Oxurion Nv · EURONEXT:OXUR
Oxurion Nv — Investor Presentation (November 2021)
35 slides from Oxurion Nv's investor presentation, November 2021
Slide 1: Establishing new standards of care in retinal diseases
Establishing new standards of care in retinal diseases Company presentation Oxurion NV (Euronext: OXUR) November 2021
Slide 2: Forward looking statement
Forward looking statement This document has been prepared by Oxurion NV (the "Company") and is being supplied to you solely for your information and use by you at the Company presentation. This document and its contents and matters discussed at the presentation (the “Information”) are confidential a
Slide 3: Oxurion At a glance
Oxurion At a glance Aiming to disrupt the $12+Bn anti-VEGF market and grow the $4.5Bn DME market Understand Identify Translate Develop Disease pathogenesis Valid targets Novel therapeutics Benefits for patients THR-149, second line DME for 40-50% of patients not doing well on anti-VEGFs, large unm
Slide 4: The regulatory pathway for vascular retinal diseases is well established
The regulatory pathway for vascular retinal diseases is well established Low regulatory risk with well established primary endpoint - BCVA (Best Corrected Visual Acuity) CST (Central Subfield Thickness) established secondary endpoint 4
Slide 5: Progressive vision loss is a significant patient and caregiver burden
Progressive vision loss is a significant patient and caregiver burden Resulting in a payor friendly environment Loss of Visual function Disabilities Negative impact of QoL Normal vision Reading Recognizing faces Psychosocial Professional Blurred vision Faded colors Scotoma* Distorted vision Vision w
Slide 6: Anti-VEGF market is $12+Bn across all indications
Anti-VEGF market is $12+Bn across all indications THR-149 aims to grow the DME market targeting the 40-50% of patients not responding well to anti-VEGFs THR-687 has potential as first line therapy across all indications disrupting the anti-VEGF market Worldwide retinal vascular disease market DME 4.
Slide 7: Current treatments have multiple unresolved challenges
Current treatments have multiple unresolved challenges Anti-VEGF is the mainstay of therapy, but unmet needs persist Initiation phase Maintenance phase Monthly IVT injections* IVT injections scheduled according to various treatment regimens** Target value proposition for Extent of effect Oxurion sol
Slide 8: Differentiated molecules, in validated pathways, with novel mechanisms of action
Differentiated molecules, in validated pathways, with novel mechanisms of action and first in class potential Plasma kallikrein inhibitor Pan-RGD integrin antagonist THR-149 THR-687 Potential to be new standard of care Potential to disrupt the entire for the 40-50% of DME patients who anti-VEGF mark
Slide 9: Ongoing & planned clinical developments in DME, wet AMD & RVO
Ongoing & planned clinical developments in DME, wet AMD & RVO Wholly owned pipeline targeting validated pathways R&D stage Potential Development Candidate Target indication(s) Preclinical Phase 1 Phase 2 Phase 3 Filing Status Plasma Phase 2 - Part B, THR-149 kallikrein 2nd Line DME Enrolling Pan-RGD
Slide 10: THR-149
THR-149 Highly potent plasma kallikrein inhibitor targeting a VEGF-independent pathway Potential to grow the DME market as the SOC for 40-50% of DME patients who respond suboptimally to anti-VEGFs
Slide 11: DME prevalence fueled by global diabetes pandemic
DME prevalence fueled by global diabetes pandemic 1/3 of people with diabetes will develop Diabetic Retinopathy (DR) 20% of DR patients will develop DME People with Diabetes 463 million (worldwide) Patients 144 million with DR (worldwide) Patients 28 million with DME (worldwide) Abbreviation(s): DME
Slide 12: DME market is $4.5Bn 40-50% don't respond well to anti-VEGFs
