PCI Biotech: First half year 2017 report and presentation

Oslo, 29 August 2017 - Please find enclosed the financial report and presentation for second quarter and first half year 2017.

PCI Biotech reported important progress for the fima
Chem
programme during 1H 2017, with early promising signs of effect in Phase I. The study has also provided encouraging interim overall survival data averaging 15.6 months per end July 2017 (median 14.4 months), with 25% of the patients still being alive. These promising results may be further strengthened by repeating the treatment. Safety for repeated treatment will be investigated in a Phase I extension study and the first patient in this study was treated in August. Regulatory interactions to clarify the fastest way to market and subsequent preparations for Phase II will run in parallel with the extension study, thereby minimising time to initiation of a potential pivotal Phase II study with repeated treatment.

Clinical translation of the fima
Vacc
asset is progressing with tolerability being established and the initial results on overall T-cell responses from the study are expected to be available during 2H 2017.

The fima
NAc
programme has showed positive progress and the research collaborations with RXi Pharmaceuticals and a top-10 pharma company have both entered into new stages during 2017.

The rights issue completed in Q1 2017 enables PCI Biotech to progress the fima
Chem
programme through regulatory interactions to determine the fastest way to market, as well as the Phase I extension study and other preparations for initiation of Phase II. The proceeds, together with a grant from the Norwegian Research Council, will also cover the clinical translation of the promising fima
Vacc
asset. The organisation will be strengthened with Dr Olivecrona as Chief Medical Officer (CMO) from October 2017.

Per Walday, CEO of PCI Biotech, comments:
"After the rapid initiation of the fimaChem Phase I extension study, we now have full focus on effective completion of this study and the regulatory interactions to clarify fastest route to market. We are also eagerly awaiting the initial results on overall T-cell responses from the fimaVacc Phase I study and will revert to the market as soon as these are available."

Highlights

fima

Chem

• Encouraging interim overall survival data from Phase I
• First patient treated in the Phase I extension study

fima
Vacc
 

• Tolerability of the vaccination technology established - awaiting initial results on overall T-cell responses

fima
NAc

• RXi Pharmaceuticals collaboration expanded into the field of immuno-oncology
• Top-10 pharma collaboration extended and entered into
  in vivo
  studies

Corporate

• Dr Hans Olivecrona appointed as Chief Medical Officer
• Completion of a fully underwritten rights issue of NOK 70 million
• Awarded up to NOK 14.3 million in public grants for further development of the vaccination platform

A presentation in English will be held today, Tuesday 29 August 2017, at Oslo Cancer Cluster Innovation Park.

Time: Tuesday August 29 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, see link (
http://webtv.hegnar.no/presentation.php?webcastId=58639798
). 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:

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

Forward-looking statements  


This announcement may contain forward-looking statements, which as such are not historical facts, but are based upon various assumptions, many of which are based, in turn, upon further assumptions. These assumptions are inherently subject to significant known and unknown risks, uncertainties and other important factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this announcement by such forward-looking statements. PCI Biotech disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.