Skip to main content

AI assistant

Sign in to chat with this filing

The assistant answers questions, extracts KPIs, and summarises risk factors directly from the filing text.

PCI Biotech Holding Earnings Release 2016

Feb 28, 2017

3709_rns_2017-02-28_2d3b7a70-80e6-4331-89dc-f4a56bad5ef1.html

Earnings Release

Open in viewer

Opens in your device viewer

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.