Oslo, 16 May 2017 – Please find enclosed the financial report and presentation for first quarter 2017.
- Presentation of the Phase I data at The International Liver Congress and the Annual Meeting of the US Cholangiocarcinoma Foundation
- Interaction with authorities to determine fastest way to market
- Preparing for repeated treatments in Phase II through an extension of Phase I
- Progressing the Phase I study in healthy volunteers for clinical validation of the vaccination technology
- Awarded up to NOK 14.3 million from the Norwegian Research Council for further development of the vaccination platform
- Completed the fully underwritten rights issue of NOK 70 million
CEO, Per Walday, comments:
“The emerging interim Phase I data in bile duct cancer presented at the International Liver Congress supports our regulatory interactions to determine the fastest way to market for fimaCHEM. It is still early days, but we have promising signs of effect and survival from Phase I in this orphan indication. The completed fully underwritten rights issue of NOK 70 million enables PCI Biotech to strengthen the fimaChem asset through a Phase I extension, to explore safety of repeated treatments in parallel with the preparations for Phase II.
The near-term focus for the company is to get regulatory clarity on the requirements for a marketing authorisation for fimaporfin in bile duct cancer, initiate the Phase I extension and to complete the clinical translation of the promising preclinical results with fimaVACC“.
A presentation in English will be held today, Tuesday 16 May 2017, at Oslo Cancer Cluster Innovation Park.
Time: Tuesday May 16 2017, 09.00am -10.00am CEST (local time).
Venue: Jónas Einarsson aud. (2nd floor, entrance 2B), Oslo Cancer Cluster
Innovation Park, Ullernchausséen 64, Oslo.
The presentation can be followed as a live audiocast from Hegnar TV (http://webtv.hegnar.no/presentation.php?webcastId=52726738), and it will be possible to post questions through the webcast console.
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
PCI Biotech Holding ASA, Ullernchausséen 64, N-0379 Oslo
Ronny Skuggedal, CFO, firstname.lastname@example.org, Mobile: +47 9400 5757