Zenas Biopharma, Inc. · NASDAQ:ZBIO
Zenas Biopharma — Investor Presentation (June 2025)
25 slides from Zenas Biopharma's investor presentation, Jun 4, 2025
Slide 1: Zenas BioPharma Corporate Presentation June 2025
1 Zenas BioPharma Corporate Presentation June 2025 Enabling patients with autoimmune diseases to reimagine life
Slide 2: Disclaimer
2 Disclaimer FORWARD - LOOKING STATEMENTS: This presentation contains “forward - looking statements” which involve risks, uncertainties and contingencies, many of which are beyond the control of the Company, which may cause actual results, performance, or achievements to differ materially from antic
Slide 3: Zenas: Creating a global, immunology-based development and commercial biotechnology company
3 Potentially highly differentiated I&I franchise molecule Obexelimab is the first bifunctional B cell targeting (CD19 x Fc γ RIIb) antibody in a Phase 3 trial (IgG4 - Related Disease), and randomized Phase 2 trials (RMS and SLE), which represent a potential multi - billion - dollar commercial oppor
Slide 4: Obexelimab: Multiple upcoming Phase 2 and Phase 3 data readouts
4 Obexelimab: Multiple upcoming Phase 2 and Phase 3 data readouts 1 Zenas acquired exclusive worldwide rights to obexelimab from Xencor, Inc. 2 Bristol Myers Squibb & Co. holds exclusive development and commercialization rights in JPN, SK, TWN, HK, SGP, AUS 3 Randomized versus placebo Next Milestone
Slide 5: Obexelimab: A potentially differentiated B cell targeted therapy
5 Obexelimab: A potentially differentiated B cell targeted therapy 1 Chu et al . Molecular Immunology 2008 & Zenas data on file 2 Szili et al . mAbs 2014 3 Chu et al . Journal of Translational Autoimmunity 2021 4 Chu et al. Arthritis & Rheumatology 2014 Source: Zenas BioPharma • Fc γ RIIb mimics nat
Slide 6: Obexelimab demonstrated clinical activity in multiple, completed clinical trials
6 Obexelimab demonstrated clinical activity in multiple, completed clinical trials SAD = Single Ascending Dose, HV = Healthy Volunteers, PK = Pharmacokinetics, MAD = Multiple Ascending Dose 1 Wang, X. American College of Rheumatology 2022 poster presentation 2 Wang, X. American College of Rheumatolo
Slide 7: Obexelimab indication strategy and development approach
7 • Scientific merit examples: Role of B cells in disease pathogenesis, prior preclinical or clinical data supporting activity of B cell therapies • Regulatory merit examples: Ease/clarity of regulatory path, validated endpoints, trial size and duration etc. • Commercial merit examples: Level of unm
Slide 8: Obexelimab: IgG4-RD
Z, Zenas VY BioPharma Obexelimab: IgG4-RD
Slide 9: IgG4-RD disease overview, pathophysiology and patient population
9 Disease Overview: • Presents with single or multi - organ involvement • A s disease progresses patients experience new or worsening symptoms ( e.g., flare) • E arly inflammatory disease state moves to a fibrotic stage, which can lead to major irreversible tissue damage and organ failure Pathophysi
Slide 10: Patients with IgG4-RD will likely experience continued flares despite first-line treatment
10 Patients with IgG4 - RD will likely experience continued flares despite first - line treatment 1 Perugino, C. et al. Nature Reviews Rheumatology . 16, 702 – 714 (2020) 2 As measured by secondary endpoints in ongoing Phase 3 INDIGO trial Repeated disease flares can damage new or existing disease s
Slide 11: Obexelimab: Phase 2 IgG4-RD results demonstrated rapid, robust, and sustained reduction in disease activity
11 • Induction and Maintenance • 100% of patients who completed trial met primary endpoint 2 • No flares or steroid use after Day 57 • 93% with ongoing response at end of trial • 80% with prior rituximab achieved complete remission • Well tolerated; most frequent AEs were IV infusion - related gastr
Slide 12: Phase 2 IgG4-RD trial: Obexelimab induced rapid remission and durable responses
12 Phase 2 IgG4 - RD trial: Obexelimab induced rapid remission of active flares and maintained durable responses Source: Perugino CA et al. Lancet Rheumatol . 2023; Carruthers MN et al. Ann Rheum Dis . 2015 Note: No comparative head - to - head trials were conducted GC=glucocorticoid; RI=responder i
