Oslo, 28 February 2017 – Please find enclosed the financial report and presentation for fourth quarter and preliminary full year 2016.
- 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 Gastroenterology Week 2016
- Granted Orphan Drug Designation in EU
- Successful Investigational New Drug (IND) application
- Initiated interaction with authorities to determine fastest way to market
- Lancet Oncology publication of the fimaporfin (Amphinex) first-in-man Phase I study, with independent expert commentary
- Initiated Phase I in healthy volunteers for clinical validation of the vaccination technology – a major development milestone
- Research collaboration with Ultimovacs signed
- Research collaboration agreement with BioNTech and eTheRNA signed
- Extension of the existing top 10 pharma agreement until end of Q2 2017
- The fully underwritten rights issue of NOK 70 million completed
- Awarded up to NOK 13.8 million for further development of fimaVACC
CEO, Per Walday, comments:
“It has been a transformative year for PCI Biotech, with promising signs of efficacy in the fimaCHEM Phase I bile duct cancer study, initiation of clinical Phase I for fimaVACC, and establishment of further high quality partnerships in the fimaNAc programme. On the back of this progress, we also completed a fully underwritten rights issue of NOK 70 million that was more than 100% oversubscribed. The near term focus for the company is now to get regulatory clarity on the requirements for a marketing authorisation for fimaporfin in bile duct cancer and to complete the clinical translation of the promising preclinical results with fimaVACC“.
A presentation in English will be held today, Tuesday 28 February 2017, at Oslo Cancer Cluster Innovation Park.
Time: Tuesday February 28 2017, 11.00am -12.00 noon CET (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=47521316), and it will be possible to post questions through the webcast console.
PCI Biotech will additionally hold a presentation in Norwegian at Fondsfinans / Beringer Finance Oslo.
Time: Tuesday February 28, 13:30pm – 14:30pm CET (local time).
Venue: Haakon VII gate 2, Oslo.
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