Sab Biotherapeutics, Inc. · NASDAQ:SABS
Sab Biotherapeutics — Investor Presentation (January 2024)
28 slides from Sab Biotherapeutics's investor presentation, Jan 19, 2024
Slide 1: Fully Human Antithymocyte Biologic to Delay Onset or Progression of Type 1 Diabetes
© 2024 SAB BIOTHERAPEUTICS, INC. FULLY HUMAN ANTITHYMOCYTE BIOLOGIC DEVELOPED TO DELAY ONSET OR PROGRESSION OF TYPE 1 DIABETES NASDAQ: SABS SAB BIOTHERAPEUTICS INTRODUCTION JANUARY 2024 EXHIBIT 99.1
Slide 2: Forward-Looking Statements
Forward-Looking Statements 2 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
Slide 3: Investment Thesis
Investment Thesis 3 SAB Biotherapeutics is a next generation antibody platform company with human data in > 700 patients across three indications, currently focused on prevention of Type 1 diabetes. MoA of SAB-142 in T1D is a proven therapeutic approach with support and enthusiasm from clinicians, o
Slide 4: Experienced Management Team
Experienced Management Team Christoph Bausch, PhD, MBA EVP & CHIEF OPERATING OFFICER 20+ years research and discovery, biomanufacturing, business development, and platform technology commercialization MilliporeSigma (Merck KGaA) Stowers Institute for Medical Research Postdoc Eddie J. Sullivan, PhD P
Slide 5: Transgenic bovine carrying entire human immunoglobulin loci
Only transgenic animal that carries the entire human immunoglobulin (Ig) heavy and light (κ) chain loci. HAC is subject to mitosis along with the other 60 Tc Bovine chromosomes. HAC present in the Tc Bovine allows for the highest production of human immunoglobulin repertoire most similar to humans
Slide 6: SAB-142: A Human Anti-Thymocyte Globulin – Focused Program in Type 1 Diabetes
SAB-142: A Human Anti-Thymocyte Globulin (hATG) – Focused Program Development in Type 1 Diabetes © 2024 SAB BIOTHERAPEUTICS, INC.
Slide 7: SAB-142 Production Similar to FDA Approved rATG
SAB-142 Production Similar to FDA Approved rATG rpAbs hpAbs Thymocytes Thymocytes Rabbit Immunization Rabbit Antibody Production Plasma Collection Purification Rabbit Antibodies SAB-142 Anti-Thymocyte Globulin (Human) © 2024 SAB BIOTHERAPEUTICS, INC.
Slide 8: Disease Modification is Just Beginning
Disease Modification is Just Beginning SAB-142: Fully-human profile has the potential to advance Standard of Care Stage 2 Prevention Market Stage 3 Recent Onset Market Projected to reach >$1B in WW sales1 by 2028 In the US, only family relatives are screened for T1D (<10% of patients), but screening
Slide 9: SAB-142: MoA Clinically Validated by Rabbit ATG (Thymoglobulin)
SAB-142: MoA Clinically Validated by Rabbit ATG (Thymoglobulin) Haller MJ, Long SA, Blanchfield JL, Schatz DA, Skyler JS, Krischer JP, Bundy BN, Geyer SM, Warnock MV, Miller JL, Atkinson MA, Becker DJ, Baidal DA, DiMeglio LA, Gitelman SE, Goland R, Gottlieb PA, Herold KC, Marks JB, Moran A, Rodrigue
Slide 10: SAB-142 In Vivo Proof of Principle
SAB-142 In Vivo Proof of Principle Demonstrated impact on major relevant T-cell subsets SAB-142 impacts major relevant T-cell subsets in vivo1 2 Identical In Vitro Binding1 SAB-142 vs. Rabbit THYMO-AF488 SAB-142 Anti-Thymocyte Globulin (Human) 1 © 2024 SAB BIOTHERAPEUTICS, INC. 1. Data on file
Slide 11: Teplizumab (Tzield) vs Thymoglobulin
Teplizumab (Tzield) Phase 3 study Thymoglobulin Phase 2 data Take-away/Added Value Age 8-17yo 12-45yo rATG shown to work in the broader range of patients, i.e. adults & pediatric/adolescent Significant market size won’t be eligible for tmt with TZIELD Dosing Two courses of IV daily therapy for 12 da
Slide 12: SAB-142 Has a Similar MoA to rATG with Distinct Safety Advantages
SAB-142 Has a Similar MoA to rATG with Several Distinct Safety Advantages Majority of patients develop grade 3 serum sickness Safety Efficacy No serum sickness expected due to fully human product Lower half-life and inability to re-dose due to anti-drug antibodies Improved PK and opportunity to re-d
Slide 13: SAB-142: Clinical Development Plan in T1D
SAB-142: Clinical Development Plan in T1D STUDY DESIGN "Fully HUman anti-thymocyte biologic in first-in-MAN clinical study (HUMAN trial)” Phase 1: First in Human, Randomized, Single Ascending Dose trial SAB-142 dose range: 0.03mg/kg up to 2.5mg/kg ENDPOINTS Primary end point: Acute (serum sickness,
Slide 14: SAB-142-201: Phase 2B SAFEGUARD Study Design
SAB-142-201: Phase 2B SAFEGUARD Study Design Screening Within 3 weeks of study treatment Screening visit 2 MMTT Study Day 1 (6-12 hour IV infusion) Study Day 2 (2nd 6-12 hour IB infusion) Follow-up Visit 1 (1 week) Follow-up Visit 2 (2 weeks) Follow-up Visit 3 (4 weeks) Follow-up Visit 4 (3 months)
