHOLM, Nov. 9, 2020 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ:CALTX) (NASDAQ:CALT) ("Calliditas") today announced positive topline results from Part A of the global Phase 3 clinical trial NefIgArd, which investigated the effect of Nefecon® versus placebo in patients with primary IgA nephropathy (IgAN).

    The trial met its primary objective of demonstrating a statistically significant reduction in urine protein creatinine ratio, UPCR or proteinuria, after 9 months of treatment with 16 mg of Nefecon compared to placebo, with significant continued improvement at 12 months. The trial also met the key secondary endpoint showing a statistically significant difference in estimated glomerular filtration rate or eGFR after 9 months of treatment with Nefecon compared to placebo. Collectively the efficacy data from 9 months treatment with 16 mg of Nefecon indicated a significant and beneficial effect on key factors correlated to the progression to end stage renal disease (ESRD) for IgAN patients. In addition, the trial showed that Nefecon was generally well-tolerated.

    On the basis of these results, Calliditas plans to submit for accelerated approval with the US Food and Drug Administration (FDA) in Q1 2021 followed by a submission for conditional approval with the European Medicines Agency in H1 2021. Subject to approval by the FDA, Calliditas intends to commercialize Nefecon for IgAN by itself in the United States and through collaborations in other regions. 

    "We are delighted with this strong data set which confirms the results seen in the Phase 2b trial and provides further support for effectively treating IgAN at its origin. Calliditas has been a pioneer in IgAN for many years and we are excited to be the only company to have reported out a positive Phase 3 trial in this indication. This result brings hope to thousands of patients who today have no approved treatment alternatives.", said CEO Renée Aguiar-Lucander.

    Topline Results

    The analysis included 199 patients diagnosed with primary IgA Nephropathy and who were on a background of optimised and stable renin-angiotensin system, or RAS inhibitor therapy. The patients were randomised in a 1:1 ratio into one of two treatment groups - Nefecon 16 mg/day or placebo - and treated orally for 9 months daily.

    24-hour UPCR (proteinuria) Data

    The primary endpoint analysis showed a 31% mean reduction in the 16 mg arm versus baseline, with placebo showing a 5% mean reduction versus baseline, resulting in a 27% mean reduction at 9 months (p=0.0005) of the 16 mg arm versus placebo.  

    eGFR Data

    The key secondary endpoint, eGFR, showed a treatment benefit of 7% versus placebo at 9 months, reflecting stabilisation in the treatment arm and a 7% decline of eGFR in the placebo arm (p=0.0029). This reflected an absolute decline of 4.04 ml/min/1.73m2 in the placebo group over 9 months compared to a 0.17 ml/min/1.73m2 decline in the treatment group.  

    Safety Profile

    The results indicate that Nefecon was generally well-tolerated and were consistent with the known safety profile of Budesonide. The number of withdrawals in the trial was significantly less than what was seen in the Phase 2b NEFIGAN trial.

    "I would like to thank all of the investigators, site staff and of course patients for their commitment and dedication to this important trial. I look forward to continuing this excellent work through completion of Part B of the trial," said Calliditas CMO, Dr. Richard Philipson.

    The NefIgArd trial is continuing on a blinded basis with patients continuing in the observational Part B of the trial for a 12 month follow up period post their completion of Part A. Calliditas is recruiting an additional 160 patients for inclusion in Part B during 2020 and aims to complete the recruitment in Q4 2020 or Q1 2021, depending on the impact of COVID-19.

    Trial Design

    The pivotal, global Phase 3 NefIgArd trial consists of two parts.

    Part A, which is the basis for potential regulatory submissions and approvals, provides data on the efficacy and safety of Nefecon. The first patient in the NefIgArd trial was randomized by Calliditas in November 2018, and in December 2019 Calliditas announced the full recruitment of Part A, across approximately 146 sites in 19 countries.

    Patients with biopsy-confirmed primary IgA Nephropathy (IgAN), over or at 18 years of age and with a total urine protein of ≥ 1g / day, were eligible to take part in the trial. The inclusion criteria also required patients to have an eGFR of ≥ 35 mL/min * 1.73m2 and ≤ 90 ml/min * 1.73m2. In the lead up to the trial, the patients had to be on optimised and stable RAS treatment for at least 3 months, and remain on optimised stable RAS blockade throughout the trial.

    Main exclusion criteria included secondary forms of IgAN, tuberculosis, kidney transplant, or treatment with high dose corticosteroids or immunosuppressants in the past 12 months.

    Following screening, patients were randomized into either oral placebo or a once-daily 16 mg oral dose of Nefecon. After receiving 9 months of daily double-blind treatment, there was a two-week tapering, during which patients on drug received a once-daily 8mg oral dose of Nefecon and patients in the placebo arm continued to receive oral placebo. Following tapering, there was a 10-week follow-up where no trial drug was administered and during which blinding remained in place.

    The primary endpoint for the trial is the effect of Nefecon on UPCR over 9 months compared to placebo, which is calculated from measured 24-hour urine samples. This is the same primary endpoint as the successful Phase 2b NEFIGAN trial. Secondary outcomes, assessed at various timepoints, include changes in eGFR, 24-hour urine protein excretion and urine albumin creatinine ratio (UACR).

    Part B is designed to be a confirmatory post-market approval observational trial to confirm long-term renal protection. This trial consists of 360 patients, where recruitment of the 160 patients required, in addition to the 200 patients from Part A, is ongoing. Calliditas expects to complete recruitment of these patients in Q4 2020 or Q1 2021, depending on the impact of COVID-19.

    Conference Call

    The Company will host a live webcast for investors on 14.30 CET Monday 9th of November. Details will be distributed prior to the conference call.

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas

    Tel.: +44 7955129845, email: marie.galay@calliditas.com

    Mikael Widell, Head of Communications and IR

    Tel.: +46 703 11 99 60, email: mikael.widell@calliditas.com

    The information in the press release is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was sent for publication, through the agency of the contact persons set out above, on November 8, 2020 at 12:45 p.m. CET.

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 trial within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

    About Nefecon

    Nefecon is a patented oral formulation of a potent and well-known active substance - budesonide - for targeted release. The formulation is designed to deliver the drug to the Peyer's patch region of the lower small intestine, where the disease originates, as per the predominant pathogenesis models. Nefecon is derived from the TARGIT technology, which allows for the substance to pass through the stomach and intestine without being absorbed, and to be released in a pulse like fashion only when it reaches the lower small intestine.

    The combination of dose and optimized release profile is required to be effective in patients with IgA nephropathy, as shown in a large Phase 2b trial, completed by the company. In addition to its potent local effect, another advantage of using this active substance is that it has very low bioavailability, i.e. around 90% of it is inactivated in the liver before it reaches the systemic circulation. This means that a high concentration can be applied locally where needed but with only very limited systemic exposure and side effects.

    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 regulatory pathway for Nefecon, plans for submissions for marketing approvals, plans and strategies for commercialization of Nefecon, if approved, the conduct of Part B of the NefIgArd clinical trial, Calliditas' strategy, business 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 regulatory filings submissions for Nefecon, the continuation of Part B of the NefIgArd study, Calliditas'' business, operations, 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 and other filings 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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  41. STOCKHOLM, Nov. 3, 2020 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX - CALTX; NASDAQ - CALT) today announced the closing of the acquisition of 62.7% of Genkyotex SA ("Genkyotex") (Euronext Paris & Brussels: FR0013399474 - GKTX) in an off-market transaction.

    On August 13, 2020, Calliditas announced that it had entered into an agreement to acquire 7,236,515 ordinary shares of Genkyotex from Genkyotex's largest shareholders and management team (the "Block Sellers"), representing 62.7% of the share capital and voting rights. Having now received clearance from the French Minister of Economy and Finance regarding foreign investments into France, Calliditas has closed the off-market block trade for a total consideration…

    STOCKHOLM, Nov. 3, 2020 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX - CALTX; NASDAQ - CALT) today announced the closing of the acquisition of 62.7% of Genkyotex SA ("Genkyotex") (Euronext Paris & Brussels: FR0013399474 - GKTX) in an off-market transaction.

    On August 13, 2020, Calliditas announced that it had entered into an agreement to acquire 7,236,515 ordinary shares of Genkyotex from Genkyotex's largest shareholders and management team (the "Block Sellers"), representing 62.7% of the share capital and voting rights. Having now received clearance from the French Minister of Economy and Finance regarding foreign investments into France, Calliditas has closed the off-market block trade for a total consideration of €19.8M in cash (€2.73 per ordinary share*) plus contingent rights payable upon regulatory approvals of setanaxib, Genkyotex's lead asset.

