Interim Report January - June 2024 APRIL - JUNE 2024 (COMPARED TO APRIL - 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

Interim Report January - June 2024

(COMPARED TO APRIL - JUNE 2023)

(COMPARED TO JANUARY - JUNE 2023)

1 Management uses and presents IFRS results as well as the non-IFRS measure of adjusted operating profit to evaluate and communicate its performance. While non-IFRS measures should not be construed as alternatives to IFRS measures, management believes non-IFRS measures are useful to further understand Calliditas's current performance, performance trends, and financial condition. Adjusted operating profit is defined as IFRS operating profit (loss), less provisions for social security contributions for incentive programs and advisor fees for the Asahi Kasei public offer. A reconciliation of adjusted operating profit to operating profit (loss), which is the most directly comparable IFRS measure, is set forth on page 31 of this report.

Key takeaways from Q2, 2024

Key events after the reporting period

Outlook 2024: Updated

Total net sales from the Nefecon franchise, including milestones, are estimated to be USD 165-185 million for the year ending December 31, 2024.

Calliditas - pioneering new treatments for rare diseases

Calliditas Therapeutics leverages scientific expertise and disease specific insights to help improve the lives of patients. We are a commercial-stage biopharma company that researches, develops and commercializes novel therapies that seek to address significant unmet needs in relation to the treatment of rare diseases. We are committed to expanding treatment options and establishing new standards of care for patients with rare diseases, reflected by our pipeline of innovative medicines that target unmet medical needs.

Our lead product provides a treatment option that has been demonstrated to be disease-modifying for IgA nephropathy (IgAN) - also known as Berger's Disease - a progressive autoimmune disease of the kidney that for many patients leads to end-stage renal disease (ESRD), requiring dialysis or organ transplantation. This drug product, developed under the name Nefecon , was granted accelerated approval by the FDA in 2021 and full approval in December 2023, and is today marketed in the US under the brand name TARPEYO . TARPEYO is now the first and only fully approved treatment for IgAN and is approved based on a measure of kidney function. Nefecon has also been granted full marketing authorisation by the European Commission under the brand name Kinpeygo in the European Economic Area (EEA) and conditional marketing authorisation in the UK.

Nefecon has been granted conditional approval in China, Singapore, Hong Kong and Macau, and is being reviewed by regulators in South Korea. Nefecon was launched commercially by Everest Medicines in China in May 2024. Calliditas has also entered into a partnership with Viatris to develop and commercialize Nefecon in Japan.

IgA nephropathy is the most common primary glomerulonephritis worldwide, so the market potential for Nefecon is substantial, as evidenced by our early commercial success and out-licensing deals with potential payments exceeding USD 300 million, encompassing upfront payments and predefined milestones, as well as ongoing royalty obligations.

Our late-stage pipeline is based on a first-in-class platform of NOX inhibitors. Our lead compound, setanaxib, inhibits enzymes involved in inflammation and fibrosis pathways and is the first drug of this class to reach the clinical stage. Setanaxib is currently undergoing clinical trials targeting rare diseases characterized by inflammation and fibrosis, including Alport syndrome, and there is also an investigator led trial ongoing in idiopathic pulmonary fibrosis (IPF). Calliditas read out positive topline data from a Phase 2 proof-of-concept trial with setanaxib in head and neck cancer in May 2024 and positive topline data from the Phase 2b trial in Primary Biliary Cholangitis (PBC) in July 2024.

While our headquarter is in Stockholm, Sweden, we maintain a significant presence in the United States, with offices in New York and New Jersey. We also have offices in France and Switzerland, where our discovery team is based. Calliditas Therapeutics ordinary shares were listed on NASDAQ Stockholm in 2018 (CALTX) and subsequently American Depositary Shares representing our ordinary shares were listed on the NASDAQ Global Select Market in the United States in 2020 (CALT).

We are flexible and able to rapidly pivot and adapt to changing situations and requirements.

