Mereo BioPharma Group plc · NASDAQ:MREO
Mereo BioPharma — Investor Presentation (May 2026)
52 slides from Mereo BioPharma's investor presentation, May 2026
Slide 1: Corporate presentation
Corporate presentation Advancing promising therapies for rare diseases With purpose, partnership and performance May 2026
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 vision
Our vision We are working toward a future where people and families living with rare diseases, especially those with few or no treatment options, have access to therapies that can transform their lives.
Slide 4: Strategic principles guide our journey
Strategic principles guide our journey • Acquire and develop programs in rare diseases with high prevalence – partner of choice for in-licensing • Focus on our core competencies and experience in rare diseases • Develop pipeline of rare disease programs which have already received significant invest
Slide 5: Two pivotal rare disease programs and a capital efficient model
Two pivotal rare disease programs and a capital efficient model Setrusumab Alvelestat Vantictumab (early-stage) Indication: Indication: Indication: Osteogenesis Imperfecta (OI) Alpha-1 Antitrypsin Deficiency (AATD-LD) Osteopetrosis (ADO2) Current status: Current status: Current status: Phase 3 data
Slide 6: Track record of value-creating partnerships
Track record of value-creating partnerships Potential to provide future milestone payments and royalties • Setrusumab: • Acquired from Novartis • Partnered with Ultragenyx • Mereo retains European rights • Alvelestat: • Acquired from AstraZeneca • Vantictumab: • Licensed to āshibio – Mereo retains E
Slide 7: Addressing patient populations with high unmet needs and significant market opportunities
Addressing patient populations with high unmet needs and significant market opportunities Alpha-1 Antitrypsin Osteogenesis Imperfecta Osteopetrosis Deficiency Rare genetic bone condition Rare genetic progressive lung Rare genetic bone disease Disease leading to problems including disease characteriz
Slide 8: We have achieved key designations available for rare diseases
We have achieved key designations available for rare diseases Setrusumab Alvelestat for Osteogenesis Imperfecta for AATD-associated Lung Disease Orphan Drug Designation - Breakthrough Ultragenyx Designation achieved in 2024 Fast-track Designation - PRV Not relevant designation Orphan Designation - P
Slide 9: Late-stage pipeline
Late-stage pipeline Candidate Preclinical Phase 1 Phase 2 Phase 3 Partner Next milestone Orbit (5 - 25 yrs old) Setrusumab Regulatory Osteogenesis interactions Imperfecta Cosmic (2 - 6 yrs old) Partnering Potential Alvelestat process partnering & AATD-LD ongoing Phase 3 initiation Vantictumab IND in
Slide 10: Patient quote from Brittle Bone Society trustee
“It’s always a pleasure to come and speak with people who are actually making a difference on the ground and making a difference for people like myself and for others in the community. Because it is what you do that helps us to live the lives that we want and that we deserve.” Thines Ganeshamoorthy,
Slide 11: Setrusumab (UGX143)
OIFE Meeting and AGM Setrusumab (UGX143) June 2025 Osteogenesis Imperfecta: a rare genetic bone condition with no FDA or EMA approved therapy
Slide 12: Setrusumab: a >$1Bn market opportunity in OI
Setrusumab: a >$1Bn market opportunity in OI A serious, but not Clear need for Established community mysterious condition treatment options • 80-90% linked to a • Well-established • No FDA / EMA approved mutation in Type I Community groups therapy collagen2,3 (Type I, III (OIFE + national • Current
Slide 13: Setrusumab – a well-defined Mechanism of Action
Setrusumab – a well-defined Mechanism of Action Increased BMD and bone strength, decreased fracture rate 13
Slide 14: Orbit & Cosmic – Phase 3 studies completed
Orbit* & Cosmic** – Phase 3 studies completed Setrusumab vs. bisphosphonates 1:1 Setrusumab vs. placebo 2:1 randomization Objective randomization Double blind Open label 158 subjects ages 5 to 25 years with 69 subjects ages 2 to 6 years with Enrollment OI Types I, III, or IV OI Types I, III, or IV I
Slide 15: Phase 3 results Setrusumab for osteogenesis imperfecta
