Pci Biotech Holding Asa · LSE:0JGL
Pci Biotech Holding Asa — Q4 2021 Earnings Presentation
28 slides from Pci Biotech Holding Asa's earnings presentation, Feb 17, 2022
Slide 1: Q4 & Preliminary Full-Year 2021 Presentation
Q4 & Preliminary Enabling Full-Year 2021 intracellular delivery Presentation February 18, 2022 Per Walday, CEO Ronny Skuggedal, CFO www.pcibiotech.com
Slide 2: Teleconference and webcast information
www.pcibiotech.no PCI Biotech This presentation will also be presented through a teleconference, Q&A session mainly facilitated for investors intending to ask questions verbally during the Q&A session. through teleconference If you plan to use this facility, please join the event 5-10 minutes prior
Slide 3: Important notice and disclaimer
www.pcibiotech.no 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 a
Slide 4: Table of Contents
Table of Contents Highlights Operational review Key financials Outlook Q&A www.pcibiotech.com 4
Slide 5: Highlights
Highlights 2021 5
Slide 6: Highlights 2021: fimaCHEM
www.pcibiotech.com Highlights 2021 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
Slide 7: Highlights 2021: fimaVACC
www.pcibiotech.com Highlights 2021 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
Slide 8: Highlights 2021: fimaNAC
www.pcibiotech.com Highlights 2021 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
Slide 9: Highlights 2021: Corporate
www.pcibiotech.com Highlights 2021 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 9
Slide 10: Pipeline
www.pcibiotech.com Pipeline LEVERAGING THE PCI TECHNOLOGY PLATFORM WITHIN IMMUNOTHERAPY & NUCLEIC ACID THERAPEUTICS Development programmes Programme Indications/Therapeutics Preclinical Phase I Phase II Photochemical internalisation (PCI) is a platform technology with two ongoing programmes targetin
Slide 11: Operational review by programme
Operational review by programme 11
Slide 12: fimaCHEM operational review
www.pcibiotech.com fimaCHEM Operational ► Recruitment to the RELEASE study has been closed review following presentation of results from the randomised Phase III TOPAZ-1 study at ASCO GI Jan. 20-22, 2022 ► The TOPAZ-1 study demonstrated that a combination of immune checkpoint inhibition with gemcita
Slide 13: fimaCHEM operational review: trial closure
www.pcibiotech.com fimaCHEM Operational ► Such a change in the standard of care treatment will review 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 populati
Slide 14: fimaVACC: leveraging the PCI platform within immunotherapy
www.pcibiotech.com fimaVACC Leveraging the PCI technology platform within immunotherapy Operational review ► Compelling preclinical results with unique mode of action Particularly strong CD8 T-cell immune responses ► Successfully translated into humans Phase I study in healthy volunteers – resul
Slide 15: fimaVACC: compelling preclinical results
www.pcibiotech.com fimaVACC Compelling preclinical results Operational review - preclinical 15
Slide 16: fimaVACC: versatile vaccination platform
www.pcibiotech.com fimaVACC Versatile vaccination platform Operational ► In January 2022, positive results from preclinical studies review - preclinical on BCG vaccination performed in collaboration with The University of Zurich and ETH Zurich were accepted for publication in Frontiers in Immunology
Slide 17: fimaVACC: Phase I study shows enhanced immune responses
www.pcibiotech.com fimaVACC Phase I study shows enhanced immune responses compared to a state-of-the-art adjuvant Operational review - clinical ► Addition of fimaVACC induces: Substantial increase in number of T-cell responders to HPV E7 peptides CD8 T-cell response Clearly enhanced overall T-ce
Slide 18: fimaVACC: progressing towards Phase II proof-of-concept study
www.pcibiotech.com fimaVACC Progressing towards initiation of a Phase II clinical proof-of-concept study Operational ► Start small and build upon the results review - clinical ► Study in cancer patients with a goal to demonstrate anti-tumour activity ► Recurrent/metastatic head and neck cancer – per
Slide 19: Harness the power of fimaVACC to address unmet medical needs
www.pcibiotech.com fimaVACC Harness the power of fimaVACC to address unmet medical needs Operational review - clinical 19
Slide 20: fimaVACC operational review: status
www.pcibiotech.com fimaVACC Operational ► Ongoing activities focusing on preparation of the study review - status protocol, CMC and operational activities ► A forum of clinical investigators has been established to support the preparations and conduct of the study ► Further information will be annou
Slide 21: fimaNAC: intracellular delivery solution for nucleic acid therapeutics
www.pcibiotech.com fimaNAC Providing an intracellular delivery solution for nucleic acid therapeutics Operational review ► Compelling preclinical results Strong data for a range of nucleic acid therapeutics ► Addressing a major hurdle for this class of drugs Intracellular delivery remains a majo
Slide 22: fimaNAC: strategy
www.pcibiotech.com fimaNAC Operational ► Initial focus will be on easily illuminable clinical review - strategy conditions with supporting preclinical results Skin applications where preclinical experiments suggest substantial enhancement of delivery and transfection, with excellent spatial specif
Slide 23: fimaNAC: status
www.pcibiotech.com fimaNAC Operational ► Encouraging collaborative data on enhanced delivery of mRNA for review - status various medical applications presented at the UK based 12th Annual RNA Therapeutics Virtual Conference The data suggest that fimaNAC provides an appealing intracellular delivery
Slide 24: Research collaborations
www.pcibiotech.com Research collaborations Operational review ► Research collaborations offer valuable scientific knowhow, encouraging results and intellectual property ► Currently six collaborations, spanning across different classes of drugs and therapeutic applications ► The most recently establi
Slide 25: Key financials, Outlook, Q&A
Key financials Outlook Q&A 25
Slide 26: Finance: key financial figures
www.pcibiotech.com Finance ► Estimated financial run-way well into 2023 Current cost base for RELEASE will be reduced over time Closure process for RELEASE under review Potential capital need for next clinical phase of fimaVACC under evaluation ► Decision to close RELEASE is a non-adjusting af
Slide 27: Outlook
www.pcibiotech.com Outlook Enabling intracellular fimaVACC fimaNAC delivery ► Development of treatment applications ► Progressing towards initiation of a Phase II clinical proof of concept study in the most attractive areas for the technology ► Aiming to improve the response to immune checkpoint inh
Slide 28: Q&A
Q&A Enabling intracellular PCI Biotech delivery For enquiries: Per Walday, CEO Mobile phone: +47 917 93 429 E-mail: pw@pcibiotech.com Ronny Skuggedal, CFO Mobile phone: +47 940 05 757 E-mail: rs@pcibiotech.com www.pcibiotech.no 28