We leverage our strong internal experience and competencies while complementing our strengths through knowledge sharing and external collaborations as needed.

We take responsibility for our actions and hold ourselves to the highest ethical standards, guided by our moral principles to make the right decisions.

We explore novel approaches and empower each other to find new ways of operating in a compliant, innovative and pragmatic manner.

Investment highlights

RECENT AND ANTICIPATED DRIVERS

Record Revenues and Achievement of Profitability Target

Following on from the record quarter of Q1 with regards to enrolments as well as new prescribers, the success of Q2 is a consequence of our consistent corporate priorities and investment strategy, reflected by investment decisions taken in Q3 of 2023 in expectation of full approval of TARPEYO by the FDA in December of 2023. In Q2, we saw a record 750 new enrolments for TARPEYO in the US and we generated record revenues of SEK 560 million for the quarter, out of which net product revenues from TARPEYO represented SEK 493 million ($46.3m), which represents a 90% growth over Q2, 2023 and 77% over Q1, 2024. With the combination of our significant, but judicious investments into a broader field presence in the US, additional marketing and market access infrastructure combined with experienced and senior US leadership resources, we clearly achieved our stated long-term goals for the company this quarter. We cemented our clear market leadership position and delivered on continued significant revenue growth. In the quarter we had expenses related to the Asahi Kasei offer, and expenses related to provisions for social security contribution for incentive programs, totaling 101.7 MSEK. Excluding these expenses our adjusted operational profitability was SEK 70 million for the quarter. This brings Nefecon franchise related revenues for the first 6 months of 2024 to around $80 million, with an additional EUR 10 million milestone payment from STADA secured in Q3 related to the full approval of Kinpeygo, announced on July 26th.

As previously disclosed, our interactions with payors were intense over the first several months of the year and as of the end of June we had seen the vast majority of the major insurance plans adjust their rules based on the new TARPEYO indication. This has continued in July and August and we are nearly through the update cycle related to the new label with the vast majority of plans providing updates in line with the new label.

In addition to these very significant commercially related achievements, we also saw the validation of our pipeline in Q2, based on the positive topline data readout from our Phase 2 Head and Neck cancer trial. With statistically significant results both in terms of PFS (progression free survival) and OS (overall survival) in combination with a statistically significant fourfold increase in tumor infiltrating lymphocytes in the treatment arm, it clearly supports the presumed anti fibrotic mode of action of setanaxib and we are very excited about the potential of this proprietary and unique platform.

This was further supported in the post reporting period, when we reported out topline data from our Phase 2b PBC (Primary Biliary Cholangitis) trial which showed statistically significant improvement versus placebo of the primary endpoint of Alkaline Phosphatase (ALP) for both doses; 1200 mg/day and 1600 mg/day. This was particularly exciting as the study population was a heavily treated population, with over 40% on the standard of care of UDCA as well as one additional medication, either Ocaliva, or Bezafibrate, a PPAR agonist. In addition, 13% of the study population was on all three medications, reflecting the very different composition of the placebo arm, versus all earlier Phase 2 or 3 trials in PBC. We are therefore very excited about the outcome in this highly non responder population and we look forward to the read out of the other ongoing Phase 2 trials with setanaxib in IPF and Alport syndrome, and we will review the data and competitive environment to assess in which rare disease it would be most appropriate to potentially conduct a pivotal trial.

It is with great pride that I look back at what the team at Calliditas has achieved over the last 4 years, since the successful read out of the interim data of the NefIgArd Phase 3 trial in December of 2020. These regulatory, commercial and development successes were accomplished against a backdrop of highly challenging capital markets environment for biotech companies, as well as an extremely volatile macro situation. I am struck by how far we have come as an organization and extremely grateful for the amazing contribution of each and every employee of Calliditas, who have enabled the company to achieve this outcome.

On May 28th Asahi Kasei announced a public take-over bid for the company, recommended by the Calliditas Board of directors and supported by major shareholders representing 44.65% of the shares. The tender offer documents were published on July 17th with the tender offer period started on July 18th and is expected to close on August 30th, 2024. The result is expected to be announced on or about September 2nd, 2024. If over 90% of the shares are tendered, we expect a subsequent squeeze out and delisting of the shares.

