Calliditas Therapeutics AB (publ) (NASDAQ:CALT) Q2 2024 Earnings Conference Call August 13, 2024 8:30 AM ET
Company Participants
Renée Aguiar-Lucander - CEO
Richard Philipson - CMO
Maria Tornsen - President, North America
Fredrik Johansson - CFO
Conference Call Participants
Operator
Welcome to Calliditas Q2 2024 Report. [Operator Instructions] And there will be no Q&A session after the presentation.
Now I will hand the conference over to the speakers. Please go ahead.
Renée Aguiar-Lucander
Thank you very much. Welcome to our Q2 2024 report. My name is Renée Aguiar-Lucander, CEO of Calliditas. And I'm joined today by Richard Philipson, Chief Medical Officer; Fredrik Johansson, our Chief Financial Officer; and Maria Tornsen, President of North America.
Next page, please. I'd like to draw your attention to disclaimer notice, which covers forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as amended, and I refer to our public filings, including those containing risk factors.
Next page, please. So I'd like to review some of the key events in Q2, which included the conclusion of our Phase 3 study, NefIgArd, with the readout of the open-label extension from which we reported nine months efficacy and safety data, similar to that observed in the active arm of the Phase 3 trial for those patients who are retreated with Nefecon after 15 months of observation.
In April, we reported positive top line data from our Phase 2 proof-of-concept study in head and neck cancer, with a lead product candidate from our novel and unique NOX inhibitor platform, setanaxib. This shows statistically significant impact on both progression-free survival as well as overall survival. We also were granted a new patent by the USPTO for the treatment with setanaxib in cancer with expiry in 2039.
In May, our partner, Everest Medicines, launched Nefecon in China, and EMA issued a positive opinion for full approval of Kinpeygo in Europe. We also participated on several important conferences where we presented additional data, which Richard will cover a bit later in the call.
Next page. In the quarter, there was an offer announced by Asahi Kasei on May 28. Asahi Kasei announced a public cash offer for all shares in Calliditas for SEK 208 per share, valuing the company at approximately SEK 1.2 billion.
The tender is presently ongoing, with the last day announced to be August 30, subject to any potential extensions. The offer is recommended by the Board and around 45% of shareholders have entered into undertaking to accept the offer, subject to customary conditions.