Summary of the period July–September 2024
- Net turnover was SEK 147,993 (210,947)
- Cash flow from operating activities was SEK -5,126,552 (-4,325,051)
- Profit/loss after financial items was SEK -5,681,292 (-4,938,361)
- Profit/loss after tax was SEK -5,681,292 (-4,938,361)
- Earnings per share were SEK -5.80 (-10.62)
Summary of the period January–September 2024
- Net turnover was SEK 578,611 (494,684)
- Cash flow from operating activities was SEK -19,747,872 (-19,761,647)
- Profit/loss after financial items was SEK -18,850,105 (-19,564,732)
- Profit/loss after tax was SEK -18,850,105 (-19,564,732)
- Earnings per share were SEK -21.39 (-42.48)
Final step of the strategy
The reporting period has been impacted by three key events. Because the SFDA has now announced market authorization for the migraine indication in Saudi Arabia, the Company can immediately start the introduction of Ozilia®Migraine, which further strengthens our Proof-of-Concept. Our post-market surveillance study PM010 shows promising results in monitoring collected data—so far the objectives of the study have been confirmed. Partner International Switzerland GmbH was recently appointed as an advisor to find an international buyer for the business. Overall, these three events entail that we have now taken a large step forward in the final step of the Company’s exit strategy.
- Market authorization for the migraine indication and a first migraine order from Saudi Arabia
- Positive results from the ongoing migraine study PM010
- Swiss advisor appointed to initiate exit process
- Commencement of TO8 subscription period
Market authorization for the migraine indication and a first migraine order from Saudi Arabia
We received the first order for two Ozilia systems from Saudi Arabia at the end of September. Several weeks later, the Saudi Food and Drug Authority also approved our application for market authorization for the migraine indication with the product system Ozilia®Migraine. Following the successes with Ozilia® for chronic rhinitis in Saudi Arabia, we are pleased that we can now immediately follow up with the introduction of Ozilia® in the migraine area as well. Given the approved market authorization for the migraine indication, our distributor Janin Medical can now immediately roll out on a broad front the introduction of the migraine treatment that was prepared in the spring.
Positive results from the ongoing migraine study PM010
After having recruited approximately 25 percent of the patient population to the long-term open study PM010, the decision was made to perform a monitoring session of the data collected so far. The study is still ongoing, and recruitment of patients is not affected by this data summary.
The conclusion reported by the study statistician is that the results are promising, which was also supported by the sensitivity analyses performed for each objective.
What is important in this post-market surveillance study is how the patients’ perception of their difficulties changed during the twelve-month period that they were monitored. More data needs to be accumulated before the conclusion can be reported in its final form.
Swiss advisor appointed to initiate exit process
In mid-October, the Company announced the Board of Director’s resolution to appoint Partner International Switzerland GmbH as an advisor to find an international buyer for the business. This marks the initiation of the final step in the Company's strategy. Partner International is a group with offices in Switzerland, Canada, USA and Australia that over 24 years has built a strong reputation as an advisor in numerous international deals in licensing, partnerships, and corporate sales, focusing on the life sciences sector.
We have made significant progress in establishing clear market validation in our focus markets, and this work will continue at the same rate in parallel to Partner International initiating its work to find the best buyer for the business.
Consolidation of shares completed
At the end of August, the Company’s Board of Directors set August 30, 2024, as the record date for the previously decided consolidation of shares. Through the consolidation, the total number of shares in the Company decreased from 490,111,500 to 980,223. In conjunction with this, the Company’s shares changed ISIN code to SE0022726139.
Commencement of TO8 subscription period
The subscription period for shares with the support of warrant series TO 8 commenced on November 4, 2024, and will run until November 18, 2024. The Company will primarily use the raised capital for the ongoing exit process, continued establishment of market validation, and the ongoing studies.
Focus during the rest of 2024
- Market introduction of the migraine indication in Saudi Arabia and Switzerland
- Exit process development
- The studies PM009 and PM010
Kista, November 2024
Anders Weilandt, CEO