Our cash position remains strong with SEK 797 million ($75m) on the balance sheet at the end of the quarter, reflecting the very limited cash burn in the quarter. We believe that the remaining quarters of 2024 will deliver positive operating profitability for the business operating in the ordinary course, based on the continued revenue growth of TARPEYO and the overall development of the Nefecon franchise. We adjust our guidance to $165 - 185 million of net revenues from the Nefecon franchise for 2024.

Ren e Aguiar-Lucander, CEO

Calliditas' lead product has been fully approved in the US and EU and has conditional approval in China. Our pipeline consists of development programs derived from a first-in-class NOX inhibitor platform. The lead compound, setanaxib, was designed to be a selective NOX 1 and NOX 4 inhibitor and is the first product candidate to reach the clinical stage. Calliditas read out topline data from its trial with setanaxib in squamous cell carcinoma of the head & neck (SCCHN) in May 2024 and from its Phase 2b trial in primary biliary cholangitis (PBC) in July 2024. Calliditas is also presently running a trial with setanaxib in Alport syndrome. There is also an ongoing investigator-led trial in idiopathic pulmonary fibrosis (IPF).

* Approved in the US under the tradename TARPEYO to reduce the loss of kidney function in adults with primary IgAN at risk for disease progression. Approved in the EEA and granted conditional marketing authorization UK under the tradename Kinpeygo for the treatment of primary IgAN in adults at risk of rapid disease progression, and granted conditional approval in China under the tradename Nefecon .

Exciting journey ahead

Our commercial product

On December 20, 2023, Calliditas' lead product, TARPEYO, became the first and only drug granted full approval by the US Food and Drug Administration for patients affected by IgA nephropathy (IgAN). It is the only treatment specifically designed to target the origin of IgAN and to be disease-modifying.

IgAN is a serious progressive disease, in which up to 50% of patients end up at risk of developing end-stage renal disease (ESRD) within ten to twenty years. This product, which was developed under the name Nefecon , is approved under the brand name TARPEYO in the United States. It was also granted conditional approval by the European Commission under the brand name Kinpeygo in July 2022 and full approval in July 2024, and conditional approval by the MHRA for the UK in February 2023. Nefecon received conditional approval in China by the China NMPA in November 2023.

Although IgAN manifests in the kidney, the evidence indicates that it is a disease that starts in the distal part of the intestine, specifically in the ileum. Peyer's patches, which are concentrated within the gut-associated lymphoid tissue in the ileum, have been identified as a major source of mucosal-type IgA antibodies. Patients with IgA nephropathy have elevated levels of mucosal-type IgA, which - in contrast to the majority of the IgA in the blood - are predominately dimeric or polymeric and are galactose-deficient. In IgAN patients, a combination of a genetic predisposition and environmental, bacterial and dietary factors is presumed to lead to an increased production of these galactose-deficient IgA antibodies. This increased production, potentially in conjunction with increased intestinal permeability, leads to these secretory antibodies appearing in the blood.

Successful Phase 3 trial readout

NefIgArd is the first Phase 3 trial in IgA nephropathy to show a statistically significant and clinically relevant kidney protective effect as measured by eGFR. Calliditas' full approval for Nefecon from the FDA was based on the strong eGFR data from this trial. The trial confirmed that targeting the origin of the disease with a non chronic approach had a significant long-term impact on kidney function.

The full Phase 3 NefIgArd trial consisted of a total of 364 patients, including 200 patients from the interim analysis, based upon which Calliditas successfully filed for accelerated approval with the FDA and for conditional approval with the European Commission, UK MHRA, and China NMPA. The full trial included 9 months of treatment and a 15-month post-treatment observational period for all study participants to confirm long-term renal protection. The endpoint of the full Phase 3 trial assessed 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 data read-out took place in March 2023, and in August 2023 was published in The Lancet.

