PCI Biotech interim Q4 2022 results

Oslo (Norway), 17 February 2023 – PCI Biotech (OSE: PCIB), today announces its interim Q4 2022 results. Please find enclosed the report and presentation.

Highlights

fimaNAc – dermatology and bioprocessing

*The first phase of the dermatology program, to demonstrate topical fimaNAc-mediated nucleic acid delivery in a preclinical wound model, is on track for readout 1H 2023. Positive results will be utilised for seeking co-development with partners having nucleic acid-based drug candidates

*The bioprocessing program has matured, and the first patent application has been filed on use of fimaNAc in viral vector manufacturing. Further studies are planned for 1H 2023 to strengthen fimaNAc‘s value proposition and intellectual property

fimaVacc – intratumoural immunotherapy

*PCI Biotech is exploring approaches aimed at identifying novel immunotherapy treatment combination, and first patent application for an undisclosed treatment approach is underway for filing in Q1 2023

Corporate

*The cash position of NOK 57 million per year-end enables an extended estimated financial runway towards the end of 2024 with current plans

*All major study closure activities for the RELEASE trial are completed and the estimated remaining cash effect for the closure process is less than NOK -1 million. Downsizing of the full clinical team, reported in August, was enacted during second half of 2022 with full cost reduction effect in Q1 2023

*The company focusses its efforts and resources on pre-clinical research in areas where there is need for novel drug delivery systems, with a partnership-driven development strategy. fimaNAc is focussed on dermatology and bioprocessing applications, and fimaVacc on intratumoural immunotherapy

Ronny Skuggedal, CEO of PCI Biotech, comments: “The first phase of the fimaNAc dermatology program to demonstrate topical delivery of a model mRNA in a human skin wound model has been initiated, with the intention to act as a stepping-stone to partnership-driven development. The bioprocessing program has made good progress, and we have started to seek external feedback on our approach. The restructuring process is close to be completed, and with increased visibility our financial runway is extended towards the end of 2024 with current plans.”

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PCI Biotech will for future quarterly reports disclose more condensed interim financial information, tailored to its operations and effective from Q1 2023.

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A live webcast in Norwegian will be held today, Friday 17 February 2023, at 08:30am – 09:30am CET (local time).

The presentation can be followed as a live webcast, accessed through the link 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 / Sweden / Denmark / 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 Q4 2022

The interim report and the presentation will also be available on and on the company's webpage,  from 07:00am (CET) today.

For further information, please contact:

Ronny Skuggedal, CEO / CFO

Email:

Mobile:

About PCI Biotech        

PCI Biotech is a biopharmaceutical company focussing on development and commercialisation of novel therapies 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 fimaNAc programme utilises the proven capability of the PCI technology for intracellular delivery of nucleic acids. The technology can be used for most types of nucleic acids, ranging from oligonucleotides through mRNA and plasmids to viral vectors. The development of the fimaNAc programme is currently focussed on selected applications within dermatology and bioprocessing, well suited to the specific strengths of the PCI technology. The fimaVacc programme aims to enhance immunotherapy in cancer, by triggered endosomal release of antigens or nucleic acids encoding antigens, or immunostimulatory factors. For further information, please visit:

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 the Norwegian Securities Trading Act

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