DexTech Medical AB, Year-end report July 1, 2020 - June 30, 2021
Summary of the Fourth Quarter (April 1 - June 30, 2021)
• Net sales amounted to MSEK 0,0 (0,0)
• Operating profit/loss amounted to MSEK -1,5 (-1,9)
• Earnings per share* SEK -0.10 (-0.13)
* 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.
Financial year (2020-07-01 - 2021-06-30)
• Net sales amounted to MSEK 0,0 (0,0)
• Operating profit/loss amounted to MSEK -6,1 (-7,7)
• Earnings per share** SEK -0.41 (-0.52)
• Cash and cash equivalents at the end of the period amounted to MSEK 3,5 (6,1)
* 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 14,912,278. Amounts in brackets refer to the corresponding period last year.
CEO's comment
The preclinical results regarding the OsteoDex´ (ODX) effect on multiple myeloma (MM) announced on August 24, 2021, are significant to the company. DexTech hereby begins the planning of a clinical “proof of concept” study (short study showing the effect of ODX treatment on a limited number of patients). MM is a form of blood cancer originating from plasma cells in the bone marrow. MM also causes the breakdown of bone, very similar to skeletal metastases in prostate cancer (mCRPC). MM is an incurable cancer where different approved drugs are used to slow down the disease. The disease eventually becomes resistant to existing drugs, which also often have severe side effects.
ODX's unique mechanism of action has both a potent tumor cell killing effect and a strong inhibitory effect on bone-degrading cells (osteoclasts), which together with very mild side effects make the ODX a strong candidate for the treatment of MM. In several in vitro experiments at Karolinska Institutet, ODX showed potent cell-killing effect at very low concentrations. The tumor cell killing effect appears superior to the MM drug Melphalan (used in comparison). The company claims that in view of MM's market size and ODX's clear potential against the disease, it is of the highest priority to obtain supplementary clinical data, where positive results will confirm and strengthen ODX's value as a potential cancer drug.
The global market size for MM in 2018 was $ 19.5 billion and is expected to grow to $ 31 billion by 2026 (https://www.fortunebusinessinsights.com/multiple-myeloma-market-102693). The figures indicate a more than twice as large market size compared to CRPC.
ODX has the potential to be better than existing myeloma drugs, certainly with regard to the absence of significant side effects. The dual effect of ODX, potent tumor cell killing and strong osteoclast inhibition, is unique and is not found in any other MM drug.
The financing of the MM study will take place through a directed new issue, which is a prerequisite for the implementation of the study. Details of the new share issue will be presented when the preparatory work for the study has been completed, which is expected to be completed during the second half of 2021.
In June 2020, DexTech's Phase IIb study regarding the drug candidate ODX for the treatment of skeletal metastatic castration-resistant prostate cancer (mCRPC) was completed, when 2-year follow-up results were obtained from the last patients. The follow-up results from the study were very positive and indicate that treatment with ODX can slow down the disease. The results show significantly longer survival for patients who responded to the treatment. The treatment was very well tolerated (no serious side effects) and disease inhibiting effect was seen even in the lowest doses. ODX showed a slowdown and regression of the disease in patients where the disease has progressed after treatment with one or more of the other available drugs for castration-resistant prostate cancer.
DexTech continues to work towards the company's primary goal, to enter into an agreement with a licensee for the company's drug candidate ODX. The company intends to sign a license agreement that reflects the true value of ODX. Regarding the ongoing pandemic, the increased vaccination rate can hopefully enable physical meetings with stakeholders in the future.
A video presentation explaining the possibilities of the Guadex platform, the situation in the treatment of prostate cancer and the ODX place in the treatment has been published on the company's website and on YouTube (www.youtube.com/watch?v=LQ2NUdPj6DY).
Although the company's main track is ODX-CRPC, complementary positive ODX-MM results will further strengthen the possibilities for a favorable license agreement. The company will not enter into a license agreement that does not reflect ODX true value, including the potential for treatment of multiple myeloma.
Anders R Holmberg
CEO
Contact
Anders Holmberg, CEO, +46 73 324 27 82
Gösta Lundgren, CFO, +46 70 710 47 88
This information is such information that DexTech Medical AB is required to disclose in accordance with the EU Market Abuse Regulation. The information was submitted for publication on August 30, 2021 through the care of the above contact persons.
DexTech Medical AB is a Swedish research company that, based on its technology platform, has developed four drug candidates that are protected by patents. The main candidate is OsteoDex for the treatment of castration-resistant prostate cancer (CRPC) with skeletal metastases. A successful Phase II clinical study has been conducted with OsteoDex where the result shows high tolerability with mild side effects as well as efficacy and treatment effect on patients who fail on existing drugs. DexTech's goal is to, after completing a phase II study, license each drug candidate. DexTech Medical AB is listed on the Spotlight Stock Market.