The primary endpoint of the Phase 3 trial was a time-weighted average of eGFR observed at each time point over two years. The primary endpoint was successfully met with a highly statistical p value of <0.0001. At 9 months the absolute difference in eGFR of the treatment arm was an improvement of 0.7 mL/min/1.73 m2 versus a loss of 4.6 mL/min/1.73 m2 for the placebo arm. The treatment benefit was preserved during the period of observation, reflected by a loss of kidney function at two years in the placebo arm of 12.0 mL/min/1.73 m2 versus 6.1 mL/min/1.73 m2 for the treatment arm. This was also confirmed by a difference in slope of 3 mL/min/year in favor of TARPEYO.

There was a cumulative improvement in proteinuria in patients treated with Nefecon versus placebo during the 9-month treatment period, which continued to significantly improve after end of treatment, resulting in a decline of over 50% at 12 months. At month 24, proteinuria levels in patients who had received Nefecon were still at a reduced level, similar to that observed at the 9-month time point, reflecting the durability of the proteinuria reduction of a 9-month course of treatment.

Regulatory approvals

On the basis of this positive data, Calliditas submitted an sNDA to the FDA seeking full approval of TARPEYO for the complete study population from the Phase 3 NeflgArd study. On December 20, 2023, the FDA approved TARPEYO (budesonide) delayed release capsules to reduce the loss of kidney function in adults with primary IgAN at risk for disease progression. Marking a significant milestone, TARPEYO is now the first fully FDA-approved treatment for IgAN reflecting the impact on a measure of kidney function.

Calliditas' partner STADA received a full approval from the European Commission for Kinpeygo in July 2024. Kinpeygo has also received conditional approval from the UK MHRA, and is awaiting regulatory review for full approval. Nefecon received conditional approval in China in November 2023 and has also approvals in Macau, Singapore and Hong Kong. Calliditas' partner Everest Medicines will be commercialising this product in these territories.

IgA nephropathy a significant market opportunity

Our commercial partnerships

Nefecon was granted full marketing authorisation by the European Commission in July 2024, and hold a conditional marketing authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom in February 2023, under the brand name Kinpeygo for the treatment of IgAN in adults at risk of rapid disease progression. Kinpeygo is marketed in the European Economic Area (EEA), the UK and Switzerland, if approved in this jurisdiction, exclusively by STADA Arzneimittel AG, with whom Calliditas entered into a license agreement in July 2021 to register and commercialize Kinpeygo in Europe. STADA launched Kinpeygo in Germany in September 2022, with additional European countries to follow.

In 2019, Calliditas entered into a license agreement with Everest Medicines (HKEX 1952.HK) for Everest to develop and commercialize Nefecon for IgAN in Greater China and Singapore. In March 2022, this agreement was expanded to include South Korea.

Everest first launched Nefecon in China's Hainan Boao Pilot Zone as a First-in-Disease therapy for IgA nephropathy in April 2023. This program allows innovative overseas drugs and medical devices that have been approved in other territories to be sold and used in real-world clinical settings in Hainan Province before regulatory approval by the NMPA. Several hundreds of patients signed up for this early access program, making it one of the most successful EAP programs launched in China.

Nefecon was awarded conditional approval in IgAN by China's National Medical Products Administration (NMPA) in November 2023. Everest launched Nefecon in mainland China in May 2024. In addition to being approved and commercially launched in Mainland China, Nefecon has also received approval in Macau, Hong Kong and Singapore, and was successfully commercially launched and first prescribed in Macau at the end of 2023. New Drug Applications (NDA) for Nefecon were also accepted for review in Taiwan and South Korea at the end of 2023.

