PCI Biotech

Update on operational implications of the corona pandemic

Oslo, Norway, 25 March, 2020: PCI Biotech (OSE: PCIB) has closely monitored potential implications on its short- and long-term operations following the latest development of the coronavirus pandemic. PCI Biotech’s over-riding priority is the safety of its staff, patients participating in the clinical trial and its collaborators.

The main identified near-term implications concern the RELEASE study in bile duct cancer, a rare disease with no approved treatment alternatives. The pandemic has negatively impacted both the opening of new sites and new patient enrolment into the trial, by postponement of site activation dates, and by the changing priorities and physical constraints that are being implemented at the hospitals as a consequence of the pandemic. Since the Q4 2019 reporting an additional 4 sites have been activated, meaning that 34 of the originally planned 40 sites in Europe and US are currently activated. In addition, PCI Biotech has made regulatory progress in the process of adding Asian sites into the RELEASE study, having secured recently regulatory approval in Taiwan. PCI Biotech has not identified any major short-term shortage in supplies of investigational products and devices for the trial. The main priorities are now identification and implementation of potential mitigating actions for RELEASE study progress during the pandemic, as well as the previously communicated opportunities for removal of unnecessary recruitment hurdles in the study protocol. PCI Biotech has per date of this announcement not a complete picture of the long-term consequences regarding timelines and costs for the RELEASE study, but short-term delays and increased costs are expected. For the fimaVacc and the fimaNAc programmes the main identified implications are short-term downturn in business development activities.

PCI Biotech has a solid cash position, placed in NOK and EUR, and neither the going concern assumption nor the previously reported preliminary full year 2019 figures are impacted by the pandemic as of date of this announcement.

The status update above is based on PCI Biotech’s current assessment of the situation and subject to changes as the situation evolves. PCI Biotech will update the market as appropriate if there are relevant changes to operations.

For further information, please contact:
Per Walday, CEO
Email: [e-mail]
Mobile: [phone]

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