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Calliditas Therapeutics AB (NASDAQ: CALT, Nasdaq Stockholm: CALTX) is a clinical and commercial-stage biopharmaceutical company dedicated to identifying, developing, and commercializing novel treatments specifically targeting orphan indications with significant unmet medical needs, particularly in renal and hepatic diseases. Headquartered in Stockholm, Sweden, Calliditas is pioneering therapies aimed at addressing complex conditions with limited treatment options.
The company's lead product, TARPEYO® (also known as Nefecon outside the United States), is an innovative medication designed to reduce proteinuria in patients suffering from IgA nephropathy (IgAN), a progressive autoimmune disease affecting the kidneys. TARPEYO® has received full approval from the U.S. FDA and conditional marketing authorization in the EU, marking a significant milestone in the treatment landscape for IgAN. Recent data from the ongoing global Phase 3 NefIgArd study and its Open Label Extension (OLE) demonstrate the drug's consistent efficacy and safety profile over an extended period.
Besides TARPEYO®, Calliditas' robust pipeline includes setanaxib, a NOX enzyme inhibitor showing promise in various indications, including squamous cell carcinoma of the head and neck (SCCHN). Recent Phase 2 trial results indicated statistically significant improvements in progression-free survival and overall survival, thus reinforcing the potential of setanaxib in oncological applications.
Calliditas is also expanding its market presence through strategic global partnerships. A notable achievement is the commercial launch of Nefecon in China by its partner, Everest Medicines. This launch is a critical step in addressing the high prevalence and unmet medical needs of IgAN patients in Asia.
Financially, Calliditas continues to strengthen its position, driven by ongoing commercial efforts and strategic equity initiatives. The company remains committed to enhancing shareholder value through advancements in its pipeline, strategic collaborations, and robust operational execution.
Calliditas Therapeutics will host a Capital Markets Day in Stockholm, Sweden, on January 20, 2021, featuring presentations from the management team and key opinion leaders. The event will cover an overview of the company's clinical development, including the successful topline data from the Phase 3 study, regulatory updates on Nefecon, and US commercialization plans. The program will run from 1:00 p.m. to 5:00 p.m. CET and will be accessible via webcast.
Calliditas Therapeutics has announced the composition of its nomination committee for the upcoming 2021 Annual General Meeting (AGM). The committee includes Patrick Sobocki, Spike Loy, Karl Tobieson, and Elmar Schnee as chairman. They are responsible for proposing candidates for the board of directors and auditors, as well as determining fees. Shareholders can submit proposals to the committee until April 5, 2021, ahead of the AGM scheduled for May 27, 2021. Calliditas is focused on developing treatments for orphan diseases, particularly IgA nephropathy.
Calliditas Therapeutics AB has announced the composition of its nomination committee for the 2021 Annual General Meeting (AGM). The committee includes Patrick Sobocki, Spike Loy, Karl Tobieson, and Elmar Schnee as chairman. Their responsibilities will involve preparing proposals for the elections of board members, auditors, and fee determinations ahead of the AGM scheduled for May 27, 2021. Shareholders can submit proposals to the committee until April 5, 2021. Calliditas is focused on developing treatments for orphan diseases, including its lead product candidate, Nefecon.
On November 12, 2020, Calliditas announced the acquisition of a 62.7% stake in Genkyotex for €19.8 million, aimed at enhancing its portfolio in inflammatory diseases. The company reported positive topline results from its Phase 3 NefIgArd trial, confirming previous Phase 2b results for IgA nephropathy treatments. For Q3 2020, Calliditas reported an operating loss of SEK 104.9 million, with no recognized sales and a cash balance of SEK 1,396.9 million. The company plans to submit regulatory filings for accelerated approval in 2021.
Calliditas Therapeutics will release its Q3 2020 business update on November 12, 2020, at 07:00 am CET. A telephone conference with a presentation of the results will be held at 2:30 pm CET, hosted by CEO Renée Aguiar-Lucander and CFO Fredrik Johansson. The presentation will be accessible on the company's website and via audio cast. Dial-in numbers are provided for participation. Calliditas, focused on orphan indications, is advancing its lead product Nefecon for IgA nephropathy and is listed under ticker CALT.
On November 8, 2020, Calliditas announced positive topline results from Part A of the global Phase 3 clinical trial NefIgArd, examining Nefecon® in patients with primary IgA nephropathy (IgAN). The results suggest potential efficacy in treating this autoimmune renal disease, which currently lacks approved therapies. A telephone conference to discuss the results will be held on November 9, 2020, at 2:30 pm CET, with participation details provided. Calliditas aims to commercialize Nefecon in the U.S. if approved, positioning itself strongly in the orphan drug market.
Calliditas Therapeutics announced positive topline results from Part A of the Phase 3 NefIgArd clinical trial for Nefecon, showing a statistically significant reduction in urine protein creatinine ratio (UPCR) after 9 months compared to placebo. The trial also indicated a 7% beneficial effect on estimated glomerular filtration rate (eGFR). Nefecon was well-tolerated, and Calliditas plans to seek FDA approval in Q1 2021 and EMA approval in H1 2021 for commercialization. The trial followed 199 patients diagnosed with primary IgA nephropathy, affirming the drug's efficacy in this indication.
Calliditas Therapeutics has successfully closed an acquisition of 62.7% of Genkyotex, valued at €19.8M, at €2.73 per share. This acquisition received foreign investment clearance from the French government. Following this, Calliditas plans to conduct a simplified mandatory cash tender offer for the remaining shares at €2.80 each, with potential additional payouts linked to regulatory approvals of Genkyotex's lead asset, setanaxib. The total acquisition cost for 100% ownership is projected at approximately €31.7M, plus contingent rights up to €55M based on future approvals.
Calliditas Therapeutics announced presentations for its lead product Nefecon at the ASN Kidney Week 2020 conference from October 19-25. Key sessions include a poster by Professor Jonathan Barratt detailing the NefIgArd trial design, focused on patients with IgA Nephropathy at risk of End Stage Renal Disease. Additionally, Dr. Karen Molyneux will present Nefecon's impact on biomarkers in patients with the same condition. Nefecon, an investigational drug for IgAN, aims to fulfill a significant unmet medical need as there are currently no approved treatments.
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