Sab Biotherapeutics, Inc. · NASDAQ:SABS
Sab Biotherapeutics — Investor Presentation (July 2022)
38 slides from Sab Biotherapeutics's investor presentation, Jul 11, 2022
Slide 1: Advancing Powerful New Class of Immunotherapeutic Antibodies
ADVANCING POWERFUL NEW CLASS OF IMMUNOTHERAPEUTIC ANTIBODIES July 2022 © 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL 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: Experienced Management Team
Experienced Management Team Christoph Bausch, PhD, MBA CHIEF OPERATING OFFICER 15+ years platform technology commercialization Sigma Aldrich Stowers Institute Postdoc Eddie J. Sullivan, PhD PRESIDENT & CEO / CO-FOUNDER 20 years new technology development 25+ years biotech Former Japanese pharma BIO
Slide 4: Novel DiversitAb Platform for Developing Highly-Differentiated Immunotherapies
Novel DiversitAb™ Platform for Developing Highly-Differentiated 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 US Government funded pr
Slide 5: Versatile Antibody Platform with Ability to Capture Multiple Markets
Versatile Antibody Platform with Ability to Capture Multiple Markets 5 Human Antibody Discovery & Development Engine, New Source for IgG, Therapeutic Production Represents Multibillion-Dollar Market Opportunity Monoclonal Antibody Discovery –Larger volume of antibodies –Greater diversity; higher aff
Slide 6: 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 US Gov. Rapid Response Biodefense & Public Health Security: Emerging Infectious Disease & Biothreats Multi-Prong
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: Polyclonal vs Monoclonal Approach
FDA: CENTER FOR DRUG EVALUATION & RESEARCH (CDER) FDA: CENTER FOR BIOLOGICS EVALUATION & RESEARCH (CBER) pAbs TARGET Monoclonal Approach Highly-targeted with specific activity Iterative Ab identification and selection process Selected and cloned in vitro May promote escape mutants via selective pres
Slide 9: 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 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: Intellectual Property
Intellectual Property © 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL 11
Slide 12: Intellectual Property
Intellectual Property © 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL 12
Slide 13: Scaled Infrastructure & Capacity: Tc Bovine & Plasma Production Facility
Scaled Infrastructure & Capacity: Tc Bovine & Plasma Production Facility 13 © 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL
Slide 14: Scaled Infrastructure & Capacity: Laboratory & Manufacturing
Scaled Infrastructure & Capacity: Laboratory & Manufacturing Manufacturing Facility (200L) Plasma Purification Suite (50L) 14 © 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL CET Lab Labeling Suite Fill Suite Cell Culture Lab 50L Suite
Slide 15: Selected Pipeline Programs
Yew BIOTHERAPEUTICS SELECTED PIPELINE PROGRAMS
Slide 16: Robust Biologic Pipeline with Broad Polyclonal Therapeutic Reach
Robust Biologic Pipeline with Broad Polyclonal Therapeutic Reach © 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL
Slide 17: Clinical Development Programs: Focus on the Next 4+ Years
Clinical Development Programs: Focus on the Next 4+ Years Consistent delivery of one IND per year SAB-195 IND (C. diff.) SAB-176 2023-2024 flu season Phase 2b FPI SAB-142 IND (T1D) SAB-142 Phase 1/POBA in T1D early onset FPI SAB-195 Phase 1/POBA FPI SAB-195 Phase 2 FPI SAB-176 2023-2024 flu/C
Slide 18: SAB-195: Clostridioides difficile Infections - Fast to Proof of Concept Option
SAB-195: Clostridioides difficile Infections - Fast to Proof of Concept Option © 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL
Slide 19: Clostridioides difficile Infection Overview
Clostridioides difficile Infection (CDI or C. diff.) 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
Slide 20: Value Proposition: SAB-195 Key Differentiators
Value Proposition: SAB-195 Key Differentiators First in class fully human polyclonal antibody treatment with dual mechanism of action designed to treat severe CDI and reduce CDI recurrence in high-risk patients © 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL First in class fully human polyclonal ant
Slide 21: SAB-195 Preclinical Data
