PCI Biotech fourth quarter and preliminary full year 2021 results

Oslo (Norway), 18 February 2022 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company, today announces its interim Q4 and preliminary full-year 2021 results. Please find enclosed the report and presentation.

Highlights

fimaChem
*The RELEASE trial was closed to recruitment in January 2022 due to changes in the competitor situation that renders the trial challenging to complete and potentially inadequate for approval

*Approximately 30% of the 41 enrolled patients will continue to receive study treatments for up to 6 months, enabling a swift wind-down of the trial

*The trial results will be analysed to evaluate how the data can be utilised going forward

fimaVacc
*The programme is progressing towards initiation of a Phase II clinical proof-of-concept study, with product definition and overall study design clarified following comprehensive consultations with international experts

*US patent granted for the use of fimaVACC in combination with immune checkpoint inhibitors

fimaNAc
*Focused development plan initiated based on strategic research and collaborations, targeting applications suited to the specific strengths of the PCI technology

*Encouraging data on enhanced delivery of mRNA for various medical applications presented at the UK based 12th Annual RNA Therapeutics Virtual Conference

*Established extensive research collaboration with the South Korean company OliX Pharmaceuticals, a leading developer of RNAi therapeutics

*In January 2022, PCI Biotech entered into a preclinical collaboration with the South Korean company MDimune, developing innovative drug delivery technologies for modifying cellular and disease processes

Corporate
*Significantly strengthened the organisation with three highly skilled individuals; an experienced clinical operational leader, and two key employees within clinical science and business development focusing on fimaVACC and fimaNAC

2021 in review – managing RELEASE and preparing the ground for fimaVACC
A lot of effort was put into accelerating the RELEASE study in bile duct cancer last year, as the Covid-19 pandemic continued to have a strong negative impact on study progress with fluctuating recruitment through the year. The strong efforts resulted in enhanced screening and enrolment of bile duct cancer patients towards the end of the year, with the ambitious target of 12 patients included per quarter being reached in Q4. However, the clinical performability and business opportunity for the RELEASE programme changed radically when a clinical pivotal study with an immune checkpoint inhibitor reported overall positive results, with clinically meaningful benefit on progression free survival and overall survival. The results presented at ASCO GI in January 2022 showed significant clinical benefit in the RELEASE patient population. This is expected to quickly change the standard of care for these patients. These results are positive news for patients but will unfortunately render the RELEASE study challenging to complete, and the study was therefore terminated late January 2022. Stopping RELEASE was a hard decision to make and we would like to thank all contributors to the study. It 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. We are now focusing on a swift and cost-effective closing of the study, whilst ensuring that any potential residual value is captured.
The fimaVACC programme is progressing towards manufacturing of a defined vaccine product and the next clinical phase. It is now the lead programme in the company and a group of international expert investigators has been established to support the development. The aim is to combine the fimaVACC technology with relevant immunomodulation therapy, initially focusing on the most apposite indication before a potential broadening of the deployment of this versatile platform. To this end, another important patent was added to the fimaVACC IP portfolio by the US granting a patent covering combination with relevant immune checkpoint inhibitors. Positive collaborative data for the fimaNAc technology for intracellular delivery of nucleic acid therapeutics were presented last year. These data have helped boosting further interest in the fimaNAc technology and two collaborations were initiated with South Korean companies. Last year, a strategic review of the fimaNAc technology and collaborative opportunities resulted in the initiation of a focused development plan targeting applications suited to the specific strengths of the technology. The organisation was also reinforced with specific expertise to support the further development of both fimaVACC and fimaNAc.

***
A presentation in English will be held today, Friday 18 February 2022, at Oslo Cancer Cluster Innovation Park.

Time: Friday 18 February, 08:30am – 09:30am CET (local time).
Venue: Jónas Einarsson aud. (2nd floor, entrance 2B), Oslo Cancer Cluster Innovation Park, Ullernchausséen 64, Oslo.

The presentation can be followed as a live webcast, access through link https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20220218_2 or the company’s website under “Investors – Reports and presentations – Webcasts”.

Q&A session        
There will be a Q&A session at the end of the presentation and it will be possible to post written questions through the webcast console. The presentation will also be presented through a teleconference, mainly facilitated for investors intending to ask questions verbally during the Q&A session.

Dial–in details for teleconference, mainly facilitated for verbal questions during Q&A session:
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 below. A line mediator will provide information on how to ask questions.

Norway +47 2195 6342 / Sweden +46 40682 0620 / Denmark +45 7876 8490 / United Kingdom +44 203 7696 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: Quarterly Report – Q4

The interim report and the presentation will also be available on www.newsweb.no and on the company’s webpage, www.pcibiotech.com from 07:00am (CET) on 18 February 2022.

For further information, please contact:
Ronny Skuggedal, CFO
Email: rs@pcibiotech.no
Mobile: +47 9400 5757

About PCI Biotech        
PCI Biotech is a biopharmaceutical clinical stage development company focusing on development and commercialisation of novel therapies for the treatment of cancer through its innovative photochemical internalisation (PCI) technology platform. PCI induces triggered endosomal release that is used to unlock the true potential of therapeutic modalities.

The company’s lead programme fimaVACC aims to enhance immunotherapy in cancer, by triggered endosomal release of antigens or nucleic acids encoding antigens, or immunostimulatory factors. Enhancement of relevant immune responses with protein- and peptide-based vaccines were successfully demonstrated in humans through an extensive Phase I study in healthy volunteers and a Phase II study is in planning with the aim to demonstrate enhancement of immunotherapy for treatment of solid tumours. In the fimaNAC programme endosomal release is utilised 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.

Attachments

• PCI Biotech Q4 2021 Interim Report
• PCI Biotech Q4 2021 Presentation