Poolbeg Pharma Plc · LSE:POLB
Poolbeg Pharma — Investor Presentation (May 2024)
38 slides from Poolbeg Pharma's investor presentation, May 2024
Slide 1: Company Presentation
Company Presentation May 2024
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: Poolbeg Pharma - Well Positioned for Success
Poolbeg Pharma - Well Positioned for Success • Successfully built three public life science companies & achieved multiple exits Industry Leading • Three key former Amryt Pharma leaders recruited with a track record of establishing and scaling sales Team infrastructures in the US & ROW Revenue Focuse
Slide 4: High Value Programmes
High Value Programmes Actively engaging in partnering discussions Product / Programme Pre-Clinical Phase I Phase II Phase III Other Partnerships/Collaborations POLB 001 >$10bn Market Cancer immunotherapy-induced CRS Opportunity €2.3m in non-dilutive grant funding secured to POLB 001 develop a Phas
Slide 5: Significant Progress Made
Significant Progress Made 2023 Highlights Other Key Milestones POLB 001 expanded Interest from to oncology & global industry • Influenza AI-led programme: Multiple novel drug targets identified with prioritised targets strong data generated leaders in the field at endorsed by Poolbeg’s SAB • RSV AI-
Slide 6: Gathering Momentum into 2024
Gathering Momentum into 2024 Highlights to date Looking Ahead Option to acquire Positive in vivo data Rare Disease Drug & support from • New patent applications filed independent advisory board tPTX for Behçet's • In-house capability to develop, Disease POLB 001 partner and commercialise innovative
Slide 7: POLB 001
POLB 001 Opportunity across multiple disease areas Cancer Immunotherapy- Severe Influenza induced CRS
Slide 8: CRS is a Rate Limiting Side Effect Associated with Emerging Cancer Immunotherapies
CRS is a Rate Limiting Side Effect Associated with Emerging Cancer Immunotherapies Cytokine Release Syndrome The Impact • Severe life-threatening side effect of some • Extended hospitalisation and high therapies and infections consumption of healthcare resources • >70%1 of patients undergoing CAR T
Slide 9: POLB 001 Demonstrated Strong Efficacy/Safety Profile
POLB 001 Demonstrated Strong Efficacy/Safety Profile Phase 1b LPS Human Challenge Clinical Trial Positive In Vivo Animal Results Validate POLB 001's Potential to Address Cancer Immunotherapy-Induced CRS Excellent safety & tolerability profile Major reduction of key inflammatory markers Potent target
Slide 10: ASH Abstract And Poster Presentation
ASH Abstract And Poster Presentation Presentation at 65th American Society of Garnered interest from global Hematology (ASH) Annual Meeting to industry leaders in the field of provide insight into POLB 001's potential bispecific antibodies and CAR T to treat CRS associated with cancer cell therapi
Slide 11: Significant Market Opportunity in a Rapidly Growing Field
Significant Market Opportunity in a Rapidly Growing Field CRS is rate limiting in delivering cancer immunotherapies Monoclonal Antibodies Bispecific Antibodies & CAR T Therapies1-3 $30bn $120bn c. $120bn $25bn Growth $20bn Bispecific Antibody and CAR T $90bn Therapy market expected to Sales $15bn $6
Slide 12: CRS Preventative Therapy: a >$10bn Market Opportunity
CRS Preventative Therapy: a >$10bn Market Opportunity A significant opportunity exists for POLB 001 as adjunct therapy to BsAb and CAR T treatment Addressable MM and DLBCL Cancer immunotherapies are used to treat a growing number of population by 2030 in the US and EU5 cancers, rapid advancements ar
Slide 13: CRS Creating a "Bottleneck"
CRS Creating a "Bottleneck" Effective prevention of CRS by POLB 001 may enable broader access to cancer immunotherapies GRADE 1 CRS 56% Trial population An effective CRS $7,517 Treatment cost2 ~500,000 Patients prevention could remove the bottleneck GRADE 2 CRS CAR-T BsAb 37% Trial population Eligib
