Corporate Overview
Building the Next
Immunology Leader
Last Updated: October 2023
©2023 Zura Bio Ltd.
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Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. You should carefully consider the risks and uncertainties described in the "Risk Factors" sections of Zura Bio's recent filings with the SEC. These filings would identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Many of these factors are outside Zura Bio's control and are difficult to predict. Many factors could cause actual future events to differ from the forward-looking statements in this communication, including but not limited to: (1) the outcome of any legal proceedings that may be instituted against Zura Bio; (2) volatility in the price of Zura Bio's securities; (3) the ability of Zura Bio to successfully conduct research and development activities, grow and manage growth profitably, maintain relationships with customers and suppliers, and retain key employees; (4) costs related to financing transactions and the ongoing costs relating to operating as a public company; (5) changes in the applicable laws or regulations; (6) the possibility that Zura Bio may be adversely affected by other economic, business, and/or competitive factors; (7) the risk of downturns and a changing regulatory landscape in the highly competitive industry in which Zura Bio operates; (8) the impact of the global COVID-19 pandemic; (9) the potential inability of Zura Bio to raise additional capital needed to pursue its business objectives or to achieve efficiencies regarding other costs; (10) the enforceability of Zura Bio's intellectual property, including its patents, and the potential infringement on the intellectual property rights of others, cyber security risks or potential breaches of data security; and (11) other risks and uncertainties described in the Registration Statement and such other documents filed by Zura Bio from time to time with the SEC. These risks and uncertainties may be amplified by the COVID-19 pandemic or other unanticipated global disruption events, which may continue to cause economic uncertainty. Zura Bio cautions that the foregoing list of factors is not exclusive or exhaustive and not to place undue reliance upon any forward-looking statements, including projections, which speak only as of the date made. Zura Bio gives no assurance that it will achieve its expectations.
Zura Bio does not undertake or accept any obligation to publicly provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, or should circumstances change, except as otherwise required by securities and other applicable laws.
©2023 Zura Bio Ltd. 2
Experienced management team with proven ability to successfully execute and build a leading market position
Nasdaq: ZURA
Executive Team
Someit Sidhu M.D. | Verender Badial | Chris Cabell M.D. | Gary Whale Ph.D. | Kim Davis | Mike Howell Ph.D. | ||||||||
Chief Executive Officer and Director | Chief Financial Officer | Chief Medical Officer and | Chief Technology Officer | Chief Legal Officer | Chief Scientific Officer and | ||||||||
Head of Research and Development | Head of Translational Science | ||||||||||||
Board of Directors
Amit Munshi | Garry Neil, M.D. | Jennifer Jarrett | Neil Graham, M.D. | Parvinder Thiara | Sandeep Kulkarni, M.D. | Someit Sidhu, M.D. | Steve Schoch |
Chairman | Director | Director | Director | Director | Director | Director | Director |
©2023 Zura Bio Ltd. 3
Sizeable Total Addressable Market Exists
Across Number of Validated Mechanisms
Nasdaq: ZURA
Approximately $4 Billion in | Room for growth across |
growth anticipated by 2029 | our three indications |
alopecia areata | hidradenitis suppurativa | systemic sclerosis | ||
$8.7 | $21.4 | $7.1 | ||||
2023 | $5.5 | 2029 | ||||
$7.1 | $17.1 | |||||
US | Billion | US | ||||
Total Addressable Market1 | Billion | Total Addressable Market2 | ||||
$4.5 | $5.6 | |||||
US TAM estimated ~$21 Billion by 20292 | Systemic sclerosis has unlocked potential with only two |
specific SSc-ILD approved products | |
Sources: 1 Based on current annual gross price of marketed products | 2 Based on 2023 gross price, adjusted for population and price growth. | ©2023 Zura Bio Ltd. | 4 |
Clinical stage pipeline targeting key immunology pathways
Nasdaq: ZURA
ZURA BIO PROGRAM | INDICATION | NEXT CLINICAL PHASE | EXPECTED KEY MILESTONES | |||
Preclinical | Phase 1 | Phase 2 | Phase 3 | |||
Transition asset from Eli-Lilly
systemic sclerosis | Open IND rheumatology division | ||
