Mereo BioPharma Group plc · NASDAQ:MREO
Mereo BioPharma — Investor Presentation (February 2022)
34 slides from Mereo BioPharma's investor presentation, February 2022
Slide 1: Unlocking the potential of novel targets for cancer and rare diseases
Unlocking the potential of novel targets for cancer and rare diseases February 2022 Mereo BioPharma Group plc NASDAQ: MREO
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: Mereo – A Rare Disease and Oncology Company
Mereo – A Rare Disease and Oncology Company Our Mission To improve the lives of patients with rare diseases and cancer Strategic Principles #1 #2 #3 #4 Acquire & develop programs in Commercialize rare disease Partner programs where it Focus on our core oncology and rare diseases products makes strat
Slide 4: A Diversified Mid-Late Stage Pipeline
A Diversified Mid-Late Stage Pipeline Core Programs Product candidate / indication Phase 1a Phase 1b Phase 2 Phase 3 Next Milestone Etigilimab Phase 1b/2 full enrolment Solid tumors and data Phase 2 cohort expansion Alvelestat COPD/CF/Bronchiectasis AATD Alpha-1 antitrypsin deficiency COVID-19** AAT
Slide 5: Etigilimab (MPH-313)
TSO Mereo BioPharma ~~ Etigilimab (MPH-313)
Slide 6: The role of TIGIT in Immune Cell responses
The role of TIGIT in Immune Cell responses TIGIT* is a Negative Regulator of T cell Responses Blocking TIGIT in cancer • Negative regulator of T-cell response What is TIGIT? • Competes with CD226 for PVR, and disrupts CD226 activation • Highly expressed on regulatory T cells (tregs), Where is TIGIT
Slide 7: Etigilimab – Early but promising initial Phase 1b/2 data
Etigilimab – Early but promising initial Phase 1b/2 data Efficacy Safety Biomarker data • In Phase 1a monotherapy – seven subjects (30%, n=23) with stable disease • Target engagement demonstrated in Phase • Majority heavily pre-treated with • No DLTs observed; generally well-tolerated 1a prior check
Slide 8: ACTIVATE: Guiding Principles for Differentiated Clinical Development of Etigilimab
Guiding Principles for Differentiated Clinical Development of Etigilimab Leverage TIGIT Biology: Expression of TIGIT/PVR CPI-naïve Populations Higher PoS for IO combination Low ORR with CPIs Demonstrate benefit of adding TIGIT Clinical data from Phase 1a/b Potential signal in gynonc High Unmet Need
Slide 9: ACTIVATE Phase 1b/2 Study Design: Multiple Parallel Cohorts
ACTIVATE Phase 1b/2 Study Design: Multiple Parallel Cohorts Evaluating Etigilimab + Nivolumab in Select Recurrent Advanced/Metastatic Solid Tumors Study Endpoints 6 cohorts, N=~125 Primary Cohort A: Endometrial, CPI-naïve Overall Response Rate Investigator-assessed (RECIST 1.1; Collect and hold) Coh
Slide 10: ACTIVATE Trial: Preliminary Efficacy
ACTIVATE Trial: Preliminary Efficacy Investigator RECIST 1.1 assessment per timepoint* Objective Cohort Responses A B C E F G H Total by RECIST EC H&N Cervical TMB- Uveal- 6 EC Ovarian evaluable (CPI- H/MSS Sarcoma-5 (Post- n=201 naïve) GCT-1 CPI) Efficacy analysis2 N=0 N=1 N=1 N=4† N=12† N=0 N=4 n=
Slide 11: Preliminary Efficacy by Subject: Key Biomarker Correlations
Preliminary Efficacy by Subject: Key Biomarker Correlations* Benefit in PD-L1 negative/PVR positive patients Subject ID Cohort/Tumor PD-L1 status Other pertinent biomarkers Response and Study Status cCR, 102-101-C001 Positive PVR – N/A Cervical cancer Off study^ uSD 102-101-E025† TMB-H/MSS Positive
Slide 12: ACTIVATE Trial: Interim Biomarker Analysis
