Pci Biotech Holding Asa · LSE:0JGL
Pci Biotech Holding Asa — Q1 2021 Earnings Presentation
29 slides from Pci Biotech Holding Asa's earnings presentation, May 7, 2021
Slide 1: PCI Biotech Q1 2021 Presentation
PCI Biotech Enabling intracellular delivery Q1 2021 PRESENTATION May 7, 2021 Per Walday, CEO Ronny Skuggedal, CFO 1
Slide 2: Important notice and disclaimer
PCI BIOTECH Important notice and disclaimer This presentation may contain certain forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on PCI Biotech’s bu
Slide 3: 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 investors intending to ask questions verbally during the Q&A session. If you plan to use this facility, please join the event 5-10 minutes pr
Slide 4: A biotech company with an oncology focused pipeline
PCI BIOTECH – ENABLING INTRACELLULAR DELIVERY A biotech company with an oncology focused pipeline Programme Indications/Therapeutics Preclinical Phase I Phase II Pivotal Photochemical internalisation (PCI) is a platform technology with three programmes targeting an attractive and growing oncology
Slide 5: PCI Technology – Mode of Action
PCI TECHNOLOGY – MODE OF ACTION Enabling drugs to reach intracellular therapeutic targets 5
Slide 6: PCI Technology – Enabling drugs to reach intracellular targets
PCI TECHNOLOGY Enabling drugs to reach intracellular therapeutic targets PCI – the solution to a key challenge for several modalities 6
Slide 7: Q1 2021 Highlights – fimaCHEM RELEASE first US patient
Q1 2021 HIGHLIGHTS fimaCHEM RELEASE – first patient included in US ► Increased screening and enrolment to RELEASE in Q1 after implementation of the amended protocol and the opening of Asian sites ► The full effect of these study optimisation initiatives is not expected until the Covid-19 situation
Slide 8: Q1 2021 Highlights – fimaCHEM enrolment and timeline
Q1 2021 HIGHLIGHTS fimaCHEM RELEASE – first patient included in US ► Continued focus on enrolment of patients into the RELEASE study, with the emphasis going forward being on regular trial management, including performance evaluation and replacement of underperforming sites ► The expected timeline
Slide 9: Q1 2021 Highlights – fimaVACC
Q1 2021 HIGHLIGHTS fimaVACC ► Successful Phase I vaccination proof of concept study published in the high impact immunology journal, Frontiers in Immunology ► The published data demonstrates that fimaVACC enhances the immune response to peptide- and protein-based vaccines in healthy volunteers ► T
Slide 10: Q1 2021 Highlights – fimaNAC
Q1 2021 HIGHLIGHTS fimaNAC ► Encouraging data on enhanced delivery of mRNA for various medical applications was presented at the UK based 12th Annual RNA Therapeutics Virtual Conference in February 2021 ► In May 2021, PCI Biotech entered into an extensive research collaboration with the South Kore
Slide 11: fimaCHEM – first line treatment for bile duct cancer
fimaCHEM PCI BIOTECH fimaCHEM – first line treatment for the orphan indication bile duct cancer Positive early clinical results ▪ Encouraging tumour response and survival data Pathway to market settled by regulatory interactions ▪ Single pivotal study with potential accelerated approval based on i
Slide 12: fimaCHEM – Excellent fit with medical need and existing treatments
fimaCHEM fimaCHEM Excellent fit with medical need and existing treatments ► Efficacy: mOS1 of 22.8 months at selected dose (cohort IV) in Phase I dose-escalation (vs. 11-12 months2 with SoC for inoperable CCA treatments) ► Easy to use: Illumination through standard endoscopic methods compatible wi
Slide 13: Bile Duct Cancer – RELEASE Study
fimaCHEM BILE DUCT CANCER – RELEASE STUDY Pivotal study with potential accelerated/conditional approval on interim analysis • Rare disease • Majority of cases are inoperable upon presentation • Median overall survival of less than one year • No approved treatment, limited development pipeline • Ap
Slide 14: RELEASE Study – Pivotal study status
fimaCHEM BILE DUCT CANCER – RELEASE STUDY USA Pivotal study status ► Open sites in South Korea, Taiwan, USA and 11 European South Taiwan countries Korea ► 46 sites currently open for patient enrolment – plan to have approximately 50 ► 9 sites open in Asia – first Asian patient enrolled Oct’20 ► 6
Slide 15: RELEASE Study – Pivotal study progress
fimaCHEM BILE DUCT CANCER – RELEASE STUDY USA Pivotal study progress ► Increased screening and enrolment in Q1 2021, but the South Taiwan full effect of these measures are not expected until the Korea COVID-19 situation improves ► Focus going forward is on regular trial management, including perfo
Slide 16: RELEASE Study – Endpoints, milestones and timelines