    Calliditas will now, in compliance with French and Belgian securities law, file with the French Financial Market Authority (Autorité des Marchés Financiers - the "AMF") a simplified mandatory cash tender offer for the remaining Genkyotex shares at €2.80 per ordinary share plus contingent rights payable upon regulatory approvals of setanaxib. The outcome from the tender offer, if approved by the AMF, is expected to be reported in December and will be followed by a squeeze-out of the non-tendered shares under the same terms if Calliditas then holds more than 90% of the outstanding Genkyotex shares.

    "We are excited to announce the closing of this transaction, paving the way for continued clinical development of Setanaxib and related compounds. The class of NOX inhibitors has the potential to make an imprint on the clinical approach of treating fibrotic diseases and we are excited to contribute to this development", said CEO Renée Aguiar-Lucander.

    Total acquisition cost for 100% of Genkyotex shares outstanding will amount to approximately €31.7M, plus potential future value relating to contingent rights amounting to a maximum of €55M, subject to future regulatory approvals of setanaxib.

    * Certain transaction costs (amounting to circa €0.07 per share) have been deducted from the price paid to the block sellers.

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas

    Tel.: +44 7955129845

    email: marie.galay@calliditas.com

    The information was sent for publication, through the agency of the contact persons set out above, on November 3, 2020 at 3:15 p.m. CET.

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.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, business plans and focus, including the proposed acquisition of a controlling interest in Genkyotex, plans for acquisition of the remaining shares of Genkyotex and the intended benefits of such transaction. 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, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, the ability of the parties to complete the Genkyotex transaction and to realize the intended benefits therefrom, and other risks identified in the section entitled "Risk Factors" 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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  42. STOCKHOLM, Oct. 19, 2020 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") today announced upcoming presentations concerning Nefecon, its lead product candidate, at the American Society of Nephrology (ASN) Kidney Week 2020 Reimagined conference, to be held virtually October 19-25, 2020.

    At the "Glomerular Diseases: Clinical, Outcomes, and Trials" session, a poster will be presented by Professor Jonathan Barratt from the Mayer IgA Nephropathy Laboratory at the University of Leicester. The poster describes the design of the NefIgArd trial, which is exploring the effect of Nefecon in patients with IgA Nephropathy (IgAN) who are at risk of developing End Stage Renal Disease.

    At the oral abstract session "Glomerular Diseases: Charting…

    STOCKHOLM, Oct. 19, 2020 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") today announced upcoming presentations concerning Nefecon, its lead product candidate, at the American Society of Nephrology (ASN) Kidney Week 2020 Reimagined conference, to be held virtually October 19-25, 2020.

    At the "Glomerular Diseases: Clinical, Outcomes, and Trials" session, a poster will be presented by Professor Jonathan Barratt from the Mayer IgA Nephropathy Laboratory at the University of Leicester. The poster describes the design of the NefIgArd trial, which is exploring the effect of Nefecon in patients with IgA Nephropathy (IgAN) who are at risk of developing End Stage Renal Disease.

    At the oral abstract session "Glomerular Diseases: Charting New Territory," a presentation will be given by the University of Leicester's Dr Karen Molyneux on the effect of Nefecon on circulating levels of BAFF and soluble BCMA and TACI in patients with IgAN.

    Poster Presentation:

    "The NefIgArd trial: The Effect of Nefecon® (Budesonide) in Patients with Primary IgA Nephropathy at Risk of Developing ESRD"

    Session: "Glomerular Diseases: Clinical, Outcomes, and Trials - 1"

    Date & Time: Thursday 22nd October 2020, 10:00am - 12:00pm EDT (4:00pm - 6:00pm CET)

    Link: https://www.asn-online.org/education/kidneyweek/2020/program-abstract.aspx?controlId=3439759 

    Oral Presentation:

    "Nefecon® (Budesonide) Selectively Reduces Circulating Levels of BAFF (BLyS) and Soluble BCMA and TACI in IgA Nephropathy."

    Oral Abstract Session: "Glomerular Diseases: Charting New Territory."

    Date & Time: Friday 23rd October 2020, 5:00pm - 7:00pm EDT (11:00pm - 1:00am CET)

    Link: https://www.asn-online.org/education/kidneyweek/2020/program-abstract.aspx?controlId=3439751 

    For further information, please contact:

    Marie Galay, IR Manager, Calliditas

    Tel.: +44 7955129845, email: marie.galay@calliditas.com

    The information was sent for publication, through the agency of the contact persons set out above, on October 19, 2020 at 8:00 a.m. CET.

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon,* is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

    Nefecon is an investigational product that has not been approved by regulatory authorities in any jurisdiction. The name "Nefecon" is Calliditas' current proprietary name for its budesonide product candidate; the final proprietary name has not yet been determined.

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  43. STOCKHOLM, Oct. 1, 2020 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") today announced that the last visit of the 200th patient has taken place in Part A of the pivotal NeflgArd Phase 3 study

    The NefIgArd trial is studying the effect of Nefecon versus placebo in patients with IgA nephropathy (IgAN) at approximately 150 sites in 19 countries. It has a substantially similar design to the successful Phase 2b NEFIGAN trial, the results of which were published in the Lancet in 2017. The first patient in NeflgArd was randomized in November 2018, and in December 2019 Calliditas announced the full recruitment of Part A, encompassing 200 patients required to support a regulatory submission for potential market approval in the US and…

    STOCKHOLM, Oct. 1, 2020 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") today announced that the last visit of the 200th patient has taken place in Part A of the pivotal NeflgArd Phase 3 study

    The NefIgArd trial is studying the effect of Nefecon versus placebo in patients with IgA nephropathy (IgAN) at approximately 150 sites in 19 countries. It has a substantially similar design to the successful Phase 2b NEFIGAN trial, the results of which were published in the Lancet in 2017. The first patient in NeflgArd was randomized in November 2018, and in December 2019 Calliditas announced the full recruitment of Part A, encompassing 200 patients required to support a regulatory submission for potential market approval in the US and Europe (Part A). Topline data for the subjects included in Part A will read out in Q4 of 2020, and subject to positive data Calliditas plans to submit applications for market approval with regulatory agencies in the United States and the European Union in the first half of 2021.

    "This is consistent with our communication that our Phase 3 trial remains on track to read out in Q4 of this year.  We will now focus on ensuring a timely database lock in order to enable us to present top line data in this quarter.  We are very excited to have reached this important milestone and look forward to sharing the trial results as they become available." said Renée Aguiar-Lucander, CEO of Calliditas Therapeutics.     

    For further information, please contact:  

    Marie Galay

    Investor Relations Manager 

    Tel.:  +44-7955129845

    email: marie.galay@calliditas.com  

    The information was sent for publication, through the agency of the contact persons set out above, on October 1, 2020 at 9:45 a.m. CET. 

    About Calliditas 

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.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, business 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, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, and other risks identified in the section entitled "Risk Factors" 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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  44. STOCKHOLM, Sept. 30, 2020 /PRNewswire/ -- During September, Calliditas Therapeutics AB (publ) has allotted 111,250 common shares within the company's warrant program issued in 2017. Thus, as of September 30, 2020, the number of shares and votes in the company amounts to 49,941,584.

    For further information, please contact:

    Mikael Widell
    Investor relations
    Tel.: +46-703-11-99-60
    email: mikael.widell@calliditas.com

    The information in the press release is such that Calliditas Therapeutics AB (publ) is required to disclose pursuant to the Swedish Financial Instruments Trading Act. The information was submitted for publication, through the agency of the contact persons set out above, at 10:00 a.m. CEST on September 30, 2020.

    About Calliditas

    Calliditas…

    STOCKHOLM, Sept. 30, 2020 /PRNewswire/ -- During September, Calliditas Therapeutics AB (publ) has allotted 111,250 common shares within the company's warrant program issued in 2017. Thus, as of September 30, 2020, the number of shares and votes in the company amounts to 49,941,584.

    For further information, please contact:

    Mikael Widell

    Investor relations

    Tel.: +46-703-11-99-60

    email: mikael.widell@calliditas.com

    The information in the press release is such that Calliditas Therapeutics AB (publ) is required to disclose pursuant to the Swedish Financial Instruments Trading Act. The information was submitted for publication, through the agency of the contact persons set out above, at 10:00 a.m. CEST on September 30, 2020.

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT).

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  45. STOCKHOLM, Sept. 8, 2020 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") today announced that the first patient in China has been randomized into confirmatory part of the NefIgArd Phase 3 trial by its partner, Everest Medicines.

