Poolbeg Pharma Plc · LSE:POLB
Poolbeg Pharma — Investor Presentation (June 2025)
34 slides from Poolbeg Pharma's investor presentation, June 2025
Slide 1: Company Presentation
Company Presentation June 2025 AIM: POLB
Slide 2: Disclaimer
Disclaimer The contents of this presentation and the informati on which you are gi ven at the time of the presentation hav e not been approved by an aut horised person within the meaning of the Fi nancial Serv ices and Markets Act 2000 (the “Act”). Reliance on this presentation for the purpose of en
Slide 3: Investment Highlights
Investment Highlights Highly experienced team with proven track record High value programmes targeting critical unmet medical needs Multiple near-term clinical value inflection points High partnering potential - pipeline in areas of interest to the pharmaceutical industry Cash runway into 2027, fund
Slide 4: High Value Pipeline Programmes
High Value Pipeline Programmes Multiple near-term clinical value inflection points – positioned well for partnering Upcoming Expected Product Modality Indication Preclinical Phase 1 Phase 2 Phase 3 Clinical Milestones ▪ 1st patient dosed in Phase 2a trial expected H2 2025 Cancer POLB 001 p38 MAPK Im
Slide 5: POLB 001
POLB 001 Potentially breakthrough orally delivered p38 MAPK inhibitor to prevent cancer immunotherapy-induced Cytokine Release Syndrome (CRS) 5
Slide 6: Cancer Immunotherapy-induced CRS is a High Unmet Need
Cancer Immunotherapy-induced CRS is a High Unmet Need Effective preventative therapy represents a >US$10B market opportunity Cytokine Release Syndrome (CRS) >70%1 of patients experience CRS A severe, potentially life-threatening side on certain bispecific antibody / CAR T effect of cancer immunother
Slide 7: POLB 001: Potential to Make Cancer Immunotherapies Safer and More Accessible
POLB 001: Potential to Make Cancer Immunotherapies Safer and More Accessible POLB 001 Strong Preclinical & Clinical Data • Selective p38 MAPK inhibitor • Phase 2 ready – key value inflection point • Orally administered • Favourable safety and tolerability profile • Prevents excessive inflammation wi
Slide 8: POLB 001 has Progressed Rapidly into Oncology
POLB 001 has Progressed Rapidly into Oncology From concept to validated preclinical data in c.12 months; Phase 2 ready in just c.24 months 2023 2024 Today • Strategic expansion of POLB 001 into • >US$10B market opportunity confirmed • First patient dosed in Phase 2a trial oncology as a CRS preventat
Slide 9: POLB 001 Prevented CRS in Humanised Mouse Model
POLB 001 Prevented CRS in Humanised Mouse Model Highly effective and superior to a TNF-α antibody in a gold standard model of CRS Study Design Study Groups ASH ‘24 Day 0 Day 5 Day 6 No CRS Control Humanisation Tumour induction CRS induction CRS Control POLB 001 Low αCD28 Day 0 1 2 3 4 5 6 7 8 9 10 P
Slide 10: LPS Human Challenge – Potent Inhibition of Excessive Inflammation
LPS Human Challenge – Potent Inhibition of Excessive Inflammation Positive data supports the potential of POLB 001 to effectively prevent CRS ASH ‘23 Trial Design Results - IL-6 Levels Heart Rate Rise (bpm) Day 4 Day 6 Single ID Single IV dose LPSSug dose LPS Day 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 D
Slide 11: POLB 001 Phase 2a Trial
POLB 001 Phase 2a Trial Prevention of CRS in relapsed refractory multiple myeloma patients receiving bispecific antibody • Proposed trial expected to start H2 2025, interim Proposed Trial Design analysis expected H1 2026 & topline data expected H2 2026 Step Up Step Up First Tx Weekly BsAb Dose 1 Dos
Slide 12: Significant Market Opportunity in a Rapidly Growing Field
Significant Market Opportunity in a Rapidly Growing Field CRS is a major issue and rate limiting in delivering cancer immunotherapies BsAb & CAR T Market Expected to Grow Exponentially Potential Benefits of FDA Orphan Drug Designation $120bn c. US$120B Growth $90bn Sales 1,2,3 $60bn $30bn Granted Ma
Slide 13: CRS Preventative Therapy: >US$10B US Market Opportunity
CRS Preventative Therapy: >US$10B US Market Opportunity Significant opportunity exists for POLB 001 as CRS preventative for BsAb and CAR T treatment3 1st, 2nd and 3rd line+ MM and DLBCL patients in Addressable MM and DLBCL population by 2030 in the US and EU5 the US and EU5, receive CAR T and bispec
Slide 14: Potential to Greatly Enhance Uptake of BsAb and CAR T Therapies
Potential to Greatly Enhance Uptake of BsAb and CAR T Therapies Effective prevention of CRS by POLB 001 may enable broader access to cancer immunotherapies ~500,000 Patients Bottleneck * An effective CRS preventative therapy may remove the bottleneck CRS Eligible bispecific antibody / CAR T >US$10B1
Slide 15: GLP-1 Programme
GLP-1 Programme Oral encapsulated GLP-1R agonist targeting the obesity market 15
Slide 16: Oral GLP-1R Agonist Targeting the Obesity Market
