Capitalisation and deepened partnership with Neuraxpharm
We are pleased to report that the company has successfully completed capital raise, and we would like to extend our warm thanks to you, our shareholders, for your continued confidence and support.
In parallel, we have reached an agreement with our partner Neuraxpharm (NRX) on additional financing through a convertible loan, subject to final documentation. We view NRX’s commitment very positively — it is a clear testament to their long-term confidence in our projects and strengthens the company’s position ahead of the upcoming capital raise.
Regulatory dialogues and regulatory progress
Just before year end, we held a scientific advisory meeting with the Swedish Medical Products Agency (Läkemedelsverket). Their feedback on our overall development plan was in line with Dizlin’s view of the activities considered necessary to support a future application for approval of Infudopa SubC.
We are also awaiting written feedback from the German medicines authority, which is expected to arrive in early March.
Work going forward includes:
- Update of stability data
- Preparation of briefing document ahead of FDA meeting
- Completion of CE marking of the pump (planned for April)
Manufacturing and study planning
Extensive work is ongoing to secure manufacturing both for the upcoming tolerability study and for future commercial production. We have identified a shortlist of manufacturing partners, and the work is being carried out in close collaboration with NRX to ensure a cost-effective and scalable solution.
Change of CEO
I have for some time planned the board of my wish to step down from the role of CEO for personal reasons. The decision is entirely unrelated to the company’s development, and my confidence in Dizlin’s projects remains very strong.
My successor, Pontus Salomonson, will take up the position in mid-March. I will remain as an adviser during a transition period.
Pontus has over 20 years of experience from the pharmaceutical, biotech and MedTech industries, with several senior commercial leadership roles. He has extensive experience of the Parkinson’s market and is well acquainted with both the disease area and the commercial dynamics.
We warmly welcome Pontus to Dizlin.
Focus in the coming months
- Introduction of new CEO
- Update of development and study plan together with NRX
- Completion of stability and biocompatibility tests
- Contracting of manufacturing partner
- CE marking of pump
- Preparations for planned capital raise of at least €6 million
Our products
We continue to develop our projects:
Infudopa IntraV – intended for Parkinson’s patients undergoing surgery under general anaesthesia. No equivalent treatment currently exists on the market.
Infudopa SubC – the company’s main project for the continuous treatment of Parkinson’s patients in an advanced stage of the disease, with significant commercial potential.
With hopes for an early spring,
Björn
Björn Velin
Tel: +46 (0)76 879 23 25