ACTIVATE Trial: Interim Biomarker Analysis Tumor # Response PDL1 PVR TIGIT Cervical C001 CR positive n/a n/a TMB-H/MSS E025 SD positive 90% positive Cervical Ovarian H024 PR negative 65% positive H029 SD negative 55% positive Uveal F020 SD negative 70% negative F030 SD n/a n/a n/a n/a (not available
Slide 13: Summary of AEs (Safety Analysis Set - n=22)
Summary of AEs (Safety Analysis Set - n=22)* • AEs related to study treatment occurred in 10 subjects – mostly low grades • There were 18 events related to study treatment • Most were related to both etigilimab and nivolumab • The most common treatment-related AEs were due to skin reactions – 7 even
Slide 14: Etigilimab - Anti-TIGIT Antibody With Differentiated Development Path
Etigilimab - Anti-TIGIT Antibody With Differentiated Development Path Etigilimab - ACTIVATE Biomarker Strategy IgG1 antibody 1b/2 data • Early signs of efficacy esp • IgG1 backbone activates gynonc - 1CR, 1PR and 4 SDs of ACTIVATE Trial antibody-dependent cellular 15 patients with a minimum of • Bio
Slide 15: Alvelestat (MPH-966)
TSO Mereo BioPharma ~~ Alvelestat (MPH-966)
Slide 16: Alvelestat - An Oral Inhibitor Of Neutrophil Elastase (NE)
Alvelestat - An Oral Inhibitor Of Neutrophil Elastase (NE) ➢ Alvelestat is a potent, reversible, oral inhibitor of neutrophil elastase, with safety established in >1000 subjects Two development pathways : Alpha-1 anti-trypsin Signal Seeking deficiency (AATD) AATD - two Phase II PoC Signal seeking st
Slide 17: AATD-Lung Disease - A Rare Progressive Disease With A High Unmet Need
AATD-Lung Disease - A Rare Progressive Disease With A High Unmet Need Alph-1 antitrypsin (AAT) inhibits the action of neutrophil elastase. Individuals who lack AAT or produced misfolded inactive AAT are at risk from progressive lung damage and early onset emphysema. AATD-LD Unmet Need • Current trea
Slide 18: Linking Biomarkers to Pathological Pathway
Linking Biomarkers to Pathological Pathway AATD-Lung Disease Pathogenic Pathway Blood NE Aα-Val360 Desmosine CT Density Elastase Activity Unopposed NE Alveolar Elastin Lung Tissue Breakdown Loss/Emphysema Increased elastase Increase in elastase- Elastin breakdown activity driven target fragments (fi
Slide 19: Study Design: ASTRAEUS, A 12-week PoC Study In Participants With AATD-LD
Study Design: ASTRAEUS, A 12-week PoC Study In Participants With AATD-LD A 12-week Study Treating Participants Who Have alpha1-antitrypsin-related COPD with alvelestat or Placebo. 12 week dosing period, 4 weeks follow-up Expected to enrol ~ 100 patients Alvelestat Placebo bid Randomization Alvelesta
Slide 20: ATALANTa A 12 Week Investigator Led Study Of Alvelestat In AATD-LD
ATALANTa A 12 Week Investigator Led Study Of Alvelestat In AATD-LD Mark Dransfield, University of Alabama at Birmingham • ATALANTa includes patients who are currently on augmentation therapy Alvelestat for the Treatment of ALpha-1 ANTitrypsin Deficiency “ATALANTa” Alvelestat Placebo bid N=33 Randomi
Slide 21: Signal Seeking Studies For Indication Expansion
Signal Seeking Studies For Indication Expansion * Graft vs. host disease - Bronchiolitis Obliterans Syndrome COVID-19 GVHD BOS* • Neutrophil extracellular traps (NETosis) is a pathogenic mechanism in COVID- • NE is a pro-inflammatory and pro-fibrotic driver of lung disease in BOS and BOS Rationale 1
Slide 22: Alvelestat Key Differentiating Features
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 – elastase inh
Slide 23: Setrusumab (BPS-804 / UX143)
Setrusumab (BPS-804 / UX143)
