Zenas Biopharma, Inc. · NASDAQ:ZBIO
Zenas Biopharma — Merger or Acquisition (October 2025)
49 slides from Zenas Biopharma's merger presentation, Oct 8, 2025
Slide 1: Transformational Global Collaboration With InnoCare Pharma Conference Call
1 Transformational Global Collaboration With InnoCare Pharma Conference Call October 8, 2025
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 Zenas BioPharma, Inc. (the “ Company” or “Zenas”), which may cause actual results, performance, or achiev
Slide 3: Today's agenda and speakers
3 Today’s agenda and speakers Lonnie Moulder CEO & Chairman Joe Farmer President & COO Jennifer Fox CFO & CBO Lisa von Moltke, M.D. Head of R&D & CMO Haley Laken, Ph.D. CSO 1. Transaction overview and financial support 2. BTKi and progressive forms of MS 4. Oral IL - 17AA/AF and brain - penetrant TY
Slide 4: Transformative InnoCare Collaboration Agreement
4 Transformative InnoCare Collaboration Agreement
Slide 5: Collaboration agreement with InnoCare
5 Collaboration agreement with InnoCare, an established, globally recognized, fully - integrated, biopharmaceutical company • $ 35 million cash, 5 million shares of Zenas common stock issued upfront and: » Orelabrutinib: up to an additional 2 million shares of Zenas stock and up to $240 million in d
Slide 6: Transaction expected to accelerate Zenas' goal to become a multi-franchise company
6 Transaction expected to accelerate Zenas’ goal to become a multi - franchise, global, fully - integrated, commercial - stage biopharmaceutical company □ Two late - stage franchise programs for four I&I indications □ Global development and commercialization capabilities □ Two early - stage programs
Slide 7: Building I&I and MS franchises of four potentially best-in-class programs
7 Building compelling I&I and MS franchises consisting of four potentially best - in - class programs Territory Phase 3 Phase 2 Phase 1 Preclinical Indication Compound Global excluding JPN, SK, TWN, HK , SGP, AUS 1 IgG4 - RD Obexelimab (CD19 and Fc ɣ RIIb bifunctional mAb) ) RMS SLE Global PPMS Orel
Slide 8: Numerous value-creating milestones expected in the next 24 months
8 Numerous potentially value - creating milestones expected in the next 24 months 2025 2027 2026 Obexelimab Early 4 th quarter: Phase 2 RMS 12 - week data ~Year - end: Phase 3 IgG4 - RD topline data Obexelimab 2 nd quarter: IgG4 - RD BLA submission Mid - year: Phase 2 SLE topline data Obexelimab Fir
Slide 9: BTK: A Compelling Target for Progressive Multiple Sclerosis
9 BTK: A Compelling Target for Progressive Multiple Sclerosis
Slide 10: SPMS and PPMS have the highest unmet need across MS subtypes
10 SPMS and PPMS have the highest unmet need across MS subtypes and limited therapeutic options SPMS (>125K diagnosed patients in U.S.) 1,2 RRMS treatments used off - label 4 Therapies that prevent disability progression Initially RRMS followed by steady increase in disability without relapses Disab
Slide 11: BTK is a validated target in MS
11 BTK is a validated target in MS with unique potential to address compartmentalized inflammation and disease progression 1 Reich DS et al. NEJM 2018. 2 Gandhi R et al. J Neuroimmunol . 2010; 3 Saberi et al . 2023, Vong et al. 2022 Greenberg 2024, Krämer et al. 2023; 4 Oh et al. NEJM 2025, Fox et a
Slide 12: CNS penetrant BTK inhibitor potential to prevent disease progression in MS
12 CNS penetrant BTK inhibitor potential to prevent disease progression in MS; confirmed in Phase 3 SPMS and RRMS Trials SPMS: Fox et al . Tolebrutinib in Non - relapsing Secondary Progressive Multiple Sclerosis. NEJM April 2025 RRMS: Oh et al . Tolebrutinib versus Teriflunomide in Relapsing Multipl
Slide 13: Orelabrutinib Phase 3 SPMS trial expected to initiate in 1Q 2026
