PCI Biotech first quarter 2021 interim results

Oslo (Norway), 7 May 2021 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company, today announces its interim Q1 2021 results. Please find enclosed the report and presentation.


*Increased screening and enrolment to RELEASE in Q1 after implementation of the amended protocol and the opening of Asian sites. The full effect of these initiatives is not expected until the Covid-19 situation improves further

*The first US patient was enrolled in the RELEASE study in April

*Continued focus on enrolment of patients into the RELEASE study, with the emphasis going forward being on regular trial management, including performance evaluation and replacement of underperforming sites

*The expected timeline for the planned interim analysis remains in the range from 2H 2022 to 1H 2023

*Successful Phase I vaccination proof of concept study published in the high impact immunology journal, Frontiers in Immunology, demonstrating that fimaVacc enhances the immune response to peptide- and protein-based vaccines in healthy volunteers. The focus going forward is utilising the Phase I results in partnering efforts and planning for clinical proof-of-concept in a disease setting

*Encouraging data on enhanced delivery of mRNA for various medical applications was presented at the UK based 12th Annual RNA Therapeutics Virtual Conference in February 2021

*In May 2021, PCI Biotech entered into an extensive research collaboration with the South Korean company OliX Pharmaceuticals, a leading developer of RNAi therapeutics

Per Walday, CEO of PCI Biotech, comments: “We have seen a good increase in patient screening and enrolment into the RELEASE study in Q1 2021, which is encouraging and supports the relevance of our study optimisation efforts. We expect to see the full force of these modifications when the healthcare systems are no longer afflicted by the pandemic. The situation has been difficult in the US, but an increase in activity during Q1 resulted in the first patient being enrolled in April. We are now fully focused on optimal study performance and progress, with the attention to site performance and management of study specific risks. For fimaVacc, we were pleased to see the successful proof-of-concept study published in the high impact immunology journal, Frontiers in Immunology. The focus going forward is utilising these results in partnering efforts and planning for clinical proof-of-concept in a disease setting. We were proud to present the strong collaborative fimaNAc data at a relevant international conference in February. We will be using these results to draw further attention and interest among relevant players within nucleic acid therapeutics. The broad and exciting collaboration recently announced with OliX Pharmaceuticals in South Korea signifies the strengths of our data and we look forward to exploring synergies between our technologies.”

An online presentation in English will be held today, Friday 7 May 2021, at 08.30am CEST (local time). The presentation can be followed as a live webcast, access through link https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20210507_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 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.

Dialin 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.

Norway +47 2100 2610 / Sweden +46 (0)8 5033 6574 / Denmark +45 35 15 80 49 / United Kingdom +44 (0)330 336 9105 / United States +1 929-477-0402. 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: 5592549        
Event title: PCI Biotech Q1 2021 Conference Call

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 7 May 2021.

For further information, please contact:
Ronny Skuggedal, CFO
Email: rs@pcibiotech.no
Mobile: +47 9400 5757

About PCI Biotech        
PCI Biotech is a biopharmaceutical late stage clinical development company focusing on development and commercialisation of novel therapies for the treatment of cancer through its innovative photochemical internalisation (PCI) technology platform. PCI is applied to three distinct anticancer paradigms: fimaChem (enhancement of chemotherapeutics for localised treatment of cancer), fimaVacc (T-cell induction technology for therapeutic vaccination), and fimaNAc (nucleic acid therapeutics delivery).

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. 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.


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