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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 has announced the completion of the last visit for the 200th patient in Part A of the pivotal NefIgArd Phase 3 study, focusing on IgA nephropathy (IgAN). The trial, involving around 150 sites across 19 countries, follows the successful Phase 2b NEFIGAN trial. Full recruitment was completed in December 2019, with top-line data expected in Q4 2020. If results are positive, Calliditas plans to seek market approval in the US and EU in early 2021.
Calliditas Therapeutics announced the completion of the last visit of the 200th patient in Part A of the pivotal NefIgArd Phase 3 study, evaluating Nefecon for IgA nephropathy. The trial, involving 150 sites across 19 countries, follows the successful Phase 2b NEFIGAN study. With recruitment finished, topline data is expected in Q4 2020, and if positive, Calliditas plans to file for regulatory approval in the US and Europe in H1 2021. The CEO expressed excitement over this milestone, emphasizing the focus on timely data analysis.
On September 30, 2020, Calliditas Therapeutics AB announced the allotment of 111,250 common shares as part of its 2017 warrant program. Following this issuance, the total number of shares and votes in the company increased to 49,941,584. Calliditas focuses on developing novel treatments for orphan diseases, emphasizing its lead candidate Nefecon for IgA nephropathy, an autoimmune renal disease. The company is advancing through a global Phase 3 study for Nefecon, aiming for commercialization in the U.S.
Calliditas Therapeutics announced the enrollment of the first patient in the confirmatory part of the Phase 3 NefIgArd trial in China, facilitated by Everest Medicines. The trial's Part A, involving 200 patients, completed recruitment in December 2019, with topline data expected in Q4 2020. The ongoing Part B aims to recruit an additional 160 patients to validate the proteinuria surrogate marker. Successful results could lead to regulatory approvals in the US and Europe. This trial addresses significant unmet medical needs in Asia.
Calliditas Therapeutics announced the enrollment of the first patient in China into the confirmatory part of the NefIgArd Phase 3 trial, conducted by Everest Medicines. This trial follows prior IND approval by NMPA in December 2019. Calliditas previously completed recruitment of 200 patients for regulatory submission and is targeting topline data for Q4 2020. The trial aims to validate proteinuria as a surrogate marker. Successful outcomes may lead to regulatory approval in the US and Europe, addressing a significant unmet medical need in Asia.
Calliditas Therapeutics announced the appointment of Jonathan Schur as Group General Counsel, effective October 1, 2020. With over 30 years of legal experience, Schur has expertise in the pharmaceutical sector, advising on collaborations, clinical trials, and regulatory compliance. His role is crucial as the company progresses its lead candidate, Nefecon, towards potential commercialization, particularly in the U.S. market. CEO Renée Aguiar-Lucander expressed confidence in Schur's ability to support Calliditas's growth and strategy.
Calliditas Therapeutics AB announced the appointment of Jonathan Schur as Group General Counsel, effective October 1, 2020. Schur brings over 30 years of legal experience, focusing on the pharmaceutical sector, with expertise in U.S. and European legal and regulatory frameworks. This strategic hire is aimed at supporting the company’s growth and advancing its lead product candidate, Nefecon, towards registration. CEO Renée Aguiar-Lucander emphasized the critical role of an experienced legal resource as the company prepares for its next developmental stage.
Calliditas Therapeutics successfully closed a $90 million U.S. IPO on NASDAQ in June 2020, raising total gross proceeds of $97 million after a greenshoe option was exercised in July. This funding will support the completion of their Phase 3 clinical trial for Nefecon, a treatment for IgA nephropathy. Despite no net sales reported for Q2 2020, cash reserves increased to SEK 1,459.6 million. Significant events included the appointment of a new CMO and an agreement to acquire Genkyotex SA, expected to close in October 2020.
Calliditas Therapeutics has announced an agreement to acquire 62.7% of Genkyotex for €20.3M in cash at €2.80 per share, with a total consideration of approximately €32M for 100% of the shares. This acquisition focuses on Genkyotex's lead therapy, setanaxib, which is in late-stage development for Primary Biliary Cholangitis (PBC). Expected milestone payments of up to €55M are contingent upon regulatory approvals. This strategic acquisition enhances Calliditas's pipeline in orphan diseases and expands its capabilities in targeting fibrotic conditions.
On August 13, 2020, Calliditas Therapeutics will release its Q2 2020 business update at 07:00 am CET, followed by a conference call at 2:30 pm CET led by CEO Renée Aguiar-Lucander and CFO Fredrik Johansson. The update will be accessible on their website under Financial Reports and Presentations. Dial-in numbers include SE: +46856642693, UK: +443333009264, US: +18335268383. Calliditas focuses on developing treatments for orphan diseases, with their lead candidate Nefecon targeting IgA nephropathy.
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