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PCI Biotech Holding — Earnings Release 2016
Feb 28, 2017
3709_rns_2017-02-28_2d3b7a70-80e6-4331-89dc-f4a56bad5ef1.html
Earnings Release
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PCI Biotech: Fourth quarter and preliminary 2016 results
PCI Biotech: Fourth quarter and preliminary 2016 results
Oslo, 28 February 2017 - Please find enclosed the financial report and
presentation for fourth quarter and preliminary full year 2016.
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 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
fimaVacc
* Initiated Phase I in healthy volunteers for clinical validation of the
vaccination technology - a major development milestone
* Research collaboration with Ultimovacs signed
fimaNAc
* Research collaboration agreement with BioNTech and eTheRNA signed
* Extension of the existing top 10 pharma agreement until end of Q2 2017
Post- period
* 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
If you wish to attend the presentation in Norwegian please confirm with an e-
mail to [email protected] or [email protected].
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.
For more information visit: www.pcibiotech.com
Contact information: PCI Biotech Holding ASA, Ullernchausséen 64, N-0379
Oslo
Ronny Skuggedal, CFO, [email protected], Mobile: +47 9400 5757
This information is subject to the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.