Zura Bio Limited · NASDAQ:ZURA
Zura Bio — Investor Presentation (August 2024)
37 slides from Zura Bio's investor presentation, Aug 14, 2024
Slide 1: Three unique dual-pathway biologics, clinically validated for therapeutic areas with unmet needs
©2024 Zura Bio Ltd. Nasdaq Ticker: ZURA Three unique dual - pathway biologics, clinically validated for therapeutic areas with unmet needs August 2024
Slide 2: Forward Looking Statements Disclaimer
©2024 Zura Bio Ltd. 2 Forward Looking Statements Disclaimer This communication includes “forward - looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 . Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “an
Slide 3: Company Summary
zurabio.com High - Potential Biologics: Three novel, clinically validated dual - pathway biologics, each with multi - billion - dollar potential, ready for Phase 2. Lead Asset Development: Phase 2 study for tibulizumab targeting SSc starts in 4Q 2024, followed by HS in 2Q 2025. Strategic Milestones:
Slide 4: Pipeline of novel dual-pathway biology clinical stage assets
©2024 Zura Bio Ltd. Pipeline of novel dual - pathway biology clinical stage assets potentially offers broader and improved clinical responses 4 78 Participants Dosed Across Three Ph 1/1b studies 57 participants with single dose 21 participants with multiple doses up to 12 weeks 93 Participants Dosed
Slide 5: Zura is led by a strong leadership team
©2024 Zura Bio Ltd. 5 Zura is led by a strong leadership team with a successful track record in drug and business development ROBERT LISICKI Chief Executive Officer and Director GARY WHALE Ph.D. Chief Technology Officer VERENDER BADIAL Chief Financial Officer KIM DAVIS J.D. Chief Legal Officer KIRAN
Slide 6: Key Anticipated Events through 2026
©2024 Zura Bio Ltd. 6 Key Anticipated Events through 2026 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 2024 2025 2026 Tibulizumab SSc study 1 (4Q - 2024) Phase 2 study Initiation (4Q - 2026) Phase 2 study completion (2Q - 2025) Phase 2 study Initiation (3Q - 2026) Phase 2 study completion Tibulizumab HS study 1 An
Slide 7: Key Highlights for tibulizumab in systemic sclerosis
©2024 Zura Bio Ltd. IL - 17 and BAFF are upregulated in SSc, and present in serum and skin of SSc patients In separate studies, brodalumab [IL - 17] and belimumab [BAFF] have demonstrated clinically relevant biological effects in lung & skin in phase 2 and phase 3 studies 1,2 Tibulizumab's dual - pa
Slide 8: Tibulizumab targets two clinically validated pathways for SSc
©2024 Zura Bio Ltd. Tibulizumab is designed to target the combination of two clinically validated pathways for SSc 8 Brodalumab IL - 17 receptor antagonist ▪ Achieved 1º endpoint of treatment difference of least square mean: (−21.2 [95% CI - 3.9, - 18.5]; P<0.001), in mRSS and 2º endpoint of improve
Slide 9: Significant unmet need in systemic sclerosis
©2024 Zura Bio Ltd. Significant unmet need in systemic sclerosis No advanced - line agents currently approved for skin and lung Global prevalence of 200,000 patients with 100,000 SSc patients in US Penetration of advanced line agents projected to peak at ~35% TAM projected to reach $2B by 2028 SSc f
Slide 10: Tibulizumab addresses three critical gaps
©2024 Zura Bio Ltd. 02 The two components of tibulizumab have been safely administered to ~150,000 study participants or patients 1 TOLERABILITY 03 Designing to avoid onerous monitoring and potentially offer convenient Q4W SC dosing CONVENIENCE 01 Potential for broader and improved clinical effect i
Slide 11: Scientific validation of IL-17 and B cells in hidradenitis suppurativa
©2024 Zura Bio Ltd. Scientific validation of the role of IL - 17 and B cells in hidradenitis suppurativa Multiple positive phase 2 and phase 3 studies in the industry with IL - 17 inhibitors or B cell depleting therapies 1 Despite new options unmet need remains, PBO adjusted HiSCR75 deltas are in th
Slide 12: HS competitive landscape of clinical assets
©2024 Zura Bio Ltd. 12 Company Asset* COSENTYX ® remibrutinib * BIMZELX ® sonelokimab sonelokimab izokibep izokibep fostamatinib Mechanism IL - 17 A BTKi IL - 17 A/F IL - 17 A/F IL - 17 A/F IL - 17 A/A IL - 17 A/A SYK inhibitor Administration SC/IV PO SC SC SC SC SC PO Phase Phase 3 Phase 2b Phase 2
Slide 13: Significant opportunity and clinical need in hidradenitis suppurativa
