Stockholm, Sweden

Calliditas announces

positive TRANSFORM Phase 2b topline data in primary biliary cholangitis

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 arm") over 24 weeks of treatment. The basis for the analysis

consisted of a dataset of 76 patients with primary biliary cholangitis (PBC) and elevated liver stiffness.

The treatment groups were

relatively well-balanced with no clinically relevant differences between the groups observed at baseline. The result is particularly

encouraging as over 40% of the trial population was on dual therapy, ie was receiving UDCA (ursodeoxycholic acid) and either Ocaliva

(obeticholic acid) or Bezafibrate (PPAR agonist) as base therapy and 13% were receiving all three therapies during the study, reflecting

setanaxib having clinically relevant incremental benefit beyond existing standard of care. Patients treated with setanaxib showed statistically

significant improvements in the primary endpoint of ALP of 19% in the 1600mg arm and 14% in the 1200mg arm and showed positive trends

on liver stiffness assessed by FibroScan at 24 weeks. Setanaxib treatment was generally well tolerated with overall number of TEAEs

(treatment emergent adverse events), as well as serious TEAEs, being similar between active treatment and placebo. The frequency

of TEAEs leading to study discontinuation was higher in patients receiving active treatment compared to placebo.

"It is very encouraging

to see a statistically significant treatment effect in this hard-to-treat population which is already on multiple medications in this

relatively small study," said Professor Dave Jones OBE; Director, NHIP Academy; Director, Newcastle Centre for Rare Disease; Professor

of Liver Immunology, Newcastle University; and Honorary Consultant Hepatologist, Newcastle upon Tyne Hospitals.

"These positive data

provide further clinical evidence of the potential of setanaxib in multiple rare diseases, and we are very pleased that we now have additional

positive clinical evidence in support of our unique, first in class NOX platform. We also look forward to the read out of the investigator

led study in IPF as well as the ongoing study in Alport syndrome in due course." said CEO Ren e Aguiar-Lucander.

"I am delighted that

we have seen statistically significant and clinically meaningful improvements in ALP with encouraging trends in other outcomes in this

population of patients with PBC. I'd like to extend my thanks to investigators, clinical trial site staff, and most importantly

patients, who have all contributed to this important study." said CMO Richard Philipson.

The company is conducting

additional clinical trials with setanaxib and is expecting the investigator led Phase 2 trial in IPF (idiopathic pulmonary fibrosis)

to provide top line data in Q4 2024 / Q1, 2025. There is also an ongoing Phase 2 proof of concept trial in Alport syndrome, which is

expected to deliver top line data in 2025.

For further information,

sa Hillsten, Head of

IR & Sustainability, Calliditas

Tel.: +46 76 403 35 43, Email:

The information was sent

for publication, through the agency of the contact persons set out above, on July 26, 2024 at 08:00 a.m. CET.

About Primary biliary

PBC is a progressive and chronic

autoimmune disease of the liver that causes immune injury to biliary epithelial cells, resulting in cholestasis and fibrosis. It is an

orphan disease and, based on its known prevalence rates, we estimate that there are approximately 140,000 patients in the United States,

where the annual incidence ranges from 0.3 to 5.8 cases per 100,000.

Calliditas Therapeutics is

a biopharma company headquartered in Stockholm, Sweden, focused on identifying, developing, and commercializing novel treatments in orphan

indications with significant unmet medical needs. Calliditas' common shares are listed on Nasdaq Stockholm (ticker: CALTX) and

its American Depositary Shares are listed on the Nasdaq Global Select Market (ticker: CALT). Visit Calliditas.com for further information.

Forward-Looking Statements

contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended,

including, without limitation, statements regarding Calliditas' strategy, commercialization efforts, business plans,

regulatory submissions, clinical development plans, revenue and product sales projections or forecasts and focus. The words

"may," "will," "could," "would," "should," "expect,"

"plan," "anticipate," "intend," "believe," "estimate,"

"predict," "project," "potential," "continue," "target," and similar

expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these

identifying words. Any forward-looking statements in this press release are based on management's current expectations and

beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ

materially from those expressed or implied by any forward-looking statements contained in this press release, including, without

limitation, any related to Calliditas' business and operations, the presumed mechanism of action of setanaxib, the safety and

efficacy of setanaxib in PBC or other potential indications, anticipated timelines and other risks identified in the section

entitled "Risk Factors" in Calliditas' reports filed with the Securities and Exchange Commission. The results of

early clinical trials may not predict those of future, later-stage clinical trials. The clinical data presented herein involves a

limited number of patients, and these results may not be replicated in larger clinical trials. 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.