Slide 13: INDIGO and MITIGATE trial designs substantially similar
13 1 Stone, DH et al. Inebilizumab for Treatment of IgG4 - Related Disease. NEJM , November, 2024. MoA = mechanism of action; RoA = route of administration; RCP = Randomized controlled period INDIGO and MITIGATE trial designs substantially similar MITIGATE 1 (Uplizna ® ) INDIGO (obexelimab) B cell d
Slide 14: INDIGO Trial Summary
14 INDIGO Trial Summary: • Design: Randomized, double - blind, placebo controlled • Treatment: weekly obexelimab 250 mg subcutaneous or placebo control; GC taper to 0 mg by week 8 • Primary endpoint: Time to disease flare through week 52 • Secondary endpoints include: 52 - week flare rate, Achieveme
Slide 15: Obexelimab represents a $1 billion+ commercial revenue opportunity in the U.S. alone
15 Obexelimab represents a compelling $1billion+ commercial revenue opportunity in the U.S. alone Estimated U.S. prevalence: 30 - 40K Current U.S. diagnosed prevalence:~20K Treated with frontline Tx (steroids and non - steroidal immunosuppressants): ~20K Stable remission: ~8K - 10K Chronic disease ~
Slide 16: Obexelimab: Multiple Sclerosis
16 Obexelimab: Multiple Sclerosis
Slide 17: Phase 2 MoonStone RMS trial design
17 Phase 2 MoonStone RMS trial (n~110) Standard design with MRI measurements; highly predictive of successful outcome in large randomized trials SCREENING Active RMS ( relapsing remitting MS or relapsing secondary progressive MS) : • EDSS <5.5 * Open label extension 2:1 Randomization Obexelimab Q1W
Slide 18: MoonStone key inclusion/exclusion criteria similar to previous Phase 2 B cell-directed programs
18 Moonstone key inclusion/exclusion criteria are similar to those of previous Phase 2 B cell - directed programs Previous B cell - directed therapy global Phase II trials * Obexelimab / MoonStone Phase II Key inclusion criteria • One or more relapses in the past year and/or two+ within the past two
Slide 19: MoonStone data can drive several Phase 3 development paths in multiple sclerosis
19 MoonStone data can potentially drive several Phase 3 development paths for obexelimab in multiple sclerosis 2027+ 2026 2025 Phase 3 RMS trial 1 Phase 3 RMS trial 2 MoonStone Phase 2 (RMS) Phase 3 nrSPMS trial Phase 3 PPMS trial With its CD19 targeting, non - depleting mechanism of action, conveni
Slide 20: Obexelimab: Systemic Lupus Erythematosus
20 Obexelimab: Systemic Lupus Erythematosus
Slide 21: Potential for improved clinical activity with an optimized obexelimab dosing regimen
21 Potential for improved clinical activity with an optimized obexelimab dosing regimen 17% 35% 52% 0% 10% 20% 30% 40% 50% 60% Intention - to - treat population 1 Optimized exposure population 2 Biomarker positive population 3 Patients at W32 without loss of improvement (∆" vs. PBO") Source: Merrill
Slide 22: Phase 2 SunStone SLE trial design and primary endpoint
22 Primary Endpoint: Reduction of SLE disease activity at week 24 by BILAG - Based Composite Lupus Assessment (BICLA) Phase 2 SunStone SLE trial 1 enrolling Designed to confirm obexelimab activity in all - comer and biomarker populations SCREENING Active SLE: • BILAG ≥1A or ≥2B • SLEDAI ≥6 • PI conf
Slide 23: Obexelimab's differentiated profile positions it for multiple I&I diseases
23 Obexelimab’s differentiated profile potentially positions it to be a market - leading therapy for multiple I&I diseases Systemic Lupus Erythematosus (SLE) Multiple Sclerosis (RMS, PPMS) Immunoglobulin G4 Related Disease (IgG4 - RD) Indication ~150,000 patients (US) ~170,000 patients (EU) ~650,000
Slide 24: Accomplished Executive Team
24 Accomplished Executive Team Extensive experience developing and commercializing biopharmaceuticals Haley Laken, Ph.D. CSO Lonnie Moulder CEO & Chairman Joe Farmer President & COO Jennifer Fox CFO & CBO COLLECTIVELY, ZENAS MANAGEMENT HAS: • 70+ IND filings • 30+ BLA/NDA filings • 30+ Commercial pr
Slide 25: Obexelimab, an I&I franchise molecule
25 Obexelimab, an I&I franchise molecule Obexelimab is a potentially differentiated B cell therapeutic in development for IgG4 - RD, RMS and SLE, each representing a potential multi - billion - dollar commercial opportunity 1 Multiple upcoming Phase 2 and Phase 3 data updates expected Obexelimab Pha