DME market is $4.5Bn 40-50% don’t respond well to anti-VEGFs Urgent and growing need for novel therapies to better treat DME $4.5 billion • Market dominated by anti-VEGF therapies (>90%) • 40-50% suboptimal responders to anti-VEGF therapies Abbreviation(s): DME, diabetic macular edema Source(s): b
Slide 13: THR-149 Highly potent plasma kallikrein inhibitor for DME
THR-149 Highly potent plasma kallikrein inhibitor for DME Selective and stable peptide targeting plasma kallikrein to treat the 40-50% of patients who do not respond well to anti-VEGFs • Plasma kallikrein is a clinically well validated target for edema, inflammation, and the prevention of microhem
Slide 14: THR-149 Rationale for targeting plasma kallikrein in DME
THR-149 Rationale for targeting plasma kallikrein in DME Not all patients have elevated VEGF levels, two distinct, independent pathways linked to DME PKal levels 3,500 20 VEGF levels 3,000 • PKal is a key driver in 15 2,500 DME PKal (fold increase) VEGF (pg/mL) 2,000 • PKal inhibitors have 10 1,50
Slide 15: THR-149 Phase 1 Clinical evidence Safe and Effective
THR-149 Phase 1 Clinical evidence Safe and Effective • THR-149 is safe and well-tolerated • No dose limiting toxicities, no ocular serious adverse events • All other ocular AEs were unrelated to THR-149 • Rapid onset of action and a clinically meaningful improvement in BCVA with a single injecti
Slide 16: THR-149 Phase 2 Part A in DME Anti-VEGF suboptimal responders
THR-149 Phase 2 Part A in DME Anti-VEGF suboptimal responders Primary Endpoint was BCVA Secondary Endpoints include CST, AEs Part A Dose level selection THR-149 N=18, rando 1:1:1 0.01 mg 0.04 mg 0.13 mg N Phase 2 Part A Anti-VEGF suboptimal 6 responders: • First time multiple IVT of THR-149
Slide 17: Phase 2 clinical trial THR-149-002 (KALAHARI)
Phase 2 clinical trial THR-149-002 (KALAHARI, NCT0452107) High dose (0,13 mg) of THR-149 was selected for Part B, based on safety & efficacy at month 3 • Favorable safety profile with no serious ocular AEs at any dose Treatment safety • No inflammation in the study eye of any patient at any dose • N
Slide 18: Categorical gain in BCVA from baseline at month 3
Phase 2 clinical trial THR-149-002 (KALAHARI, NCT0452107) Categorical gain in BCVA from baseline at month 3* in the high dose group of THR-149** 100% 80% Proportion of subjects, % 5 subjects 60% 3 subjects 40% 20% 1 subject 0% >= 1 linegain 5-letter >=2 linesgain 10-letter >=3 linesgain 15-let
Slide 19: THR-149 Phase 2 Part B in DME Anti-VEGF suboptimal responders
THR-149 Phase 2 Part B in DME Anti-VEGF suboptimal responders Phase 2 Part B multiple injections Multicenter, randomized, 2-part study 122 targeted patients 64 targeted sites (US & EU) Part A High dose selected for Part B Part B Compare THR-149 to aflibercept - enrolling Topline Part B data
Slide 20: THR-149 Phase 2 Part B in DME Anti-VEGF suboptimal responders
THR-149 Phase 2 Part B in DME Anti-VEGF suboptimal responders Primary Endpoint is BCVA Secondary Endpoints include CST, AEs Part B Topline data N=104, rando 1:1 Results Mid 2023 THR-149 0.13 mg Aflibercept 2 mg Phase 2 Part B N • Potential for substantial part (40%-50%) of 52 currently under
Slide 21: THR-687
THR-687 Pan-RGD integrin antagonist with the potential to disrupt the entire anti-VEGF market
Slide 22: Anti-VEGF market is $12+Bn across all indications
Anti-VEGF market is $12+Bn across all indications THR-687 has potential as first line therapy across all indications Worldwide retinal vascular disease market DME 4.0 2019 6.5 Market value ($Bn) Wet AMD 0.5 DR (w/o 1.2 DME) RVO Abbreviations: AMD, age-related macular degeneration; DME, diabetic macu
Slide 23: THR-687 Pan-RGD integrin antagonist
THR-687 Pan-RGD integrin antagonist Broad MoA targeting dysfunctional cell-cell interactions in the neurovascular compartment • Inhibition of integrins targets multiple processes involved in pathological angiogenesis and vascular leakage • Integrin antagonists work both upstream and downstream of
