Sab Biotherapeutics, Inc. · NASDAQ:SABS
Sab Biotherapeutics — Investor Presentation (November 2022)
45 slides from Sab Biotherapeutics's investor presentation, Nov 21, 2022
Slide 1: Advancing a Powerful New Class of Immunotherapeutic Antibodies
ADVANCING A POWERFUL NEW CLASS OF IMMUNOTHERAPEUTIC ANTIBODIES November 2022 © 2022 SAB BIOTHERAPEUTICS, INC. EXHIBIT 99.1
Slide 2: 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 3: Advancing a New Class of Immunotherapies
Advancing a New Class of Immunotherapies Vertical integration enables rapid, scalable development of multi-targeted products Robust, growing clinical-stage pipeline spanning multiple therapeutic areas Established proof-of-concept through funded programs & partnerships totaling ~$200MM Strong corpora
Slide 4: Forward-Looking Statements
Forward-Looking Statements 4 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 5: Tc Bovine Human Polyclonal Antibodies
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 antibody repertoire most similar to humans. Tc B
Slide 6: Versatile Antibody Platform with Ability to Capture Multiple Modalities
Versatile Antibody Platform with Ability to Capture Multiple Modalities 6 Human Antibody Discovery & Product Development Engine, New Source for Novel Treatments Monoclonal Antibody Discovery –Larger volume of antibodies –Greater diversity; higher affinity –Robust (ruminant) immune response –Fully-hu
Slide 7: DiversitAb Platform
DiversitAb™ Platform Advancing a new class of fully-human polyclonal Tc bovine-derived antibodies without the need for human serum ANTIGEN PATHOGEN TC BOVINE™ HYPERIMMUNIZATION HUMAN ANTIBODIES PURIFICATION TARGETED HIGH-POTENCY IMMUNOTHERAPY Reliable, controlled, consistent production of diverse, h
Slide 8: pAbs Key Product Differentiators
pAbs Key Product Differentiators: Multi-target capability in a single therapeutic Natural multi-epitope targeted pAb selected and produced in vivo Ability to target multiple antigens to disease Specifically driven high-potency antibody titers and avidity Naturally activates cellular immunity Effecti
Slide 9: SAB Biotherapeutics Fact Sheet
SAB Biotherapeutics Fact Sheet 2 11 90 700 0 1 Years or less from concept to IND filing Anti-infective assets with proven efficacy in Discovery or Development stages Percent success rate from concept to IND and beyond Subjects treated with SAB therapeutics in clinical trials across DIVERSITAB platfo
Slide 10: DiversitAb Platform is Clinically Validated Across Several Targets
DiversitAb™ Platform is Clinically Validated Across Several Targets Referenced Trials: Safety, Tolerability, and Pharmacokinetics of SAB-176 in Healthy Participants – Full Text View - ClinicalTrials.gov Study of SAB-176 in Healthy Adult Participants - Full Text View - ClinicalTrials.gov Safety, Tole
Slide 11: Demonstrated Human Safety and Efficacy in Multi-Dosing Regimen
High-dose therapy resulted in improved clinical parameters associated with reduced M. hominis burden following two subsequent infections JARED N SILVER, CAMERON D ASHBAUGH, JACOB J MILES, HUA WU, GREGORY T MARECKI, JOYCE K HWANG, JIN-AN JIAO, MARK ABRAMS, EDDIE J SULLIVAN, DUANE R WESEMANN, DEPLOYME
Slide 12: Selected Pipeline Programs
SELECTED PIPELINE PROGRAMS © 2022 SAB BIOTHERAPEUTICS, INC.
Slide 13: Robust Biologic Pipeline with Broad Polyclonal Therapeutic Reach
Robust Biologic Pipeline with Broad Polyclonal Therapeutic Reach © 2022 SAB BIOTHERAPEUTICS, INC.
