Pci Biotech Holding Asa · LSE:0JGL
Pci Biotech Holding Asa — Q2 2022 Earnings Presentation
25 slides from Pci Biotech Holding Asa's earnings presentation, Aug 30, 2022
Slide 1: PCI Biotech - Q2 and 1H 2022 Interim Report
PCI Biotech - Enabling intracellular Q2 and 1H 2022 Interim Report delivery Presentation August 31, 2022 Ronny Skuggedal, Interim CEO / CFO Morten Luhr, BD and Scientific Alliance Manager www.pcibiotech.com
Slide 2: Q&A session through teleconference and webcast console
PCI Biotech Q&A session through teleconference and webcast console This presentation will also be presented through a teleconference, mainly facilitated for attendees intending to ask questions verbally during the Q&A session. If you plan to use this facility, please join the event 5-10 minutes prio
Slide 3: Important notice and disclaimer
PCI Biotech Important notice and disclaimer This presentation may contain certain forward-looking Factors that could cause these differences include, but are not limited to, statements and forecasts based on uncertainty, since they implementation of PCI Biotech’s strategy and its ability to further
Slide 4: Table of Contents
Table of Contents Highlights Operational review Key financials Outlook www.pcibiotech.com 4
Slide 5: Highlights 1H 2022: Corporate
Highlights 1H 2022 The reported efforts to finance a Ph II clinical trial did not under the current market conditions Corporate result in a feasible way forward. PCI Biotech will not conduct a company-sponsored Ph II trial with the fimaVACC technology Focus efforts and resources on non-clinical
Slide 6: Highlights 1H 2022: fimaVACC
Highlights 1H 2022 fimaVACC ► The results from preclinical studies on BCG vaccination performed in Intratumoural collaboration with the University of Zurich and ETH Zurich, strengthened immunotherapy the understanding of the immunological effects of PCI treatment and its potential for use in intratu
Slide 7: Highlights 1H 2022: fimaNAC
Highlights 1H 2022 fimaNAC Focused development for applications specifically suited to the strengths of Dermatology the PCI technology Bioprocessing Dermatology Bioprocessing The platform technology for use in the exciting field of mRNA-based therapies was presented at the TIDES USA 2022 con
Slide 8: Highlights 1H 2022: fimaCHEM
Highlights 1H 2022 fimaCHEM RELEASE terminated due to changes in the competitive landscape that rendered the trial challenging to complete and potentially inadequate for approval Available data are insufficient to draw conclusions regarding the efficacy or safety of the PCI treatment All major
Slide 9: Highlights 1H 2022: Collaborations
Highlights 1H 2022 Collaborations Preclinical collaboration established in January with MDimune, developing innovative drug delivery technologies for modifying cellular and disease processes In August 2022, a preclinical collaboration was initiated with Mymetics, aiming to explore technological
Slide 10: Operational review
Operational review CxXFiot0cn 10
Slide 11: fimaVACC: Leveraging intratumoural immunotherapy
fimaVACC Leveraging intratumoural immunotherapy to achieve a Operational systemic anti-tumour immune response review ► Despite representing a major breakthrough in cancer treatment, a large proportion of patients do not respond to immune checkpoint inhibitors (ICIs) or progress shortly after initial
Slide 12: fimaVACC: Treat locally, act globally
fimaVACC Leveraging intratumoural immunotherapy to achieve a Operational systemic anti-tumour immune response review “Treat locally – act globally” ► For intratumoural treatment, systemic adverse effects are limited, enabling combination treatments not feasible with systemic treatment ► Therapy may
Slide 13: Intratumoural therapy with fimaVACC gives systemic anti-tumour immune response
fimaVACC Intratumoural therapy with fimaVACC gives systemic anti-tumour immune response ► In animal studies, fimaVACC gives a very good effect Operational with intratumoural vaccination, also on untreated review tumour lesions Intratumoural vaccination in animals with two tumours. ► fimaVACC has sho
Slide 14: fimaNAC: Delivery of nucleic acids to skin
fimaNAC Delivery of nucleic acids to skin Operational review Chronic skin ulcers (e.g. diabetic ulcers) have unmet medical need Often complex biology that can benefit greatly from the ability of nucleic acid therapies to affect gene mutations, gene regulation and tissue developmental (regenerati
Slide 15: fimaNAC for delivery of nucleic acids to skin
fimaNAC IVIS imaging after i.d. inj. of luciferase mRNA and subsequent i.v. inj. of the substrate luciferin Operational fimaNAC for delivery of nucleic acids to skin review Data from animal experiments indicate that fimaNAC can strongly enhance Control PCI nucleic acid delivery in the skin Enzymat
Slide 16: fimaNAC: Bioprocessing
fimaNAC Bioprocessing - Manufacturing capacity is a major limiting factor Operational to treating more patients review Markets: Rapid growth Cell culture Short time to market Cell and gene therapy Cost-effective development Urgent need for novel technology Viral manufacturing fimaNAC has shown promi
Slide 17: fimaNAC in vitro data transferrable to bioprocessing
fimaNAC fimaNAC in vitro data is highly transferrable to bioprocessing Operational review fimaNAC Nucleic acids successfully delivered by fimaNAC (In vitro) Bioprocessing Type of Delivery vehicle nucleic acid PEI, cationic peptides, cationic lipids, polylysine ++ Plasmids Targeting to EGF-R, transfe
Slide 18: fimaNAC: Capitalising on developments
fimaNAC Capitalising on developments Operational review Feasibility Prototype Perform in-house Partnership-driven development Pursue multiple applications Targets: Biotech Contract development and manufacturing organisations (CDMOs, CMOs) Programme Application Feasibility Prototype Comme
Slide 19: fimaCHEM: RELEASE study terminated
fimaCHEM Operational RELEASE study terminated review Expected rapid change in SoC trial challenging to complete and likely inadequate for approval Available data reviewed Radiographic data from 34 out of 41 enrolled patients evaluated for PFS/ORR Data are insufficient to allow drawing co
Slide 20: Research collaborations
Research collaborations (formerly Immunicum) Offer valuable scientific knowhow, encouraging results and intellectual property Collaborations span different classes of drugs and applications Two collaborations closed and two new established in 2022 PCI Biotech continues to pursue new and valu
Slide 21: Corporate, Key financials, Outlook
Corporate Key financials Outlook Q&A 21
Slide 22: Corporate: Organisational changes
Corporate Organisational Organisational changes changes Consolidation of management team • Former CEO and CBO left in May • CMO to leave in September • Ronny Skuggedal, CFO and CEO effective 1st September R&D team fit for purpose • Downsizing of clinical team to be enacted during 2H 2022 www.p
Slide 23: Finance
Finance ► Financial run-way estimated into 2024 RELEASE closure, estimated future cash effect up to NOK -5 million Organisational changes will further reduce costs over time Explore financing and strategic opportunities as non-clinical pipeline matures Key financial figures (figures in NOK 1,0
Slide 24: Outlook
Outlook Leveraging the PCI technology platform within immunotherapy, nucleic acid therapeutics, and bioprocessing Enabling Programme Therapeutics Preclinical Phase 1 Phase 2 intracellular delivery Intratumoural fimaVACC immunotherapy fimaNAC Dermatology Programme Application Feasibility Prototype Co
Slide 25: PCI Biotech
Enabling intracellular PCI Biotech delivery For enquiries: Ronny Skuggedal, CFO Mobile phone: +47 940 05 757 E-mail: rs@pcibiotech.com www.pcibiotech.com 25