©2024 Zura Bio Ltd. 13 Significant opportunity and clinical need in hidradenitis suppurativa Assumes COSENTYX® becomes first line biologic for HS following FDA approval for HS on 31 - Oct - 2023. Sources: Medical Literature, MEDACorp KOLs, Company websites, IQVIA, US Department of Veteran’s Affairs,
Slide 14: Developing tibulizumab as a differentiated treatment for HS patients
©2024 Zura Bio Ltd. 02 The two components of tibulizumab have been safely administered to ~150,000 study participants or patients 1 TOLERABILITY 03 Developing to avoid onerous monitoring; potentially offer convenient Q4W SC dosing CONVENIENCE 01 Combined IL - 17 + BAFF inhibition potentially results
Slide 15: Systemic sclerosis (SSc): tibulizumab
©2024 Zura Bio Ltd. systemic sclerosis (SSc) tibulizumab ZB - 106 Anti - BAFF x IL - 17 Tibulizumab, is a humanized bispecific dual antagonist antibody, and has been engineered to bind to and neutralize both BAFF and IL - 17A. Our approach with tibulizumab is to inhibit both pathways with a single a
Slide 16: Systemic sclerosis is a rare and life-threatening disease with no approved therapy
©2024 Zura Bio Ltd. 16 Systemic sclerosis is a rare & life - threatening disease with no approved therapy ~200,000 people with SSc in US, EU and Japan 1 40 - 60% mortality in 10 years 2 Zero SSc - specific * drugs approved $2B+ annual potential market opportunity Sources: Medscape, BMJ best practice
Slide 17: Combined approaches to address T-cell and B-cell drivers of autoimmunity
©2024 Zura Bio Ltd. 17 Combined approaches to address T - cell and B - cell drivers of autoimmunity have the potential to increase clinical benef it IL - 17 and BAFF - Mediated Inflammation both contribute to SSc progression IL - 17 is a pro - inflammatory cytokine that has been identified as a key
Slide 18: Synergistic benefit of IL-17 and BAFF neutralization in CIA model
©2024 Zura Bio Ltd. Synergistic benefit of IL - 17 and BAFF Neutralization has been demonstrated in classic Collagen Induced Arthritis (CIA) model 18 Sources: Zura Internal Data, IND Briefing Isotype control Anti - BAFF Anti - IL 17 Anti - BAFF + Anti - IL 17 Anti - BAFF + Anti - IL - 17 7.5 5.0 2.5
Slide 19: Tibulizumab is Clinically De-Risked Through Phase 1b
©2024 Zura Bio Ltd. Tibulizumab is Clinically De - Risked Through Phase 1b 19 78 Participants Dosed Across Three Phase 1/1b studies 57 participants with single dose; 21 participants with multiple dose up to 12 weeks ▪ SAD Studies: No deaths or SAEs ▪ MAD study: No deaths, single related SAE of neutr
Slide 20: Phase 2 SSc study focused on skin/lung endpoints
©2024 Zura Bio Ltd. Phase 2 SSc study focused on skin/lung endpoints 20 Key Inclusion Criteria &UHDWHGE\$O]DP IURPWKH1RXQ3URMHFW ▪ Early diffuse cutaneous SSc, enriched for SSc - ILD ▪ mRSS 15 - 45 ▪ Disease duration < 5years ▪ Stable background therapy, including MMF for 6 months ▪ Anti - centromer
Slide 21: Assessing Skin Thickness and Fibrosis with mRSS
©2024 Zura Bio Ltd. Assessing Skin Thickness and Fibrosis with modified Rodnan skin score (mRSS) 21 Severe skin thickening and tightening restricts movement and causes painful ulcers on the hands and fingers, significantly impairing daily activities and quality of life. vs Fine Wrinkles (0/3) Severe
Slide 22: Assessing Interstitial Lung Disease progression in SSc
©2024 Zura Bio Ltd. Assessing Interstitial Lung Disease (ILD) progression in SSc 22 FEV1/FVC Ratio Volume exhaled FVC FEV1 FEV1 FEV1 FVC FVC Restrictive diseases Obstructive diseases 1 second Time (seconds) Normal lungs ILD encompasses a diverse group of pulmonary disorders characterized by inflamma
Slide 23: Historic drivers of SSc study failures
©2024 Zura Bio Ltd. 23 ©2024 Zura Bio Ltd. Historic drivers of SSc study failures 1. Novel, and unvalidated mechanisms 2. Inclusion/exclusion criteria misses 3. Balancing sample size for mRSS and ILD participants Increase probability of success 1. Larger study sample size increases probability of su
Slide 24: Hidradenitis suppurativa (HS): tibulizumab
©2024 Zura Bio Ltd. hidradenitis suppurativa (HS) tibulizumab ZB - 106 Anti - BAFF x IL - 17 Tibulizumab, is a humanized bispecific dual antagonist antibody, and has been engineered to bind to and neutralize both BAFF and IL - 17A. Our approach with tibulizumab is to inhibit both pathways with a sin
Slide 25: Overview of hidradenitis suppurativa (HS)