Slide 14: Key Opinion Leaders Supportive of POLB 001's Significant Potential
Key Opinion Leaders Supportive of POLB 001’s Significant Potential Access to CAR T and Bispecific “Bispecific antibodies will only be Antibody therapy is restricted delivered in specialist cancer centres “CAR T therapy inpatient capacity is a until there is a way to make them to specialist centres
Slide 15: Topical PTX
Topical PTX Potential to transform the lives of patients Behçet's Disease
Slide 16: Behçet's Disease
Behçet's Disease Debilitating Disease with No Cure No. Patients1 Country • Inflammation of blood vessels and ~350,000 Turkey tissues ~19,0002 Japan • Life-long symptoms ~18,000 USA • Oral ulcers - impact essential functions ~4,800 France like eating, drinking and speaking ~4,800 UK • Current standar
Slide 17: Topical muco-adherent formulation of Pentoxifylline (tPTX)
Topical muco-adherent formulation of Pentoxifylline (tPTX) Orphan drug candidate for Behçet's Disease Novel therapeutic with Fast Track and Orphan Designation Timothy R. Coté, Potentially transformative 12-month option agreement M.D., M.P.H. • Formulation designed to deliver • Complete due diligence
Slide 18: Phase 2 Proof-of-Concept Trial Conducted by Silk Road Therapeutics
Phase 2 Proof-of-Concept Trial Conduced by Silk Road Therapeutics Novel therapeutic with Fast Track and Orphan Designation Metrics Phase 2 Trial Trial Design • March – July 2019 • Conducted under FDA IND in Turkey • Randomized 41 patients to SOC (colchicine therapy) or SOC + topical PTX • Enrolled p
Slide 19: Phase 2 Proof-of-Concept Trial Results
Phase 2 Proof-of-Concept Trial Conduced by Silk Road Therapeutics PTX demonstrates accelerated ulcer healing and decreased pain compared to SOC Accelerated ulcer healing compared to standard of care Decreased pain compared to standard of care 9 100% Mean Group Pain Scores-Changes from 8 Mean Index U
Slide 20: Oral Delivery Platform
Oral Delivery Platform Proprietary encapsulation to enhance API stability and uptake Oral Encapsulated Metabolic Diseases Oral Vaccines GLP-1R Agonist
Slide 21: Proprietary Oral Delivery Platform
Proprietary Oral Delivery Platform Capital light prototype and piloting process enables further strategic collaborations Obesity: Oral GLP-1R Agonist Strategic Collaboration with a Oral Vaccine Programme • Preparing a proof-of-technology Nasdaq Listed Biopharma • €2.3m in non-dilutive grant funding
Slide 22: Artificial Intelligence Programmes
Artificial Intelligence Programmes Unlocking insights from unique human challenge trial data Influenza RSV 22
Slide 23: AI Programmes Underpinned by Unique Human Challenge Trial Data
AI Programmes Underpinned by Unique Human Challenge Trial Data Proprietary data set enables training of cutting-edge AI algorithms leading to higher quality outputs Benefits of Challenge Data Supplemented with data from Stage 3 hospitalized severe influenza patients Multi-parametric Volunteers under
Slide 24: AI-Led Discovery Programmes
AI-Led Discovery Programmes Extensive clinical database analysed using leading artificial intelligence technology AI analysis of Influenza data AI analysis of RSV data Novel influenza drug targets identified and prioritised Unique RSV drug targets and treatments identified and following positive fee
Slide 25: Investment Case
Investment Case Positioned to generate value for shareholders, while addressing significant unmet medical needs >US$10bn Option to acquire market opportunity Rare Disease Drug for POLB 001 in tPTX for Behçet's Industry Leading Revenue Focused oncology alone Disease Team Business Model High Value Tri
Slide 26: Appendix
1 POOLBEG PHARMA Appendix
Slide 27: Proven Leadership Team