    Following IND approval by the NMPA in December of 2019 and subsequent approval by Human Genetic Resources Administration of China (HGRAC), the first patient in China has now been randomized in the Phase 3 NefIgArd trial. The first patient in NeflgArd was randomized by Calliditas in November 2018, and in December 2019 Calliditas announced the full recruitment of the 200 patients required for regulatory submission (Part A). Topline data for these 200 subjects is targeted for Q4 of 2020, which subject to…

    STOCKHOLM, Sept. 8, 2020 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") today announced that the first patient in China has been randomized into confirmatory part of the NefIgArd Phase 3 trial by its partner, Everest Medicines.

    Following IND approval by the NMPA in December of 2019 and subsequent approval by Human Genetic Resources Administration of China (HGRAC), the first patient in China has now been randomized in the Phase 3 NefIgArd trial. The first patient in NeflgArd was randomized by Calliditas in November 2018, and in December 2019 Calliditas announced the full recruitment of the 200 patients required for regulatory submission (Part A). Topline data for these 200 subjects is targeted for Q4 of 2020, which subject to positive data will form the basis for regulatory approval and market access in the US and Europe. The study has continued to recruit an additional 160 patients in order to complete the confirmatory part (Part B) of the trial, which relates to the validation of the surrogate marker, proteinuria. Everest Medicines is contributing to the recruitment of these 160 patients, based on the roll-out across centers in China. 

    "We are very pleased to now have the first patient from mainland China enrolled into the NefIgArd trial.  As this disease represents a significant unmet need in Asia, we are excited that Everest Medicines have achieved this milestone, which supports the goal of completing recruitment before the end of the year," said Renée Aguiar-Lucander, CEO of Calliditas Therapeutics.   

    For further information, please contact:

    Renée Aguiar-Lucander

    CEO

    Calliditas

    Email: renee.lucander@calliditas.com

    Mikael Widell

    Investor Relations 

    Tel.: +46-703-11-99-60

    email: Mikael.widell@calliditas.com  

    The information was sent for publication, through the agency of the contact persons set out above, on September 8, 2020 at 08:00 a.m. CET.

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.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, business 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, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, and other risks identified in the section entitled "Risk Factors" 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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  46. SHANGHAI, China, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Everest Medicines, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, announced today that the first patient has been randomized in China into the NefIgArd Phase 3 global registrational study evaluating Nefecon as a treatment for IgA Nephropathy (IgAN).

    NefIgArd is a double-blind, randomized, placebo controlled, multi-center Phase 3 global clinical study to evaluate the efficacy and safety of Nefecon in 360 patients with primary IgA nephropathy at risk of progressing to end-stage renal disease (ESRD), despite maximum tolerated treatment…

    SHANGHAI, China, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Everest Medicines, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, announced today that the first patient has been randomized in China into the NefIgArd Phase 3 global registrational study evaluating Nefecon as a treatment for IgA Nephropathy (IgAN).

    NefIgArd is a double-blind, randomized, placebo controlled, multi-center Phase 3 global clinical study to evaluate the efficacy and safety of Nefecon in 360 patients with primary IgA nephropathy at risk of progressing to end-stage renal disease (ESRD), despite maximum tolerated treatment with renin-angiotensin system (RAS) blockade using angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs). 

    "IgAN is the most common primary glomerular disease and has much higher prevalence in China than in western countries, with an estimated 2 million people in China living with IgAN. IgAN is a chronic and progressive disease that can cause a significant portion of patients to gradually lose kidney function and results in end-stage kidney failure," said Zhengying Zhu, Ph.D, Chief Medical Officer for Internal Medicine at Everest Medicines. "With this milestone, we are one step closer to bringing Nefecon, as the potential first novel therapeutic option, to IgAN patients in China, and are also contributing to the acceleration of Nefecon's global late-stage development."

    About Nefecon

    Nefecon, an oral, targeted-release formulation of budesonide, is a potential first-in-disease product for the treatment of IgA nephropathy. This novel formulation delivers budesonide to the Peyer's patch in the ileum, which is responsible for the production of secretory immunoglobulin A. Treatment with Nefecon was previously demonstrated to cause a statistically significant reduction in proteinuria levels and stabilization of eGFR, compared to placebo, in a randomized, double-blind Phase 2b clinical trial conducted by our partner Calliditas Therapeutics AB (NASDAQ:CALT). Nefecon has been granted Orphan Drug Designation for the treatment of IgAN by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize Nefecon in Mainland China, Hong Kong, Macau, Taiwan and Singapore. 

    About IgA Nephropathy

    IgA Nephropathy(IgAN) a leading cause of chronic kidney disease (CKD) and renal failure, is a chronic, progressive, autoimmune disease associated with progressive renal impairment. A central finding in patients with lgAN is the presence of circulating and glomerular immune complexes comprised of galactose-deficient IgA1, an IgG autoantibody directed against the hinge region O-glycans, and C3. Glomerular sclerosis, renal interstitial fibrosis, renal dysfunction, proteinuria and hypertension are associated with disease progression. 50% of IgAN patients will develop end stage renal disease within 30 years. The standard of care for ESRD is dialysis or kidney transplant, which represents a significant health economic burden as well as a material impact on patients' quality of life. Currently, there are no approved treatments for IgAN in China and globally. 

    About Everest Medicines

    Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of eight potentially global first-in-class or best-in-class molecules, many of which are in late stage clinical development. The Company's therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. For more information, please visit its website at www.everestmedicines.com.

    For further information, please contact:

    Everest Medicines

    Media in US and Europe:

    Darcie Robinson

    Vice President

    Westwicke PR

    (203) 919-7905

    darcie.robinson@icrinc.com



    Media in China:

    Edmond Lococo

    Managing Director

    ICR Asia

    +86 (10) 6583-7510

    edmond.lococo@icrinc.com

    Primary Logo

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  47. STOCKHOLM , Aug. 25, 2020 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") today announced the appointment of Jonathan Schur as Group General Counsel, effective October 1, 2020.

    Jonathan Schur has over 30 years of experience as a lawyer and is a member of the New York and Paris Bars. His practice focuses on work for pharmaceutical companies at all stages of development, from biotech companies advancing breakthrough technologies, to specialty and large pharmaceutical companies building commercial franchises. Having practiced in Paris for most of his career, Jonathan bridges the gap between the US and European legal and regulatory traditions. He advises companies on collaborations, product acquisitions, product distribution, the…

    STOCKHOLM , Aug. 25, 2020 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") today announced the appointment of Jonathan Schur as Group General Counsel, effective October 1, 2020.

    Jonathan Schur has over 30 years of experience as a lawyer and is a member of the New York and Paris Bars. His practice focuses on work for pharmaceutical companies at all stages of development, from biotech companies advancing breakthrough technologies, to specialty and large pharmaceutical companies building commercial franchises. Having practiced in Paris for most of his career, Jonathan bridges the gap between the US and European legal and regulatory traditions. He advises companies on collaborations, product acquisitions, product distribution, the legal and regulatory aspects of product and pricing authorizations, clinical trials, agreements with hospitals and physicians, marketing practices and privacy compliance.

    Prior to joining Calliditas, Mr. Schur was a Partner in the Life Sciences team at Goodwin Procter LLP, and before that a partner and co-managing partner of the Paris Office of Dechert LLP. He is a graduate of Harvard College and Harvard Law School.

    "As Calliditas grows its overall footprint and advances its lead product candidate Nefecon towards registration and, if approved, commercialization, the importance of an experienced in-house legal resource becomes increasingly critical. We are excited that Jonathan has agreed to join us and help prepare Calliditas for its next stage of development," said Renée Aguiar-Lucander, Chief Executive Officer.

    "The Calliditas management team has demonstrated its ability to identify products and technologies with significant potential and develop and implement approaches that can maximize their chances of success. I am looking forward to helping Calliditas execute its ambitious and exciting strategy," said Jonathan Schur.

    For further information, please contact:

    Renée Aguiar-Lucander, CEO, Calliditas

    Email: renee.lucander@calliditas.com 

    Mikael Widell, Communications and IR

    Tel.: +46 703 11 99 60, email: mikael.widell@calliditas.com

    The information was sent for publication, through the agency of the contact persons set out above, on August 25, 2020 at 08:00 a.m. CET.

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

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  48. Successful capital raise on NASDAQ

    STOCKHOLM, Aug. 13, 2020 /PRNewswire/ -- "In June we successfully closed a $90m U.S. IPO on NASDAQ, which including the greenshoe that was exercised in July, resulted in gross proceeds of $97m in total. This successful and pioneering transaction, which was the first time a Swedish life science company raised capital on NASDAQ Global Select in an IPO, secured the funding we believe will be necessary to fully complete our Phase 3 study and, if approved,  commercially launch the product in the U.S. The U.S. IPO also gave us added flexibility to pursue additional development initiatives related either to our existing pipeline or potential external additions.

