Oslo, October 27, 2016 - Reference is made to PCI Biotech Holding ASA's ("PCI Biotech" or the "Company") stock exchange announcement on 30 August 2016 in relation to the Q2 2016 report and its evaluation of the Company's strategic options, capital need and financing alternatives. The Board of Directors has, in understanding with the largest shareholders, initiated a process with the objective to carry out a share issue in the range of NOK 40-50 million to be conducted by the end of November 2016, details of which will be determined. 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 promising results from the Phase I part of the Phase I/II study of fima Chem in bile duct cancer and the recently granted orphan designation in EU have provided the Company with new exciting 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 fima Vacc 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 fima NAc programme will continue to be an opportunistic approach, pursuing out-licensing opportunities.
In summary: Proceeds from the planned share issue is expected to enable the Company to reach regulatory clarity on requirements for market approval of fima Chem , complete the fima Vacc Phase I study, and further pursue partnership opportunities. The Company will continue to follow a flexible partnering strategy for all programmes.
About PCI Biotech
PCI Biotech is a biopharmaceutical company focusing on development and commercialisation of novel therapies for the treatment of cancer through its innovative photochemical internalisation (PCI) technology platform. PCI is applied to three distinct anticancer paradigms: fima Chem (enhancement of chemotherapeutics for localised treatment of cancer), fima Vacc (T-cell induction technology for therapeutic vaccination), and fima NAc (nucleic acid therapeutics delivery).
Photochemical internalisation induces triggered endosomal release that is used to unlock the true potential of a wide array of therapeutic modalities. The company's lead fima Chem programme consists of a Phase I/II clinical study in bile duct cancer, an orphan indication with a high unmet need and without approved products. fima Vacc applies a unique mode of action to enhance the essential cytotoxic effect of therapeutic cancer vaccines, which works in synergy with several other state-of-the-art vaccination technologies. fima NAc utilises the endosomal release to provide intracellular delivery of nucleic acids, such as mRNA and siRNA therapeutics, thereby addressing one of the major bottlenecks facing this emerging and promising field.
For more information visit: www.pcibiotech.com
PCI Biotech Holding ASA, Ullernchausséen 64, N-0379 Oslo
Per Walday, CEO, firstname.lastname@example.org, Mobile: +47 917 93 429