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
*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
*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
*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.”
An online presentation in English will be held today, Wednesday 6 May 2020, at 08.30am CEST (local time). The presentation can be followed as a live webcast (access through link https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20200506_3 ) or the company’s website under “Investors – Reports and presentations – Webcasts”. It will be possible to post questions through the webcast console.
For further information, please contact:
Ronny Skuggedal, CFO
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
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.