Mereo BioPharma Group plc · NASDAQ:MREO
Mereo BioPharma — Investor Presentation (November 2020)
35 slides from Mereo BioPharma's investor presentation, November 2020
Slide 1: Unlocking the potential of novel targets for cancer and rare diseases
Unlocking the potential of novel targets for cancer and rare diseases November 2020 Mereo BioPharma Group plc NASDAQ: MREO, AIM: MPH
Slide 2: Disclaimer
Disclaimer This presentation has been prepared by Mereo BioPharma Group plc (the “Company”) solely for your information and for the purpose of providing background information on the Company, its business and the industry in which it operates or any particular aspect thereof. For the purposes of thi
Slide 3: Our Core Purpose, Strategy & Vision guide us
Our Core Purpose, Strategy & Vision guide us SUMMARY Mission Strategy Our Track Record Fundamentals • #1 priority – the patients Improving lives of • In-licence or acquire • Acquired/in-licensed 6 Our partners we seek to serve patients with oncology programs for oncology and programs with Phase 1b/2
Slide 4: Late Stage Diversified Clinical Pipeline
Late Stage Diversified Clinical Pipeline Core Programs Product Candidate / Indication Phase 1a Phase 1b Phase 2 Phase 3 Next Milestones Etigilimab Phase 1b/2 Solid tumors Alvelestat Alpha-1 antitrypsin deficiency Phase 2 AATD Phase 1b/2 COVID COVID-19 Setrusumab Extension study Osteogenesis imperfec
Slide 5: Experienced Management Team and Board
Experienced Management Team and Board Board of Directors Dr. Peter Fellner Chairman Dr. Denise Scots-Knight The Executive Director, Leadership CEO & Co-Founder Team Peter Bains Dr. Denise Scots-Knight Christine Fox Dr. Alastair Mackinnon Former CEO, Sosei Heptares Chief Executive Officer Chief Finan
Slide 6: Etigilimab
—Sw Mereo BioPharma ~~ Etigilimab
Slide 7: TIGIT is a negative regulator of T cell responses
TIGIT is a negative regulator of T cell responses T cell Immunoreceptor with IG and ITIM domains (TIGIT) Negative regulator of T cell response: • Competes with CD226 for PVR, disrupts CD226 activation, and directly inhibits T cells in cis Expressed on CD4, CD8 and NK cells and is elevated upon activ
Slide 8: Etigilimab is an IgG1 anti-TIGIT antibody with inhibitory and ADCC characteristics
Etigilimab is an IgG1 anti-TIGIT antibody with inhibitory and ADCC characteristics Control Ab Effector function competent Effector function silent Mereo Biopharma Group plc 7
Slide 9: Phase 1 study design
Phase 1 study design Phase 1A Phase 1B Dose Escalation 20mg/kg Q2W Dose Escalation N=3+3 Tumor types for inclusion 10mg/kg Q2W Tumor types for inclusion 20mg/kg Q2W + nivolumab in dose escalation cohort: N=3+3 in dose escalation cohort: N=3+3 • Histologically confirmed • Histologically confirmed adv
Slide 10: Phase 1a best % reduction in target lesion size & duration on study
Phase 1a best % reduction in target lesion size & duration on study Etigilimab monotherapy Waterfall Plot of Best Percentage Change in SLD from Baseline (ITT Population) Duration on Study Patient Dose Cancer Patient Dose Cancer 004-013 10mg/kg adenocarcinoma of the pancreas 001-025 20mg/kg* Endometr
Slide 11: Phase 1b best % reduction in target lesion size & duration on study
Phase 1b best % reduction in target lesion size & duration on study Etigilimab + nivolumab Waterfall 120 Plot of Best Percentage Change in SLD from Baseline (ITT Population) Duration on Study Head and Neck Cancer, 20.0 mg/kg + nivolumab Gastric Cancer, 20.0 mg/kg + nivolumab 100 NSCLC, 3.0 mg/kg + n
Slide 12: Phase 1 clinical & biomarker findings
Phase 1 clinical & biomarker findings Seven subjects (30%, n=23) had stable disease as their best response in the single-agent Phase 1a cohort • Majority of patients with tumor types typically non-responsive to anti-PD1 agents One partial response and 1 stable disease evident in initial Phase 1b (co
Slide 13: Phase 1b/2 basket study scheme
Phase 1b/2 basket study scheme HNSCC* Primary endpoint • Overall Response Rate Cervical carcinoma* Secondary • Safety and Tolerability Initiation of Phase Gastric/GE carcinoma* • PK/PD 1b/2 study planned • Duration of response for this quarter Exploratory Endometrial carcinoma • Focus on IO-naïve •
Slide 14: Biomarkers established for tumor analysis and potential patient selection
Biomarkers established for tumor analysis and potential patient selection Robust multiplex IHC assays and staining for PVR, TIGIT, and ~15 immune related tumor parameters Mereo Biopharma Group plc 13
Slide 15: Summary: Mereo's etigilimab has key differentiating features
Summary: Mereo’s etigilimab has key differentiating features High affinity Phase 1a and Phase 1b Advanced Biomarker dose escalation and capabilities in place IgG1 antibody safety data available • IgG1 backbone activates • Active IND and drug product • Target engagement of etigilimab antibody-depende
Slide 16: Alvelestat (MPH-966)
—Sw Mereo BioPharma ~~ Alvelestat (MPH-966)
Slide 17: Alvelestat mechanism of action
Alvelestat mechanism of action Potent, reversible, oral inhibitor of neutrophil elastase (NE) Compared to natural inhibitors i.e., alpha-1 antitrypsin native protein • Comparable association constant • Not susceptible to oxidative inactivation at sites of inflammation • Active against both soluble a
