Half-year report July 1 – December 31, 2022

Summary of the second quarter (2022-10-01 – 2022-12-31)

• Net sales amounted to MSEK 0,0 (0,0)
• Operating profit/loss amounted to MSEK -1,2 (-1,1)
• Earnings per share* SEK -0.06 (-0.08)

* Before and after dilution. Earnings per share: Profit for the period divided by the average number of shares 18,485,857. For the comparison period, the average number of shares was 14,920,478. Amounts in brackets refer to the corresponding period last year.

Summary of the first half-year (2022-07-01 – 2022-12-31)

• Net sales amounted to MSEK 0,0 (0,0)
• Operating profit/loss amounted to MSEK -2,0 (-2,1)
• Earnings per share* SEK -0.11 (-0.14)
• Cash and cash equivalents at the end of the period amounted to MSEK 30,4 (35,5)

* Before and after dilution. Earnings per share: Profit for the period divided by the average number of shares 18,485,857. For the comparison period, the average number of shares was 15,366,150. Amounts in brackets refer to the corresponding period last year.

CEO’s comment

The application for a clinical phase 1 study regarding OsteoDex treatment of multiple myeloma was approved by the Swedish Medical Products Agency and permission was announced on August 10, 2022. The study will include 20 patients with multiple myeloma and be conducted at approximately 4–5 hospital centers in Sweden and the rest of the Nordic region.

Principal investigator (PI) is Dr Katarina Uttervall, MD, PhD, Division of Hematology/HERM, Karolinska University Hospital, Huddinge. The main blood markers will be analyzed at the Central Laboratory, Karolinska University Hospital, NKS, Solna. The patients included have relapsed/treatment-resistant disease and have received 1–3 prior lines of therapy. The primary objective is to confirm safety and tolerability and as a secondary objective to determine treatment response documented by changes in the level of disease-related biomarkers. Documentation of quality of life will also be done (QoL scores).

Completion of study material (GMP manufactured OsteoDex) is underway at Biovian Turku, Finland, which is the company’s CMO. The study is expected to start in 2023 and is expected to be completed during Q3 2024.

Anders R Holmberg

CEO