Slide 24: THR-687 Highly potent pan-RGD integrin antagonist
THR-687 Highly potent pan-RGD integrin antagonist Strong binding to “efficacy” receptors and weak binding to “side effect” receptors THR-687 Integrin Integrin Receptor Class IC50 ± SD (nM) IIb RGD Integrin receptors αvβ3 4.4 ± 2.7 αvβ5 1.3 ± 0.5 β3 α5 β1 6.8 ± 3.2 β5 5 αvβ6 RGD binding 9.0 ± 5.3
Slide 25: THR-687 Phase 1 Clinical evidence Safe and well tolerated
THR-687 Phase 1 Clinical evidence Safe and well tolerated • THR-687 is safe and well-tolerated • No dose limiting toxicities, no serious adverse events occurred in the study • All treatment-related AEs were unrelated to THR-687 • 3 subjects received rescue medication; 1 in the middle dose group
Slide 26: THR-687 Phase 1 Mean change BCVA from baseline
THR-687 Phase 1 Clinical evidence Mean change BCVA from baseline* Single injection; High dose - highest BCVA gain, with mean 12.5 letters gain at M3 ✓ Speed of onset ✓ Extent of effect ✓ Durability of effect Overall (N=12) THR-687 2.5mg (N=6) THR-687 0.4mg and 1.0mg (N=6) 15 from Baseline (ETDRS
Slide 27: THR-687 Phase 2 study in first line DME
THR-687 Phase 2 study in first line DME Phase 1 single injection Results Phase 2 multiple injections Safety Multicenter, randomized, 2-part study Safe and well tolerated, no DLTs or ocular serious AEs Speed of onset 303 targeted patients 3.1 letters BCVA gain as of the day after the IVT injectio
Slide 28: THR-687 Phase 2 Part A in DME Treatment naïve patients
THR-687 Phase 2 Part A in DME Treatment naïve patients Dose level selection for use in Part B Part A Dose level selection THR-687 N=12, rando 1:1 Results H1 2022 1.2 mg* 2.0 mg* Phase 2 Part A N • Dose selection for Part B Treatment naïve • First time multiple IVT of THR-687 in treatment 6 DME
Slide 29: THR-687 Phase 2 Part B in DME Treatment naïve & previously treated
THR-687 Phase 2 Part B in DME Treatment naïve & previously treated Primary Endpoint is BCVA Secondary Endpoints include CST, AEs Part B Topline data Treatment naïve, N=231, rando 2:1 Results H2 2023 Previously treated, N=60, rando 1:1 Selected dose THR-687 Part A Aflibercept 2 mg Phase 2 Par
Slide 30: THR-687 Phase 2 in DME Treatment naïve & previously treated
THR-687 Phase 2 in DME Treatment naïve & previously treated Primary Endpoint is BCVA Secondary Endpoints include CST, AEs Part A Dose level selection THR-687 Part B Topline data Treatment naïve, N=231, rando 2:1 N=12, rando 1:1 Results H1 2022 Results H2 2023 Previously treated, N=60, rando
Slide 31: Company highlights
Company highlights Establishing new standards of care in retinal diseases
Slide 32: Company recap value proposition
Company recap value proposition A clear positive company benefit-risk ratio An attractive business model, relatively de-risked Attractive business model Relatively de-risked 0 +++ Low High Company benefit-risk framework • Limited competition in OXUR MoAs (first- Front runner Long shot in-class pot
Slide 33: Oxurion has several value inflection points in the near term
Oxurion has several value inflection points in the near term Plasma kallikrein inhibitor THR-149 Initiate Phase 2 - Part B Phase II Part B Topline data in DME in DME H1 2021 H2 2021 H1 2022 H2 2022 H1 2023 H2 2023 Phase 2 - Part A Initiate Phase 2 dose selection in Wet AMD/RVO data in DME Pan-RGD in
Slide 34: Oxurion At a glance
Oxurion At a glance Aiming to disrupt the $12+Bn anti-VEGF market and grow the $4.5Bn DME market Understand Identify Translate Develop Disease pathogenesis Valid targets Novel therapeutics Benefits for patients THR-149, second line DME for 40-50% of patients not doing well on anti-VEGFs, large unm
Slide 35: Thank you for your attention
Thank you for your attention www.oxurion.com