13 Quarter and year reflect clinical trial primary completion dates from clinicaltrials.gov or as projected by sponsor Orelabrutinib Phase 3 SPMS trial is expected to initiate in 1Q 2026 Orelabrutinib is a potential best - in - class therapy for progressive MS and is well - positioned to take advant
Slide 14: Orelabrutinib: a Potentially Best-in-Class BTKi
14 Orelabrutinib: a Potentially Best - in - Class BTKi
Slide 15: Orelabrutinib's pharmacologic attributes impart best-in-class potential
15 Orelabrutinib’s pharmacologic attributes impart best - in - class potential combining high selectivity and CNS penetrant activity Non - covalent / 200mg BID Covalent / 60mg QD Covalent / 80mg QD Binding / dosing 1 Selectivity 2 ( scanMAX (Eurofins ) kinome scan at 1µM) High Lower High CNS concent
Slide 16: Phase 2 RRMS trial summary
16 Phase 2 RRMS Trial Summary: • Design: double - blind, randomized, placebo - controlled with placebo crossover at week 12 • Treatment: 4 different doses of orelabrutinib vs. placebo control through week 12 • MRI endpoint assessing new T1 Gd - enhancing lesions at week 12 • Secondary endpoints incl
Slide 17: Orelabrutinib Phase 2 trial baseline characteristics
17 Orelabrutinib Phase 2 trial baseline characteristics 35.4 (9.8) • Age, mean (SD), years 100 (63.4%) • Female, n (%) 5.8 (5.8) • Time since diagnosis at screening, mean (SD), years 2.6 (1.5) • EDSS score, median (SD) 1.8 (4.3) • # of GdE T1 hyperintense lesions at baseline, mean (SD) 53 (33.5%) •
Slide 18: Rapid and deep reduction in new GdE+ T1 lesions across all doses
18 Orelabrutinib treatment resulted in a rapid and deep reduction in new GdE+ T1 lesions across all evaluated doses 4.34 1.14 0.82 0.42 0.0 1.5 3.0 4.5 Placebo (n=27) 50mg QD (n=30) 50mg BID (n=29) 80mg QD (n=29) 74% 81% > 90% (P=0.0018) (P=0.0073) (P=0.0278) 0.0 1.5 3.0 4.5 0 4 8 12 Placebo Orelabr
Slide 19: Data out to 96 weeks support sustained clinical activity
19 Orelabrutinib data out to 96 - week support sustained clinical activity and potential impact on disability progression 20.5 9.3 0 6 12 18 24 Baseline Week 96 - 55% 2.7 2.5 0.0 1.5 3.0 Baseline Week 96 - 9% Serum NfL: Indicative of disease activity and progression EDSS Score: Indicative of neurolo
Slide 20: Orelabrutinib generally well tolerated; safety in line with other BTKi
20 Orelabrutinib was generally well tolerated; safety in - line with other BTKi in development for MS 1 • TEAEs for orelabrutinib (n=118) vs. placebo (n=40) during the 12 - week RCP » All TEAEs: 53% vs. 30% » Serious TEAEs: 2% vs. 0% » Liver - related TEAEs: 10% vs. 7.5% o Observed within first 8 we
Slide 21: Phase 3 protocols cleared with FDA and positive EMA Scientific Advice
21 Orelabrutinib Phase 3 protocols cleared with FDA and positive EMA Scientific Advice PPMS Study Design; trial initiated in U.S. Primary Endpoint: Time to onset of 12 - week cCDP Primary Endpoint: Time to onset of 24 - week CDP SPMS Study Design; trial expected to initiate 1Q 2026
Slide 22: Global MS market expected to reach >$30B
22 Global MS market expected to reach >$30B with approval of new therapies; SPMS and PPMS represent >$12B+ Diagnosed prevalence of MS in the US: ~640K 1 Patients with SPMS and PPMS: 30 - 35%+ 2 Current SPMS and PPMS prevalence: 190 - 225K Non - DMT treated (~30%) 3 ~60K - 70K DMT treated (~70%) 3 ~1
Slide 23: Registration-directed trials in untapped progressive MS segments
23 Orelabrutinib registration - directed trials to begin in largely untapped progressive MS market segments Highly positive Phase 2 results in RMS with 96 weeks of data; Phase 3 PPMS trial initiated and Phase 3 trial for SPMS expected to initiate in 1Q 2026 Peer BTKi under FDA review for SPMS; an ac
