PCI Biotech

First quarter 2020 results

Oslo (Norway), 6 May 2020 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company, today announces its interim first quarter 2020 results. Please find enclosed the report and presentation.

Highlights in the quarter

fimaChem
*The main priorities during the COVID-19 pandemic has been identification and implementation of potential mitigating actions for the RELEASE study progress, as well as identification and removal of unnecessary recruitment hurdles in the study protocol. PCI Biotech has not yet a complete picture of the consequences for the RELEASE study, but delays in patient recruitment and increased costs are expected

*Several new initiatives to recoup long-term recruitment projections are being implemented, including potential modifications to screening parameters and further expansion into new countries. These new initiatives are being implemented to accelerate patient inclusion when the current restrictions of the COVID-19 pandemic are resolved, with the aim to reach interim analysis by Q2 2022. It is however currently not clear that the cash-position will suffice to reach interim read of the RELEASE trial, given the uncertainty surrounding long-term consequences of the unprecedented situation with the COVID-19 pandemic

*The majority of sites have halted or reduced patient screening and we are still awaiting enrolment of the first US patient. Site activations are delayed, but nonetheless 1 European and 3 US RELEASE study sites have opened since the Q4 2019 report. 34 of the 40 initially planned sites were open by end-April 2020

*Site preparations are ongoing for addition of Asian sites in 2020, to provide access to hospitals and KOL’s in a region with higher prevalence of bile duct cancer and to enhance patient recruitment. So far progress has not been significantly impacted by the COVID-19 pandemic and regulatory approval has been achieved in Taiwan

fimaVacc
*Two US patents granted in 2020 with broad coverage for the combination of fimaVacc with various cytokines and a new important class of adjuvants

*A two-pronged development strategy is pursued, with Phase I results being used both in direct partnering efforts and planning for clinical proof of concept in a disease setting

Corporate
*The management team has been strengthened with appointment of CMO Dr Amir Snapir and CBO Mr Ludovic Robin

Per Walday, CEO of PCI Biotech, comments: “The COVID-19 pandemic has temporarily changed the ways of working and the clinical trial environment dramatically, and our highest priority in this unprecedented situation is the safety of our patients, employees and collaborators. This pandemic will result in yet undeterminable delays and increased cost, but it is encouraging to witness the working spirit and the progress being achieved despite these unfortunate circumstances. Four RELEASE study sites have opened since the Q4 2019 report and regulatory/ethics approval has been granted in Taiwan. Two very important fimaVacc patents have also been granted in the US. We are very pleased to have strengthened the executive team with two very competent and experienced individuals: Dr Amir Snapir as CMO and Mr Ludovic Robin as CBO. We are now focusing our efforts to ensure that we are optimally prepared to accelerate development when the COVID-19 restrictions are lifted.”