©2024 Zura Bio Ltd. Overview of hidradenitis suppurativa (HS) 25 ▪ Hidradenitis suppurativa is an inflammatory follicular skin disease ▪ Skin lesions develop in axillae, in the groin, and under the breasts, are formed as a result of inflammation & infection of sweat glands and are characterized by:
Slide 26: B Cell Signaling Potentiates HS Disease
©2024 Zura Bio Ltd. B Cell Signaling Potentiates HS Disease 26 Sources: 1 Van der Zee, H.H., et al. British Journal of Dermatology, doi:10.1111/j.1365 - 2133.2011.10698.x. 2 Rumberger , Beth E., et al. Inflammation Research, doi:10.1007/s00011 - 020 - 01381 - 7. 3 Sabat , Robert, et al. Journal of A
Slide 27: Novartis phase 2b platform study of B cell targeting in HS
©2024 Zura Bio Ltd. 27 Ongoing Novartis phase 2b multicenter platform study offers additional clinical evidence of B cell targeting benefit in HS *Study started in February 2019 and is currently ongoing. BAFF - R, B - cell activating factor of the tumor necrosis alpha family receptor; b.i.d., twice
Slide 28: Novartis interim results presented at 2024 AAD
©2024 Zura Bio Ltd. 28 Novartis’ interim results presented at ‘24 AAD, BTKi PBO adjusted delta in line with approved and in development agents Presented at the American Academy of Dermatology Annual Meeting; March 8 – 12, 2024; San Diego, CA. *The sHiSCR is defined as a ≥50% reduction in the abscess
Slide 29: HS innovator positioned to capture 1st, 2nd, and 3rd-line HS patients
©2024 Zura Bio Ltd. HS innovator expected to be uniquely positioned to capture opportunities across 1st, 2nd, and 3rd - line HS patients (*) Assumes Cosentyx® becomes first line biologic for HS following FDA approval for HS on 31 - Oct - 2023. Sources: Medical Literature, MEDACorp KOLs, Company webs
Slide 30: Planned Phase 2 HS Trial Design
©2024 Zura Bio Ltd. Planned Phase 2 HS Trial Design* 30 KEY SAFETY ENDPOINTS KEY EFFICACY ENDPOINTS &UHDWHGE\YLJRUQ IURPWKH1RXQ3URMHFW &UHDWHGE\$O]DP IURPWKH1RXQ3URMHFW Moderate to Severe HS Total abscess and inflammatory count (AN) ≥ 5 KEY INCLUSION CRITERIA • HiSCR • Improvement in baseline AN cou
Slide 31: Crebankitug ZB-168 Anti-IL-7Rα + TSLP
©2024 Zura Bio Ltd. crebankitug ZB - 168 Anti - IL - 7R α + TSLP Crebankitug is a high - affinity, fully human monoclonal antibody that neutralizes the IL - 7 receptor alpha (IL - 7R α ) chain, potentially blocking the immune pathways of IL - 7 and thymic stromal lymphopoietin (TSLP).
Slide 32: Crebankitug, a multi-functional antibody via IL-7R and TSLP pathways
©2024 Zura Bio Ltd. 32 Crebankitug, a multi - functional antibody with cytokine signaling via IL - 7R and TSLP pathways IL - 7R α is a key receptor in immune regulation, central to the signaling of cytokines IL - 7 and TSLP Positioning crebankitug for diverse immune - related and autoimmune conditio
Slide 33: TSLP and IL-7 role in activating Th1, Th2 and Th17 inflammation
©2024 Zura Bio Ltd. Both TSLP and IL - 7 have a role in activating Th1, Th2 and Th7 driven inflammation 33 B Cell Development T Cell Activation CD4/CDB Effector Cells B Cell Maturation T Cell B Cell ILC2 DC Mast Cell Basophil Eosinophil Airway Epithelium Keratinocytes Stromal cell IL - 7Ra γ C IL -
Slide 34: Torudokimab ZB-880 Anti-IL-33
©2024 Zura Bio Ltd. torudokimab ZB - 880 Anti - IL - 33 Torudokimab is a fully human, high affinity monoclonal antibody that neutralizes IL - 33, preventing ST2 - dependent and ST2 - independent (e.g., RAGE) inflammation.
Slide 35: Torudokimab Asset Overview
©2024 Zura Bio Ltd. Mechanism of Action About torudokimab Initial Focus on Respiratory, Dermatologic, Gastrointestinal and Orphan Autoimmune Indications Torudokimab Asset Overview 35 Sources: 1. Cohen et al. 2015 Nature, 2. https://clinicaltrials.gov/ct2/show/NCT03913260; https://clinicaltrials.gov/
Slide 36: Torudokimab IL-33 Pathway
©2024 Zura Bio Ltd. Torudokimab IL - 33 Pathway 36 Sources: 1. Chan, 2019. Frontiers Immunol, 2. doi.org/10.1016/j.cyto.2022.155891, 3. https://doi.org/10.1038/ng.323 and doi:1 0.1 016/j.jaci.2020.04.051 , 4. .:https://doi.org/10.1016/S2213 - 2600(22)00005 - 4; doi:10.1056/NEJMoa2024257 and doi: 10.
Slide 37: Torudokimab Has Potential for Best-in-Class Activity
©2024 Zura Bio Ltd. Torudokimab Has Potential for “Best - in - Class” Activity 37 Torudokimab was 2.9 and 5.5 - fold more potent than etokimab and itepekimab , respectively, inhibiting IL - 33 - induced GM - CSF production by human mast cells Sources: Zura Bio Internal data Antibody k on (M - 1 s -