New Risk • Jun 14
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 8.3% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (kr4.2m revenue, or US$441k). Minor Risk Share price has been volatile over the past 3 months (8.3% average weekly change). Announcement • Jun 04
DexTech Medical AB Reports Positive Preliminary Results From Fully Recruited Myeloma Study With OsteoDex DexTech Medical AB conducted a study at Karolinska University Hospital Huddinge and at Uddevalla Hospital. The treatment has lasted for a total of 14 weeks with 2 doses per month. Three dose levels of OsteoDex (ODX) have been studied, 3mg/kg body weight, 6mg/kg, and 9mg/kg. Analysis of biomarkers takes place at the Central Laboratory, Karolinska University Hospital Solna, NKS. Adult myeloma patients with, according to IMWG (International Myeloma Working Group) criteria, progressive treatment-resistant disease, who had previously received 1-5 lines of treatment were included in the study. The primary objective is to confirm ODX safety and tolerability and with a secondary objective to demonstrate indications of treatment response. The last patient in dose group 2 (6mg/kg) was fully treated week 50, 2025 (7 doses). The patient continued to have stable, i.e. non-progressive, disease just over 5 months after the end of treatment and before new progress resumed. All patients in dose group 3 (9mg/kg) had achieved stable (non-progressive) disease after discontinuation of treatment at the end of February. The patients have continued to maintain non-progressive disease at the end of May. No significant ODX-related adverse events have been noted. Thus, no induced toxicity on organ systems, such as kidneys, liver, or bone marrow. Primary endpoint has been met, with the absence of significant ODX-related toxicity. The results also show that all patients responded positively to ODX treatment, with a transition from progressive (according to IMWG criteria) to non-progressive disease during ODX treatment. More than 70% of the patients maintained their achieved stable, non-progressive, disease even after the ODX treatment was discontinued. This is consistent with the mechanism of action, i.e. significant enrichment of ODX in the myeloma areas of the skeleton. The patients in dose group 3 are now being followed continuously (>June) until new disease progression, which is why the completion of the CSR (clinical study report) is postponed until all results from the extended follow-up are available. The company has analyzed all clinical data, including the prostate cancer studies (mCRPC), and finds the effects of the same mode of action (MOA) in both mCRPC and multiple myeloma. Simply described, ODX rapidly changes/modifies the tumor cells' microenvironment and thereby impairs their breeding ground and the conditions for continued growth (progression). The mechanism is unique to ODX as an anticancer drug and has very interesting implications for the treatment of other cancers with bone involvement, e.g. breast cancer. The absence of ODX-related toxicity opens up great opportunities for combination therapies (very common in modern cancer treatment) without adding toxicity. Board Change • May 20
No independent directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 7 experienced directors. 3 highly experienced directors. No independent directors (6 non-independent directors). Director Peter Benson was the last director to join the board, commencing their role in 2023. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Insufficient board refreshment.