China has the highest prevalence of primary glomerular diseases in the world, with an estimated five million IgAN patients. Results from the Chinese subpopulation analysis of the Phase 3 NefIgArd trial, presented at the American Society of Nephrology (ASN) Kidney Week 2023, provided evidence that the treatment effect of Nefecon in the Chinese cohort was greater than in the global data set with regards to kidney function, proteinuria and microhematuria. In the Chinese cohort, the mean absolute change from baseline in eGFR at 24 months showed an approximately 66% reduction in loss of this measure of kidney function with Nefecon compared with a 50% reduction in loss of eGFR in the global data set.

At the end of 2022, Calliditas entered into a partnership to commercialize Nefecon in Japan with Viatris Pharmaceuticals Japan, a subsidiary of Viatris Inc. (Nasdaq: VTRS). In July, 2024, Viatris initiated a phase III clinical trial in Japan with Nefecon in Japanese patients with IgA nephropathy.

1Veeva OpenData for 2023, including all active HCPs where the primary specialty is Nephrology

2Spherix RealWorld Dynamix

TARPEYO: Moving from supportive care to treating IgAN

TARPEYO and Kinpeygo were the first-ever medications approved for IgAN by the FDA and European Commission, respectively, and the only treatments specifically designed to target the origin of IgAN and to be disease-modifying. TARPEYO is the only fully FDA-approved treatment for IgAN and the only treatment approved based on protection of kidney function.

1 Pitcher D, Braddon F, Hendry B, et al. Long-Term Outcomes in IgA Nephropathy. Clin J Am Soc Nephrol. 2023;18(6):727-738. doi:10.2215/CJN.000000000000013

Kwon CS, Daniele P, Forsythe A, Ngai C. A Systematic Literature Review of the Epidemiology,, Health-Related Quality of Life Impact, and Economic Burden of Immunoglobulin A Nephropathy. J Health Econ Outcomes Res. 2021 Sep 1;8(2):36-45. doi: 10.36469/001c.26129. PMID: 34692885; PMCID: PMC8410133.

Continued Strong Demand for TARPEYO in Q2

During the second quarter, the US team continued to build on the momentum from the previous quarter, focusing on leveraging the full FDA approval of TARPEYO to inform and engage nephrology healthcare professionals, payors, and patient communities about TARPEYO's clinical data and its pivotal role in treating IgAN.

In the second quarter of 2024, TARPEYO achieved another quarterly record with 750 new patient enrolments, demonstrating continued quarter-over-quarter growth. We added 343 new prescribers this quarter, bringing the total number of prescribers to 2,336, underscoring the growing market acceptance and demand for TARPEYO. This positive momentum is expected to continue throughout 2024, supported by the new label and indication, further reinforcing TARPEYO's positioning as a cornerstone treatment in IgAN. We have also made significant progress with payers in Q2, with over 80% of commercial lives covered in alignment with the updated label. We are continuing to educate the payer community to promote open access.

In the second quarter, our medical and commercial teams had a robust presence at major nephrology conferences, such as the National Kidney Foundation (NKF) and European Renal Association (ERA). At ERA, the presented efficacy analysis using a matching-adjusted indirect comparison (MAIC) methodology of Nefecon and sparsentan, showed that treatment with Nefecon was associated with estimated glomerular filtration rate (eGFR) benefit compared with continuous treatment with sparsentan. Additionally, a real-world analysis highlighted the challenges associated with conventional systemic glucocorticoids (SGC), such as prednisone. This analysis demonstrated significant side effects and costs for IgAN patients treated with conventional SGC compared to those not treated with SGC.

In Q2 we also presented initial data from the open-label extension study, which showed positive results and a treatment response consistent with the NeflgArd study across the endpoints of UPCR and eGFR at 9 months for all patients, including those who previously received TARPEYO treatment in the NeflgArd study.

Pipeline: NOX Inhibitor platform

Calliditas' pipeline consists of development programs based on a first-in-class NOX inhibitor platform. Calliditas has been running clinical trials with lead compound setanaxib in squamous cell carcinoma of the head & neck (SCCHN), which read out positive topline data in May 2024, as well as in primary biliary cholangitis (PBC), and is running a clinical trial in Alport syndrome. Setanaxib is also being evaluated in an investigator-led study in idiopathic pulmonary fibrosis (IPF).

