Oslo, 22 November 2016 - Please find enclosed the financial report for third quarter 2016 for PCI Biotech Holding ASA.
Highlights
fima Chem
- 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
fima Vacc
- Initiated clinical validation of the vaccination technology - a major development milestone
fima NAc
- 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 fima Chem 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 fima Vacc technology into man. Improving immunogenicity of vaccine candidates is a main priority in the immunotherapy industry and we believe that the fima Vacc technology may play an important part in solving this challenge. We are also facing increased interest in our fima NAc 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: 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
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.
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