With the capital we raised in September/October, we have been able to complete both the user study for the pump and the preclinical program. We know that both projects have gone well, although we have not yet received the final reports, which we will receive shortly. During the autumn, we intensified our efforts to secure additional capital to carry out the pilot study. At the time of writing, we have an international institutional investor who says they are willing to cover about half of our investment need, which amounts to SEK 60 million. Thus, our focus is now on finding one or more strategic investors who can secure the remaining amount. However, as mentioned in the shareholder letter in September, the discussions and the due diligence process take time. We aim to close the investment round in the first quarter of 2024.
Below is a brief update:
- Patents: Things are continued to be very promising on the patent side. In addition to the three most important markets – EU, US, and Japan – we have added markets such as Mexico, the UK, South Africa, Turkey, etc. Our active patent strategy, which aims to ensure that all significant markets worldwide are protected against patent infringement, is successful as we continuously add new countries.
- Preclinical Study: Our preclinical study (with the aim of investigating local skin tolerance) conducted in Denmark, has recently been completed with good results. We expect to receive a draft report before the end of the year. The study is the last in the preclinical program and will be part of the New Drug Application (NDA) for the approval of Infudopa SubC.
- Pump: As mentioned above, the development project regarding the design of the pump to be used for treatment with Infudopa SubC in outpatient care is complete. The pump has been fully validated and was used in the preclinical study mentioned above. In our second study, the so-called usability study, where the aim is to evaluate how patients and healthcare professionals handle the pump and its functions, has been completed. Here we will receive a final report during the first quarter of 2024. This report will be used as a basis for EU approval of the pump.
- Manufacturing: Intensive work is underway to identify a pharmaceutical manufacturer, for commercial manufacturing, that can fill Dizlin’s Infudopa SubC syringes. Dizlin’s ambition is to distribute pre-filled syringes at launch, which will make it easier for both patients and healthcare professionals.
- Registration Status: As previously communicated, Dizlin has received feedback from both the U.S. Food and Drug Administration (FDA) and the Swedish Medical Products Agency regarding Infudopa SubC. Dizlin’s planned development program, i.e., the implementation of a small pilot study of approximately 15 patients for 2 weeks and a larger tolerability study, appears to be sufficient for approval in Europe. For approval in the US, we also need to supplement with a small study on healthy volunteers – however, the FDA states that this study (as well as the larger tolerability study) can also be conducted in Europe (rather than the US), which makes it a significantly lower cost study to perform. Regarding the registration of our product Infudopa IntraV, our assumption is that only the work to ensure quality of manufacturing, i.e., to carry out a number of test batches, is required for approval in Sweden first, followed by the remaining countries in the EU. For the United States, we need to supplement, as mentioned above, with a small study on healthy volunteers, which is done simultaneously and included in the same study as SubC.
We in management and the board believe we see a glimmer of light in the investment darkness as several have shown an interest in the company. Raising capital as soon as possible is essential for the company allowing us to drive our important projects forward.
We are also optimistic about how the ongoing projects have developed and look forward with confidence to raising the capital we so badly need to carry out our projects in 2024.
A picture of our well-functioning pump is attached below.
Wishing you pleasant holidays and happy new year.
CEO, Dizlin Pharmaceuticals AB