Year-end report 1 July 2024 – 30 June 2025
29 August, 2025
Summary of year-end report
Fourth quarter (2025-04-01 – 2025-06-30)
• Net sales amounted to SEK 0.0 million (0.0)
• Operating profit amounted to SEK -1.6 million (-1.6)
• Earnings per share* SEK -0.08 (-0.07)
• European patent granted for GMP manufacture of Osteodex
• The majority so far in the myeloma study (67%) have achieved stable disease. No significant side effects
Full year (2024-07-01 – 2025-06-30)
• Net sales amounted to SEK 0.0 million (0.0)
• Operating profit amounted to SEK -5.3 million (-5.5)
• Earnings per share* SEK -0.26 (-0.25)
• Cash and cash equivalents at the end of the financial year amounted to SEK 14.7 (19.0) million
* 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.
Comments from the CEO
The ongoing myeloma study is being conducted at Uddevalla Hospital, PI (principal investigator) Dr Dorota Knut and at Karolinska University Hospital, Huddinge, PI Dr Katarina Uttervall dept. Hematology/HERM. Biomarkers are analysed at the Central Laboratory, Karolinska University Hospital, NKS, Solna.
The primary objective is to confirm safety and tolerability and as a secondary objective to determine indications of treatment response. The patients who can be included in the study (inclusion criteria), must have relapsed/treatment-resistant disease and received 1-5 prior lines of therapy. Treatment with ODX is given in a maximum of 7 doses, one dose every two weeks. Patients are divided into 3 dose groups, 3mg/kg, 6mg/kg and 9mg/kg, 4 patients in each group. An amendment (add-on study protocol) enables follow-up of patients who responded to ODX treatment and refers to the time to new disease progression after completion of ODX treatment. No other anti-cancer treatment is given during the follow-up period.
Dose group 2 (6mg/kg) is expected to be fully recruited in August/September. Two patients in dose group 2 had progressive disease after completion of treatment. This means that so far, 67% of patients have responded positively to ODX treatment (transition from progressive disease to stable disease). No significant, ODX-related, side effects have been noted.
Follow-up of all patients who had so far achieved stable disease shows that the disease-inhibiting effect lasted at most just over six months without initiation of other cancer treatment.
A meeting of the DMC (the independent data monitoring committee) is expected to be held in September to approve the continuation to dose group 3.
The results so far, i.e. for patients with relapsed/treatment-resistant disease, must be seen as very promising.
Anders R Holmberg