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Bulletin from the extraordinary general meeting of Calliditas Therapeutics AB (publ)

The following resolutions were passed at Calliditas Therapeutics AB (publ) (“Calliditas”) extraordinary general meeting held today, on 30 September 2024, in Stockholm.Determination of the number of board members The extraordinary general meeting resolved, in accordance with Asahi Kasei Corporation’s proposal, that the number of members of the board of directors to be elected by the general meeting shall be three (3) without alternate members of the board of directors. Election and removal of board members                                                                     The

Delisting of Calliditas Therapeutics AB (publ) from Nasdaq Stockholm

Nasdaq Stockholm has decided that Calliditas Therapeutics AB (publ) will be delisted from Nasdaq Stockholm. The last day of trading in the share will be on Thursday, October 10, 2024. For further information, please contact: Åsa Hillsten, Head of IR & Sustainability, Calliditas Tel.: +46 76 403 35 43, Email: asa.hillsten@calliditas.com The information was sent for publication, through the agency of the contact person set out above, on September 16, 2024 at 15:30 CET. About Calliditas Calliditas Therapeutics is a biopharma company headquartered in Stockholm, Sweden, focused

Calliditas Therapeutics takes certain corporate actions following announcement by Asahi Kasei

Stockholm, Sweden, September 3, 2024 – Following the announcement by Asahi Kasei Corporation (“Asahi Kasei”) on September 2, 2024 that it controls more than 90 percent of the outstanding shares of Calliditas Therapeutics AB (Nasdaq: CALT) (“Calliditas” or the “Company”), and declared its offers to purchase all of the outstanding Common Shares and ADSs of Calliditas unconditional and intends to initiate compulsory redemption of the remaining shares of the Company, the Board of Directors of Calliditas has resolved, in accordance with a request from Asahi Kasei, to take certain corporate actions.

Notice of extraordinary meeting of Calliditas Therapeutics AB (publ)

The shareholders of Calliditas Therapeutics AB (publ) (“Calliditas Therapeutics”), Reg. No. 556659-9766, with registered office in Stockholm, are summoned to the extraordinary general meeting on Monday 30 September 2024 at 12:00 p.m. CEST at Advokatfirman Vinge’s premises on Smålandsgatan 20, SE-111 46, Stockholm, Sweden. Registration starts at 11:30 a.m. CEST.Background Asahi Kasei Corporation (“Asahi Kasei”), which has announced that the public offer made regarding the company’s shares has been accepted to such extent that Asahi Kasei becomes the owner of more than 90 per cent of the

Calliditas Interim Report January to June 2024

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX): April to June 2024 (compared to April to June 2023) · Net sales amounted to SEK 559.8 million, of which TARPEYO[®] net sales amounted to SEK 493.4 million, for the three months ended June 30, 2024. For the three months ended June 30, 2023, net sales amounted to SEK 269.4 million, of which TARPEYO net sales amounted to SEK 259.2 million. · Operating loss amounted to SEK 31.5 million and SEK 75.2 million for the three months ended June 30, 2024, and 2023, respectively. However, expenses related to the Asahi Kasei

Invitation to the presentation of Calliditas´s interim report January – June 2024

Calliditas's interim report for the second quarter, April – June 2024 will be published in Swedish and English on Tuesday 13 August 2024 at 07.00 a.m. CET.A combined audio cast and telephone conference with the opportunity to ask questions will be held at 14.30 p.m. CET on the same day, with CEO Renée Aguiar-Lucander and CFO Fredrik Johansson, CMO Richard Philipson and President North America Maria Törnsén. The presentation will be given in English. Link to the webcast:  https://ir.financialhearings.com/calliditas-therapeutics-q2-report-2024 To participate via conference call

Number of shares and votes in Calliditas Therapeutics

During July, the number of shares and votes in Calliditas Therapeutics AB (publ) has changed due to the exercise of warrants under the company’s long-term incentive program issued in 2020, ESOP 2020 and Board of Directors program LTIP 2021. As of today, the total number of outstanding shares in Calliditas Therapeutics AB (publ) amounts to 59,941,465 ordinary shares. The number of votes in Calliditas Therapeutics AB (publ) as of today amounts to 59,941,465. The share capital has increased by SEK 14,455.12 from SEK 2,383,203.48 to SEK 2,397,658.60. For further information, please contact:

Calliditas partner STADA receives European Commission decision for full approval of Kinpeygo® for the treatment of IgA Nephropathy

