Potential of Targeting PNAG

The broad distribution of PNAG allows for an expansive range of targets and indications to be pursued. These immune therapeutics will be effective whether or not the microbe is resistant to antibiotics. A key aspect of the company’s plan is to initially focus on areas we believe have an increased potential for regulatory approval. Success there would justify and support pursuit of several other indications. As is detailed in the individual pipeline discussions, we plan to initially focus on two indications - prevention of infections caused by Streptococcus pneumoniae for vaccine AV0328 and ICU infections for monoclonal antibody F598.

However, the data generated in pre-clinical studies and the completed clinical trials supports pursuit of other indications as well. Of note, there is growing evidence to suggest that PNAG-positive microbes may be critical factors in a wide range of diseases not usually associated with infections. Ineffective removal of PNAG-expressing microbes or their fragments can contribute to the development of diabetes, Alzheimer’s disease and other chronic debilitating conditions. There are an increasing number of conditions where an infection has been identified as the initial trigger for inflammation and associated tissue destruction. While not the initial focus of the Company, these are areas that have great future potential.