Slide 15: 2023 SAB-142: R&D and Clinical Progress
2023 SAB 142: R&D and Clinical Progress JAN 2023 Completed IND-enabling GLP toxicology study OCT 2023 Approval by the Human Research Ethics Committee (HREC) to commence a First-in-Human Phase 1 clinical trial in Australia OCT 2023 Registered Phase 1 trial with Australian New Zealand Clinical Trials
Slide 16: SAB-142 Key Milestones
FPI = First Patient In POC = Proof of Concept DRF = Dose-Range Finding Study CTA = Clinical Trial Application CTN = Clinical Trial Notification Phase 1 / Phase 2 Major Outcomes: 0% serum sickness 0% ADA/nADA (Anti-Drug Antibodies) Superior efficacy vs TZIELD on C-peptide Superior efficacy vs TZIELD
Slide 17: Committed T1D Clinical Development and Investor Partners
Committed T1D Clinical Development and Investor Partners 17 T1D Committed Investor Partners: Financing of up to $110 million in gross proceeds dedicated to clinically advance SAB-142 through 2026 and Topline Phase 2 results: Sessa Capital BVF Partners RTW Investments Marshall Wace ATW JDRF T1D Fund
Slide 18: SAB-142 Factors for Success
SAB-142 Factors for Success Haller MJ, Gitelman SE, Gottlieb PA, Michels AW, Perry DJ, Schultz AR, Hulme MA, Shuster JJ, Zou B, Wasserfall CH, Posgai AL, Mathews CE, Brusko TM, Atkinson MA, Schatz DA. Antithymocyte Globulin Plus G-CSF Combination Therapy Leads to Sustained Immunomodulatory and Metab
Slide 19: Appendix
APPENDIX © 2024 SAB BIOTHERAPEUTICS, INC.
Slide 20: Proven Clinical Regulatory Path for IgG Polyclonal Antibody Products
Proven Clinical Regulatory Path for IgG Polyclonal Antibody Products Human IgG Polyclonal Antibodies (Tc Bovine-derived products) Human Polyclonal Antibodies (human-derived immune globulin products) Animal Polyclonal Antibodies (animal-derived immune globulin products) Botulism Antitoxin Bivalent (E
Slide 21: SAB-142 Demonstrates Similar T-Cell Subset Binding Profile as rATG
SAB-142 Demonstrates Similar T-Cell Subset Binding Profile as rATG Targets T-cells (CD3+), T-Helper Cells (CD4+), and T-Killer Cells (CD8+ ) similar to rATG suggesting similar muti-target binding CD3+ CD4+ CD8 + SAB-142 T-Lymphocytes CD3 Helper T-Cells CD4 Cytotoxic T-Cells CD8 © 2024 SAB BIOTHERAPE
Slide 22: SAB-142 Potential for Best-in-Class Safety Profile with Higher Potency
SAB-142 Has Potential for a Best-in-Class Safety Profile with Higher Potency Compared to FDA Approved Rabbit ATG (Thymoglobulin) Better Safety Profile Sample Activity (µg/mL) Thymoglobulin® 20 SAB-142 280 Red Blood Cell Binding Hemagglutinin (HA) Titer : (Protein conc/endpoint titer/dilution) *1000
Slide 23: T1D Pathophysiology
T1D Pathophysiology1 Major relevant immune-cell subsets Destruction of beta cells with decreased insulin secretion Autoantigens from on insulin-producing beta cells and circulate in the blood stream and lymphatics Processing and presentation of autoantigen by antigen-presenting cells Activation of T
Slide 24: SAB-142 Potential to Control or Prevent T1D Over the Entire Life Span
SAB-142 has Strong Potential to Control or Prevent T1D Over the Entire Life Span Ages: from birth to early adulthood (average age of onset: 13 yo) Ages: Average life expectancy ~72 years of age Genetic Risk Immune Activation Immune Response Stage 1 Starting Point 15x increased risk of T1D in those w
Slide 25: SAB-142-101 Study Schematic: Adaptive Design
SAB-142-101 Study Schematic: Adaptive Design with Topline by End of Dec 2024 Significant cost-savings to conduct Phase 1 in AUS and in HVs © 2024 SAB BIOTHERAPEUTICS, INC.
Slide 26: SAB-142-201 SAFEGUARD Study Key Design Features
SAB-142-201 SAFEGUARD Study Key Design Features 111 T1D patients enrolled SAB-142 High, SAB-142 Low, placebo Enrolled in 1:1:1 37 patients/arm SAB-142 doses: High dose TBC based on Phase 1 data Low dose: TBC based on Phase 1 data Enrollment to begin Q12025 Enrollment timeframe: target 12 months IF a
Slide 27: SAB-142-201: A Phase 2B Study
A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study Evaluating the Efficacy and Safety of SAB-142 for the delay of progression of Type 1 Diabetes in new/recent onset Stage 3 T1D patients SAB-142-201: A Phase 2B Study 27 Primary Objective: To evaluate the change in stimulated
Slide 28: Summary
Summary 28 SAB-142: First-in-class fully-human multi-target antibody treatment aimed to provide superior safety and efficacy for delaying onset or progression of Type 1 Diabetes. MoA of SAB-142 in T1D is clinically- validated in numerous clinical trials with rabbit ATG Safety database with human dat
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