Zura Bio Limited · NASDAQ:ZURA
Zura Bio — Investor Presentation (September 2024)
48 slides from Zura Bio's investor presentation, Sep 9, 2024
Slide 1: Three Unique Dual-Pathway Biologics, Clinically Validated
©2024 Zura Bio Ltd. Nasdaq Ticker: ZURA Three Unique Dual-Pathway Biologics, Clinically Validated for Therapeutic Areas with Unmet Needs September 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: Company Summary
zurabio.com Company Summary 2022 2023 2024 Nasdaq: ZURA Zura founded as a limited company incorporated under the laws of England and Wales crebankitug in-licensed from Pfizer torudokimab in-licensed from Eli Lilly and Co. Began trading on Nasdaq under “ZURA” ticker tibulizumab in-licensed from Eli L
Slide 4: Pipeline of Novel Dual-Pathway Biology
©2024 Zura Bio Ltd. Torudokimab has been studied in three Phase 1/2 clinical studies to date *** 244 participants dosed - n= 81 single dose - n=163 multiple doses up to 52 weeks Actively assessing the competitive landscape and evaluating potential therapeutic indications to guide our future developm
Slide 5: Dual-Biology Pathways Present Opportunities with Attractive Market Potential
©2024 Zura Bio Ltd. Dual-Biology Pathways Present Opportunities for High-Impact Therapeutic Targets with Attractive Market Potential 5 (*) Germany, France, Italy, Spain, and United Kingdom Sources: 1 Clarivate/DRG. Accessed 19 August 2024. Projected Prevalence and TAM 2032; “Alopecia Areata - Nation
Slide 6: Zura Leadership Team
©2024 Zura Bio Ltd. 6 Zura is Led by a Strong Leadership Team with a Proven Track Record in Drug and Business Development ROBERT LISICKI Chief Executive Officer and Director GARY WHALE PhD Chief Technology Officer VERENDER BADIAL Chief Financial Officer KIM DAVIS JD Chief Legal Officer and Corporate
Slide 7: Key Anticipated Events Through 2026
©2024 Zura Bio Ltd. 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 Anticipated
Slide 8: Systemic Sclerosis (SSc) – Tibulizumab ZB-106
©2024 Zura Bio Ltd. systemic sclerosis (SSc) tibulizumab ZB-106 Anti-BAFF + 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 9: Rationale for Phase 2 Study in Systemic Sclerosis
©2024 Zura Bio Ltd. Rationale for Phase 2 Study in Systemic Sclerosis Patients Sources: 1 Spherix Global Insights: Market Dynamix: Systemic Sclerosis (US) 2024 Acronyms: B, billion; BAFF, B cell-activating factor; IL, interleukin; SSc, systemic sclerosis; TAM, total addressable market Increased Prob
Slide 10: Systemic Sclerosis is a Multi-Organ Disease with No Effective Treatments
©2024 Zura Bio Ltd. Systemic Sclerosis is a Multi-Organ Disease with No Effective Treatments 10 Systemic sclerosis is a rare & life-threatening disease ~300,000 people with SSc in US, EU and Japan 1 Zero SSc-specific * drugs approved (*) no effective treatment exists that combats the disease across
Slide 11: Unmet Need for New Pharmacological Treatment Options
©2024 Zura Bio Ltd. 11 Unmet Need for New Pharmacological Treatment Options % of respondents 16% 23% 26% 33% 43% 56% 61% 96% 84% 77% 74% 67% 56% 44% 36% Systemic Sclerosis (SSc) Sjogren's Syndrome (SjS) Dermatomyositis (DM) Lupus Nephritis (LN) Systemic Lupus Erythematosus (SLE) Giant Cell Arteritis
Slide 12: IL-17A and BAFF Inflammation Contribute to SSc Progression
