Pci Biotech Holding Asa · LSE:0JGL
Pci Biotech Holding Asa — Q3 2021 Earnings Presentation
32 slides from Pci Biotech Holding Asa's earnings presentation, Nov 16, 2021
Slide 1: PCI Biotech Q3 2021 Presentation
PCI Biotech Enabling intracellular delivery Q3 2021 PRESENTATION November 17, 2021 Per Walday, CEO Amir Snapir, CMO Anders Høgset, CSO 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: Table of Contents
TABLE OF CONTENTS • Highlights • Operational review ‒ Clinical ‒ Preclinical • Key financials • Outlook 4
Slide 5: Q3 2021 Highlights: fimaCHEM RELEASE enrolment
Q3 2021 HIGHLIGHTS fimaCHEM RELEASE – enrolment fluctuations continues ► Enrolment of patients into the RELASE study is still challenging and fluctuating – Covid-19 has a continued negative impact on the study and with August being a low recruitment month due to the holiday season, only five patie
Slide 6: Q3 2021 Highlights: recruitment and retention strategies
Q3 2021 HIGHLIGHTS fimaCHEM RELEASE – pursuing strategies to address recruitment and retention ► Thirty patients have per end of October been included in the RELEASE study and the expected timeline for interim analysis remains 2H 2023 ► Proactively pursuing strategies to address recruitment and re
Slide 7: Q3 2021 Highlights: fimaVACC
Q3 2021 HIGHLIGHTS fimaVACC ► The fimaVACC programme is progressing towards initiation of a Phase II clinical proof-of-concept study, with product definition and study design clarified following comprehensive consultations with international experts 7
Slide 8: Q3 2021 Highlights: fimaNAC
Q3 2021 HIGHLIGHTS fimaNAC ► Development plan initiated based on strategic research and collaborations, targeting applications suited to the specific strengths of the PCI technology 8
Slide 9: Q3 2021 Highlights: Corporate
Q3 2021 HIGHLIGHTS Corporate ► Significantly strengthening the organisation with three highly skilled individuals; an experienced operational leader for RELEASE and two key employees within clinical science and business development focusing on fimaVACC and fimaNAC 9
Slide 10: An oncology focused pipeline targeting significant unmet needs
PCI BIOTECH – ENABLING INTRACELLULAR DELIVERY An oncology focused pipeline targeting significant unmet needs Programme Indications/Therapeutics Preclinical Phase I Phase II Pivotal Photochemical internalisation (PCI) is a platform technology with three programmes targeting an attractive and growin
Slide 11: Operational review - clinical
Operational review - clinical 11
Slide 12: Amphinex as first line treatment for bile duct cancer
PCI BIOTECH Amphinex® as 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 interim
Slide 13: fimaCHEM: Excellent fit with medical need and existing treatments
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 standard of care for inoperable bile duct cancer treatments) ► Easy to use: Illumination through standard endoscopic meth
Slide 14: Bile duct cancer RELEASE study: pivotal study with potential accelerated approval
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 • Approx. 50
Slide 15: RELEASE study: pivotal study status
BILE DUCT CANCER – RELEASE STUDY USA Pivotal study status ► 47 sites currently open for patient enrolment South ▪ 32 sites in Europe, 9 in Asia and 6 in the US Taiwan Korea ► Several initiatives implemented with the aim to recoup the COVID-19 caused delay – the most important being increased numbe
Slide 16: RELEASE study: endpoints, milestones and timelines
BILE DUCT CANCER – RELEASE STUDY Endpoints, milestones and timelines Endpoints: Interim analysis: Primary Endpoint: Objective Response Rate (ORR) • Orphan drug designation in EU, USA and South Korea – potential Secondary endpoint: Overall Survival (OS) accelerated approval Final analysis: Primary
Slide 17: RELEASE study: patient retention
BILE DUCT CANCER – RELEASE STUDY Patient retention Background • Ability to analyse the primary endpoint requires a specific number of events to occur in the trial • Retention imbalance between arms could lead to bias and require additional statistical analyses by regulatory authorities Challenges
Slide 18: RELEASE study: patient recruitment
