Poolbeg Pharma (POLB) investor relations material

Pipeline overview

• POLB 001, an oral p38 MAPK inhibitor for immunotherapy-induced CRS, is the lead programme; the pipeline also includes an oral encapsulated GLP-1R agonist for obesity, plus influenza, RSV and AI drug-discovery programmes.

• POLB 001 is positioned as a preventative approach that could reduce CRS and broaden cancer immunotherapy delivery from specialist centres to community hospitals and home-based care.

POLB 001 rationale and evidence

• p38 MAPK inhibition is intended to reduce multiple pro-inflammatory cytokines without ablating immune function; the presentation cites a favourable safety profile versus existing treatment options.

• In a Phase 1b LPS human challenge, POLB 001 showed a clear dose response and reduced IL-6 by 57.4% and 63.5% at 70 mg and 150 mg; IL-8 reductions were 80.7% and 76.7%, respectively.

• The Phase 1b trial reported excellent safety and tolerability; it was a single-site, randomized placebo-controlled study with 9 participants per group and exploratory endpoints.

TOPICAL trial and development

• The first-in-patient TOPICAL trial is evaluating POLB 001’s safety and ability to reduce CRS in ~30 relapsed or refractory multiple myeloma patients receiving teclistamab supplied by Johnson & Johnson.

• Interim safety data from 6 patients received a positive recommendation to continue as planned, with no protocol changes; recruitment continues across UK sites, with further sites activating.

• FDA pre-IND feedback in May 2026 clarified the nonclinical package, indication, Phase 3 design and endpoints, supporting a proposed route to market and pivotal-trial initiation through partnering.

• POLB 001 has FDA Orphan Drug Designation for prevention of T-cell engager bispecific antibody-induced CRS; key patents provide coverage to at least 2044.