PCI Biotech interim first-half year 2022 results
Oslo (Norway), 31 August 2022 – PCI Biotech
(OSE: PCIB), a cancer focused biopharmaceutical company, today
announces its interim first-half year 2022 results. Please find
enclosed the report and presentation.
Highlights
Corporate*The previously
reported 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 PCI Biotech will not conduct a
company-sponsored Ph II trial with the fimaVacc technology
*The company will focus its efforts and
resources on non-clinical research, developing further the current
pipeline opportunities while exploring new fields of use for the
PCI technology utilising fimaVacc for intratumoural immunotherapy,
and fimaNAc for dermatology and bioprocessing applications
fimaVacc –
intratumoural immunotherapy*The results from preclinical studies on
BCG vaccination performed in collaboration with The University of
Zurich and ETH Zurich, published in January this year, strengthened
the understanding of the immunological effects of PCI treatment and
its potential for use in intratumoural immunotherapy
*A Ph.D. candidate grant of up to NOK 2.5
million, commencing 1st January 2023, was received from the
Research Council of Norway. The grant is dedicated to the
development of intratumoural immunotherapy
fimaNAc –
dermatology and bioprocessing*In addition to progressing the
current programs we are now also exploring applications
specifically suited to the strengths of the PCI technology within
bioprocessing
*An overview of PCI Biotech’s proprietary
platform technology for use in the exciting field of mRNA-based
therapies was presented at the TIDES USA 2022 conference in May
fimaChem*The
RELEASE trial was terminated due to changes in the competitive
landscape that rendered the trial challenging to complete and
potentially inadequate for approval. Available data from the
RELEASE trial are insufficient to draw conclusions regarding the
efficacy or safety of the PCI treatment
*The last patient discontinued the study in May
and all clinical sites were closed by the end of June. All major
study closure activities are expected to be completed during Q3.
The closure process has an expected cash effect, from 1st July
2022, of up to NOK -5 million
Collaborations*Preclinical
collaboration established in January with MDimune, developing
innovative drug delivery technologies for modifying cellular and
disease processes
*In August 2022, a preclinical collaboration was
initiated with Mymetics, aiming to explore technological synergies
for possible enhancement of cancer therapy
*All collaborations are reviewed for progress
and value, and priorities have been set. Two of the collaborations
(eTheRNA and Aposense) are closed as a result of this
evaluation
Corporate - other*Per Walday
stepped down as CEO at the end of May 2022. Ronny Skuggedal, CFO,
was appointed Interim CEO effective 1st June, and will be further
promoted to CEO effective from 1st September 2022
*Following the decision to terminate the RELEASE
trial, the clinical organisation was reduced, with last notice
period ending August 2022. The decision not to pursue a company
sponsored fimaVacc Ph II clinical study entails additional
reduction of the clinical team staff, which will be enacted during
the second half of 2022. The CBO, Ludovic Robin, left the company
in May 2022 and the CMO, Amir Snapir, will be leaving the company
in September 2022
*The financial runway is estimated to be into
2024. The company will continue to explore financing and strategic
opportunities as the non-clinical pipeline matures
*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 expertise and experience in
the field of targeted delivery of nucleic acids and protein
therapeutics
Ronny Skuggedal, Interim CEO of PCI Biotech,
comments: “2022 has been challenging and difficult for the company.
As we no longer run clinical projects, the organisation has been
restructured to match the resource needs going forward. We have
started exploring the use of PCI technology for applications within
emerging therapeutic modalities, with opportunities for value
inflection points based on non-clinical data, and where we apply a
partnership-driven development strategy. I’m honoured by the
opportunity to lead PCI Biotech going forward, and to further build
upon our opportunity for future success”
"PCI Biotech is going through a challenging
transformation from being clinically oriented to focusing on
pre-clinical and process development. As interim CEO, Ronny
Skuggedal has demonstrated excellent leadership taking PCI Biotech
through the transition. The Board of Directors is happy that Ronny
has accepted taking the CEO position on a permanent basis and will
lead the restructured and refocused company going forward.", says
Hans Peter Bøhn, Chairperson of the Board of Directors.
***A live webcast in English will be held today,
Wednesday 31 August 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/20220831_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 Holding Half-yearly Report
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 31 August
2022.
For further information, please contact:Ronny
Skuggedal, Interim 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 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 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.
This information is subject to the disclosure
requirements pursuant to section 5-12 of the Norwegian Securities
Trading Act.
- PCI Biotech Q2 Report
- PCI Biotech Q2 Presentation
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