BILE DUCT CANCER – RELEASE STUDY Patient recruitment Background • CCA is a rare disease and RELEASE targets a subpopulation of CCA patients • The COVID-19 pandemic has affected both patients and clinicians – hesitation to come to hospitals; hospital shifting resources; increased workload on health
Slide 19: Aiming to enhance the effect of immunotherapeutics
PCI BIOTECH Aiming to enhance the effect of immunotherapeutics 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 – results published Versatile vaccinati
Slide 20: Planned fimaVACC study in cancer patients: strategy
PLANNED fimaVACC STUDY IN CANCER PATIENTS Strategy Start small and build upon the results Small number of patients Study in cancer patients with a goal to One cancer indication Expansion cohort demonstrate anti-tumour activity PCI vaccine Same settings as in Part A Immunomodulation therapy O
Slide 21: Improving the response to immune checkpoint inhibition
PLANNED fimaVACC STUDY IN CANCER PATIENTS Improving the response to immune checkpoint inhibition Study treatment • Combination with relevant immunomodulation therapy for effective immunotherapy • Fimaporfin, a mix of relevant peptide antigens, and a synergistic adjuvant will be included • Intrader
Slide 22: Operational review - preclinical
Operational review - preclinical 22
Slide 23: Nucleic acid delivery with PCI
NUCLEIC ACID DELIVERY WITH PCI ► Nucleic acids – a rapidly growing area with potential for the treatment and prophylaxis for many diseases, and with approvals in e.g.: ▪ Covid-19 – mRNA prophylactic vaccines ▪ Treatment of SMA (high price levels) • Spinraza – oligonucleotide for treatment of spinal
Slide 24: PCI strongly improves delivery of naked mRNA to skin
PCI STRONGLY IMPROVES DELIVERY OF NAKED mRNA TO SKIN PCI can enhance functional naked mRNA delivery to skin (intradermal inj.) about 30 times IVIS imaging after i.d. inj. of luciferase mRNA Enzymatic luciferase activity in skin samples after and subsequent i.v. inj. of the substrate luciferin i.d. i
Slide 25: PCI vs. LNPs for mRNA delivery to tumours
PCI VS. LNPS FOR mRNA DELIVERY TO TUMOURS PCI enhances delivery and prevents undesirable off-target effects IVIS imaging after intratumoural inj. of luciferase mRNA and Luciferase expression in MC38 tumours and liver after intratumoural subsequent i.v. inj. of the substrate luciferin delivery of l
Slide 26: Naked mRNA delivery with PCI: different applications
NAKED MRNA DELIVERY WITH PCI – DIFFERENT APPLICATIONS Best effect seen for intratumoural delivery Fold increase of mRNA expression with PCI 60 ► Local delivery technology ▪ mRNAs and fimaporfin can be mixed and administered as 50 one injection, with illumination in the same procedure 40 ▪ mRNA exp
Slide 27: PCI for nucleic acid delivery: top priorities
PCI FOR NUCLEIC ACID DELIVERY – TOP PRIORITIES Easily illuminable Intratumoural immuno- Nucleic conditions therapy Acids (scars, ulcers, others) • Good technological fit – a lot of interesting • Good technological fit – a lot of interesting options options • PCI delivery works well in animals • PCI
Slide 28: Development of PCI for nucleic acid delivery
DEVELOPMENT OF PCI FOR NUCLEIC ACID DELIVERY RNA intratumoural immunotherapy • Pro-actively develop technology and seek further partnerships for intratumoural immunotherapy, based on current data • Already collaboration with a leading company in this area (eTheRNA) • Also possibilities for own produ
Slide 29: Finance
FINANCE ► Key financial figures ► CF impacted by timing difference of received annual SkatteFUNN grant (Q3 21 vs Q4 20) ► Cash position with an expected financial runway into Q4 2022 at current cost base (figures in NOK 1,000) Q3 2021 Q3 2020 YTD 2021 YTD 2020 FY 2020 Other income (public grants) 1
Slide 30: Progressing the PCI-technology pipeline
PROGRESSING THE PCI-TECHNOLOGY PIPELINE Strengthened the organisation with recruitment of three key senior employees Progressing development in bile duct cancer towards marketing authorisation application - RELEASE study with interim read for potential accelerated approval ongoing across three con
Slide 31: 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 32: 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 32