Poolbeg Pharma PLC · LSE:POLB
Poolbeg Pharma — Investor Presentation (January 2023)
46 slides from Poolbeg Pharma's investor presentation, January 2023
Slide 1: Company Presentation
Company Presentation January 2023 AIM: POLB OTCQB: POLBF
Slide 2: Disclaimer
Disclaimer The contents of this presentation and the information which you are given at the time of the presentation have not been approved by an authorised person within the meaning of the Financial Services and Markets Act 2000 (the “Act”). Reliance on this presentation for the purpose of engaging
Slide 3: A Leading Biopharma Company Specialising in Infectious Disease
A Leading Biopharma Company Specialising in Infectious Disease Becoming a ‘one-stop-shop’ for pharma and biotech seeking programmes to in-licence Spun out from Fully funded £18.9m cash (30 June 2022) Deep roots in infectious disease & clinical trials Smart, cost effective R&D approach Rapidly advanc
Slide 4: Four Steps To Generating Sustainable Shareholder Value
Four Steps To Generating Sustainable Shareholder Value 1 Non-dilutive Portfolio approach – Identifying funding Multiple shots on goal – high potential advancing multiple opportunities mitigating risk opportunities programmes in parallel 4 2 Optimised asset selection: Generating Funds Early major • C
Slide 5: Poolbeg's Exciting Pipeline of Assets
Poolbeg’s Exciting Pipeline of Assets Pipeline – clinical development Product Candidate Pre Clinical Phase I Phase II Phase III Upcoming Catalysts • LPS challenge trial: full data read-out POLB 001 expected Q2 23 Severe influenza treatment • Out-licensing discussions initiated POLB 001 • Clinical tr
Slide 6: POLB 001
POLB 001 Potential blockbuster immunomodulator Significant opportunity across multiple disease areas Severe influenza Oncology
Slide 7: POLB 001 - Unique Data & Samples Identified
POLB 001 - Unique Data & Samples Identified Road to identifying POLB 001 as the best p38 MAPK inhibitor Comparison of 63 Analyse Severe & Mild Influenza Cases • Samples taken from patients with severe influenza were compared against human challenge trial subjects with mild influenza 24 Possible Drug
Slide 8: POLB 001 – Driving Meaningful Change for Patients by Dampening CRS
POLB 001 – Driving Meaningful Change for Patients by Dampening Cytokine Release Syndrome (CRS) Potent anti-inflammatory Hyper-inflammation: a source of LPS challenge trial results immunomodulator toxicity in many patient groups Potentially indicative of POLB 001 May have utility across This includes
Slide 9: Potential to Block p38 MAPK Driven CRS
Potential to Block p38 MAPK Driven CRS Benefitting severe flu patients, CAR T cell patients and beyond Severe influenza Severe influenza infections causes hypercytokinaemia, also known as CRS Immune over-activation Other viral infections Breakdown of Immune cell Covid-19 and other respiratory 1 5 ti
Slide 10: POLB 001 – p38 MAPK Inhibitor for Severe Influenza
POLB 001 – p38 MAPK Inhibitor for Severe Influenza Strain agnostic, shelf stable oral drug ideal for seasonal & pandemic stockpiling LPS Challenge Trial Objective: To evaluate the effect of POLB Positive initial data from LPS challenge trial 001 on inflammatory responses following an intradermal and
Slide 11: CAR T Cell Therapy: Engineering Patient's Immune Cells to Treat Cancers
CAR T Cell Therapy: Engineering Patient’s Immune Cells to Treat Cancers How does it work? Derived from a patient’s own blood T-cells are engineered to be specific to an Therapies are approved in advanced or from a healthy donor antigen on the surface of the tumour leukaemia and lymphoma i.e. autolog
Slide 12: CAR T Cell Associated Toxicities Such as CRS are a Challenge in the Clinic
CAR T Cell Associated Toxicities Such as CRS are a Challenge in the Clinic Up to 95% of CAR T cell patients suffer treatment related side effects Treatment is reactive at onset of signs Steroids and general organ support Anti-IL-6 receptor antibody (tocilizumab) - approved Severe cases are life-thre
Slide 13: Launch of POLB 001 Oncology Programme
Launch of POLB 001 Oncology Programme IP expansion: targeting conditions where POLB 001 can treat hyperinflammatory diseases Targeting CAR T cell patients who develop CRS Clinical IP Advisory Programme Proof of Protection Board Initiation Concept ✓ Patent filed January 2023 ✓ Collaborating with glob
Slide 14: Expanding the Addressable Market for POLB 001
Looking to Expand the Addressable Market for POLB 001 to Include Both Severe Influenza and CAR T Cell Patients Severe Influenza Oncology 3-5 Million 18-19 Million Severe influenza cases globally Annual cancer cases globally 500k+ 9.5 Million+ Influenza-related Annual cancer deaths globally respirato
Slide 15: Artificial Intelligence Programmes
Artificial Intelligence Programmes Unlocking the power of unique human challenge trial data Influenza RSV
Slide 16: Unlocking the Value in Human Challenge Trial Data
