Summary of the period April–June 2022
- Net turnover was SEK 19,538 (165,699)
- Cash flow from operating activities amounted to SEK -5,812,210 (-5,183,818)
- Profit/loss after financial items was SEK -5,962,508 (-5,056,471)
- Profit/loss after tax was SEK -5,962,508 (-5,056,471)
- Earnings per share were SEK -0.04 (-0.05)
Summary of the period January–June 2022
- Net turnover was SEK 88,170 (267,328)
- Cash flow from operating activities was SEK -13,228,791 (-10,695,986)
- Profit/loss after financial items was SEK -13,341,661 (-10,855,568)
- Profit/loss after tax was SEK -13,341,661 (-10,855,568)
- Earnings per share were SEK -0.08 (-0.10)
COMMENTS FROM CEO ANDERS WEILANDT
RESULTS FROM THE MIGRAINE STUDY ARE COMING
The migraine study is finally finished after all of the coronavirus-related delays. Subgroup results from the German patient group will be made public on September 8 in London. Very exciting times. We are continuing to deepen our work with the market through directly engaged experts and are moving away from the distributor model.
- The migraine study is presenting subgroup results in September and has been closed at the clinic
- Market access agreement for Germany and Israel
- Second phase in the FDA project continues
- Study plan for support studies presented
Clinical study on migraines is complete
We have all waited a long time, but the study is now completed. The final Finnish patient went through their final follow-up at the beginning of August. All of the study data is now undergoing a rigorous control process and statistical analysis in order to serve as a basis for the final report and scientific articles for publication.
Since the same process has already been applied to the study data from the German patient group in the spring, the study organization was able to perform a so-called subgroup analysis. The 97 German patients left the study, and the five study clinics were formally closed at the end of 2021. Now that the Finnish study patients are done, the study is complete, with a total of 132 patients.
A subgroup analysis shows the results from a sample of the study data, for example gender, age span, other illnesses or, like in this case, geography. A subgroup result should be viewed as independent from the final study results but is often viewed as in-depth and interesting.
The subgroup results will be presented as a poster at the scientific symposium Migraine Trust International Symposium 2022, September 8–11 in London.
There are not really any words to describe how exciting this is. A large percentage of the study sample is represented, 97 out of 132, and it is clear that the expectations are high. The interim analysis from May 2019 was clearly very strong, so it is logical to hope for an even better result now. As always, though, science is always science, and a lot can happen in a study — which is what makes it so unbelievably exciting.
Model with market consultants underway in Germany and Israel
We are adding Germany as a focus market for the introduction of migraine treatment. Preparations have been ongoing for some time, and starting with the subgroup results from the migraine study that will be presented soon, we will be moving into high gear. For this, we signed a consulting services agreement with MTIGER GmbH in Munich. MTIGER’s consultants are highly competent and very experienced in the area of migraines. We are applying the concept of market access consults to Israel as well and are progressing with a consulting assignment for market access with one of the owners of our former Israeli distributor. Pharmore PSR Ltd has more than 30 years’ experience and a valuable contact network from the Israeli neurology market.
FDA project continues
We continue to work with the second phase of the project to register the migraine treatment after a first round with the US authority. We need to adapt a number of technical matters since the requirements on tests and verifications are different from those in the EU. The study results that will be presented shortly are also crucial for the continued steps that may need to be taken in the project.
Two new studies
To support our marketing and sales work, we are starting a follow-up study of 200 patients in several countries and a smaller pilot study that will target the patients who did not obtain results from treatment with CGRP inhibitors.
In the cards for 2022
Everything is progressing according to plan so far. We continue to follow the marketing plan for 2022. This applies naturally to both the migraine and the rhinitis indications, but we will have a stronger focus on migraine.
Kista, August 2022 Anders Weilandt, CEO