PCI Biotech first half-year 2021 interim results


Oslo (Norway), 31 August 2021 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company, today announces its interim first half-year 2021 results. Please find enclosed the report and presentation.


*The implementation of the amended protocol and the opening of Asian sites provided increased screening and enrolment to RELEASE in Q1, but the activity declined significantly in Q2 with only three patients included. The expected timeline for the interim analysis for potential accelerated approval is revised to 2H 2023

*Recruitment in Q3 started stronger with four patients included in July and the company continues to focus on enrolment of patients into the RELEASE study, with the emphasis on regular trial management, including overall performance evaluation and site replacement

*First US patient enrolled in the RELEASE study

*Orphan drug designation granted in South Korea

*Successful Phase I vaccination proof of concept study published in the high impact immunology journal, Frontiers in Immunology, demonstrating that fimaVacc enhances the immune response to peptide- and protein-based vaccines in healthy volunteers

*US patent granted for the use of fimaVacc in combination with immune checkpoint inhibitors

*Encouraging data on enhanced delivery of mRNA for various medical applications was presented at the UK based 12th Annual RNA Therapeutics Virtual Conference

*Established extensive research collaboration with the South Korean company OliX Pharmaceuticals, a leading developer of RNAi therapeutics

*Significantly strengthening the organisation with three highly skilled individuals; an experienced operational leader for RELEASE, and two key employees within clinical science and business development focusing on fimaVacc and fimaNAc

Per Walday, CEO of PCI Biotech, comments: “The organisation has been focused on the implementation of all the initiatives to recoup delays to the RELEASE study inflicted by the Covid-19 pandemic. On the positive side, South Korea has contributed strongly to the recruitment in 2021. Asia is a region with higher prevalence of bile duct cancer and South Korea is a key market in this region. The granting of orphan drug designation for fimaporfin in South Korea was an important step in the development of fimaChem for bile duct cancer and a recognition of the therapeutic benefits we seek to bring to the patients. The pandemic situation is however still fluid in 2021 and we have seen fluctuating recruitment this year, which unfortunately means that we need to revise our estimated timelines. The situation is expected to improve as the vaccination rates increase going forward. We are fully focused on optimal study performance and progress, with attention to site performance and proactive management of study specific risks. The focused efforts needed for RELEASE during the pandemic has unfortunately reduced available resources for fimaVacc and fimaNAc. We have strong confidence in the commercial potential of all our programmes and have therefore strengthened the organisation significantly, with three highly skilled employees that will play key roles in driving the progress of all programmes. For fimaVacc, the US patent granted for the use in combination with immune checkpoint inhibitors (ICI’s) provides important intellectual property for the further development of this programme. Increasing the response rates to ICI's is a main priority in the pharma industry and therapeutic cancer vaccination is a rational approach to this aim, with well-suited characteristics of the fimaVacc technology. For fimaNAc, we were pleased to announce a broad and exciting collaboration with OliX Pharmaceuticals in South Korea, and we continue to pursue new and value-adding collaborative opportunities.

An online presentation in English will be held today, Tuesday 31 August 2021, at 08.30am CEST (local time). The presentation can be followed as a live webcast, access through link https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20210831_1 or the company’s website under “Investors – Reports and presentations – Webcasts”.

Q&A session        
There will be a Q&A session at the end of the presentation and it will be possible to post written questions through the webcast console. The presentation will also be presented through a teleconference, mainly facilitated for investors intending to ask questions verbally during the Q&A session.

Dial-in details for teleconference, mainly facilitated for verbal questions during Q&A session:
If you plan to use this facility, please join the event 5-10 minutes prior to the scheduled start time using the dial-in numbers below. A line mediator will provide information on how to ask questions.

Norway +47 2195 6342 / Sweden +46 4 0682 0620 / Denmark +45 7876 8490 / United Kingdom +44 20 3769 6819 / United States +1 646 787 0157. If your country is not listed, we recommend that you use the dial-in details for UK.

When prompted, provide the confirmation code or event title.

Confirmation Code: 436187        
Event title: PCI Biotech Holding conference call Q2

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 31 August 2021.

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 considered to be inside information pursuant to the EU Market Abuse Regulation and is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act. This stock exchange announcement was published by Ronny Skuggedal, CFO, PCI Biotech Holding ASA, on 31 August 2021.



PCI Biotech Q2 2021 Interim Report PCI Biotech Q2 2021 Presentation