PCI Biotech interim Q3 2022 report
Oslo (Norway), 23 November 2022 – PCI Biotech
(OSE: PCIB), today announces its interim Q3 2022 results. Please
find enclosed the report and presentation.
Highlights
Corporate*Efforts to finance a
Ph II clinical trial in head and neck cancer did not, under the
current market conditions, result in a feasible way forward and the
company reported in August that it will not conduct a
company-sponsored Ph II trial with the fimaVacc technology. This
entailed a downsizing of the clinical team, which is enacted during
the second half of 2022, with full cost reduction effect in Q1
2023. The cash position of NOK 67 million per end of Q3 enables an
estimated financial runway into 2024
*The company now focus its efforts and resources
on non-clinical research, exploring new fields of use for the PCI
technology platform utilising fimaNAc for dermatology and
bioprocessing applications, and fimaVacc for intratumoural
immunotherapy
fimaNAc –
dermatology and bioprocessing*The first step for the dermatology
discovery project is to demonstrate fimaNAc-mediated nucleic acid
delivery in a wound model. External feasibility experiments are
contracted, with expected readout 1H 2023
*The bioprocessing discovery project exploring
applications specifically suited to the strengths of the PCI
technology has matured and is now focused on in-house experiments
of fimaNAc for use in viral manufacturing
fimaVacc –
intratumoural immunotherapy*Exploring approaches aiming to identify
novel immunotherapy treatment combinations with promising
efficacy
fimaChem*All
major study closure activities are expected to be completed before
the end of the year. The remaining cash effect for the closure
process is estimated up to NOK -3 million from 1st October 2022
Collaborations*In August 2022,
a preclinical collaboration was initiated with Mymetics, aiming to
explore technological synergies for possible enhancement of cancer
therapy
*The collaboration with Mendus has been reviewed
for progress and value and was closed in November 2022
Corporate -
other*Ronny Skuggedal was appointed Interim CEO effective
1st June and promoted to CEO effective 1st September 2022. Amir
Snapir, CMO, left the company in September 2022
Ronny Skuggedal, CEO of PCI Biotech, comments:
“The company has during the restructuring process managed to
maintain momentum and focus. The next step for fimaNAc in
dermatological applications is taken to demonstrate
fimaNAc-mediated delivery of a model mRNA in an ex vivo human skin
wound model, acting as a stepping-stone to partnership-driven
development. The bioprocessing project has advanced by further
assessments to narrow down the most promising areas for fimaNAc and
to secure IP. There is a significant need for improvements within
bioprocessing and we believe that our technology has potential to
address challenges within viral manufacturing”
***A live webcast in Norwegian will be held
today, Wednesday 23 November 2022, 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/20221123_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 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 Holding Quarterly Report – Q3
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) on 23 November
2022.
For further information, please contact:Ronny
Skuggedal, CEO / CFOEmail: rs@pcibiotech.noMobile: +47 9400
5757
About PCI
Biotech PCI
Biotech is a biopharmaceutical company focusing 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
fimaVacc
programme 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 subjects. 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.
- PCI Biotech Q3 2022 Interim Report
- PCI Biotech Q3 2022 Presentation
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