NOX Enzyme Inhibitors

NOX enzymes, also known as nicotinamide adenine dinucleotide phosphate (NADPH) oxidases, are the only known enzymes that are solely dedicated to producing reactive oxygen species (ROS). At appropriate concentrations, ROS help regulate cell proliferation, differentiation, and migration, as well as modulate the innate immune response, inflammation, and fibrosis.

The disruption of redox homeostasis has been implicated in multiple disease pathways, with oxidative stress caused by excess ROS being a likely underlying mechanism for many disorders, including cardiovascular diseases, neurodegenerative disorders, and cancer. As such, NOX enzyme inhibitors emerged as promising novel experimental drugs in a new therapeutic class.

Setanaxib, which is the first NOX inhibitor to reach the clinical stage, inhibits NOX1 and NOX4, enzymes that are implicated in fibrosis and inflammation pathways and that represent a high-potential therapeutic target.

Alport syndrome is a genetic disorder arising from the mutations in the genes that code for type IV collagen. The type IV collagen alpha chains are primarily located in the kidneys, eyes, and cochlea, and thus the condition is characterized by kidney disease, loss of hearing, and eye abnormalities. Eventually, patients present with proteinuria, hypertension, progressive loss of kidney function (gradual decline in GFR), and ESRD. It is estimated that approximately 67,000 people in the United States have this disorder, and it is a significant cause of chronic kidney disease (CKD), leading to ESRD in adolescents and young adults and accounting for 1.5% to 3.0% of children on renal replacement therapies in EU and the US.

Based on supportive pre-clinical work, Calliditas launched a randomized, placebo-controlled Phase 2 study in Alport syndrome including around 20 patients. The study will evaluate overall safety as well as impact on proteinuria. The study was initiated in November 2023 and on the basis of the data readout we will decide on a full regulatory program in Alport.

Calliditas was granted orphan drug designation for the treatment of Alport syndrome with setanaxib by the FDA in September 2023, and by the EMA in November 2023.

Primary biliary cholangitis

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 received FDA Fast Track Designation for setanaxib in PBC in August 2021.

Ursodeoxycholic acid, a generic drug also known as ursodiol or UDCA, and obeticholic acid, known as Ocaliva, are the only treatments for PBC approved by the FDA. However, despite these treatment options, there is still an unmet medical need among PBC patients, in particular when it comes to important quality of life outcomes.

Phase 2 data from a trial with setanaxib in 111 patients with PBC demonstrated that setanaxib had a more pronounced effect on fibrosis and ALP reduction (alkaline phosphatase, an established independent predictor of prognosis in PBC) in patients with an estimated liver fibrosis stage of F3 or higher. Patients with elevated liver stiffness are at greater risk of disease progression.

Calliditas is conducting a randomized, placebo-controlled, double-blind Phase 2b trial in PBC patients with elevated liver stiffness and in July, 2024, Calliditas announced positive topline data where the trial met its primary endpoint, showing statistically significant improvement in ALP for both doses tested versus placebo.

Pipeline: NOX Inhibitor platform

Setanaxib in squamous cell carcinoma of the head and neck

In May 2024, Calliditas read out topline data from its proof-of-concept Phase 2 trial evaluating setanaxib in combination with pembrolizumab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). The trial was a randomized, placebo-controlled, double-blind Phase 2 study investigating the effect of setanaxib 800mg twice daily in conjunction with pembrolizumab 200mg IV, administered every 3 weeks, (a standard treatment regimen for SCCHN) with the full dataset reflecting all patients having had the opportunity to complete at least 15 weeks of treatment. The basis for the analysis consisted of 55 enrolled patients with recurrent or metastatic SCCHN and moderate or high CAF-density tumors. A tumor biopsy was taken prior to randomization and then again after at least 9 weeks of treatment.

