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Subject 2016.03(IR letter) Business Updates
Writer ViroMed
Date 2016/03/23

In regard to recent announcement of capital increase with consideration on March 18th, ViroMed would like to brief on the background and our future business plan.

ViroMed is in the middle of license-out effort to global pharmaceuticals in an effort to commercialize VM202, a DNA therapeutics that has entered into clinical trial phase III in the US. ViroMed has learned that most of pharmaceuticals who are in the data review process are largely satisfied with the safety and the efficacy results in each indication study of VM202.

Contrary to chemical drugs which address symptom relief only, VM202 has the characteristics of regenerative medicine. For example, the pain relieving effect shown in VM202’s clinical trials are the outcomes from microvascular and/or peripheral neuron regeneration. In addition, VM202 targets for 4 different indications with two at phase III trials. The unique features of VM202 require extensive review process by many pharmaceutical companies involving various departments and a large number of associated experts to understand, verify, and form a consensus.

The boards confidently believe in VM202’s commercial success and determined that it is critical to keep the fast phase of development process in order to increase the value of VM202 as well as strengthen bargaining power in license out. All the reasons have led to the board’s participation in terms of third party placement to accelerate the development process.

ViroMed has developed VM202 from the initial design, to numerous preclinical and clinical trials in the last 15 years. This will be a particularly exciting year for us as we will launch 3 pivotal studies in the US. We appreciate your continual interest and encouragement for ViroMed, and we promise to keep doing what we do best.


Clinical Development Status

Among US pivotal clinical trials of VM202, VM202-DPN (diabetic peripheral neuropathy) is planned to have first patient injection in 2016 2Q. VM202-ALS (amyotrophic lateral sclerosis) is planned to submit IND for phase II/III, followed by patient recruitment of VM202-PAD targeting diabetic foot ulcer.

Project

Target Indication

Status

VM202-DPN

diabetic peripheral neuropathy

US

Phase III initiated

Plan to initiate 2Q (patient agreement/injection)

VM202-PAD

peripheral artery disease

US

Phase III in preparation

China

Phase II study report submitted and

phase III IND in preparation

VM202-ALS

amyotrophic lateral sclerosis

(“Lou Gehrig’s Disease”)

US

IND for II/III in preparation (expected in 3Q)

VM202-CAD

coronary artery disease

Korea

Phase II IND in preparation

VM206

breast cancer

Korea

Phase II IND in preparation

VM501

thrombocytopenia due to cancer treatment

China

Phase III in process

HX106

may aid memory improvement

Korea

Health functional food claim obtained and

new product launch in preparation