Sirona Biochem CEO's Report on Progress - Seite 2

The data that has been generated by Wanbang is currently being used in licensing discussions with a potential partner in India that recently approached us.

Skin Lightener, TFC-849 (Valeant) and Library

Our skin lightener, TFC-849 remains in scale-up at a French CRO for clinical studies. We did anticipate that this would be finalized earlier in 2016, however, the CRO experienced some complications and therefore it has been delayed until January. Valeant is aware of the delays in scale-up and has not altered plans to commercialize.

In 2016 we also completed the development of several other skin lighteners. This group contains potential lead compounds which can be licensed with TFC-1067 or separately in multiple markets. We have begun preliminary testing to determine the most effective new compounds, and expect results in Q1 2017.

Cell Preservation and Regenerative Compounds

We have now concluded testing of our glycoprotein compound library. We showed a protective effect in human fibroblasts (skin cells) under various stress conditions. Our subsidiary, TFChem has developed a comprehensive report of the data to be shared with potential partners. While the compounds have very interesting properties, they are still considered early stage, which means that the partnerships we seek will be considered "Research and Development" (R&D) collaborations. The compounds also have numerous potential applications and we need to take time to evaluate the best path to market. This is something we will advance with partner organizations.

One potential application is in storage of various cells and tissues. In May, we entered into a research program with Dr. Caigan Du's laboratory (Vancouver Coastal Health Research Institute) on red blood cell storage and preservation. Results showed that while the compounds did not improve total blood cell count, they did improve the health of the cells that survived. This could result in more cells remaining viable in transfusions (where many typically die). Testing in commercial storage protocols will begin in 2017.

Dr. Du also carried out a study on oxidative stress in skin cells. The results confirmed what our previous CROs have found, which is a significant preservation under stress conditions. This data is currently being compiled and will be used for partnering discussions.

Acne Compound

Our acne compound is in chemistry development and expected to be completed and ready for testing in mid-2017. It will likely be our next major pipeline candidate. This project utilizes our successful business model of applying our proprietary technology to a known compound with stability issues. There is an excellent opportunity to produce a new therapy in this market which is estimated to be $8 Billion USD worldwide annually. Acne is the most common skin condition in the United States affecting some 50 million Americans and costing $3 Billion USD annually.