Oxurion Nv · EURONEXT:OXUR
Oxurion Nv — Investor Presentation (February 2022)
45 slides from Oxurion Nv's investor presentation, February 2022
Slide 1: Establishing new standards of care in retinal diseases
Establishing new standards of care in retinal diseases Company presentation Oxurion NV (Euronext: OXUR) February 2022
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: Strong and experienced management team
Strong and experienced management team Seasoned leadership team with a solid drug development track record Tom Graney, Andy De Deene, Prof Alan Stitt, C.F.A., M.B.A. M.D., M.B.A. Ph.D. Chief Executive Officer Chief Development Chief Scientific Officer Officer 4
Slide 5: 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 6: 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 Target value Monthly IVT injections* IVT injections scheduled according to various treatment regimens** proposition for Oxurion solutions Extent of
Slide 7: 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 7
Slide 8: 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 9: 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 10: Ongoing & planned clinical developments in DME, wet AMD & ME-RVO
Ongoing & planned clinical developments in DME, wet AMD & ME-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-
Slide 11: 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 12: 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 and have limited treatment options • Plasma kallikrein is a clinically well validated target for edema, inflammat
Slide 13: 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 14: 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 15: 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=20, rando 1:1:1 0.01 mg 0.04 mg 0.13 mg Phase 2 Part A N Anti-VEGF suboptimal 6 responders: • First time multiple IVT of THR-149
Slide 16: THR-149 Phase 2 Part A clinical trial
THR-149 Phase 2 Part A clinical trial High dose (0.13 mg) 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 • No rescue medication need High d
Slide 17: Mean Change in BCVA from Baseline in the High Dose Group
Mean Change in BCVA from Baseline in the High Dose Group a • Clinically meaningful improvement at month 3 with durability THR-149 0.13mg (N=8, PPS) 15 from Baseline (ETDRS letters) Mean change in BCVA (SE) 10 5 7,5 6,0 6,1 0 -5 -10 BL M1 M2 M3 Study Visit a No rescue treatment was given in the high
Slide 18: Mean Change in BCVA from Baseline in the High Dose Group
Mean Change in BCVA from Baseline in the High Dose Group a • Clinically meaningful improvement at month 3 with durability THR-149 0.13mg (N=8, PPS) 15 from Baseline (ETDRS letters) Mean change in BCVA (SE) 10 5 7,5 6,0 6,1 6,1 4,0 4,6 0 -5 -10 BL M1 M2 M3 M4 M5 M6 Study Visit a No rescue treatment w
Slide 19: Mean Change in BCVA from Baseline in the High Dose Group, Post-hoc Analysis
Mean Change in BCVA from Baseline in the High Dose Group a Post-hoc Analysis • CRC, masked to clinical data including BCVA, identified 2 subjects with abnormalities on OCT • Post-hoc analysis excluding these 2 subjects showed a mean gain in BCVA of ³ 9 letters up to Month 6 • Part B protocol amended
Slide 20: Categorical Gain in BCVA from Baseline in the High Dose Group
Categorical Gain in BCVA from Baseline in the High Dose Group a Post-hoc Analysis • In the post-hoc analysis, 3/6 (50%) subjects had at least a 2-line improvement up to Month 6, without the need for rescue treatment, 4 months after their last THR-149 injection ¢ THR-149 0.13mg (N=8, PPS) ¢ THR-149 0
Slide 21: 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 128 targeted patients (Part A, 20; Part B, 108) 67 targeted sites (US & EU) Part A High dose selected for Part B Part B Compare THR-149 to aflibercept - enroll
Slide 22: 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=108, rando 1:1:1:1 Results Mid 2023 THR-149 0.13 mg Aflibercept 2 mg Sham Phase 2 Part B N Anti-VEGF suboptimal 27 • Potential for substantial par
Slide 23: THR-687
THR-687 Pan-RGD integrin antagonist with the potential to disrupt the entire anti-VEGF market
Slide 24: THR-687 Pan-RGD integrin antagonist
THR-687 Pan-RGD integrin antagonist Addresses ALL four disease hallmarks in retinal vascular diseases • Inhibition of integrins targets multiple processes involved in pathological angiogenesis and vascular leakage • Integrin antagonists work both upstream and downstream of VEGF with broader potent
