PCI Biotech: Update on operational implications of the corona pandemic

Posted on Mar 25, 2020

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: pw@pcibiotech.no

Mobile: +47 917 93 429

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.