Phase 3 results Setrusumab for osteogenesis imperfecta Neither study achieved primary endpoint of reduction in AFR1 compared to placebo (Orbit) or bisphosphonates (Cosmic) Both studies demonstrated statistically significant increases in bone mineral density (BMD) Additional data shows reduction in v
Slide 16: Two randomized Phase 3 studies provide large data set
Two randomized Phase 3 studies provide large data set Setrusumab vs. placebo Setrusumab vs. bisphosphonates Objective 2:1 randomization, Double blind 1:1 randomization, Open label Follow-up 18-24 months Follow-up 18-24 months 159 subjects (with >1 AFR) ages 5 to 25 years 69 subjects (with >1 AFR) ag
Slide 17: Baseline fractures are comparable between groups in both studies
Baseline fractures are comparable between groups in both studies Orbit: more severe type III/IV patients exited placebo via rescue criteria Setrusumab vs. placebo Setrusumab vs. bisphosphonates Objective 2:1 randomization, Double blind 1:1 randomization, Open label Follow-up 18-24 months Follow-up 1
Slide 18: Setrusumab is substantially more effective in increasing BMD
Setrusumab is substantially more effective in increasing BMD Setrusumab demonstrated clinically Setrusumab demonstrated clinically & & statistically significant increases statistically significant increases in in BMD vs placebo BMD vs active comparator P<0.0001 P=0.0116 *Based on Month 12 timepoint
Slide 19: Orbit: Setrusumab patients showed an increase in fractures over a low placebo rate
Orbit: Setrusumab patients showed an increase in fractures over a low placebo rate, but were the same as placebo when all fractures were considered (p=ns) Confirmed fractures by x-ray & skeletal survey Primary Endpoint1 Key Secondary Excl. mVFTFS All Fractures # of fractures 142 191 Setrusumab AFR M
Slide 20: Orbit: disease severity reduced and pain/comfort improved in peds/teens
Orbit: In setrusumab patients, disease severity (PGIS) in peds/teens reduced and pain/comfort & sports/activity improved Peds/Teens patients constitute 85% of subjects in Orbit Ph3 study (135/159) Patient Global Impression Pain/Comfort Sports/Activity Scale of Severity (PGIS) POSNA-PODCI POSNA-PODCI
Slide 21: Pain is the most common & impactful sign, symptom or clinical event
Pain is the most common & impactful sign, symptom or clinical event amongst peds and teens with OI Top 5 clinical events, signs and symptoms in Top 5 clinical events, signs and symptoms in proxy proxy peds & adolescents with OI by prevalence1 peds & adolescents ranked as mod-to-severe impact1 74% 63
Slide 22: Cosmic: Setrusumab treatment shows reduced fractures over IV-BP
Cosmic: Setrusumab treatment shows reduced fractures over IV-BP (p=ns) Confirmed fractures by x-ray & skeletal survey Primary Endpoint Key Secondary Total fractures Excl. mVFTFS # of fractures 102 82 Setrusumab Mean (SD, SE) 1.87 (1.69, 0.29) 1.53 (1.53, 0.26) AFR (n=34) Median (Q1, Q3) 2.02 (0.00,
Slide 23: Cosmic: Large reduction in vertebral fractures on setrusumab
Cosmic: Large (59%) reduction in vertebral fractures on setrusumab (p=0.081) Despite more severe type III/IV patients on setrusumab (65% setrusumab vs 54% IV-BP) Radiographically confirmed fractures Comparing 19 vs 46 vertebral All Vertebral Total Fractures Vertebral Fractures fractures* Fractures S
Slide 24: No new safety concerns identified
No new safety concerns identified, reported TEAEs are consistent with the anticipated safety profile for setrusumab • No serious-related TEAEs • No serious related TEAEs Treatment • Low incidence (<2%) severe-related • Low incidence (<3%) severe-related emergent adverse TEAEs TEAE events (TEAE) • Lo
Slide 25: Overall data suggest an impact of setrusumab on OI disease
Overall data suggest an impact of setrusumab on OI disease The largest BMD improvements found in the lumbar spine BMD are associated with reduced vertebral fractures and improved pain and functional outcomes in pediatric patients Improved Lumbar Spine BMD Reduced Vertebral Fractures Improved functio
Slide 26: Sizeable pediatric OI opportunity in Europe validated by Crysvita
