The report summarizes the results in four parts.

1. The successful conclusion of the Phase I/II study. The report states that "the results demonstrated good safety and efficacy, which is very encouraging and supports the continued development of Alpha1H towards a Phase III trial".
2. Transfer of the drug manufacturing methodology to a larger commercial facility. This challenging process has been achieved and the new product has been tested and found to be fully active in cancer cells in the laboratory.
3. Initiation of contact with the FDA/EMA. Based on a positive gap analysis by Target Health of the existing data, interactions have been initiated in order to start to plan the presentation of the Phase III study design to the US FDA.
4. Marketing and risk analysis. A marketing and risk analysis plan for the bladder cancer project has been presented. Options are to co-develop Alpha1H for this indication together with Large Pharma partners through for example a licensing deal, or with investor funding.

We greatly appreciate the continued support from the Horizon 2020 program (2.1 million Euro) which accelerates our development.