Slide 14: Clinical Development Programs: Focus Over the Next 4+ Years
Clinical Development Programs: Focus Over the Next 4+ Years SAB-195 IND (CDI, targeting H2 2023-H1 2024) SAB-176 2023-2024 flu season Phase 2b FPI SAB-142 IND (T1D) SAB-142 Phase 1/POBA FPI SAB-195 Phase 1/POBA FPI SAB-195 Phase1/POBA topline SAB-176 2023-2024 flu season Phase 2b topline SAB
Slide 15: SAB-176: First-In-Class Biologic Anti-Influenza Treatment
SAB-176: First-In-Class Biologic Anti-Influenza Treatment © 2022 SAB BIOTHERAPEUTICS, INC.
Slide 16: Unmet Need of Seasonal Influenza
Unmet Need of Seasonal Influenza Devastating health and economic impacts Estimated 30,000 - 50,000 deaths/year U.S. with 290,000 - 650,000 globally ~500,000 hospitalizations annually in U.S. Average US hospital stay: $8,000 - $9,000/day; 4-8 days/stay Often 30% - 70% failure rate for vaccine; vaccin
Slide 17: Value Proposition: SAB-176
Value Proposition: SAB-176 © 2022 SAB BIOTHERAPEUTICS, INC. First and only broadly neutralizing polyclonal biologic for prophylaxis and treatment of influenza in high-risk patients Adaptive and cross-reactive to multiple influenza strains Fully-human polyclonal antibodies uniquely positioned to mana
Slide 18: SAB-176 Protected Mice from Weight Loss While Oseltamivir Didn't
0% survival in 100mg/kg/d Oseltamivir-treated groups SAB-176 Protected Mice from Weight Loss While Oseltamivir Didn’t Efficacy Against Mutational Drift: Oseltamivir Resistant (OR) H1N1pdm Virus Challenge Model 18 © 2022 SAB BIOTHERAPEUTICS, INC. SAB-176 Showed 100% Protection at All Dose Levels From
Slide 19: Established Proof-of-Concept for SAB-176: Phase 2a Primary Endpoint Met
Established Proof-of-Concept for SAB-176: Met Primary Endpoint of Viral Load Reduction in Phase 2a Challenge Study Mean Viral Load by Nasal Samples qRT-qPCR by Day Relative to Viral Challenge 19 Mean Total Symptom Score by Day Relative to Viral Challenge SAB-176 Achieved Statistically Significant (p
Slide 20: SAB-176: Clinical Development Plan
SAB-176: Clinical Development Plan Phase 1: Healthy Volunteers Planned Phase 2a Challenge Study: Healthy Volunteers Planned Phase 2b and Phase 3 Designs STUDY DESIGN Randomized, double-blind, placebo-controlled 27 healthy volunteers Single ascending dose study 1, 10, 25 and 50 mg/kg 60 total partici
Slide 21: SAB-176 Development Timelines
SAB-176 Development Timelines Study Startup Activities Phase 2b Study First Patient In Phase 2b Study Ongoing Phase 2b Topline Results Phase 3 Study First Patient In 2022-2023 Q4 2023 2023-2024 Influenza Season 2024 2025 © 2022 SAB BIOTHERAPEUTICS, INC.
Slide 22: SAB-185: COVID-19
SAB-185: COVID-19 © 2022 SAB BIOTHERAPEUTICS, INC.