Phase 2 study initiation, to enable | |||
2H-24' | |||
tibulizumab | seamless transition to Ph3 | ||
ZB-106 | |||
Anti-BAFF x IL-17 | |||
Transition asset from Eli-Lilly | |||
hidradenitis suppurativa | Open IND dermatology division | 2H-24' | |
Phase 2 initiation | 2H-24' |
Transition asset from Pfizer | ||||||||
ZB-168 Anti-IL-7R | alopecia areata | Open IND dermatology division | ||||||
Completed technology transfer to CDMO | ||||||||
Phase 2 initiation* | 1H-24' | |||||||
ZB-880 torudokimab Anti-IL-33
allergy / respiratory
Conduct all necessary CMC and regulatory tasks to prepare the asset for Phase 2 readiness**
(*) pending expected phase 2 external catalysts in atopic dermatitis (AD) and ulcerative colitis (UC)
(**) pending expected phase 2 and 3 external catalysts in asthma and chronic obstructive pulmonary disease (COPD)
Sources: Zura Internal Data and Planning. | ©2023 Zura Bio Ltd. | 5 |
Current development plans and trial designs are subject to change due to factors such as regulatory feedback |
Key External Catalysts Through 1H-2025
Nasdaq: ZURA
2024 | 2025 | ||||
Q1 | Q2 | Q3 | Q4 | Q1 | Q2 |
(1Q-2024)
Topline data from Ph2b/3 in PsA
Acelyrin, izokibep (IL-17)
(1Q-2024)
Topline data from Ph2b in PsA
MoonLake, sonelokimab (IL-17)
(4Q-2023 to 1Q-2024)
Topline Ph2 in UC
OSE Immunotherapeutics , OSE-127(anti-IL-7RmAb)
(1Q-2024)
Topline Ph2 in COPD
Astra Zeneca / Amgen, tezepelumab (TSLP)
(4Q-2024)
Topline Ph2b/3 in Uveitis
Acelyrin, izokibep (IL-17)
(3Q-2024)
Topline Ph2 in Plaque psoriasis
Dice (part of Eli Lilly), DC-806(IL-17)
(3Q-2024)
Ph2 in SLE
Novartis, Ianalumab (VAY736) (BAFF) & iscalimab (CFZ533) (anti-CD40)
(3Q-2024)
Topline Ph3 in Asthma
Astra Zeneca / Amgen, tezepelumab (TSLP)
(3Q-2024)
Topline in Ph2a in AA
Q-32 Bio/Horizon (part of Amgen), ADX-914(IL-7 /TSLP)
(2Q-2025)
Ph3 in COPD (AERIFY-1 /AERIFY-II)
Sanofi/Regeneron, itepekimab (anti-IL-33mAb)
LEGEND:
ZB-106 Program: External Catalyst
ZB-168 Program: External Catalyst
(1Q/2Q-2024)
Topline in Ph2 in AD
Q-32 Bio/Horizon (part of Amgen), ADX-914(IL-7 /TSLP)
(1Q/2Q-2024)
Initiate Ph1/2 trial in AA
Nektar Therapeutics, rezpegaldesleukin
(4Q-2024)
Topline in Ph1b / 2a in AA Inmagene, IMG-007 (OX40)
ZB-880 Program: External Catalyst
(Ongoing through Q4-2026) Topline Readouts in Multi-yearB-cell Platform Study in HS
Novartis, CFZ533, LYS006, MAS825, LOU064 and VAY736
Sources: ClinicalTrial.gov, Company Press Release | ©2023 Zura Bio Ltd. | 6 |
Abbreviations: AA, alopecia areata; AD, atopic dermatitis; COPD, chronic obstructive pulmonary disease; HS, hidradenitis suppurativa, PsA, psoriatic arthritis; SLE, systemic lupus erythematosus; UC, ulcerative colitis |
Our Strategic Approach
Pioneering dual pathway biology
Integrating two validated mechanisms in disease indications where each has demonstrated individual efficacy
Pioneering dual pathway biology
Paradigm shift for complex diseases
Potent molecules with highly validated pathways
Our clinical-stage assets are positioned as potentially best-in-class in pathways driving efficacy, aiming to profoundly alter the trajectory of chronic autoimmune diseases.
Potential best-in- class potency on clinically validated pathways
Paradigm shift for patients
Our approach could signify a paradigm shift for patients suffering from severe and intricate autoimmune diseases. These patients currently find their needs unmet by the conventional "single" pathway approach.
©2023 Zura Bio Ltd. 7
Paradigm shifting not incrementalism
Nasdaq: ZURA
CURRENT APPROACHES ARE INCREMENTAL
Systemic sclerosis
- Skin, lung, kidney and other organs are affected by SSc
- Two drugs approved for severe lung complications (SSc-ILD)
- No treatment addresses the disease across multiple organ systems, currently, only lung complications are being addressed
Hidradenitis suppurativa
- IL-17treatments seem to have reached their efficacy ceiling
- Overall disease burden still exists
- Persistent inflammatory burden remains with a B-cell driven component
Alopecia areata
- Efficacy bar is set at the low or mid dose of JAK inhibitors (JAKi)
- The JAKi class carries black box warnings limiting broad adoption for AA
- Efficacious, safer and better tolerated treatments are needed
PATIENTS NEED A PARADIGM SHIFT
Broader efficacy
Works in more patients not just certain subsets
Efficacy | Deeper efficacy |
Raising the efficacy bar for all patients
Tox | Tox |
Patient tolerability and safety | |
Sources: Company Presentations, Publications and Research.
