Pci Biotech Holding Asa · LSE:0JGL
Pci Biotech Holding Asa — Q2 2021 Earnings Presentation
30 slides from Pci Biotech Holding Asa's earnings presentation, Aug 30, 2021
Slide 1: PCI Biotech Q2 & 1H 2021 Presentation
PCI Biotech Enabling intracellular delivery Q2 & 1H 2021 PRESENTATION August 31, 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: 1H 2021 Highlights – fimaCHEM revised timelines
1H 2021 HIGHLIGHTS fimaCHEM RELEASE – revised timelines due to fluctuating patient recruitment in 2021 ► The implementation of the amended protocol and the opening of Asian sites provided increased screening and enrolment to RELEASE in Q1 ► Activity declined significantly in Q2 with only three pat
Slide 8: 1H 2021 Highlights – first US patient and ODD in South Korea
1H 2021 HIGHLIGHTS fimaCHEM RELEASE – first US patient recruited and ODD granted in South Korea ► First US patient enrolled in the RELEASE study ► Orphan drug designation granted in South Korea for bile duct cancer treatment with fimaporfin in combination with gemcitabine ► Continued focus on enro
Slide 9: 1H 2021 Highlights – fimaVACC
1H 2021 HIGHLIGHTS fimaVACC ► Successful Phase I vaccination proof of concept study published in the high impact immunology journal, Frontiers in Immunology, demonstrating that fimaVACC enhances the immune response to peptide- and protein-based vaccines in healthy volunteers ► US patent granted fo
Slide 10: 1H 2021 Highlights – fimaNAC
1H 2021 HIGHLIGHTS fimaNAC ► Encouraging data on enhanced delivery of mRNA for various medical applications presented at the UK based 12th Annual RNA Therapeutics Virtual Conference ► Established extensive research collaboration with the South Korean company OliX Pharmaceuticals, a leading develop
Slide 11: 1H 2021 Highlights – Corporate
1H 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 11
Slide 12: 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
Slide 13: 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 standard of care for inoperable bile duct cancer treatments) ► Easy to use: Illumination through standard endosc
Slide 14: Orphan drug designation granted in South Korea
fimaCHEM fimaCHEM Orphan drug designation granted in South Korea ► In May 2021, the Ministry of Food and Drug Safety (MFDS) in South Korea granted Orphan Drug Designation (ODD) to fimaporfin for combination treatment with gemcitabine in patients with inoperable locally advanced or metastatic bile
Slide 15: 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 16: RELEASE Study – Pivotal study status
fimaCHEM BILE DUCT CANCER – RELEASE STUDY USA Pivotal study status ► 47 sites currently open for patient enrolment South ▪ 9 sites in Asia – first Asian patient enrolled Oct’20 Taiwan Korea ▪ 6 sites in the US – first US patient enrolled Apr’21 ► Several initiatives implemented autumn 2020 with th
Slide 17: RELEASE Study – Pivotal study progress and timelines
fimaCHEM BILE DUCT CANCER – RELEASE STUDY Pivotal study progress and timelines ► Focus going forward is on regular trial management, including overall performance evaluation with replacement of underperforming sites, and proactive management of study specific risks, such as retention of randomised
Slide 18: 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) • Orphan drug designation in EU, USA and South Korea– potential Secondary endpoint: Overall Survival (OS) accelerated approval Final analysis:
Slide 19: fimaVACC – aiming to enhance the effect of immunotherapeutics
fimaVACC PCI BIOTECH fimaVACC – 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 Versatile vaccinati
Slide 20: Intratumoural immunotherapy with naked mRNA
fimaVACC INTRATUMOURAL IMMUNOTHERAPY WITH NAKED MRNA Encouraging preclinical results Fold increase of expression with fimaVACC ► Intratumoural immunotherapy with fimaVACC ▪ Systemic therapeutic effects can be achieved ▪ For use with mRNA encoding antigens and/or immuno- stimulating factors ▪ Expre
Slide 21: Progress of the fimaVACC programme – clinical proof-of-concept
fimaVACC PROGRESS OF THE fimaVACC PROGRAMME Successful clinical proof-of-concept with protein/peptide-based vaccines ► 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 conce
Slide 22: Progress of the fimaVACC programme – Phase I published
fimaVACC PROGRESS OF THE fimaVACC PROGRAMME Growing robust evidence, with Phase I study published ► The full Phase I study results were published early January 2021 in Frontiers in Immunology, a high impact immunology journal ► In June 2021, a new US patent was granted covering the use of fimaVACC
Slide 23: 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 24: Naked mRNA delivery with fimaNAC – different applications
fimaNAC NAKED MRNA DELIVERY WITH fimaNAC – DIFFERENT APPLICATIONS Encouraging collaborative results presented at an international conference on RNA therapeutics Fold increase of mRNA expression with fimaNAC ► Local delivery technology 60 ▪ mRNAs and fimaporfin can be mixed and administered as one
Slide 25: Collaboration established with OliX Pharmaceuticals
fimaNAC RESEARCH COLLABORATION 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 co
Slide 26: Collaborations within fimaNAC and fimaVACC
RESEARCH COLLABORATIONS Collaborations within fimaNAC and fimaVACC ► Currently five collaborations, spanning across different classes of drugs and therapeutic applications ► Providing valuable scientific knowhow, encouraging results and intellectual property ► The most recently established collabo
Slide 27: Finance
FINANCE ► Key financial figures ► Fluctuations in exchange rate, effects on bank deposits and net financial result ► BIA grant for fimaVACC ended Q2 2021, with NOK 13.4 million accumulated funding ► Solid cash position, partly placed in Euro, with an expected financial runway into 2H 2022 (figures i
Slide 28: 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 29: 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 30: 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 30