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PCI Biotech interim Q3 2022 report

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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 / CFO
Email: rs@pcibiotech.no
Mobile: +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.

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