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PCI Biotech fourth quarter and preliminary full year 2020 results

Oslo (Norway), 24 February 2021 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company, today announces its interim Q4 and preliminary full year 2020 results. Please find enclosed the report and presentation.
Highlights

fimaChem
*The first Asian patient was enrolled in the RELEASE study in South Korea in October, less than three months after opening of the first study site in Asia. All the nine planned study sites in South Korea and Taiwan have been opened, with initial good screening activity

*Several initiatives have been implemented in the RELEASE study to recoup long-term recruitment projections. Besides going into Asia, the most important initiatives are the protocol amendment made to expand the eligible patient population and the addition of new clinical sites

*A total of 47 RELEASE study sites are open by end-January 2021 across EU, US and Asia and all these sites are operating under the amended protocol

*The second wave of the Covid-19 pandemic is still having a severe impact in many countries, and the full consequences of the pandemic and the recruitment initiatives for the RELEASE study cannot yet be fully established. We are seeing indications of increased screening and enrolment after implementation of the new amended protocol and the opening of Asian sites, although we do not expect to see the full effect of these initiatives until the Covid-19 situation improves

*The company continues to have full focus on enrolment of patients into the RELEASE study. The expected timeline for the planned interim analysis remains in the range from 2H 2022 to 1H 2023

*European patent for treatment of bile duct cancer granted. The patent provides an extended protection of the intended use of fimaChem lasting several years beyond the potential market exclusivity offered by the orphan drug designation

*In November a case report series from the Phase I study was published in Endoscopy International Open, providing detailed descriptions of treatment effects in three select patients at the dose chosen for the RELEASE study

fimaVacc
*Successful Phase I vaccination proof of concept study published in high impact immunology journal, demonstrating that fimaVacc enhances the immune response to peptide- and protein based vaccines in healthy volunteers

fimaNAc
*In October 2020 PCI Biotech was informed that AstraZeneca elected not to enter into a definitive agreement for the fimaNAc technology. Encouraging preclinical results have been achieved with fimaNAc in this collaboration and the decision not to enter into a definitive agreement is primarily based on a strategic evaluation by AstraZeneca of their current development priorities

*In February 2021 PCI Biotech presented the encouraging mRNA data from this collaboration at the UK based 12th Annual RNA Therapeutics Virtual Conference

2020 in review - expanding and optimising the RELEASE study
The Covid-19 pandemic has affected all aspects of business and life, and accentuated the importance of being adaptive and agile in response to changes. For PCI Biotech, with a global pivotal study open in many of the countries most affected by the pandemic, the greatest impact has been on clinical study progress in the fimaChem programme. The main focus during the year has therefore been on mitigating the effects of the pandemic by both optimising and expanding the pivotal RELEASE study, with the aim to minimise the delays inflicted by the pandemic. The early period of the pandemic was used to analyse eligibility failure logs and review investigator feedback on study design and procedures. The study protocol was thereafter amended, and an optimised protocol implemented during the autumn 2020. The expansion to include new countries and sites have run in parallel and the RELEASE study now spans across 47 sites. The expansion to Asia has shown initial good screening and enrolment. The study communication has also been strengthened, both by the establishment of several online tools, interaction with patient organisations and publication of case reports. We expect to see the full effect of these efforts when the Covid-19 vaccination starts to reduce the effect of the pandemic on the healthcare systems.
The foundation of the fimaVacc programme has been reinforced by the granting of two key patents in the US, providing protection for the combination with two important classes of immunomodulators commonly used in the development of vaccines. The publication of the Phase I results in a high-impact immunology journal was another important fimaVacc milestone. The focus is now on utilising the Phase I results in partnering efforts and planning for clinical proof-of-concept in a disease setting.
The fimaNAc collaboration with AstraZeneca ended in 2020, but it has produced important data for the further development of this platform. The results, which were recently presented at a conference on RNA therapeutics, suggest that the fimaNAc technology provides an appealing intracellular delivery solution for certain applications within this class of therapeutics. The rapid development progress of mRNA-based vaccines against Covid-19 has generated a lot of attention to the potential of this class of drugs and we will now focus our efforts towards the most attractive opportunities.
On the corporate side, the medical and business development areas of the organisation have been further strengthened by the appointment of Dr. Amir Snapir as CMO and Mr. Ludovic Robin as CBO. The organisation will continue to be reinforced as we are pursuing multiple potential business opportunities.

***
An online presentation in English will be held today, Wednesday 24 February 2021, at 08.30am CET (local time). The presentation can be followed as a live webcast, access through link https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20210224_2 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.

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.

Norway +47 2350 0296 / Sweden +46 (0)8 5065 3942 / Denmark +45 35 15 81 21 / United Kingdom +44 (0)330 336 9411 / 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: 9072639     
Event title: PCI Biotech Q4 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 (CET) on 24 February 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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