Sab Biotherapeutics, Inc. · NASDAQ:SABS

Sab Biotherapeutics — Investor Day (January 2025)

43 slides from Sab Biotherapeutics's investor day presentation, Jan 28, 2025

  1. Slide 1: SAB Bio Innovation Day: Accelerating Disease-Modifying Treatments in Autoimmunity

    SAB BIO INNOVATION DAY ACCELERATING DISEASE-MODIFYING TREATMENTS IN AUTOIMMUNITY January 28, 2025 (Nasdaq: SABS) EXHIBIT 99.2

  2. Slide 2: Today's Speakers

    Today’s Speakers Chairman and CEO Samuel Reich Alexandra Kropotova, MD Michael Haller, MD Chief Medical Officer & EVP Professor and Chief Pediatric Endocrinology University of Florida

  3. Slide 3: Forward-Looking Statements

    Forward-Looking Statements The material in this presentation has been prepared by SAB Biotherapeutics, Inc. (“SAB”) and is general background information about SAB’s activities current as of the date of this presentation. This information is given in summary form and is not intended to be complete.

  4. Slide 4: Welcome and Opening Comments

    Welcome and Opening Comments Samuel J. Reich Chairman and Chief Executive Officer

  5. Slide 5: Today's Agenda

    Today’s Agenda Opening Comments Samuel J. Reich SAB-142: Phase 1 Study Design and Safety Profile Alexandra Kropotova, MD Q&A All Speakers SAB-142: PD data, Phase 2 Plan and Overview Michael Haller, MD

  6. Slide 6: Michael J. Haller, MD, Pediatric Endocrinologist

    Michael J. Haller, MD, Pediatric Endocrinologist © 2025 SAB BIOTHERAPEUTICS, INC. Division Chief of the Pediatric Endocrinology Division at the University of Florida Silverstein Family Eminent Scholar Chair in Pediatric Endocrinology Dr. Haller has been involved in type 1 diabetes research since the

  7. Slide 7: Type 1 Diabetes is One of the Greatest Health Challenges of Our Lifetime

    Type 1 Diabetes is One of the Greatest Health Challenges of Our Lifetime 1. https://www.breakthrought1d.org/explore-research/research-strategy/ 2. https://www.t1dindex.org/ 35 years of healthy life lost, on average, per person ~1.4M ~9.4M ~16.4M People with T1D globally by 20402 People with T1D glob

  8. Slide 8: It's time to change the story

    It’s time to change the story. We can change the lives of the millions of people impacted by T1D through unique disease-modifying therapies like SAB-142.

  9. Slide 9: SAB-142 Phase 1 Study Design and Safety Profile

    SAB-142 Phase 1 Study Design and Safety Profile Alexandra Kropotova, MD, MBA Chief Medical Officer

  10. Slide 10: SAB-142 has Established MOA to Potentially Control or Prevent T1D Over the Entire Life Span

    SAB-142 has Established MOA to Potentially Control or Prevent T1D Over the Entire Life Span Indication 2: Stage ½: “Delay the onset of T1D Indication 1: “Delay the progression of Stage 3” Indication 3: “Maintenance of Stage 3” Genetic Risk Immune Activation Immune Response Stage 1 Starting Point 15x

  11. Slide 11: SAB-142: Potential Best-In-Class T1D Immunotherapy

    SAB-142: Potential Best-In-Class T1D Immunotherapy © 2025 SAB BIOTHERAPEUTICS, INC. Phase 1 topline results support advancement to Phase 2b SAFEGUARD study in adult and pediatric patients with new onset T1D SAB-142 demonstrated clinically validated multi-target MOA with sustained immunomodulation in

  12. Slide 12: SAB-142-101 Study Design

    SAB-142-101 Study Design © 2025 SAB BIOTHERAPEUTICS, INC. Data generated for doses: 0.03, 0.1, 0.5, 1.5, and 2.5mg/kg IV 2 cohorts at 2.5mg/kg target dose Dosing: IV infusion on Day 1 and 2 Safety & Tolerability PK Data Immunogenicity: ADA Proof of Biological Activity: FACS and Cytokines

