Second quarter and first half-year 2018 results

Posted on Aug 30, 2018

Oslo (Norway), 30 August 2018 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company today announces its interim second quarter and first half-year 2018 result. Please find enclosed the report and presentation.

The proposed fully underwritten rights issue of NOK 360 million provides PCI Biotech with the funds needed for the pivotal fimaCHEM study until interim read-out for potential accelerated approval. The established underwriting syndicate shows that we both have a supportive shareholder base and significant interest from external investors, including a reputable international specialist investor.

The Phase I efficacy data at the dose selected for the fimaCHEM pivotal study is now mature enough for presentation. Median overall survival is currently 21.2 months in this cohort, and three of the five patients with measurable tumours show tumour response. 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 as quickly as possible, through successful performance of the pivotal study, which is expected to start early 2019.

The dose-finding part of the fimaVACC Phase I study is completed with more than 90 subjects included, and a well-tolerated dosing regimen is identified. The focus in the coming months will be on in-depth analysis and characterisation of the immune responses.

Continued positive development in the fimaNAc programme, with two new research collaborations established over the past couple of months and the top-10 pharma collaboration extended to end of 2018.

Per Walday, CEO of PCI Biotech, comments: ”The apparent strong emerging survival and response results from the last cohort in the fimaCHEM Phase I study in bile duct cancer verify the selection of this dose for the pivotal study. With the recently proposed fully underwritten rights issue that was supported by both major shareholders and an international specialist investor, we are now all set to execute the pivotal study to interim readout and potential accelerated approval. The near-term focus for the fimaVACC Phase I study will be to further characterise the promising clinical immune responses and strategic assessment of the most value-enhancing path forward. We see a continued strong interest in the fimaNAc programme and are pleased to see the addition of two new research collaborations with key players in the immunotherapy field.”

Highlights

  • Proposed fully underwritten rights issue of NOK 360 million
  • Encouraging data from the Phase I study at the dose level selected for the fimaCHEM pivotal study
  • Initial data suggests that two fimaCHEM treatments are well tolerated and preparation for pivotal study progressing towards initiation early 2019
  • Phase I fimaVACC interim data suggests enhancement of several parameters of importance for vaccination – near-term focus is on analysis and characterisation of the clinical immune responses
  • Extension of the top-10 pharma fimaNAc collaboration and new research collaborations established with the immunotherapy focused companies IMV in Canada and Bavarian Nordic in Denmark

A presentation in English will be held today, Thursday 30 May 2018, at Oslo Cancer Cluster Innovation Park.
Time: Thursday 30 May 2018, 08.30am – 09.30am 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 (access through the link http://webtv.hegnar.no/presentation.php?webcastId=92033877) 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 Q2 2018 Interim Reporting
PCI Biotech Q2 2018 Presentation