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Subject 2019.03(IR letter)
Writer ViroMed
Date 2019/03/29

To the Investors of ViroMed:

Here are some recent developments in 1Q19:

    • We have initiated a 3-month extension study to DPN 3-1. We hope that this study will provide useful data for the DPN
      3-2 study and improve chances of agency approval of BLA in the future.
    • DFU phase 3 has 44 patients enrolled as of March 12, 2019. This is slower than expected. We will conduct an interim
      analysis in 2H19 and may amend the study protocol to expedite enrollment based on our findings.
    • Genopis, the plasmid DNA production facility owned by ViroMed, is now fully staffed and expected to complete the
      GMP run in 3Q19.  
    • Dr. Miwon Son, who heads the phytotherapeutics division at ViroMed, was recently appointed Chair of the Science
      and Technology Innovation Subcommittee under the Presidential Advisory Council. She will play a vital role in
      reshaping the regulatory landscape of the biotech industry.
    • Our phytotherapeutics research team has found that PG102 has significant therapeutic effects on the psoriasis mouse
      model. The findings have been published in Mediators of Inflammation. We are investigating PG102’s potential for
      treating various skin diseases.

I would also like to share a long-term plan for the company:

4 new gene therapy candidates that target therapeutic areas, including neuromuscular and neuroischemic diseases, are currently in pre-clinical studies. We expect to have the current candidates in phase 1 by 2021. By 2025, we hope to have at least three candidates in phase 3 that are believed to exceed the market potential of VM202 in phase 3. One of the candidates in particular is designed to be a complementary or next generation medicine/medication/drug to VM202 and would allow us to capture vast majority of the DPN market. We will keep you updated as we move forward.

 

Respectfully yours,

 

Sunyoung Kim, DPhil
CEO