    In Q2 as we were faced with some extreme circumstances…

    Successful capital raise on NASDAQ

    STOCKHOLM, Aug. 13, 2020 /PRNewswire/ -- "In June we successfully closed a $90m U.S. IPO on NASDAQ, which including the greenshoe that was exercised in July, resulted in gross proceeds of $97m in total. This successful and pioneering transaction, which was the first time a Swedish life science company raised capital on NASDAQ Global Select in an IPO, secured the funding we believe will be necessary to fully complete our Phase 3 study and, if approved,  commercially launch the product in the U.S. The U.S. IPO also gave us added flexibility to pursue additional development initiatives related either to our existing pipeline or potential external additions.

    In Q2 as we were faced with some extreme circumstances due to COVID-19, we pulled out all the stops to ensure that any impact on the NefIgArd clinical trial was mitigated and any serious disruption kept to a minimum. Special task forces were created, communication and collaboration with our global network of national coordinators were intensified and every detail of every part of the trial was reviewed, assessed and where needed, mitigating solutions were implemented. As a result, the trial remains on plan to report top line data in Q4 as the first Phase 3 clinical trial in IgA nephropathy to do so on a global basis. We are excited and proud to be in this position under these extreme circumstances."

    Renée Aguiar-Lucander, CEO

    Summary of Q2 2020

    April 1 - June 30, 2020           

    • No net sales for the three months ended June 30, 2020 were recognized. For the three months ended June 30, 2019 net sales amounted to SEK 138.2 million.
    • Operating profit/(loss) amounted to (SEK 66.6 million) and SEK 85.4 million for the three months ended June 30, 2020 and 2019, respectively.
    • Profit/(loss) before income tax amounted to (SEK 61.3 million) and SEK 83.2 million for the three months ended June 30, 2020 and 2019, respectively.
    • Earnings/(loss) per share before dilution amounted to (SEK 1.50) and SEK 2.36, and after dilution amounted to (SEK 1.50) and SEK 2.35 for the three months ended June 30, 2020 and 2019, respectively.
    • Cash amounted to SEK 1,459.6 million and SEK 534.9 million as of June 30, 2020 and 2019, respectively.

    Significant events during Q2 2020, in summary           

    • In April 2020, Calliditas appointed Dr. Richard Philipson as Chief Medical Officer (CMO).
    • In April 2020, Calliditas provided an update on its business activities and financial position on the evolving COVID-19 pandemic, focused on the continuity of the ongoing Phase 3 trial.
    • In June 2020, Calliditas completed an initial public offering on The Nasdaq Global Select Market in the United States for gross proceeds of approximately USD 90 million before deduction of issuance costs.
    • In June 2020, the Annual General Meeting of Calliditas was held and, among other things, the meeting decided on the election of Molly Henderson to the Board of Directors.

    Significant events after the end of reporting period, in summary           

    • In July 2020, Calliditas announced the exercise of the partial over-allotment option from the IPO on The Nasdaq Global Select Market. Calliditas was thereby provided with additional gross proceeds of approximately USD 6.9 million before deduction of issuance costs.
    • In August 2020, Calliditas announced it has reached an agreement to acquire a controlling interest in Genkyotex SA, a leader in NOX inhibition therapies, with expected closing in October 2020.

    Investor Presentation August 13, 14:30 CET

    Audio cast with teleconference, Q2 2020, August 13, 2020, 14:30 (Europe/Stockholm)

    Webcast: https://tv.streamfabriken.com/calliditas-therapeutics-q2-2020

    Teleconference: SE: +46856642693 UK: +443333009264 US: +18335268383

    Financial calendar

    Interim report for the period January 1 - September 30, 2020  November 12, 2020

    Year-end report for the period January 1 - December 31, 2020  February 18, 2021

    Interim report for the period January 1 - March 31, 2021   May 13, 2021

    For further information, please contact:

    Renée Aguiar-Lucander, CEO at Calliditas

    Email: renee.lucander@calliditas.com

    Telephone: +46 722 52 10 06

    Mikael Widell, Investor Relations

    Email: mikael.widell@calliditas.com

    Telephone: +46 703 11 99 60

    The information was submitted for publication, through the agency of the contact persons set out above, at 07:00 CET on August 13, 2020.

    About Calliditas Therapeutics

    Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden. It is focused on developing high quality pharmaceutical products for patients with a significant unmet medical need in niche indications, in which the Company can partially or completely participate in the commercialization efforts. The Company is focused on the development and commercialization of the product candidate Nefecon, a unique two-step formulation optimized to combine a time lag effect with a concentrated release of the active substance budesonide, within a designated target area. This patented, locally acting formulation is intended for treatment of patients with the inflammatory renal disease IgA nephropathy (IgAN). Calliditas Therapeutics is running a global Phase 3 study within IgAN and aims to commercialize Nefecon in the US. The company is listed on Nasdaq Stockholm (TICKER:CALTX). Visit www.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, business 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, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, and other risks identified in the section entitled "Risk Factors" 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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  49. STOCKHOLM, Aug. 13, 2020 /PRNewswire/ -- Transaction adds late-stage orphan pipeline asset and platform in inflammation and fibrosis. Calliditas to acquire 62.7% of Genkyotex for €20.3M in cash at €2.80 per share in an off-market transaction. Following the closing of the control transaction a mandatory simplified cash tender offer on the same terms for the remaining outstanding shares would be launched. Total consideration for 100% of Genkyotex would amount to ~€32M, not including milestones of up to €55M payable upon regulatory approvals of setanaxib.

    Calliditas Therapeutics AB (publ) ("Calliditas" or the Company) (Nasdaq OMX - CALTX) (NASDAQ - CALT) announced today that the Company has reached an agreement to acquire a controlling interest…

    STOCKHOLM, Aug. 13, 2020 /PRNewswire/ -- Transaction adds late-stage orphan pipeline asset and platform in inflammation and fibrosis. Calliditas to acquire 62.7% of Genkyotex for €20.3M in cash at €2.80 per share in an off-market transaction. Following the closing of the control transaction a mandatory simplified cash tender offer on the same terms for the remaining outstanding shares would be launched. Total consideration for 100% of Genkyotex would amount to ~€32M, not including milestones of up to €55M payable upon regulatory approvals of setanaxib.

    Calliditas Therapeutics AB (publ) ("Calliditas" or the Company) (Nasdaq OMX - CALTX) (NASDAQ - CALT) announced today that the Company has reached an agreement to acquire a controlling interest in Genkyotex SA ("Genkyotex") (Euronext Paris & Brussels: FR0013399474 - GKTX), a leader in NOX inhibition therapies.

    Genkyotex's lead clinical candidate, setanaxib (GKT831), is in development for Primary Biliary Cholangitis (PBC), a chronic orphan liver disease resulting from progressive destruction of the bile ducts in the liver. In a Phase 2 clinical trial, setanaxib demonstrated evidence of anti-fibrotic activity combined with a favorable tolerability profile, as well as a statistically significant impact on fatigue. In April 2020, Genkyotex completed an End of Phase 2 meeting with the US Food and Drug Administration (FDA) and in June 2020 obtained scientific advice from the European Medicine Agency's (EMA) Scientific Advice Working Party (SAWP) that provide a path forward for the late stage development and potential registration of setanaxib in PBC. "We believe this transaction represents an exciting expansion of our pipeline in orphan diseases related to inflammation and fibrosis", says Calliditas' CEO Renée Aguiar-Lucander. "We believe Genkyotex's novel NOX inhibition technology may have broad clinical utility not just in PBC, but as a platform therapy with the potential to target other fibrotic indications, including Primary Sclerosing Cholangitis (PSC), selected kidney diseases and Idiopathic Pulmonary Fibrosis (IPF), in which an investigator led Phase 2 trial is expected to start recruitment later this year."

    "We look forward to leveraging our strong late stage clinical team, CMC and regulatory expertise as well as our learnings from our Phase 3 Nefecon program to navigate and execute an efficient path forward for setanaxib. We continue to deliver on our strategy focusing on adding late stage assets with an orphan focus and encouraging data in patients to build a company focused on delivering solution for patients with diseases with high unmet needs", Ms. Aguiar-Lucander concludes.  

    Calliditas has agreed to acquire through an off-market block trade 7,236,515 ordinary shares of Genkyotex representing 62.7% of the share capital and voting rights of Genkyotex[1] from Genkyotex's largest shareholders and management team (the "Block Sellers")[2] for a total consideration of €20.3M payable in cash at closing (€2.80 per ordinary share) representing a 25% premium over Genkyotex's volume weighted average price (VWAP) over the preceding month immediately prior to this announcement and non- transferable contingent rights to receive additional cash payments on confirmation of regulatory approvals or marketing authorizations of setanaxib, as described below. The off-market block trade is expected to close in early October 2020 and remains subject to customary conditions precedent, including the clearance from the French Minister of Economy and Finance regarding foreign investments into France. Calliditas will finance the block trade from its cash reserves.

