PCI Biotech has initiated a process with the objective to carry out a share issue in the range of NOK 40-50 million by the end of November 2016.

Two of the largest shareholders have pledged that they will at least follow up their pro-rata in the share issue. Fondsfinans is retained as advisors in this process.

The results from the Phase I part of the Phase I/II study of fimaChem in bile duct cancer and the recently granted orphan designation in EU have provided the company with new opportunities.  The company has initiated processes to assess whether a well-designed pivotal Phase II study may provide market authorisation, which would significantly shorten the time to market for this orphan indication.

The proceeds from the contemplated share issue will allow the company to complete regulatory interactions with European and US authorities, to determine the fastest way to market. The Phase I results have also furnished increased external interest, which will be assessed in relation to various financing and partnering alternatives for further development.

Establishing fimaVacc as a clinical asset in immunotherapy is a major milestone towards commercialisation and the proceeds will also be used to fund completion of the Phase I study. The initiated Phase I study in healthy volunteers is designed to show enhancement of the cellular immune responses important for therapeutic effect of vaccines, with expected read-out of results in the first half of 2017.

The strategy for the fimaNAc programme will continue to be an opportunistic approach, pursuing out-licensing opportunities.

Source: Oslo Cancer Cluster