  13. Slide 13: SAB-142 Safety Profile Enables Desired Ambulatory Dosing

    Majority of adverse events (AEs) are mild, associated with Day 1-2 infusions and resolved by the end of the first week SAB-142 Safety Profile Enables Desired Ambulatory Dosing © 2025 SAB BIOTHERAPEUTICS, INC. Safety profile enables ambulatory dosing Overall summary of treatment emergent adverse even

  14. Slide 14: SAB-142 Demonstrated MOA to Deliver Potentially Best-in-Class T1D Immunotherapy

    SAB-142 Demonstrated MOA to Deliver Potentially Best-in-Class T1D Immunotherapy © 2025 SAB BIOTHERAPEUTICS, INC. No sustained lymphodepletion (Unlike rabbit ATG that causes decrease in CD4+ T-cells for up to 2 years) No sustained total lymphodepletion No sustained CD4+ and CD8+ T-cell lymphodepletio

  15. Slide 15: SAB-142 Doesn't Deplete Any Cells

    SAB-142 Doesn’t Deplete Any Cells: No Difference vs. PBO and Baseline From Day 7 Onward © 2025 SAB BIOTHERAPEUTICS, INC. 4.35 No RBC depletion No neutropenia No thrombocytopenia Sustained immunomodulation mostly through T-cell exhaustion without any sustained cell depletion

  16. Slide 16: SAB-142 Shown Not to be Immunogenic

    SAB-142 Shown Not to be Immunogenic At the target dose (2.5mg/kg), both cohorts of SAB-142 didn’t generate anti-SAB-142 antibodies in HVs This demonstrated that SAB-142, fully human IgG pAbs, is less immunogenic than Thymoglobulin, rabbit IgG pAbs* *MRD=1:10 © 2025 SAB BIOTHERAPEUTICS, INC. CONCLUSI

  17. Slide 17: SAB-142-101 Topline Data Confirms Potential for Safe and Reliable Lifetime Dosing

    SAB-142-101 Topline Data Confirms Potential for Safe and Reliable Lifetime Dosing © 2025 SAB BIOTHERAPEUTICS, INC. Why is it important? Serum sickness (SS) is a hypersensitivity reaction, a result of the formation of immune complexes between human proteins and heterologous (non-human) proteins SS is

  18. Slide 18: Fully Human Multi-target Biologic

    01 Fully Human 02 Multi-target Directly induces CD4+ and CD8+ exhaustion phenotype without lymphodepletion High-titer, high-avidity multi-target modality directly targets multiple receptors on CD4+ and CD8+ cells 03 High responder rate 100% Immunological Response achieved 100% of subjects dosed with

  19. Slide 19: SAB-142 Overview, Phase 1 Topline Data, Phase 2 Design

    SAB-142 Overview, Phase 1 Topline Data, Phase 2 Design Presented by: Michael Haller, MD Professor and Chief, Pediatric Endocrinology Silverstein Family Eminent Scholar Chair University of Florida SAFEGUARD Chief Investigator and Chair of the SAB-142 Advisory Board

  20. Slide 20: Type 1 Diabetes Pathogenesis

    Type 1 Diabetes Pathogenesis Atkinson, M; Eisenbarth, G.S.; Michels, A. Lancet, 2014 © SAB-142-101 data provided by SAB

  21. Slide 21: Why C-Peptide vs. A1c vs. Insulin Dose?

    Why C-Peptide vs. A1c vs. Insulin Dose ? J Clin Invest. 2021 Feb 1;131(3):e143011. doi: 10.1172/JCI143011 C-peptide IS the ONLY true measure of Beta Cell Function LONG-TERM risk of complications REDUCED LONG-TERM complication free survival...C-Peptide DCCT / EDIC – C-pep > 0.03 nmol/L associated wit

  22. Slide 22: Why C-Peptide vs. A1c vs. Insulin Dose?

    Why C-Peptide vs. A1c vs. Insulin Dose ? Trial Outcome Markers Initiative (TOMI) Subjects from multiiple positive/negative studies...Power Lancet - 2023 Breakthrough T1D – Diabetes 2024 © SAThe Lancet Diabetes & Endocrinology, Volume 11, Issue 12, 2023, Pages 915-925, 2023