Sizeable pediatric OI opportunity in Europe validated by Crysvita ~5,000 identified treated OI peds pts in EU5 ~3,000 peds pts With XLH in EU5 Pediatric patients treated in 5-10 according to Kyowa Kirin1 specialist sites per country ~$383M EMEA 2025 revenue across peds & adults1,2 60%-70% XLH Crysvi
Slide 27: The Ultragenyx partnership, a highly effective collaboration
The Ultragenyx partnership, a highly effective collaboration • Ultragenyx leads and funds the global development plan, including CMC (Dec 2020) • Mereo retains European rights (including UK) and Ultragenyx has the USA and Rest of the World rights • Mereo received $50M upfront and a $9m milestone wit
Slide 28: The Ultragenyx partnership ─ potential attractive cash flows
The Ultragenyx partnership ─ potential attractive cash flows ROW European revenue revenue Flat royalty on EU sales % of proceeds from Ultragenyx (ROW)* Tiered royalty ROW sales Mereo Novartis Ultragenyx Tiered royalties on European revenue ≤ $245M in milestones BioPharma Share of PRV proceeds * Subj
Slide 29: Alvelestat (MPH966)
Alpha 1 UK Meeting Alvelestat (MPH966) September 2023 Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD): a rare progressive lung disease with high unmet need
Slide 30: Alvelestat: a potential >$1bn market opportunity in AATD-LD
Alvelestat: a potential >$1bn market opportunity in AATD-LD A rare progressive Alvelestat targets root Two Phase 2 trials in Significant market disease with high unmet cause of lung damage AATD-LD opportunity need • Presents age 20 to 50 • Lack of AAT → risk of ASTRAEUS • Augmentation revenues with
Slide 31: Alvelestat – Extensive dataset with evidence of efficacy
Alvelestat – Extensive dataset with evidence of efficacy in neutrophil driven respiratory disease and large safety database • 9 completed Clinical studies ~1,200 patients Phase 2 Bronchiectasis (Stockley et al 2013) • 60 mg alvelestat or placebo BD for 4 weeks • 38 randomized, 16 alvelestat, 22 plac
Slide 32: Symptomatic improvement (SGRQ) in AATD patients supports Ph3 strategy
Symptomatic improvement (SGRQ) in AATD patients at early stages of respiratory disease supports Ph3 strategy for earlier intervention prior to FEV1 decline ATALANTa study (non-augmentation subgroup) – Change in SGRQ Total Score • ATALANTa study – Non-augmentation subgroup (median FEV1 89.3%). Betwee
Slide 33: Decreasing rate of elastin breakdown
Decreasing rate of elastin breakdown – Alvelestat is expected to be a long-term disease-modifying therapy going beyond augmentation therapy Long-term effect of alvelestat Reduction in desmosine for 240 mg alvelestat at 12 weeks favorable to augmentation therapy Desmosine levels have been shown to Au
Slide 34: In AATD patients every component of the SGRQ score worsens with exacerbation frequency
In AATD patients every component of the SGRQ score worsens with exacerbation frequency SGRQ Components vs. Exacerbation History in last year in AATD Patients, n=2,4561 0 exacerbations 1 exacerbation 2 or more exacerbations 100 90 80 69 70 59 60 53 55 50 50 41 40 37 38 37 40 29 30 26 20 10 0 SGRQ Sym
Slide 35: Preliminary data support a protective effect on acute exacerbations
Preliminary data support a protective effect of alvelestat on acute exacerbations in AATD-LD • Reduction in acute exacerbations observed in % patients with exacerbations by week 16 ATALANTa + ASTRAEUS combined, all doses n=161 Phase 2 program o Effect observed across all levels of GOLD severity1 25%
Slide 36: Data from two AATD Phase 2 studies demonstrated good overall safety
Data from two AATD Phase 2 studies, demonstrated good overall safety vs. placebo and builds on extensive safety database Alvelestat 240 mg Alvelestat 120 mg Placebo n=40 (%) n=54 (%) n=67 (%) SAE 3 (7.5) 1 (1.9) 0 (0) Adverse Events of 11 (27.5) 10 (18.5) 18 (26.9) Special Interest Infections requir
Slide 37: Well-defined plan for Phase 3 registrational trial in AATD-LD
Well-defined plan for Phase 3 registrational trial in AATD-LD Earlier stage severe PI*ZZ patients observed to have Clinical greater response in SGRQ (Total and activity) Data Earlier stage patients (higher FEV1) may be more likely to show spirometry benefit Broader Early → late stage – Pi*ZZ genotyp
Slide 38: Vantictumab
Vantictumab Osteopetrosis: a rare bone disease with high unmet need