Unlocking the Value in Human Challenge Trial Data The first time AI is used to analyse RSV & influenza human challenge trial data Cleaner data Greater precision Time ✓ Known infection time ✓ Powered dataset ✓ Exact timing ✓ Matched demographics ✓ Controlled GCP ✓ Commercial processing ✓ Medical hist
Slide 17: First Time RSV Drug Candidates Identified Using AI
First Time RSV Drug Candidates Identified Using AI Respiratory syncytial virus (RSV) Potential candidates Contract Model Build & Drug Targets identified Signed Optimisation Identified Feb June Nov Dec 2022 Lab based 2022 2022 2022 validation Prioritising drugs with existing Phase I safety data – red
Slide 18: AI-Identified Influenza Drug Targets Expected Q2 2023
AI-Identified Influenza Drug Targets Expected Q2 2023 Influenza Contract Model Build & Outputs Signed Optimisation Expected Mar Nov Q2 Identify 2022 2022 2023 products to in-licence Day 2 v Day 0 CytoReason work with Infected several of the world's top pharma companies Genes up regulated At baseline
Slide 19: Oral Delivery Platform
Oral Delivery Platform Using innovative encapsulation technology Significant opportunity across multiple disease areas Metabolic syndrome Vaccines related diseases
Slide 20: Oral Vaccine Delivery Platform
Oral Vaccine Delivery Platform Transformative oral vaccine platform funded by the Disruptive Technologies Innovation Fund (DTIF) • Developing oral vaccine delivery platform that generates ‘mucosal immunity’ Poolbeg-led consortium - Preventing pathogens from infecting the body awarded €2.3m in non- -
Slide 21: Innovative Oral Delivery Technology for Metabolic Syndrome Related Diseases
Innovative Oral Delivery Technology for Metabolic Syndrome Related Diseases Oral GLP-1 - clinical trial to commence H1 2023 Dec Licence Clinical trial to determine that the patented microencapsulation and 2022 technology nanoencapsulation technologies can safely deliver a Glucagon-like Peptide 1 rec
Slide 22: Metabolic Diseases – A Fast Growing Market
Metabolic Diseases – A Fast Growing Market Worldwide obesity has nearly tripled since 1975 & obesity Significant interest to develop therapeutics treatment could quickly become a top-12 global therapy within the metabolic disease space $173BN Eli Lilly enters deal with Nimbus for Cost to US Healthca
Slide 23: POLB 002
POLB 002 First-in-class, broad spectrum RNA-based intranasal immunotherapy Novel approach to tackle respiratory virus infections
Slide 24: A Global Need for Respiratory Virus Infection Products
POLB 002 – A Global Need for Respiratory Virus Infection Products Most respiratory virus infections cannot be treated 15% 85% INFLUENZA NON-INFLUENZA RVIs VACCINES RVIs Protection variable FEW AVAILABLE ANTI-VIRAL THERAPIES TREATMENTS Require diagnosis of virus type “A broad spectrum antiviral that
Slide 25: POLB 002 – Respiratory Virus Infection Immunotherapy
POLB 002 – Respiratory Virus Infection Immunotherapy First-in-class, broad spectrum, RNA-based • Derived from 20 years research by world class researchers • Single dose, intranasal, dual action prophylactic & therapeutic - Triggers nasal cells into an antiviral state to protect against the virus In
Slide 26: POLB 003
POLB 003 Vaccine candidate for melioidosis Late preclinical stage
Slide 27: POLB 003 – Melioidosis Vaccine Candidate
POLB 003 – Melioidosis Vaccine Candidate Background to melioidosis CDC designated Tier 1 Select Agent Biothreat • Burkholderia pseudomallei causes severe disease in humans • Recent outbreak highlights the Biothreat of & animals Melioidosis – creating stock piling potential • Infection routes: inhala
Slide 28: POLB 003 – Melioidosis Vaccine Candidate
POLB 003 – Melioidosis Vaccine Candidate Late pre-clinical stage Efficacy data Safety data • 75% survival rate of immunized mice over 81 days • No safety signals in GLP toxicology study • Subsequent characterisation of immune responses confirmed T-cell (CD25 and CD44 activation) and B-Cell responses
Slide 29: Additional Vaccine Candidates from UCD
Additional Vaccine Candidates from UCD Option agreement for 5 additional vaccine antigen candidates O157 E.coli/STEC/ Pseudomonas Acinetobacter Klebsiella Burkholderia VTEC aeruginosa baumannii pneumoniae cepacia complex • Lead antigen • Multiple antigens • Multiple antigens • Lead antigen • Lead an
Slide 30: Strong Investment Case
Strong Investment Case Several compelling reasons supporting Poolbeg’s investment case 1 2 Near Term Value Inflection Points Experienced Team • POLB 001 – full data read-out expected Q2 23 • Exceptional track record having previously created • RSV AI programme – lab-based validation stage c. $2 bill
Slide 31: Appendices
Appendices AIM: POLB OTCQB: POLBF
Slide 32: Experienced Leadership Team
Experienced Leadership Team Cathal Friel Jeremy Skillington Ian O’Connell Carol Dalton Chairman CEO CFO VP IR & PR • Co-founder & Chairman of hVIVO plc • 19 years global industry experience: US, • Financial professional with healthcare & • Co-founder & VP Investor Relations & • Co-founder & sharehol