Slide 24: Osteogenesis Imperfecta (OI): A Rare Genetic Bone Disease
Osteogenesis Imperfecta (OI): A Rare Genetic Bone Disease • A rare genetic bone disease, linked to a mutation in Type I collagen.1,2 • Symptoms include frequent bone fractures, skeletal deformities, pain, respiratory and gastric problems – early diagnosis & no FDA or EMA approved therapies What is O
Slide 25: Summary of Phase 2b Results from ASTEROID
Summary of Phase 2b Results from ASTERIOD Study Overview Efficacy Results Safety Findings Clear, dose-dependent, statistically significant bone building effect (DXA scans) at multiple anatomical sites and consistent Phase 2b study (n=90) blinded with 3 dose across all OI subtypes studied* Setrusumab
Slide 26: Ultragenyx – Mereo Partnership and Long Term Plan
Ultragenyx – Mereo Partnership and Long Term Plan Mereo – Ultragenyx partnership Clinical Development Commercialization in Mereo Territories • Ultragenyx funding global development • Led by Ultragenyx & supported by Mereo plan in pediatrics and adults • Phase 2/3 pediatric study in OI in patients •
Slide 27: Upcoming Milestones
TSO Mereo BioPharma ~~ Upcoming Milestones
Slide 28: Upcoming Key Milestones & Opportunities
Upcoming Key Milestones & Opportunities Upcoming Milestone For Core Programs Product Candidate Indication 2022 2023 2024 Partner Next Milestone Phase 1b/2 full enrolment Etigilimab Solid tumors Phase 1b/2 basket study with potential cohort expansion and data Phase 2 cohort expansion AATD Phase 2 PoC
Slide 29: Financial Highlights
Financial Highlights Cap Table ADSs1 (September 30, 2021) (in thousands) Cash runway into 2024 Shareholders > 5% holding 47,489 $134.2 million (£99.7m) as of Shareholders < 5% holding 63,613 Share capital - Issued and outstanding 111,102 September 2021, including: • $50 million upfront in January 20
Slide 30: Investment Highlights
Investment Highlights Developing therapeutics for oncology and rare diseases based on novel targets with strong biological rationale • Etigilimab – an anti-TIGIT antibody with early promising data in an ongoing Phase 1b/2 basket study • Alvelestat – an oral neutrophil elastase inhibitor in Phase 1b/
Slide 31: Mereo BioPharma Group plc
Mereo BioPharma Group plc One Cavendish Place London, W1G 0QF UK +44 (0)333 0237 300 Mereo Biopharma Group plc
Slide 32: Our Core Programs – A Diversified Mid-Late Stage Pipeline
Our Core Programs – A Diversified Mid-Late Stage Pipeline • An IgG1 anti-TIGIT antibody • Phase 1b/2 ACTIVATE basket trial combination of etigilimab with nivolumab in multiple solid tumors Etigilimab • Early clinical benefit observed in gyn/onc tumors with good safety profile • Integral biomarker st
Slide 33: Etigilimab - designed to balance interaction with different cell populations
Etigilimab - designed to balance interaction with different cell populations Etigilimab Depletes High Expressing T-reg Cells But Spares Effector T- Pre-clinical Model Showing PVR Binding And NK Cells ➢ Activation of NK and T-cell subpopulations ➢ Reduction of T-regulatory cells ➢ Increased CD8/Treg
Slide 34: ACTIVATE Phase 1b/2 Early Data Summary and Conclusions
ACTIVATE Phase 1b/2 Early Data Summary and Conclusions Efficacy Safety Biomarker Data • Preliminary signs of efficacy noted with 1CR, 1PR and 4 SDs out of 15 patients with a minimum of one scan • Correlation of clinical benefit rates with PVR • Potential early signal in gynonc cohorts • The combinat
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