Slide 39: Vantictumab has the potential to address the opportunity in ADO2
Vantictumab has the potential to address the significant opportunity in underserved rare bone disorder, ADO2 The Unmet Need in ADO21 Vantictumab’s Potential to Address the Need ADO2 is an inherited metabolic bone disorder characterized by impaired osteoclast function Dense, brittle bones lead to mul
Slide 40: Vantictumab development timelines
Vantictumab development timelines VAN sig. decreased areal BMD in ADO2 mice and improved measures of bone structure and quality2 2011-2017 Vantictumab investigated ~100 patients in 4 Phase 1a/b oncology trials Biomarker evidence highlighted potent impact on osteoclast function & high bone turnover w
Slide 41: Key milestones, other programs and financials
Key milestones, other programs and financials
Slide 42: Mereo is in a strong position to execute into 2027
Mereo is in a strong position to execute into 2027 Financial discipline delivers cash runway into mid-2027. Following Phase 3 Orbit and Cosmic results, preserving cash through delays and reductions in pre-commercial and manufacturing activities. Setrusumab Alvelestat Vantictumab Regulatory interacti
Slide 43: Other programs could hold future upside
Other programs could hold future upside Other current partnerships Leflutrozole – global rights out-licensed to ReproNovo for further development in infertility in men with low testosterone • Upfront plus up to $64 million in milestones and royalties Navicixizumab – global rights out-licensed to Fen
Slide 44: Financial highlights
Financial highlights Cap Table ADSs (March 2026) (in thousands) Shareholders > 2% holding 62,741 Shareholders < 2% holding 96,875 Cash runway into mid-2027 $36.2 million as of Share capital – Issued March 31, 2026 as of March 31, 20261 159,616 Potential Future Dilution: Warrants and other equity2 2,
Slide 45: Appendix
OIFE Topical Appendix Meeting June 2023
Slide 46: Phase 2b ASTEROID study demonstrated increased BMD in adults with OI
Phase 2b ASTEROID study demonstrated increased BMD in adults with OI Type I, III and IV Statistically significant dose-dependent increases in areal BMD by DXA following 12 months of setrusumab therapy 12 6 Lumbar Spine Total Hip Femoral Neck Mean (SEM) Change From Baseline at Month 12, % *** * 10 8
Slide 47: Phase 2 Orbit showed increased BMD and Z-score increases
Phase 2 Orbit showed increased BMD and Z-score increases1 Improvements consistent across all OI Types studied Lumbar Spine BMD1 Lumbar Spine BMD1 % Change from Baseline Z-Score Change from Baseline 1.25 ± 0.17 22.25 ± 2.71 p<0.0001 p<0.0001 0.85 ± 0.13 14.19 ± 2.15 0.58 ± 0.10 9.16 ± 1.43 Change in
Slide 48: Orbit Phase 2 – increase in BMD observed in all age groups
Orbit Phase 2 – increase in BMD observed in all age groups,1,2 Younger patients showed a 29% increase in BMD at Month 12 Lumbar Spine BMD by Age Group % Change from Baseline to Month 12 Data consistent with ASTEROID Phase 2 data in adults2 Age Groups 1. Data as of June 2024; 2. Lewiecki EM et al. Ev
Slide 49: Treatment with setrusumab resulted in a 67% reduction in annualized fracture rate
Treatment with setrusumab (mean duration of 16 months) resulted in a 67% reduction in annualized fracture rate (AFR) compared to pre-treatment AFR 6 y/o male patient with Type IV OI, increased mobility after 17 months on study 49
Slide 50: Building a foundation for commercial success in Europe
Building a foundation for commercial success in Europe Setting the baseline: Impact / Regulatory scientific advice & Validated “library” of data Burden of Disease in OI in Adult HTA & Payor advice sources to answer and Pediatric patients across authorities’ questions: at time Mereo European territor
Slide 51: Mereo IP strategy
Mereo IP strategy Candidate European IP Strategy • Setrusumab antibody (2028) Setrusumab • Use of setrusumab for treating osteogenesis imperfecta (2037) Osteogenesis Imperfecta o Possibility of SPC to 2041/2042 • Potential additional IP to 2042 • Tosylate salt of alvelestat (2030) • Use of alvelesta
Slide 52: Thank you
Thank you With a special thank you to members of our community, who generously agreed to be featured in this presentation.
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