Slide 33: Experienced Team to Execute
Experienced Team to Execute CMO Liam Tremble Sultanah Rajbally Ross Crockett David English Clinical Operations Project Global Programme Director Financial Controller VP of Business Development • Industry leading CMO Manager • Bachelor of Science degree • Extensive experience in • > 16 years of diver
Slide 34: POLB 001 – a Broad, Pan-Viral Mechanism of Action
POLB 001 – a Broad, Pan-Viral Mechanism of Action Targeting post anti-viral treatment window (48 hrs+) p38 MAPK in DAMP signalling p38 MAPK is a central node for TLR signalling and is a convergent point of 6 Infectious pathogen infects cells of A high viral burden can activate focus in severe influe
Slide 35: POLB 001 – Ideally Suited as a Severe Influenza Therapeutic
POLB 001 – Ideally Suited as a Severe Influenza Therapeutic What is p38 MAP Kinase? • Central role in regulation of pro-inflammatory signalling networks, cytokine synthesis in immune cells, and inflammatory diseases1 • Responsive to stress stimuli2 such as inflammatory cytokines • Inhibition shown t
Slide 36: POLB 001 – Successful Phase I Study Already Completed
POLB 001 – Successful Phase I Study Already Completed Safety & tolerability demonstrated – rapid progression to challenge study Phase I key outcomes Dose dependent reduction in inflammation IL 8 (H A ) Predictable and durable response **** **** Data collected in this study demonstrate that POLB 001
Slide 37: Patent Protection Strategy
Patent Protection Strategy Drug class protection • There are p38 MAPK inhibitors that are in Novelty development, have been shelved or are available for out licensing Patentability • No p38 MAPK inhibitors have been developed for use Non obviousness / inventive step criteria to in CAR T cell related
Slide 38: Proof Of Concept: Insulin & GLP-1 Agonist Liraglutide
Proof Of Concept: Insulin & GLP-1 Agonist Liraglutide Proven delivery of intact peptide to the gut • In small scale clinical trials oral dosage of both insulin and liraglutide were shown to reduce blood glucose levels compared to placebos. • Insulin trials with Type 1 diabetics using different oral
Slide 39: Oral Peptides: Protecting the Payload
Oral Peptides: Protecting the Payload Processing Storage Consumption Stomach Target Uptake can occur via Processes suitable for use Product can be ingested as API is 100% protected passive uptake from the Solid product is shelf with heat labile and a solid, as part of a food from harsh stomach gut l
Slide 40: $68 Billion Worth of Licensing Transactions Took Place in H1 2022
$68 Billion Worth of Licensing Transactions Took Place in H1 2022 30 Licensing Deals by Major Pharma Companies – H1 2022 20 No. of deals 10 0 Roche J&J Novartis AZ Eli Lilly Merck & Co. Pfizer Sanofi BMS Dr. Reddy's Merck KGaA Astellas GSK Daewoong Boehringer Telix Ingelheim 160 Licensing Deals by D
Slide 41: Big Pharma is In-Licensing Earlier and Out-Licensors are Receiving Larger Upfronts
Big Pharma is In-Licensing Earlier and Out-Licensors are Receiving Larger Upfronts in Deals In-Licensing by Large Cap Biopharma ($50B): Share of Deals by Range of Upfront Cash & Equity Share of R&D Partnerships by Stage Pre-Phase II Phase II Phase III <$10 Million $10-$100 Million >$100 Million 100%
Slide 42: Cultivating Collaboration Through In-Licensing
Cultivating Collaboration Through In-Licensing Partnering to make meaningful change within life-threating infectious diseases Complimenting partners innovation with our internal Search Engage Agree Deliver expertise Defined areas Partners for initial On the optimal way A lasting of interest conversa
Slide 43: Out-Licensing to Pharma Following Early Human Efficacy Data
Out-Licensing to Pharma Following Early Human Efficacy Data Aids the Commercialisation of Novel Medicines Partnering to make meaningful change within life-threating infectious diseases Accelerating partners Rapidly advancing exciting portfolio of programmes infectious disease R&D De-risking and unlo
Slide 44: ViralPredict Biomarker Platform for Predicting Severe Disease
ViralPredict™ Biomarker Platform for Predicting Severe Disease Potential to transform the way infectious diseases are treated, opportunity to licence this tool to Big Pharma Further patent applications submitted – October 2021 ViralPredict™ Biomarker Diagnostics vs Traditional Diagnosis of Disease A
Slide 45: Unique Vaccine Discovery Platform
Unique Vaccine Discovery Platform Harnessing the human challenge model to discover new vaccines What is an Epitope? • Part of a pathogen that the immune Step 1. T Cell Generation Step 2. Vaccine Discovery system recognises • It is the smallest unit of a molecule required to engage the immune system
Slide 46: Stay in touch
Stay in touch www.PoolbegPharma.com @PoolbegPharma AIM: POLB Poolbeg Pharma OTCQB: POLBF IR@PoolbegPharma.com
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