Third quarter 2018 results

Posted on Nov 13, 2018

Oslo (Norway), 13 November 2018 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company today announces its interim third quarter 2018 result. Please find enclosed the report and presentation.

The fully underwritten rights issue of NOK 360 million completed in October 2018 provides PCI Biotech with the funds needed for the pivotal fimaCHEM study, beyond interim read-out of results for potential accelerated/conditional marketing approval.

The emerging data from the dose-escalation part of the Phase I study continues to deliver positive early signs of efficacy. Median overall survival for the dose selected for the pivotal study ended in October 2018 at 21.7 months, with two out of six patients in this cohort still being alive. Although the data sample is small, the results indicate a clear improvement over the best comparable published data. Our focus is now to bring fimaCHEM to the market for the treatment of inoperable bile duct cancer through successful performance of the pivotal study, which is expected to start in the first half of 2019.

The dose-finding part of the fimaVACC Phase I study identified a well-tolerated dosing regimen. PCI Biotech is collaborating with international immunotherapy experts for further in-depth analysis and characterisation of the immune responses.

Continued positive development in the fimaNAc programme, with one new research collaboration established in the third quarter of 2018.

Per Walday, CEO of PCI Biotech, comments: “The recently completed rights issue is a game-changer for the company, as it provides the required funds for the fimaCHEM programme to reach interim read-out and potential filing for accelerated approval in bile duct cancer. Our full focus is now on initiation and delivery of the pivotal study, and we have to that end further strengthened the organisation with experienced operational expertise in clinical project delivery. We are also very pleased to have established a collaboration with the internationally renowned expert group at Leiden University Medical Center under the leadership of Professor Sjoerd van der Burg for the finalisation of the in-depth characterisation of the immune responses to fimaVACC. The US patent granted for the band-aid like illumination device represents another important milestone for this programme.”

Highlights

  • Completed fully underwritten rights issue of NOK 360 million
  • Continued positive early signs of efficacy from fimaCHEM Phase I
  • Preparations for the pivotal fimaCHEM study progressing towards initiation in the first half of 2019
  • Presented Phase I dose-escalation fimaCHEM results at the 2018 ESMO congress
  • Entered collaboration with a renowned international cancer immunology institute for analysis and characterisation of the fimaVACC clinical immune response
  • US patent granted for “band-aid-like“ device for fimaVACC skin illumination / injection
  • Established new fimaNAc research collaboration with Bavarian Nordic, an immunotherapy-focused biotechnology Company
  • Further strengthened the clinical organisation

A presentation in English will be held today, Tuesday 13 November 2018, at Oslo Cancer Cluster Innovation Park.
Time: Tuesday 13 November 2018, 08.30am – 09.30am 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 (access through link https://www.hegnar.no/TV/kvartalspresentasjon/97451591) or the company’s website under “Investors – Reports and presentations – Webcasts. It will be possible to post questions through the audiocast 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.

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.

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

Attachments
PCI Biotech Q3 2018 Interim Report
PCI Biotech Q3 2018 Interim Presentation