Oxurion Nv · EURONEXT:OXUR
Oxurion Nv — Investor Presentation (May 2022)
21 slides from Oxurion Nv's investor presentation, May 2022
Slide 1: Pioneering Life Changing Treatments for Diabetic Retinal Disease
Pioneering Life Changing Treatments for Diabetic Retinal Disease Oxurion NV (Euronext: OXUR) Company Presentation May 2022 YOUR VISION IS OUR VISION 1
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 grow the $5B+ diabetic macular edema (DME) market THR-149 | potential SOC for the up to 50% of DME patients not doing well on anti-VEGFs, large unmet need Near-term value drivers| Phase 2 clinical trial ongoing, data in mid-2023 Accomplished senior leadership | R&D team
Slide 4: DME is a Large and Growing Public Health Concern
DME is a Large and Growing Public Health Concern DME is the leading cause of blindness in working-age adults 2021 2045 537 million 783 million Adults (20-79 years) Adults (20-79 years) Patients with diabetes Any DR 120 million 174 million DME 22 million 33 million Patients with … Note(s): worldwide
Slide 5: DME: Serious Sight-Threatening, Life-Altering Disease
DME: Serious Sight-Threatening, Life-Altering Disease Significant patient and caregiver burden ● Compelling health economic story Loss of Visual function Disabilities Negative impact of QoL Normal vision Reading Recognizing faces Psychosocial Professional Blurred vision Faded colors Scotoma* Distort
Slide 6: SOC Therapy is Suboptimal for up to 50% DME Patients
SOC Therapy is Suboptimal for up to 50% DME Patients Anti-VEGF treatment is the mainstay but… 40-50% of patients treated with anti-VEGF therapies do not achieve clinically meaningful vision gain 1st-line Anti-VEGF therapy Current & upcoming anti-VEGF therapies have reached a plateau in terms of effi
Slide 7: Unmet Patient Needs Persist in DME Management
Unmet Patient Needs Persist in DME Management Current treatment options; anti-VEGF and corticosteroids, have multiple challenges Improve Treatment Outcomes Durability Longer sustained treatment response Efficacy Higher gain on visual function and better quality of life Safety Better long-term
Slide 8: Rationale for Targeting PKal in DME
Rationale for Targeting PKal in DME Two distinct pathways linked to DME: not all patients have elevated VEGF levels VEGF levels PKal levels 3,500 20 3,000 • PKal is a key driver in the 2,500 15 pathogenesis of DME PKal (fold increase) • PKal inhibitors have VEGF (pg/mL) 2,000 1,500 10 potential to a
Slide 9: THR-149: Highly Potent PKal Inhibitor for DME
THR-149: Highly Potent PKal Inhibitor for DME Selective and stable peptide • Plasma Kallikrein is a mediator of vascular leakage, inflammation, micro-hemorrhages and neurodegeneration. • Human vitreous shows elevated PKal levels in DME patients. • THR-149, a potent and selective PKal inhibitor1, has
Slide 10: KALAHARI Phase 2 Part A: Dose Selection Suboptimal Responders to anti-VEGF
KALAHARI Phase 2 Part A: Dose Selection Suboptimal Responders to anti-VEGF Primary endpoint BCVA, secondary endpoints 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 in
Slide 11: KALAHARI Phase 2 Part A Clinical Trial
KAHALARI Phase 2 Part A Clinical Trial High dose (0.13 mg) selected for Part B, based on safety and 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 do
Slide 12: Mean Change in BCVA from Baseline in High Dose Group
Mean Change in BCVA from Baseline in High Dose Group a Clinically meaningful improvement with impressive 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 was giv
Slide 13: Mean Change in BCVA from Baseline in High Dose Group (post hoc analysis)
Mean Change in BCVA from Baseline in High Dose Group a (post hoc analysis Feb. 2022) • 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 > 9 letters up to Month 6 • Part B protocol
Slide 14: Categorical Gain in BCVA from BL in the High Dose Group
Categorical Gain in BCVA from BL in the High Dose Group a (post hoc analysis Feb. 2022) • 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 0.13mg (N=6, PPS excl. 2
Slide 15: KALAHARI Phase 2 Part B Clinical Trial
KAHALARI Phase 2 Part B Clinical Trial Phase 2 Part B multiple injections Multicenter, randomized, 2-part study 128 targeted patients (Part A, 20; Part B, 108) 81 targeted sites (US & EU) Part A High dose selected for Part B Part B Compare THR-149 to aflibercept - enrolling Topline Part B data Mid-2
Slide 16: KALAHARI Phase 2 Part B
KALAHARI Phase 2 Part B Evaluate THR-149 against anti-VEGF market leader aflibercept for DME Part B • Topline Data Part B of the KALAHARI trial building on N=108, rando 1:1 Mid-2023 Part A in/exclusion criteria learnings: • Primary endpoint BCVA Anti-VEGF suboptimal responders: • Secondary endpoint
Slide 17: KALAHARI Phase 2 Part B
KALAHARI Phase 2 Part B Evaluate THR-149 in combination with anti-VEGF therapy Provide preliminary data on use of THR-149 Optimizing trial design protocol to in combination with anti-VEGF therapy evaluate THR-149 in combination through a flip over injection at Month 3 with anti-VEGF market leader af
Slide 18: The Oxurion Opportunity
The Oxurion Opportunity Pioneering Life Changing Treatments for Diabetic Retinal Disease Oxurion NV (Euronext: OXUR) YOUR ADVANCING VISION ISSCIENCE. OUR VISION ® ENHANCING VISION. 18
Slide 19: Oxurion Investment Thesis
Oxurion Investment Thesis An attractive business model, relatively de-risked Attractive business model Relatively de-risked • Limited competition in THR-149 MoA (first- in-class potential) • Validated MoA • Large addressable market • Regulatory endpoints well established • No existing novel 2nd-line
Slide 20: Oxurion At-a-Glance
Oxurion At-a-Glance Aiming to grow the $5B+ diabetic macular edema (DME) market THR-149 | potential SOC for the up to 50% of DME patients not doing well on anti-VEGFs, large unmet need Near-term value drivers| Phase 2 clinical trial ongoing, data in mid-2023 Experienced senior leadership | R&D team
Slide 21: Thank you
Thank you YOUR VISION IS OUR VISION