Interim report July 1, 2021 – September 30, 2021
22 October, 2021
Summary of the First Quarter (2021-07-01 – 2021-09-30)
• Net sales amounted to MSEK 0,0 (0,0)
• Operating profit/loss amounted to MSEK -0,9 (-1,5)
• Earnings per share* SEK -0,06 (-0.10)
• Cash and cash equivalents at the end of the period amounted to MSEK 3,0 (5,5)
* Before and after dilution. Earnings per share: Profit for the period divided by the average number of shares 14,920,478. For the comparison period, the average number of shares was 14,920,478. Amounts in brackets refer to the corresponding period last year.
There are significant similarities between skeletal metastases from mCRPC and multiple myeloma, such as growth site, bone degradation and stimulation from osteoclasts. The preclinical results regarding the DexTex drug candidate OsteoDex (ODX) effect on multiple myeloma announced on August 24, 2021 are significant. Based on these facts, DexTech has begun planning a clinical proof of concept study (short study showing the relevance of the drug to a limited number of patients). Multiple myeloma is a hematologic malignancy that occurs in plasma cells in the bone marrow, and like skeletal metastases from prostate cancer (mCRPC), causes bone resorption. Multiple myeloma is incurable where several different drugs are used to slow the progression. The disease eventually becomes resistant to existing drugs. The treatments often have serious side effects.
DexTech has shown in extensive preclinical studies conducted at Karolinska Institutet in Stockholm that OsteoDex has a very significant tumor cell killing effect demonstrated on different myeloma cell cultures. In summary, a potent cytotoxic effect is visible even at low OsteoDex concentrations. Efficacy at low concentration is an important result in in vitro testing and indicates possible efficacy in vivo (in living organism). The observed cell-killing effect is superior to the compared substance, Melphalan, which is an old standard medicine for the treatment of multiple myeloma. The company sees OsteoDex as very promising for the treatment of multiple myeloma based on its mechanism of action along with mild side effects.
A formal study protocol for clinical research is now being prepared. The study is planned to be conducted at approximately five hospital centers in Scandinavia and involve approximately 20 selected patients with multiple myeloma. The aim is for the study to provide proof of concept and thus further verify Osteodex’s high value as a potential cancer drug. The global multiple myeloma market size is expected to grow to approximately USD 31 billion by 2026, which is more than double the market size of CRPC.
The financing of the MM study will be through a directed share issue. Details of the issue will be presented in November 2021. The preparatory work for the study is expected to be completed by the end of 2021.
Although the company’s main track is ODX-CRPC, supplemented positive ODX-MM results will strengthen the possibilities for a favorable license agreement. The Company will not enter into a license agreement that does not reflect ODX’s actual value. By showing ODX potential even against MM, ODX’s value can be appreciated and lead to a favorable license agreement.
Ahead of the upcoming study, the company strengthens the board by co-opting Håkan Åström, who has extensive experience from leading positions in the international pharmaceutical industry.
Anders R Holmberg