Slide 24: Oral IL-17AA/AF and Brain Penetrant TYK2 Programs
24 Oral IL - 17AA/AF and Brain Penetrant TYK2 Programs
Slide 25: IL-17 biologics: a blockbuster drug class
25 • Currently a $10B global market with ~50% average annual growth since first approval » Three biologics approved for seven rheumatic and dermatologic autoimmune indications * » Market expected to grow with additional IL - 17 approvals and launches in other indications ZB021: a novel oral IL - 17A
Slide 26: ZB021's best-in-class potential supported by in vitro and in vivo activity
26 ZB021’s best - in - class potential is supported by robust in vitro and in vivo activity 0 2 4 6 8 10 12 14 0 3 4 5 6 7 8 9 Normal control Vehicle Anti - IL - 17 biologic ICP - 054 0.3 mg/kg ICP - 054 1 mg/kg ICP - 054 3 mg/kg ICP - 054 10 mg/kg Days post - treatment Clinical Score Robust efficac
Slide 27: ZB022: a brain-penetrant TYK2 inhibitor
27 ZB022: a brain - penetrant TYK2 inhibitor with significant opportunity in neuroinflammatory and neurodegenerative diseases • Complementary mechanism to expand upon potential neurology franchise led by orelabrutinib » Allosteric JH2 inhibition improves selectivity and specificity » Favorable PK/PD
Slide 28: Obexelimab: a Potential I&I Franchise Molecule
28 Obexelimab: a Potential I&I Franchise Molecule
Slide 29: Obexelimab: Phase 3 and multiple Phase 2 data readouts expected
29 Obexelimab: Phase 3 and multiple Phase 2 data readouts expected Territory Next Milestone Phase 3 Phase 2 Phase 1 Preclinical Indication Compound Global excluding JPN, SK, TWN, HK, SGP, AUS 3 Phase 3 Topline Results expected around year end 2025 IgG4 - RD Obexelimab 1 (CD19 and Fc ɣ RIIb bifunctio
Slide 30: Obexelimab: differentiated B cell targeted therapy with bifunctional MoA
30 Obexelimab is a potentially differentiated B cell targeted therapy with a novel bifunctional MoA 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 5 Abeles et a
Slide 31: Obexelimab for Relapsing Multiple Sclerosis
31 Obexelimab for Relapsing Multiple Sclerosis
Slide 32: MoonStone Trial Summary
32 MoonStone Trial Summary: • Design: double - blind, randomized, placebo - controlled with placebo crossover at week 12 • Treatment: obexelimab 250mg SC weekly vs. placebo control (through week 12) • MRI endpoint assessing T1 Gd - enhancing lesions at week 12 • Secondary and exploratory endpoints:
Slide 33: MoonStone baseline characteristics
33 MoonStone baseline characteristics 42 (9.5) • Age, mean (SD), years 81 (70%) • Female, n (%) 7.54 (8.6) • Time since diagnosis at screening, mean (SD), years 3 (0.0 - 5.5) • EDSS score, median (range) 0.71 (2.2) • # of GdE T1 hyperintense lesions at screening, mean 25 (21.6) • Patients with GdE T
Slide 34: Historical benchmarks for GdE+ T1 lesions from Phase 2 RMS trials
34 Historical benchmarks for GdE+ T1 lesions from Phase 2 RMS trials Baseline GdE+ T1 lesions and baseline characteristics most similar to fenebrutinib Assessment GdE T1 Lesions* Phase 2 Program At week 12 0.27 vs. 0.03 • Fenebrutinib (BTKi) Cumulative week 12 4.34 vs. 0.42 • Orelabrutinib (BTKi) At
Slide 35: Blinded review of MoonStone data shows rapid decline in lesions
35 Blinded review of MoonStone’s randomized controlled data shows rapid decline in new and new/existing lesions per scan up to week 12 0.71 0.09 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 Baseline * 0.53 Week 4 0.13 Week 8 Week 12 0.71 0.60 0.18 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 Baseline Week 4 0.35 Week
Slide 36: Approval of new drugs for RMS is challenging
36 Approval of new drugs for RMS is challenging due to the evolving treatment landscape and current pivotal trial endpoints • Shifting clinical trial recruitment dynamics » Slower recruitment » Patients now have less active disease • Challenging to show benefit given less active population » Agents
