Pci Biotech Holding Asa · LSE:0JGL
Pci Biotech Holding Asa — FY 2024 Earnings Presentation
19 slides from Pci Biotech Holding Asa's earnings presentation, Feb 27, 2025
Slide 1: PCI Biotech - Preliminary full-year 2024 Interim Report
PCI Biotech - Preliminary full-year 2024 Interim Report Presentation February 27, 2025 Ronny Skuggedal, CEO / CFO Morten Luhr, CSO www.pcibiotech.com 1
Slide 2: 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 3: Table of Contents
Table of Contents Operational review - highlights Key financials Outlook Q&A www.pcibiotech.com 3
Slide 4: Improving manufacturing productivity to make AAV gene therapy more accessible
2024 GENE THERAPY – ADVANCED MEDICINAL PRODUCTS WITH GROUNDBREAKING POTENTIAL Bioprocessing Improving manufacturing productivity to make AAV gene therapy more accessible www.pcibiotech.com 4
Slide 5: Gene therapy - advanced medicinal products with groundbreaking potential
2024 GENE THERAPY – ADVANCED MEDICINAL PRODUCTS WITH GROUNDBREAKING POTENTIAL Luxturna Bioprocessing (inherited retinal dystrophy) Image: Charles Njuguna Cause Mutation in the RPE65 gene Severe vision loss from young age, most Symptoms become blind by age 20 Treatment effect Luxturna improves vision
Slide 6: AAV manufacturing: resource-demanding and inefficient
2024 AAV MANUFACTURING: RESOURCE-DEMANDING AND INEFFICIENT Bioprocessing Producer cell Viral vectors Upstream yield Purified viral vector Net yield Manufacturing challenges for viral vectors include host-cell impurities and low viral vector yield from cell lysis, and up to >70% loss of AAV material
Slide 7: Photochemical lysis (PCL) - next generation viral vector extraction
2024 PHOTOCHEMICAL LYSIS (PCL) - NEXT GENERATION VIRAL VECTOR EXTRACTION (LYSIS) Bioprocessing PCL selectively releases viral vectors from producer cells with reduced host-cell impurities compared with the industry standard This novel technology, developed by PCI Biotech, has the potential to increa
Slide 8: Developing a broadly applicable technology
2024 DEVELOPING A BROADLY APPLICABLE TECHNOLOGY Bioprocessing Vessel: Plate Shake-flask Mini benchtop bioreactor Producer cells: Adherent Suspension Suspension AAV8 Field testing + CDMO AAV2 Field testing + CDMO Serotype AAV9 In-house A new shake-flask AAV production lab will advance internal progra
Slide 9: R&D milestones
2024 R&D MILESTONES Bioprocessing Vessel: Plate Shake-flask Mini benchtop bioreactor Producer cells: Adherent Suspension Suspension Important progress has been made in mini benchtop bioreactor in 2024, with results indicating: Photosensitiser is cleared in downstream processing of AAV Photosensitise
Slide 10: R&D milestones: upstream yield and impurities
2024 R&D MILESTONES Upstream yield Upstream impurities Bioprocessing 1.5 2.5×10 5 Host-cell protein (AAV genomes) 1.4 2×10 5 Fold increase (ng/mL) 1.3 1.5×10 5 1.2 1×10 5 1.1 5×10 4 Mini benchtop bioreactor Suspension cells 1.0 0 Standard lysis PCL Standard lysis PCL PCL enhanced upstream yield comp
Slide 11: Roadmap: accelerating the path to commercial manufacturing
2024 ROADMAP: ACCELERATING THE PATH TO COMMERCIAL MANUFACTURING Feasibility Prototype & Research-Use Clinical & Commercial Bioprocessing Compatible with downstream processes Demonstrated upstream scalability Increased net AAV yield Plate Shake-flask Mini benchtop bioreactor Bioreactor (0.5-1 mL) (20
Slide 12: Roadmap: accelerating the path to commercial manufacturing
2024 ROADMAP: ACCELERATING THE PATH TO COMMERCIAL MANUFACTURING Bioprocessing 500x during 2022-2025 500x scale-up of PCL and adaptation to suspension cells has been achieved There are 50 L (and larger) off-the-shelf LED bioreactors suitable for AAV manufacturing 50x 2-year plan Scale-up to 50 L bior
Slide 13: The AAV manufacturing market
2024 THE AAV MANUFACTURING MARKET Bioprocessing 2 1 The manufacturing market is driven by development and success of AAV therapies 1. External market assessment 2. Source: GlobalData www.pcibiotech.com 13
Slide 14: The AAV manufacturing market
2024 THE AAV MANUFACTURING MARKET Bioprocessing 1 PCL may increase AAV batch yield This improves manufacturing productivity, a highly sought-after feature Improvement in batch yield’s impact on PCL asset value is exemplified for 2028 1. External market assessment www.pcibiotech.com 14
Slide 15: Target customers and collaborators
2024 TARGET CUSTOMERS AND COLLABORATORS Upcoming meetings Bioprocessing Target customers Big pharma Biotech CDMOs Universities Key geographies are USA and Europe 1. External market assessment www.pcibiotech.com 15
Slide 16: Key financials, Outlook, Q&A
Key financials Outlook Q&A 16
Slide 17: Finance - FY 2024 key financial figures
Finance FY 2024 Key financial Focus on securing financing for continued development figures Cash position estimated to support operations into Q4 2025 Opportunity window to demonstrate the commercial potential in mini benchtop bioreactor Key figures 2024 Cash at NOK 27m per year-end Incr
Slide 18: Outlook: Advancing manufacturing of gene therapies
Outlook Advancing manufacturing of gene therapies Bioprocessing Goals • Complete early-stage field testing • Demonstrate technology in commercially representative model: Upstream Downstream • Ready for late-stage field testing in 2H 2025 IR New investor presentation and “one-pager” will be available
Slide 19: PCI Biotech - Enabling advanced therapies
Enabling advanced PCI Biotech therapies For enquiries: Ronny Skuggedal, CEO / CFO Mobile phone: +47 940 05 757 E-mail: rs@pcibiotech.com www.pcibiotech.com 19