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that the European Commission has granted a full marketing authorization for Kinpeygo for the treatment of adults with primary immunoglobulin A nephropathy (IgAN).The European Commission has granted a full marketing authorization of Kinpeygo®. The granting of the full approval results in a significantly broader label for patients with primary IgAN, moving from a urine protein excretion (UPCR) limitation of > 1.5g/g to encompassing the entire study population, defined as UPCR of ≥ 0.8g/g, or

Calliditas announces positive TRANSFORM Phase 2b topline data in primary biliary cholangitis

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that the Phase 2b TRANSFORM trial met its primary endpoint, showing statistically significant improvement in ALP (Alkaline Phosphatase) for both doses tested versus placebo.  The trial evaluated setanaxib, a NOX enzyme inhibitor, in patients with primary biliary cholangitis (PBC) and elevated liver stiffness.The TRANSFORM trial is a double-blind, randomized, placebo-controlled Phase 2b study investigating the effect of setanaxib 800 mg AM + 400 mg PM, (“1200 mg arm”) and 800 mg BID (“1600 mg

Launch of Phase 3 clinical trial with Nefecon in Japan

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announces that its partner Viatris Pharmaceutical Japan G.K. (“Viatris”) has initiated a phase III clinical trial in Japan with Nefecon, named VR-205 in the Japanese market, in Japanese patients with IgA nephropathy (IgAN).The clinical trial is a bridging study requiring a limited number of Japanese patients to participate in a study similar in design to that of the global NefIgArd trial. IgA nephropathy is a designated retractable disease in Japan, with an estimated 33,000 patients in Japan* assumed to

Calliditas provides setanaxib patent update

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that the United States Patent and Trademark Office (USPTO) has issued a patent for application no. 16/760,910 entitled “Use of NOX Inhibitors for Treatment of Cancer.”The patent covers a method of treating a solid tumor presenting resistance to PD-1 inhibitor immunotherapy by administering setanaxib in combination with a PD-1 inhibitor. The patent will have an expiration date in 2039. Calliditas has corresponding applications and patents in several additional territories around the world,

Bulletin from the annual general meeting of Calliditas Therapeutics AB (publ)

The following resolutions were passed at Calliditas Therapeutics AB (publ) (“Calliditas”) annual general meeting held today, on 17 June 2024, in Stockholm.Adoption of income statement and balance sheet for the financial year 2023 and discharge from liability The annual general meeting resolved to adopt the income statement and the consolidated income statement for the financial year 2023 as well as the balance sheet and consolidated balance sheet as of 31 December 2023. The members of the Board of Directors and the CEO were discharged from liability for the financial year 2023.

Calliditas partner STADA receives positive CHMP opinion recommending full approval for Kinpeygo[®] for the treatment of IgA nephropathy

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of full marketing authorisation for Kinpeygo for the treatment of adults with primary immunoglobulin A nephropathy (IgAN).Kinpeygo, which was granted conditional marketing authorisation in EU on 15 July 2022, was the first ever approved treatment for IgAN in the EU and UK. The full approval results in a significantly broader label for

Calliditas Therapeutics Presents Data at the 61[st] European Renal Association Congress

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”), today announced the presentations of an additional efficacy analysis of Nefecon (TARPEYO® (budesonide) delayed release capsules)) as well as a real-world analysis of the use of systemic glucocorticoids (SGC) in IgA nephropathy (IgAN). These were presented at ERA 2024 virtually and in Stockholm on May 23 – 26, 2024.The presented efficacy analysis of Nefecon and sparsentan showed that treatment with Nefecon for 9 months was associated with estimated glomerular filtration rate (eGFR) benefit compared with

Statement by the Board of Directors of Calliditas Therapeutics AB (publ) in relation to the public offer by Asahi Kasei Corporation

The Board of Directors of Calliditas Therapeutics AB (publ) unanimously recommends that the shareholders and holders of American Depositary Shares (“ADS”) of Calliditas Therapeutics AB (publ) (jointly the “Securityholders”) accept the public tender offer by Asahi Kasei Corporation.Background                                                                                                                                                                                This statement is made by the Board of Directors (the “Board”) of Calliditas Therapeutics AB (publ) (“Calliditas” or the “