  23. Slide 23: Tzield/Teplizumab 1992 to 2022

    Tzield/Teplizumab 1992 to 2022: 30 Years

  24. Slide 24: TZIELD (teplizumab-mzwv) vs. Thymoglobulin (rabbit ATG)

    TZIELD® (teplizumab-mzwv) vs. Thymoglobulin (rabbit ATG)

  25. Slide 25: Thymoglobulin Depletes and Modulates

    Thymoglobulin Depletes and Modulates © SAB-142-101 data provided by SAB

  26. Slide 26: Thymoglobulin

    Thymoglobulin Human Thymus / T-cells > Immunized Rabbit Polyclonal Mix of Rabbit Anti-Human Antibodies FDA approved ~30 years Standard in Renal Transplant – up to 10mg/kg Near complete depletion of Treg and Teff with slow recovery at Transplant dose What about lower dose?

  27. Slide 27: Thymoglobulin in Type 1 Diabetes

    Thymoglobulin in Type 1 Diabetes George Eisenbarth – 1985 – ATGAM START Trial - 2013 - 6.5mg/kg Low-Dose ATG - 2015 - 2.5mg/kg TrialNet Low-Dose ATG – 2018 – 2.5mg/kg Low-Dose ATG – 2024 - Stage 2 T1D Diabetes Care. 2024 Feb 1;47(2):285-289. JCI Insight. 2023 Aug 22;8(16):e161812 Diabetes Technol Th

  28. Slide 28: T-cell Exhaustion Phenotype is Universally Linked to C-peptide Preservation

    T-cell Exhaustion Phenotype is Universally Linked to C-peptide Preservation Responders to low-dose ATG induce CD4+ T cell exhaustion in type 1 diabetes - PubMed Exhausted-like CD8+ T cell phenotypes linked to C-peptide preservation in alefacept-treated T1D subjects - PubMed Remodeling T cell compart

  29. Slide 29: SAB-142 Demonstrates MOA Analogous to Rabbit ATG

    Transient increase in IL-6 and TNF-alpha SAB-142 Demonstrates MOA Analogous to Rabbit ATG Key Parameters Correlative to C-peptide Preservation © SAB-142-101 data provided by SAB Responders to low-dose ATG induce CD4+ T cell exhaustion in type 1 diabetes - PubMed Treg preservation 01 Durable CD4+ exh

  30. Slide 30: Phase 1 Topline Results Support Advancement to Phase 2b SAFEGUARD

    Phase 1 topline results support advancement to Phase 2b SAFEGUARD study in adult and pediatric patients with new onset T1D SAB-142 Topline Phase 1 Data from Healthy Volunteer Cohorts SAB-142 demonstrated clinically validated multi-target MOA with sustained immunomodulation in Phase 1 Phase 1 data co

  31. Slide 31: SAB-142 Induces a Sustained Cellular Exhaustion Profile on CD4+ and CD8+ T-cells

    SAB-142 Induces a Sustained Cellular Exhaustion Profile on Both CD4+ and CD8+ T-cell Subsets Demonstrating Superior Multi-target Modality © SAB-142-101 data provided by SAB Shift towards exhaustion profile across multiple markers Sustained CD4+ exhaustion profile Sustained CD8+ exhaustion profile Bo

  32. Slide 32: SAB-142 Clearly Induces a Sustained Cellular Exhaustion Profile

    SAB-142 Clearly Induces a Sustained Cellular Exhaustion Profile on Both CD4+ and CD8+ T-cell Subsets © SAB-142-101 data provided by SAB SAB-142 induces a sustained cellular exhaustion profile on both CD4+ and CD8+ T-cell subsets demonstrating superior multi-target modality

  33. Slide 33: SAB-142 Produces Increasing PD-1 MFI Expression Levels

    SAB-142 Produces Increasing PD-1 MFI Expression Levels on Both CD4+ and CD8+ T-cells Supporting Continued Reprogramming of These Targeted Cells SAB-142 results in PD-1 MFI increase in notable dose-response manner © SAB-142-101 data provided by SAB SAB-142 produces PD1 MFI with tight grouping of indi

