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On August 31, 2021, Calliditas Therapeutics announced an increase in its share count due to a directed issue of 2,400,000 new shares completed on August 12, 2021. The total number of shares and votes now stands at 52,341,584. This increase may impact shareholder equity and market dynamics as the company continues to focus on its lead product, Nefecon, aimed at treating primary IgA nephropathy, an autoimmune renal disease with significant unmet medical needs.
On August 19, 2021, Calliditas Therapeutics announced its Q2 2021 financial results, revealing an operating loss of SEK 159.4 million with no net sales. The company is pursuing accelerated FDA and EMA approvals for its product Nefecon, with a PDUFA goal date of September 15, 2021. Calliditas secured over $100 million in non-dilutive financing, enhancing financial stability pre- and post-approval. A significant partnership with STADA Arzneimittel for Nefecon’s commercialization in Europe was also established. Cash reserves stood at SEK 709.3 million as of June 30, 2021.
Calliditas Therapeutics has closed a directed share issue of 2,400,000 common shares at SEK 135 each, totaling approximately SEK 324 million. This capital raise, approved by the Board under powers granted at the May 27, 2021 AGM, aims to fund ongoing clinical projects and strengthen the shareholder base among institutional investors. The share issue will dilute existing shares by about 4.6%. Proceeds will support clinical and commercial development for Nefecon, pending FDA approval, and general corporate purposes.
Calliditas Therapeutics (Nasdaq: CALT) has obtained Fast Track Designation from the FDA for its lead candidate, setanaxib, aimed at treating primary biliary cholangitis (PBC). Previously granted orphan drug status, setanaxib showed anti-fibrotic activity in Phase 2 trials and is planned for a pivotal Phase 2/3 study. The Fast Track program enhances development speed for serious conditions and allows rolling submissions of marketing applications. CEO Renée Aguiar-Lucander expressed optimism in establishing setanaxib as a first-in-class treatment for PBC patients.
Calliditas Therapeutics AB (Nasdaq: CALT) has entered a licensing agreement with STADA Arzneimittel AG to register and commercialize its new drug candidate for IgA Nephropathy (IgAN) in the EEA, UK, and Switzerland. Calliditas will receive an upfront payment of 20M EUR and up to 77.5M EUR in milestone payments. If approved, this will be the first authorized treatment for IgAN in the EU, addressing a significant unmet medical need, with a prevalence of 4 in 10,000. The product could be available in early 2022, pending regulatory approvals.
Calliditas Therapeutics AB (Nasdaq: CALT) has secured a loan agreement of up to €75 million with Kreos Capital. The funds will support the launch of Nefecon, pending FDA approval, and assist in clinical development and corporate needs. The loan is structured in three tranches of €25 million, with specific drawdown conditions. The initial interest rate is set at 9.00%, potentially reducing to 7.95% based on milestones. This funding broadens Calliditas’ financial options and will help enhance its commercial capabilities for Nefecon in the U.S.
Calliditas Therapeutics AB (Nasdaq: CALT) has submitted a Marketing Authorisation Application for its drug Nefecon to the European Medicines Agency to treat primary IgA Nephropathy (IgAN). This application is supported by positive data from the pivotal NefIgArd Phase 3 study, which met its primary endpoint for proteinuria reduction. Nefecon is positioned as the first approved treatment for IgAN, with potential availability in Europe by H1 2022. The drug has been granted an Accelerated Assessment by the EMA for quicker review.
Calliditas Therapeutics announced its participation in the Jefferies Virtual Healthcare Conference on June 1, 2021, at 2:30 pm CET/8:30 am ET. The management will present and host 1x1 meetings during the event. Registration is available via the provided link, and the presentation will be archived for 30 days post-event. Calliditas focuses on developing treatments for orphan diseases, with its lead product candidate, Nefecon, targeting IgA nephropathy, a condition with no approved treatments. The company trades on NASDAQ under the ticker CALT.
The annual general meeting of Calliditas Therapeutics AB, held on May 27, 2021, confirmed the income statements and balance sheets for 2020, with no dividend declared. Key resolutions included re-election of board members and auditors, introduction of two long-term incentive programs, and an authorization to issue new shares, allowing a maximum dilution of 20%. The meeting approved a remuneration report and amended the articles of association. The company aims to commercialize its lead product, Nefecon, for IgA nephropathy, with ongoing clinical trials for other treatments.
Calliditas Therapeutics submitted a New Drug Application (NDA) for Nefecon to the FDA, receiving Priority Review with a PDUFA goal date of September 15, 2021. The NDA follows successful outcomes in the Phase 3 NefIgArd trial. In Q1 2021, no net sales were reported, with an operating loss of SEK 150.8 million, contrasting with SEK 72.3 million in Q1 2020. The company bolstered its US team to prepare for potential commercialization in Q4 2021 if approved. Additionally, the EMA granted accelerated assessment for the NDA in April 2021.