Slide 23: Value Proposition: SAB-185
Value Proposition: SAB-185 © 2022 SAB BIOTHERAPEUTICS, INC. First-in-class fully human broadly-neutralizing polyclonal antibody treatment for COVID-19 Only biologic treatment showing neutralizing activity against mAb escape mutants In-vivo and in-vitro data demonstrate efficacy against all tested SA
Slide 24: SAB-185 Protects Hamsters from SARS-CoV-2 Variants Including Omicron
SAB-185 Protects Recombinant hACE2 Hamsters from Mortality and/or Severe Morbidity from SARS CoV-2 Variants Including Omicron © 2022 SAB BIOTHERAPEUTICS, INC. 24 SAB-185 protection from mortality in hamsters challenged with six variant SARS CoV-2 isolates SAB-185 protection from clinical signs in ha
Slide 25: NIH ACTIV-2 Trial Confirms SAB-185 Met Virology Endpoints
Phase 2 Data from NIH ACTIV-2 Trial Confirms SAB-185 Met Virology Endpoints for Graduation to Phase 3 * The choice of 0.6 for this Bayesian probability indicates that there is a 3 to 2 odds of the agent being better than placebo by the desired amount (≥0.5 log10 /ml) for the outcome measure. INTERIM
Slide 26: SAB-195: Clostridioides difficile Infections
SAB-195: Clostridioides difficile Infections: Fast to Proof-of-Concept © 2022 SAB BIOTHERAPEUTICS, INC.
Slide 27: Clostridioides difficile Infection (CDI)
Clostridioides difficile Infection (CDI) is a bacterial infection of the large intestine (colon). A spectrum of clinical disease ranges from mild diarrhea to severe. CDI is characterized by abdominal pain, fever, diarrhea, nausea, and vomiting. Complications of severe CDI include kidney failure, tox
Slide 28: Value Proposition: SAB-195
Value Proposition: SAB-195 © 2022 SAB BIOTHERAPEUTICS, INC. First-in-class fully human polyclonal antibody treatment Only treatment with dual mode of action: Unlike bezlotoxumab, SAB-195 targets surface antigens on C. diff bacteria and spores Unlike antibiotics, SAB-195 targets several C. diff toxin
Slide 29: SAB-195 Preclinical Data
SAB-195 Preclinical Data Tc bovine Immunized with Antigen Fusion Proteins Constructed from Receptor Binding Domain of C. diff Toxin A (TcdA), C. diff Toxin B (TcdB)(630) and (TcdB)(027) and Binary Toxin (CDT) Tc bovine-derived anti-quadrivalent toxin hIgG provided 90% to 100% protection in hamsters
Slide 30: SAB-195: Clinical Development Plan
SAB-195: Clinical Development Plan CDI: Two Indications Phase 1/Proof of Biological Activity (POBA) Phase 1 in adult healthy volunteers (HVs), followed by subjects meeting high-risk criteria and patients with CDI Phase 2b - 3: Adult patients with moderate to severe CDI at risk for recurrent CDI STUD
Slide 31: SAB-195 Development Timelines
SAB-195 Development Timelines Preclinical/ IND Enabling IND Filing Phase 1 in Healthy Volunteers Topline Data Phase 1/Proof of Biological Activity Phase 2b in Target Patient Population Phase 2b Topline 2022-2023 H2 2023 -H1 2024 2024 2024 2024 - 2025 H2 2025 © 2022 SAB BIOTHERAPEUTICS, INC.
Slide 32: SAB-142: Type 1 Diabetes (T1D) Prevention
SAB-142: Type 1 Diabetes (T1D) Prevention © 2022 SAB BIOTHERAPEUTICS, INC.
Slide 33: Disease-Modifying Treatments in Late-Stage Development in Type 1 Diabetes
Disease-modifying treatments in late-stage development: >100 active interventional trials with small molecules, biologics, and cell therapies in Type 1 Diabetes Type 1 Diabetes High Unmet Medical Needs Drive High Level of Competition © 2022 SAB BIOTHERAPEUTICS, INC.