  34. Slide 34: SAB-142 Demonstrates CD4+ T-cell Exhaustion Analogous to Rabbit ATG

    SAB-142 Demonstrates CD4+Tcell Exhaustion Analogous to Rabbit ATG Exhausted CD4+ T cells (percentage PD-1+KLRG1+CD57– on CD4+ T cells) (n = 279) Low-dose ATG was found to persistently induce expression of coinhibitory receptors (PD-1, KLRG1) on T cells and, thus, exhaustion-like phenotypes in CD4+ T

  35. Slide 35: SAB-142 Preserves Tregs and Induces T-reg Activation State

    SAB-142 Not Only Preserves Tregs but Also Induces T-reg Activation State © SAB-142-101 data provided by SAB SAB-142 T-regulatory cells “sparing” effect demonstrated by no difference vs. baseline and PBO from Day 14 onwards SAB-142 triggers activated state of T-regulatory cells demonstrated by increa

  36. Slide 36: SAB-142 Doesn't Cause Sustained Total, T or B-cell Lymphodepletion

    SAB-142 Doesn’t Cause Sustained Total, T or B-cell Lymphodepletion © SAB-142-101 data provided by SAB No sustained total lymphodepletion No sustained CD4+ and CD8+ T-cell lymphodepletion No sustained B-cell lymphodepletion

  37. Slide 37: Efficacy of Rabbit ATG is Not Associated with the Degree of Lymphodepletion

    Efficacy of Rabbit ATG is Not Associated with the Degree of Lymphodepletion © SAB-142-101 data provided by SAB Rabbit ATG results in sustained CD4+ decrease for up to 2 years Sustained decrease in CD4+ or CD8+ T-cells has not been shown to correlate with C-peptide preservation Responders to low-dose

  38. Slide 38: SAB-142 Doesn't Lymphodeplete T Regulatory Cells, Unlike Teplizumab

    SAB-142 Doesn’t Lymphodeplete T Regulatory Cells, Unlike Teplizumab © SAB-142-101 data provided by SAB https://pubmed.ncbi.nlm.nih.gov/28844471/ Within the pool of circulating CD4 T cells, teplizumab reduced Treg more than non-Treg (~58% vs. ~35% change from baseline, respectively) SAB-142 T-regulat

  39. Slide 39: SAB-142 Demonstrated Competitive MOA with T-Cell Exhaustion Signature

    SAB-142 CD4+ exhaustion signature CD8+ exhaustion signature Treg preservation No sustained lymphodepletion (Tconv and/or Tregs) No anti-drug antibodies No serum sickness C-peptide preservation Primary endpoint 39 SAB-142 exhibits multi-target T-cell exhaustion profile and Treg-sparing without sustai

  40. Slide 40: SAB-142 Topline Data Supports Potentially Best-in-Class T1D Immunotherapy

    SAB-142 Topline Data Supports Potentially Best-in-Class T1D Immunotherapy © SAB-142-101 data provided by SAB TARGET pathway 1 TARGET pathway 2 CD4+ Exhaustion profile CD8+ Exhaustion profile Target dosing over 2-3 days vs. 12-14 days with teplizumab Infusion over ~6 hrs vs 12 hrs in MELD-ATG MOA ind

  41. Slide 41: Robust Clinical Data Supports Efficient Full Development

    Robust Clinical Data Generated Across Multiple Clinical Studies of SAB-142 Supports Efficient Full Development Low-Dose rabbit ATG preserved C-Peptide vs. placebo in stage 3 T1D patients informing SAB to pursue SAB-142 in human clinical studies Decline in C-Peptide AUC Mean Over 2 Years SAB-142 demo

  42. Slide 42: SAB-142: Multicenter Global Phase 2b in Stage 3 Type 1 Diabetes Patients

    SAB-142: Multicenter Global Phase 2b in Stage 3 Type 1 Diabetes Patients SAFEGUARD study: SAFety and Efficacy of human anti-thymocyte immunoGlobUlin SAB-142 ARresting progression of type 1 Diabetes United Kingdom (MHRA) Europe (EMA) Australia (TGA) Endpoints Primary: Stimulated C-peptide following 2

  43. Slide 43: Q&A Session

    Q&A Session Chairman and CEO Samuel Reich Alexandra Kropotova, MD Michael Haller, MD Chief Medical Officer & EVP Professor and Chief Pediatric Endocrinology University of Florida

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