Third quarter 2016 results
Oslo, 22 November 2016 - Please find enclosed the financial report for third quarter 2016 for PCI Biotech Holding ASA.
Highlights
fimaCHEM
Completed Phase I study in bile duct cancer, with early promising results confirmed at central expert review
Oral presentation of the Phase I results as late-breaking news at United European Gastro Week 2016
Granted Orphan Drug Designation of fimaporfin for treatment of bile duct cancer in EU
Lancet Oncology publication of the fimaporfin (Amphinex) first-in-man Phase I study, with independent expert commentary
fimaVACC
Initiated clinical validation of the vaccination technology – a major development milestone
fimaNAc
Research collaboration agreement with BioNTech signed
Financials
The Company proposes to carry out a fully underwritten rights issue of NOK 70 million at a subscription price of NOK 7 per share
CEO, Per Walday, comments:
“We have reached several important milestones for the fimaChem program in 2016. On the back of this progress, we were very pleased to recently announce a fully underwritten rights issue of NOK 70 million. The funding will enable the company to complete the initiated interactions with regulatory authorities to determine the best approach to marketing approval. In addition, the rights issue will fully fund translation of our fimaVacc technology into man. Improving immunogenicity of vaccine candidates is a main priority in the immunotherapy industry and we believe that the fimaVacc technology may play an important part in solving this challenge. We are also facing increased interest in our fimaNAc technology and we look forward to explore synergies with BioNTech's pioneering disruptive technologies.“
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: fimaCHEM (enhancement of chemotherapeutics for localised treatment of cancer), fimaVACC (T-cell induction technology for therapeutic vaccination), and fimaNAc (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 fimaCHEM 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. fimaVACC 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. fimaNAc 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.
Contact information:
PCI Biotech Holding ASA,Ullernchausséen 64,N-0379 Oslo
Ronny Skuggedal, CFO, rs@pcibiotech.no, Mobile: +47 9400 5757
This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.