fimaCHEM BILE DUCT CANCER – RELEASE STUDY Endpoints, milestones and timelines Endpoints: Interim analysis: Primary Endpoint: Objective Response Rate (ORR) Secondary endpoint: Overall Survival (OS) • Orphan drug designation in EU & USA – potential accelerated approval Final analysis: Primary endpoi
Slide 17: fimaVACC – enhancing immunogenicity of vaccines
fimaVACC PCI BIOTECH fimaVACC – aiming to enhance immunogenicity of vaccines for immunotherapy field Compelling preclinical results ▪ Particularly strong CD8 T-cell immune responses Successfully translated into humans ▪ Phase I study in healthy volunteers with peptide- and protein-based vaccines V
Slide 18: Progress of the fimaVACC programme – clinical proof-of-concept
fimaVACC PROGRESS OF THE fimaVACC PROGRAMME Successful clinical proof-of-concept ► Phase I study provided successful clinical proof-of-concept for fimaVACC ▪ Overall objective to determine the safety, tolerability and immune response of fimaVACC ▪ Proof of concept and efficacy in terms of intrader
Slide 19: Progress of the fimaVACC programme – Phase I published
fimaVACC PROGRESS OF THE fimaVACC PROGRAMME Growing robust evidence, with Phase I study published ► Positive clinical study results presented at ESMO Immuno-Oncology Congress in December 2019 ► The full study results were published early January 2021 in Frontiers in Immunology, a high impact immun
Slide 20: fimaNAC – targeted intracellular delivery of nucleic acid therapeutics
fimaNAC PCI BIOTECH fimaNAC – efficient and targeted intracellular delivery of nucleic acid therapeutics Compelling preclinical results ▪ Strong data for a range of nucleic acid therapeutics and works in synergy with several vehicles Addressing a major hurdle for this class of drugs ▪ Intracellula
Slide 21: Research Collaborations
fimaNAC RESEARCH COLLABORATIONS Collaborations provide important knowhow and encouraging results ► Currently five collaborations within delivery of nucleic acid therapeutics, spanning across different classes of drugs and therapeutic applications ► The collaborations provide valuable scientific kn
Slide 22: Naked mRNA delivery with fimaNAC – different applications
fimaNAC NAKED MRNA DELIVERY WITH fimaNAC – DIFFERENT APPLICATIONS Enhanced delivery to skin and muscle – best effect seen for intratumoural delivery Fold increase of mRNA expression with fimaNAC ► Intratumoural immunotherapy 60 ▪ Systemic therapeutic effects can also be achieved 50 ▪ mRNA encoding
Slide 23: Naked mRNA delivery with fimaNAC – Summary
fimaNAC NAKED MRNA DELIVERY WITH fimaNAC – SUMMARY ► Local delivery technology ▪ mRNAs and fimaporfin can be mixed in aqueous solution and administered as one injection without local or systemic side effects ▪ mRNA administration and illumination can be done in the same procedure ▪ mRNA expression s
Slide 24: Collaboration established with OliX Pharmaceuticals
fimaNAC RESEARCH COLLABORATIONS Collaboration established with OliX Pharmaceuticals ► In May 2021, PCI Biotech entered into an extensive research collaboration with the South Korean company OliX Pharmaceuticals, a leading developer of RNAi therapeutics ► OliX Pharmaceuticals and PCI Biotech will c
Slide 25: Collaborations within nucleic acid therapeutics
fimaNAC RESEARCH COLLABORATIONS Collaborations within nucleic acid therapeutics ► Currently five active collaborations ► The most recently established collaboration is with OliX Pharmaceuticals, a South Korean biotech company with a novel RNAi technology ► PCI Biotech continues to pursue new and v
Slide 26: Finance
FINANCE ► Key financial figures ► Fluctuations in exchange rate, effects on bank deposits and net financial result ► Solid cash position, partly placed in Euro (figures in NOK 1,000) Q1 2021 Q1 2020 FY 2020 Other income (public grants) 1 588 1 919 7 368 Operating results -21 171 -15 974 -82 121 Net
Slide 27: Recent Key Achievements & Near-Term Milestones
RECENT KEY ACHIEVEMENTS & NEAR-TERM MILESTONES 2H 2020 ✓ fimaCHEM First Asian patient enrolled in the RELEASE study 2H 2020 ✓ fimaCHEM Optimised protocol and procedures implemented at all sites 1H 2021 ✓ fimaVACC Phase I results published in high-impact immunology journal 1H 2021 ✓ fimaNAC Results f
Slide 28: Investment Highlights
INVESTMENT HIGHLIGHTS Broad platform PCI is a platform technology with three programmes targeting an attractive and growing oncology technology market, with a clear path to a high unmet need orphan oncology market for the lead candidate Advanced lead fimaCHEM – Amphinex® is an orphan designated (EU
Slide 29: PCI Biotech – For enquiries
PCI Biotech Enabling intracellular delivery For enquiries: Per Walday, CEO Ronny Skuggedal, CFO Mobile phone: +47 917 93 429 Mobile phone: +47 940 05 757 E-mail: pw@pcibiotech.com E-mail: rs@pcibiotech.com www.pcibiotech.com 29