Interim report July 1- September 30, 2023
27 October, 2023
Summary of the first quarter (2023-07-01 – 2023-09-30)
- Net sales amounted to MSEK 0,0 (0,0)
- Operating profit/loss amounted to MSEK -1,1 (-0,8)
- Earnings per share* SEK -0.05 (-0.04)
- Cash and cash equivalents at the end of the period amounted to MSEK 23,6 (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. Some inclusion criteria have been adjusted which means that more patients can be included.
Principal investigator (PI) is Dr Katarina Uttervall, MD, PhD, Department of Hematology/HERM, Karolinska 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 delivered to the respective hospitals. We are excited to conduct this study.
The company has 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