Zura Bio Limited · NASDAQ:ZURA
Zura Bio — Investor Presentation (April 2024)
32 slides from Zura Bio's investor presentation, Apr 23, 2024
Slide 1: Advancing clinical outcomes through pioneering dual-pathway biology
©2024 Zura Bio Ltd. Nasdaq Ticker: ZURA Advancing clinical outcomes through pioneering dual-pathway biology April 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,” “antic
Slide 3: Key Highlights
©2024 Zura Bio Ltd. 3 KEY HIGHLIGHTS Nasdaq ticker: ZURA Three clinical stage assets in-licensed from Top 10 Pharmaceutical innovators, each accompanied by early-phase clinical data packages Pioneering dual-pathway biology, with potential to modify treatment in diseases with unmet need Cash runway i
Slide 4: Strong leadership team with successful track record in drug and business development
©2024 Zura Bio Ltd. 4 Zura is led by a strong leadership team with a successful track record in drug and business development Nasdaq: ZURA Mike Howell Ph.D. Chief Scientific Officer and Head of Translational Medicine Kim Davis J.D. Chief Legal Officer Kiran Nistala M.D., Ph.D. Chief Medical Officer
Slide 5: Scientific Advisory Board of prominent autoimmune and inflammatory disease specialists
©2024 Zura Bio Ltd. 5 Scientific Advisory Board formed with prominent specialists in autoimmune and inflammatory diseases AJAY NIRULA, M.D., Ph.D. SVP of Immunology | Eli Lilly & Company Research Laboratories Led immunology research and early clinical development at Lilly since joining in 2015 Contr
Slide 6: Pipeline of novel dual-pathway biology clinical stage assets
©2024 Zura Bio Ltd. Pipeline of novel dual-pathway biology clinical stage assets potentially offers of broader and improved clinical responses 6 PROGRAM INDICATION PRECLINICAL PHASE 1 PHASE 2 PHASE 3 PROJECTED MILESTONES** tibulizumab ZB-106 Anti-BAFF + IL-17 systemic sclerosis CRO selection (contra
Slide 7: Participants Dosed Across Three Ph 1/1b studies
©2024 Zura Bio Ltd. 7 Nasdaq: ZURA 7 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 60 participants with single dose 33 participants with multiple doses up to 12 weeks 244 Participants Dosed
Slide 8: Predicted BAFF and IL-17 Response in phase 1b
©2024 Zura Bio Ltd. 8 Predicted BAFF and IL-17 Response in phase 1b* Table 11.11. Model-Predicted Maximum Change from Baseline of Free Unbound BAFF and IL-17 Concentration Following the Last Dose of LY3090106 Administration per Protocol Maximum Percent Change from Baseline of Free Targets (Median [9
Slide 9: 2024 anticipated milestones to enhance value
©2024 Zura Bio Ltd. 2024 anticipated milestones to enhance value Anticipated Zura milestones: CRO contract, FDA Type B response, commencing phase 2 SSc trial, and expecting guidance for projected TLD for phase 2 SSc Up to 6 potential meaningful industry read-outs for IL-7, TSLP and IL-33 - Phase 2:
Slide 10: Key anticipated events through 2026
©2024 Zura Bio Ltd. 10 Key anticipated events through 2026 (2Q-2025) IL-33 Ph3 in COPD Sanofi/Regeneron, itepekimab (1Q/2Q-2024) IL-7 Ph2 in UC OSE Immunotherapeutics , OSE-127 (1Q/2Q-2024) TSLP Ph2 in COPD AZ/ Amgen, tezepelumab (4Q-2024) IL-7/TSLP Ph2 in AD Q32 Bio, bempikibart (4Q-2024) IL-7/TSLP
Slide 11: IL-17 and BAFF are upregulated in SSc
©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-pathway
Slide 12: 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 12 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 improved FVC
Slide 13: 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 for
Slide 14: Tibulizumab components safely administered to ~150,000 participants
©2024 Zura Bio Ltd. 0 2 The two components of tibulizumab have been safely administered to ~150,000 study participants or patients 1 TOLERABILITY 0 3 Designing to avoid onerous monitoring and potentially offer convenient Q4W SC dosing CONVENIENCE 0 1 Potential for broader and improved clinical effec
Slide 15: 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 the 20
Slide 16: HS competitive landscape and clinical data
©2024 Zura Bio Ltd. 16 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 Phase 2 Phase
Slide 17: Significant opportunity and clinical need in hidradenitis suppurativa
©2024 Zura Bio Ltd. 17 Significant opportunity and clinical need in hidradenitis suppurativa tibulizumab | ZB-106 | HS 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
