Year-end report July 1, 2019 – June 30, 2020
28 August, 2020
By “Company” or “DexTech” is meant DexTech Medical AB with organization number 556664-6203.
Summary of the Fourth Quarter (April 1 – June 30, 2020)
- Net sales amounted to MSEK 0,0 (0,0)
- Operating profit/loss amounted to MSEK -1,9 (-2,2) • Earnings per share* SEK -0.13 (-0.15)
* 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 14,752,833. Amounts in brackets refer to the corresponding period last year.
Financial year (2019-07-01 – 2020-06-30)
- Net sales amounted to MSEK 0,0 (0,0)
- Operating profit/loss amounted to MSEK -7,7 (-8,4)
- Earnings per share** SEK -0.52 (-0.57)
- Cash and cash equivalents at the end of the period amounted to MSEK 6,1 (0,0)
** Before and after dilution. Earnings per share: Profit for the period divided by the average number of shares 14,912,278 For the comparison period, the average number of shares was 14,752,833. Amounts in brackets refer to the corresponding period last year.
In June, DexTech’s Phase IIb study of the drug candidate OsteoDex for the treatment of advanced prostate cancer, skeletal metastatic castration-resistant prostate cancer (mCRPC), was completed, with 2-year follow-up results obtained from the last patients.
The phase IIb study’s primary endpoints regarding bone metabolism markers had been well achieved. A clear majority of patients showed reduction in their skeletal markers in blood by the given treatment with OsteoDex. The treatment was very well tolerated (few and mild side effects) and good disease- inhibiting effect was seen even in the lowest doses. Slowing and regression of the disease was also seen in patients where the disease has progressed after treatment with several of the other available drugs for castration-resistant prostate cancer.
In the phase IIb study’s secondary endpoints, there is overall survival that was studied through 24 months of follow-up after completion of treatment.
The follow-up results from the study were very positive and show that OsteoDex treatment can slow down the disease. The results show significantly longer survival for patients who responded to the treatment with a median survival longer than 27 months, compared with non-responders, with a median survival of 14 months (statistical significance, p <0.05). The survival 2 years after the start of the study is 65% for the patients who responded to the treatment, with slowing down or stabilization of the disease, compared with 28% for the non-responders (significance, p <0.05). Data regarding overall survival should be seen as an indication, as these data, for natural reasons, need to be confirmed in a much larger, so-called Phase III study.
The formal clinical study report (CSR) for the phase IIb study was available in December 2018. The results show that OsteoDex works as an antidepressant at mCRPC. The course of the disease in the skeleton was slowed down in a majority of the patients who completed the entire treatment. The study also confirmed the results from phase I, i.e. OsteoDex has a very high tolerability with the absence of serious side effects. The treatment of mCRPC has as its fundamental goal to be life-prolonging and preferably with tolerable side effects.
None of the modern drugs is curative in castration-resistant prostate cancer and there is therefore a great need (unmet need) for new potent and well-tolerated drugs. OsteoDex has a clear potential to meet this need.
DexTech is working towards the company’s primary goal, to enter into an agreement with a licensee for the company’s drug candidate OsteoDex for the treatment of skeletal metastases in advanced prostate cancer (mCRPC) before the end of 2020. A majority of our interested parties had expressed a desire for new contact when the follow-up results were completed, which can to a large extent be considered understandable as the result should give an indication of whether the OsteoDex treatment affects survival (i.e. the ultimate intention). In addition, we now also address contacts with new interested parties. Although the ongoing Corona pandemic has not affected DexTech’s finances, as the costly clinical work has been completed, it has affected the outlicensing work to such an extent that contacts with interested parties are slower and meetings are limited to teleconferencing.
The rights issue carried out during the summer of 2019 (July 2019), which provided the company with SEK 9.2 million after issue costs, gives the company sustainability and a solid capital base that finances the license negotiations, including legal costs, and secures the company’s continued R&D.
Anders R Holmberg
See the whole report: Dextech – Year-end report Juli 2019 – June 2020