PCI Biotech interim first quarter 2022 results
Oslo (Norway), 11 May 2022 – PCI Biotech (OSE:
PCIB), a cancer focused biopharmaceutical company, today announces
its interim Q1 2022 results. Please find enclosed the report and
presentation.
Highlights
fimaVacc*The
programme is progressing towards initiation of a Phase II clinical
proof-of-concept study
*Established group of international clinical
experts to provide clinical guidance and support the development
and performance of the trial
*Good project readiness – preparation of
clinical trial application and sourcing of study treatments
ongoing, and selection of clinical sites in EU5 started
fimaNAc*Progressing the focused
development plan, targeting applications suited to the specific
strengths of the PCI technology
*Established a preclinical collaboration with
the South Korean company MDimune, developing innovative drug
delivery technologies for modifying cellular and disease
processes
fimaChem*The
RELEASE trial was closed to recruitment in January 2022 due to
changes in the competitor situation that renders the trial
challenging to complete and potentially inadequate for approval
*Available data from the RELEASE trial have been
reviewed – there is not sufficient data to show differences between
the treatment arms and last patient will leave the study in May 10,
2022
*RELEASE will be closed as quickly as possible,
with an expected future cash effect of up to NOK -10 million
Corporate*Per Walday will step
down as CEO at the end of May 2022 and Ronny Skuggedal, CFO, is
appointed as Interim CEO effective 1st June
*The CBO, Ludovic Robin, will leave the company
in May 2022
*The organisation has been reduced by 4 FTE
(25%), with notice periods ending during Q2. The financial runway,
with current commitments, is estimated to be towards the end of
2023
*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 distinguished expertise and
experience in the field of targeted delivery of nucleic acids and
protein therapeutics
Per Walday, CEO of PCI Biotech, comments: “The
company is now fully focused on the progress of the fimaVacc
programme. The planned next step is a clinical Phase 2
proof-of-concept study in recurrent/metastatic head and neck
cancer, which has been discussed and endorsed by a core group of
international clinical experts and key opinion leaders within head
and neck cancer and immunotherapy. Manufacturing and sourcing of
study treatments for this exciting project is well underway, and
selection of clinical sites has started.
Results from the RELEASE study that was closed
to recruitment in January have been analysed but the data were
insufficient to allow a conclusion on potential differences between
the treatment arms. The study is therefore being closed as quickly
and cost efficiently as possible without further follow-up of
patients. The organisation of PCI Biotech has been reduced
accordingly to fit the resource need going forward.
Ronny Skuggedal, CFO, will take the helm of PCI
Biotech from 1st June as Interim CEO. The company has a
well-functioning and competent team and an exciting technology
platform with strong data supporting applications within emerging
therapeutic modalities. I am confident that the team will succeed
in delivering value to both patients and shareholders, and I will
follow the company’s path and progress closely. I would like to
take this opportunity to thank all our shareholders, the board, our
collaborators, and not least the fantastic team at PCI Biotech for
their trust and support during my tenure.”
"On behalf of the entire company, I wish Dr
Walday all the best in his new endeavours and sincerely thank him
for his 14 years period as CEO of PCI Biotech. Per will surely be
missed by us all. At the same time we are happy to have Ronny
Skuggedal take over as interim CEO, setting the scene for stability
and continuity going forward.", says Hans Peter Bøhn, Chairperson
of the Board of Directors.
***A live webcast in English will be held today,
Wednesday 11 May 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/20220511_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 Quarterly Report - Q1
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 11 May
2022.
For further information, please contact:Ronny
Skuggedal, CFOEmail: rs@pcibiotech.noMobile: +47 9400 5757
About PCI
Biotech PCI
Biotech is a biopharmaceutical clinical stage development 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 company’s lead programme fimaVacc 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 volunteers and a
Phase II study is in planning with the aim to demonstrate
enhancement of immunotherapy for treatment of solid tumours. 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 Q1 2022 Report
- PCI Biotech Q1 2022 Presentation
Pci Biotech Holding Asa (LSE:0JGL)
Gráfica de Acción Histórica
De Oct 2023 a Nov 2023
Pci Biotech Holding Asa (LSE:0JGL)
Gráfica de Acción Histórica
De Nov 2022 a Nov 2023
