PCI Biotech third quarter 2020 results

Oslo (Norway), 11 November 2020 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company, today announces its interim Q3 2020 results. Please find enclosed the report and presentation.

Highlights

fimaChem

*The first patient has been enrolled in the RELEASE study in South Korea, less than three months after opening of the first study site in Asia. All the nine planned study sites in South Korea and Taiwan are now open, with initial good screening activity

*Several initiatives are being implemented in the RELEASE study to recoup long-term recruitment projections. Besides going into Asia, the most important initiative is the protocol amendment made to expand the eligible patient population. Full approvals of the protocol amendment are received in 10 European countries, South Korea, Taiwan and US. Seven sites are pending local ethic approvals and the focus is now on achieving the remaining approvals

*A total of 45 RELEASE study sites are open by end-October 2020 across EU, US and Asia and 38 of these sites are open under the new amended protocol

*The consequences of the COVID-19 pandemic and the new recruitment initiatives for the RELEASE study cannot yet be fully established. The second wave of the pandemic is currently sweeping over many countries, but we are seeing early indications of increased screening activity after implementation of the new amended protocol and the opening of Asian sites. The situation is more uncertain in the US and the implementation of the new amendment by local ethics is still pending at most sites, so first patient enrolled in the US may slide into 2021

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

fimaVacc

*A new research collaboration is established with DCprime to explore novel cancer vaccination concepts. DCprime is a clinical stage, privately held cancer immunotherapy focused company and the companies will perform an extensive evaluation of technology compatibility and synergy based on preclinical studies. The results will be evaluated and explored for the potential for further development and partnership

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 continued to be achieved with the fimaNAC platform in this collaboration and the decision not to enter into a definitive agreement is primarily based on a strategic evaluation by AstraZeneca’s of their current development needs. The companies will work together to publish the preclinical results from this collaboration

Per Walday, CEO of PCI Biotech, comments: “The RELEASE screening activities have increased since the summer and I am very pleased with the efforts and good progress made by the organisation to ensure an optimised RELEASE study. With the first patient already enrolled in Asia and most of the sites screening for patients under the new amended protocol, we are now well positioned to accelerate the RELEASE study. We are already seeing early indications of increased screening activity, but it remains to be seen how the second wave of the COVID-19 pandemic will affect further progress. We were disappointed that AZ did not elect to enter into a definitive agreement. This collaboration has however provided us with positive results and important knowhow. We are confident in the potential of the fimaNAc technology and will use these data and learnings to further enhance and promote the technology. We have also established a new broad and exciting research collaboration with DCprime spanning both fimaVacc and fimaNAc, and we look forward to exploring synergies between our technologies.”

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An online presentation in English will be held today, Wednesday 11 November 2020, at 08.30am CET (local time). The presentation can be followed as a live webcast (access through link ) 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 asking questions verbally 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 / Sweden +46 (0)8 5033 6574 / Denmark / United Kingdom +44 (0)330 336 9125 / United States . 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: 2202572     

Event title: PCI Biotech Holding ASA Q3 conference call

The interim report and the presentation will also be available on and on the company's webpage,  from 07:00am (CET) on 11 November 2020.

For further information, please contact:

Ronny Skuggedal, CFO

Email:

Mobile:

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:                        

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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