Year-end Report - January-December 2020

STOCKHOLM – 11 February 2021. Karolinska Development AB (Nasdaq Stockholm: KDEV) today publishes its Year-end Report - January-December 2020. The full report is available on the Company's website.

“Whilst Aprea Therapeutics’ phase 3 trial failed to achieve its primary endpoint, it is too early to assess the consequences of this for the continued development of eprenetapopt in myelodysplastic syndrome. We are now looking forward to an in-depth data analysis and the results of other ongoing studies of the candidate drug. The quarter was otherwise characterised by the progress made by Umecrine Cognition, which has now established solid plans for the further clinical development of its candidate drug, and by Modus Therapeutics, with its intention to declare a new indication during the first quarter 2021.”, says Viktor Drvota, CEO, Karolinska Development.

Significant events during the fourth quarter

• The US Food and Drug Administration (FDA) accepted an Investigational New Drug (IND) application by the Aprea Therapeutics portfolio company in respect of its novel candidate drug, APR-548, to treat TP53-mutant myelodysplastic syndrome (MDS). APR-548 is a next-generation reactivator of mutant p53 that is being developed for oral administration (October 2020).
• An article describing the OssDsign portfolio company’s unique regenerative implants was published in the reputable scientific journal, PNAS (Proceedings of the National Academy of Sciences of the United States). The article describes how OssDsign’s implant concept and patented material composition contribute to bone regeneration and adhesion with existing bone (October 2020).
• The portfolio company, OssDsign, acquired Sirakoss Ltd – a company operating in the field of bone graft substitutes. The acquisition, which is expected to give OssDsign immediate access to a five times larger addressable market, was partly financed by a heavily oversubscribed directed share issue of approximately SEK 65 million before transaction costs. A large number of Swedish and international investors took part in the issue (November 2020).
• The portfolio company, Aprea Therapeutics, was granted Fast Track designation by the FDA for eprenetapopt in the treatment of patients with acute myeloid leukaemia (AML) (November 2020).
• Aprea Therapeutics reported the results from a phase 3 study of eprenetapopt in myelodysplastic syndrome (MDS). The trial failed to meet its primary endpoint of complete remission (Complete response, CR). Analysis of the primary endpoint at this data cut demonstrated a higher CR rate in the experimental arm receiving eprenetapopt in combination with azacitidine versus the control arm receiving azacitidine alone, but did not reach statistical significance. Karolinska Development is now awaiting the forthcoming in-depth data analysis to gain a better understanding of the consequences for the further development of eprenetapopt in myelodysplastic syndrome and other potential indications (December 2020).
• Karolinska Development AB announced that the company will, on the basis of an external valuation, increase the book value of its holding in the portfolio company, Umecrine Cognition, by SEK 234 million. The background to this is that Umecrine Cognition has now, based on previously communicated positive phase 2a results, established a plan for the continued clinical development of the candidate drug, golexanolone, within the field of hepatic encephalopathy (December 2020).