Slide 25: 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 potential “side effect” receptors THR-687 Integrin Integrin Receptor Class IC50 ± SD (nM) aIIb RGD Integrin receptors αvβ3 4.4 ± 2.7 αvβ5 1.3 ± 0.5 β3 α5β1 6.8 ± 3.2 β5 a5 αvβ6 RGD binding
Slide 26: 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 27: THR-687 Phase 1 Clinical evidence 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 ü Speed of onset ü Extent of effect ü Durability of effect Overall (N=12) THR-687 2.5mg (N=6) 15 from Baseline (ETDRS letters) Mean change in BCVA
Slide 28: 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 29: 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 30: 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 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 +++ • Techni
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 Initiate Phase 2 Phase 2 - Part B - Part B in DME Topline data in DME THR-149 Angiogenesis H1 2021 H2 2021 H1 2022 H2 2022 H1 2023 H2 2023 Phase 2 - Part A Initiate Phase 2 in dose selection Wet AMD/ME-RVO data
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: Company risks
Company risks Overview of the Company’s material risks
Slide 36: Overview of the Company's material risks
Overview of the Company’s material risks The risks and uncertainties that the Company believes to be material are described below. The occurrence of Concerning the possible sources of funding, the Company has entered into a funding program with Negma one or more of these risks may have a material ad
Slide 37: The Company is a clinical stage biotech with no history of profitability
The Company is a clinical stage biotech with no history of profitability due to substantial investments in The Company is currently engaged in the Trials with its Clinical Assets for DME. The Company currently product development, and the Company requires additional external funding on a going forwa
Slide 38: Clinical Development risks
Clinical Development A significant delay in either of the Trials could cause the costs of those Trials to increase and seriously impact The Company only has two products in development, one or both of which could fail the Company’s value and ability to raise additional funding. Delays in clinical tr
Slide 39: Regulatory Risks and Market Acceptance Risk
Market Acceptance Risk Regulatory Risks The Clinical Assets will have to compete against the established market for anti-VEGFs, which are widely The Company may not obtain marketing authorization for one or both of its Clinical Assets in important accepted by physicians territories Anti-VEGFs have w
Slide 40: Reimbursement and intellectual property risks
The Clinical Assets are geared at creating alternatives to anti-VEGF therapy. Considering the innovative Although to date no patent infringement claim has been made against Oxurion, if either of the Clinical Assets nature of Oxurion’s Clinical Assets and the lack of similar products, reimbursement l
Slide 41: Data security and patent protection risks
Oxurion has taken preventative measures and established procedures regarding data processing and data Patent Protection. Furthermore, although Oxurion and its licensors have a robust patent portfolio protecting security. However, data protection violations, data breaches, loss of data and unauthoriz
Slide 42: Confidentiality and clinical investigator risks
Furthermore, Oxurion cannot provide any assurance that any of its Receiving Parties, either accidentally or Further, with respect to the Trials, the clinical investigators and CROs are not employees of Oxurion and through willful misconduct, will not cause serious damage to its programs and/or its s
Slide 43: Manufacturing and personnel risks
Notwithstanding these contractual requirements, a third-party manufacturer may not comply with the Although this has not occurred in the past, were Oxurion to lose key members of its personnel or be unable to required quality standards or devote sufficient resources to the manufacturing of Oxurion’s
Slide 44: Risks relating to the shares
The Company has and may continue to issue subscription rights that are exercisable for new shares or raise Risks relating to the shares capital through public or private offerings of convertible debt (in the context of the Funding Program, the The market price of the shares may fluctuate widely in r
Slide 45: Thank you for your attention
Thank you for your attention www.oxurion.com