Interim report July 1, 2024 – March 31, 2025
29 April, 2025
Summary of the third quarter (2025-01-01 – 2025-03-31)
- Net sales amounted to MSEK 0,0 (0,0)
- Operating profit/loss amounted to MSEK -1,3 (-1,5)
- Earnings per share* SEK -0.07 (-0.08)
Summary of the nine-month period (2024-07-01 – 2025-03-31)
- Net sales amounted to MSEK 0,0 (0,0)
- Operating profit/loss amounted to MSEK -3,7 (-3,9)
- Earnings per share* SEK -0.18 (-0.18)
- Cash and cash equivalents at the end of the period amounted to MSEK 15,6 (19,0)
* 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, Dr Dorota Knut, and Dr Katarina Uttervall dept. Haematology/HERM, Karolinska University Hospital, Huddinge, Katarina Uttervall is principal investigator (PI). 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 earlier amendment (add-on study protocol) allows for follow-up of patients who have responded to ODX treatment and intends to record time to new disease progression after completion of ODX treatment.
The follow-up shows remarkable results. At the first follow-up after completion of treatment (after 2 weeks), all patients in dose group 1 (3 mg/kg) have stable disease. The patients have then been followed, without other cancer treatment, until new progression of the disease (according to the amendment). Time to progress was 89 days, 59 days, 188 days and 39 days. None of the patients had any significant side effects from the ODX treatment. The results indicate that ODX is effective against multiple myeloma and that the slowing effect persists over time without other treatment. It should be noted when comparing time to progress with established myeloma drugs where the drug is given continuously until treatment resistance, cf. ODX, where the treatment is completed after only 7 doses. The time to progress after ODX treatment is nevertheless comparable to existing drugs against relapsed/treatment-resistant disease.
Recruitment and treatment dose group 2 (6mg/kg) is ongoing, and results are eagerly awaited.
Anders R Holmberg