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.
*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
*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
*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”.
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 / CFO
Mobile: +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
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.