Calliditas Q1 report, January – March 2024

Calliditas Therapeutics AB (Nasdaq Stockholm: CALTX): Target market expansion following full approval in the USJANUARY – MARCH 2024 (COMPARED TO JANUARY – MARCH 2023) · Net sales amounted to SEK 295.5 million, of which TARPEYO® net sales amounted to SEK 278.3 million, for the three months ended March 31, 2024. For the three months ended March 31, 2023, net sales amounted to SEK 191.4 million, of which TARPEYO net sales amounted to SEK 185.7 million. · Operating loss amounted to SEK 203.8 million and SEK 180.1 million for the three months ended March 31, 2024, and 2023,

In-Person & Virtual R&D Day: The Anti-Fibrotic Effects of Setanaxib and TARPEYO’s Mode of Action

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that it will hold an in-person and virtual R&D day on Thursday, May 30, 2024 at 3:00 PM CET (9:00 AM ET). The event will be held at Inderes Event Studio, Västra Trädgårdsgatan 19, Stockholm.The event will feature Gareth J. Thomas, PhD (University Hospital Southampton) and Jonathan Barratt, PhD, FRCP (University of Leicester) with the following program: · Supportive preclinical data and Phase 2 POC trial evaluating setanaxib, the Company's lead candidate from its NOX platform, in patients

Invitation to the presentation of Calliditas´s interim report January – March 2024

Calliditas´s interim report for the first quarter, January – March 2024 will be published in Swedish and English on Thursday 23 May 2024 at 07.00 a.m. CET.A combined audio cast and telephone conference with the opportunity to ask questions will be held at 14.30 p.m. CET on the same day, with CEO Renée Aguiar-Lucander and CFO Fredrik Johansson, CMO Richard Philipson and President North America Maria Törnsén. The presentation will be given in English. Link to the webcast:  Calliditas Therapeutics Q1 Report 2024 (financialhearings.com) 

Calliditas Therapeutics to Present Data at ERA 2024 May 23 – 26 in Stockholm

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”), today announced upcoming data presentations and a sponsored symposium at the 61[st] European Renal Association (ERA) Congress, in Stockholm, Sweden on May 23 – 26, 2024.Data presentations will include an efficacy analysis of Nefecon (TARPEYO® (budesonide) delayed release capsules)) in primary immunoglobulin A nephropathy (IgAN) as well as a real-world analysis of the challenges associated with the use of systemic glucocorticoids (SGC) in IgAN. “We are delighted to participate in ERA and look forward to

Notice of annual general meeting of Calliditas Therapeutics AB (publ)

The shareholders of Calliditas Therapeutics AB (publ) (“Calliditas Therapeutics”), Reg. No. 556659-9766, with registered office in Stockholm, are summoned to the annual general meeting on Monday 17 June 2024 at 2.00 p.m. CEST at Klara, Klarabergsviadukten 90, SE-111 64 Stockholm, Sweden. Registration starts at 1.30 p.m. CEST.Right to participate in the annual general meeting and notice of participation Participation in the annual general meeting at the venue A shareholder who wishes to participate in the annual general meeting at the venue in person or represented by a proxy must (i)

Calliditas’ Partner Everest Medicines Starts Commercial Launch of Nefecon in China

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announces that its partner Everest Medicines (HKEX: 1952.HK) (“Everest”) has launched Nefecon® in China.China, which is estimated to have up to 5 million patients suffering from the progressive autoimmune disease, IgA nephropathy (IgAN), has the highest prevalence of primary glomerular diseases in the world, with IgAN accounting for about 35% to 50% of cases with a biopsy proven incidence of over 100,000 patients per year. There is a very significant unmet medical need for novel therapies among IgAN

Calliditas announces positive topline results of Phase 2 head and neck cancer trial with lead NOX inhibitor candidate, setanaxib

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced data from the proof-of-concept Phase 2 trial evaluating setanaxib, its lead NOX enzyme inhibitor, in combination with pembrolizumab, in patients with squamous cell carcinoma of the head and neck (SCCHN).  The analysis showed statistically significant improvements in progression-free survival (PFS), as well as in overall survival (OS), with statistically significant changes in tumor biology consistent with the mechanism of action of setanaxib.The trial is a randomized, placebo-controlled, double-

Calliditas Therapeutics’ 2023 Annual Report Published

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announces that the Annual Report for 2023 now is available at the company’s website: www.calliditas.comFor further information, please contact: Åsa Hillsten, Head of IR & Sustainability, Calliditas Tel.: +46 76 403 35 43, Email: asa.hillsten@calliditas.com This information is information that Calliditas Therapeutics AB is obliged to make public pursuant to the Securities Markets Act. The information was sent for publication, through the agency of the contact persons set out above, on April 24,

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