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PCI Biotech: First half-year 2020 results

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Oslo (Norway), 26 August 2020 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company, today announces its interim first half-year and Q2 2020 results. Please find enclosed the report and presentation.


Highlights

fimaChem
*The main priorities during the COVID-19 pandemic has been identification and implementation of potential mitigating actions for progressing the RELEASE study. Screening into the RELEASE study has been severely affected in the first half of 2020 with only one patient recruited during the pandemic, and the study has yet to enrol the first US patient. The situation is still unclear and the long-term consequences of the pandemic are uncertain

*Good progress in Asia, with the first 8 RELEASE study sites recently opened. A total of 44 sites are open by mid-August 2020 across EU, US and Asia and >50 sites are planned to be included into the study

*The Asian clinical sites are located in South Korea and Taiwan, providing access to hospitals and KOL’s in a commercially interesting region with higher prevalence of bile duct cancer than in the US and EU

*Several new initiatives to recoup long-term recruitment projections are being implemented, with the aim to accelerate patient inclusion when the current constraints on clinical trials inflicted by the COVID-19 pandemic are resolved. A complete picture of the consequences for the RELEASE study and the effect of the new initiatives are not yet available, but a delay of 6-12 months may be anticipated. The expected timeline for the planned interim analysis by 1H 2022 is therefore extended to range from 2H 2022 to 1H 2023, and the current cash-position may not be sufficient to reach interim read of the RELEASE study

*An article with a case report series from the Phase I study has been accepted for publication in Endoscopy International Open. The article provides a detailed description of treatment effects in three select patients at the dose chosen for RELEASE

fimaVacc
*Two new US patents have been granted in 2020, providing broad coverage for the combination of fimaVACC with various cytokines and a new important class of adjuvants

fimaNAc
*The evaluation period under the preclinical research collaboration with AstraZeneca has been extended by 6 months and the evaluation of the potential for a further collaboration now runs to the end of 2020

*The research collaborations have recently been reviewed for progress and value to PCI Biotech, and prioritised accordingly, resulting in closure of three collaborations

Corporate
*The management team was in May 2020 strengthened by the appointment of Dr Amir Snapir as CMO and Mr Ludovic Robin as CBO

Per Walday, CEO of PCI Biotech, comments: “Our highest priority during the COVID-19 pandemic has been the safety of our patients, employees and collaborators. We have previously communicated that this pandemic will result in yet undeterminable delays and increased cost, and we now see that recruitment into the RELEASE study has been severely affected by the COVID-19 pandemic. This is probably due to several factors, including the study being done in busy tertiary hospitals often requiring patient travel, involving treatment procedures demanding key hospital resources, and CCA being a rare disease. On the other hand, we have seen good progress in the work to ensure an optimised study when the pandemic issues are resolved, with regulatory approval and sites initiated in both South Korea and Taiwan, 10 new RELEASE study sites opened since the Q1 2020 report, and good progress in our efforts to relax relevant patient eligibility criteria. We have initiated work to include Ukraine in the study and are also considering further Asian countries. We should now be well positioned to accelerate the RELEASE study when the COVID-19 pandemic subsides. Two important fimaVacc patents have been granted in the US and we are intensifying our efforts to find partners and move this programme to clinical proof-of-concept in a disease setting. With all these tasks at hand, we are very pleased to have strengthened the executive team with Dr Amir Snapir as CMO and Mr Ludovic Robin as CBO, who have both taken strong strategic and operational ownership in the work.”

***
An online presentation in English will be held today, Wednesday 26 August 2020, at 08.30am CEST (local time). The presentation can be followed as a live webcast (access through link https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20200826_2) or the company’s website under “Investors – Reports and presentations – Webcasts”. It will be possible to post questions through the webcast console.

The interim report and the presentation will also be available on www.newsweb.no and on the company's webpage, www.pcibiotech.com from 07:00am (CEST) on 26 August 2020.

For further information, please contact:
Ronny Skuggedal, CFO
Email: rs@pcibiotech.no
Mobile: +47 9400 5757

About PCI Biotech         
PCI Biotech is a biopharmaceutical late stage clinical development 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 programme fimaChem consists of a pivotal 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 RNAi therapeutics, thereby addressing one of the major bottlenecks facing this emerging and promising field.

For further information, please visit: www.pcibiotech.com
Contact information: PCI Biotech Holding ASA, Ullernchausséen 64, N-0379 Oslo                

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.

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