Half-year report July 1 – December 31, 2023

15 February, 2024

Summary of the second quarter (2023-10-01 – 2023-12-31)

  • Net sales amounted to MSEK 0,0 (0,0)
  • Operating profit/loss amounted to MSEK -1,4 (-1,2)
  • Earnings per share* SEK -0,06 (-0.06)

* 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 18,485,857. Amounts in brackets refer to the corresponding period last year.

Summary of the first half-year (2023-07-01 – 2023-12-31)

  • Net sales amounted to MSEK 0,0 (0,0)
  • Operating profit/loss amounted to MSEK -2,5 (-2,0)
  • Earnings per share* SEK -0.11 (-0.11)
  • Cash and cash equivalents at the end of the period amounted to MSEK 22.2 (25.2)

* 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 18,485,857. Amounts in brackets refer to the corresponding period last year.

CEO’s comment

The company’s Phase 1 study regarding OsteoDex’s treatment of multiple myeloma is underway and patient recruitment is ongoing. The first patient was treated in December at Karolinska University Hospital in Huddinge. The first test results from patient 1 were received on January 23 and show a very strong effect on the marker of osteoclast activity (CTX). The baseline value for CTX decreases by about 80% after 3 doses of OsteoDex. The other values are fairly constant (cf. baseline). Osteo-clasts break down bone (resorb) and CTX reflects osteoclast activity that is elevated in multiple myeloma.

Principal investigator (PI) is Dr Katarina Uttervall, MD, PhD, Department of Hematology/HERM, Ka- rolinska University Hospital, Huddinge. Biomarkers are analysed at the Central Laboratory, Karolinska University Hospital, NKS, Solna. Patients with relapsed/treatment-resistant disease who have received 1-5 prior lines of therapy are included. The primary objective is to confirm safety and tolerability and as a secondary objective to determine possible response to treatment. Documentation of quality of life will also be done (QoL scores).

Study material, GMP manufactured OsteoDex, is produced by Biovian OY, Turku, Finland and is de- livered to the respective hospitals.
In October, the Company filed a new patent application with the European Patent Office regarding the GMP production of OsteoDex (GMP = good manufacturing practice). If the application is granted, patent protection will be granted until approximately 2044. We believe that the conditions for approval of the application are very good.

Anders R Holmberg

 

DexTech – Half-year report July – December 2023