©2024 Zura Bio Ltd. 12 Both IL-17A and BAFF-Mediated Inflammation Contribute to SSc Progression Selective antibody therapy may be insufficient to address the heterogeneity of SSc B cell activating factor (BAFF) is a potent B-cell activator and promotes the survival and differentiation of B-cells. -
Slide 13: Tibulizumab Designed to Engage IL-17A, BAFF, or Both
©2024 Zura Bio Ltd. Tibulizumab Was ‘designed and engineered’ to Enable Engagement with IL-17A, BAFF, or Both Simultaneously 13 Monoclonal Antibody z May not address disease heterogeneity Targets a single, selective molecule in the body 1st Generation Bispecific Antibody activated Activation may req
Slide 14: Tibulizumab Targets IL-17A, BAFF, or Both Simultaneously
©2024 Zura Bio Ltd. Tibulizumab Targets IL-17A, BAFF, or Both Simultaneously 14 Tibulizumab uniquely targets BAFF for B cell regulation and IL-17A for inflammation control, offering a comprehensive approach to treating autoimmune and inflammatory diseases. IL-17A CD4+ CD8+ T Cell TH17 Inflammatory C
Slide 15: Pre-Clinical Evidence of Additive Benefit
©2024 Zura Bio Ltd. Pre-Clinical Evidence of Additive Benefit from Inhibiting IL-17A and Neutralizing BAFF 15 Isotype control Anti-BAFF Anti-IL 17 Anti-BAFF + Anti-IL 17 7.5 5.0 2.5 0.0 20 30 40 50 Day Cumulative disease score Histology score 70 60 ** * * * Anti-BAFF + Anti-IL 17 Isotype control Ant
Slide 16: Inhibiting IL-17A or BAFF Has Demonstrated Efficacy in SSc
©2024 Zura Bio Ltd. Separately Inhibiting IL-17A or BAFF Has Demonstrated Efficacy in SSc Placebo-Controlled Studies 16 Sources: 1 Fukasawa, T., et al. Annals of the Rheumatic Diseases, doi:10.1136/annrheumdis-2022-eular.2519. 2 Gordon, Jessica K., et al. Arthritis Rheumatology, doi:10.1002/art.4035
Slide 17: Planned Phase 2 SSc Study Design
©2024 Zura Bio Ltd. Planned Phase 2 SSc Study* is Focused on Demonstrating Benefit in Skin and Lung Endpoints 17 (*) Study design is subject to change. Sources: Zura Internal Planning Acronyms: CRISS, Composite Response Index in Systemic Sclerosis; FVC, forced vital capacity; HAQ-DI, health assessme
Slide 18: modified Rodnan Skin Score Endpoint
©2024 Zura Bio Ltd. modified Rodnan Skin Score (mRSS): Endpoint for Assessing Skin Thickness and Fibrosis 18 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 Wrinkles1 (0
Slide 19: Lung Involvement Using qHRCT as Key Secondary Endpoint
©2024 Zura Bio Ltd. In Phase 2, Lung Involvement using qHRCT will be a Key Secondary Endpoint 19 Sources: Goldin, J.., et al. Annals of the American Thoracic Society, doi:10.1513/annalsats.201802-079oc; Zura Bio internal planning Acronyms: ILD, interstitial lung disease; MMF, mycophenolate mofetil;
Slide 20: External Development Programs in SSc and SSc-ILD
zurabio.com (*) As of September 2024. Does not include trials only conducted in Japan (**) Studies on clinicaltrials.gov where the primary condition listed is systemic sclerosis (diffuse or limited cutaneous) (***) Studies on clinicaltrials.gov with the condition listed is systemic sclerosis with in
Slide 21: Revised CRISS Endpoint in SSc Assessment
©2024 Zura Bio Ltd. Revised CRISS Endpoint in SSc Assessment 21 If no significant SSc-related event, proceed to Step 2 STEP 1: Assess for significant SSc-related events: STEP 2: Assess each core measure for improvement / worsening: New scleroderma renal crisis New decline in percent predicted FVC≥15
Slide 22: Phase 2 SSc Development Aims to Reduce Historical Risks
