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PCI Biotech interim first quarter 2022 results

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Oslo (Norway), 11 May 2022 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company, today announces its interim Q1 2022 results. Please find enclosed the report and presentation.

Highlights

fimaVacc
*The programme is progressing towards initiation of a Phase II clinical proof-of-concept study

*Established group of international clinical experts to provide clinical guidance and support the development and performance of the trial

*Good project readiness – preparation of clinical trial application and sourcing of study treatments ongoing, and selection of clinical sites in EU5 started

fimaNAc
*Progressing the focused development plan, targeting applications suited to the specific strengths of the PCI technology

*Established a preclinical collaboration with the South Korean company MDimune, developing innovative drug delivery technologies for modifying cellular and disease processes

fimaChem
*The RELEASE trial was closed to recruitment in January 2022 due to changes in the competitor situation that renders the trial challenging to complete and potentially inadequate for approval

*Available data from the RELEASE trial have been reviewed – there is not sufficient data to show differences between the treatment arms and last patient will leave the study in May 10, 2022

*RELEASE will be closed as quickly as possible, with an expected future cash effect of up to NOK -10 million

Corporate
*Per Walday will step down as CEO at the end of May 2022 and Ronny Skuggedal, CFO, is appointed as Interim CEO effective 1st June

*The CBO, Ludovic Robin, will leave the company in May 2022

*The organisation has been reduced by 4 FTE (25%), with notice periods ending during Q2. The financial runway, with current commitments, is estimated to be towards the end of 2023

*The Scientific Advisory Committee is further strengthened with Prof. Ernst Wagner at the Ludwig-Maximilians-Universität (LMU) and the Center of Nanoscience in Munich, Germany, contributing with distinguished expertise and experience in the field of targeted delivery of nucleic acids and protein therapeutics

Per Walday, CEO of PCI Biotech, comments: “The company is now fully focused on the progress of the fimaVacc programme. The planned next step is a clinical Phase 2 proof-of-concept study in recurrent/metastatic head and neck cancer, which has been discussed and endorsed by a core group of international clinical experts and key opinion leaders within head and neck cancer and immunotherapy. Manufacturing and sourcing of study treatments for this exciting project is well underway, and selection of clinical sites has started.

Results from the RELEASE study that was closed to recruitment in January have been analysed but the data were insufficient to allow a conclusion on potential differences between the treatment arms. The study is therefore being closed as quickly and cost efficiently as possible without further follow-up of patients. The organisation of PCI Biotech has been reduced accordingly to fit the resource need going forward.

Ronny Skuggedal, CFO, will take the helm of PCI Biotech from 1st June as Interim CEO. The company has a well-functioning and competent team and an exciting technology platform with strong data supporting applications within emerging therapeutic modalities. I am confident that the team will succeed in delivering value to both patients and shareholders, and I will follow the company’s path and progress closely. I would like to take this opportunity to thank all our shareholders, the board, our collaborators, and not least the fantastic team at PCI Biotech for their trust and support during my tenure.

"On behalf of the entire company, I wish Dr Walday all the best in his new endeavours and sincerely thank him for his 14 years period as CEO of PCI Biotech. Per will surely be missed by us all. At the same time we are happy to have Ronny Skuggedal take over as interim CEO, setting the scene for stability and continuity going forward.", says Hans Peter Bøhn, Chairperson of the Board of Directors.

***
A live webcast in English will be held today, Wednesday 11 May 2022, at 08:30am – 09:30am CEST (local time).

The presentation can be followed as a live webcast, accessed through the link https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20220511_4 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 webcast and it will be possible to post written questions through the webcast console or through a teleconference, mainly facilitated for attendees intending to ask questions verbally during the Q&A session.

Dial-in details for the 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 40682 0620 / Denmark +45 7876 8490 / United Kingdom +44 203 7696 819 / 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 Quarterly Report - Q1

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 11 May 2022.

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

About PCI Biotech
PCI Biotech is a biopharmaceutical clinical stage development company focusing on development and commercialisation of novel therapies for the treatment of cancer through its innovative photochemical internalisation (PCI) technology platform. PCI induces triggered endosomal release that is used to unlock the true potential of therapeutic modalities.

The company’s lead programme fimaVacc aims to enhance immunotherapy in cancer, by triggered endosomal release of antigens or nucleic acids encoding antigens, or immunostimulatory factors. Enhancement of relevant immune responses with protein- and peptide-based vaccines were successfully demonstrated in humans through an extensive Phase I study in healthy volunteers and a Phase II study is in planning with the aim to demonstrate enhancement of immunotherapy for treatment of solid tumours. In the fimaNAc programme endosomal release is utilised 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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