Slide 37: Obexelimab for IgG4-RD
4 §SnOs Obexelimab for IgG4-RD
Slide 38: IgG4-RD patients likely to experience disease progression independent of flares
38 Patients with IgG4 - RD are likely to experience disease progression independent of flares with cumulative organ damage Subclinical / smoldering disease Disease course over time Clinically evident disease flares Repeated disease flares can damage new or existing disease sites 1 Subclinical inflam
Slide 39: Obexelimab Phase 2 IgG4-RD results
39 Obexelimab’s Phase 2 IgG4 - RD results demonstrated rapid, robust, and sustained reduction in IgG4 - RD disease activity 1 • Rapid induction of remission and sustained reduction in disease activity (IgG4 - RD RI) • 100% of patients who completed trial met primary endpoint (2 - point IgG4 - RD RI
Slide 40: Phase 3 INDIGO trial summary
40 SCREENING • 20 - 60 mg GC Tx for flare • 20mg GC at trial entry Placebo SC Q1W for 52 weeks (n=~100) Open label extension 1:1 Obexelimab SC Q1W for 52 weeks (n=~100) GC taper to 0mg by week 8 GC taper to 0mg by week 8 1 Stone, et al. Inebilizumab for Treatment of IgG4 - Related Disease. NEJM . No
Slide 41: Obexelimab potential to become best-in-class in IgG4-RD
41 Obexelimab has the potential to become a best - in - class therapy in the evolving IgG4 - RD treatment landscape Potential to achieve faster responses and higher complete remission rates No premedication and no risk of infusion - related reactions Potential to allow for vaccinations or management
Slide 42: Obexelimab $1 billion+ U.S. commercial revenue opportunity
42 Obexelimab represents a compelling $1billion+ commercial revenue opportunity in the U.S. alone 1 Estimated U.S. prevalence: ~30 - 40K 2 Current U.S. diagnosed prevalence: ~20K 1 Patients treated with systemic therapies: ~20K 3 Stable remission: ~8K - 10K Chronic disease ~10K - 12K x Diagnosed pre
Slide 43: Obexelimab for Systemic Lupus Erythematosus
43 Obexelimab for Systemic Lupus Erythematosus
Slide 44: Potential for improved clinical activity with optimized SC dosing
44 Potential for improved clinical activity with an optimized obexelimab subcutaneous dosing regimen 17% 35% 52% 0% 10% 20% 30% 40% 50% 60% Intention - to - treat population 1 Optimized exposure (C trough ) population 2 Biomarker positive population 3 Patients at W32 without loss of improvement (∆"
Slide 45: Phase 2 SunStone SLE trial enrolling
45 Phase 2 SunStone SLE trial enrolling Designed to confirm obexelimab activity in all - comer and biomarker populations SCREENING Active SLE: • BILAG ≥1A or ≥2B • SLEDAI ≥6 • PI confirmation Stable steroids Placebo Q1W for 24 weeks (n= 95 ) Follow - up 1:1 Obexelimab Q1W for 24 weeks (n= 95 ) • SC
Slide 46: Future Catalysts and Corporate Summary
46 Future Catalysts and Corporate Summary
Slide 47: Numerous value-creating milestones expected in the next 24 months
47 Numerous potentially value - creating milestones expected in the next 24 months 2025 2027 2026 Obexelimab Early 4 th quarter: Phase 2 RMS 12 - week data ~Year - end: Phase 3 IgG4 - RD topline data Obexelimab 2 nd quarter: IgG4 - RD BLA submission Mid - year: Phase 2 SLE topline data Obexelimab Fi
Slide 48: Corporate summary
48 Obexelimab; an I&I franchise molecule A potentially best - in - class B cell therapeutic with Phase 3 data for IgG4 - RD expected year - end, SLE Phase 2 trial enrolling, and RMS Phase 2 data expected early 4Q 2025; each representing a potential multi - billion - dollar commercial opportunity 1 E
Slide 49: Q&A Session
N Gagne Q&A Session
Zenas BioPharma — Merger or Acquisition (October 2025) on 6ix