©2024 Zura Bio Ltd. ©2024 Zura Bio Ltd. 22 Phase 2 SSc Development Aims to Reduce Historical Risks in Therapeutic Area Development Acronyms: CT, computed tomography; FVC, forced vital capacity; IL, interleukin; ILD, interstitial lung disease; mRSS, modified Rodnan Skin Score Historic Drivers of SSc
Slide 23: Hidradenitis Suppurativa (HS) – Tibulizumab ZB-106
©2024 Zura Bio Ltd. hidradenitis suppurativa (HS) tibulizumab ZB-106 Anti-BAFF + 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 24: Rationale for Phase 2 Study in Hidradenitis Suppurativa
©2024 Zura Bio Ltd. Rationale for Phase 2 Study in Hidradenitis Suppurativa Patients Acronyms: BAFF, B cell-activating factor; HiSCR, Hidradenitis Suppurativa Clinical Response; HS, hidradenitis suppurativa; IL, interleukin; TAM, total addressable market Increased Probability of Success Through Scie
Slide 25: An Overview of Hidradenitis Suppurativa
zurabio.com An Overview of Hidradenitis Suppurativa ©2024 Zura Bio Ltd. 25 DISEASE OVERVIEW Recurrent nodules and abscesses resulting in pus-like discharge Difficult-to-heal open wounds and scarring Hidradenitis suppurativa is an inflammatory follicular skin disease Increased Th1/Th17 and B cell med
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 Allergy and
Slide 27: Clinical Effect Remains Modest with Single-Pathway Inhibition
©2024 Zura Bio Ltd. Role of IL-17A and B Cells Is Clinically Validated; However, Clinical Effect Remains Modest with Single-Pathway Inhibition 27 company and drug INN >> secukinumab remibrutinib* bimekizumab sonelokimab Mechanism IL-17 A BTKi IL-17 A/F IL-17 A/F Administration SC/IV PO SC SC Phase P
Slide 28: Tibulizumab IL-17A Component Has Class-Leading Binding Affinity
©2024 Zura Bio Ltd. 28 Tibulizumab* IL-17A Component Has Class-Leading Binding Affinity Against IL-17A and IL-17A/F Ixekizumab is a humanized IgG4 monoclonal antibody (*) Tibulizumab was engineered from Taltz® (ixekizumab) Sources: 1 Taltz®. Prescribing Information. Lilly USA, LLC, https://taltz.lil
Slide 29: Novartis Phase 2b Platform Study in HS
©2024 Zura Bio Ltd. 29 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 dail
Slide 30: Novartis Interim Results Presented at AAD 2024
©2024 Zura Bio Ltd. 30 Novartis’ Interim Results Presented at ‘24 AAD: BTKi PBO-Adjusted Delta Aligns 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 an
Slide 31: Planned Phase 2 HS Study Design
©2024 Zura Bio Ltd. Planned Phase 2 HS Study Design* 31 (*) Study design is subject to change. Sources: Zura Internal Planning Acronyms: DLQI, dermatology life quality index; HiSCR, Hidradenitis Suppurativa Clinical Response; HS, hidradenitis suppurativa; IHS4, international hidradenitis suppurativa
Slide 32: Tibulizumab Summary
©2024 Zura Bio Ltd. 32 The Phase 2 development programs for systemic sclerosis and hidradenitis suppurativa are progressing The strategy follows validated pathways with the potential for improved outcomes, supported by related mechanism-of-action data from IL-17 and BAFF/B-cell depletion therapies W
Slide 33: Crebankitug ZB-168 Anti-IL-7Rα + TSLP
©2024 Zura Bio Ltd. crebankitug ZB-168 Anti-IL-7Rα + TSLP Crebankitug is a high-affinity, fully human monoclonal antibody that neutralizes the IL-7 receptor alpha (IL-7Rα) chain, potentially blocking the immune pathways of IL-7 and thymic stromal lymphopoietin (TSLP).
