PCI Biotech: Update on the RELEASE trial

Oslo (Norway), 24 January 2022 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company, today announced that the company has decided to stop the RELEASE study and focus their drug development efforts on the promising immunotherapy opportunities with both fimaVacc and fimaNAc assets.

The decision to stop the RELEASE study is based on recent randomised Phase III clinical trial results presented at the American Society of Clinical Oncology Gastrointestinal Cancer Symposium (ASCO GI, January 20-22, 2022) from the TOPAZ-1 study, demonstrating that a combination of immune checkpoint inhibition with gemcitabine and cisplatin provides a significant survival benefit to patients with advanced biliary tract cancer compared with placebo plus gemcitabine and cisplatin. These results are expected to rapidly change the first line standard treatment for patients with unresectable perihilar or distal bile duct cancer, which is the intended patient population of the RELEASE trial. Such a change in the standard of care treatment will render the RELEASE trial challenging to complete and potentially inadequate for approval and will significantly diminish the opportunity for PCI Biotech’s treatment approach in this patient population.

The impact on the RELEASE trial of the recent clinical trial results presented at ASCO GI has been discussed with key opinion leaders, confirming an expected rapid change and early adoption of immunotherapy plus chemotherapy as the new standard of care treatment for the RELEASE trial’s target population.

Per Walday, CEO of PCI Biotech said: “The significant survival benefit from the combination of immunotherapy with chemotherapy is great news for patients. Previous results from studies with immunotherapy in extrahepatic bile duct cancer have not been compelling, and therefore a significant benefit on overall survival in this population was not expected. Stopping RELEASE was a hard decision to make, but it is necessary to act decisively when the competitive landscape shifts. The RELEASE trial has been a tremendous effort, not least by the enrolled patients, the clinical sites, and our investors, willing to contribute to the benefit of future patients and their relatives.

PCI Biotech’s cash position at year-end 2021 is around NOK 115 million, and we will now focus on a cost-efficient closing process of RELEASE and bringing our promising fimaVacc vaccination technology forward as lead asset, and further develop fimaNAc in the emerging field of nucleic acid therapy”.

The RELEASE trial enrolled a total of 41 patients, of which around 30% will continue to receive the study treatments for a duration of up to six months. This should enable a swift wind-down of RELEASE, allowing PCI Biotech to reallocate resources to the other drug development programmes. The company will analyse the results of RELEASE and evaluate how these can be utilised for fimaChem going forward.

PCI Biotech will in due course communicate more information on the next steps for the promising fimaVacc and fimaNAc assets. The fimaVacc technology with a peptide-based vaccine is planned to enter a Phase II proof-of-concept development stage in cancer patients, following the encouraging immune response results in Phase I. Detailed plans for the further development of the fimaNAc asset have been prepared, supported by strong preclinical results in the emerging field of nucleic acid therapeutics.

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PCI Biotech will host a webcast at 14:00 CET (local time) on Tuesday, January 25, elaborating on the strategic decision to stop RELEASE including a Q&A session. The webcast will be hosted by CEO Per Walday, CMO Amir Snapir and CFO Ronny Skuggedal. The Chairman of the Board, Hans Peter Bøhn will also be present. The webcast will be held in English and can be accessed through this link https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20220125_2.

There will be a Q&A session at the end of the webcast and written questions can be posted to post@pcibiotech.com prior to the event or via the webcast console during the event. For those who intend to ask verbal questions please see the dial-in details below.

Norway +47 2195 6342 / Sweden +46 (0)40682 0620 / Denmark +45 7876 8490 / United Kingdom +44 2037 696 819 / United States +1 646 787 0157. 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: 436187        

Event title: PCI Biotech conference call

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. A line mediator will provide information on how to ask questions.

For further information, please contact:                Per Walday, CEO        Email: pw@pcibiotech.no        Mobile: +47 917 93 429

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 considered to be inside information pursuant to the EU Market Abuse Regulation and is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act. This stock exchange announcement was published by Ronny Skuggedal, CFO, PCI Biotech Holding ASA, on 24 January 2022.

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