©2023 Zura Bio Ltd. | 8 |
Pioneering Dual Pathway Biology
ZB-106 is an IgG-scFv engineered by the fusion of ixekizumab (TALTZ®) and tabalumab 1, 2, 3 | ZB-106 inhibits BAFF-mediated proliferation in | |
T1165 cells in an IL-17 independent manner 3 | ||
BAFF * | IL-17* | |
Nasdaq: ZURA
ZB-106 tabalumab ZB-106 + IL- 17A tabalumab + IL- 17A
tibulizumab
Anti BAFFxIL17
tabalumab
Anti-BAFF Ab
TALTZ®
Anti-IL-17 scFv
ZB-106 inhibits IL-17 mediated CXCL1 in epithelial
cells in a BAFF independent manner 3
ZB-106
TALTZ®
ZB-106 + BAFF
TALTZ® + BAFF
- ZB-106neutralizes IL-17A or BAFF regardless of whether the other binding sites are occupied
- ZB-106binds in the same way as Taltz and tabalumab with the same number of binding sites
- Activity is mediated through direct target engagement and not ADCC
- t1/2 is 26.9 days
Sources: 1 Liu, Ling, et al. Journal of Inflammation Research, doi:10.2147/jir.s100940. | 2 Manetta, Joseph et al. Journal of Inflammation Research, doi:10.2147/jir.s67751. | 3 Benschop, Robert J., et al. mAbs, doi:10.1080/19420862.2019.1624463. | ©2023 Zura Bio Ltd. | 9 |
(*) Figure Generated with BioRender |
Potent molecules with highly validated pathways
Nasdaq: ZURA
tibulizumab: BAFF / IL-17 | ZB-168:IL-7R / TSLP | ||||||
BAFF | |||||||
tabalumab | IL-7R | ||||||
γc | TSLPR | ||||||
Anti-BAFF Ab | |||||||
TALTZ®
Anti-IL-17 scFv | IL-17 |
DOSING TO DATE 2
78 Participants Dosed Across Three Ph1/1b studies | 93 Participants Dosed | |
57 participants with single dose | 60 participants with single dose | |
21 participants with multiple dose up to 12 weeks | 33 participants with multiple doses up to 12 weeks | |
POTENCY | ||
IL-17 binds to IL-17A preventing IL-17A/A and IL-17A/F | • ZB-168 is nearly 10-fold more | • ZB-168 is >300-fold more potent |
heterodimerization1 | potent than AZ/AMG's | than Q32Bio / Horizon's ADX-914 |
tezepelumab, and | in TSLP-induced markers, but | |
tezepelumab does not inhibit | similar in IL-7-induced pSTA58 | |
IL-7 signaling |
torudokimab: IL-33 / RAGE
244 Participants Dosed
81 participants with single dose
163 participants with multiple doses up to 52 weeks
Torudokimab was 2.9 and 5.5-fold more potent than etokimab and itepekimab, respectively, inhibiting IL-33-induced GM-CSFproduction by human mast cells
half-life | |
( t1/2 ) | |
tibulizumab | 26.9 days |
sonelokimab | 11-12 days |
izokibep | ~11 days |
UPB-101 | tezepelumab | bempikibart | |
(α-TSLPR) | (TSLP) | (IL-7Rα) | |
α-TSLPR mAb | IL-7Rα mAb | ||
TSLP mAb | |||
TSLP-Induced | 16.1 ng / ml / | 67 ng / ml / | 24 nM |
Signals | 0.1nM (CCL17)(7) | 0.44nM (CCL17)(7) | (CCL2)(8) |
0.6 nM | |||
IL-7-Induced | Neg | Neg | (IL-7 at 0.25ng/ml)(8) |
Signals | 2.1 nM | ||
(IL-7 at 2.5ng/ml)(8)
ZB-168
(IL-7Rα)
IL-7Rα mAb
7.5 ng / ml / 0.05nM (CCL17)(5) 11 ng / ml / 0.07nM (CCL22)(5)
0.08 nM (CCL2)(8)
0.46nM (pSTAT5)(6)
Antibody | kon (M-1s-1) | koff (s-1) | kd (pM) | torudokimab |
Potency | ||||
torudokimab (LY3375880) | 1.7 x 106 | 6.7 x 10-5 | 39 | |
etokimab (AnaptysBio) | 9.4 x 105 | 1.2 x 10-4 | 112 | 2.9x |
itepekimab (Regeneron) | 7.6 x 105 | 1.6 x 10-4 | 215 | 5.5x |
Sources: 1 Liu, Ling, et al. Journal of Inflammation Research, doi:10.2147/jir.s100940. 2 IB and CSR, 3 Manetta, Joseph et al. Journal of Inflammation Research, doi:10.2147/jir.s67751. 4 Benschop, Robert J., et al. mAbs, doi:10.1080/19420862.2019.1624463. 5 Zura Internal Data. 6 Herold, Kevan C., et al. JCI Insight, doi:10.1172/jci.insight.126054. 7 Numazaki, Mako, et al. Journal of Pharmacology and Experimental Therapeutics, doi:10.1124/jpet.121.000686. 8.BMS patent https://patents.google.com/patent/WO2020154293A1/en
©2023 Zura Bio Ltd. 10
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Zura Bio Ltd. published this content on 25 October 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 25 October 2023 12:55:37 UTC.