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Subject 2019.06(IR letter)
Writer ViroMed
Date 2019/06/05

Dear Valued Investors,

 

Here are some recent developments at Helixmith.

 

  • We recently announced the rights offering to raise KRW 159.6 billion. We plan to use this money for clinical trials (VM202-DPN, VM202-PAD, VM202-ALS, and VM202-DPN Opioid Sparing Study); BLA application and pre-marketing efforts; R&D for other pipelines; and dedicated research facilities at our new Magok Headquarters which is under construction. The CEO plans to fully exercise the rights allocated.

  • The VM202-DPN Phase III clinical trial completion is a few months ahead. The nine-month efficacy follow-up has been completed for 433 subjects, and we are currently conducting a three-month extension study to collect additional safety and efficacy data. After the final follow-up, any gaps will be checked and filled. We expect to break the blind sometime in August. We look forward to sharing the results with you after the data analysis, which may take a month or two given the complexity and vast amount of data. .

  • One notable new trial in preparation is the “Opioid Sparing Study”, which will look into VM202’s potential to reduce opioid use. Conducted at Harvard Medical School, this will be the world’s first trial with such goal, and is expected to gain attention from the government and advocacy groups as well as the pharmaceutical industry, in light of the ongoing opioid crisis in the US. We will also consult the FDA about modifying the VM202-PAD patient enrollment criteria in the latter half of this year, in order to expedite the study on diabetic foot ulcers and expand the market. In addition, VM202-DPN's second phase 3 and ALS-2 trials will be initiated within the year.

  • New products are being developed with the aim to reach even larger markets than VM202, bringing together the knowledge and technology accumulated by Helixmith researchers. We plan to initiate three or four trials in the US in 2021. We will keep you updated as we move forward.

 

We appreciate your continued support.

 

Respectfully,

 

 

Sunyoung Kim, DPhil

CEO