Slide 18: Signal seeking in Neutrophil-driven diseases (1): cystic fibrosis
Signal seeking in Neutrophil-driven diseases (1) cystic fibrosis – anti-inflammatory and clinical effect Desmosine alvelestat:placebo ratio at week 4 Alvelestat decreases Trial Summary urinary and plasma DESs in CF (n=56); *P<0.05 • Double-blind, placebo controlled • > 16 years • Clinical diagnosis
Slide 19: Signal seeking in Neutrophil-driven diseases (2): bronchiectasis
Signal seeking in Neutrophil-driven diseases (2) bronchiectasis – anti-inflammatory and clinical effect Spirometry at week 4 Lung Function Improvement over Trial Summary P Value Parameter placebo LSM(SEM) • Double-blind, placebo controlled FEV1 100 mls (34.0) 0.006 SVC 130 mls (74.0) 0.079 • 18-80 y
Slide 20: Alpha-1 antitrypsin deficiency (AATD) – disease impact
Alpha-1 antitrypsin deficiency (AATD) – disease impact A rare, serious genetic AATD-Lung Disease disorder that results in Natural protease inhibitor early onset pulmonary is either absent or levels are insufficient disease and dysfunctional Unopposed neutrophil elastase → progressive and severe lung
Slide 21: AATD – current standard of care
Alpha-1 antitrypsin deficiency (AATD) – current standard of care A rare, serious genetic Clinical Management disorder that results in ‘COPD’ maintenance treatment, personal lifestyle early onset pulmonary management, e.g., avoidance of smoking and disease pollution Intravenous plasma-derived augment
Slide 22: Astraeus Phase 2 study design in Alpha-1 Antitrypsin Deficiency
Astraeus Phase 2 study design (NCT03636347) in Alpha-1 Antitrypsin Deficiency A 12-week Study Treating Participants Who Have alpha1-antitrypsin-related COPD with Alvelestat (MPH966) or Placebo. (ASTRAEUS) Primary Endpoint • Within-individual % change in N = 165 12 week dosing period plasma desmosine
Slide 23: Alvelestat for the Treatment of AATD “ATALANTa”
Alvelestat (MPH966) for the Treatment of ALpha-1 ANTitrypsin Deficiency “ATALANTa” (Investigator-initiated – Prof Mark Dransfield, UAB) N = 66 12 week dosing period 1:1 active to placebo Primary Endpoint Alvelestat Placebo bid N=55 • Within-individual % change in plasma desmosine/isodesmosine Random
Slide 24: Alvelestat MOA in NETosis-driven disease (COVID-19)
Alvelestat MOA in NETosis-driven disease (COVID-19) Alvelestat shows preclinical activity in NETosis in Adapted from EBioMedicine Volume 59, 102942, Sept 01, 2020 mouse models Mereo Biopharma Group plc 23
Slide 25: COVID-19 Phase 1b/2 Investigator-initiated study “COSTA”
COVID-19 Phase 1b/2 Investigator-initiated study “COSTA” (Prof. Mike Wells, UAB) Primary Endpoint • Safety and tolerability (Day 60) • Mortality (Day 90) 10 day dosing period N = 15 2:1 active to placebo Secondary Endpoints Alvelestat bid Pharmacodynamic Biomarkers of: • NETosis Randomisation Follow
Slide 26: Alvelestat key differentiating features
SUMMARY Alvelestat key differentiating features Profile for long term treatment of AATD lung disease and NETosis-driven diseases Rapid onset of Combination of Highly specific action < 4 hours twice daily dosing neutrophil elastase High neutrophil to > 90% enzyme and high neutrophil inhibition – elas
Slide 27: Setrusumab (BPS-804)
—Sw Mereo BioPharma ~~ Setrusumab (BPS-804)
Slide 28: Anti-Sclerostin as a target for OI
Anti-Sclerostin as a target for OI Mereo Biopharma Group plc 27
Slide 29: Osteogenesis imperfecta (OI)
Osteogenesis imperfecta (OI) • Rare genetic bone disease, key symptoms include: • Frequent bone fractures, skeletal deformities, pain and respiratory insufficiency • 85-90% linked to a mutation in Type I collagen1,2 • Tangible symptomatology leads to early diagnosis: • More than 55,000 patients in U
Slide 30: Summary of phase 2b data
Summary of phase 2b data Hierarchical primary Secondary end-points Study not powered to Phase 2b – 110 adult end-point based on based on areal bone show a difference in OI patients comparing HRPQCT mineral density fracture rates but a 3 doses of setrusumab • Trabecular vBMD at the measured by DXA tr
Slide 31: Upcoming Milestones
—Sw Mereo BioPharma ~~ Upcoming Milestones
Slide 32: Mereo upcoming key milestones & opportunities
Mereo upcoming key milestones & opportunities Product Candidate / Indication 2020 2021 2022 Etigilimab Solid tumors Phase 1b/2 study Alvelestat Alpha-1 antitrypsin deficiency Phase 2 PoC study ASTRAEUS and ATALANTA COVID-19 Phase 1b/2 study COSTA Setrusumab Adult 12-m extension study Osteogenesis im
Slide 33: Investment highlights
Investment highlights Developing therapeutics for oncology and rare diseases based on novel targets with strong biological rationale Etigilimab is an anti-TIGIT antibody which actively engages FcyR in a Phase 1b/2 oncology basket study Alvelestat is an oral neutrophil elastase inhibitor in Phase 2 s
Slide 34: Thank You
Thank You Mereo BioPharma Group plc N A S D A Q : M R E O, A I M : M P H
Slide 35: Mereo BioPharma Group plc
Mereo BioPharma Group plc One Cavendish Place London, W1G 0QF UK +44 (0)333 0237 300 Mereo Biopharma Group plc 34
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