Highlights
fimaChem
*Enrolment of patients into the RELASE study is still challenging and fluctuating – Covid-19 has a continued negative impact on the study and with August being a low recruitment month due to the holiday season, only five patients were enrolled in Q3
*Three patients were enrolled into the RELEASE study in October and the company continues to have a strong focus on recruitment, with the emphasis on regular trial management, including overall performance evaluation and site replacement
*Thirty patients have per end of October been included in the RELEASE study and the expected timeline for interim analysis remains 2H 2023
*Proactively pursuing strategies to address recruitment and retention, including interactions with FDA and EMA about an alternative study design
fimaVacc
*The programme is progressing towards initiation of a Phase II clinical proof-of-concept study, with product definition and study design clarified following comprehensive consultations with international experts
fimaNAc
*Development plan initiated based on strategic research and collaborations, targeting applications suited to the specific strengths of the PCI technology
Corporate
*Significantly strengthening the organisation with three highly skilled individuals; an experienced operational leader for RELEASE, and two key employees within clinical science and business development focusing on fimaVacc and fimaNAc
Per Walday, CEO of
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The presentation will be held in English today, Wednesday
Q&A session
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 presentation will also be presented through a teleconference, mainly facilitated for investors intending to ask questions verbally during the Q&A session.
Dial-in details for 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.
When prompted, provide the confirmation code or event title.
Confirmation Code: 7356590
Event title:
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
For further information, please contact:
Email: rs@pcibiotech.no
Mobile: +47 9400 5757
About
Photochemical internalisation induces triggered endosomal release that is used to unlock the true potential of a wide array of therapeutic modalities. The company’s lead programme fimaChem consists of a pivotal study in bile duct cancer, an orphan indication with a high unmet need and without approved products. fimaVacc applies a unique mode of action to enhance the essential cytotoxic effect of therapeutic cancer vaccines, which works in synergy with several other state-of-the-art vaccination technologies. fimaNAc utilises the endosomal release 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.
This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.
Attachments
PCI Biotech Q3 2021 Interim ReportPCI Biotech Q3 2021 Presentation
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