Stockholm, Sweden

Calliditas Announces Positive Topline Results from Pivotal Phase 3 NefIgArd Trial

Calliditas Therapeutics

AB (OMX 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

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.

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.

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 Ren e Aguiar-Lucander.

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.

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.

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.

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.

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

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.

Phase 3 NefIgArd trial consists of two parts.

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).

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.

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,

Tel.: +44 7955129845,

email: marie.galay@calliditas.com

of Communications and IR

99 60, email: mikael.widell@calliditas.com

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.

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 (ticker: CALT).

Visit www.calliditas.com for further information.

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.

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