    Calliditas is seeking to acquire all outstanding Genkyotex shares and, as soon as reasonably practicable after and subject to completion of the off-market block trade, in compliance with French and Belgian securities law, Calliditas will file with the French Financial Market Authority (Autorité des Marchés Financiers - the "AMF") a mandatory simplified cash tender offer for the remaining Genkyotex shares on the same terms as the block trade,  €2.80 per share in cash and non-transferable contingent rights as further described below. The tender offer will be followed by a squeeze-out of the non-tendered shares under the same terms (including the contingent rights) if the legal requirements are met. Total acquisition cost would in such case amount to approximately €32.3M with total contingent rights amounting to a maximum of €55M, subject to future regulatory approvals of setanaxib.

    The Block Sellers and the Genkyotex shareholders who tender their shares in the centralized tender offer will be eligible to the following additional cash payments (expressed in relation to 100% of the Genkyotex shares on a fully diluted basis) on confirmation of regulatory approvals or marketing authorizations of setanaxib no later than within ten years of the closing of the tender offer:       

    • €30M on approval of setanaxib for a first indication by the FDA;
    • €15M on approval of setanaxib for a first indication by the European Commission (EC); and
    • €10M on approval of setanaxib by the FDA or the EC for either IPF or type 1 diabetes (unless such milestone already has been paid out for such indication by the FDA or the EC as per above).

    Bryan Garnier & Co acted as financial advisor to Calliditas in this transaction. Latham & Watkins LLP and Vinge acted as legal advisers to Calliditas.

    For further information, please contact:

    Renée Aguiar-Lucander, CEO, Calliditas

    Tel.: +46 722 52 10 06, email: renee.lucander@calliditas.com

    Mikael Widell, Investor Relations, Calliditas

    Tel.: +46 703 11 99 60, email: mikael.widell@calliditas.com

    The information in the press release is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was sent for publication, through the agency of the contact persons set out above, on August 13, 2020 at 07:00 a.m. CET.

    This press release does not constitute an offer to purchase, or a solicitation of an offer to sell, any securities of Genkyotex. The documentation relating to the tender offer which, if filed, will state the terms and conditions of the tender offer, will be submitted to the review of the AMF. Investors and shareholders are strongly advised to read the documentation relating to the tender offer when it becomes available, if the offer is filed, as well as any amendments and supplements to those documents as they will contain important information about Calliditas, Genkyotex and the proposed transaction.

    The transaction is notably subject to the obtaining of required regulatory authorizations and other customary conditions. The tender offer would only be filed with the AMF after such conditions have been fulfilled and the off-market block trade has been closed.

    This press release must not be published, broadcast or distributed, directly or indirectly, in any country in which the distribution of this information is subject to legal restrictions. The tender offer will not be open to the public in jurisdictions in which its launch is subject to legal restrictions. The publication, broadcasting or distribution of this press release in certain countries may be subject to legal or regulatory restrictions. Therefore, persons located in countries where this press release is published, broadcasted or distributed must inform themselves about and comply with such restrictions. Calliditas disclaims any responsibility for any violation of such restrictions.

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

    About Genkyotex

    Genkyotex is the leading biopharmaceutical company in NOX therapies, listed on the Euronext Paris and Euronext Brussels markets. Its unique platform enables the identification of orally available small-molecules which selectively inhibit specific NOX enzymes that amplify multiple disease processes such as fibrosis, inflammation, pain processing, cancer development, and neurodegeneration. Genkyotex is developing a pipeline of first-in-class product candidates targeting one or multiple NOX enzymes. The lead product candidate, setanaxib (GKT831), a NOX1 and NOX4 inhibitor has shown evidence of anti-fibrotic activity in a Phase II clinical trial in primary biliary cholangitis (PBC, a fibrotic orphan disease). Based on its positive Phase II results, a phase 3 trial with setanaxib in PBC is being planned. Setanaxib is also being evaluated in an investigator-initiated Phase II clinical trial in Type 1 Diabetes and Kidney Disease (DKD). A grant from the United States National Institutes of Health (NIH) of $8.9 million was awarded to Professor Victor Thannickal at the University of Alabama at Birmingham (UAB) to fund a multi-year research program evaluating the role of NOX enzymes in idiopathic pulmonary fibrosis (IPF), a chronic lung disease that results in fibrosis of the lungs. The core component of this program is a Phase 2 trial with setanaxib in patients with IPF scheduled to recruit patients in the course of 2020. This product candidate may also be active in other fibrotic indications.

    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, business 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, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, and other risks identified in the section entitled "Risk Factors" 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.

    [1] Based on the total number of issued shares and voting rights of Genkyotex on the date of this press release (11,548,562)

    [2] The Block Sellers are Andera Partners (25,3%), Eclosion 2 (12,1%), Vesalius Biocapital (9,4%), Neomed Inovation (8,1%), N5 Investments (0,6%), Wellington Partners (4,2%), Elias Papatheodorou (1,3%), Philippe Wiesel (1%) and Alexandre Grassin (0,6%).

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  50. STOCKHOLM, Aug. 11, 2020 /PRNewswire/ -- On August 13, 2020, at 07:00 am CET, Calliditas Therapeutics ("Calliditas") will publish its business update for the second quarter 2020. Calliditas will also host a telephone conference, which will include a presentation of the results, on the same day at 2:30 pm CET. The event will be hosted by the company's CEO, Renée Aguiar-Lucander, and CFO Fredrik Johansson. The presentation will be held in English.

    The presentation will be live on the company's website during the call under Financial Reports and Presentations and will also be made available online after the call. To participate in the telephone conference, please use the dial-in details shown below:

    Dial-in numbers, SE: +46856642693 UK: +443333009264…

    STOCKHOLM, Aug. 11, 2020 /PRNewswire/ -- On August 13, 2020, at 07:00 am CET, Calliditas Therapeutics ("Calliditas") will publish its business update for the second quarter 2020. Calliditas will also host a telephone conference, which will include a presentation of the results, on the same day at 2:30 pm CET. The event will be hosted by the company's CEO, Renée Aguiar-Lucander, and CFO Fredrik Johansson. The presentation will be held in English.

    The presentation will be live on the company's website during the call under Financial Reports and Presentations and will also be made available online after the call. To participate in the telephone conference, please use the dial-in details shown below:

    Dial-in numbers, SE: +46856642693 UK: +443333009264 US: +18335268383

    A link to audio cast can be found on the Calliditas website under Financial Reports and Presentations or here:

    https://financialhearings.com/event/12808

    The information was released for public disclosure on August 11, 2020 at 14.00 CET.

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

    For further information, please contact:

    Mikael Widell

    Investor Relations

    Email: mikael.widell@calliditas.com

    Telephone: +46-703-11-99-60

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  51. STOCKHOLM, July 31, 2020 /PRNewswire/ -- During July, Calliditas Therapeutics AB (publ) has issued 706,676 common shares as a result of the exercise of the over-allotment option within the initial public offering on The Nasdaq Global Select Market and the concurrent private placement of common shares to certain qualified investors in Europe and certain other jurisdictions outside of the United States. Further, during July, warrants within the company's warrant program issued in 2017 have been converted to 1,185,250 common shares. Thus, as of July 31, 2020, the number of shares and votes in the company amounts to 49,830,334.

    For further information, please contact:

    Renée Aguiar-Lucander, CEO at Calliditas

    Tel.: +46-722-52-10-06, email: renee.lucander@calliditas.com

    STOCKHOLM, July 31, 2020 /PRNewswire/ -- During July, Calliditas Therapeutics AB (publ) has issued 706,676 common shares as a result of the exercise of the over-allotment option within the initial public offering on The Nasdaq Global Select Market and the concurrent private placement of common shares to certain qualified investors in Europe and certain other jurisdictions outside of the United States. Further, during July, warrants within the company's warrant program issued in 2017 have been converted to 1,185,250 common shares. Thus, as of July 31, 2020, the number of shares and votes in the company amounts to 49,830,334.

    For further information, please contact:

    Renée Aguiar-Lucander, CEO at Calliditas

    Tel.: +46-722-52-10-06, email: renee.lucander@calliditas.com

    Mikael Widell, Head of Communications and IR

    Tel.: +46-703-11-99-60, email: mikael.widell@calliditas.com

    The information in the press release is such that Calliditas Therapeutics AB (publ) is required to disclose pursuant to the Swedish Financial Instruments Trading Act. The information was submitted for publication, through the agency of the contact persons set out above, at 12:00 pm CEST on July 31, 2020.

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

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  52. STOCKHOLM, July 24, 2020 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") today announced that it has reorganized its management team.