Slide 34: Value Proposition: SAB-142
Value Proposition: SAB-142 © 2022 SAB BIOTHERAPEUTICS, INC. First-in-class fully human polyclonal antibody treatment aimed to provide superior efficacy for delaying onset of clinical Stage 3 T1D Validated Mechanism of Action by a 3rd party ATG demonstrating reduction in loss of C-peptide vs. placebo
Slide 35: SAB-142: Similar Activity to Approved Rabbit ATG
SAB-142: Similar Activity to Approved Rabbit Anti-Thymocyte Globulin (ATG) Targets CD8 and Protects T-Regulatory Cells CD8 T Cells Treg Cells Live cells in CD8* gate Live CD4+CD25+Foxp3- Activated CD4 T Cells Live CD4+CD25+Foxp3- Naïve CD4 T Cells Live CD4+CD25+Foxp3- © 2022 SAB BIOTHERAPEUTICS, INC
Slide 36: SAB-142 Preclinical Data Continued
SAB-142 Preclinical Data Continued Major Subsets of Peripheral Blood Lymphocytes Changes in major subsets of peripheral blood lymphocytes (total lymphocytes. T and B cells, CD4+ and CD8+ T helpers and killers, respectively) following SAB-142 and ATG treatments. Red: 5 mg/kg ATG; Blue: 1 mg/kg SAB-14
Slide 37: SAB-142: MoA Clinically Validated by 3rd Party Compound
SAB-142: MoA Clinically Validated by 3rd Party Compound 37 p=0.00005 ATG vs Placebo Placebo *RABBIT ATG FROM SANOFI – NOT SAB-142 (HUMAN TC-BOVINE DERIVED ATG) Haller et al. Diabetes. 2019. June, 68(6): 1267-1276 EQUINE ATGAM-AF488 Tc Bovine Human-PB, Rabbit THYMO-AF488, Equine ATGAM-AF488 and Anti-
Slide 38: SAB-142: Clinical Development Plan
SAB-142: Clinical Development Plan Type 1 Diabetes (T1D) Phase 1-2: Early Onset T1D in Adults, followed by adults and adolescents at C-peptide interim analysis Phase 3: New and Recent Onset T1D in Adults and Children (Study 1) At Risk Adults and Children (Study 2) STUDY DESIGN Open-label Teplizumab
Slide 39: SAB-142 Type 1 Diabetes Development Timelines
SAB-142 Type 1 Diabetes Development Timelines Preclinical / IND Enabling IND Filing Phase 1 / Proof of Biological Activity in Adult Type 1 Diabetes Phase 1 / Proof of Biological Activity in Adult + Pediatric Type 1 Diabetes Phase 1 / Proof of Biological Activity in Topline 2022-2023 2024 2024 2025 2
Slide 40: Summary
Summary 40 Executive Management: Proven team with biotech startup, rapid drug development, and entrepreneurial experience. Platform: Innovative DiversitAb™ platform produces a new class of targeted fully-human, highly-potent polyclonal antibodies, with a broad efficacy spectrum in a broad range of i
Slide 41: Appendix
APPENDIX © 2022 SAB BIOTHERAPEUTICS, INC.
Slide 42: Multi-Pronged Business Strategy Powered by Novel Proprietary Platform
Product Development of Pipeline Assets: Best-in-Class, First-in-Class & Unmet Needs Industry Partnering & Research Collaborations: Monoclonal Discovery & Polyclonal Development/Production Global Public Health Security: Emerging Infectious Disease & Biothreats Multi-Pronged Business Strategy Powered
Slide 43: Intellectual Property
Intellectual Property 11 © 2022 SAB BIOTHERAPEUTICS, INC.
Slide 44: Scaled Infrastructure & Capacity: Tc Bovine & Plasma Production Facility
Scaled Infrastructure & Capacity: Tc Bovine & Plasma Production Facility 44 © 2022 SAB BIOTHERAPEUTICS, INC.
Slide 45: Scaled Infrastructure & Capacity: Laboratory & Manufacturing
Scaled Infrastructure & Capacity: Laboratory & Manufacturing Manufacturing Facility (200L) Manufacturing Facility (50L) 45 CET Lab Labeling Suite Fill Suite Cell Culture Lab 50L Suite © 2022 SAB BIOTHERAPEUTICS, INC.
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