Proven Leadership Team Experience in commercialising and developing innovative medicines Cathal Friel Jeremy Skillington PhD Ian O’Connell Executive Chairman Chief Executive Officer Chief Financial Officer Founder of Raglan Capital, completing 4 IPOs (Amryt Employee #1 at Inflazome - €380m+ exit
Slide 28: Non-Executive Directors
Non-Executive Directors A long history of success in the life sciences industry Prof Luke O’Neill Eddie Gibson Prof Brendan Buckley Non-Executive Director Non-Executive Director Non-Executive Director Co-Founder Inflazome which was acquired Market access expert Former Chief Medical Officer at
Slide 29: Grades & Severity of CRS
Grades & Severity of CRS CRS occurs in the majority of CAR-T and Bispecific Antibody treatments CRS Parameter1 Grade 1 Grade 2 Grade 3 Grade 4 Fever Fever ≥ 38°C (not attributable to any other cause). In patients who have CRS then receive antipyretics or anticytokine therapy such as tocilizumab or s
Slide 30: POLB 001 – A Human LPS Challenge Trial
POLB 001 – A Human LPS Challenge Trial Evidence for benefit of POLB 001 in the therapy of LPS-induced inflammation Randomised, double-blind, placebo-controlled, multiple dose, inflammatory challenge trial in healthy volunteers Trial design Endpoints D4 D6 Intravenous LPS challenge Challenge 4 intrad
Slide 31: Potent and Selective Inhibition of p38 MAPK Signaling
Potent and Selective Inhibition of p38 MAPK Signaling Effective target engagement demonstrated in LPS human challenge trial Levels of phosphorylated p38 MAPK in circulating monocytes • POLB 001 was widely distributed • POLB 001 inhibited p38 MAPK activation, direct measurement of activation • POLB 0
Slide 32: Reduced Key Inflammatory Cytokines Following LPS Challenge
Reduced Key Inflammatory Cytokines Following LPS Challenge Dose dependent reductions, without ablation of immune function TNF-α IL-6 IL-8 TNF-α reduction of 73.5% and 56.2% seen for IL-6 reduction of 57.4% and 63.5% seen for IL-8 reduction of 80.7% and 76.7% seen for 70 mg and 150 mg doses respectiv
Slide 33: Reduced Key Indicators of LPS-Induced Systemic Inflammation
Reduced Key Indicators of LPS-Induced Systemic Inflammation The reduction of systemic cytokines align with improvement in clinically meaningful endpoints Mean Body Temperature Heart Rate Rise (bpm) C-Reactive Protein (CRP) No significant effect on body temperature with a Suppressed increase in heart
Slide 34: POLB 001 Effectively Reduced Inflammation in Tissue
POLB 001 Effectively Reduced Inflammation in Tissue POLB 001 150 mg significantly reduced IL-1β† and TNF-α† responses in blister exudate compared to placebo in LPS challenge TNF-α in blister exudate IL-1β in blister exudate Placebo 150mg POLB 001 †The exploratory analysis suggested statistically sig
Slide 35: Exclusively Licensed Oral Delivery Platform
Exclusively Licensed Oral Delivery Platform Adaption of a proven food and beverage application for the repurposing of APIs Encapsulated Prototypes • Poolbeg have exclusively licensed AnaBio Technologies encapsulation platform for all metabolic indications • AnaBio developed and commercialised their
Slide 36: POLB 002 – Respiratory Virus Infection Immunotherapy
POLB 002 – Respiratory Virus Infection Immunotherapy First-in-class, broad spectrum, RNA-based Overview In vivo influenza A challenge2 • Late preclinical stage with extensive preclinical data package • Derived from 20 years research by world class researchers • No reduction in efficacy or safety iss
Slide 37: POLB 003 – Melioidosis Vaccine Candidate
POLB 003 – Melioidosis Vaccine Candidate Late preclinical stage Overview1 Significantly enhances survival in a model of chronic melioidosis • Burkholderia pseudomallei causes severe disease in humans • Late preclinical stage with extensive preclinical data package & animals • Infection routes: inhal
Slide 38: Stay in touch
1 POOLBEG PHARMA Stay in touch eo Bae in