    From today, the company's management team will consist of:

    Renée Aguiar-Lucander, CEO

    Fredrik Johansson, CFO

    Dr Richard Philipson, CMO

    Frank Bringstrup, Vice President Regulatory Affairs

    Andrew Udell, Head of North America, Commercial

    Katayoun Welin-Berger, Vice President Operations

    "Calliditas will continue to build and benefit from a broad and highly competent senior team which operates in an integrated manner.  As the company has grown there is now need for a smaller and more focused executive group to support this structure and continue to leverage this cross functional expertise.", said CEO…

    STOCKHOLM, July 24, 2020 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") today announced that it has reorganized its management team.

    From today, the company's management team will consist of:

    Renée Aguiar-Lucander, CEO

    Fredrik Johansson, CFO

    Dr Richard Philipson, CMO

    Frank Bringstrup, Vice President Regulatory Affairs

    Andrew Udell, Head of North America, Commercial

    Katayoun Welin-Berger, Vice President Operations

    "Calliditas will continue to build and benefit from a broad and highly competent senior team which operates in an integrated manner.  As the company has grown there is now need for a smaller and more focused executive group to support this structure and continue to leverage this cross functional expertise.", said CEO Renée Aguiar-Lucander.

    Due to the growing number of employees in the US, Andrew Udell has been appointed as Head of North America, Commercial and will be responsible for implementation and execution of medical affairs, market access, as well as sales and marketing in the US.

    The information was sent for publication, through the agency of the contact persons set out above, on July  24, 2020 at 8:00 a.m. CET.

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

    For further information, please contact:

    Renée Aguiar-Lucander

    CEO at Calliditas

    Tel.: +46-722-52-10-06

    Email: renee.lucander@calliditas.com

    Mikael Widell

    Head of Communications and IR

    Tel.: +46-703-11-99-60

    Email: mikael.widell@calliditas.com

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  53. STOCKHOLM, July 2, 2020 /PRNewswire/ -- Citigroup Global Markets Inc. ("Citigroup"), in its capacity as Joint Global Coordinator, notifies that the stabilization period relating to Calliditas Therapeutics AB (publ)'s ("Calliditas" or the "Company") American Depositary Shares ("ADSs"), traded on The Nasdaq Global Select Market has ended and no further stabilization transactions will be effected. The over-allotment option is partially exercised by Citigroup and Jefferies LLC on behalf of the underwriters, which means that 706,676 new common shares, represented by 353,338 ADSs, will be issued by the Company.

    As announced by the Company in connection with the initial public offering on The Nasdaq Global Select Market, by way of an issuance of new…

    STOCKHOLM, July 2, 2020 /PRNewswire/ -- Citigroup Global Markets Inc. ("Citigroup"), in its capacity as Joint Global Coordinator, notifies that the stabilization period relating to Calliditas Therapeutics AB (publ)'s ("Calliditas" or the "Company") American Depositary Shares ("ADSs"), traded on The Nasdaq Global Select Market has ended and no further stabilization transactions will be effected. The over-allotment option is partially exercised by Citigroup and Jefferies LLC on behalf of the underwriters, which means that 706,676 new common shares, represented by 353,338 ADSs, will be issued by the Company.

    As announced by the Company in connection with the initial public offering on The Nasdaq Global Select Market, by way of an issuance of new common shares in the form of ADSs, each representing two (2) underlying new common shares of Calliditas, (the "U.S. Offering"), and a concurrent private placement of common shares to certain qualified investors in Europe and certain other jurisdictions outside of the United States (together with the U.S. Offering, the "Global Offering"), Citigroup may, acting as Joint Global Coordinator and stabilization manager, carry out transactions aimed at supporting the market price of the ADSs at levels above those which might otherwise prevail in the market.

    Stabilization transactions have been possible to undertake on The Nasdaq Global Select Market, in the over-the-counter market or otherwise, at any time during the period starting on the day of pricing of the ADSs on The Nasdaq Global Select Market, June 4, 2020, and ending no later than 30 calendar days thereafter. Citigroup has, however, not been obliged to undertake any stabilization and there was no assurance that stabilization would be undertaken. Undertaken stabilization has been possible to discontinue at any time without prior notice. In no event has transactions been effected at a price higher than the price in the U.S. Offering, i.e. USD 19.50. No stabilization measures have taken or will take place on Nasdaq Stockholm.

    The board of directors of the Company has granted Citigroup, Jefferies LLC and Stifel, Nicolaus & Company, Inc. (together the "Book Running Managers") an over-allotment option, which may be utilized in whole or in part for 30 days from the day of pricing of the ADSs on The Nasdaq Global Select Market, to issue up to 692,306 ADSs, representing 1,384,612 underlying common shares, corresponding to up to 15 percent of the total number of common shares in the Global Offering, at a price corresponding to the price in the U.S. Offering, to cover any over-allotment in connection with the Global Offering (the "Over-allotment option"). The Book Running Managers now notify that the Over-allotment option with respect to 353,338 ADSs, representing 706,676 common shares has been exercised. The Company will thereby be provided with additional gross proceeds of approximately USD 6,890,000, which means that the Company has been provided with in total approximately USD 96,890,000, corresponding to approximately SEK 902,666,000, in gross proceeds as a result of the Global Offering and the Over-allotment option. Immediately following registration of the new common shares issued pursuant to the Over-allotment option, the number of common shares and votes in the Company will amount to 49,161,584 and the number of issued ADSs will amount to 4,506,723.

    Citigroup has, in its capacity as stabilization manager, on June 12 and June 24, 2020 notified in accordance with article 5(4) in the Market Abuse Regulation 596/2014 that stabilization measures have been undertaken, in accordance with Reg M, Rule 104 of the U.S. Securities Act of 1933, as amended, on The Nasdaq Global Select Market as specified below. No stabilization measures have been undertaken since June 24, 2020. The contact person at Citigroup is Dean Poniros (tel: +1 212 723 6137, e-mail: dean.poniros@citi.com).

                                       

                                       

    Stabilization information:

                                       

    Issuer:

                                       

    Calliditas Therapeutics AB (publ)

                                                   

                                       

    Securities:

                                       

    American Depositary Shares (ISIN: US13124Q1067)

                                                   

                                       

    Offering size:

                                       

    692,306 ADSs, representing 1,384,612 underlying common shares

                                                   

                                       

    Offer price:

                                       

    USD 19.50

                                                   

                                       

    Ticker:

                                       

    CALT

                                                   

                                       

    Stabilization manager:

                                       

    Citigroup Global Markets Inc.

                                       

    The stabilization period regarding the Global Offering has now ended and no further stabilization transactions will be effected. Specified below is a summary of the stabilization transactions which have been effected during the stabilization period in accordance with the press releases of June 12 and June 24, 2020, respectively. All transactions during the stabilization period have been effected on The Nasdaq Global Select Market and no stabilization transactions have been effected on other dates than those specified below.

                                       

                                       

    Stabilization transactions:

                                       

    Date

                                       

    Quantity,  ADS

                                       

    Price (highest)

                                       

    Price (lowest)

                                       

    Price (volume weighted average)

                                       

    Currency

                                       

    Trading venue

                                                   

                                       

    2020-06-05

     

    296,174

     

    19.50

     

    19.50

     

    19.50

                                       

    USD

                                       

    The Nasdaq Global Select Market

                                                   

                                       

    2020-06-11

     

    30,221

     

    19.50

     

    19.40

     

    19.4827

                                       

    USD

                                       

    The Nasdaq Global Select Market

                                                   

                                       

    2020-06-12

     

    2,319

     

    19.40

     

    19.40

     

    19.40

                                       

    USD

                                       

    The Nasdaq Global Select Market

                                                   

                                       

    2020-06-15

     

    75

     

    19.25

     

    19.25

     

    19.25

                                       

    USD

                                       

    The Nasdaq Global Select Market

                                                   

                                       

    2020-06-16

     

    600

     

    19.25

     

    19.25

     

    19.25

                                       

    USD

                                       

    The Nasdaq Global Select Market

                                                   

                                       

    2020-06-18

     

    4,666

     

    19.15

     

    19.15

     

    19.15

                                       

    USD

                                       

    The Nasdaq Global Select Market

                                                   

                                       

    2020-06-19

     

    4,913

     

    19.00

     

    19.00

     

    19.00

                                       

    USD

                                       

    The Nasdaq Global Select Market

                                       

    This information is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation 596/2014. The information was submitted for publication, through the agency of the contact person set out above, at 8.45 am CEST on July 2, 2020.

