Guard Therapeutics has received approval from the Swedish Medical Products Agency to try an even higher dose of ROSgard in their phase Ia program due to good safety profile. This will be the next step for ROSgard before entering the MAD study.
Guard Therapeutics has decided to broaden their Phase Ia study with one extra dose level which will be higher than earlier. The company has received approval from the Swedish Medical Products Agency to conduct this study and if the study with a higher dose would be successful, also approval for the multiple-dose study (MAD). To continue with the study, approval from the ethical review authority is required, and we estimate this to happen shortly. The reason to evaluate ROSgard with a higher dose is to strengthen the project for future clinical development.
Guard also repeats that they expect to conduct the first study in patients during 2020, which is according to their original plan. We see positive on the news that Guard has received approval for both a higher dose and to start the MAD study. Both studies will be exciting catalyst for the stock going forward. The news don’t affect our valuation, and we still believe that Guard will stick to the original timeline with topline data from a phase Ib during 2020.
We have a Base Case of SEK 2.3 per share with a Bull and Bear Case of SEK 5 and SEK 0.4 per share, respectively.