SAB-195 Preclinical Data Tc bovine Immunized with Antigen Fusion Proteins Constructed from RBD of TcdA,TcdB(630), TcdB(027) and CDT Tc bovine-derived anti-quadrivalent toxin hIgG provided 90% to 100% protection in hamsters against C. difficile strain 630 or more virulent epidemic strain NAP1 Clostri
Slide 22: SAB-195 Development Timelines
SAB-195 Development Timelines Pre-Clinical/ IND Enabling IND Filing Phase I in HVs Top Line Data Phase 1 POBA Phase 2a/b in Target Patient Population Phase 2b Top Line 2022-2023 H2 2023 -H1 2024 2024 2024 2024 - 2025 H2 2025 © 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL
Slide 23: SAB-176: First In Class Biologic Anti-Influenza Treatment
SAB-176: First In Class Biologic Anti-Influenza Treatment © 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL
Slide 24: 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 25: Value Proposition: SAB-176 Key Differentiators
Value Proposition: SAB-176 Key Differentiators First in class fully human polyclonal antibody treatment aimed to provide superior long-lasting efficacy for prophylaxis and management of influenza in patients at high risk © 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL First and only biologic for man
Slide 26: Adaptive & Cross Reactive to Mutating Strains
B/Florida/04/2006 Challenge strain SOURCE: NEXTFLU AT HTTPS://NEXTFLU.ORG/VIC/12Y/ Antibodies produced to B/Phuket/3073/2013 protected against B/Florida/04/2006 2006 2017 B/Phuket/3073/2013 Vaccination strain Highly-Mutational Influenza Virus BYAM PHYLOGENIC TREE 100% Protection at All Dose Levels i
Slide 27: Established Proof of Concept for SAB-176: Met Primary Endpoint
Established Proof of Concept for SAB-176: Met Primary Endpoint of Viral Load Reduction in Phase 2a Challenge Study Achieved Statistically Significant (p = 0.026) Reduction in Viral Load Mean Viral Load by Nasal Samples qRT-qPCR by Day Relative to Viral Challenge 27 Mean Total Symptom Score by Day Re
Slide 28: 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 29: SAB-176 Development Timelines
SAB-176 Development Timelines Study Startup Activities Phase 2b Study First Patient In Phase 2b Study Ongoing Phase 2b Top Line Results Phase 3 Study First Patient In 2022-2023 Q4 2023 2023-2024 Influenza Season 2024 2025 © 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL
Slide 30: SAB-142: Asset with a Multi-Indication Potential
SAB-142: Asset with a Multi-Indication Potential © 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL
Slide 31: Type 1 Diabetes: High Unmet Medical Needs Drive High Level of Competition
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. – CONFIDENTIAL
Slide 32: Value Proposition: SAB-142 Key Differentiators
Value Proposition: SAB-142 Key Differentiators First in class fully human polyclonal antibody treatment aimed to provide superior efficacy for delaying onset of clinical Stage 3 T1D © 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL First in class fully human polyclonal antibody treatment aimed to prov
Slide 33: SAB-142: Similar Activity to Approved Rabbit ATG
SAB-142: Similar Activity to Approved Rabbit 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. – CONFIDENTIAL
Slide 34: SAB-142 Pre-clinical Data Continued
SAB-142 Pre-clinical Data Continued Major subsets of peripheral blood lymphocytes Figure. 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/
Slide 35: SAB-142: MoA Clinically Validated by 3rd Party Compound
SAB-142: MoA Clinically Validated by 3rd Party Compound 35 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 © 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL EQUINE ATGAM-AF488 Tc Bovine Human-PB,
Slide 36: SAB-142: Clinical Development Plan
SAB-142: Clinical Development Plan 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 or ATG more likely
Slide 37: SAB-142 Development Timelines
SAB-142 Development Timelines Pre-clinical / IND Enabling IND Filing Phase 1 / Proof of Biological Activity in Adult T1D Phase 1 / Proof of Biological Activity in Pediatric T1D Phase 1 / POBA Top Line 2022-2023 2024 2024 2025 2026 © 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL
Slide 38: Summary
Summary 38 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
SAB Biotherapeutics — Investor Presentation (July 2022) on 6ix