Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX; NASDAQ – CALT) today announced the program for the upcoming virtual R&D Day for investors, analysts and journalists on January 20, 2021, which will take place between 1pm and 5pm CET. The R&D Day will feature presentations from executive management and Key Opinion Leaders and will be webcast live and accessible at: https://tv.streamfabriken.com/calliditas-therapeutics-cmd-january-2021.
The agenda will be as follows:
|1:00pm||Introduction & Corporate overview||CEO Renée Aguiar-Lucander|
|1:20pm||Pathophysiology of IgA nephropathy & Nefecon Clinical Biomarker Data||Professor Jonathan Barratt|
|1:40pm||A Review of the Phase 3 NefIgArd Trial Data||CMO Dr Richard Phillipson|
|2:00pm||Commentary on the NefIgArd Phase 3 Data||Professor Jonathan Barratt|
|2:10pm||Regulatory Review of Nefecon||Vice President of Regulatory Affairs Frank Bringstrup|
|2:20pm||Live Q&A Session||Professor Jonathan Barratt, Dr Richard Phillipson & Frank Bringstrup|
|2:40pm||Market Access & Preparations for Commercialization in the USA||Head of North America Commercial, Andrew Udell, & Vice President Market Access, Christopher Ngai|
|3:10pm||Live Q&A Session||Andrew Udell and Christopher Ngai|
|3:20pm||Overview of NOX Inhibitors||Calliditas’ Medical Advisor, Dr Philippe Wiesel|
|3:40pm||Setanaxib – Applications in Oncology||Professor Gareth Thomas|
|4:00pm||Clinical Development – Pipeline Review||Dr Richard Phillipson|
|4:15pm||Positioning overview||Renée Aguiar-Lucander|
|4:25pm||Live Q&A Session||Dr Philippe Wiesel, Professor Gareth Thomas, Dr Richard Phillipson & Renée Aguiar-Lucander|
|4:45pm||Closing Summary||Renée Aguiar-Lucander, Fredrik Johansson, CFO|
The presentations will be made available on the company´s website after the end of the meeting. Please note that the Q&A Sessions will only be available to view live.
Professor Jonathan Barratt leads the Renal Research Group within the College of Life Sciences, University of Leicester. His research interests span a range of areas across renal medicine and include glomerular disease, multi-system renal disease and complications of chronic kidney disease, in particular renal associated anemia. He is the IgA nephropathy Rare Disease Group lead for the UK National Registry of Rare Kidney Diseases (RaDaR) and a member of the steering committee for the International IgA Nephropathy Network. He is also a Chief Investigator for five international randomized controlled clinical trials in IgA nephropathy, and has attended both the FDA and EMA as an expert witness for new therapies in IgA nephropathy. He is a member of the FDA and American Society of Nephrology Kidney Health Initiative: Identifying Surrogate Endpoints for Clinical Trials in IgA Nephropathy Work group.
Professor Gareth J. Thomas is Chair and Professor of Experimental Pathology at University Hospital Southampton NHS Foundation. He leads a group that investigates the effect of the tumor microenvironment on tumor development and progression, particularly the role of cancer-associated fibroblasts in regulating immune escape and tumor invasion. Prior to his current position, Gareth Thomas was Professor of Oral Pathology and Consultant in Oral and Maxillofacial Pathology at Bart’s and the London. Gareth Thomas trained in Oral & Maxillofacial Pathology at University College Hospital, London and undertook his PhD as an MRC Clinical Fellow at University College London and the Richard Dimblebey Department of Cancer Research.
For further information, please contact:
Marie Galay, IR Manager, Calliditas
The information was sent for publication, through the agency of the contact persons set out above, on January 15, 2021 at 9:00 a.m. CET.
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 study 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.