Year-end report 1 July 2025 – 30 June 2026
31 August, 2026
Fourth quarter summary, April – June 2026
- Net sales amounted to MSEK 0.0 (0.0)
- Operating profit amounted to MSEK -1.9 (-1.6)
- Earnings per share* SEK -0.10 (-0.08)
Clinical highlights
- All patients in the phase I/IIa study with OsteoDex in multiple myeloma were fully treated. Patients with achieved stable disease continue to be followed until new disease progression.
- The primary safety endpoint was met. No significant ODX-related adverse events were noted.
Summary of the financial year, July 2025 – June 2026
- Net sales amounted to MSEK 0.0 (0.0)
- Operating profit amounted to MSEK -6.6 (-5.3)
- Earnings per share* SEK -0.35 (-0.26)
- Cash and cash equivalents at the end of the period amounted to MSEK 8.6 (14.7)
Clinical highlights
- All treated patients transitioned from progressive to stable disease according to IMWG criteria during ongoing ODX treatment. More than 70 percent retained stable disease even after completion of treatment.
- During the year, the study advanced to the highest dose level, 9 mg/kg, where all patients achieved stable disease. Follow-up is ongoing until new progress and the study report, CSR, will be completed when the results are available.
* 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 for income statement and cash flow items and the end of the previous financial year for balance sheet items.
Comments from the CEO
The Company’s Phase I/IIa clinical study with OsteoDex (ODX) for the treatment of patients with relapsed treatment-resistant multiple myeloma has been completed. The last patients received their last treatments at the end of February. The study has been conducted at Uddevalla Hospital and Karolinska University Hospital in Huddinge. Patients who have achieved stable disease during treatment will continue to be followed until new disease progression.
During the quarter, we were able to report that the last patient in dose group 2, 6 mg/kg, had continued stable, non-progressive, disease for just over five months after completion of treatment. All patients in dose group 3 (9 mg/kg), achieved stable disease after completion of treatment at the end of February 2026, had continued to maintain stable disease at the end of May 2026 and are being monitored continuously.
No serious adverse events (SAEs) have been noted. The primary study objective has thus been met by the absence of severe ODX-related toxicity. The secondary study objective has also been met by the preliminary results showing that all patients responded positively to ODX treatment, with a transition from progressive disease, according to IMWG criteria, to non-progressive disease during treatment. More than 70% of the patients maintained their stable, non-progressive, disease even after treatment was discontinued.
The completion of the formal clinical study report (CSR) and other formalities will be postponed until all results from the patient follow-up are available.
The company has analyzed all clinical data, including data from mCRPC (prostate cancer, phase 1, phase 2) and sees the same mode of action (MOA) in both mCRPC and multiple myeloma. The conclusion is that the ODX treatment changes/modifies the tumor cells’ microenvironment and thus slows/inhibits continued growth. The mechanism is unique and also has applications for other cancers with skeletal involvement, such as late-stage breast cancer. The very good safety profile opens up great opportunities for combination treatments without adding additional toxicity.
As previously announced, updated cost forecasts and current liquidity show that working capital is sufficient to finance the current operations until the end of 2028.
Anders R Holmberg