This trial built on promising in vivo preclinical data from Professor Gareth Thomas' research at the School of Cancer Sciences at the University of Southampton. The response to immuno-oncology therapies can be affected by the tumor microenvironment, in particular by the numbers of tumor-infiltrating lymphocytes (TILs) and cancer-associated fibroblasts (CAFs) in the tumor. A relationship between CAFs and prognosis in SCCHN has been established. NOX4 is highly over-expressed in CAFs and drives myofibroblastic activation within tumors, shielding them from CD8+ TILs.

There is increasing use of pembrolizumab as 1st line mono-therapy in patients with relapsed or metastatic SCCHN, although response rates are low (ORR approx. 20%). Using a CAF-rich tumor model in mice, administration of setanaxib + pembrolizumab (versus either treatment alone) resulted in improved penetration of TILs into the centre of the tumor, slowing of tumor growth and improved survival.

Expanded patent protection

In April 2024, Calliditas received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no. 16/760,910 entitled "Use of NOX Inhibitors for Treatment of Cancer". This Notice of Allowance resulted in the issuance of a U.S. patent in June 2024 covering 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.

Phase 2 data readout

The treatment groups were well-balanced with no clinically relevant differences between the groups observed at baseline. Patients treated with pembrolizumab and setanaxib showed statistically significant improvements in the key secondary endpoints of progression-free survival, (PFS median 5 months versus 2.9 months; Hazard ratio= 0.58) and overall survival (OS at 6 months 92% vs 68%; OS at 9 months 88% vs 58%; Hazard ratio=0.45) compared to patients treated with pembrolizumab and placebo.

There was also an improvement in disease-control rate in setanaxib-treated patients, with 70% in the setanaxib arm showing a best response of at least stable disease compared to 52% in the placebo arm.

No significant difference in the primary endpoint of best percentage change from baseline in tumor size was observed. Transcriptomic analysis of tumor biopsy samples showed a statistically significant increase in CD8+ T-cells in tumor tissue from patients treated with setanaxib, indicating an increase in tumor immunological activity consistent with the mechanism of action of setanaxib. The tolerability of setanaxib when given with pembrolizumab was generally good, with no new safety signals identified.

INTERVIEW WITH TEONA JOHNSON

Head of Marketing Teona Johnson

Q2 has been the strongest quarter yet in terms of enrollments. What have been the key initiatives that have helped to drive this result in 2024?

The full approval of TARPEYO at the end of December 2023, based on our confirmatory endpoint of eGFR, was a significant milestone. This eGFR data, crucial to nephrologists as it measures kidney function, has been met with overwhelmingly positive feedback from the nephrology community. The recognition of TARPEYO's ability to reduce the loss of kidney function has led to increased demand and utilization of TARPEYO for patients diagnosed with IgAN.

Our key initiatives across all functions have been around educating healthcare professionals, payers, and the patient community on TARPEYO's clinical value proposition through targeted programs and tactics. These efforts aim to drive not just awareness of the new indication but also a thorough understanding of the entire clinical data of TARPEYO and its position as a cornerstone treatment in IgAN.

Since the full approval of TARPEYO, what has been the focus of the marketing team?

Our marketing team has been laser-focused on engaging with healthcare professionals (HCPs), as well as patient and advocacy groups. We've recognized the critical role of peer-to-peer education and have intensified our efforts to facilitate speaker programs and other peer-to-peer educational initiatives. Our approach is customer-centric and comprehensive, ensuring that our customers can interact with Calliditas and TARPEYO in their preferred ways of communication. We've implemented surround-sound promotional campaigns across various channels, delivering consistent messaging that effectively communicates the clinical value of TARPEYO.

On the patient side, our focus has been on empowering patients with knowledge about TARPEYO as a treatment option. We want them to feel confident advocating for a disease-specific treatment and discussing TARPEYO with their doctors. The TARPEYO Ambassador program, in particular, has been a resounding success, providing a platform for patients to hear from others who have first-hand experience with TARPEYO. This peer support has been instrumental in increasing patient acceptance of TARPEYO.