Slide 34: Crebankitug
©2024 Zura Bio Ltd. Crebankitug 34 Crebankitug, a fully human IL-7Rα antibody Originally developed by Pfizer IL-7Rα inhibition has potential to inhibit two critical immune pathways (IL-7 and TSLP) Potential applicability in broad range of T-cell mediated diseases and atopic diseases. Well tolerated
Slide 35: Crebankitug Blocks Signaling via IL-7 and TSLP Pathways
©2024 Zura Bio Ltd. 35 Crebankitug: A Multi-Functional Antibody That Blocks Signaling via IL-7 and TSLP Pathways crebankitug | ZB-168 IL-7Rα is a key receptor in immune regulation, central to the signaling of cytokines IL-7 and TSLP Positioning crebankitug for potential applications in diverse immun
Slide 36: TSLP and IL-7 Role in Th1, Th2, Th17 Inflammation
©2024 Zura Bio Ltd. Both TSLP and IL-7 Have a Role in Activating Th1, Th2, and Th17-Driven Inflammation 36 B Cell Development T Cell Activation CD4/CDB Effector Cells B Cell Maturation T Cell B Cell DC ILC2 Mast Cell Basophil Eosinophil Keratinocytes Airway Epithelium Stromal cell IL-7Ra γC IL-7Ra γ
Slide 37: Only mAb to Potently Inhibit Both IL-7R and TSLP
©2024 Zura Bio Ltd. 37 Crebankitug Is the Only mAb to Potently Inhibit Both IL-7R and TSLP tezepelumab (TSLP) bempikibart (IL-7Rα) crebankitug (IL-7Rα) TSLP mAb IL-7Rα mAb IL-7Rα mAb TSLP-Induced Signals 67 ng / ml / 0.44nM (CCL17)(3) 24 nM (CCL2)(4) 7.5 ng / ml / 0.05nM (CCL17)(1) 11 ng / ml / 0.07
Slide 38: Dual Inhibition of Th1 and Th2 in Atopic Dermatitis
©2024 Zura Bio Ltd. Dual Inhibition of Th1 and Th2 May Offer Broader or Deeper Levels of Response in Atopic Dermatitis 38 crebankitug | ZB-168 TSLP and IL-25 activate Th2 cells, which are crucial in the early stages of atopic dermatitis. As the condition progresses, the influence of Th2 decreases, w
Slide 39: Crebankitug Provides Optionality for Indications
©2024 Zura Bio Ltd. 39 Crebankitug Provides Optionality for Clinically Validated Development or Novel Indications Explore the potential indication space Solid biologic rationale for IL-7 / TSLP Expected Clinical Readout1 Zura Internal Evaluation of New or Orphan Indications2 Common autoimmune diseas
Slide 40: Crebankitug Summary
©2024 Zura Bio Ltd. 40 Crebankitug targets immune-related and autoimmune conditions linked to IL-7R or TSLP signaling In three Phase 1 and 1b studies involving 93 participants, crebankitug was well-tolerated, with most adverse events being mild and unrelated to the treatment Only anti-IL-7Rα program
Slide 41: 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 42: 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 42 Sources: 1 Cohen, S., et al. Nature Communications, doi:10.1038/ncomms9327; 2 Clinicaltrials.Gov, clinicaltrials.gov/
Slide 43: Torudokimab IL-33 Pathway
©2024 Zura Bio Ltd. Torudokimab IL-33 Pathway 43 Sources: 1 Chan, B., et al. Frontiers in Immunology, doi:10.3389/fimmu.2019.00364; 2 Cayrol, C. and Girard, J.P. Cytokine, doi:10.1016/j.cyto.2022.155891. 3 Gudbjartsson, D., et al. Nature Genetics, doi:10.1038/ng.323; Ketelaar, M., et al. Journal of
Slide 44: Torudokimab Has Potential for Best-in-Class Activity
©2024 Zura Bio Ltd. Torudokimab Has Potential for “Best-in-Class” Activity 44 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 Internal Data Antibody kon (M-1 s-1 ) koff (s-1 ) kd (pM
Slide 45: Team and Cash Runway
©2024 Zura Bio Ltd. Corporate Update Team and Cash Runway
Slide 46: Zura's Leadership: Driving Innovation in I&I
©2024 Zura Bio Ltd. Zura’s Leadership: Driving Innovation in I&I 46 Robert Lisicki Chief Executive Officer and Director Steve Schoch Director Jennifer Jarrett Director Parvinder Thiara Director Someit Sidhu, MD Founder and Director Arnout Ploos van Amstel Director Amit Munshi Chairman Neil Graham, M
Slide 47: Key Milestones Expected Through 2026
©2024 Zura Bio Ltd. Key milestones* expected through 2026 47 2H-2024 2025 2026 tibulizumab SSc study HS study crebankitug Indication Planning Ongoing torudokimab Indication Evaluation On-going (*) The timing of regulatory and clinical trial milestones are subject to change and additional discussion
Slide 48: Summary and Cash Position
©2024 Zura Bio Ltd. 48 Source: 1 Cash includes cash and cash equivalents as of 30-June-2024; 2 S-3 dated 03-Sept-2024 Acronyms: ATM, at-the-market offering; IPO, initial public offering Nasdaq ticker: ZURA April 2024 Photo courtesy of ©Nasdaq, Inc. Our mission: Driving scientific breakthroughs by tu