Slide 18: Tibulizumab as a differentiated treatment for HS patients
©2024 Zura Bio Ltd. 0 2 The two components of tibulizumab have been safely administered to ~150,000 study participants or patients 1 TOLERABILITY 0 3 Developing to avoid onerous monitoring; potentially offer convenient Q4W SC dosing CONVENIENCE 0 1 Combined IL-17 + BAFF inhibition potentially result
Slide 19: 2024 anticipated milestones to enhance value
©2024 Zura Bio Ltd. 2024 anticipated milestones to enhance value Anticipated Zura milestones: CRO contract, FDA Type B response, commencing phase 2 SSc trial, and expecting guidance for projected TLD for phase 2 SSc Up to 6 potential meaningful industry read-outs for IL-7, TSLP and IL-33 - Phase 2:
Slide 20: Systemic sclerosis (SSc) tibulizumab ZB-106
©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 agent, po
Slide 21: Zura's unique phase 2 trial approach in SSc
©2024 Zura Bio Ltd. .. Traditional Approach: 6-MONTH RANDOMIZED (mRSS) + 6-MONTH OLE (FVC) Zura’s Unique Approach: RANDOMIZED TRIAL (w/HRCT)* Increased Potential for Successful Readout n = 50-60 EFFICACY PERIOD (24 WEEKS) PLACEBO (n = 25-30) ZB-106 DOSE 1 (n = 25-30) R 1:1 ZB-106 (n = 25-30) OLE PER
Slide 22: SSc FDA approval requirements and ZB-106 development plan
©2024 Zura Bio Ltd. 22 SSc FDA approval is likely to require evidence of improvement in1 - Skin assessed by modified Rodnan skin score, mRSS - Internal organs: ILD is most common affected organ, assessed by FVC - Patient global assessment and HAQ mRSS has historically failed in phase 2/3, typically
Slide 23: Addressing Historical SSc Trial Challenges: Our Global Approach
©2024 Zura Bio Ltd. 23 Addressing Historical SSc Trial Challenges: Our Global Approach HISTORICAL CHALLENGES OUR POTENTIAL SOLUTIONS Highly variable mRSS placebo improvements Enrich for mRSS fast progressors using clinical features & autoantibodies identified from review of historical trial data in
Slide 24: Increase probability of success and accelerate development timelines
©2024 Zura Bio Ltd. 24 Increase probability of success - Larger study sample size increases probability of success (mRSS) - High Resolution CT highly correlates with FVC > ILD read-through - 6-month design, eliminate cost and time of open-label study extension for FVC Accelerate development timeline
Slide 25: Hidradenitis suppurativa (HS) tibulizumab ZB-106
©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 single agen
Slide 26: Overview of hidradenitis suppurativa (HS)
©2024 Zura Bio Ltd. Overview of hidradenitis suppurativa (HS) 26 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: - Re
Slide 27: B Cell Signaling Potentiates HS Disease
©2024 Zura Bio Ltd. B Cell Signaling Potentiates HS Disease 27 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 Allergy and
Slide 28: Novartis phase 2b platform study offers evidence of B cell targeting benefit in HS
©2024 Zura Bio Ltd. 28 Ongoing Novartis phase 2b multicenter platform study offers additional clinical evidence of B cell targeting benefit in HS tibulizumab | ZB-106 | HS *Study started in February 2019 and is currently ongoing. BAFF-R, B-cell activating factor of the tumor necrosis alpha family re
Slide 29: Novartis interim results presented at 2024 AAD
©2024 Zura Bio Ltd. 29 Novartis’ interim results presented at ‘24 AAD, BTKi PBO adjusted delta in line with approved and in development agents tibulizumab | ZB-106 | HS Presented at the American Academy of Dermatology Annual Meeting; March 8–12, 2024; San Diego, CA. *The sHiSCR is defined as a ≥50%
Slide 30: HS innovator positioned to capture 1st, 2nd, and 3rd-line opportunities
©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 websites,
Slide 31: Planned Phase 2 HS Trial Design
©2024 Zura Bio Ltd. Planned Phase 2 HS Trial Design* 31 KEY SAFETY ENDPOINTS KEY EFFICACY ENDPOINTS Moderate to Severe HS Total abscess and inflammatory count (AN) ≥ 5 KEY INCLUSION CRITERIA • HiSCR • Improvement in baseline AN counts • IHS4 • PGA • DLQI • PK / PD assessments • General Safety and To
Slide 32: Tibulizumab Summary
©2024 Zura Bio Ltd. 32 Accelerated development plans may provide topline data by 2026* Plan informed and supported by related MoA read-outs from IL-17 and BAFF/B cell depleting therapies in SSc and HS Tibulizumab uniquely positioned as a potential first-in-class dual-pathway biologic in development