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Highlights review
Operations
PCI Biotech’s 2024 development goals were to demonstrate scalability and
manufacturing process benefits of the photochemical-based technology (PCL) in
viral vector (AAV) manufacturing by advancing the technology into mini benchtop
bioreactors, which are considered representative for commercial manufacturing.
Recent mini benchtop bioreactor results indicate that PCL has the potential to
release increased levels of viral vectors in the upstream AAV manufacturing
process, accompanied by reduced impurity levels. This is an important milestone
for PCL and we consider PCL’s scalability as demonstrated by the encouraging
upstream results.
These results are in sum expected to translate into increased net manufacturing
yield after downstream processing, a highly sought-after feature by the
industry. However, more runs in mini benchtop bioreactors with a robust
downstream process are needed to prove PCL’s ability to increase net AAV yield
in an end-to-end process.
New mini benchtop bioreactor runs to reproduce the recent positive upstream
results and demonstrate downstream process benefits are in preparation.
Successful results may pave the way for external late-stage field testing in
2H 2025 and potentially make the technology ready for the research market. A 2-
year development plan to mark PCL’s readiness for the larger commercial market
is in planning.
Corporate
The cash position of NOK 27.1 million per end of December 2024 is estimated to
support operations into Q4 2025 with current plans, providing an opportunity
window to demonstrate the commercial potential of the technology platform. The
company will continue to explore financing and strategic opportunities to secure
continued operations.
Ronny Skuggedal, CEO of PCI Biotech, comments: “After receiving encouraging
early-stage field testing feedback at the beginning of 2024, we accelerated
development by scale-up to mini benchtop bioreactor. Now with encouraging
upstream results from two test runs, we consider PCL’s scalability demonstrated
also in bioreactor. Feedback from partnering activities underscores the
importance of being able to translate these upstream results into increased net
manufacturing yield after downstream processing. New test runs for demonstrating
PCL’s end-to-end manufacturing benefits are in planning, and we are eager to
continue working at this commercially representative scale. We have in parallel
started to look at a potential development leap directly into commercial
systems, made possible by an off-the-shelf 50L bioreactor with built-in LEDs
suitable for PCL. A successful demonstration in 50L bioreactor would mark PCL’s
readiness to address the capacity challenges in the commercial viral vector
manufacturing market.”
A live webcast in Norwegian will be held today, 27 February 2025, at 08:30am -
09:00am CET (local time).
The presentation can be followed as a live webcast, accessed through the link
https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20250227_1 or the
company’s website under “Investors - Reports and presentations - Webcasts”.
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 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 focusing on developing and
commercialising new technologies and novel therapies through its photochemical
technology platform originating from world-leading research at the Oslo
University Hospital. The technology platform is under development in two
different areas. (1) Photochemical lysis (PCL), inducing selective light-
triggered cell lysis, which may enhance yield and purity in viral vector
manufacturing. (2) Photochemical internalisation (PCI), inducing light-triggered
endosomal release, which may unlock the potential of a wide array of
modalities.
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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