Oral GLP-1R Agonist Targeting the Obesity Market Proof of concept trial expected to commence H2 2025, topline data expected H1 2026 • Proprietary delivery technology with leading expert in Trial Investigator: Prof Carel le Roux obesity & metabolic medicine Site: University of Ulster Oral Objective:
Slide 17: Significant Potential for Oral GLP-1 to Claim Market Share
Significant Potential for Oral GLP-1 to Claim Market Share Major shortcomings within currently approved treatment options Large Growing Market Shortcomings of Existing Options Economic impact c.99% >45% of obesity on US US$347B businesses & API wasted in Patients discontinue current oral options4 GL
Slide 18: Strategic & Financial Highlights
Strategic & Financial Highlights Funded through key clinical milestones in high interest areas 18
Slide 19: Strategic & Financial Highlights
Strategic & Financial Highlights Clear plan to deliver shareholder returns • Partnering Focused Model: Cost-effective trials designed to produce high-quality human data and accelerate partnering discussions • Proven Team: Expertise in trial execution and deal-making – CEO Jeremy Skillington was inst
Slide 20: Upcoming Catalysts: Executing on a Focused, Funded Plan
Upcoming Catalysts: Executing on a Focused, Funded Plan Positioned to deliver data-driven value with a steady cadence of clinical milestones Upcoming Expected Clinical Milestones 2025 2026 Programme Indication H1 H2 H1 H2 Cancer immunotherapy- Phase 2a interim POLB 001 Phase 2a FPD Phase 2a topline
Slide 21: Investment Highlights
Investment Highlights Highly experienced team with proven track record High value programmes targeting critical unmet medical needs Multiple near-term clinical value inflection points High partnering potential - pipeline in areas of interest to the pharmaceutical industry Cash runway into 2027, fund
Slide 22: Questions
POOLBEG PHARMA Questions
Slide 23: Appendix
POOLBEG PHARMA Appendix
Slide 24: Leadership Team with Record of Delivering Value
Leadership Team with Record of Delivering Value Track record of building successful life-science companies Cathal Friel Jeremy Skillington PhD Ian O’Connell Executive Chairman Chief Executive Officer Chief Financial Officer 24
Slide 25: Board Includes Leading Non-Executive Directors
Board Includes Leading 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 Ch
Slide 26: An Oral p38 MAPK Inhibitor That Selectively Targets Key Inflammatory Path
POLB 001 An Oral p38 MAPK Inhibitor That Selectively Targets Key Inflammatory Path Without Broad Immunosuppression Phase 2 ready asset with a comprehensive pre-clinical and clinical data package Favourable Safety and Tolerability Profile Designed to Prevent Immunotherapy-Induced CRS 97 subjects dose
Slide 27: Potent and Selective Inhibition of p38 MAPK Signalling
POLB 001 Potent and Selective Inhibition of p38 MAPK Signalling 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 activatio
Slide 28: Reduced Key Indicators of LPS-Induced Systemic Inflammation
POLB 001 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) Placebo 30 mg POLB 001 70 mg POLB 001 150 mg POLB 001 No significant
Slide 29: Grades & Severity of CRS
POLB 001 Grades & Severity of CRS CRS is a common adverse event following CAR T and bispecific antibody treatment 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 anti- cytokine therapy such
Slide 30: POLB 001: Oncology CRS - Regulatory Exclusivity / Patent Timeline
POLB 001 POLB 001: Oncology CRS - Regulatory Exclusivity / Patent Timeline Orphan exclusivity – 10 years* Europe Medical use protection for class of p38 inhibitors – patent application pending SPC TBC Orphan exclusivity – 7 years Method of treatment protection for class of p38 inhibitors – patent gr
Slide 31: POLB 001: Flu & Hypercytokinemia - Regulatory Exclusivity / Patent Timeline
POLB 001 POLB 001: Flu & Hypercytokinemia - Regulatory Exclusivity / Patent Timeline Market Exclusivity – 11 years Orphan exclusivity* – 10 years Europe Medical use protection for class of p38 inhibitors – patent granted, further application pending Market Exclusivity – 5 years Orphan Exclusivity* –
Slide 32: Oral Encapsulated GLP-1 - Regulatory Exclusivity / Patent Timeline
Oral Encapsulated GLP-1 Oral Encapsulated GLP-1 - Regulatory Exclusivity / Patent Timeline Exclusively in-licensed rights – patents granted and further applications pending †* Europe Potential for new patent applications to extend term** Exclusively in-licensed rights – patent granted and further ap
Slide 33: Human Challenge Data has Attracted Expert AI Collaborators
Human Challenge Data has Attracted Expert AI Collaborators Novel influenza drug targets successfully identified and Successfully identified drugs with potential to combat RSV prioritised with existing clinical data in other indications CytoReason’s Partners OneThree Biotech’s Partners “Human challen
Slide 34: Stay in touch
Stay in touch Listed on the London Stock Exchange, AIM ticker: POLB