Mereo BioPharma Group plc · NASDAQ:MREO
Mereo BioPharma — Investor Presentation (October 2026)
49 slides from Mereo BioPharma's investor presentation, October 2026
Slide 1: Corporate presentation
Corporate presentation Advancing promising therapies for rare diseases With purpose, partnership and performance October 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 programs in rare bone and respiratory diseases with high prevalence • Partner of choice for in-licensing for programs that have already received significant investment • Focus on our core competencies and experience in rare diseases • Partner our prog
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: Partnered wit
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 • Partnered with Sentynl for US rights • Mereo retains
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) Potential option Alvelestat exercise and AATD-LD Phase 3 initiation Vantictumab First Clinical Osteopetros
Slide 10: Patient community quote
“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: 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 159 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 14: Baseline characteristics for Phase 3 studies
Baseline characteristics for Phase 3 studies Setrusumab: N=107 Placebo: N=52 Setrusumab: N=34 IV-BP: N=35 46% 44% 40% 40% 40% 40% 37% OI 35% Type 19% 20% 21% 17% % split Type I Type III Type IV Type I Type III Type IV 1.1 0.6 0.7 0.4 0.0 Demo- -1.1 graphics* -1.6 -1.7 -2.1 -2.1 Z-Scores -2.6 -2.6 -2
Slide 15: Setrusumab for OI: Phase 3 status
Setrusumab for OI: Phase 3 status 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 vertebral fractures an
Slide 16: 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 17: Orbit: disease severity reduced and pain/comfort & sports/activity improved
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 18: Additional analyses support meaningful reductions in AFR in patients with >3 fractures
Additional analyses support meaningful reductions in AFR in patients with >3 fractures at baseline in previous 2 years Control AFR lower than the anticipated rates Post-hoc analyses revealed that fracture assumed for planning rates may have been impacted by: • More frequent OI Type III in Setrusumab
Slide 19: Orbit post-hoc analysis shows numerically lower AFR vs. placebo
Orbit post-hoc analysis shows numerically lower AFR on setrusumab vs. placebo (p=0.063) Confirmed fractures by Baseline and 12-mo intervening “For-Cause” x-rays Cumulative number of fractures Clinical fractures, excluding survey Excluding skeletal survey Setrusumab # of fractures 51 AFR (n=30) Mean
Slide 20: Cosmic post-hoc analysis shows significantly lower AFR vs. IV-BP
Cosmic post-hoc analysis shows significantly lower AFR in patients treated with setrusumab vs. IV-BP (p=0.009) Confirmed fractures by Baseline and 12-mo intervening “For-Cause” x-rays Cumulative number of fractures Clinical fractures, excluding survey Excluding skeletal survey Setrusumab # of fractu
Slide 21: 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 22: Setrusumab for OI: Summary and next steps
Setrusumab for OI: Summary and next steps • Neither Orbit nor Cosmic met the primary endpoint of reducing annualized fracture rate (AFR) • Significant improvements occurred in a number of key endpoints including BMD, Z-score, vertebral fractures and, relative to placebo, patient-important outcomes •
Slide 23: 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 24: 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 25: 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 26: 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 27: 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-LD2 opportunity need • Presents age 20 to 50 • Lack of AAT → risk of ASTRAEUS • Augmentation revenues with
Slide 28: 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 29: Effect of alvelestat on moderate/severe exacerbations
Effect of alvelestat on moderate/severe exacerbations % patients with exacerbations by week 16 Annualized exacerbation rate by week 16 ATALANTa + ASTRAEUS combined, all doses, n=161 ATALANTa + ASTRAEUS combined3, all doses, n=161 26% 1.09 Placebo Placebo Alvelestat wk 16 Alvelestat wk 16 -48% -36% 1
Slide 30: 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 31: Current Phase 3 registrational trial in AATD-LD
Current Phase 3 registrational trial in AATD-LD Evidence of efficacy across biomarkers, patient reported Clinical outcomes and exacerbations Data Existing data in broad patient populations including early & late-stage disease, including on background augmentation Broader Estimated ~220-250 patients
Slide 32: Option and licence agreement with Sentynl
Option and licence agreement with Sentynl Sentynl Therapeutics Option fee with short exercise period to collaborate on OPTION refining the global Phase 3 study design ➢ Commercial-stage, US- • Timing to facilitate initiation of the Phase 3 in early 2027 based biopharma company assuming exercise foll
Slide 33: Vantictumab
Vantictumab Autosomal dominant osteopetrosis Type 2 (ADO2): a rare bone disease with high unmet need
Slide 34: 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 Disease overview of ADO21 Vantictumab’s Potential to Address the Need2 ADO2 is an inherited metabolic bone disorder characterized by impaired osteoclast function Dense, brittle bones lead to
Slide 35: 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 36: Key milestones, other programs and financials
Key milestones, other programs and financials
Slide 37: Mereo is in a strong position to execute into late 2027
Mereo is in a strong position to execute into late 2027 Financial discipline delivers cash runway into late-2027. Following Phase 3 Orbit and Cosmic results, preserving cash through delays and reductions in pre-commercial and manufacturing activities. Setrusumab Alvelestat Vantictumab Regulatory int
Slide 38: Other programs could hold future upside
Other programs could hold future upside Partner Asset Leflutrozole Navicixizumab MOA Aromatase inhibitor Anti-DLL4/VEGF bi-specific Rights Global rights out-licensed Global rights out-licensed Indication Male Fertility Ovarian Cancer Upfront plus up to $64M Payments of up to $300M Terms in milestone
Slide 39: Financial highlights
Financial highlights Cap Table ADSs (June 2026) (in thousands) Shareholders > 2% holding 58,932 Shareholders < 2% holding 100,687 Cash runway into late-2027 $30.1 million as of Share capital – Issued June 30, 2026 as of June 30, 20261 159,619 Potential Future Dilution: Warrants and other equity2 2,2
Slide 40: Appendix
OIFE Topical Appendix Meeting June 2023
Slide 41: Mereo IP strategy
Mereo IP strategy Candidate 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 alvelestat in pati
Slide 42: 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 43: 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 43
Slide 44: 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 45: 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 46: Symptomatic improvement (SGRQ) in early-stage AATD patients supports Ph3
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 • Respiratory health measured by SGRQ is significantly impaired from ear
Slide 47: 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 48: Pain is the most common & impactful sign, symptom amongst peds with OI
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 49: 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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