    About Calliditas

    Calliditas Therapeutics AB is a specialty pharmaceutical company based in Stockholm, Sweden. It is focused on developing high quality pharmaceutical products for patients with a significant unmet medical need in niche indications, in which Calliditas can partially or completely participate in the commercialization efforts. Calliditas is focused on the development and commercialization of the product candidate Nefecon, a unique two step formulation optimized to combine a time lag effect with a concentrated release of the active substance budesonide, within a designated target area. This patented, locally acting formulation is intended for treatment of patients with the inflammatory renal disease IgA nephropathy (IgAN). Calliditas is running a global Phase 3 study within IgAN and aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and The Nasdaq Global Select Market (NASDAQ:CALT).              

    Important information

    This announcement does not constitute an offer to sell nor a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    No announcements or information regarding the initial public offering may be disseminated to the public in jurisdictions where a prior registration or approval is required for such purpose. No steps have been taken, or will be taken, for the offering of Shares or ADSs in any jurisdiction where such steps would be required. The issue or sale of shares or ADSs, and the subscription for or purchase of shares or ADSs are subject to special legal or statutory restrictions in certain jurisdictions. Calliditas is not liable if these restrictions are not complied with by any other person.

    This announcement is not a prospectus for the purposes of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 (the "Prospectus Regulation") and has not been approved by any regulatory authority in any jurisdiction. Calliditas has not authorized any offer to the public of shares or rights in any member state of the EEA and no prospectus has been or will be prepared in connection therewith. In any EEA member state, this communication is only addressed to and is only directed at qualified investors in that member state within the meaning of the Prospectus Regulation.

    In the United Kingdom, this document and any other materials in relation to the securities described herein is only being distributed to, and is only directed at, and any investment or investment activity to which this document relates is available only to, and will be engaged in only with, "qualified investors" who are (i) persons having professional experience in matters relating to investments who fall within the definition of "investment professionals" in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order"); or (ii) high net worth entities falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as "relevant persons"). In the United Kingdom, any investment or investment activity to which this communication relates is available only to, and will be engaged in only with, relevant persons. Persons who are not relevant persons should not take any action on the basis of this document and should not act or rely on it.

    For further information, please contact:

    Renée Aguiar-Lucander, CEO at Calliditas

    E-mail: renee.lucander@calliditas.com

    Telephone: +46-722-52-10-06

    Mikael Widell, Head of Communications at Calliditas

    E-mail: mikael.widell@calliditas.com

    Telephone: +46-703-11-99 60

    www.calliditas.se/en/-

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  54. STOCKHOLM, June 30, 2020 /PRNewswire/ -- During June, Calliditas Therapeutics AB (publ) has issued 9,230,770 common shares as a result of the initial public offering on The Nasdaq Global Select Market in the United States and concurrent private placement of common shares to certain qualified investors in Europe and certain other jurisdictions outside of the United States. Thus, as of June 30, 2020, the number of shares and votes in the Company amounts to 47,938,408.

    For further information, please contact:

    Renée Aguiar-Lucander, CEO at Calliditas

    Tel.: +46-722-52-10-06, email: renee.lucander@calliditas.com

    Mikael Widell, Head of Communications and IR

    Tel.: +46-703-11-99-60, email: mikael.widell@calliditas.com

    The information in the press

    STOCKHOLM, June 30, 2020 /PRNewswire/ -- During June, Calliditas Therapeutics AB (publ) has issued 9,230,770 common shares as a result of the initial public offering on The Nasdaq Global Select Market in the United States and concurrent private placement of common shares to certain qualified investors in Europe and certain other jurisdictions outside of the United States. Thus, as of June 30, 2020, the number of shares and votes in the Company amounts to 47,938,408.

    For further information, please contact:

    Renée Aguiar-Lucander, CEO at Calliditas

    Tel.: +46-722-52-10-06, email: renee.lucander@calliditas.com

    Mikael Widell, Head of Communications and IR

    Tel.: +46-703-11-99-60, email: mikael.widell@calliditas.com

    The information in the press release is such that Calliditas Therapeutics AB (publ) is required to disclose pursuant to the Swedish Financial Instruments Trading Act. The information was submitted for publication, through the agency of the contact persons set out above, at 5.30 pm CEST on June 30, 2020.

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

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  55. STOCKHOLM, June 25, 2020 /PRNewswire/ -- The following resolutions were passed at Calliditas Therapeutics AB (publ) ("Calliditas") annual general meeting held today, on June 25, 2020, in Stockholm.

    Adoption of income statement and balance sheet for the financial year 2019 and discharge from liability

    The annual general meeting resolved to adopt the income statement and the consolidated income statement for the financial year 2019 as well as the balance sheet and consolidated balance sheet as of 31 December 2019. The members of the board of directors and the managing director were discharged from liability for the financial year 2019.

    Allocation of profit or loss

    The annual general meeting resolved, in accordance with the board of directors…

    STOCKHOLM, June 25, 2020 /PRNewswire/ -- The following resolutions were passed at Calliditas Therapeutics AB (publ) ("Calliditas") annual general meeting held today, on June 25, 2020, in Stockholm.

    Adoption of income statement and balance sheet for the financial year 2019 and discharge from liability

    The annual general meeting resolved to adopt the income statement and the consolidated income statement for the financial year 2019 as well as the balance sheet and consolidated balance sheet as of 31 December 2019. The members of the board of directors and the managing director were discharged from liability for the financial year 2019.

    Allocation of profit or loss

    The annual general meeting resolved, in accordance with the board of directors' proposal, that no dividend shall be paid for 2019 and that the results of the Company shall be carried forward.

    Election of board members, auditors, fees to the board of directors and auditors

    The annual general meeting resolved, in accordance with the nomination committee's proposal, that the number of members of the board of directors shall be five without deputies and that the number of auditors shall be one without deputies.

    In accordance with the nomination committee's proposal, Elmar Schnee, Hilde Furberg, Lennart Hansson and Diane Parks were re-elected as members of the board of directors, and Molly Henderson was elected as new member of the board of directors, for the period until the end of the next annual general meeting. Elmar Schnee was re-elected as the chairman of the board of directors. The audit firm Ernst & Young AB was elected auditor of the Company for the period until the end of the next annual general meeting, and it was noted that the authorized public accountant Fredrik Norrman will continue as auditor in charge.

    The annual general meeting further resolved, in accordance with the nomination committee's proposal and for the time period until the end of the next annual general meeting, that the directors' fees shall be paid in the amount of SEK 850,000 to the chairman of the board of directors and in the amount of SEK 250,000 to each of the other members, with SEK 150,000 to the chairman of the audit committee and with 75,000 SEK to the other members of the audit committee as well as with SEK 50,000 to the chairman of the remuneration committee and SEK 25,000 to the other members of the remuneration committee. In addition to the above remuneration, it was determined that board members residing in the United States shall receive an additional amount of SEK 140,000 and that board members residing in Europe, but outside the Nordics, shall receive an additional amount of SEK 50,000. The annual general meeting further resolved, in accordance with the nomination committee's proposal, that the remuneration to the auditor shall be paid in accordance with approved statement of costs.

    Nomination committee for the next annual general meeting

    The annual general meeting resolved, in accordance with the nomination committee's proposal, on principles for appointing the nomination committee. In short, the nomination committee should be composed of the chairman of the board of directors together with one representative of each of the three largest shareholders, based on ownership in the Company as of the expiry of the third quarter of the financial year.

    Guidelines on remuneration to group management and board members

    The annual general meeting resolved, in accordance with the proposal from the board of directors, on guidelines for remuneration to group management and board members. In short, the guidelines state that remuneration within Calliditas shall be based on principles of performance, competitiveness and fairness. The remuneration to group management and board members may consist of fixed remuneration, variable remuneration, share and share price-related incentive programs, pension and other benefits.

    Long-term performance-based incentive program for certain members of the board of directors

    The annual general meeting resolved, in accordance with the nomination committee's proposal, to adopt a new long-term performance-based incentive program for certain members of the board of directors, including a resolution to issue not more than 40,000 warrants to ensure delivery of shares to participants under the program. The incentive program entails that main owner independent members of the board of directors will be granted share awards, free of charge, that can entitle to shares in Calliditas, subject to the fulfilment of certain performance conditions.

    Authorization to issue new shares

    The annual general meeting resolved, in accordance with the board of directors' proposal, to authorize the board of directors, at one or several occasions and for the period up until the next annual general meeting, to increase the Company's share capital by issuing new shares. Such share issue resolution may be carried out with or without deviation from the shareholders' preferential rights and with or without provisions for contribution in kind, set-off or other conditions. The authorization may only be utilised to the extent that it corresponds to a dilution of not more than 20 per cent of the total number of shares outstanding at the time of the general meeting's resolution on the proposed authorization.

    Amendment to the articles of association

    The annual general meeting resolved, in accordance with the board of directors' proposal, to amend the articles of association by introduction of a new section regarding forum for resolving any complaint in the United States, should such be filed.

