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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.”
PCI Biotech will for future quarterly reports disclose more condensed interim
financial information, tailored to its operations and effective from Q1 2023.
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
https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20230217_2 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 Q4 2022
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 (CET) today.
For further information, please contact:
Ronny Skuggedal, CEO / CFO
Email: rs@pcibiotech.no
Mobile: +47 9400 5757
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: www.pcibiotech.co
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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