    For further information, please contact:

    Mikael Widell, Head of Communications

    Email: mikael.widell@calliditas.com

    Telephone: +46-703-11 99 60

    The information was submitted for publication, through the agency of the contact person set out above, at 6.30 pm CEST on June 25, 2020.

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

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  56. STOCKHOLM, June 25, 2020 /PRNewswire/ -- Citigroup Global Markets Inc. ("Citigroup"), in its capacity as Joint Global Coordinator, notifies that stabilization measures have been undertaken in Calliditas Therapeutics AB's ("Calliditas" or the "Company") American Depositary Shares ("ADSs"), traded on The Nasdaq Global Select Market.

    As announced by the Company in connection with the initial public offering on The Nasdaq Global Select Market, by way of a capital increase of new common shares in the form of ADSs, each representing two (2) underlying new common shares of Calliditas, (the "U.S. Offering"), and a concurrent private placement of common shares to certain qualified investors in Europe and certain other jurisdictions outside of the United

    STOCKHOLM, June 25, 2020 /PRNewswire/ -- Citigroup Global Markets Inc. ("Citigroup"), in its capacity as Joint Global Coordinator, notifies that stabilization measures have been undertaken in Calliditas Therapeutics AB's ("Calliditas" or the "Company") American Depositary Shares ("ADSs"), traded on The Nasdaq Global Select Market.

    As announced by the Company in connection with the initial public offering on The Nasdaq Global Select Market, by way of a capital increase of new common shares in the form of ADSs, each representing two (2) underlying new common shares of Calliditas, (the "U.S. Offering"), and a concurrent private placement of common shares to certain qualified investors in Europe and certain other jurisdictions outside of the United States (together with the U.S. Offering, the "Global Offering"), Citigroup may, acting as Joint Global Coordinator and stabilization manager, carry out transactions aimed at supporting the market price of the ADSs at levels above those which might otherwise prevail in the market.

    Stabilization transactions may be undertaken on The Nasdaq Global Select Market, in the over-thecounter market or otherwise, at any time during the period starting on the day of pricing of the ADSs on The Nasdaq Global Select Market, 4 June 2020, and ending no later than 30 calendar days thereafter. Citigroup is, however, not required to undertake any stabilization and there is no assurance that stabilization will be undertaken. Stabilization, if undertaken, may be discontinued at any time without prior notice. In no event will transactions be effected at a price higher than the price in the U.S. Offering, i.e. USD 19.50. No stabilization measures have taken or will take place on Nasdaq Stockholm.

    The board of directors of the Company have granted the Joint Global Coordinators an over-allotment option which may be utilized in whole or in part for 30 days from the date of pricing of the Company's ADSs, to sell up to 692,306 ADS corresponding to up to 15 percent of the total number of common shares in the Global Offering, at a price corresponding to the price in the U.S. Offering, i.e. USD 19.50 per ADS, to cover any over-allotment in connection with the Global Offering.

    Citigroup has, in its capacity as stabilization manager, notified in accordance with article 5(4) in the Market Abuse Regulation 596/2014 that stabilization measures have been undertaken, in accordance with Reg M, Rule 104 of the U.S. Securities Act of 1933, as amended, on The Nasdaq Global Select Market as specified below. Undertaken stabilization measures were also announced on 12 June 2020. The contact person at Citigroup is Dean Poniros (tel: +1 212 723 6137, e-mail: dean.poniros@citi.com).

    Stabilization information:

    Issuer:

    Calliditas Therapeutics AB (publ)

    Securities:

    American Depositary Shares (ISIN: US13124Q1067)

    Offering size:

    692,306 ADSs, representing 1,384,612 underlying common shares

    Offer price:

    USD 19.50

    Ticker:

    CALT

    Stabilization manager:

    Citigroup Global Markets Inc.

    Stabilization transactions:

    Date

    Quantity,  ADS

    Price (highest)

    Price (lowest)

    Price (volume weighted average)

    Currency

    Trading venue

    2020-06-15

    75

    19.25

    19.25

    19.25

    USD

    The Nasdaq Global Select Market

    2020-06-16

    600

    19.25

    19.25

    19.25

    USD

    The Nasdaq Global Select Market

    2020-06-18

    4,666

    19.15

    19.15

    19.15

    USD

    The Nasdaq Global Select Market

    2020-06-19

    4,913

    19.00

    19.00

    19.00

    USD

    The Nasdaq Global Select Market

     

    www.calliditas.se/en/

    This information is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation 596/2014. The information was submitted for publication, through the agency of the contact person set out below, at 10:45 pm CEST on 24 June 2020.

    About Calliditas

    Calliditas Therapeutics AB is a specialty pharmaceutical company based in Stockholm, Sweden. It is focused on developing high quality pharmaceutical products for patients with a significant unmet medical need in niche indications, in which Calliditas can partially or completely participate in the commercialization efforts. Calliditas is focused on the development and commercialization of the product candidate Nefecon, a unique two step formulation optimized to combine a time lag effect with a concentrated release of the active substance budesonide, within a designated target area. This patented, locally acting formulation is intended for treatment of patients with the inflammatory renal disease IgA nephropathy (IgAN). Calliditas is running a global Phase 3 study within IgAN and aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and The Nasdaq Global Select Market (NASDAQ:CALT).

    For further information, please contact:

    Renée Aguiar-Lucander, CEO at Calliditas

    E-mail: renee.lucander@calliditas.com

    Telephone: +46 722 52 10 06

    Mikael Widell, Head of Communications at Calliditas

    E-mail: mikael.widell@calliditas.com

    Telephone: +46 703 11 99 60

    This information was brought to you by Cision http://news.cision.com

    https://news.cision.com/calliditas-therapeutics/r/citigroup-notifies-that-stabilization-measures-have-been-undertaken-in-calliditas-therapeutics--adss,c3141344

    The following files are available for download:

    Cision View original content:http://www.prnewswire.com/news-releases/citigroup-notifies-that-stabilization-measures-have-been-undertaken-in-calliditas-therapeutics-adss-traded-on-the-nasdaq-global-select-market-301083385.html

    SOURCE Calliditas Therapeutics

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  57. STOCKHOLM, June 22, 2020 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") today announced that its CEO Renée Aguiar-Lucander will exercise warrants granted pursuant to Calliditas' Warrant Program 2017/2020, which corresponds to an investment totaling SEK 15.7 million. Following the exercise, Ms. Aguiar-Lucander's total shareholding in Calliditas corresponds to 412,000 shares.

    The information was sent for publication, through the agency of the contact persons set out above, on June 22, 2020 at 8:00 a.m. CET.

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus…

    STOCKHOLM, June 22, 2020 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") today announced that its CEO Renée Aguiar-Lucander will exercise warrants granted pursuant to Calliditas' Warrant Program 2017/2020, which corresponds to an investment totaling SEK 15.7 million. Following the exercise, Ms. Aguiar-Lucander's total shareholding in Calliditas corresponds to 412,000 shares.

    The information was sent for publication, through the agency of the contact persons set out above, on June 22, 2020 at 8:00 a.m. CET.

    About Calliditas

    Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.

    For further information, please contact:

    Renée Aguiar-Lucander

    CEO, Calliditas

    Email: renee.lucander@calliditas.com

    Telephone: +46-722-52-10-06

    Mikael Widell

    Head of Communications

    Email: mikael.widell@calliditas.com

    Telephone: +46-703-11-99-60

    This information was brought to you by Cision http://news.cision.com

    https://news.cision.com/calliditas-therapeutics/r/ceo-renee-aguiar-lucander-exercises-warrants-and-invests-sek-15-7m--appr--usd-1-7m--in-calliditas,c3138657

    The following files are available for download:

    Cision View original content:http://www.prnewswire.com/news-releases/ceo-renee-aguiar-lucander-exercises-warrants-and-invests-sek-15-7m-appr-usd-1-7m-in-calliditas-301080842.html

    SOURCE Calliditas Therapeutics

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  58. STOCKHOLM, June 13, 2020 /PRNewswire/ -- Citigroup Global Markets Inc. ("Citigroup"), in its capacity as Joint Global Coordinator, notifies that stabilization measures have been undertaken in Calliditas Therapeutics AB's ("Calliditas" or the "Company") American Depositary Shares ("ADSs"), traded on The Nasdaq Global Select Market.

    As announced by the Company in connection with the initial public offering on The Nasdaq Global Select Market, by way of a capital increase of new common shares in the form of ADSs, each representing two (2) underlying new common shares of Calliditas, (the "U.S. Offering"), and a concurrent private placement of common shares to certain qualified investors in Europe and certain other jurisdictions outside of the United

    STOCKHOLM,